A Dose-Finding Study Evaluating Safety and Efficacy in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Fluticasone Propionate/Formoterol Fumarate
* Drug: Fluticasone Propionate/Formoterol Fumarate
* Drug: Fluticasone Propionate/Formoterol Fumarate
* Drug: Fluticasone Propionate/Formoterol Fumarate
* Drug: Fluticasone Propionate
* Drug: Formoterol Fumarate
* Drug: Fluticasone Propionate/Salmeterol Xinafoate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C 10/1<br> | Drug: Fluticasone Propionate/Formoterol Fumarate<br>* Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks<br>|
| Experimental: C 5/2<br> | Drug: Fluticasone Propionate/Formoterol Fumarate<br>* Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks<br>|
| Experimental: C 5/1<br> | Drug: Fluticasone Propionate/Formoterol Fumarate<br>* Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks<br>|
| Experimental: FP 1000<br> | Drug: Fluticasone Propionate<br>* Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks<br>|
| Experimental: FF 20<br> | Drug: Formoterol Fumarate<br>* Inhalation Solution for nebulization 20 mcg bid for 2 weeks<br>|
| Active Comparator: AD 250/50<br> | Drug: Fluticasone Propionate/Salmeterol Xinafoate<br>* Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks<br>|
| Placebo Comparator: Plc<br> | Drug: Placebo<br>* Inhalation Solution for nebulization 2 mL bid for 2 weeks<br>|
| Experimental: C 10/2<br> | Drug: Fluticasone Propionate/Formoterol Fumarate<br>* Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-hour post-dose FEV1 |  | 2 weeks | 
| AUC(0-12) and Cmax in plasma |  | 2 weeks | 
| pre-dose FEV1 |  | 2 weeks | 
| Amount and percent total dose excreted in urine |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 AUC(0-2) |  | 2 weeks | 
| COPD exacerbations |  |  | 
| Treatment Emergent Adverse Events |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic, Obstructive, Pulmonary, Disease, COPD, Safety, Efficacy, Pharmacokinetic, Dose-finding