AsthmaNCT05593315
Efficacy of the Combination of Mindfulness and Buteyko Techniques for the Improvement of Poorly Controlled Asthma.
A study testing Mindfulness and Buteyko techniques in people with Asthma and Anxiety, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Administration of a combined program for general (Mindfulness) and respiratory (Buteyko technique) relationship in patients with poorly controlled asthma and anxiety/stress to determine if it provides an improvement in current control and future risk of asthma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Mindfulness and Buteyko techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to 31 Dec 2025
- 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
- Diagnosis of poorly controlled asthma
- In treatment with a combination of ICS/LABA at medium doses
- Anxiety and/or functional dyspnea
- Attended in the outpatient consultations of the Asthma Unit of the Pneumology and Allergy Service of the Hospital de la Santa Creu i Sant Pau in Barcelona
Who cannot join
- Severe asthma exacerbation in the last 30 days
- Severe disabling comorbidity
- Severe psychiatric illness
- Inability to complete questionnaires.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
Barcelona, 08041
Vicente Plaza, MD, +34-935565972, vplaza@santpau.cat
About this study
Official title: Efficacy of the Combination of General Relaxation (Mindfulness) and Respiratory (Buteyko) Techniques for the Improvement of Poorly Controlled Asthma. The MBA Study
Administration of a combined program for general (Mindfulness) and respiratory (Buteyko technique) relationship in patients with poorly controlled asthma and anxiety/stress to determine if it provides an improvement in current control and future risk of asthma.
Read the detailed description
A Mindfulness relaxation program and a Buteyko technique respiratory rehabilitation program will be administered individually and weekly, in 10 sessions (5 face-to-face and 5 telematic sessions afterwards). Patients will be visited 4 times (at inclusion, one month, 6 months and 12 months after the double intervention), where data on asthmatic morbidity, pulmonary function (spirometry), bronchial inflammation (FENO) will be collected and some questionnaires will be administered.
- Being tested
- Mindfulness and Buteyko techniques
- Keywords
- Asthma, Anxiety, Stress, Mindfulness, Buteyko
- Medical subject headings
- Asthma, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and Buteyko techniquesOther
Joint implementation of a general relaxation program and a respiratory rehabilitation program in patients with poorly controlled asthma.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness and Buteyko techniques | Other | A Mindfulness relaxation program and a Buteyko technique respiratory rehabilitation program will be administered individually and weekly, in 10 sessions (5 face-to-face and 5 telematic sessions afterwards). Receives: Other: Mindfulness and Buteyko techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
% patients with changed asthma control
Changes in asthma symptoms measured with the asthma control test (minimum 5 as worse value; maximum 25, as the best value)
Measured: 1 year
Changes in asthma exacerbation
Changes in asthma exacerbation measured by number of hospital admissions and medical treatments received
Measured: 1 year
Secondary outcomes (5)
Anxiety
Improvement of the anxiety level measured with the test hospital anxiety and depression scale (minimum 0 as the best value, maximum 42 as the worst value)
Measured: 1 year
Functional dyspnea
Changes in functional dyspnea measured with the test Nijmegen (minimum 0 as the worst value, maximum 64 as the worst value)
Measured: 1 year
Pulmonary function
Changes in pulmonary function with spirometry (Forced Expiratory Volume in 1 Second and forced vital capacity)
Measured: 1 year
Bronchial inflammation
Changes in bronchial inflammation with FENO
Measured: 1 year
Therapeutic adherence of patients to inhalers
Changes in therapeutic adherence of patients to inhalers with the "Inhaler Adhesion Test"
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 posted25 Oct 2022
- Study start1 Mar 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Mindfulness relaxation program and a Buteyko technique respiratory rehabilitation program will be administered individually and weekly, in 10 sessions (5 face-to-face and 5 telematic sessions afterwards).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593315
- Sponsor's protocol ID
- IIBSP-MBA-2022-95
- Status last verified
- Mar 2023
- First submitted
- 10 Oct 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share IPD is undecided
Publications
Partridge MR, van der Molen T, Myrseth SE, Busse WW. Attitudes and actions of asthma patients on regular maintenance therapy: the INSPIRE study. BMC Pulm Med. 2006 Jun 13;6:13. doi: 10.1186/1471-2466-6-13.
