Sildenafil for Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Double-blind, Placebo-controlled, Crossover Study of Sildenafil in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104637
• Other study ID #: 1022
• 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

• Chronic Disease
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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