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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)

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ClinicalTrials.gov Identifier: NCT01055405
Recruitment Status : Completed
First Posted : January 25, 2010
Last Update Posted : April 4, 2012
Sponsor:
Information provided by (Responsible Party):
Joan Albert Barbera Mir, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment Phase
COPD Pulmonary Hypertension Drug: Sildenafil Other: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Endurance time [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: April 4, 2012
Last Verified: April 2012

Keywords provided by Joan Albert Barbera Mir, Hospital Clinic of Barcelona:
Exercise tolerance
COPD
Pulmonary hypertension
Sildenafil

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