BronchiectasisoPEP-vs-ADNCT03013452
Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis
A study testing oPEP and Autogenic drainage in people with Bronchiectasis, run by Carmel Medical Center at 2 sites in Israel.
Trial summary
In this study, investigating two modes of chest physiotherapy on lung clearance index (LCI), 50 patients with bronchiectasis will be randomized to either oPEP or autogenic drainage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- oPEP and Autogenic drainage
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesIsrael
- Study dates
- 9 Mar 2017to 30 Jun 2020
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High Resolution chest computerized tomography (HRCT) during stable disease imaging bronchiectasis in at least 2 lung lobes
- Sputum production during most days of the year
- Stable chronic therapy during last 4 weeks
- FEV1 = 70% predicted or higher on spirometry
- Able to give informed consent or assent
- Age: 18- 80 years
Who cannot join
- An exacerbation during last 4 weeks before randomization
- Any change in respiratory medications during the past 4 weeks before randomization
- A diagnosis of cystic fibrosis
- A diagnosis of primary ciliary dyskinesia
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Carmel Medical Center
Haifa, 3436209
Michal Shteinberg, Md PhD, 972506265846, michalsh4@clalit.org.il
- Recruiting
Pulmonology Institute, Carmel Medical Center
Haifa, 34362
Michal Shteinberg, MD, PhD, 97248250517, michal.shteinberg@gmail.com
97248250517
About this study
Official title: A Randomized Controlled Trial of Long Term Airway Clearance With Oscillating Positive End Expiratory Pressure Device Versus Autogenic Drainage in People With Bronchiectasis
In this study, investigating two modes of chest physiotherapy on lung clearance index (LCI), 50 patients with bronchiectasis will be randomized to either oPEP or autogenic drainage.
Read the detailed description
One of the fundamental treatments in the management of bronchiectasis is airway clearance, which effectively rids the airways of mucus to prevent secondary infection and inflammation. While effective airway clearance is widely accepted as a first line treatment, the choice of airway clearance method is complicated by lacking evidence base. One of the obstacles to establishing evidence of efficacy of an airway clearance technique or device is the limitations in the choice of endpoints.
Aerobika (Trudell medical international, Canada) is an oscillating positive expiratory pressure (oPEP) device, designed and developed for the effective clearance of secretions in people with suppurative lung diseases. It has been tested and found safe and effective in chronic obstructive pulmonary disease (COPD) - chronic bronchitis.
The lung clearance index (LCI) measured by multiple breath washout (MBW) is a measure of ventilation inhomogeneity and has been shown to be a sensitive lung function test in early lung disease. Its usefulness has been demonstrated in cystic fibrosis (CF), particularly in children and adults with mild disease. LCI has been assessed in bronchiectasis and has been found to be significantly different from normal subjects, and to correlate with Forced Expiratory Volume in 1 second (FEV1).
The aim of this study is to test the long term effect of daily lung clearance on LCI, quality of life and exacerbations using the Aerobika oPEP device versus autogenic drainage (AD) in people with bronchiectasis.
50 patients with confirmed bronchiectasis will be enrolled in this study. Participants will be randomized to daily physiotherapy with either Aerobika or Autogenic drainage. Change in LCI, measured before and after one month, will be the primary endpoint of this study.
- Conditions
- Bronchiectasis
- Being tested
- oPEP, Autogenic drainage
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oPEPDevice
Also called Aerobika device
Daily chest clearance (chest physiotherapy) using an oPEP (Aerobika) device.
Autogenic drainageBehavioural
Daily chest clearance (chest physiotherapy) by Autogenic Drainage method.
| Study group | Role | What they receive |
|---|---|---|
| Autogenic drainage | Active comparator | Chest physiotherapy by autogenic drainage daily for 15 minutes each day, for 1 month. Instruction by a physiotherapist as to proper technique will be given at the beginning of the study. Receives: Behavioral: Autogenic drainage |
| oPEP | Active comparator | Chest physiotherapy with an Aerobika oPEP device daily for 15 minutes each day for 1 month. Instruction by a physiotherapist as to proper technique will be given at the beginning of the study. Receives: Device: oPEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LCI
LCI will be determined before intervention and after 1 month and change will be recorded.
Measured: 1 month
Secondary outcomes (4)
Total score on QOL- B questionnaire
Patients will answer QOL-B questionnaire before and after 1 month of the intervention, and total score will be recorded.
