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CompletedNCT00700388UNIKOUpdated Aug 4, 2011

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

A Phase 4 interventional study of TPEP device (UNIKO) and MABT (Manually assisted breathing techniques) in Chronic Hypersecretions, sponsored by Villa Pineta Hospital. Completed at 6 sites in Italy. Open to participants aged 25 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-08-04.

Sponsored by Villa Pineta Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
25 Years to 85 Years
Sex
All
01

Study 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

Read the 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)
02

Conditions studied

  • Chronic Hypersecretions

Keywords

  • Chronic bronchitis
  • COPD
  • Bronchiectasis
03

In context

Lead sponsor

Villa Pineta Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 85 Years
Sexes eligible
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

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    1

    TPEP added to conventional manually assisted breathing techniques (MABT)

    Device: TPEP device (UNIKO)

  • Active comparator
    2

    Manually assisted breathing techniques (MABT) alone

    Procedure: MABT (Manually assisted breathing techniques)

Interventions

  • DeviceTPEP 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.

    Also known as: UNIKO

  • ProcedureMABT (Manually assisted breathing techniques)

    Conventionally manually assisted breathing techniques

    Also known as: MABT

06

What researchers measure

Primary outcomes

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

    Time frame: Day 10

Secondary outcomes

  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

07

Study locations

6 sites
  • Fondazione Maugeri IRCCS
    Lumezzane, Brescia, Italy
  • Villa Pineta Hospital
    Pavullo nel Frignano, Modena 41026, Italy
  • Fondazione Maugeri IRCCS
    Veruno, Novara, Italy
  • Centro Riabilitazione Auxilium Vitae
    Volterra, Pisa, Italy
  • Ospedale San Raffaele IRCCS
    Volterra, Roma 00049, Italy
  • Ospedale San Giuseppe - Riabilitazione Specialistica
    Milano, 20100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00700388
Lead sponsor
Villa Pineta Hospital
Collaborators
University of Modena and Reggio Emilia
First posted
Jun 18, 2008
Start date
Jul 2008
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Aug 4, 2011

Study contacts

Enrico M. Clini, MD
study director · University of Modena - Villa Pineta Hospital
Nicolino Ambrosino, MD
study chair · AOU Pisana - Cisanello (Pisa)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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