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

NCT00700388 | Completed Phase 4 DMC

• 1 other identifier: 69/08
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

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

Conditions

Chronic Hypersecretions

Keywords

Chronic bronchitis; COPD; Bronchiectasis

Outcome Measures

Primary Outcomes (1)

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

  Day 10

Secondary Outcomes (4)

• Sputum volume

  Day 1 to 10

• Sputum characteristics

  Day 1 to 10

• Individual's perceived sensation (VAS scale)

  Day 1 to 10

• Lung function (volumes and respiratory muscle performance)

  Day 1 - 3 - 10

Study Arms (2)

1

EXPERIMENTAL

TPEP added to conventional manually assisted breathing techniques (MABT)

Device: TPEP device (UNIKO)

2

ACTIVE COMPARATOR

Manually assisted breathing techniques (MABT) alone

Procedure: MABT (Manually assisted breathing techniques)

Interventions

TPEP device (UNIKO) DEVICE

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

1

MABT (Manually assisted breathing techniques) PROCEDURE

Conventionally manually assisted breathing techniques

Also known as: MABT

2

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Villa Pineta Hospital: lead
• University of Modena and Reggio Emilia: collaborator

Study Sites (6)

Fondazione Maugeri IRCCS

Lumezzane, Brescia, Italy

Location

Villa Pineta Hospital

Pavullo nel Frignano, Modena, 41026, Italy

Location

Fondazione Maugeri IRCCS

Veruno, Novara, Italy

Location

Centro Riabilitazione Auxilium Vitae

Volterra, Pisa, Italy

Location

Ospedale San Raffaele IRCCS

Volterra, Roma, 00049, Italy

Location

Ospedale San Giuseppe - Riabilitazione Specialistica

Milan, 20100, Italy

Location

MeSH Terms

Conditions

Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive; Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enrico M. Clini, MD

  University of Modena - Villa Pineta Hospital

  STUDY DIRECTOR

• Nicolino Ambrosino, MD

  AOU Pisana - Cisanello (Pisa)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 18, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 4, 2011

Record last verified: 2010-01

Locations

IT (6)