Back to resultsStudy of Sildenafil Effects in Combination With Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Associated Pulmonary Hypertension (SIL-COPD-02)
Primary Purpose
COPD, Pulmonary Hypertension
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Sildenafil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring Exercise tolerance, COPD, Pulmonary hypertension, Sildenafil
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
Sites / Locations
- Hospital Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sildenafil plus pulmonary rehabilitation
Placebo plus pulmonary rehabilitation
Arm Description
Outcomes
Primary Outcome Measures
Endurance time
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
Full Information
NCT ID
NCT01055405
First Posted
January 22, 2010
Last Updated
April 3, 2012
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT01055405
Brief Title
Study of Sildenafil Effects in Combination With Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Associated Pulmonary Hypertension
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Pulmonary Hypertension
Keywords
Exercise tolerance, COPD, Pulmonary hypertension, Sildenafil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sildenafil plus pulmonary rehabilitation
Arm Type
Experimental
Arm Title
Placebo plus pulmonary rehabilitation
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
Revatio
Intervention Description
Sildenafil 20mg TID orally
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo TID orally
Primary Outcome Measure Information:
Title
Endurance time
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Albert Barbera, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
23429918
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.
Results Reference
derived
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Study of Sildenafil Effects in Combination With Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Associated Pulmonary Hypertension
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