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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00730067
• Other study ID #: 2008-002237-73
• Status: Withdrawn
• Phase: Phase 4
• First received: August 4, 2008
• Last updated: August 22, 2012
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Hypertension

Intervention

Drug:
• sildenafil
Sildenafil 50 mg three times daily
• placebo
tablet with Laetose mono hydrat, talc,Potato tarch, Gelatin, Magnesium stearate.

Locations

Country	Name	City	State
Denmark	Department of Pulmonary Diseases, Århus Sygehus	Århus
Denmark	Department of Cardiology, Skejby sygehus	Århus N

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walk test		at base line, after 2 hours and after 3 months	No
Secondary	assessment of life quality		At baseline and follow up after three months	No
Secondary	Systolic pulmonary pressure		At baseline and follow-up after three months	No
Secondary	Activity of symptoms measured by use of short acting beta agonists		At baseline and follow-up after three months	No
Secondary	Levels of NT-proBNP and apelin		At baseline and follow-up after three months	No