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

Phase 2

Completed

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

• Registration Number: NCT00403286
• Lead Sponsor: Dey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-21
• Study First Submitted QC: 2006-11-22
• Study First Posted: 2006-11-23
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-26
• Last Update Posted: 2009-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 457

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C 5/2	Fluticasone Propionate/Formoterol Fumarate	-
C 5/1	Fluticasone Propionate/Formoterol Fumarate	-
C 10/2	Fluticasone Propionate/Formoterol Fumarate	-
C 10/1	Fluticasone Propionate/Formoterol Fumarate	-
FF 20	Formoterol Fumarate	-
AD 250/50	Fluticasone Propionate/Salmeterol Xinafoate	-
Plc	Placebo	-
FP 1000	Fluticasone Propionate	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
FEV1 AUC(0-2)	2 weeks
COPD exacerbations
Treatment Emergent Adverse Events	2 weeks

Trial Locations

Locations (1)

Research Site; 🇺🇸 Milwaukee, Wisconsin, United States