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Efficacy of Temporary Positive Expiratory Pressure (TPEP) in Chronic Hypersecretion (UNIKO)

This study has been completed.
Sponsor:
Collaborator:
University of Modena and Reggio Emilia
Information provided by:
Villa Pineta Hospital
ClinicalTrials.gov Identifier:
NCT00700388
First received: June 17, 2008
Last updated: August 2, 2011
Last verified: January 2010
History of Changes
  Purpose

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 technology (namely TPEP® - Temporary Positive Expiratory Pressure) has been recently developed with the aim to improve the respiratory condition in patients suffering from chronic respiratory diseases. This trial has the aim to assess the clinical efficacy of TPEP in patients with chronic hypersecretion and airways obstruction, but with a normal competence of the cough reflex


Condition Intervention Phase
Chronic Hypersecretions
 Device: TPEP device (UNIKO)
Procedure: MABT (Manually assisted breathing techniques)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Multicenter Controlled Trial on Efficacy of TPEP Device in Adult Patients With Chronic Hypersecretion

Resource links provided by NLM:

MedlinePlus related topics: Cough
U.S. FDA Resources

Further study details as provided by Villa Pineta Hospital:

Primary Outcome Measures:
  • arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index) [ Time Frame: Day 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sputum volume [ Time Frame: Day 1 to 10 ] [ Designated as safety issue: No ]
  • Sputum characteristics [ Time Frame: Day 1 to 10 ] [ Designated as safety issue: No ]
  • Individual's perceived sensation (VAS scale) [ Time Frame: Day 1 to 10 ] [ Designated as safety issue: No ]
  • Lung function (volumes and respiratory muscle performance) [ Time Frame: Day 1 - 3 - 10 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: July 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TPEP added to conventional manually assisted breathing techniques (MABT)
 Device: TPEP device (UNIKO)
This technique is mainly based on a continuous low-pressure insufflation in the airways, which is likely to reduce (or even avoid) the potential pressure-related damages of other commonly used devices. This device should be used only in those individuals who are showing a normal competence of their cough reflex, thus it should be considered as a means which may help those techniques normally adopted for the individual's bronchial hygiene.
Other Name: UNIKO
Active Comparator: 2
Manually assisted breathing techniques (MABT) alone
 Procedure: MABT (Manually assisted breathing techniques)
Conventionally manually assisted breathing techniques
Other Name: MABT

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 including TPEP added to conventional MABT (Intervention) or MABT alone (Control). Active therapy will last 10 consecutive daily sessions in both groups.

Primary outcome

Efficacy comparison on change in:

a.arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)

Secondary outcomes

Efficacy comparison on change in:

  1. Sputum characteristics
  2. Daily sputum volume
  3. Perceived sensation
  4. Lung functions (as assessed by spirometry and RM strength)
  Eligibility

Ages Eligible for Study:   25 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700388

Locations
Italy
Fondazione Maugeri IRCCS
Lumezzane, Brescia, Italy
Villa Pineta Hospital
Pavullo nel Frignano, Modena, Italy, 41026
Fondazione Maugeri IRCCS
Veruno, Novara, Italy
Centro Riabilitazione Auxilium Vitae
Volterra, Pisa, Italy
Ospedale San Raffaele IRCCS
Volterra, Roma, Italy, 00049
Ospedale San Giuseppe - Riabilitazione Specialistica
Milano, Italy, 20100
Sponsors and Collaborators
Villa Pineta Hospital
University of Modena and Reggio Emilia
Investigators
Study Director: Enrico M. Clini, MD University of Modena - Villa Pineta Hospital
Study Chair: Nicolino Ambrosino, MD AOU Pisana - Cisanello (Pisa)
  More Information

No publications provided

Responsible Party: Prof. Enrico Clini, University of Modena - Villa Pineta Hospital
ClinicalTrials.gov Identifier: NCT00700388     History of Changes
Other Study ID Numbers: 69/08
Study First Received: June 17, 2008
Last Updated: August 2, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: National Institute of Health

Keywords provided by Villa Pineta Hospital:
Chronic bronchitis
COPD
Bronchiectasis

ClinicalTrials.gov processed this record on May 16, 2013