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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00515840
Other study ID # 03/014
Secondary ID
Status Completed
Phase Phase 3
First received August 13, 2007
Last updated November 4, 2015
Start date October 2003
Est. completion date December 2007

Study information

Verified date November 2015
Source University of Aberdeen
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

Breathing retraining supervised by a physiotherapist will result in improvements in the quality of life and asthma control of patients treated for asthma in the community with symptoms suggestive of dysfunctional breathing.

To investigate the effects of breathing retraining on clinical and physiological parameters of asthma control, to identify the characteristics of patients who benefit, to perform a health economic evaluation.


Description:

Objectives:

- To assess the effect of breathing retraining on asthma-related health status, asthma control and objective indices of asthma severity (bronchial hyper-reactivity (BHR), sputum eosinophilia and nitric oxide production) in patients with symptomatic asthma.

- To compare the relationship between symptoms of dysfunctional breathing (Nijmegen Questionnaire screening score), changes in asthma-related health status and other parameters resulting from breathing retraining

- To explore the relationship between dysfunctional breathing, baseline asthma symptoms, treatment and asthma-related quality of life.

- To estimate the cost effectiveness of the breathing retraining intervention


Recruitment information / eligibility

Status Completed
Enrollment 182
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 17 Years to 70 Years
Eligibility Inclusion Criteria:

- Asthma diagnosis in medical records

- Age 17-70 yrs.

- One or more prescription for asthma medication in previous 12 months

- Impaired asthma related quality of life (AQLQ score <5.5)

Exclusion Criteria:

- COPD

- Unstable or under-treated asthma at enrollment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Physiotherapist
Physiotherapist administered breathing retraining programme

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
P Burns University Hospitals, Leicester

Outcome

Type Measure Description Time frame Safety issue
Primary Change in AQLQ scores between intervention and control groups in subjects with positive NQ screening scores 1 month post intervention Change in AQLQ scores between intervention groups of subjects with positive and negative NQ screening scores Dec 2006
Secondary Changes in bronchial hyperresponsiveness(PC 20), sputum eosinophil counts and exhaled NO between intervention and control groups in subjects with positive and negative NQ screening scores Change in ACQ Score between the intervention and the control gr Dec 2007
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