PubMed 16772035Olaguibel JM, Quirce S, Julia B, Fernandez C, Fortuna AM, Molina J, Plaza V; MAGIC Study Group. Measurement of asthma control according to Global Initiative for Asthma guidelines: a comparison with the Asthma Control Questionnaire. Respir Res. 2012 Jun 22;13(1):50. doi: 10.1186/1465-9921-13-50.
PubMed 22726416Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014 Jun 12;24:14009. doi: 10.1038/npjpcrm.2014.9.
PubMed 24921985Di Marco F, Verga M, Santus P, Giovannelli F, Busatto P, Neri M, Girbino G, Bonini S, Centanni S. Close correlation between anxiety, depression, and asthma control. Respir Med. 2010 Jan;104(1):22-8. doi: 10.1016/j.rmed.2009.08.005. Epub 2009 Sep 4.
PubMed 19733042Heaney LG, Conway E, Kelly C, Gamble J. Prevalence of psychiatric morbidity in a difficult asthma population: relationship to asthma outcome. Respir Med. 2005 Sep;99(9):1152-9. doi: 10.1016/j.rmed.2005.02.013. Epub 2005 Mar 23.
PubMed 16085217Ji Z, Lopez-de-Andres A, Jimenez-Garcia R, Maestre-Miquel C, Zamorano-Leon JJ, Scarano-Pereira JP, Fuentes-Alonso M, Giron-Matute WI, de Miguel-Diez J. Mental health in patients with asthma: A population-based case-control study. Respir Med. 2022 Mar;193:106758. doi: 10.1016/j.rmed.2022.106758. Epub 2022 Jan 31.
PubMed 35123357Wisnivesky JP, Lorenzo J, Feldman JM, Leventhal H, Halm EA. The relationship between perceived stress and morbidity among adult inner-city asthmatics. J Asthma. 2010 Feb;47(1):100-4. doi: 10.3109/02770900903426989.
PubMed 20100028Janssens T, Verleden G, De Peuter S, Van Diest I, Van den Bergh O. Inaccurate perception of asthma symptoms: a cognitive-affective framework and implications for asthma treatment. Clin Psychol Rev. 2009 Jun;29(4):317-27. doi: 10.1016/j.cpr.2009.02.006. Epub 2009 Mar 4.
PubMed 19285771Martinez-Moragon E, Perpina M, Belloch A, de Diego A. [Prevalence of hyperventilation syndrome in patients treated for asthma in a pulmonology clinic]. Arch Bronconeumol. 2005 May;41(5):267-71. doi: 10.1016/s1579-2129(06)60221-8. Spanish.
PubMed 15919008Veidal S, Jeppegaard M, Sverrild A, Backer V, Porsbjerg C. The impact of dysfunctional breathing on the assessment of asthma control. Respir Med. 2017 Feb;123:42-47. doi: 10.1016/j.rmed.2016.12.008. Epub 2016 Dec 18.
PubMed 28137495Sedeh FB, Von Bulow A, Backer V, Bodtger U, Petersen US, Vest S, Hull JH, Porsbjerg C. The impact of dysfunctional breathing on the level of asthma control in difficult asthma. Respir Med. 2020 Mar;163:105894. doi: 10.1016/j.rmed.2020.105894. Epub 2020 Feb 8.
PubMed 32056838Bruton A, Lee A, Yardley L, Raftery J, Arden-Close E, Kirby S, Zhu S, Thiruvothiyur M, Webley F, Taylor L, Gibson D, Yao G, Stafford-Watson M, Versnel J, Moore M, George S, Little P, Djukanovic R, Price D, Pavord ID, Holgate ST, Thomas M. Physiotherapy breathing retraining for asthma: a randomised controlled trial. Lancet Respir Med. 2018 Jan;6(1):19-28. doi: 10.1016/S2213-2600(17)30474-5. Epub 2017 Dec 14.
