A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS 250/50mcg Plus SPIRIVA HANDIHALER Versus SPIRIVA HANDIHALER Plus Placebo DISKUS in Subjects With Chronic Obstructive Pulmonary Disease (COPD). SPIRIVA and HANDIHALER Are Trade Marks of Boehringer Ingelheim

Pulmonary Disease, Chronic Obstructive Clinical Trial

— ADC111114  

Official title:

A 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR DISKUS (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784550
• Other study ID #: 111114
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2008
• Last updated: September 13, 2012
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: September 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA HANDIHALER 18mcg (TIOTROPIUM)compared to SPIRIVA HANDIHALER 18mcg (TIOTROPIUM) in patients with COPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• COPD diagnosis

• At least 10 pack year smoking history

• Post-albuterol FEV1 greater than or equal to 40% to less than or equal to 80% of predicted normal

• An FEV1/FVC ratio of less than or equal to 0.70

Exclusion Criteria:

• Current diagnosis of asthma

• Other respiratory disorder other than COPD

• Abnormal and clinical significant ECG

• Chest x-ray clinically significant abnormality not believed to be due to COPD

• Body Mass Index of greater than or equal to 40/kg/m2

• Use of Long Term Oxygen Therapy

• Lung resection surgery

• Women pregnant or lactating at Visit 1

• Previously diagnosed cancer unless in complete remission for 2 years at Visit 1

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tiotropium Bromide
Long-acting muscarinic antagonist
• FLuticasone Propionate/Salmeterol
Inhaled corticosteroid plus long-acting bronchodilator

Locations

Country	Name	City	State
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Boerne	Texas
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Coeur D'Alene	Idaho
United States	GSK Investigational Site	Cumberland	Rhode Island
United States	GSK Investigational Site	Deland	Florida
United States	GSK Investigational Site	Elizabeth City	North Carolina
United States	GSK Investigational Site	Elkhart	Indiana
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Fort Collins	Colorado
United States	GSK Investigational Site	Gaffney	South Carolina
United States	GSK Investigational Site	Gillespie	Illinois
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Milan	Tennessee
United States	GSK Investigational Site	Mooresville	North Carolina
United States	GSK Investigational Site	Naranja	Florida
United States	GSK Investigational Site	Newport News	Virginia
United States	GSK Investigational Site	Olathe	Kansas
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Riverside	California
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	St. Charles	Missouri
United States	GSK Investigational Site	Statesville	North Carolina
United States	GSK Investigational Site	Sunset	Louisiana
United States	GSK Investigational Site	Union	South Carolina
United States	GSK Investigational Site	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hanania NA, Crater GD, Morris AN, Emmett AH, O'Dell DM, Niewoehner DE. Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD. Respir Med. 2012 Jan;106(1):91-101. doi: 10.1016/j.rmed.2011.09.002. Epub 2011 Oct 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint	Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.	Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant)	No
Secondary	Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint	Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.	Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of 2 hour post-dose FEV1 for each participant)	No
Secondary	Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Vital Capacity (FVC) at Endpoint	Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FVC fore each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration.	Baseline and Endpoint (defined as the last recorded measure [up to Week 24] of AM pre-dose FVC for each participant)	No
Secondary	Mean Change From Baseline in 2 Hour Post-dose FVC at Endpoint	Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FVC for each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration (FVC).	Baseline and Endpoint (defined as the last recorded measure of 2 hour post-dose FVC [up to Week 24] for each participant)	No
Secondary	Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-Dose Inspiratory Capacity (IC) at Endpoint	Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose IC for each participant) value minus the baseline value. IC is defined as the amount of air that can be inhaled after a normal expiration. IC is a measure of pulmonary function.	Baseline and Endpoint (defined as the last recorded measure of AM pre-dose IC [up to Week 24] for each participant)	No
Secondary	Mean Change From Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint	The CRQ-SAS measures 4 domains of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately.	Baseline and Endpoint (defined as the last recorded score [up to Week 24 or the early withdrawal visit] on each of the questions on this questionnaire)	No