Sildenafil for Chronic Obstructive Pulmonary Disease

Kawut, Steven, MD

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive; Emphysema

Treatments: Drug: Placebo; Drug: sildenafil citrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00104637

1022

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 2 patient groups, including a placebo group

Sildenafil / Placebo

Active Comparator group

Description:

Sildenafil first, followed by washout, followed by placebo

Treatment:

Drug: sildenafil citrate

Drug: Placebo

Placebo / Sildenafil

Placebo Comparator group

Description:

Placebo first, followed by washout, followed by Sildenafil

Treatment:

Drug: sildenafil citrate

Drug: Placebo