NCT07025616

Brief Summary

This randomized controlled trial study aimed to measure the effectiveness of the combination of 4-weeks Buteyko breathing exercises and pharmacological therapy compared with pharmacological therapy alone in children with uncontrolled asthma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 8, 2025

Last Update Submit

June 13, 2025

Conditions

Keywords

AsthmaButeykobreathing retrainingpediatrics

Outcome Measures

Primary Outcomes (1)

  • Asthma control

    Level of asthma control measured by Asthma Control Questionnaire (ACQ) - Indonesian version. Minimum value 0, maximum value 6. Higher score means worse outcome.

    At enrollment and end of fourth-week

Secondary Outcomes (7)

  • Asthma Quality of Life

    At enrollment and end of fourth-week

  • Bronchodilator use

    At end of fourth-week

  • FEV1

    At enrollment and end of fourth-week

  • FVC

    At enrollment and end of fourth-week

  • FEV1/FVC

    At enrollment and end of fourth-week

  • +2 more secondary outcomes

Study Arms (2)

Buteyko

EXPERIMENTAL

Buteyko breathing exercise plus pharmacological treatment

Behavioral: ButeykoDrug: Asthma reliever and controller

Control

ACTIVE COMPARATOR

Pharmacological treatment

Drug: Asthma reliever and controller

Interventions

ButeykoBEHAVIORAL

The Buteyko breathing exercise is a method that encourages nasal breathing, reducing breathing volume, and using breath-holding exercises to normalize breathing pattern

Buteyko

Asthma reliever and controller according to GINA (Global Initiative for Asthma) guideline

ButeykoControl

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 7-17 years
  • Uncontrolled or partially controlled asthma (GINA Symptom Control Tool score \> 1)
  • Receive bronchodilator therapy, either oral or inhaler from a pediatrician.
  • Children and parents/care givers agree to participate in the study until the end, and parents/care givers sign the informed consent form.
  • Can understand instructions.

You may not qualify if:

  • Inpatients
  • Have received Buteyko breathing exercises or other breathing exercises.
  • Have congenital heart disease, pneumonia, or other significant and uncontrolled health disorders.
  • Have severe physical disabilities or mental retardation that could potentially prevent the implementation of Buteyko breathing exercises.
  • Have contraindications for spirometry examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Indonesia, Faculty of Medicine

Jakarta Pusat, Dki Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Ivan S Wibowo, Medical Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
dr.

Study Record Dates

First Submitted

June 8, 2025

First Posted

June 17, 2025

Study Start

June 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

June 17, 2025

Record last verified: 2025-06

Locations