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

NCT ID: NCT00387036

Last Updated: 2016-01-21

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Arm 1: drug, crossing over to Pbo comparator

Group Type OTHER

Fluticasone

Intervention Type DRUG

fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.

2

Arm 2: Pbo comparator, crossing over to drug

Group Type OTHER

Fluticasone

Intervention Type DRUG

fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.

Comparator: Placebo

Intervention Type DRUG

Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.

Interventions

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Fluticasone

fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.

Intervention Type DRUG

Comparator: Placebo

Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type RESULT
PMID: 21917440 (View on PubMed)

Other Identifiers

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036

Identifier Type: -

Identifier Source: secondary_id

2006_039

Identifier Type: -

Identifier Source: secondary_id

0000-036

Identifier Type: -

Identifier Source: org_study_id

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