Sildenafil for Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Kawut, Steven, MD
ClinicalTrials.gov Identifier:
NCT00104637
First received: March 3, 2005
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Emphysema
Drug: sildenafil citrate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Crossover Study of Sildenafil in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Kawut, Steven, MD:

Primary Outcome Measures:
  • 6 Minute Walk Distance [ Time Frame: Period 1 and Period 3 ( within 8 weeks) ] [ Designated as safety issue: No ]
    The distance a subject walked within 6 minutes was measured and documented.

  • VO2 Peak (Oxygen Consumption at Peak Exercise) [ Time Frame: Period 1 and Period 3 ( within 8 weeks) ] [ Designated as safety issue: No ]
    Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3.


Secondary Outcome Measures:
  • Pulmonary Function FVC (Forced Vital Capacity) [ Time Frame: Period 1 (4 weeks) ] [ Designated as safety issue: No ]
    Data to calculate results for FVC was based on Period 1.

  • Forced Expiratory Volume in the First Second (FEV1 ) [ Time Frame: Period 1 ( 4 weeks) ] [ Designated as safety issue: No ]
    The volume of air exhaled in the first second. Data to calculate results for FEV1 was based on Period 1 only.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Diffusing Capacity of Carbon Monoxide (DLCO) [ Time Frame: Period 1 and Period 3 ( within 8 weeks) ] [ Designated as safety issue: No ]
    Carbon Monoxide Diffusing Capacity was measured on the same days as the pulmonary function tests.

  • Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG) [ Time Frame: Period 1 and Period 3 ( within 8 weeks) ] [ Designated as safety issue: No ]
    Partial pressure of carbon dioxide in ABG performed breathing room air at rest.

  • Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG) [ Time Frame: Period 1 and Period 3 ( within 8 weeks) ] [ Designated as safety issue: No ]
    Partial Pressure of Oxygen in ABG breathing room air at rest.

  • A-a Gradient (Alveolar-arterial Gradient) [ Time Frame: Period 1 and Period 3 ( within 8 weeks) ] [ Designated as safety issue: No ]
    A-a gradient was measured with ABG breathing room air at rest.

  • Oxygen Pulse [ Time Frame: Period 1 and Period 3 ( within 8 weeks) ] [ Designated as safety issue: No ]
    Oxygen pulse during Cardiopulmonary exercise test at peak exercise.

  • O2 Saturation at Peak Exercise [ Time Frame: Period 1 and Period 3 ( within 8 weeks) ] [ Designated as safety issue: No ]
    O2 Saturation at Peak Exercise measured during the Cardiopulmonary exercise test.


Enrollment: 10
Study Start Date: February 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104637

Locations
United States, New York
Columbia Univeristy, College of Physicians and Surgeons
New York, New York, United States, 10032
Sponsors and Collaborators
Kawut, Steven, MD
Pfizer
Investigators
Principal Investigator: Steven M Kawut, M.D., M.S. Columbia University
  More Information

No publications provided by Kawut, Steven, MD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kawut, Steven, MD
ClinicalTrials.gov Identifier: NCT00104637     History of Changes
Other Study ID Numbers: 1022
Study First Received: March 3, 2005
Results First Received: April 4, 2012
Last Updated: May 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Kawut, Steven, MD:
Chronic Obstructive Pulmonary Disease
Emphysema
Phosphodiesterase inhibitors
Sildenafil
Exercise testing
Quality of life

Additional relevant MeSH terms:
Chronic Disease
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Phosphodiesterase Inhibitors
Sildenafil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Phosphodiesterase 5 Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014