Clinical trial NCT00104637: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Emphysema
Keywords: Chronic Obstructive Pulmonary Disease
Emphysema
Phosphodiesterase inhibitors
Sildenafil
Exercise testing
Quality of life
Lead sponsor: Kawut, Steven, MD
Sponsor class: INDIV
Collaborators: name: Pfizer
First posted: 2005-03-04
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 6 Minute Walk Distance
timeFrame: Period 1 and Period 3 ( within 8 weeks)
measure: VO2 Peak (Oxygen Consumption at Peak Exercise)
timeFrame: Period 1 and Period 3 ( within 8 weeks)
Secondary outcomes:
measure: Pulmonary Function FVC (Forced Vital Capacity)
timeFrame: Period 1 (4 weeks)
measure: Forced Expiratory Volume in the First Second (FEV1 )
timeFrame: Period 1 ( 4 weeks)
measure: Borg Dyspnea(Scale That Measures Breathlessness) Score at Finish of 6 Minute Walk Test (6MWT)
timeFrame: Period 1 and Period 3 ( within 8 weeks)
measure: Diffusing Capacity of Carbon Monoxide (DLCO)
timeFrame: Period 1 and Period 3 ( within 8 weeks)
measure: Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG)
timeFrame: Period 1 and Period 3 ( within 8 weeks)
measure: Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG)
timeFrame: Period 1 and Period 3 ( within 8 weeks)
measure: A-a Gradient (Alveolar-arterial Gradient)
timeFrame: Period 1 and Period 3 ( within 8 weeks)
measure: Oxygen Pulse
timeFrame: Period 1 and Period 3 ( within 8 weeks)
measure: O2 Saturation at Peak Exercise
timeFrame: Period 1 and Period 3 ( within 8 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Univeristy, College of Physicians and Surgeons
state: New York
Study officials:
affiliation: Columbia University
name: Steven M Kawut, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
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.