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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00403286

Enrollment

457

Registered

2006-11-23

Start date

2006-11-30

Completion date

2007-05-31

Last updated

2009-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic, Obstructive, Pulmonary, Disease, COPD, Safety, Efficacy, Pharmacokinetic, Dose-finding

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.

Interventions

DRUGFluticasone Propionate/Formoterol Fumarate

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

DRUGFluticasone Propionate

Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks

DRUGFormoterol Fumarate

Inhalation Solution for nebulization 20 mcg bid for 2 weeks

DRUGFluticasone Propionate/Salmeterol Xinafoate

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

DRUGPlacebo

Inhalation Solution for nebulization 2 mL bid for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

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

Measure	Time frame
COPD exacerbations	—
Treatment Emergent Adverse Events	2 weeks
FEV1 AUC(0-2)	2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026