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

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ClinicalTrials.gov Identifier: NCT00387036
Recruitment Status : Terminated (Termininated for business reasons)
First Posted : October 12, 2006
Results First Posted : May 26, 2010
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : December 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Fluticasone

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Standardized Dyspnea Score at Isotime During Exercise [ Time Frame: 2 Weeks ]

    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 :
  1. Exercise Endurance Time [ Time Frame: 2 Weeks ]
    Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387036


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

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00387036    
Other Study ID Numbers: 0000-036
036
2006_039
First Posted: October 12, 2006    Key Record Dates
Results First Posted: May 26, 2010
Last Update Posted: January 21, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents