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 measure
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 (if study stopped)
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
Trusts, charities, foundations (both public and private)
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19285849
Publication citations
-
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.