BronchiectasisNCT01854788
3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis
A study testing Autogenic drainage, Slow expiration with glottis opened in lateral posture and Temporary-positive expiratory pressure in people with Bronchiectasis, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Study design: a randomized, crossover trial. Each patient performed three different airway clearance techniques (Autogenic drainage, slow expiratory with glottis opened in lateral posture [ELTGOL], temporary- positive expiratory pressure [T-PEP] with not similar autonomy degree in a randomized order. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Autogenic drainage, Slow expiration with glottis opened in lateral posture and Temporary-positive expiratory pressure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2010to Aug 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Non Cystic Fibrosis bronchiectasis diagnosed by High Resolution Computed Tomographic
- - Mean sputum production ≥ 15 ml /24h
- - Clinical stability in the last 6 weeks
- - Not carrying out regular chest physiotherapy
- - Forced expiratory volume in 1 second ≥ 30% pred. ; Forced Vital Capacity ≥ 45% pred. and peak expiratory flow >270 L/s
Who cannot join
- - Smoker or non-smoker form less than 2 years
- - Cystic fibrosis
- - Active tuberculosis or sarcoidosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Three Airway Clearance Techniques With Different Autonomy Degrees in Non Cystic Fibrosis Bronchiectasis: Randomized Cross-over Trial.
Study design: a randomized, crossover trial. Each patient performed three different airway clearance techniques (Autogenic drainage, slow expiratory with glottis opened in lateral posture [ELTGOL], temporary- positive expiratory pressure [T-PEP] with not similar autonomy degree in a randomized order. Each technique were applied in 3 sessions during one week at alternate days (Monday /Wednesday/Friday or Tuesday/Thursday/Saturday). The time spent in each bronchial session was 40 minutes. Seven days were the wash-out time period between the different techniques.
- Conditions
- Bronchiectasis
- Being tested
- Autogenic drainage, Slow expiration with glottis opened in lateral posture, Temporary-positive expiratory pressure
- Keywords
- Airway clearance techniques, Mucus clearance, Chest physiotherapy, Autogenic drainage, Slow expiration with glottis opened in lateral posture(ELTGOL), Temporary-positive expiratory pressure (T-PEP), Non cystic fibrosis bronchiectasis
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenic drainageOther
It was performed following J. Chevallier recommendations.In this trial it was considered a self-administrated technique because physiotherapist only gave oral advice in order to ensure a correct performance of the technique.
Slow expiration with glottis opened in lateral postureOther
Also called Slow expiratory with glotis opened in lateral position
It was performed following Postiaux´s recommendations. In this trial the technique was considered active-assisted because the physiotherapy played a role important in their execution.
Temporary-positive expiratory pressureOther
The diaphragmatic breathing was required for this technique whereas patients remain seated in front of the device with a nose clip. The inspiratory /expiratory ratio was 1:2.It was taken into account as a device-administrated technique for this trial.
| Study group | Role | What they receive |
|---|---|---|
| Autogenic drainage | Active comparator | All patients performed all interventions in a randomized order. Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes Receives: Other: Autogenic drainage |
| Slow expiration with glottis opened in lateral posture | Active comparator | All patients performed all interventions in a randomized order.Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes Receives: Other: Slow expiration with glottis opened in lateral posture |
| Temporary-Positive Expiratory Pressure | Active comparator | All patients performed all interventions in a randomized order. Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes Receives: Other: Temporary-positive expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight of sputum expectorated during each airway clearance therapy session
Wet weight sputum production were recollected in one pre-weighted containers. It was measured in grams.
Measured: 40 minutes
Weight of sputum expectorated 24 hours post each bronchial session
Wet weight sputum production were recollected in one pre-weighted containers. It was measured in grams.
Measured: 24 hours
Secondary outcomes (2)
Saint George Respiratory Questionnaire (SGRQ)
Saint George Respiratory Questionnaire (SGRQ) is a self-completed health-related quality of life questionnaire.It was validated in bronchiectasis. It was administrated at the start and at the end of trial.
Measured: Change from baseline at 5 weeks
Leicester Cough Questionnaire (LCQ)
Leicester Cough Questionnaire is a self-completed quality of life measure of the impact of cough severity. It was validated in bronchiectasis. It was administrated at the start and at the end of each technique.
Measured: Changes from baseline arm to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startSep 2010
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Herrero, Hospital Clinic of Barcelona
- Investigators
- Beatriz Herrero, Phy, Principal investigator, Hospital Clinic of BarcelonaEva Polverino, Doctor, Study director, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854788
- Sponsor's protocol ID
- Uniko2010.01
- Status last verified
- May 2013
- First submitted
- 8 Aug 2012
- Last updated
- 16 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Herrero-Cortina B, Alcaraz-Serrano V, Torres A, Polverino E. Reliability and Minimum Important Difference of Sputum Weight in Bronchiectasis. Respir Care. 2020 Oct;65(10):1478-1487. doi: 10.4187/respcare.07175. Epub 2020 Feb 18.
