A Multi-Center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Safety and Efficacy of Fluticasone Propionate Combined With Formoterol Fumarate in Patients With Chronic Obstructive Pulmonary Disease
Overview
- Phase
- Phase 2
- Intervention
- Fluticasone Propionate/Formoterol Fumarate
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Dey
- Enrollment
- 457
- Locations
- 1
- Primary Endpoint
- 2-hour post-dose FEV1
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of COPD
- •Female of child-bearing potential to use adequate birth control
- •Smoker or ex-smoker with history of at least 10 years of smoking at least one pack of cigarettes per day
- •Meet lung function requirements
Exclusion Criteria
- •Diagnosis of asthma
- •Other significant disease than COPD
- •Pregnant or lactating female
- •Female planning to become pregnant
Arms & Interventions
C 10/1
Intervention: Fluticasone Propionate/Formoterol Fumarate
C 5/2
Intervention: Fluticasone Propionate/Formoterol Fumarate
C 5/1
Intervention: Fluticasone Propionate/Formoterol Fumarate
FP 1000
Intervention: Fluticasone Propionate
FF 20
Intervention: Formoterol Fumarate
AD 250/50
Intervention: Fluticasone Propionate/Salmeterol Xinafoate
Plc
Intervention: Placebo
C 10/2
Intervention: Fluticasone Propionate/Formoterol Fumarate
Outcomes
Primary Outcomes
2-hour post-dose FEV1
Time Frame: 2 weeks
AUC(0-12) and Cmax in plasma
Time Frame: 2 weeks
pre-dose FEV1
Time Frame: 2 weeks
Amount and percent total dose excreted in urine
Time Frame: 2 weeks
Secondary Outcomes
- FEV1 AUC(0-2)(2 weeks)
- COPD exacerbations
- Treatment Emergent Adverse Events(2 weeks)