Clinical trial NCT00700388: Efficacy of Temporary Positive Expiratory Pressure (TPEP) in Chronic Hypersecretion
Official title: Multicenter Controlled Trial on Efficacy of TPEP Device in Adult Patients With Chronic Hypersecretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hypersecretions
Keywords: Chronic bronchitis
COPD
Bronchiectasis
Lead sponsor: Villa Pineta Hospital
Sponsor class: OTHER
Collaborators: name: University of Modena and Reggio Emilia
First posted: 2008-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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)

Primary outcomes:
measure: arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)
timeFrame: Day 10
Secondary outcomes:
measure: Sputum volume
timeFrame: Day 1 to 10
measure: Sputum characteristics
timeFrame: Day 1 to 10
measure: Individual's perceived sensation (VAS scale)
timeFrame: Day 1 to 10
measure: Lung function (volumes and respiratory muscle performance)
timeFrame: Day 1 - 3 - 10
Other outcomes:
Locations:
city: Lumezzane
country: Italy
facility: Fondazione Maugeri IRCCS
state: Brescia
city: Pavullo nel Frignano
country: Italy
facility: Villa Pineta Hospital
state: Modena
city: Veruno
country: Italy
facility: Fondazione Maugeri IRCCS
state: Novara
city: Volterra
country: Italy
facility: Centro Riabilitazione Auxilium Vitae
state: Pisa
city: Volterra
country: Italy
facility: Ospedale San Raffaele IRCCS
state: Roma
city: Milano
country: Italy
facility: Ospedale San Giuseppe - Riabilitazione Specialistica
Study officials:
affiliation: University of Modena - Villa Pineta Hospital
name: Enrico M. Clini, MD
role: STUDY_DIRECTOR
affiliation: AOU Pisana - Cisanello (Pisa)
name: Nicolino Ambrosino, MD
role: STUDY_CHAIR
References: