Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523991
• Other study ID #: 205.365
• Secondary ID: A44710082006-006
• Status: Completed
• Phase: Phase 4
• First received: July 9, 2007
• Last updated: May 12, 2014
• Start date: April 2007

Study information

• Verified date: May 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health Canada - Therapeutic Products DirectorateCzech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10Germany: Federal Institute for Drugs and Medical DevicesGreat Britain: MHRAGreece: National Organization of Medicines (EOF)Netherlands: Central Committee on Research involving Human Subjects (CCMO)Portugal: National Pharmacy and Medicines InstituteUkraine: Ministry of Health Care of Ukraine (MoH of Ukraine)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.

Other known NCT identifiers

• NCT00460772

Recruitment information / eligibility

• Status: Completed
• Enrollment: 457
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion criteria:

All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria:

post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio < 70% (visit 1).

Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of >=10 pack years.

Subjects must have a Medical Research Council (MRC) dyspnea score >= 2.

Exclusion criteria:

Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.

Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.

Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• tiotropium
Oral inhalation once daily of 18mcg tiotropium via handihaler
• Placebo
Oral inhalation once daily of placebo matching tiotropium via handihaler

Locations

Country	Name	City	State
Belgium	205.365.1103 Boehringer Ingelheim Investigational Site	Gilly
Belgium	205.365.1059 Boehringer Ingelheim Investigational Site	Leuven
Belgium	205.365.1057 Boehringer Ingelheim Investigational Site	Menen
Belgium	205.365.1058 Boehringer Ingelheim Investigational Site	Yvoir
Canada	205.365.1056 Boehringer Ingelheim Investigational Site	Kingston	Ontario
Canada	205.365.1041 Boehringer Ingelheim Investigational Site	Ste-Foy	Quebec
Canada	205.365.1104 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	205.365.1042 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Czech Republic	205.365.1064 Boehringer Ingelheim Investigational Site	Cvikov
Czech Republic	205.365.1107 Boehringer Ingelheim Investigational Site	Hradec Kralove
Czech Republic	205.365.1061 Boehringer Ingelheim Investigational Site	Karlovy Vary
Czech Republic	205.365.1077 Boehringer Ingelheim Investigational Site	Liberec
Czech Republic	205.365.1079 Boehringer Ingelheim Investigational Site	Neratovice
Czech Republic	205.365.1116 Boehringer Ingelheim Investigational Site	Pardubice
Czech Republic	205.365.1062 Boehringer Ingelheim Investigational Site	Praha 10
Czech Republic	205.365.1083 Boehringer Ingelheim Investigational Site	Praha 3
Czech Republic	205.365.1117 Boehringer Ingelheim Investigational Site	Praha 6
Czech Republic	205.365.1075 Boehringer Ingelheim Investigational Site	Strakonice
Czech Republic	205.365.1063 Boehringer Ingelheim Investigational Site	Tabor
Czech Republic	205.365.1076 Boehringer Ingelheim Investigational Site	Usti nad Labem
Germany	205.365.1055 Boehringer Ingelheim Investigational Site	Berlin
Germany	205.365.1066 Boehringer Ingelheim Investigational Site	Berlin
Germany	205.365.1054 Boehringer Ingelheim Investigational Site	Gelnhausen
Germany	205.365.1052 Boehringer Ingelheim Investigational Site	Rüdersdorf
Germany	205.365.1050 Boehringer Ingelheim Investigational Site	Ulm
Greece	205.365.1067 Boehringer Ingelheim Investigational Site	Athens
Greece	205.365.1127 Boehringer Ingelheim Investigational Site	Athens
Greece	205.365.1126 Boehringer Ingelheim Investigational Site	Thessaloniki
Netherlands	205.365.1070 Boehringer Ingelheim Investigational Site	Enschede
Netherlands	205.365.1072 Boehringer Ingelheim Investigational Site	Etten Leur
Netherlands	205.365.1071 Boehringer Ingelheim Investigational Site	Spijkenisse
Netherlands	205.365.1069 Boehringer Ingelheim Investigational Site	Zutphen
Portugal	205.365.1025 Boehringer Ingelheim Investigational Site	Amadora
Portugal	205.365.1020 Boehringer Ingelheim Investigational Site	Coimbra
Portugal	205.365.1022 Boehringer Ingelheim Investigational Site	Lisboa
Ukraine	205.365.1128 Boehringer Ingelheim Investigational Site	Dnipropetrovsk
Ukraine	205.365.1110 Boehringer Ingelheim Investigational Site	Kharkiv
Ukraine	205.365.1108 Boehringer Ingelheim Investigational Site	Kharkov
Ukraine	205.365.1112 Boehringer Ingelheim Investigational Site	Kharkov
Ukraine	205.365.1114 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	205.365.1115 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	205.365.1113 Boehringer Ingelheim Investigational Site	Simferopol
United Kingdom	205.365.44002 Boehringer Ingelheim Investigational Site	Garston, Watford
United Kingdom	205.365.44003 Boehringer Ingelheim Investigational Site	Harrow
United Kingdom	205.365.44004 Boehringer Ingelheim Investigational Site	Warminster
United States	205.365.1010 Boehringer Ingelheim Investigational Site	Albuquerque	New Mexico
United States	205.365.1012 Boehringer Ingelheim Investigational Site	Baltimore	Maryland
