The GPIAG/Leicester asthma and dysfunctional breathing project: The GLAD study (RESUBMITTED - PLEASE SEE UHL 8567)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr RK McKinley
Scientific

University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom

Phone	+44 0)116 258 4109
Email	nicola.turner@uhl-tr.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	1. To investigate the effects of breathing retraining supervised by a respiratory physiotherapist on clinical and physiological measures of asthma control 2. To identify the characteristics of patients who may benefit from this intervention 3. To perform a health economical evaluation of the intervention
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Asthma
Intervention	Breathing retraining supervised by a respiratory physiotherapist compared to an attention control of generic asthma education provided by a nurse.
Intervention type	Other
Primary outcome measure(s)	1. Asthma related quality of life (Juniper AQLQ) 2. Generic quality of life (Euroquol) 3. Asthma control (Juniper ACQ) 4. Nijmegen Questionnaire 5. Hospital Anxiety and Depression 6. Bronchial hyper-responsiveness (methacholine PC20) 7. Sputum eosinophil counts 8. Exhaled nitric oxide concentrations 9. Capnography 10. Hyperventilation studies Measured before and 1 month after the intervention and control procedures. The questionnaires will be re-administered 6 and 12 months following the completion of intervention.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/08/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	212
Key inclusion criteria	1. Family practice patients aged 18 - 65 years 2. A diagnosis of asthma 3. Received at least one asthma prescription in the previous year 4. With and without symptoms of dysfunctional breathing
Key exclusion criteria	Does not comply with above inclusion criteria
Date of first enrolment	01/06/2002
Date of final enrolment	31/08/2004

University Hospitals of Leicester

Leicester
LE1 4PW
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2009		Yes	No