Status:
COMPLETED
Efficacy of Temporary Positive Expiratory Pressure (TPEP) in Chronic Hypersecretion
Lead Sponsor:
Villa Pineta Hospital
Collaborating Sponsors:
University of Modena and Reggio Emilia
Conditions:
Chronic Hypersecretions
Eligibility:
All Genders
25-85 years
Phase:
PHASE4
Brief Summary
Mechanical devices to increase the individual's bronchial hygiene are commonly used in patients with chronic retention of secretions and abnormal cough reflex. In this clinical context a new technolog...
Detailed Description
This is a single-blind multicentre controlled randomized trial with consecutive recruitment. Randomization list by blocks will be available. Group comparison will be made between active therapies incl...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00700388
Start Date
July 1 2008
End Date
December 1 2010
Last Update
August 4 2011
Active Locations (6)
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1
Fondazione Maugeri IRCCS
Lumezzane, Brescia, Italy
2
Villa Pineta Hospital
Pavullo nel Frignano, Modena, Italy, 41026
3
Fondazione Maugeri IRCCS
Veruno, Novara, Italy
4
Centro Riabilitazione Auxilium Vitae
Volterra, Pisa, Italy