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Trial record 1 of 1 for:    NCT00104637
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Sildenafil for Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT00104637
Recruitment Status : Completed
First Posted : March 4, 2005
Results First Posted : May 21, 2012
Last Update Posted : May 21, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Kawut, Steven, MD

Tracking Information
First Submitted Date  ICMJE March 3, 2005
First Posted Date  ICMJE March 4, 2005
Results First Submitted Date  ICMJE April 4, 2012
Results First Posted Date  ICMJE May 21, 2012
Last Update Posted Date May 21, 2012
Study Start Date  ICMJE February 2005
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2012)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Exercise Function
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2012)
  • Pulmonary Function FVC (Forced Vital Capacity) [ Time Frame: Period 1 (4 weeks) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    A-a gradient was measured with ABG breathing room air at rest.
  • Oxygen Pulse [ Time Frame: Period 1 and Period 3 ( within 8 weeks) ]
    Oxygen pulse during Cardiopulmonary exercise test at peak exercise.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Pulmonary Function
  • Quality of Life
  • Shortness of breath score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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