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

COPD Clinical Trial

— SIL-COPD-02  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055405
• Other study ID #: JA Barbera
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2010
• Last updated: April 3, 2012
• Start date: August 2008
• Est. completion date: January 2012

Study information

• Verified date: April 2012
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

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 20mg TID orally

Other:
• Placebo
Placebo TID orally

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endurance time		3 months	Yes
Secondary	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	No