Asthma BronchialeBREATHENCT07752836
Virtual Breathing Intervention for Enhancing Asthma-related Quality of Life - A Randomized Controlled Trial
A study testing Virtual Breathing Training Program in people with Asthma Bronchiale, run by Prof. Dr. Andreas Rembert Koczulla.
Trial summary
Asthma is a common long-term lung condition that can cause symptoms such as shortness of breath, chest tightness, and anxiety. Even with appropriate medication, about 30-40% of people with asthma do not achieve good symptom control and continue to experience reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Bronchiale
- What is being tested?
- Virtual Breathing Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged ≥18 years
- Asthma bronchiale
- Partly controlled or uncontrolled asthma according to GINA 2025 criteria
- Access to internet and compatible smartphone for digital intervention and data collection
Who cannot join
- Clinically relevant nasal obstruction (e.g., severe septal deviation, nasal polyps) affecting nasal breathing
- Current regular use of structured breathing therapy or breathing training devices
- Participation in another interventional clinical trial that may interfere with outcomes
- Severe comorbid conditions limiting participation in mild physical or breathing exercise (e.g., unstable cardiovascular disease)
- Lack of willingness or ability to use required digital tools (video platform, wearable device, smartphone app)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness, Feasibility, and Acceptability of a 12-Week Virtual Breathing Training Program to Improve Disease-Specific Quality of Life in Adults With Asthma and Incomplete Symptom Control: A Randomized Controlled Trial
Asthma is a common long-term lung condition that can cause symptoms such as shortness of breath, chest tightness, and anxiety. Even with appropriate medication, about 30-40% of people with asthma do not achieve good symptom control and continue to experience reduced quality of life.
Breathing exercises are recommended as an additional, non-drug treatment for asthma. However, these programs are not widely available outside of rehabilitation clinics, and more scientific evidence is needed, especially for digital formats.
Read more
This study aims to investigate whether a 12-week structured breathing training program delivered online can improve asthma-related quality of life in adults whose asthma is not well controlled. Participants will be randomly assigned to either the intervention group or a control group receiving usual care.
The intervention consists of weekly live, group-based breathing sessions led by trained physiotherapists via videoconference, combined with short daily self-practice exercises at home. Participants will also use a simple breathing device to support the exercises. The control group will continue their usual medical care without additional breathing training.
We will assess whether the program improves quality of life, asthma control, and symptoms such as anxiety, stress, and dysfunctional breathing. The study will also evaluate whether the online format is feasible, acceptable, and satisfactory for participants.
The breathing exercises are non-invasive and low risk. The results of this study may help to develop accessible, low-cost, and evidence-based support programs for people with asthma.
- Conditions
- Asthma Bronchiale
- Being tested
- Virtual Breathing Training Program, Usual Care Group
- Keywords
- Breathing retraining, Synchronous intervention, telemedicine, digital health, nasal breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Breathing Training ProgramBehavioural
A 12-week structured, physiotherapist-led breathing training delivered via weekly live video group sessions combined with daily home-based exercises. The program includes breathing techniques such as nasal breathing, diaphragmatic breathing, and breathing control strategies. Participants also use a breathing training device to support the exercises.
Usual Care GroupOther
Standard medical care for asthma according to current guidelines without additional breathing training intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Virtual Breathing Training Program Receives: Behavioral: Virtual Breathing Training Program |
| Usual Care Group | Active comparator | Usual Care Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Asthma-related quality of life (AQLQ)
Change in disease-specific quality of life measured using the Asthma Quality of Life Questionnaire (AQLQ). The AQLQ is a validated instrument for adults with asthma. Scores range from 1 to 7, with higher scores indicating better quality of life. A change of 0.5 points is considered clinically meaningful.
Measured: Baseline to 12 weeks
Secondary outcomes (15)
Change in Asthma Control
Change in asthma control measured using the Asthma Control Test (ACT).
Measured: Baseline to 12 weeks (also assessed every 2 weeks)
Change in Dysfunctional Breathing Symptoms
Change in symptoms of dysfunctional breathing measured by the Nijmegen Questionnaire
Measured: Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Heart rate, assessed via wearable device.
Measured: Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Heart rate variability, assessed via wearable device.
Measured: Baseline to 12 weeks
Change in Physical Performance
Change in physical performance assessed using the 1-minute sit-to-stand test.
Measured: Baseline and 12 weeks
Participant Satisfaction
Participant-reported satisfaction with the intervention measured using a study-specific questionnaire (5-point Likert scale).
Measured: At 12 weeks
Number of Treatment-related Adverse Events
Incidence of adverse events including dizziness, discomfort, asthma exacerbations, changes in medication use, and use of rescue medication.
Measured: Throughout the 12-week study period
Time to Clinically Meaningful Improvement
Time to first achievement of a clinically meaningful improvement (≥0.5 points) in AQLQ or ACT.
Measured: Assessed every 2 weeks up to 12 weeks
Adherence and Engagement
Attendance at supervised sessions and frequency of home-based breathing exercises (self-reported diary).
Measured: 12-week intervention period
Change in Psychological outcomes
Changes in anxiety (GAD-7)
Measured: Baseline to 12 weeks
Change in Psychological outcomes
Changes in depression (PHQ-9)
Measured: Baseline to 12 weeks
Change in Psychological outcomes
Changes in perceived stress (PSS) scores.
Measured: Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Respiratory rate, assessed via wearable device.
Measured: Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Sleep duration, assessed via wearable device.
Measured: Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Daily physical activity (step count), assessed via wearable device.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma BronchialeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Andreas Rembert Koczulla
- Sponsor type
- University, hospital or other
- Collaborators
- Cegla Medizintechnik GmbH
- Responsible party
- Sponsor-investigator, Prof. Dr. Andreas Rembert Koczulla, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752836
- Sponsor's protocol ID
- BREATHE
- Acronym
- BREATHE
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Feasibility, and Acceptability of a 12-Week Virtual Breathing Training Program to Improve Disease-Specific Quality of Life in Adults With Asthma and Incomplete Symptom Control: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07752836
- Acronym / sponsor ID
- BREATHE / BREATHE
- Conditions
- Asthma Bronchiale
- Keywords
- Breathing retraining, Synchronous intervention, telemedicine, digital health, nasal breathing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Prof. Dr. Andreas Rembert KoczullaUniversity, hospital or other
- Collaborators
- Cegla Medizintechnik GmbH
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 7 Aug 2026 (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.
Asthma is a common long-term lung condition that can cause symptoms such as shortness of breath, chest tightness, and anxiety. Even with appropriate medication, about 30-40% of people with asthma do not achieve good symptom control and continue to experience reduced quality of life.
Breathing exercises are recommended as an additional, non-drug treatment for asthma. However, these programs are not widely available outside of rehabilitation clinics, and more scientific evidence is needed, especially for digital formats.
This study aims to investigate whether a 12-week structured breathing training program delivered online can improve asthma-related quality of life in adults whose asthma is not well controlled. Participants will be randomly assigned to either the intervention group or a control group receiving usual care.
The intervention consists of weekly live, group-based breathing sessions led by trained physiotherapists via videoconference, combined with short daily self-practice exercises at home. Participants will also use a simple breathing device to support the exercises. The control group will continue their usual medical care without additional breathing training.
We will assess whether the program improves quality of life, asthma control, and symptoms such as anxiety, stress, and dysfunctional breathing. The study will also evaluate whether the online format is feasible, acceptable, and satisfactory for participants.
The breathing exercises are non-invasive and low risk. The results of this study may help to develop accessible, low-cost, and evidence-based support programs for people with asthma.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Virtual Breathing Training ProgramVirtual Breathing Training Program |
| Usual Care Group | Active comparator | Other: Usual Care GroupUsual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥18 years
- Asthma bronchiale
- Partly controlled or uncontrolled asthma according to GINA 2025 criteria
- Access to internet and compatible smartphone for digital intervention and data collection
Key exclusion criteria (5 listed)
- Clinically relevant nasal obstruction (e.g., severe septal deviation, nasal polyps) affecting nasal breathing
- Current regular use of structured breathing therapy or breathing training devices
- Participation in another interventional clinical trial that may interfere with outcomes
- Severe comorbid conditions limiting participation in mild physical or breathing exercise (e.g., unstable cardiovascular disease)
- Lack of willingness or ability to use required digital tools (video platform, wearable device, smartphone app)
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 |
|---|---|---|
| Virtual Breathing Training ProgramA 12-week structured, physiotherapist-led breathing training delivered via weekly live video group sessions combined with daily home-based exercises. The program includes breathing techniques such as nasal breathing, diaphragmatic breathing, and breathing control strategies. Participants also use a breathing training device to support the exercises. | Behavioural | Experimental Group |
| Usual Care GroupStandard medical care for asthma according to current guidelines without additional breathing training intervention. | Other | Usual Care Group |
Primary outcome
Change in Asthma-related quality of life (AQLQ)
Time frame: Baseline to 12 weeks
Change in disease-specific quality of life measured using the Asthma Quality of Life Questionnaire (AQLQ). The AQLQ is a validated instrument for adults with asthma. Scores range from 1 to 7, with higher scores indicating better quality of life. A change of 0.5 points is considered clinically meaningful.
15 secondary outcomes
Change in Asthma Control
Time frame: Baseline to 12 weeks (also assessed every 2 weeks)
Change in Dysfunctional Breathing Symptoms
Time frame: Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Time frame: Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Time frame: Baseline to 12 weeks
Change in Physical Performance
Time frame: Baseline and 12 weeks
Participant Satisfaction
Time frame: At 12 weeks
Number of Treatment-related Adverse Events
Time frame: Throughout the 12-week study period
Time to Clinically Meaningful Improvement
Time frame: Assessed every 2 weeks up to 12 weeks
Adherence and Engagement
Time frame: 12-week intervention period
Change in Psychological outcomes
Time frame: Baseline to 12 weeks
Change in Psychological outcomes
Time frame: Baseline to 12 weeks
Change in Psychological outcomes
Time frame: Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Time frame: Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Time frame: Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: 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.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Breathing Training Program in people with Asthma Bronchiale, run by Prof. Dr. Andreas Rembert Koczulla.
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 5 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: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inga Jarosch, Dr. (+49 8652 93 ext. 1730, ijarosch@schoen-klinik.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Asthma-related quality of life (AQLQ) (time frame: Baseline to 12 weeks). 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 7 Aug 2026.