Randomised controlled trial of treating dysfunctional breathing to reduce breathlessness in severe asthma

ISRCTN	ISRCTN92818360
DOI	https://doi.org/10.1186/ISRCTN92818360
Protocol serial number	N0226167744
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	South Manchester University Hospitals NHS Trust (UK) NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Rob Niven
Scientific

North West Lung Centre
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Phone	+44 (0)161 291 2846
Email	Robert.Niven@smuht.nwest.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Randomised controlled trial of treating dysfunctional breathing to reduce breathlessness in severe asthma
Study objectives	To improve thoraco-abdominal co-ordination and hence reduce breathlessness.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Respiratory: Asthma
Intervention	1. Patients will undergo breathing retraining with senior physiotherapist 2. Control
Intervention type	Other
Primary outcome measure(s)	Change in University of California San Diego Shortness-of-Breath Questionnaire (SOBQ) score after treatment for dysfunctional breathing
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	15/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	31
Key inclusion criteria	31 patients suffering from severe asthma: 1. Patients with diagnosis of asthma requiring regular maintenance medication (that includes high dose inhaled corticosteroid and long-acting Β2 agonist) 2. High medical resource usage 3. Non-smoker for at least one year 4. Historical evidence of reversibility
Key exclusion criteria	1. Previous treatment for hyperventilation, dysfunctional breathing, or other functional disorder of respiratory mechanics 2. Participation in another trial involving respiratory intervention 3. Current or recent lower respiratory tract infection 4. Presence of other respiratory diseases 5. DLCO <70% predicted, significant co-morbid illness 6. Pregnancy or nursing mother 7. Psychiatric disorder 8. Hospitalisation for asthma within the prior 6 weeks
Date of first enrolment	06/04/2004
Date of final enrolment	15/12/2005

North West Lung Centre

Manchester
M23 9LT
United Kingdom

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