A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Pharmacodynamic Response of Fluticasone Propionate in Fixed-Dose Combination With Formoterol Fumarate in Subjects With COPD
Overview
- Phase
- Phase 2
- Intervention
- Fluticasone Propionate/Formoterol Fumarate
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Dey
- Enrollment
- 468
- Locations
- 3
- Primary Endpoint
- Change in forced expiratory volume at one second (FEV1) measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with COPD.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to understand the requirements of the study and provide written informed consent
- •A clinical diagnosis of COPD
- •A current or prior history of at least 10-pack years of cigarette smoking
- •Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study
Exclusion Criteria
- •A clinical diagnosis of Asthma
- •Other significant disease than COPD
- •Subjects who radiation or chemotherapy within the previous 12 months
- •Subjects who had any lung resection
- •QTcB greater than 0.460 seconds
- •History of illegal drug abuse or alcohol abuse within the past 5 years
Arms & Interventions
2
Intervention: Fluticasone Propionate/Formoterol Fumarate
3
Intervention: Fluticasone Propionate/Formoterol Fumarate
1
Intervention: Fluticasone Propionate/Formoterol Fumarate
4
Intervention: Fluticasone Propionate/Formoterol Fumarate
5
Intervention: Fluticasone Propionate/Formoterol Fumarate
6
Intervention: Formoterol Fumarate
7
Intervention: Placebo
Outcomes
Primary Outcomes
Change in forced expiratory volume at one second (FEV1) measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD
Time Frame: 12 Weeks
Secondary Outcomes
- Incidence of adverse events (AEs)(12 Weeks)