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

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

Sponsors

Lead Sponsor: Dey

Source 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.

Overall Status Completed
Start Date November 2006
Completion Date May 2007
Primary Completion Date May 2007
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure 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
Measure Time Frame
FEV1 AUC(0-2) 2 weeks
COPD exacerbations
Treatment Emergent Adverse Events 2 weeks
Enrollment 457
Condition
Intervention

Intervention Type: Drug

Intervention Name: Fluticasone Propionate/Formoterol Fumarate

Description: Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks

Arm Group Label: C 10/2

Intervention Type: Drug

Intervention Name: Fluticasone Propionate/Formoterol Fumarate

Description: Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks

Arm Group Label: C 10/1

Intervention Type: Drug

Intervention Name: Fluticasone Propionate/Formoterol Fumarate

Description: Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks

Arm Group Label: C 5/2

Intervention Type: Drug

Intervention Name: Fluticasone Propionate/Formoterol Fumarate

Description: Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks

Arm Group Label: C 5/1

Intervention Type: Drug

Intervention Name: Fluticasone Propionate

Description: Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks

Arm Group Label: FP 1000

Intervention Type: Drug

Intervention Name: Formoterol Fumarate

Description: Inhalation Solution for nebulization 20 mcg bid for 2 weeks

Arm Group Label: FF 20

Intervention Type: Drug

Intervention Name: Fluticasone Propionate/Salmeterol Xinafoate

Description: Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks

Arm Group Label: AD 250/50

Intervention Type: Drug

Intervention Name: Placebo

Description: Inhalation Solution for nebulization 2 mL bid for 2 weeks

Arm Group Label: Plc

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

Gender: All

Minimum Age: 40 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
Research Site | Birmingham, Alabama, 35209, United States
Research Site | Jasper, Alabama, 35501, United States
Research Site | Phoenix, Arizona, 85006, United States
Research Site | Buena Park, California, 90620, United States
Research Site | Costa Mesa, California, 92626, United States
Research Site | Encinitas, California, 92024, United States
Research Site | Los Angeles, California, 90095, United States
Research Site | San Diego, California, 92120, United States
Research Site | Wheat Ridge, Colorado, 80033, United States
Research Site | Clearwater, Florida, 33765, United States
Research Site | DeLand, Florida, 32720, United States
Research Site | Tamarac, Florida, 33321, United States
Research Site | Tampa, Florida, 33603, United States
Research Site | Atlanta, Georgia, 30309, United States
Research Site | Woodstock, Georgia, 30189, United States
Research Site | Coeur d'Alene, Idaho, 83814, United States
Research Site | Hines, Illinois, 60141, United States
Research Site | Lenexa, Kansas, 66219, United States
Research Site | Topeka, Kansas, 66606, United States
Research Site | Madisonville, Kentucky, 42431, United States
Research Site | Wheaton, Maryland, 20902, United States
Research Site | Minneapolis, Minnesota, 55402, United States
Research Site | St. Charles, Missouri, 63301, United States
Research Site | St. Louis, Missouri, 63122, United States
Research Site | Henderson, Nevada, 89014, United States
Research Site | Cherry Hill, New Jersey, 08003, United States
Research Site | Albuquerque, New Mexico, 87108, United States
Research Site | Camillus, New York, 13031, United States
Research Site | Liverpool, New York, 13088, United States
Research Site | Charlotte, North Carolina, 28207, United States
Research Site | Greenville, North Carolina, 29615, United States
Research Site | Morrisville, North Carolina, 27560, United States
Research Site | Raleigh, North Carolina, 27607, United States
Research Site | Cincinnati, Ohio, 45227, United States
Research Site | Cincinnati, Ohio, 45231, United States
Research Site | Cincinnati, Ohio, 45242, United States
Research Site | Oklahoma City, Oklahoma, 73104, United States
Research Site | Medford, Oregon, 97504, United States
Research Site | Portland, Oregon, 97213, United States
Research Site | East Providence, Rhode Island, 02914, United States
Research Site | Spartanburg, South Carolina, 29303, United States
Research Site | Austin, Texas, 78750, United States
Research Site | Dallas, Texas, 75231, United States
Research Site | San Antonio, Texas, 78229, United States
Research Site | South Burlington, Vermont, 05403, United States
Research Site | Abingdon, Virginia, 24210, United States
Research Site | Richmond, Virginia, 23225, United States
Research Site | Tacoma, Washington, 98405, United States
Research Site | Milwaukee, Wisconsin, 53217, United States
Location Countries

United States

Verification Date

June 2009

Responsible Party

Name Title: Director Clinical Affairs

Organization: Dey, L.P.

Keywords
Condition Browse
Number Of Arms 8
Arm Group

Label: C 10/1

Type: Experimental

Label: C 5/2

Type: Experimental

Label: C 5/1

Type: Experimental

Label: FP 1000

Type: Experimental

Label: FF 20

Type: Experimental

Label: AD 250/50

Type: Active Comparator

Label: Plc

Type: Placebo Comparator

Label: C 10/2

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov