Chronic HypersecretionsPhase 4UNIKONCT00700388
Efficacy of Temporary Positive Expiratory Pressure (TPEP) in Chronic Hypersecretion
A Phase 4 study testing TPEP device (UNIKO) and MABT (Manually assisted breathing techniques) in people with Chronic Hypersecretions, run by Villa Pineta Hospital at 6 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Chronic Hypersecretions
- What is being tested?
- TPEP device (UNIKO) and MABT (Manually assisted breathing techniques)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesItaly
- Study dates
- Jul 2008to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Fondazione Maugeri IRCCS
Lumezzane, Brescia
Ospedale San Giuseppe - Riabilitazione Specialistica
Milan, 20100
Villa Pineta Hospital
Pavullo nel Frignano, Modena, 41026
Fondazione Maugeri IRCCS
Veruno, Novara
Centro Riabilitazione Auxilium Vitae
Volterra, Pisa
Ospedale San Raffaele IRCCS
Volterra, Roma, 00049
About this study
Official title: Multicenter Controlled Trial on Efficacy of TPEP Device in Adult Patients With Chronic Hypersecretion
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:
- Sputum characteristics
- Daily sputum volume
- Perceived sensation
- Lung functions (as assessed by spirometry and RM strength)
- Conditions
- Chronic Hypersecretions
- Being tested
- TPEP device (UNIKO), MABT (Manually assisted breathing techniques)
- Keywords
- Chronic bronchitis, COPD, Bronchiectasis
- Medical subject headings
- Bronchitis, Chronic, Pulmonary Disease, Chronic Obstructive, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPEP device (UNIKO)Device
Also called 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.
MABT (Manually assisted breathing techniques)Procedure or surgery
Also called MABT
Conventionally manually assisted breathing techniques
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | TPEP added to conventional manually assisted breathing techniques (MABT) Receives: Device: TPEP device (UNIKO) |
| 2 | Active comparator | Manually assisted breathing techniques (MABT) alone Receives: Procedure: MABT (Manually assisted breathing techniques) |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)
Measured: Day 10
Secondary outcomes (4)
Sputum volume
Measured: Day 1 to 10
Sputum characteristics
Measured: Day 1 to 10
Individual's perceived sensation (VAS scale)
Measured: Day 1 to 10
Lung function (volumes and respiratory muscle performance)
Measured: Day 1 - 3 - 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HypersecretionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Villa Pineta Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Modena and Reggio Emilia
- Investigators
- Enrico M. Clini, MD, Study director, University of Modena - Villa Pineta HospitalNicolino Ambrosino, MD, Study chair, AOU Pisana - Cisanello (Pisa)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700388
- Sponsor's protocol ID
- 69/08
- Acronym
- UNIKO
- Status last verified
- Jan 2010
- First submitted
- 17 Jun 2008
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Controlled Trial on Efficacy of TPEP Device in Adult Patients With Chronic Hypersecretion
- ClinicalTrials.gov ID
- NCT00700388
- Acronym / sponsor ID
- UNIKO / 69/08
- Conditions
- Chronic Hypersecretions
- Keywords
- Chronic bronchitis, COPD, Bronchiectasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Villa Pineta HospitalUniversity, hospital or other
- Collaborators
- University of Modena and Reggio Emilia
- Study start
- Jul 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Sputum characteristics
- Daily sputum volume
- Perceived sensation
- Lung functions (as assessed by spirometry and RM strength)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: TPEP device (UNIKO)TPEP added to conventional manually assisted breathing techniques (MABT) |
| 2 | Active comparator | Procedure: MABT (Manually assisted breathing techniques)Manually assisted breathing techniques (MABT) alone |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- childhood
- presence of acute exacerbation
- severe concomitant cardiovascular diseases
- concomitant neoplastic diseases
- non compliance/adherence to TPEP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPEP device (UNIKO)Also: UNIKOThis 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. | Device | 1 |
| MABT (Manually assisted breathing techniques)Also: MABTConventionally manually assisted breathing techniques | Procedure or surgery | 2 |
Primary outcome
arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)
Time frame: Day 10
4 secondary outcomes
Sputum volume
Time frame: Day 1 to 10
Sputum characteristics
Time frame: Day 1 to 10
Individual's perceived sensation (VAS scale)
Time frame: Day 1 to 10
Lung function (volumes and respiratory muscle performance)
Time frame: Day 1 - 3 - 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrico M. Clini, MD study director
University of Modena - Villa Pineta Hospital
Nicolino Ambrosino, MD study chair
AOU Pisana - Cisanello (Pisa)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TPEP device (UNIKO) and MABT (Manually assisted breathing techniques) in people with Chronic Hypersecretions, run by Villa Pineta Hospital at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index) (time frame: Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2011.