Columbia Univeristy, College of Physicians and Surgeons
New York, 10032, United States
NCT Number: NCT00104637
The purpose of this study is to determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease.
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Notify Me40 year and older
All sexes
Interventional
Phase 2
New York, 10032, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
sildenafil citrate 25 mg by mouth thrice daily (po tid)
25 mg po tid
Time frame: Period 1 and Period 3 ( within 8 weeks)
The distance a subject walked within 6 minutes was measured and documented.
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.
Time frame: Period 1 (4 weeks)
Data to calculate results for FVC was based on Period 1.
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.
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.
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.
Time frame: Period 1 and Period 3 ( within 8 weeks)
Partial pressure of carbon dioxide in ABG performed breathing room air at rest.
Time frame: Period 1 and Period 3 ( within 8 weeks)
Partial Pressure of Oxygen in ABG breathing room air at rest.
Time frame: Period 1 and Period 3 ( within 8 weeks)
A-a gradient was measured with ABG breathing room air at rest.
Time frame: Period 1 and Period 3 ( within 8 weeks)
Oxygen pulse during Cardiopulmonary exercise test at peak exercise.
Time frame: Period 1 and Period 3 ( within 8 weeks)
O2 Saturation at Peak Exercise measured during the Cardiopulmonary exercise test.
Kawut, Steven, MD
Indiv
A Double-blind, Placebo-controlled, Crossover Study of Sildenafil in Patients With Chronic Obstructive Pulmonary Disease
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