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

NCT00403286 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 457

Last updated 2009-06-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Fluticasone Propionate/Formoterol Fumarate

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

DRUG

Fluticasone Propionate/Formoterol Fumarate

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

DRUG

Fluticasone Propionate/Formoterol Fumarate

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

DRUG

Fluticasone Propionate/Formoterol Fumarate

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

DRUG

Fluticasone Propionate

Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks

DRUG

Formoterol Fumarate

Inhalation Solution for nebulization 20 mcg bid for 2 weeks

DRUG

Fluticasone Propionate/Salmeterol Xinafoate

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

DRUG

Placebo

Inhalation Solution for nebulization 2 mL bid for 2 weeks

Sponsors & Collaborators

  • Dey

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00403286 on ClinicalTrials.gov