A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Fluticasone Propionate/Formoterol Fumarate
* Drug: Fluticasone Propionate/Formoterol Fumarate
* Drug: Fluticasone Propionate/Formoterol Fumarate
* Drug: Fluticasone Propionate/Formoterol Fumarate
* Drug: Fluticasone Propionate/Formoterol Fumarate
* Drug: Formoterol Fumarate
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Fluticasone Propionate/Formoterol Fumarate<br>* Inhalation Suspension<br>|
| Experimental: 2<br> | Drug: Fluticasone Propionate/Formoterol Fumarate<br>* Inhalation Suspension<br>|
| Experimental: 3<br> | Drug: Fluticasone Propionate/Formoterol Fumarate<br>* Inhalation Suspension<br>|
| Experimental: 4<br> | Drug: Fluticasone Propionate/Formoterol Fumarate<br>* Inhalation Suspension<br>|
| Experimental: 5<br> | Drug: Fluticasone Propionate/Formoterol Fumarate<br>* Inhalation Suspension<br>|
| Active Comparator: 6<br> | Drug: Formoterol Fumarate<br>* Inhalation Solution<br>|
| Placebo Comparator: 7<br> | Drug: Placebo<br>* Inhalation Solution<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary, Obstructive, lungs, COPD