AsthmaNCT02140086
Buteyko Based Remedial Breathing Therapy With Children With Asthma
A study testing Buteyko based Remedial Breathing Therapy in people with Asthma, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial summary
A randomized, controlled trial to investigate the effects of a buteyko based remedial breathing therapy on children with asthma regarding to their symptoms, use of medication and lung function tests. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Buteyko based Remedial Breathing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Nov 2014
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- signed informed consent of the parents
- age 6- 15 years
- information and consent of the consulting doctor
- levels of asthma therapy 1-3
Who cannot join
- participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
A randomized, controlled trial to investigate the effects of a buteyko based remedial breathing therapy on children with asthma regarding to their symptoms, use of medication and lung function tests.
- Conditions
- Asthma
- Being tested
- Buteyko based Remedial Breathing Therapy
- Keywords
- asthma, Buteyko, remedial breathing, children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buteyko based Remedial Breathing TherapyBehavioural
Buteyko based remedial Breathing Therapy after Dr. Buteyko
| Study group | Role | What they receive |
|---|---|---|
| Buteyko based Remedial Breathing Therapy | Experimental | Buteyko based Remedial Breathing Therapy Receives: Behavioral: Buteyko based Remedial Breathing Therapy |
| Waiting List | No intervention | Training in the course of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Betamimetics (-30%) at 3- and/or 6-month follow up
Measured: asthmaspezific parameters are measured before and after intervention as well as 3- and 6- month follow up
Secondary outcomes (8)
Asthma Control Questionnaire (ACQ)
Scores of the ACQ (Asthma Control Questionnaire)
Measured: parameters are measured before and after intervention as well as 3- and 6- month follow up
Paediatric Asthma Quality of Life Questionnaire (PAQLQ)
Scores of PAQLQ (Paediatric Asthma Quality of Life Questionnaire)
Measured: parameters are measured before and after intervention as well as 3- and 6- month follow up
ARCIM Questionnaire (AFB)
Scores of the AFB (ARCIM Questionnaire) regarding to asthma symptoms of the last 3 month (AFB is not validated)
Measured: parameters are measured before and after intervention as well as 3- and 6- month follow up
Peak Flow
Measured: parameters are measured before and after intervention as well as 3- and 6- month follow up
NO-measurement nasal and oral
Measured: parameters are measured before and after intervention as well as 3- and 6- month follow up
Buteyko-Questionnaire
Measured: parameters are measured before and after intervention as well as 3- and 6- month follow up
parameters of spirometry
Measured: parameters are measured before and after intervention as well as 3- and 6- month follow up
Paediatric asthma caregiver´s quality of life questionnaire (PACQLQ)
Measured: parameters are measured before and after intervention as well as 3- and 6- month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140086
- Sponsor's protocol ID
- RBT_03
- Other IDs
- RBT_03
- Status last verified
- Mar 2016
- First submitted
- 14 May 2014
- Last updated
- 2 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buteyko Based Remedial Breathing Therapy With Children With Asthma
- ClinicalTrials.gov ID
- NCT02140086
- Acronym / sponsor ID
- RBT_03
- Conditions
- Asthma
- Keywords
- asthma, Buteyko, remedial breathing, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 16 May 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.
A randomized, controlled trial to investigate the effects of a buteyko based remedial breathing therapy on children with asthma regarding to their symptoms, use of medication and lung function tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buteyko based Remedial Breathing Therapy | Experimental | Behavioral: Buteyko based Remedial Breathing TherapyButeyko based Remedial Breathing Therapy |
| Waiting List | No intervention | –Training in the course of the study |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- signed informed consent of the parents
- age 6- 15 years
- information and consent of the consulting doctor
- levels of asthma therapy 1-3
Key exclusion criteria (1 listed)
- participation in another study
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 |
|---|---|---|
| Buteyko based Remedial Breathing TherapyButeyko based remedial Breathing Therapy after Dr. Buteyko | Behavioural | Buteyko based Remedial Breathing Therapy |
Primary outcome
Reduction of Betamimetics (-30%) at 3- and/or 6-month follow up
Time frame: asthmaspezific parameters are measured before and after intervention as well as 3- and 6- month follow up
8 secondary outcomes
Asthma Control Questionnaire (ACQ)
Time frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
Paediatric Asthma Quality of Life Questionnaire (PAQLQ)
Time frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
ARCIM Questionnaire (AFB)
Time frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
Peak Flow
Time frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
NO-measurement nasal and oral
Time frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
Buteyko-Questionnaire
Time frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
parameters of spirometry
Time frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
Paediatric asthma caregiver´s quality of life questionnaire (PACQLQ)
Time frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
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 2 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buteyko based Remedial Breathing Therapy in people with Asthma, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
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 1 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 2 Mar 2016. 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 Germany. 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?
Reduction of Betamimetics (-30%) at 3- and/or 6-month follow up (time frame: asthmaspezific parameters are measured before and after intervention as well as 3- and 6- month follow up). 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 2 Mar 2016.