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Study of Sildenafil Effects in Combination With Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Associated Pulmonary Hypertension (SIL-COPD-02)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joan Albert Barbera Mir, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01055405
First received: January 22, 2010
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
COPD
Pulmonary Hypertension
Drug: Sildenafil
Other: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Endurance time [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: August 2008
Study Completion Date: January 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sildenafil plus pulmonary rehabilitation Drug: Sildenafil
Sildenafil 20mg TID orally
Other Name: Revatio
Placebo Comparator: Placebo plus pulmonary rehabilitation Other: Placebo
Placebo TID orally

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055405

Locations
Spain
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Joan Albert Barbera, MD Hospital Clinic of Barcelona
  More Information

No publications provided by Hospital Clinic of Barcelona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joan Albert Barbera Mir, MD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01055405     History of Changes
Other Study ID Numbers: JA Barbera
Study First Received: January 22, 2010
Last Updated: April 3, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
Exercise tolerance
COPD
Pulmonary hypertension
Sildenafil

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Sildenafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014