Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)

This study has been terminated.
(Termininated for business reasons)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00387036
First received: October 5, 2006
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Fluticasone
Drug: Comparator: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind Placebo-Controlled Crossover Study to Investigate the Effects of an Inhaled Corticosteroid on Cardiopulmonary Exercise Parameters in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Standardized Dyspnea Score at Isotime During Exercise [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

    Difference in standardized dyspnea rating at isotime during constant load exercise in patients with COPD between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.

    Isotime is the duration of the shortest exercise test on all treatment days (or the longest exercise time point common to all constant-load exercise tests). The standardized dyspnea score will be measured with the modified 10-point Borg Scale (0 [Best] - 10 [Worst] ).



Secondary Outcome Measures:
  • Exercise Endurance Time [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
    Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.


Enrollment: 12
Study Start Date: December 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Arm 1: drug, crossing over to Pbo comparator
Drug: Fluticasone
fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.
2
Arm 2: Pbo comparator, crossing over to drug
Drug: Fluticasone
fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.
Drug: Comparator: Placebo
Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.

  Eligibility

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

Inclusion Criteria:

  • 40 years and older
  • Clinical diagnosis of COPD for greater than one year
  • History of cigarette smoking

Exclusion Criteria:

  • Other lung diseases (not including COPD), such as asthma
  • A condition that could interfere with your ability to perform exercise tests
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387036

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00387036     History of Changes
Other Study ID Numbers: 0000-036, 036, 2006_039
Study First Received: October 5, 2006
Results First Received: April 8, 2010
Last Updated: September 16, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014