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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00700388
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : August 4, 2011
University of Modena and Reggio Emilia
Information provided by:
Villa Pineta Hospital

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 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 or disease Intervention/treatment Phase
Chronic Hypersecretions Device: TPEP device (UNIKO) Procedure: MABT (Manually assisted breathing techniques) Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Multicenter Controlled Trial on Efficacy of TPEP Device in Adult Patients With Chronic Hypersecretion
Study Start Date : July 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index) [ Time Frame: Day 10 ]

Secondary Outcome Measures :
  1. Sputum volume [ Time Frame: Day 1 to 10 ]
  2. Sputum characteristics [ Time Frame: Day 1 to 10 ]
  3. Individual's perceived sensation (VAS scale) [ Time Frame: Day 1 to 10 ]
  4. Lung function (volumes and respiratory muscle performance) [ Time Frame: Day 1 - 3 - 10 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00700388

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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
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Study Director: Enrico M. Clini, MD University of Modena - Villa Pineta Hospital
Study Chair: Nicolino Ambrosino, MD AOU Pisana - Cisanello (Pisa)

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Responsible Party: Prof. Enrico Clini, University of Modena - Villa Pineta Hospital Identifier: NCT00700388    
Other Study ID Numbers: 69/08
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: January 2010
Keywords provided by Villa Pineta Hospital:
Chronic bronchitis