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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00700388 |
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Date of registration:
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17/06/2008 |
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Primary sponsor: |
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Public title:
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Efficacy of Temporary Positive Expiratory Pressure (TPEP) in Chronic Hypersecretion
UNIKO |
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Scientific title:
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Multicenter Controlled Trial on Efficacy of TPEP Device in Adult Patients With Chronic Hypersecretion |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00700388 |
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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: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Contacts
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Name:
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Nicolino Ambrosino, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AOU Pisana - Cisanello (Pisa) |
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Name:
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Enrico M. Clini, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Modena - Villa Pineta Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- chronic hypersecretion as defined by > 30 mL/die sputum production (7)
- chronic airway obstruction (by definition)
- COPD, bronchiectasis, asthma, cystic disease, etc. with or without chronic
respiratory failure
- adulthood
- smoking or non-smoking habit
- Peak Cough Expiratory Flow > 150 L*min-1 (5)
- willingness to participate
Exclusion Criteria:
- childhood
- presence of acute exacerbation
- severe concomitant cardiovascular diseases
- concomitant neoplastic diseases
- non compliance/adherence to TPEP
- concomitant use of chronic mechanical ventilation
- use of amynophyllines and/or any active drugs (e.g. N-Acetyl-Cysteine)
Age minimum:
25 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Hypersecretions
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Intervention(s)
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Device: TPEP device (UNIKO)
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Procedure: MABT (Manually assisted breathing techniques)
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Primary Outcome(s)
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arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)
[Time Frame: Day 10]
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Secondary Outcome(s)
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Individual's perceived sensation (VAS scale)
[Time Frame: Day 1 to 10]
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Lung function (volumes and respiratory muscle performance)
[Time Frame: Day 1 - 3 - 10]
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Sputum characteristics
[Time Frame: Day 1 to 10]
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Sputum volume
[Time Frame: Day 1 to 10]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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