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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dey
ClinicalTrials.gov Identifier:
NCT01168310
First received: July 21, 2010
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Fluticasone Propionate/Formoterol Fumarate
Drug: Formoterol Fumarate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Dey:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of adverse events (AEs) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 468
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
Experimental: 2 Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
Experimental: 3 Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
Experimental: 4 Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
Experimental: 5 Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
Active Comparator: 6 Drug: Formoterol Fumarate
Inhalation Solution
Placebo Comparator: 7 Drug: Placebo
Inhalation Solution

  Eligibility

Ages Eligible for Study:   40 Days and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168310

  Hide Study Locations
Locations
United States, Arizona
Investigative Site
Phoenix, Arizona, United States
United States, California
Investigative Site
Fullerton, California, United States
Investigative Site
San Diego, California, United States
United States, Florida
Investigative Site
Clearwater, Florida, United States
Investigative Site
Deland, Florida, United States
Investigative Site
Tamarac, Florida, United States
United States, Georgia
Investigative Site
Lawrenceville, Georgia, United States
United States, Idaho
Investigative Site
Coeur D'Alene, Idaho, United States
United States, Kentucky
Investigative Site
Madisonville, Kentucky, United States
United States, Louisiana
Investigative Site
Sunset, Louisiana, United States
United States, Missouri
Investigative Site
Saint Louis, Missouri, United States
United States, North Carolina
Investigative Site
Charlotte, North Carolina, United States
Investigative Site
Raleigh, North Carolina, United States
United States, Ohio
Investigative site
Sylvania, Ohio, United States
United States, Oregon
Investigative Site
Medford, Oregon, United States
United States, South Carolina
Investigative Site
Easley, South Carolina, United States
Investigative Site
Gaffney, South Carolina, United States
Investigative Site
Greenville, South Carolina, United States
Investigative Site
Greer, South Carolina, United States
Investigative Site
Spartanburg, South Carolina, United States
Invesigative Site
Union, South Carolina, United States
United States, Texas
Investigative Site
San Antonio, Texas, United States
United States, Washington
Investigative Site
Spokane, Washington, United States
Sponsors and Collaborators
Dey
  More Information

No publications provided

Responsible Party: Dey
ClinicalTrials.gov Identifier: NCT01168310     History of Changes
Other Study ID Numbers: 191-090
Study First Received: July 21, 2010
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dey:
Pulmonary, Obstructive, lungs, COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Formoterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 14, 2014