Sildenafil for Chronic Obstructive Pulmonary Disease

Kawut, Steven, MD10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive Emphysema

Interventions

sildenafil citrateDRUG

sildenafil citrate 25 mg by mouth thrice daily (po tid)

PlaceboDRUG

25 mg po tid

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Columbia Univeristy, College of Physicians and Surgeons

New York, New York, United States

Outcomes

Primary Outcomes

6 Minute Walk Distance

The distance a subject walked within 6 minutes was measured and documented.

Time frame: Period 1 and Period 3 ( within 8 weeks)

VO2 Peak (Oxygen Consumption at Peak Exercise)

Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3.

Time frame: Period 1 and Period 3 ( within 8 weeks)

Secondary Outcomes

Pulmonary Function FVC (Forced Vital Capacity)

Data to calculate results for FVC was based on Period 1.

Time frame: Period 1 (4 weeks)

Forced Expiratory Volume in the First Second (FEV1 )

The volume of air exhaled in the first second. Data to calculate results for FEV1 was based on Period 1 only.

Time frame: Period 1 ( 4 weeks)

Borg Dyspnea(Scale That Measures Breathlessness) Score at Finish of 6 Minute Walk Test (6MWT)

Participants were asked to scale the breathlessness felt at the end of 6MWT from 0 to 10, with 0 being the least discomfort and 10 being the most discomfort in breathing.

Time frame: Period 1 and Period 3 ( within 8 weeks)

Diffusing Capacity of Carbon Monoxide (DLCO)

Carbon Monoxide Diffusing Capacity was measured on the same days as the pulmonary function tests.

Time frame: Period 1 and Period 3 ( within 8 weeks)

Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG)

Partial pressure of carbon dioxide in ABG performed breathing room air at rest.

Data from ClinicalTrials.gov

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