A more intensive approach to diagnosis and management of asthma in primary care: a randomised controlled trial

ISRCTN ISRCTN08067387
DOI https://doi.org/10.1186/ISRCTN08067387
Secondary identifying numbers 03/050
Submission date
13/07/2006
Registration date
17/08/2006
Last edited
25/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dominick Shaw
Scientific

17 Arleston Drive
Wollaton
Nottingham
NG8 2FR
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleA more intensive approach to diagnosis and management of asthma in primary care: a randomised controlled trial
Study objectivesUse of exhaled nitric oxide will result in fewer asthma exacerbations.
Ethics approval(s)University Hospitals of Leicester (ref. no.: 9141) and the Leicester Primary Research Care Alliance (ref. no.: 0274).
Health condition(s) or problem(s) studiedAsthma
InterventionTitrate steroid dose on basis of exhaled nitric oxide versus control group receiving treatment as per current BTS (British Thoracic Society) guidelines.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Nitric oxide
Primary outcome measureAsthma exacerbations.
Secondary outcome measuresSteroid dose (area under curve).
Overall study start date01/01/2004
Completion date01/01/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit85 Years
SexBoth
Target number of participants200
Key inclusion criteria1. Asthma
2. On treatment, providing it is a repeat prescription i.e., the patient suffers from chronic asthma
3. Aged 18-85
Key exclusion criteriaRecent exacerbation
Date of first enrolment01/01/2004
Date of final enrolment01/01/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

17 Arleston Drive
Nottingham
NG8 2FR
United Kingdom

Sponsor information

Asthma UK (UK)
Charity

Summit House
70 Wilson Street
London
EC2A 2DB
United Kingdom

Website http://www.asthma.org.uk/
ROR logo "ROR" https://ror.org/03z7xev21

Funders

Funder type

Charity

Asthma UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
Asthma UK, Asthma + Lung UK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/08/2007 Yes No

Editorial Notes

25/10/2022: Internal review.