NCT02140086

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 2, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

May 14, 2014

Last Update Submit

March 1, 2016

Conditions

Asthma

Keywords

asthmaButeykoremedial breathingchildren

Outcome Measures

Primary Outcomes (1)

  • Reduction of Betamimetics (-30%) at 3- and/or 6-month follow up

    asthmaspezific parameters are measured before and after intervention as well as 3- and 6- month follow up

Secondary Outcomes (8)

  • Asthma Control Questionnaire (ACQ)

    parameters are measured before and after intervention as well as 3- and 6- month follow up

  • Paediatric Asthma Quality of Life Questionnaire (PAQLQ)

    parameters are measured before and after intervention as well as 3- and 6- month follow up

  • ARCIM Questionnaire (AFB)

    parameters are measured before and after intervention as well as 3- and 6- month follow up

  • Peak Flow

    parameters are measured before and after intervention as well as 3- and 6- month follow up

  • NO-measurement nasal and oral

    parameters are measured before and after intervention as well as 3- and 6- month follow up

  • +3 more secondary outcomes

Study Arms (2)

Buteyko based Remedial Breathing Therapy

EXPERIMENTAL

Buteyko based Remedial Breathing Therapy

Behavioral: Buteyko based Remedial Breathing Therapy

Waiting List

NO INTERVENTION

Training in the course of the study

Interventions

Buteyko based Remedial Breathing TherapyBEHAVIORAL

Buteyko based remedial Breathing Therapy after Dr. Buteyko

Buteyko based Remedial Breathing Therapy

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • signed informed consent of the parents
  • age 6- 15 years
  • information and consent of the consulting doctor
  • levels of asthma therapy 1-3

You may not qualify if:

  • participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 16, 2014

Study Start

January 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 2, 2016

Record last verified: 2016-03

Locations

DE(1)