PubMed 29248433O'Connor E, Patnode CD, Burda BU, Buckley DI, Whitlock EP. Breathing Exercises and/or Retraining Techniques in the Treatment of Asthma: Comparative Effectiveness [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Sep. Report No.: 12-EHC092-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK109355/
PubMed 23101047Freitas DA, Holloway EA, Bruno SS, Chaves GS, Fregonezi GA, Mendonca KP. Breathing exercises for adults with asthma. Cochrane Database Syst Rev. 2013 Oct 1;(10):CD001277. doi: 10.1002/14651858.CD001277.pub3.
PubMed 24085551Prem V, Sahoo RC, Adhikari P. Comparison of the effects of Buteyko and pranayama breathing techniques on quality of life in patients with asthma - a randomized controlled trial. Clin Rehabil. 2013 Feb;27(2):133-41. doi: 10.1177/0269215512450521. Epub 2012 Jul 26.
PubMed 22837543
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Combination of General Relaxation (Mindfulness) and Respiratory (Buteyko) Techniques for the Improvement of Poorly Controlled Asthma. The MBA Study
- ClinicalTrials.gov ID
- NCT05593315
- Acronym / sponsor ID
- IIBSP-MBA-2022-95
- Keywords
- Asthma, Anxiety, Stress, Mindfulness, Buteyko
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Oct 2022 (actual)
- 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.
Administration of a combined program for general (Mindfulness) and respiratory (Buteyko technique) relationship in patients with poorly controlled asthma and anxiety/stress to determine if it provides an improvement in current control and future risk of asthma.
Detailed description
A Mindfulness relaxation program and a Buteyko technique respiratory rehabilitation program will be administered individually and weekly, in 10 sessions (5 face-to-face and 5 telematic sessions afterwards). Patients will be visited 4 times (at inclusion, one month, 6 months and 12 months after the double intervention), where data on asthmatic morbidity, pulmonary function (spirometry), bronchial inflammation (FENO) will be collected and some questionnaires will be administered.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Mindfulness relaxation program and a Buteyko technique respiratory rehabilitation program will be administered individually and weekly, in 10 sessions (5 face-to-face and 5 telematic sessions afterwards).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness and Buteyko techniques | Other | Other: Mindfulness and Buteyko techniquesA Mindfulness relaxation program and a Buteyko technique respiratory rehabilitation program will be administered individually and weekly, in 10 sessions (5 face-to-face and 5 telematic sessions afterwards). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of poorly controlled asthma
- In treatment with a combination of ICS/LABA at medium doses
- Anxiety and/or functional dyspnea
- Attended in the outpatient consultations of the Asthma Unit of the Pneumology and Allergy Service of the Hospital de la Santa Creu i Sant Pau in Barcelona
Key exclusion criteria (4 listed)
- Severe asthma exacerbation in the last 30 days
- Severe disabling comorbidity
- Severe psychiatric illness
- Inability to complete questionnaires.
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 |
|---|---|---|
| Mindfulness and Buteyko techniquesJoint implementation of a general relaxation program and a respiratory rehabilitation program in patients with poorly controlled asthma. | Other | Mindfulness and Buteyko techniques |
Primary outcome
% patients with changed asthma control
Time frame: 1 year
Changes in asthma symptoms measured with the asthma control test (minimum 5 as worse value; maximum 25, as the best value)
Changes in asthma exacerbation
Time frame: 1 year
Changes in asthma exacerbation measured by number of hospital admissions and medical treatments received
5 secondary outcomes
Anxiety
Time frame: 1 year
Functional dyspnea
Time frame: 1 year
Pulmonary function
Time frame: 1 year
Bronchial inflammation
Time frame: 1 year
Therapeutic adherence of patients to inhalers
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Results publication: PubMed 16772035Partridge MR, van der Molen T, Myrseth SE, Busse WW. Attitudes and actions of asthma patients on regular maintenance therapy: the INSPIRE study. BMC Pulm Med. 2006 Jun 13;6:13. doi: 10.1186/1471-2466-6-13.
- Results publication: PubMed 22726416Olaguibel JM, Quirce S, Julia B, Fernandez C, Fortuna AM, Molina J, Plaza V; MAGIC Study Group. Measurement of asthma control according to Global Initiative for Asthma guidelines: a comparison with the Asthma Control Questionnaire. Respir Res. 2012 Jun 22;13(1):50. doi: 10.1186/1465-9921-13-50.