PubMed 32071136Herrero-Cortina B, Vilaro J, Marti D, Torres A, San Miguel-Pagola M, Alcaraz V, Polverino E. Short-term effects of three slow expiratory airway clearance techniques in patients with bronchiectasis: a randomised crossover trial. Physiotherapy. 2016 Dec;102(4):357-364. doi: 10.1016/j.physio.2015.07.005. Epub 2015 Dec 1.
PubMed 26712530
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Three Airway Clearance Techniques With Different Autonomy Degrees in Non Cystic Fibrosis Bronchiectasis: Randomized Cross-over Trial.
- ClinicalTrials.gov ID
- NCT01854788
- Acronym / sponsor ID
- Uniko2010.01
- Conditions
- Bronchiectasis
- Keywords
- Airway clearance techniques, Mucus clearance, Chest physiotherapy, Autogenic drainage, Slow expiration with glottis opened in lateral posture(ELTGOL), Temporary-positive expiratory pressure (T-PEP), Non cystic fibrosis bronchiectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 May 2013 (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.
Study design: a randomized, crossover trial. Each patient performed three different airway clearance techniques (Autogenic drainage, slow expiratory with glottis opened in lateral posture [ELTGOL], temporary- positive expiratory pressure [T-PEP] with not similar autonomy degree in a randomized order. Each technique were applied in 3 sessions during one week at alternate days (Monday /Wednesday/Friday or Tuesday/Thursday/Saturday). The time spent in each bronchial session was 40 minutes. Seven days were the wash-out time period between the different techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autogenic drainage | Active comparator | Other: Autogenic drainageAll patients performed all interventions in a randomized order. Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes |
| Slow expiration with glottis opened in lateral posture | Active comparator | Other: Slow expiration with glottis opened in lateral postureAll patients performed all interventions in a randomized order.Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes |
| Temporary-Positive Expiratory Pressure | Active comparator | Other: Temporary-positive expiratory pressureAll patients performed all interventions in a randomized order. Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - Non Cystic Fibrosis bronchiectasis diagnosed by High Resolution Computed Tomographic
- - Mean sputum production ≥ 15 ml /24h
- - Clinical stability in the last 6 weeks
- - Not carrying out regular chest physiotherapy
- - Forced expiratory volume in 1 second ≥ 30% pred. ; Forced Vital Capacity ≥ 45% pred. and peak expiratory flow >270 L/s
Key exclusion criteria (3 listed)
- - Smoker or non-smoker form less than 2 years
- - Cystic fibrosis
- - Active tuberculosis or sarcoidosis
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 |
|---|---|---|
| Autogenic drainageIt was performed following J. Chevallier recommendations.In this trial it was considered a self-administrated technique because physiotherapist only gave oral advice in order to ensure a correct performance of the technique. | Other | Autogenic drainage |
| Slow expiration with glottis opened in lateral postureAlso: Slow expiratory with glotis opened in lateral positionIt was performed following Postiaux´s recommendations. In this trial the technique was considered active-assisted because the physiotherapy played a role important in their execution. | Other | Slow expiration with glottis opened in lateral posture |
| Temporary-positive expiratory pressureThe diaphragmatic breathing was required for this technique whereas patients remain seated in front of the device with a nose clip. The inspiratory /expiratory ratio was 1:2.It was taken into account as a device-administrated technique for this trial. | Other | Temporary-Positive Expiratory Pressure |
Primary outcome
Weight of sputum expectorated during each airway clearance therapy session
Time frame: 40 minutes
Wet weight sputum production were recollected in one pre-weighted containers. It was measured in grams.
Weight of sputum expectorated 24 hours post each bronchial session
Time frame: 24 hours
Wet weight sputum production were recollected in one pre-weighted containers. It was measured in grams.
2 secondary outcomes
Saint George Respiratory Questionnaire (SGRQ)
Time frame: Change from baseline at 5 weeks
Leicester Cough Questionnaire (LCQ)
Time frame: Changes from baseline arm to 1 week
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 16 May 2013.
- Derived from this study: PubMed 32071136Herrero-Cortina B, Alcaraz-Serrano V, Torres A, Polverino E. Reliability and Minimum Important Difference of Sputum Weight in Bronchiectasis. Respir Care. 2020 Oct;65(10):1478-1487. doi: 10.4187/respcare.07175. Epub 2020 Feb 18.
- Derived from this study: PubMed 26712530Herrero-Cortina B, Vilaro J, Marti D, Torres A, San Miguel-Pagola M, Alcaraz V, Polverino E. Short-term effects of three slow expiratory airway clearance techniques in patients with bronchiectasis: a randomised crossover trial. Physiotherapy. 2016 Dec;102(4):357-364. doi: 10.1016/j.physio.2015.07.005. Epub 2015 Dec 1.
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Bronchiectasis
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.
Beatriz Herrero, Phy principal investigator
Hospital Clinic of Barcelona
Eva Polverino, Doctor study director
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenic drainage, Slow expiration with glottis opened in lateral posture and Temporary-positive expiratory pressure in people with Bronchiectasis, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 5 inclusion and 3 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 16 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
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?
Weight of sputum expectorated during each airway clearance therapy session (time frame: 40 minutes). The study lists 2 primary outcomes in all. 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 NCT01854788, which also lists 2 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 16 May 2013.