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NCT05006703: Breathe4T

Breathing Retraining for Asthma Trial of Home Exercises for Teenagers

Completed NA Results posted Last updated 17 October 2024
What this trial tests

NA trial testing Breathe for Teens (Breathe4T) in Adolescent Behavior in 64 participants. Completed in 30 September 2022.

Timeline
22 June 2021
Primary endpoint
30 June 2022
30 September 2022

Quick facts

Lead sponsorUniversity of Southampton
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment64
Start date22 June 2021
Primary completion30 June 2022
Estimated completion30 September 2022
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University of Southampton

Who can join

Adults 12 to 17, any sex, with Adolescent Behavior or Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Asthma-specific Quality of Life Primary · 6 months

PedsQL (paediatric quality of life inventory) - asthma module - presented as a total score with a higher score indicating lower problems, and therefore better quality of life. Min 0 - Max 100. Scale scores are computed as the sum of the items over the number of items answered.

Baseline
GroupValue95% CI
Intervention Group65.4± 13.2
Control Group65.1± 15.6
6 months
GroupValue95% CI
Intervention Group66.7± 11.3
Control Group67.4± 18.1
Asthma Control Primary · 6 months

Asthma control test (ACT) - presented as a total score with a lower score indicating poor control. Overall score above 19 would indicate well-controlled asthma. Min value 0 - Max 25.

Baseline
GroupValue95% CI
Intervention Group17.2± 5.2
Control Group17.4± 4.5
6 months
GroupValue95% CI
Intervention Group16.9± 4.1
Control Group17.8± 5.2
Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar) Primary · 6 months

Self-reported in a healthcare utilisation questionnaire.

Baseline
GroupValue95% CI
Intervention Group9
Control Group11
Intervention Group23
Control Group21
6 months
GroupValue95% CI
Intervention Group5
Control Group6
Intervention Group13
Control Group16
Attendance at Emergency Department for an Exacerbation of Asthma Secondary · 6 months

Self-reported in a healthcare utilisation questionnaire

Baseline
GroupValue95% CI
Intervention Group5
Control Group4
Intervention Group27
Control Group28
6 months
GroupValue95% CI
Intervention Group0
Control Group2
Intervention Group18
Control Group20
Hospital Admission for an Exacerbation of Asthma Secondary · 6 months

Self-reported in a healthcare utilisation questionnaire

Baseline
GroupValue95% CI
Intervention Group14
Control Group17
Intervention Group18
Control Group15
6 months
GroupValue95% CI
Intervention Group0
Control Group2
Intervention Group18
Control Group20
Paediatric Quality of Life Secondary · 6 months

Paediatric asthma quality life questionnaire (PAQLQ) - presented as a total score. Higher scores represent a better quality of life. Min value 1 - max 7.

Baseline
GroupValue95% CI
Intervention Group4.5± 1.6
Control Group5.1± 1.5
6 months
GroupValue95% CI
Intervention Group5.7± 0.7
Control Group4.6± 1.5

Sponsor's own description

This trial will address the impaired quality of life of young people with asthma, despite appropriate medicines. Research shows that young people report needing to calm themselves down during an asthma attack to control their breathing. Although physiotherapist- delivered breathing retraining programmes now have a clear evidence base in adults with asthma, improving quality of life, there is a lack of evidence assessing its use in younger patients. The investigators have redesigned an adult training package to make it appropriate for young people and will now assess how effective such an intervention would be in this population. This study will include young people (12-17 years) with physician diagnosed asthma. The repurposing, optimisation and acceptability of the intervention in the adolescent age group has been undertaken in Stages 1 and 2 of the Breathe 4 Teens (BREATHE4T) project. A self-guided, breathing retraining digital intervention has been developed, delivered via a mobile friendly, online platform. The current study is a randomised, controlled feasibility trial and will provide the necessary information for a substantive cost-effectiveness trial. Participants with access to the intervention will be compared to a usual care group. Asthma and quality of life of both groups will also be assessed at baseline, 2-month and 6-month time points. At the end of the 6 months, the control group will also be given access to the website. The online nature of this study allows recruitment from across the United Kingdom. Recruitment methods would include primary care, hospital clinics, social media and posters. AsthmaUK will also provide publicity to assist recruitment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Planning a digital intervention for adolescents with asthma (BREATHE4T): A theory-, evidence- and Person-Based Approach to identify key behavioural issues.
    Easton S, Ainsworth B, Thomas M, Latter S, et al · · 2022 · cited 4× · PMID 35932183 · DOI 10.1002/ppul.26099

Verify or expand the search:

Other recruiting trials for Adolescent Behavior

Currently open trials in the same condition.

Other University of Southampton trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05006703.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing