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Sildenafil for Chronic Obstructive Pulmonary Disease - Article


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Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD)


Clinical Trial: Sildenafil for Chronic Obstructive Pulmonary Disease

This study is currently recruiting patients.

Sponsors and Collaborators: Kawut, Steven, MD
Pfizer
Information provided by: Kawut, Steven, MD

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 Treatment or Intervention Phase
Pulmonary Disease, Chronic Obstructive
Emphysema
 Drug: sildenafil citrate
Phase II

MedlinePlus related topics:  COPD (Chronic Obstructive Pulmonary Disease);   Emphysema

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Official Title: A Double-blind, Placebo-controlled, Crossover Study of Sildenafil in Patients with Chronic Obstructive Pulmonary Disease

Further Study Details: 
Primary Outcomes: Exercise Function
Secondary Outcomes: Pulmonary Function; Quality of Life; Shortness of breath score
Expected Total Enrollment:  10

Study start: February 2005;  Expected completion: June 2006
Last follow-up: June 2006;  Data entry closure: June 2006

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   -   70 Years,  Genders Eligible for Study:  Both

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 hospitaliztion in the past 3 months
  • Heart disease
  • Contraindication to sildenafil
  • Unrelated lung disease
  • Requirement for supplemental oxygen use
  • Inability to walk or pedal on a stationary bike
  • Age 71 or older
  • Pregnancy or breast-feeding
  • Pulmonary hypertension at rest

Location and Contact Information


New York
      Columbia Univeristy, College of Physicians and Surgeons, New York,  New York,  10032,  United States; Recruiting
Pat Jellen, R.N.  212-305-1158 
Fran Brogan, R.N.  (212) 305-1158 
Steven M Kawut, M.D., M.S.,  Principal Investigator
Neil W Schluger, M.D.,  Sub-Investigator
Byron M Thomashow, M.D.,  Sub-Investigator
Matthew N Bartels, M.D., M.P.H.,  Sub-Investigator
David J Lederer, M.D.,  Sub-Investigator

More Information

Study ID Numbers:  1022
Record last reviewed:  March 2005
Last Updated:  March 9, 2005
Record first received:  March 3, 2005
ClinicalTrials.gov Identifier:  NCT00104637
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 13, 2008



Page Updated: October 3, 2005
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