Contact information
Type
Scientific
Contact name
Dr Rob Niven
ORCID ID
Contact details
North West Lung Centre
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 2846
Robert.Niven@smuht.nwest.nhs.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0226167744
Study information
Scientific title
Randomised controlled trial of treating dysfunctional breathing to reduce breathlessness in severe asthma
Acronym
Study hypothesis
To improve thoraco-abdominal co-ordination and hence reduce breathlessness.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Respiratory: Asthma
Intervention
1. Patients will undergo breathing retraining with senior physiotherapist
2. Control
Intervention type
Other
Primary outcome measure
Change in University of California San Diego Shortness-of-Breath Questionnaire (SOBQ) score after treatment for dysfunctional breathing
Secondary outcome measures
Not provided at time of registration
Overall study start date
06/04/2004
Overall study end date
15/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
31
Participant 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
Recruitment start date
06/04/2004
Recruitment end date
15/12/2005
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
North West Lung Centre
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Manchester University Hospitals NHS Trust (UK) NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|