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OpenTrials
Completed

NCT Number: NCT00403286

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Disease Disease Attributes Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluticasone propionate/formoterol fumarate

Drug

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

Fluticasone propionate

Drug

Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks

formoterol fumarate

Drug

Inhalation Solution for nebulization 20 mcg bid for 2 weeks

fluticasone propionate/salmeterol xinafoate

Drug

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

Placebo

Drug

Inhalation Solution for nebulization 2 mL bid for 2 weeks

Primary outcomes

  1. 2-hour post-dose FEV1

    Time frame: 2 weeks

  2. AUC(0-12) and Cmax in plasma

    Time frame: 2 weeks

  3. pre-dose FEV1

    Time frame: 2 weeks

  4. Amount and percent total dose excreted in urine

    Time frame: 2 weeks

Secondary outcomes

  1. FEV1 AUC(0-2)

    Time frame: 2 weeks

  2. COPD exacerbations

  3. Treatment Emergent Adverse Events

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Dey

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 23, 2006
Registry last updated
Jun 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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