Measured: 1 month
Score on respiratory domain of QOL-B questionnaire
Patients will answer QOL-B questionnaire before and after 1 month of the intervention, and score on respiratory domain will be recorded.
Measured: 1 month
FEV1 (% predicted)- difference from baseline
Spirometry will be performed before and after 1 month of the intervention, and change in FEV1 (% of predicted) will be recorded.
Measured: 1 month
Forced Expiratory Volume (FVC) (% predicted)- difference from baseline
Spirometry will be performed before and after 1 month of the intervention, and change in FVC (% of predicted) will be recorded.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start9 Mar 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 modes of physiotherapy: 1- autogenic drainage; 2- oscillating positive expiratory pressure device
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rambam Health Care Campus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013452
- Sponsor's protocol ID
- CMC-16-0087-CTIL
- Acronym
- oPEP-vs-AD
- Status last verified
- Feb 2019
- First submitted
- 1 Jan 2017
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flude LJ, Agent P, Bilton D. Chest physiotherapy techniques in bronchiectasis. Clin Chest Med. 2012 Jun;33(2):351-61. doi: 10.1016/j.ccm.2012.02.009. Epub 2012 Apr 4.
PubMed 22640850Robinson PD, Latzin P, Verbanck S, Hall GL, Horsley A, Gappa M, Thamrin C, Arets HG, Aurora P, Fuchs SI, King GG, Lum S, Macleod K, Paiva M, Pillow JJ, Ranganathan S, Ratjen F, Singer F, Sonnappa S, Stocks J, Subbarao P, Thompson BR, Gustafsson PM. Consensus statement for inert gas washout measurement using multiple- and single- breath tests. Eur Respir J. 2013 Mar;41(3):507-22. doi: 10.1183/09031936.00069712. Epub 2013 Feb 8.
PubMed 23397305Gonem S, Scadding A, Soares M, Singapuri A, Gustafsson P, Ohri C, Range S, Brightling CE, Pavord I, Horsley A, Siddiqui S. Lung clearance index in adults with non-cystic fibrosis bronchiectasis. Respir Res. 2014 May 18;15(1):59. doi: 10.1186/1465-9921-15-59.
PubMed 24884343Rowan SA, Bradley JM, Bradbury I, Lawson J, Lynch T, Gustafsson P, Horsley A, O'Neill K, Ennis M, Elborn JS. Lung clearance index is a repeatable and sensitive indicator of radiological changes in bronchiectasis. Am J Respir Crit Care Med. 2014 Mar 1;189(5):586-92. doi: 10.1164/rccm.201310-1747OC.
PubMed 24428575
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Long Term Airway Clearance With Oscillating Positive End Expiratory Pressure Device Versus Autogenic Drainage in People With Bronchiectasis
- ClinicalTrials.gov ID
- NCT03013452
- Acronym / sponsor ID
- oPEP-vs-AD / CMC-16-0087-CTIL
- Conditions
- Bronchiectasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Collaborators
- Rambam Health Care Campus
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 6 Jan 2017 (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.
In this study, investigating two modes of chest physiotherapy on lung clearance index (LCI), 50 patients with bronchiectasis will be randomized to either oPEP or autogenic drainage.
Detailed description
One of the fundamental treatments in the management of bronchiectasis is airway clearance, which effectively rids the airways of mucus to prevent secondary infection and inflammation. While effective airway clearance is widely accepted as a first line treatment, the choice of airway clearance method is complicated by lacking evidence base. One of the obstacles to establishing evidence of efficacy of an airway clearance technique or device is the limitations in the choice of endpoints.
Aerobika (Trudell medical international, Canada) is an oscillating positive expiratory pressure (oPEP) device, designed and developed for the effective clearance of secretions in people with suppurative lung diseases. It has been tested and found safe and effective in chronic obstructive pulmonary disease (COPD) - chronic bronchitis.
The lung clearance index (LCI) measured by multiple breath washout (MBW) is a measure of ventilation inhomogeneity and has been shown to be a sensitive lung function test in early lung disease. Its usefulness has been demonstrated in cystic fibrosis (CF), particularly in children and adults with mild disease. LCI has been assessed in bronchiectasis and has been found to be significantly different from normal subjects, and to correlate with Forced Expiratory Volume in 1 second (FEV1).
The aim of this study is to test the long term effect of daily lung clearance on LCI, quality of life and exacerbations using the Aerobika oPEP device versus autogenic drainage (AD) in people with bronchiectasis.
50 patients with confirmed bronchiectasis will be enrolled in this study. Participants will be randomized to daily physiotherapy with either Aerobika or Autogenic drainage. Change in LCI, measured before and after one month, will be the primary endpoint of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 modes of physiotherapy: 1- autogenic drainage; 2- oscillating positive expiratory pressure device
| Arm | Type | Receives |
|---|---|---|
| Autogenic drainage | Active comparator | Behavioral: Autogenic drainageChest physiotherapy by autogenic drainage daily for 15 minutes each day, for 1 month. Instruction by a physiotherapist as to proper technique will be given at the beginning of the study. |
| oPEP | Active comparator | Device: oPEPChest physiotherapy with an Aerobika oPEP device daily for 15 minutes each day for 1 month. Instruction by a physiotherapist as to proper technique will be given at the beginning of the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- High Resolution chest computerized tomography (HRCT) during stable disease imaging bronchiectasis in at least 2 lung lobes
- Sputum production during most days of the year
- Stable chronic therapy during last 4 weeks
- FEV1 = 70% predicted or higher on spirometry
- Able to give informed consent or assent
Key exclusion criteria (4 listed)
- An exacerbation during last 4 weeks before randomization
- Any change in respiratory medications during the past 4 weeks before randomization
- A diagnosis of cystic fibrosis
- A diagnosis of primary ciliary dyskinesia
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 |
|---|---|---|
| oPEPAlso: Aerobika deviceDaily chest clearance (chest physiotherapy) using an oPEP (Aerobika) device. | Device | oPEP |
| Autogenic drainageDaily chest clearance (chest physiotherapy) by Autogenic Drainage method. | Behavioural | Autogenic drainage |
Primary outcome
Change in LCI
Time frame: 1 month
LCI will be determined before intervention and after 1 month and change will be recorded.
4 secondary outcomes
Total score on QOL- B questionnaire
Time frame: 1 month
Score on respiratory domain of QOL-B questionnaire
Time frame: 1 month
FEV1 (% predicted)- difference from baseline
Time frame: 1 month
Forced Expiratory Volume (FVC) (% predicted)- difference from baseline
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Background: PubMed 22640850Flude LJ, Agent P, Bilton D. Chest physiotherapy techniques in bronchiectasis. Clin Chest Med. 2012 Jun;33(2):351-61. doi: 10.1016/j.ccm.2012.02.009. Epub 2012 Apr 4.
- Background: PubMed 23397305Robinson PD, Latzin P, Verbanck S, Hall GL, Horsley A, Gappa M, Thamrin C, Arets HG, Aurora P, Fuchs SI, King GG, Lum S, Macleod K, Paiva M, Pillow JJ, Ranganathan S, Ratjen F, Singer F, Sonnappa S, Stocks J, Subbarao P, Thompson BR, Gustafsson PM. Consensus statement for inert gas washout measurement using multiple- and single- breath tests. Eur Respir J. 2013 Mar;41(3):507-22. doi: 10.1183/09031936.00069712. Epub 2013 Feb 8.
- Results publication: PubMed 24884343Gonem S, Scadding A, Soares M, Singapuri A, Gustafsson P, Ohri C, Range S, Brightling CE, Pavord I, Horsley A, Siddiqui S. Lung clearance index in adults with non-cystic fibrosis bronchiectasis. Respir Res. 2014 May 18;15(1):59. doi: 10.1186/1465-9921-15-59.
- Results publication: PubMed 24428575Rowan SA, Bradley JM, Bradbury I, Lawson J, Lynch T, Gustafsson P, Horsley A, O'Neill K, Ennis M, Elborn JS. Lung clearance index is a repeatable and sensitive indicator of radiological changes in bronchiectasis. Am J Respir Crit Care Med. 2014 Mar 1;189(5):586-92. doi: 10.1164/rccm.201310-1747OC.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oPEP and Autogenic drainage in people with Bronchiectasis, run by Carmel Medical Center at 2 sites in Israel.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LCI (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03013452, which also lists 4 linked publications.
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 26 Jul 2019.