BronchiectasisNCT02324855
Long-term Airway Clearance Therapy in Non-cystic Fibrosis Bronchiectasis
A study of Bronchiectasis, run by Universidad San Jorge at 1 site in Spain.
Trial summary
The main aim is to analyze whether the routine use of chest physiotherapy in non cystic fibrosis bronchiectasis (NCFB) improves the cough severity and the quality of life in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic sputum production during at least 3 months previous enrolment
- At least two confirmed exacerbations during the last year
- Patients able to understand how to perform the airway clearance techniques
- Clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk)
- To be able to provide written, informed consent
Who cannot join
- Cystic Fibrosis
- Carry out regular chest physiotherapy.
- Active haemoptysis during the previous month or recurrent hemoptysis during the last year (more than 4 episodes)
- Waiting a pulmonary transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Airway Clearance Therapy in Non Cystic Fibrosis Bronchiectasis: a Randomized Controlled Trial
The main aim is to analyze whether the routine use of chest physiotherapy in non cystic fibrosis bronchiectasis (NCFB) improves the cough severity and the quality of life in this population. In addition, the secondary end-points include incidences of exacerbations, changes in lung function, exercise capacity, airways inflammation, sputum analysis and eventual adverse events.
Read the detailed description
The present project will be a single-blind , randomized, controlled trial of 12-month daily performing chest physiotherapy compared with usual care, followed by a 3-month intervention-free in non-cystic fibrosis bronchiectasis.
Intervention group will perform daily autonomous airway clearance techniques (positive expiratory pressure technique through Acapella device and autogenic drainage technique). Patients will receive professional sessions once a month.
Control group will receive their usual care and educational sessions about their disease. Physiotherapist will call them once a month.
During the study period the patients' pharmacological treatment remained unchanged
- Conditions
- Bronchiectasis
- Being tested
- Chest physiotherapy plus usual care
- Keywords
- Autogenic drainage, Positive expiratory pressure, Airway clearance technique, Quality of life, Exacerbations, Chest physiotherapy
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest physiotherapy plus usual careOther
Subjects will perform daily chest physiotherapy during at least 30 minutes. Patients will perform a slow expiratory airway clearance technique combined with positive expiratory pressure device (Acapella device, Murray et al.) Each patient will receive 12 supervised professional sessions (once a month).
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Subjects will receive the usual medical care in accordance with Spanish non cystic fibrosis bronchiectasis guidelines. In addition they will receive educational sessions about their disease and their pharmacology treatment. |
| Chest physiotherapy plus usual care | Experimental | Subjects will introduce chest physiotherapy as part of their daily treatment Receives: Other: Chest physiotherapy plus usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire)
Auto-administered questionnaire: Leicester Cough Questionnaire
Measured: 1 year
Secondary outcomes (5)
Quality of life (Quality of life-Bronchiectasis questionnaire)
Auto-administered questionaire: Quality of Life- Bronchiectasis
Measured: 1 year
Exacerbation frequency
Number of exacerbation
Measured: 1 year
Exercise capacity (Incremental field test: shuttle test)
Incremental field test: shuttle test
Measured: 1 year
Lung function
Simple spirometry: Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75
Measured: 1 year
Airway inflammation as assessed by spontaneous sputum analysis
Inflammatory sputum markers: Myeloperoxidase (MPO) and Cytokines (IL-8)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startOct 2015
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Sponsor
- Investigators
- Beatriz Herrero, Msc, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324855
- Sponsor's protocol ID
- Exacerb_BQnoFQ
- Status last verified
- May 2021
- First submitted
- 1 Dec 2014
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Murray MP, Pentland JL, Hill AT. A randomised crossover trial of chest physiotherapy in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Nov;34(5):1086-92. doi: 10.1183/09031936.00055509. Epub 2009 Jun 18.
PubMed 19541717
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Airway Clearance Therapy in Non Cystic Fibrosis Bronchiectasis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02324855
- Acronym / sponsor ID
- Exacerb_BQnoFQ
- Conditions
- Bronchiectasis
- Keywords
- Autogenic drainage, Positive expiratory pressure, Airway clearance technique, Quality of life, Exacerbations, Chest physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- Oct 2015
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 24 Dec 2014 (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.
The main aim is to analyze whether the routine use of chest physiotherapy in non cystic fibrosis bronchiectasis (NCFB) improves the cough severity and the quality of life in this population. In addition, the secondary end-points include incidences of exacerbations, changes in lung function, exercise capacity, airways inflammation, sputum analysis and eventual adverse events.
Detailed description
The present project will be a single-blind , randomized, controlled trial of 12-month daily performing chest physiotherapy compared with usual care, followed by a 3-month intervention-free in non-cystic fibrosis bronchiectasis.
Intervention group will perform daily autonomous airway clearance techniques (positive expiratory pressure technique through Acapella device and autogenic drainage technique). Patients will receive professional sessions once a month.
Control group will receive their usual care and educational sessions about their disease. Physiotherapist will call them once a month.
During the study period the patients' pharmacological treatment remained unchanged
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Subjects will receive the usual medical care in accordance with Spanish non cystic fibrosis bronchiectasis guidelines. In addition they will receive educational sessions about their disease and their pharmacology treatment. |
| Chest physiotherapy plus usual care | Experimental | Other: Chest physiotherapy plus usual careSubjects will introduce chest physiotherapy as part of their daily treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic sputum production during at least 3 months previous enrolment
- At least two confirmed exacerbations during the last year
- Patients able to understand how to perform the airway clearance techniques
- Clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk)
- To be able to provide written, informed consent
Key exclusion criteria (4 listed)
- Cystic Fibrosis
- Carry out regular chest physiotherapy.
- Active haemoptysis during the previous month or recurrent hemoptysis during the last year (more than 4 episodes)
- Waiting a pulmonary transplant
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 |
|---|---|---|
| Chest physiotherapy plus usual careSubjects will perform daily chest physiotherapy during at least 30 minutes. Patients will perform a slow expiratory airway clearance technique combined with positive expiratory pressure device (Acapella device, Murray et al.) Each patient will receive 12 supervised professional sessions (once a month). | Other | Chest physiotherapy plus usual care |
Primary outcome
Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire)
Time frame: 1 year
Auto-administered questionnaire: Leicester Cough Questionnaire
5 secondary outcomes
Quality of life (Quality of life-Bronchiectasis questionnaire)
Time frame: 1 year
Exacerbation frequency
Time frame: 1 year
Exercise capacity (Incremental field test: shuttle test)
Time frame: 1 year
Lung function
Time frame: 1 year
Airway inflammation as assessed by spontaneous sputum analysis
Time frame: 1 year
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 18 May 2021.
- Background: PubMed 19541717Murray MP, Pentland JL, Hill AT. A randomised crossover trial of chest physiotherapy in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Nov;34(5):1086-92. doi: 10.1183/09031936.00055509. Epub 2009 Jun 18.
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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, Msc principal investigator
Universidad San Jorge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Bronchiectasis, run by Universidad San Jorge 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 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: finished, as of the sponsor's last update on 18 May 2021. 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?
Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire) (time frame: 1 year). 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 NCT02324855, which also lists 1 linked publication.
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 18 May 2021.