- Results publication: PubMed 24921985Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014 Jun 12;24:14009. doi: 10.1038/npjpcrm.2014.9.
- Results publication: PubMed 19733042Di Marco F, Verga M, Santus P, Giovannelli F, Busatto P, Neri M, Girbino G, Bonini S, Centanni S. Close correlation between anxiety, depression, and asthma control. Respir Med. 2010 Jan;104(1):22-8. doi: 10.1016/j.rmed.2009.08.005. Epub 2009 Sep 4.
- Results publication: PubMed 16085217Heaney LG, Conway E, Kelly C, Gamble J. Prevalence of psychiatric morbidity in a difficult asthma population: relationship to asthma outcome. Respir Med. 2005 Sep;99(9):1152-9. doi: 10.1016/j.rmed.2005.02.013. Epub 2005 Mar 23.
- Results publication: PubMed 35123357Ji Z, Lopez-de-Andres A, Jimenez-Garcia R, Maestre-Miquel C, Zamorano-Leon JJ, Scarano-Pereira JP, Fuentes-Alonso M, Giron-Matute WI, de Miguel-Diez J. Mental health in patients with asthma: A population-based case-control study. Respir Med. 2022 Mar;193:106758. doi: 10.1016/j.rmed.2022.106758. Epub 2022 Jan 31.
- Results publication: PubMed 20100028Wisnivesky JP, Lorenzo J, Feldman JM, Leventhal H, Halm EA. The relationship between perceived stress and morbidity among adult inner-city asthmatics. J Asthma. 2010 Feb;47(1):100-4. doi: 10.3109/02770900903426989.
- Results publication: PubMed 19285771Janssens T, Verleden G, De Peuter S, Van Diest I, Van den Bergh O. Inaccurate perception of asthma symptoms: a cognitive-affective framework and implications for asthma treatment. Clin Psychol Rev. 2009 Jun;29(4):317-27. doi: 10.1016/j.cpr.2009.02.006. Epub 2009 Mar 4.
- Results publication: PubMed 15919008Martinez-Moragon E, Perpina M, Belloch A, de Diego A. [Prevalence of hyperventilation syndrome in patients treated for asthma in a pulmonology clinic]. Arch Bronconeumol. 2005 May;41(5):267-71. doi: 10.1016/s1579-2129(06)60221-8. Spanish.
- Results publication: PubMed 28137495Veidal S, Jeppegaard M, Sverrild A, Backer V, Porsbjerg C. The impact of dysfunctional breathing on the assessment of asthma control. Respir Med. 2017 Feb;123:42-47. doi: 10.1016/j.rmed.2016.12.008. Epub 2016 Dec 18.
- Results publication: PubMed 32056838Sedeh FB, Von Bulow A, Backer V, Bodtger U, Petersen US, Vest S, Hull JH, Porsbjerg C. The impact of dysfunctional breathing on the level of asthma control in difficult asthma. Respir Med. 2020 Mar;163:105894. doi: 10.1016/j.rmed.2020.105894. Epub 2020 Feb 8.
- Results publication: PubMed 29248433Bruton A, Lee A, Yardley L, Raftery J, Arden-Close E, Kirby S, Zhu S, Thiruvothiyur M, Webley F, Taylor L, Gibson D, Yao G, Stafford-Watson M, Versnel J, Moore M, George S, Little P, Djukanovic R, Price D, Pavord ID, Holgate ST, Thomas M. Physiotherapy breathing retraining for asthma: a randomised controlled trial. Lancet Respir Med. 2018 Jan;6(1):19-28. doi: 10.1016/S2213-2600(17)30474-5. Epub 2017 Dec 14.
- Individual participant dataSharing planned: Undecided. The plan to share IPD is undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Buteyko techniques in people with Asthma and Anxiety, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 4 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 17 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vicente Plaza Moral, PhD (+34 93 556 56 01 ext. 5971, vplaza@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% patients with changed asthma control (time frame: 1 year). 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 NCT05593315, which also lists 33 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 17 Mar 2023.