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Completed

NCT Number: NCT00774761

A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.

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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

Investigative Site, San Diego, California, 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

  • Able to understand the requirements of the study and provide consent
  • Medical diagnosis of COPD
  • A current or prior history of at least 10-pack years of cigarette smoking
  • Female of child-bearing potential to use adequate birth control

Exclusion criteria

  • Diagnosis of asthma
  • Other significant disease than COPD
  • Has donated a unit of blood within 30 days of study, or intends to donate
  • QTc greater than 0.460 seconds
  • Subjects who had radiation or chemotherapy in the previous 12 months
  • Subjects who had lung resection
  • History of illegal drug abuse or alcohol abuse within the past 5 years

Treatment and study plan

fluticasone propionate/formoterol fumarate

Drug

inhalation suspension

Fluticasone propionate

Drug

inhalation suspension

formoterol fumarate

Drug

inhalation solution

Primary outcomes

  1. Plasma AUC(0-t) after 1 week of dosing

    Time frame: PK sampling over 24 hrs

Secondary outcomes

  1. FEV1

    Time frame: pre-dose and 2 hrs post-dose

Sponsors and collaborators

Lead sponsor

Dey

Industry

Registry information

Official study title

A Randomized, Multiple-Dose,Double-Blind,Crossover Trial to Assess the Systemic Exposure of Fluticasone Propionate (FP)/Formoterol Fumarate (FF) Fixed-Dose Combination in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 17, 2008
Registry last updated
May 20, 2013

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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