Back to resultsExercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fluticasone
Comparator: Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
Arm 1: drug, crossing over to Pbo comparator
Arm 2: Pbo comparator, crossing over to drug
Outcomes
Primary Outcome Measures
Standardized Dyspnea Score at Isotime During Exercise
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
Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.
Full Information
NCT ID
NCT00387036
First Posted
October 5, 2006
Last Updated
December 17, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00387036
Brief Title
Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)
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 Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Termininated for business reasons
Study Start Date
December 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Arm 1: drug, crossing over to Pbo comparator
Arm Title
2
Arm Type
Other
Arm Description
Arm 2: Pbo comparator, crossing over to drug
Intervention Type
Drug
Intervention Name(s)
Fluticasone
Intervention Description
fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.
Primary Outcome Measure Information:
Title
Standardized Dyspnea Score at Isotime During Exercise
Description
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] ).
Time Frame
2 Weeks
Secondary Outcome Measure Information:
Title
Exercise Endurance Time
Description
Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.
Time Frame
2 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21917440
Citation
Guenette JA, Raghavan N, Harris-McAllister V, Preston ME, Webb KA, O'Donnell DE. Effect of adjunct fluticasone propionate on airway physiology during rest and exercise in COPD. Respir Med. 2011 Dec;105(12):1836-45. doi: 10.1016/j.rmed.2011.08.021. Epub 2011 Sep 13.
Results Reference
result
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Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)
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