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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Fluticasone Propionate/Formoterol Fumarate; Drug: Formoterol Fumarate; Drug: Placebo

• Registration Number: NCT01168310
• Lead Sponsor: Dey

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-23
• Study Start: 2010-08
• Primary Completion: 2010-08
• Study Completion: 2011-10
• Status Verified: 2013-05
• Disposition First Submitted: 2013-05-10
• Disposition First Submitted QC: 2013-05-17
• Last Update Submitted: 2013-05-17
• Disposition First Posted: 2013-05-27
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 468

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Fluticasone Propionate/Formoterol Fumarate	-
5	Fluticasone Propionate/Formoterol Fumarate	-
1	Fluticasone Propionate/Formoterol Fumarate	-
3	Fluticasone Propionate/Formoterol Fumarate	-
4	Fluticasone Propionate/Formoterol Fumarate	-
6	Formoterol Fumarate	-
7	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidence of adverse events (AEs)	12 Weeks

Trial Locations

Locations (3)

Investigative Site; 🇺🇸 Spokane, Washington, United States

Invesigative Site; 🇺🇸 Union, South Carolina, United States

Investigative site; 🇺🇸 Sylvania, Ohio, United States