United States	205.365.1003 Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	205.365.1004 Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	205.365.1086 Boehringer Ingelheim Investigational Site	Bloomington	Minnesota
United States	205.365.1080 Boehringer Ingelheim Investigational Site	Charlotte	North Carolina
United States	205.365.1118 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	205.365.1122 Boehringer Ingelheim Investigational Site	Clarksburg	West Virginia
United States	205.365.1098 Boehringer Ingelheim Investigational Site	Jasper	Alabama
United States	205.365.1092 Boehringer Ingelheim Investigational Site	Kingsport	Tennessee
United States	205.365.1024 Boehringer Ingelheim Investigational Site	Lexington	Kentucky
United States	205.365.1085 Boehringer Ingelheim Investigational Site	Omaha	Nebraska
United States	205.365.1023 Boehringer Ingelheim Investigational Site	Palo Alto	California
United States	205.365.1033 Boehringer Ingelheim Investigational Site	Pittsburgh	Pennsylvania
United States	205.365.1006 Boehringer Ingelheim Investigational Site	Rochester	Minnesota
United States	205.365.1007 Boehringer Ingelheim Investigational Site	Rochester	New York
United States	205.365.1125 Boehringer Ingelheim Investigational Site	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czech Republic,  Germany,  Greece,  Netherlands,  Portugal,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)	Change = Week 24 Value - Baseline Value	baseline, week 24	No
Secondary	Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)	Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.	Baseline	No
Secondary	Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)	Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.	Baseline, week 8	No
Secondary	Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)	Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.	Baseline, week 16	No
Secondary	Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)	Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.	Baseline, week 24	No
Secondary	Peak Forced Expiratory Volume in 1 Second (Baseline)	Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.	Baseline	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)	Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.	Baseline, week 8	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)	Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.	Baseline, week 16	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)	Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.	Baseline, week 24	No
Secondary	Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)	Forced expiratory volume in 1 second (baseline, pre-dose)	Baseline	No
Secondary	Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)	Forced expiratory volume in 1 second (baseline, 30 minutes)	baseline, 30 minutes	No
Secondary	Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)	Forced expiratory volume in 1 second (baseline, 60 minutes)	baseline, 60 minutes	No
Secondary	Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)	Forced expiratory volume in 1 second (baseline, 120 minutes)	Baseline, 120 minutes	No
Secondary	Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)	Forced expiratory volume in 1 second (baseline, 180 minutes)	Baseline, 180 minutes	No
Secondary	Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)	Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)	baseline, week 8, pre-dose	No
Secondary	Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)	Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)	Baseline, week 8, 30 minutes	No
Secondary	Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)	Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)	baseline, week 8, 60 minutes	No
Secondary	Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)	Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)	baseline, week 8, 120 minutes	No
Secondary	Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)	Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)	baseline, week 8, 180 minutes	No
Secondary	Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)	Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)	baseline, week 16, pre-dose	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)	Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)	Baseline, week 16, 30 minutes	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)	Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)	baseline, week 16, 60 minutes	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)	Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)	baseline, week 16, 120 minutes	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)	Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)	baseline, week 16, 180 minutes	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)	Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)	baseline, week 24, pre-dose	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)	Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)	baseline, week 24, 30 minutes	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)	Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)	baseline, week 24, 60 minutes	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)	Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)	baseline, week 24, 120 minutes	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)	Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)	baseline, week 24, 180 minutes	No
