Study of Sildenafil Effects in Combination With Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Associated Pulmonary Hypertension

Study Overview
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Brief Summary
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Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD), the investigators hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition.

Detailed Description
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It is a prospective, randomized, double-blind, placebo controlled trial to assess the effect of 3 months treatment with sildenafil (20 mg/8 h), added to a pulmonary rehabilitation program, on exercise tolerance. Subjects: 60 patients (30 by treatment group). Main end-point variable: endurance time in constant work exercise test (CWET). Other measurements: 6 min walk distance, performance in incremental exercise test, physiological and metabolic response at iso-time and iso-load in CWET, dyspnea, and health-related quality of life.

Official Title
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Phase IV Study on the Effects of Sildenafil in Combination With Pulmonary Rehabilitation Program on Exercise Tolerance in Patients With COPD and Pulmonary Hypertension

Conditions
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COPD, Pulmonary Hypertension

Intervention / Treatment
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* Drug: Sildenafil
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD, FEV1 < 80% ref. and FEV1/FVC < 0.7 post bronchodilator Age 40-80 years Pulmonary hypertension Consent to participate in the study Exclusion Criteria: Pulmonary or extrapulmonary disease that modifies gas exchange or pulmonary hemodynamics Recent exacerbation (<4 weeks) (temporally) Patients treated with nitrates or CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir) Ischemic optic neuropathy Patients treated with phosphodiesterase-5 inhibitors Patients with ischemic cardiopathy Systemic disease that could modified the results Patients unable to practise exercise

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sildenafil plus pulmonary rehabilitation<br> | Drug: Sildenafil<br>* Sildenafil 20mg TID orally<br>* Other names: Revatio;|
| Placebo Comparator: Placebo plus pulmonary rehabilitation<br> | Other: Placebo<br>* Placebo TID orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endurance time |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 min walk distance, performance in incremental exercise test, physiological and metabolic response at iso-time and iso-load in CWET, dyspnea, and health-related quality of life |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise tolerance, COPD, Pulmonary hypertension, Sildenafil