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| Sponsors and Collaborators: |
Kawut, Steven, MD 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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | A Double-Blind, Placebo-Controlled, Crossover Study of Sildenafil in Patients With Chronic Obstructive Pulmonary Disease |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Columbia Univeristy, College of Physicians and Surgeons | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Steven M Kawut, M.D., M.S. | Columbia University |
More Information
| Responsible Party: | Columbia University ( Steven Kawut, MD ) |
| Study ID Numbers: | 1022 |
| Study First Received: | March 3, 2005 |
| Last Updated: | November 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00104637 |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic Obstructive Pulmonary Disease Emphysema Phosphodiesterase inhibitors |
Sildenafil Exercise testing Quality of life |
|
Pulmonary Emphysema Emphysema Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Citric Acid |
Respiration Disorders Quality of Life Sildenafil Chronic Disease Pulmonary Disease, Chronic Obstructive |
|
Vasodilator Agents Disease Attributes Phosphodiesterase Inhibitors Pathologic Processes Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions |
