Sildenafil for Chronic Obstructive Pulmonary Disease

May 18, 2012 updated by: Kawut, Steven, MD

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sildenafil / Placebo
Sildenafil first, followed by washout, followed by placebo
Drug: sildenafil citrate
sildenafil citrate 25 mg by mouth thrice daily (po tid)
Drug: Placebo
25 mg po tid
Placebo Comparator: Placebo / Sildenafil
Placebo first, followed by washout, followed by Sildenafil
Drug: sildenafil citrate
sildenafil citrate 25 mg by mouth thrice daily (po tid)
Drug: Placebo
25 mg po tid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minute Walk Distance
Time Frame: Period 1 and Period 3 ( within 8 weeks)
The distance a subject walked within 6 minutes was measured and documented.
Period 1 and Period 3 ( within 8 weeks)
VO2 Peak (Oxygen Consumption at Peak Exercise)
Time Frame: Period 1 and Period 3 ( within 8 weeks)
Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3.
Period 1 and Period 3 ( within 8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Function FVC (Forced Vital Capacity)
Time Frame: Period 1 (4 weeks)
Data to calculate results for FVC was based on Period 1.
Period 1 (4 weeks)
Forced Expiratory Volume in the First Second (FEV1 )
Time Frame: Period 1 ( 4 weeks)
The volume of air exhaled in the first second. Data to calculate results for FEV1 was based on Period 1 only.
Period 1 ( 4 weeks)
Borg Dyspnea(Scale That Measures Breathlessness) Score at Finish of 6 Minute Walk Test (6MWT)
Time Frame: Period 1 and Period 3 ( within 8 weeks)
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.
Period 1 and Period 3 ( within 8 weeks)
Diffusing Capacity of Carbon Monoxide (DLCO)
Time Frame: Period 1 and Period 3 ( within 8 weeks)
Carbon Monoxide Diffusing Capacity was measured on the same days as the pulmonary function tests.
Period 1 and Period 3 ( within 8 weeks)
Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG)
Time Frame: Period 1 and Period 3 ( within 8 weeks)
Partial pressure of carbon dioxide in ABG performed breathing room air at rest.
Period 1 and Period 3 ( within 8 weeks)
Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG)
Time Frame: Period 1 and Period 3 ( within 8 weeks)
Partial Pressure of Oxygen in ABG breathing room air at rest.
Period 1 and Period 3 ( within 8 weeks)
A-a Gradient (Alveolar-arterial Gradient)
Time Frame: Period 1 and Period 3 ( within 8 weeks)
A-a gradient was measured with ABG breathing room air at rest.
Period 1 and Period 3 ( within 8 weeks)
Oxygen Pulse
Time Frame: Period 1 and Period 3 ( within 8 weeks)
Oxygen pulse during Cardiopulmonary exercise test at peak exercise.
Period 1 and Period 3 ( within 8 weeks)
O2 Saturation at Peak Exercise
Time Frame: Period 1 and Period 3 ( within 8 weeks)
O2 Saturation at Peak Exercise measured during the Cardiopulmonary exercise test.
Period 1 and Period 3 ( within 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kawut, Steven, MD

Collaborators

Pfizer

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

March 3, 2005

First Submitted That Met QC Criteria

March 3, 2005

First Posted (Estimate)

March 4, 2005

Study Record Updates

Last Update Posted (Estimate)

May 21, 2012

Last Update Submitted That Met QC Criteria

May 18, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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