Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension

Study Overview
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Brief Summary
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Chronic obstructive pulmonary disease (COPD)can be complicated by an increased pressure in the pulmonary circulation. This worsens the prognosis, but so far it is unknown whether treatment of the increased pulmonary blood pressure betters the patients symptoms. In this study 32 patients with increased pulmonary blood pressure due to COPD will be randomized to 3 months treatment with placebo or sildenafil, which is known to lower the pulmonary blood pressure in other types of pulmonary hypertension. Our hypothesis is that treatment with sildenafil in these patients will improve the functional capacity measured by the distance walked in 6 minutes and life quality.

Official Title
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Sildenafil for COPD-associated Pulmonary Hypertension. A Randomized Double Blinded Placebo Controlled Study.

Conditions
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COPD, Pulmonary Hypertension

Intervention / Treatment
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* Drug: sildenafil
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A mean pulmonary arterial pressure of 25 mmHg measured by right heart catheterization. A diagnosis of COPD-associated pulmonary hypertension, implicating that no other potential cause of pulmonary hypertension is present. Stable COPD, defined by no subjective alterations of symptoms or use of short acting beta-antagonists for minimally six weeks. Any exacerbation resulting in admission to hospital or other contacts to a physician must have ceased for at least 6 weeks before entering the study. Age > 18 Informed written consent. Reliable anticonception for fertile women. Exclusion Criteria: Rheumatic disease limiting walking capacity. Exacerbation in COPD during the study. Age>80 years FEV1 < 25 % of predicted. Allergy towards contents of sildenafil or placebo tablets. Fall in blood pressure of > 30 mmHg systolic or >20 mmHg diastolic after intake of the first dose of trial medication. Fall in peripheral saturation of > 5% after intake of the first dose of trial medication. Treatment with nitrous vasodilators or aminophyllamines.

Ages Eligible for Study
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Minimum Age: 18 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: 1<br>Sildenafil treatment | Drug: sildenafil<br>* Sildenafil 50 mg three times daily<br>* Other names: Viagra;|
| Placebo Comparator: 2<br>placebo | Drug: placebo<br>* tablet with Laetose mono hydrat, talc,Potato tarch, Gelatin, Magnesium stearate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk test |  | at base line, after 2 hours and after 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of life quality |  | At baseline and follow up after three months | 
| Systolic pulmonary pressure |  | At baseline and follow-up after three months | 
| Activity of symptoms measured by use of short acting beta agonists |  | At baseline and follow-up after three months | 
| Levels of NT-proBNP and apelin |  | At baseline and follow-up after three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Pulmonary hypertension, Sildenafil, NT-pro BNP, apelin