Secondary	FVC AUC0-3 at Baseline	Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)	baseline	No
Secondary	FVC AUC0-3 at Week 8 Minus Baseline	Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)	baseline, week 8	No
Secondary	FVC AUC0-3 at Week 16 Minus Baseline	Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)	baseline, week 16	No
Secondary	FVC AUC0-3 at Week 24 Minus Baseline	Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)	baseline, week 24	No
Secondary	Trough Forced Vital Capacity (Baseline)	Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.	baseline	No
Secondary	Change From Baseline in Trough Forced Vital Capacity (at Week 8)	Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.	baseline, week 8	No
Secondary	Change From Baseline in Trough Forced Vital Capacity (at Week 16)	Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.	baseline, week 16	No
Secondary	Change From Baseline in Trough Forced Vital Capacity (at Week 24)	Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.	baseline, week 24	No
Secondary	Peak Forced Vital Capacity (FVC) (Baseline)	Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.	baseline	No
Secondary	Change From Baseline in Peak Forced Vital Capacity (at Week 8)	Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.	baseline, week 8	No
Secondary	Change From Baseline in Peak Forced Vital Capacity (at Week 16)	Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.	baseline, week 16	No
Secondary	Change From Baseline in Peak Forced Vital Capacity (at Week 24)	Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.	baseline, week 24	No
Secondary	Forced Vital Capacity (Baseline, Pre-dose)	Forced vital capacity (baseline, pre-dose)	baseline	No
Secondary	Forced Vital Capacity (Baseline, 30 Minutes)	Forced vital capacity (baseline, 30 minutes)	baseline, 30 minutes	No
Secondary	Forced Vital Capacity (Baseline, 60 Minutes)	Forced vital capacity (baseline, 60 minutes)	baseline, 60 minutes	No
Secondary	Forced Vital Capacity (Baseline, 120 Minutes)	Forced vital capacity (baseline, 120 minutes)	baseline, 120 minutes	No
Secondary	Forced Vital Capacity (Baseline, 180 Minutes)	Forced vital capacity (baseline, 180 minutes)	baseline, 180 minutes	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)	Change from baseline in forced vital capacity (week 8, pre-dose)	baseline, week 8, pre-dose	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)	Change from baseline in forced vital capacity (week 8, 30 minutes)	baseline, week 8, 30 minutes	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)	Change from baseline in forced vital capacity (week 8, 60 minutes)	baseline, week 8, 60 minutes	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)	Change from baseline in forced vital capacity (week 8, 120 minutes)	baseline, week 8, 120 minutes	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)	Change from baseline in forced vital capacity (week 8, 180 minutes)	baseline, week 8, 180 minutes	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)	Change from baseline in forced vital capacity (week 16, pre-dose)	baseline, week 16, pre-dose	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)	Change from baseline in forced vital capacity (week 16, 30 minutes)	baseline, week 16, 30 minutes	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)	Change from baseline in forced vital capacity (week 16, 60 minutes)	baseline, week 16, 60 minutes	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)	Change from baseline in forced vital capacity (week 16, 120 minutes)	baseline, week 16, 120 minutes	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)	Change from baseline in forced vital capacity (week 16, 180 minutes)	baseline, week 16, 180 minutes	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)	Change from baseline in forced vital capacity (week 24, pre-dose)	baseline, week 24, pre-dose	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)	Change from baseline in forced vital capacity (week 24, 30 minutes)	baseline, week 24, 30 minutes	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)	Change from baseline in forced vital capacity (week 24, 60 minutes)	baseline, week 24, 60 minutes	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)	Change from baseline in forced vital capacity (week 24, 120 minutes)	baseline, week 24, 120 minutes	No
Secondary	Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)	Change from baseline in forced vital capacity (week 24, 180 minutes)	baseline, week 24, 180 minutes	No
Secondary	Albuterol Use p.r.n. (Baseline)	Number of days that participants used albuterol prn per week	baseline	No
Secondary	Change From Baseline in Albuterol Use p.r.n. - (Week 4)	Difference in number of days that participants used albuterol prn per week between week 4 and baseline	baseline, week 4	No
Secondary	Change From Baseline in Albuterol Use p.r.n. - (Week 8)	Difference in number of days that participants used albuterol prn per week between week 8 and baseline	baseline, week 8	No
Secondary	Change From Baseline in Albuterol Use p.r.n. -(Week 12)	Difference in number of days that participants used albuterol prn per week between week 12 and baseline	baseline, week 12	No
Secondary	Change From Baseline in Albuterol Use p.r.n. - (Week 16)	Difference in number of days that participants used albuterol prn per week between week 16 and baseline	baseline, week 16	No
