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Completed

NCT Number: NCT00104637

Sildenafil for 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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Columbia Univeristy, College of Physicians and Surgeons

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sildenafil citrate

Drug

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

Placebo

Drug

25 mg po tid

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Pulmonary Function FVC (Forced Vital Capacity)

    Time frame: Period 1 (4 weeks)

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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Oxygen Pulse

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

    Oxygen pulse during Cardiopulmonary exercise test at peak exercise.

  9. 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.

Sponsors and collaborators

Lead sponsor

Kawut, Steven, MD

Indiv

Collaborators

  • Pfizer

Registry information

Official study title

A Double-blind, Placebo-controlled, Crossover Study of Sildenafil in Patients With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Mar 4, 2005
Registry last updated
May 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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