Virtual Breathing Intervention for Enhancing Asthma-related Quality of Life - A Randomized Controlled Trial (BREATHE)

August 3, 2026 updated by: Prof. Dr. Andreas Rembert Koczulla

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
Virtual Breathing Training Program
Behavioral: Virtual Breathing Training Program
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.
Active Comparator: Usual Care Group
Usual Care
Other: Usual Care Group
Standard medical care for asthma according to current guidelines without additional breathing training intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Asthma Control
Time Frame: Baseline to 12 weeks (also assessed every 2 weeks)
Change in asthma control measured using the Asthma Control Test (ACT).
Baseline to 12 weeks (also assessed every 2 weeks)
Change in Dysfunctional Breathing Symptoms
Time Frame: Baseline to 12 weeks
Change in symptoms of dysfunctional breathing measured by the Nijmegen Questionnaire
Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Time Frame: Baseline to 12 weeks
Heart rate, assessed via wearable device.
Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Time Frame: Baseline to 12 weeks
Heart rate variability, assessed via wearable device.
Baseline to 12 weeks
Change in Physical Performance
Time Frame: Baseline and 12 weeks
Change in physical performance assessed using the 1-minute sit-to-stand test.
Baseline and 12 weeks
Participant Satisfaction
Time Frame: At 12 weeks
Participant-reported satisfaction with the intervention measured using a study-specific questionnaire (5-point Likert scale).
At 12 weeks
Number of Treatment-related Adverse Events
Time Frame: Throughout the 12-week study period
Incidence of adverse events including dizziness, discomfort, asthma exacerbations, changes in medication use, and use of rescue medication.
Throughout the 12-week study period
Time to Clinically Meaningful Improvement
Time Frame: Assessed every 2 weeks up to 12 weeks
Time to first achievement of a clinically meaningful improvement (≥0.5 points) in AQLQ or ACT.
Assessed every 2 weeks up to 12 weeks
Adherence and Engagement
Time Frame: 12-week intervention period
Attendance at supervised sessions and frequency of home-based breathing exercises (self-reported diary).
12-week intervention period
Change in Psychological outcomes
Time Frame: Baseline to 12 weeks
Changes in anxiety (GAD-7)
Baseline to 12 weeks
Change in Psychological outcomes
Time Frame: Baseline to 12 weeks
Changes in depression (PHQ-9)
Baseline to 12 weeks
Change in Psychological outcomes
Time Frame: Baseline to 12 weeks
Changes in perceived stress (PSS) scores.
Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Time Frame: Baseline to 12 weeks
Respiratory rate, assessed via wearable device.
Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Time Frame: Baseline to 12 weeks
Sleep duration, assessed via wearable device.
Baseline to 12 weeks
Change in Physiological parameters (wearable-derived)
Time Frame: Baseline to 12 weeks
Daily physical activity (step count), assessed via wearable device.
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Dr. Andreas Rembert Koczulla

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cegla Medizintechnik GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BREATHE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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