GPIAG and Leicester Asthma and Dysfunctional Breathing (GLAD) Study: a Randomised Controlled Study

Phase 3

Completed

• Conditions: Asthma; Respiratory
• Interventions: Other: Physiotherapist

• Registration Number: NCT00515840
• Lead Sponsor: P Burns

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2007-08-13
• Study First Submitted QC: 2007-08-13
• Study First Posted: 2007-08-14
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-04
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Physiotherapist	equal time with health care professional (asthma nurse)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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