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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Asthma, Respiratory

Intervention / Treatment
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* Other: Physiotherapist


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 1<br>equal time with health care professional (asthma nurse) | Other: Physiotherapist<br>* Physiotherapist administered breathing retraining programme<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |