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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01382368 |
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Date of registration:
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02/05/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients
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Scientific title:
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Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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60 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT01382368 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Israel
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Contacts
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Name:
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Mordechai R Kramer, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rabin Medical Center, Belinson Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients with severe COPD GOLD stage III- IV, FEV1 30-50% or less of predicted
values, greater shortness of breath, reduced exercise capacity, repeated excretions
and\ or with chronic respiratory failure [9, 39].
2. IPF patients diagnosed essentially according to the American Thoracic and European
Respiratory Societies (ATS-ERS) by clinical diagnostic criteria of: (a)
High-resolution computed tomography (HRCT) demonstrating a pattern of "confident" or
"possible" IPF (b) Abnormal pulmonary physiology with evidence of restriction and/or
impaired gas exchange (can exist during exercise alone) (c) Exclusion of other known
causes of interstitial lung disease (e.g.: connective tissue disease, environmental
exposure,etc.)[31].
3. Patients post Pneumonectomy more than 6 month from the amputation surgery for any
diagnosis (Cancer, Trauma, and Infection- Bronchiectasis).
Exclusion Criteria:
1. Patients with known sensitivity or contraindications to phosphodiesterase 5 (PDE-5)
inhibitor therapies will be excluding from the study.
2. Thromboembolic disease will be excluded by pulmonary CT-angiography or perfusion
scan.
3. Patients with a history of left-sided heart failure will be excluded.
4. Patients will also exclude if they are on regular treatment with nitrates or PDE-5
inhibitors (Sildenafil, Tadalafil, Vardenafil).
Age minimum:
30 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Chronic Obstructive Pulmonary Disease
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Intervention(s)
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Drug: Sildenafil
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Primary Outcome(s)
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Functional Tests
[Time Frame: 2-30 days between exercise tests]
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6 min walk test
[Time Frame: 2-30 days between exercise tests]
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VO2 Peak
[Time Frame: 2-30 days between exercise tests]
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Secondary Outcome(s)
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Pulmonary Arterial Pressure
[Time Frame: 2-30 days between exercise tests]
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NT-pro-BNP
[Time Frame: 2-30 days between exercise tests]
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Secondary ID(s)
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RMCBH116278 CTIL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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