Sildenafil for Chronic Obstructive Pulmonary Disease

NCT00104637

Last updated date
Study Location
Columbia Univeristy, College of Physicians and Surgeons
New York, New York, 10032, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease, Emphysema
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or emphysema

- FEV1/FVC ratio < 70%

- FEV1 < 80%

- Stable medication regimen

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Chronic Obstructive Pulmonary Disease, EmphysemaSildenafil for Chronic Obstructive Pulmonary Disease
NCT00104637
  1. New York, New York
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sildenafil for Chronic Obstructive Pulmonary Disease
Official Title  ICMJE A Double-blind, Placebo-controlled, Crossover Study of Sildenafil in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary The purpose of this study is to determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Disease, Chronic Obstructive
  • Emphysema
Intervention  ICMJE
  • Drug: sildenafil citrate
    sildenafil citrate 25 mg by mouth thrice daily (po tid)
  • Drug: Placebo
    25 mg po tid
Study Arms  ICMJE
  • Active Comparator: Sildenafil / Placebo
    Sildenafil first, followed by washout, followed by placebo
    Interventions:
    • Drug: sildenafil citrate
    • Drug: Placebo
  • Placebo Comparator: Placebo / Sildenafil
    Placebo first, followed by washout, followed by Sildenafil
    Interventions:
    • Drug: sildenafil citrate
    • Drug: Placebo
Publications * Lederer DJ, Bartels MN, Schluger NW, Brogan F, Jellen P, Thomashow BM, Kawut SM. Sildenafil for chronic obstructive pulmonary disease: a randomized crossover trial. COPD. 2012 Jun;9(3):268-75. doi: 10.3109/15412555.2011.651180. Epub 2012 Feb 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2005)
10
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00104637
Other Study ID Numbers  ICMJE 1022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kawut, Steven, MD
Study Sponsor  ICMJE Kawut, Steven, MD
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Steven M Kawut, M.D., M.S.Columbia University
PRS Account Kawut, Steven, MD
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP