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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: November 10, 2011
Last verified: November 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Dey:

Primary Outcome Measures:
  • Change in 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

  Show 23 Study Locations
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: November 10, 2011
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 May 16, 2013