Condition category
Respiratory
Date applied
28/09/2005
Date assigned
15/11/2005
Last edited
15/07/2010
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

Mrs Sue Cooper

ORCID ID

Contact details

Division Respiratory Medicine
Clinical Sciences Building
City Hospital
Nottingham
NG5 1PB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TC03/5

Study information

Scientific title

Acronym

Study hypothesis

Taping the mouth at night to ensure nose breathing will improve asthma control

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

Other

Trial type

Treatment

Patient information sheet

Condition

Asthma

Intervention

Crossover design of taping mouth at night versus usual breathing

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Morning peak expiratory flow and symptom scores

Secondary outcome measures

1. Evening peak flow
2. Diurnal variation in peak flow
3. FEV1
4. Beta-agonist use
5. Night time waking
6. Quality of life
7. Acceptability
8. Compliance with taping

Overall trial start date

27/05/2004

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Asthma
2. Age 18-72
3. Forced expiratory volume in one second (FEV1) over 50% predicted
4. Nocturnal or early morning symptoms
5. Pro re nata (prn) (as needed) beta-agonist use

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Previous training in Buteyko technique
2. Inability to breathe through nose
3. Known sleep apnoea
4. Over 10 pack years smoking history
5. Other significant uncontrolled disease

Recruitment start date

27/05/2004

Recruitment end date

31/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division Respiratory Medicine
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Innovation Services
University Park
Nottingham
NG7 2RD
United Kingdom
paul.cartledge@nottingham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

British Lung Foundation (UK) - )ref: TC03/5)

Alternative name(s)

BLF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19285849

Publication citations

  1. Results

    Cooper S, Oborne J, Harrison T, Tattersfield A, Effect of mouth taping at night on asthma control--a randomised single-blind crossover study., Respir Med, 2009, 103, 6, 813-819, doi: 10.1016/j.rmed.2009.02.003.

Additional files

Editorial Notes