Sildenafil for Chronic Obstructive Pulmonary Disease - Full Text View

Sponsor:	Kawut, Steven, MD
Collaborator:	Pfizer
Information provided by:	Kawut, Steven, MD
ClinicalTrials.gov Identifier:	NCT00104637

Purpose

The purpose of this study is to determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive Emphysema	Drug: sildenafil citrate	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind, Placebo-Controlled, Crossover Study of Sildenafil in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Emphysema Exercise and Physical Fitness

Drug Information available for: Citric acid Sildenafil Sildenafil citrate Sodium Citrate

U.S. FDA Resources

Further study details as provided by Kawut, Steven, MD:

Primary Outcome Measures:

Exercise Function [ Time Frame: 4 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pulmonary Function [ Time Frame: 4 week ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: 4 week ] [ Designated as safety issue: No ]
Shortness of breath score [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]

Enrollment:	10
Study Start Date:	February 2005
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

sildenafil citrate 25 mg po tid

Detailed Description:

Patients with chronic obstructive pulmonary disease (COPD) suffer from impaired exercise capacity and quality-of-life, largely related to shortness of breath. Many of the therapies currently available for COPD are aimed at improving these factors. Exercise capacity is limited in part by high blood pressure in the blood vessels in the lungs. Sildenafil, also known as Viagra, is an FDA-approved therapy for male erectile dysfunction. One of its effects is to relax (or open) the lung vessels, thereby lowering the blood pressure in the lungs. We hypothesize that sildenafil will result in an improvement in exercise capacity, quality-of-life, and shortness of breath.

Enrolled subjects will receive sildenafil or placebo for 4 weeks followed by exercise tests, breathing tests, and administration of quality-of-life questionnaires. Subjects will then receive placebo or sildenafil (whichever one they did not receive for the first 4 weeks) for another 4 weeks, followed by the same testing.

Eligibility

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

Criteria

Inclusion Criteria:

Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or emphysema
FEV1/FVC ratio < 70%
FEV1 < 80%
Stable medication regimen

Exclusion Criteria:

COPD exacerbation or hospitalization in the past 3 months
Heart disease
Contraindication to sildenafil
Unrelated lung disease
Inability to walk or pedal on a stationary bike
Pregnancy or breast-feeding
Pulmonary hypertension at rest

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104637

Locations

United States, New York
Columbia Univeristy, College of Physicians and Surgeons
New York, New York, United States, 10032

Sponsors and Collaborators

Kawut, Steven, MD

Pfizer

Investigators

Principal Investigator:

Steven M Kawut, M.D., M.S.

Columbia University

More Information

No publications provided

Responsible Party:	Steven Kawut, MD, Columbia University
ClinicalTrials.gov Identifier:	NCT00104637 History of Changes
Other Study ID Numbers:	1022
Study First Received:	March 3, 2005
Last Updated:	November 14, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Kawut, Steven, MD:

Chronic Obstructive Pulmonary Disease
Emphysema
Phosphodiesterase inhibitors

Sildenafil
Exercise testing
Quality of life

Additional relevant MeSH terms:

Chronic Disease
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

Phosphodiesterase Inhibitors
Sildenafil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Phosphodiesterase 5 Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012