Clinical trial NCT01055405: Study of Sildenafil Effects in Combination With Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Associated Pulmonary Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Pulmonary Hypertension
Keywords: Exercise tolerance
COPD
Pulmonary hypertension
Sildenafil
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2010-01-25
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Endurance time
timeFrame: 3 months
Secondary outcomes:
measure: 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
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Joan Albert Barbera, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blanco I, Santos S, Gea J, Guell R, Torres F, Gimeno-Santos E, Rodriguez DA, Vilaro J, Gomez B, Roca J, Barbera JA. Sildenafil to improve respiratory rehabilitation outcomes in COPD: a controlled trial. Eur Respir J. 2013 Oct;42(4):982-92. doi: 10.1183/09031936.00176312. Epub 2013 Feb 21.