Official Title: “A Double-Blind, Placebo-Controlled, Crossover Study of Sildenafil in Patients With Chronic Obstructive Pulmonary Disease”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: November 2008

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.

Intervention(s) in this Clinical Trial

• Drug: sildenafil citrate
  • sildenafil citrate 25mg po tid

Primary Measures

• Exercise Function
  • Time Frame: 4 week
    Safety Issue?: No

Secondary Measures

• Pulmonary Function
  • Time Frame: 4 week
    Safety Issue?: No
• Quality of Life
  • Time Frame: 4 week
    Safety Issue?: No
• Shortness of breath score
  • Time Frame: 4 week
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Kawut, Steven, MD

Overall Clinical Trial Officials and Contacts

Steven M Kawut, M.D., M.S. Principal Investigator Columbia University  

Overall Contact: Fran Brogan (212) 305-1158 broganf@nyp.org

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00104637

Study ID Number: 1022

ClinicalTrials.gov Identifier: NCT00104637

Health Authority: United States: Food and Drug Administration