Condition category
Respiratory
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
24/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 0161 291 2846
Robert.Niven@smuht.nwest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0226167744

Study information

Scientific title

Acronym

Study hypothesis

To improve thoraco-abdominal co-ordination and hence reduce breathlessness.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Respiratory: Asthma

Intervention

1. Patients will undergo breathing retraining with senior physiotherapist
2. Control

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

06/04/2004

Overall trial end date

15/12/2005

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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

http://www.dh.gov.uk/Home/fs/en

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes