Skip to main content
OpenTrials
Completed

NCT Number: NCT01168310

A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with COPD.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site, Phoenix, Arizona, 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 written informed consent
  • A clinical diagnosis of COPD
  • A current or prior history of at least 10-pack years of cigarette smoking
  • Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study

Exclusion criteria

  • A clinical diagnosis of Asthma
  • Other significant disease than COPD
  • Subjects who radiation or chemotherapy within the previous 12 months
  • Subjects who had any lung resection
  • QTcB greater than 0.460 seconds
  • History of illegal drug abuse or alcohol abuse within the past 5 years

Treatment and study plan

fluticasone propionate/formoterol fumarate

Drug

Inhalation Suspension

formoterol fumarate

Drug

Inhalation Solution

Placebo

Drug

Inhalation Solution

Primary outcomes

  1. Change in forced expiratory volume at one second (FEV1) measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD

    Time frame: 12 Weeks

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

Dey

Industry

Registry information

Official study title

A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Pharmacodynamic Response of Fluticasone Propionate in Fixed-Dose Combination With Formoterol Fumarate in Subjects With COPD

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jul 23, 2010
Registry last updated
May 27, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.