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

Dey Pharma

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Fluticasone Propionate/Salmeterol Xinafoate; Drug: Fluticasone Propionate/Formoterol Fumarate; Drug: Placebo; Drug: Fluticasone Propionate; Drug: Formoterol Fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00403286

191-076

Details and patient eligibility

About

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.

Enrollment: 457 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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457 participants in 8 patient groups, including a placebo group

C 10/1

Experimental group

Treatment:

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

C 5/2

Experimental group

Treatment:

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

C 5/1

Experimental group

Treatment:

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

FP 1000

Experimental group

Treatment:

Drug: Fluticasone Propionate

FF 20

Experimental group

Treatment:

Drug: Formoterol Fumarate

AD 250/50

Active Comparator group

Treatment:

Drug: Fluticasone Propionate/Salmeterol Xinafoate

Plc

Placebo Comparator group

Treatment:

Drug: Placebo

C 10/2

Experimental group

Treatment:

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate

Drug: Fluticasone Propionate/Formoterol Fumarate