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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00104637
Other study ID # 1022
Secondary ID
Status Completed
Phase Phase 2
First received March 3, 2005
Last updated May 18, 2012
Start date February 2005
Est. completion date November 2008

Study information

Verified date May 2012
Source Kawut, Steven, MD
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
sildenafil citrate
sildenafil citrate 25 mg by mouth thrice daily (po tid)
Placebo
25 mg po tid

Locations

Country Name City State
United States Columbia Univeristy, College of Physicians and Surgeons New York New York

Sponsors (2)

Lead Sponsor Collaborator
Kawut, Steven, MD Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6 Minute Walk Distance The distance a subject walked within 6 minutes was measured and documented. Period 1 and Period 3 ( within 8 weeks) No
Primary VO2 Peak (Oxygen Consumption at Peak Exercise) Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3. Period 1 and Period 3 ( within 8 weeks) No
Secondary Pulmonary Function FVC (Forced Vital Capacity) Data to calculate results for FVC was based on Period 1. Period 1 (4 weeks) No
Secondary 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. Period 1 ( 4 weeks) No
Secondary 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. Period 1 and Period 3 ( within 8 weeks) No
Secondary Diffusing Capacity of Carbon Monoxide (DLCO) Carbon Monoxide Diffusing Capacity was measured on the same days as the pulmonary function tests. Period 1 and Period 3 ( within 8 weeks) No
Secondary Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG) Partial pressure of carbon dioxide in ABG performed breathing room air at rest. Period 1 and Period 3 ( within 8 weeks) No
Secondary Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG) Partial Pressure of Oxygen in ABG breathing room air at rest. Period 1 and Period 3 ( within 8 weeks) No
Secondary A-a Gradient (Alveolar-arterial Gradient) A-a gradient was measured with ABG breathing room air at rest. Period 1 and Period 3 ( within 8 weeks) No
Secondary Oxygen Pulse Oxygen pulse during Cardiopulmonary exercise test at peak exercise. Period 1 and Period 3 ( within 8 weeks) No
Secondary O2 Saturation at Peak Exercise O2 Saturation at Peak Exercise measured during the Cardiopulmonary exercise test. Period 1 and Period 3 ( within 8 weeks) No
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