Secondary	Change From Baseline in Albuterol Use p.r.n. -(Week 20)	Difference in number of days that participants used albuterol prn per week between week 20 and baseline	baseline, week 20	No
Secondary	Change From Baseline in Albuterol Use p.r.n. - (Week 24)	Difference in number of days that participants used albuterol prn per week between week 24 and baseline	baseline, week 24	No
Secondary	Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)	The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.; Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.	baseline	No
Secondary	Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)	The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.; Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.	week 12	No
Secondary	Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)	The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.; Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.	week 24	No
Secondary	Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)	The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.; Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.	baseline	No
Secondary	Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)	The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.; Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.	week 12	No
Secondary	Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)	The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.; Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.	week 24	No
Secondary	Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.; Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.	baseline	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.	baseline, week 4	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.	baseline, week 8	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.	baseline, week 12	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.	baseline, week 16	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.	baseline, week 20	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.	baseline, week 24	No
Secondary	Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.; Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.	baseline	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.	baseline, week 4	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.	baseline, week 8	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.	baseline, week 12	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.	baseline, week 16	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.	baseline, week 20	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.	baseline, week 24	No
Secondary	Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.; Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.	baseline	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.	baseline, week 4	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.	baseline, week 8	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.	baseline, week 12	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.	baseline, week 16	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.	baseline, week 20	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.	baseline, week 24	No
Secondary	Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.; Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.	baseline	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.	baseline, week 4	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.	baseline, week 8	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.	baseline, week 12	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.	baseline, week 16	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.	baseline, week 20	No
Secondary	Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.	baseline, week 24	No
Secondary	Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day	Light intensity is less than three metabolic equivalents.; Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.; ln in measure value unit means natural logarithm.	baseline	No
Secondary	Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day	Light intensity is less than three metabolic equivalents; Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.; ln in measure value unit means natural logarithm	baseline, week 4	No
Secondary	Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day	Light intensity is less than three metabolic equivalents; Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.; ln in measure value unit means natural logarithm	baseline, week 8	No
Secondary	Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day	Light intensity defined as less than three metabolic equivalents.; Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.; ln in measure value unit means natural logarithm	baseline, week 12	No
Secondary	Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day	Light intensity is less than three metabolic equivalents; Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.; ln in measure value unit means natural logarithm	baseline, week 16	No
Secondary	Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day	Light intensity is less than three metabolic equivalents; Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.; ln in measure value unit means natural logarithm	baseline, week 20	No
