Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Two-Week, Randomized, Modified-Blind, Double-Dummy, Parallel-Group Efficacy and Safety Study of Arformoterol Tartrate Inhalation Solution Twice-Daily, Tiotropium Once-Daily, and Arformoterol Tartrate Inhalation Solution Twice-Daily and Tiotropium Once Daily in Subjects With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424528
• Other study ID #: 091-902
• Status: Completed
• Phase: Phase 4
• First received: January 17, 2007
• Last updated: May 29, 2012
• Start date: December 2006
• Est. completion date: October 2007

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).

Description:

This study is a multicenter, randomized, modified-blind, double-dummy two-week parallel-group efficacy and safety study of arformoterol tartrate inhalation solution twice daily, tiotropium inhalation powder once daily and arformoterol tartrate inhalation solution twice daily and tiotropium inhalation powder once daily (dosed sequentially) in subjects with COPD. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Male and female subjects must be at least 45 years old at the time of consent.

• Subjects must have a pre-established primary clinical diagnosis of COPD.

• Subjects must have a baseline FEV1 of =65% of predicted normal value at Visit 1.

• Subjects must have a FEV1 = 0.70L at Visit 1.

Exclusion Criteria:

• Subjects who do not have a FEV1/forced vital capacity (FVC) ratio of =70% at Visit 1.

• Subjects who do not have a ³15 pack-year smoking history and a baseline breathlessness severity grade of ³2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Visit 1.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Arformoterol Tartrate Inhalation Solution
Arformoterol tartrate inhalation solution 15 mcg twice daily and placebo inhalation powder once daily.
• Tiotropium
Placebo inhalation solution twice daily and tiotropium inhalation powder 18 mcg once daily.
• Arformoterol and Tiotropium
Arformoterol tartrate inhalation solution 15 mcg twice daily and Tiotropium inhalation powder 18 mcg once daily.
• Placebo
Placebo inhalation solution and placebo inhalation powder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B)		24 hours following two weeks of dosing.	No
Secondary	Time-normalized Area From Study Baseline Curve for FEV1 Over 0-12 Hours (nAUC0-12B)		0-12 hours following two weeks of dosing	No
Secondary	Time Normalized Area Under the Change From Study Baseline Curve for FEV1 Over 12-24 Hours (nAUC12-24B)		Following 2 weeks of dosing	No
Secondary	Change in FEV1 From Study Baseline to the 24-hour Timepoint (Trough)	Trough FEV1 is defined as the measurement collected approximately 24 hours after the first in-clinic double-blind dose at Week 0. Change is calculated as Week 2 24 hour post first dose FEV1 - Week 0 pre-first dose FEV1.	Following 2 weeks of dosing	No
Secondary	Change in FEV1 From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication	Baseline is FEV1 measurement collected prior to the first double-blind dose at week 0. Change defined as Week 0 FEV1 - Week 2 pre first dose FEV1.	2 weeks	No
Secondary	Change in FEV1 Percent of Predicted From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication	Baseline is FEV1 collected prior to first double-blind dose at week 0. Change is defined as Week 0 FEV1 percent predicted - Week 2 pre first dose FEV1 percent predicted.	2 weeks	No
Secondary	Peak Change in FEV1 Over 12 Hours Post Dose From Study Baseline	12 hour peak change in FEV1 is defined as maximum of the post dose changes through the nominal 12 hour assessment.	2 weeks	No
Secondary	Time to Onset in Participants Who Achieved a 10% Increase in FEV1 From Visit Predose After 2 Weeks	Analyzed from end of dosing to 12 hours.	2 weeks	No
Secondary	Time to Onset in Participants Who Achieved a 15% Increase in FEV1 From Visit Predose After 2 Weeks	Analyzed from end of dosing to 12 hours.	2 weeks	No
Secondary	Change in Inspiratory Capacity From Study Baseline to the 24 Hour Timepoint (Trough) Following 2 Weeks of Dosing	Trough Inspiratory Capacity is defined as the measurement collected approximately 24 hours after the first in clinic double-blind treatment dose at week 0. Change is calculated as Week 2 24 hr post dose IC - Week 0 pre first dose IC.	2 weeks	No
Secondary	Change in Forced Vital Capacity (FVC) From Study Baseline at Each Assessed Post Dose Timepoint		2 Weeks	No
Secondary	Levalbuterol Metered Dose Inhaler (MDI) (Rescue Medication) Use in Days Per Week	Overall: Average of the levalbuterol usage in days per week over the 2 week period. Mean number of days/week=number of days levalbuterol used during time period, divided by number of days in the period, multiplied by 7. An actuation is one puff of levalbuterol.	2 weeks	No
Secondary	Levalbuterol Metered Dose Inhaler (MDI) Rescue Medication Use in Actuations Per Day	Overall: Average of the usage in number of actuations per day over the 2 week period. An actuation is one puff of levalbuterol. Mean number of actuations/day=number actuations used during time period, divided by number of days in time period.	2 weeks	No
Secondary	Transition Dyspnea Index (TDI) Focal Score	TDI Focal score (range -9 to 9) is defined as the sum of function impairment, magnitude of task, and magnitude of effort (each on a -3 to 3 scale). A score of -9 is maximum worsening and 9 is maximum improvement.	2 weeks	No
Secondary	Number of Participants With a >= 1 Unit of Improvement in the TDI Focal Score	A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important.	2 weeks	No
Secondary	Percentage of Participants With a >=1 Unit Improvement in Transition Dysnea Index (TDI) Focal Score	A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important.	2 weeks	No