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Sildenafil for Chronic Obstructive Pulmonary Disease

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Emphysema

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sildenafil citrate
Placebo
Sponsored by
Kawut, Steven, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic Obstructive Pulmonary Disease, Emphysema, Phosphodiesterase inhibitors, Sildenafil, Exercise testing, Quality of life

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia Univeristy, College of Physicians and Surgeons

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sildenafil / Placebo

Placebo / Sildenafil

Arm Description

Sildenafil first, followed by washout, followed by placebo

Placebo first, followed by washout, followed by Sildenafil

Outcomes

Primary Outcome Measures

6 Minute Walk Distance
The distance a subject walked within 6 minutes was measured and documented.
VO2 Peak (Oxygen Consumption at Peak Exercise)
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)
Data to calculate results for FVC was based on Period 1.
Forced Expiratory Volume in the First Second (FEV1 )
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)
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)
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)
Partial pressure of carbon dioxide in ABG performed breathing room air at rest.
Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG)
Partial Pressure of Oxygen in ABG breathing room air at rest.
A-a Gradient (Alveolar-arterial Gradient)
A-a gradient was measured with ABG breathing room air at rest.
Oxygen Pulse
Oxygen pulse during Cardiopulmonary exercise test at peak exercise.
O2 Saturation at Peak Exercise
O2 Saturation at Peak Exercise measured during the Cardiopulmonary exercise test.

Full Information

First Posted
March 3, 2005
Last Updated
May 18, 2012
Sponsor
Kawut, Steven, MD
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00104637
Brief Title
Sildenafil for Chronic Obstructive Pulmonary Disease
Official Title
A Double-blind, Placebo-controlled, Crossover Study of Sildenafil in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kawut, Steven, MD
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Emphysema
Keywords
Chronic Obstructive Pulmonary Disease, Emphysema, Phosphodiesterase inhibitors, Sildenafil, Exercise testing, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sildenafil / Placebo
Arm Type
Active Comparator
Arm Description
Sildenafil first, followed by washout, followed by placebo
Arm Title
Placebo / Sildenafil
Arm Type
Placebo Comparator
Arm Description
Placebo first, followed by washout, followed by Sildenafil
Intervention Type
Drug
Intervention Name(s)
sildenafil citrate
Intervention Description
sildenafil citrate 25 mg by mouth thrice daily (po tid)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
25 mg po tid
Primary Outcome Measure Information:
Title
6 Minute Walk Distance
Description
The distance a subject walked within 6 minutes was measured and documented.
Time Frame
Period 1 and Period 3 ( within 8 weeks)
Title
VO2 Peak (Oxygen Consumption at Peak Exercise)
Description
Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3.
Time Frame
Period 1 and Period 3 ( within 8 weeks)
Secondary Outcome Measure Information:
Title
Pulmonary Function FVC (Forced Vital Capacity)
Description
Data to calculate results for FVC was based on Period 1.
Time Frame
Period 1 (4 weeks)
Title
Forced Expiratory Volume in the First Second (FEV1 )
Description
The volume of air exhaled in the first second. Data to calculate results for FEV1 was based on Period 1 only.
Time Frame
Period 1 ( 4 weeks)
Title
Borg Dyspnea(Scale That Measures Breathlessness) Score at Finish of 6 Minute Walk Test (6MWT)
Description
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.
Time Frame
Period 1 and Period 3 ( within 8 weeks)
Title
Diffusing Capacity of Carbon Monoxide (DLCO)
Description
Carbon Monoxide Diffusing Capacity was measured on the same days as the pulmonary function tests.
Time Frame
Period 1 and Period 3 ( within 8 weeks)
Title
Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG)
Description
Partial pressure of carbon dioxide in ABG performed breathing room air at rest.
Time Frame
Period 1 and Period 3 ( within 8 weeks)
Title
Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG)
Description
Partial Pressure of Oxygen in ABG breathing room air at rest.
Time Frame
Period 1 and Period 3 ( within 8 weeks)
Title
A-a Gradient (Alveolar-arterial Gradient)
Description
A-a gradient was measured with ABG breathing room air at rest.
Time Frame
Period 1 and Period 3 ( within 8 weeks)
Title
Oxygen Pulse
Description
Oxygen pulse during Cardiopulmonary exercise test at peak exercise.
Time Frame
Period 1 and Period 3 ( within 8 weeks)
Title
O2 Saturation at Peak Exercise
Description
O2 Saturation at Peak Exercise measured during the Cardiopulmonary exercise test.
Time Frame
Period 1 and Period 3 ( within 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M Kawut, M.D., M.S.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia Univeristy, College of Physicians and Surgeons
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22360383
Citation
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.
Results Reference
derived

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Sildenafil for Chronic Obstructive Pulmonary Disease

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