Secondary	Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day	Light intensity is less than three metabolic equivalents; Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.; ln in measure value unit means natural logarithm	baseline, week 24	No
Secondary	Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day	Moderate or higher intensity is greater than or equal to three metabolic equivalents; Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.; ln in measure value unit means natural logarithm	baseline	No
Secondary	Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day	Moderate or higher intensity is greater than or equal to three metabolic equivalents; Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.; ln in measure value unit means natural logarithm	baseline, week 4	No
Secondary	Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day	Moderate or higher intensity is greater than or equal to three metabolic equivalents; Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.; ln in measure value unit means natural logarithm	baseline, week 8	No
Secondary	Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day	Moderate or higher intensity is greater than or equal to three metabolic equivalents; Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.; ln in measure value unit means natural logarithm	baseline, week 12	No
Secondary	Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day	Moderate or higher intensity is greater than or equal to three metabolic equivalents; Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.; ln in measure value unit means natural logarithm	baseline, week 16	No
Secondary	Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day	Moderate or higher intensity is greater than or equal to three metabolic equivalents; Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.; ln in measure value unit means natural logarithm	baseline, week 20	No
Secondary	Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day	Moderate or higher intensity is greater than or equal to three metabolic equivalents; Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.; ln in measure value unit means natural logarithm	baseline, week 24	No
Secondary	Number of Participants With Healthy Lifestyle (Baseline)	Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no	baseline	No
Secondary	Number of Participants With Healthy Lifestyle (Week 4)	Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no	week 4	No
Secondary	Number of Participants With Healthy Lifestyle (Week 8)	Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no	week 8	No
Secondary	Number of Participants With Healthy Lifestyle (Week 12)	Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no	week 12	No
Secondary	Number of Participants With Healthy Lifestyle (Week 16)	Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no	week 16	No
Secondary	Number of Participants With Healthy Lifestyle (Week 20)	Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no	week 20	No
Secondary	Number of Participants With Healthy Lifestyle (Week 24)	Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no	week 24	No
Secondary	Active Energy Expenditure (Baseline)	The amount of energy (kcal/day) that a person uses while physically active.	baseline	No
Secondary	Change From Baseline in Active Energy Expenditure (Week 4)	The amount of energy (kcal/day) that a person uses while physically active.	baseline, week 4	No
Secondary	Change From Baseline in Active Energy Expenditure (Week 8)	The amount of energy (kcal/day) that a person uses while physically active.	baseline, week 8	No
Secondary	Change From Baseline in Active Energy Expenditure (Week 12)	The amount of energy (kcal/day) that a person uses while physically active.	baseline, week 12	No
Secondary	Change From Baseline in Active Energy Expenditure (Week 16)	The amount of energy (kcal/day) that a person uses while physically active.	baseline, week 16	No
Secondary	Change From Baseline in Active Energy Expenditure (Week 20)	The amount of energy (kcal/day) that a person uses while physically active.	baseline, week 20	No
Secondary	Change From Baseline in Active Energy Expenditure (Week 24)	The amount of energy (kcal/day) that a person uses while physically active.	baseline, week 24	No
Secondary	Number of Steps Per Day (Baseline)	Number of steps per day (baseline)	baseline	No
Secondary	Change From Baseline in Number of Steps Per Day (Week 4)	Change from baseline in number of steps per day (week 4)	baseline, week 4	No
Secondary	Change From Baseline in Number of Steps Per Day(Week 8)	Change from baseline in number of steps per day (week 8)	baseline, week 8	No
Secondary	Change From Baseline in Number of Steps Per Day (Week 12)	Change from baseline in Number of steps per day (week 12)	baseline, week 12	No
Secondary	Change From Baseline in Number of Steps Per Day (Week 16)	Change from baseline in number of steps per day (week 16)	baseline, week 16	No
Secondary	Change From Baseline in Number of Steps Per Day (Week 20)	Change from baseline in number of steps per day (week 20)	baseline, week 20	No
Secondary	Change From Baseline in Number of Steps Per Day (Week 24)	Change from baseline in number of steps per day (week 24)	baseline, week 24	No

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