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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Dominick Shaw
Scientific

17 Arleston Drive
Wollaton
Nottingham
NG8 2FR
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A more intensive approach to diagnosis and management of asthma in primary care: a randomised controlled trial
Study objectives	Use 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) studied	Asthma
Intervention	Titrate steroid dose on basis of exhaled nitric oxide versus control group receiving treatment as per current BTS (British Thoracic Society) guidelines.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Nitric oxide
Primary outcome measure(s)	Asthma exacerbations.
Key secondary outcome measure(s)	Steroid dose (area under curve).
Completion date	01/01/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	85 Years
Sex	All
Target sample size at registration	200
Key inclusion criteria	1. Asthma 2. On treatment, providing it is a repeat prescription i.e., the patient suffers from chronic asthma 3. Aged 18-85
Key exclusion criteria	Recent exacerbation
Date of first enrolment	01/01/2004
Date of final enrolment	01/01/2006

17 Arleston Drive

Nottingham
NG8 2FR
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

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

25/10/2022: Internal review.