Assessment of long-term efficacy of early introduction of inhaled steroids in asthma

ISRCTN	ISRCTN00922609
DOI	https://doi.org/10.1186/ISRCTN00922609
Protocol serial number	HTA 93/14/06
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 09/08/2017

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Peter Barnes
Scientific

University of London
London
SW3 6LY
United Kingdom

Phone	+44 (0)20 7351 8174
Email	p.j.barnes@ic.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Assessment of long-term efficacy of early introduction of inhaled steroids in asthma
Study objectives	We propose to study the effect of introducing inhaled steroids in children and adults at the time of asthma diagnosis in a randomised controlled trial of parallel group design. The study will be conducted through the MRC General Practice Research Framework, which is currently carrying out another large asthma study with the National Asthma Task Force Therapy Working Group. A 21-month feasibility study is proposed in 12-16 practices within the General Practice Research Framework. 100 patients will be recruited (50 adults and 50 children). If the feasibility study is successful and we are awarded the funding for the full study it is hoped that those patients recruited to the pilot study will form the first group of patients in the main study. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/931406
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Respiratory tract diseases: Asthma
Intervention	We estimate that for the main trial it will be necessary to recruit 200 adults and 200 children which will require about 160 practices. Children (3-8 years) and adults will be randomised to receive either inhaled steroid (budesonide 100 µg and 200 µg bd.) or matched placebo and patients will be followed up at 6-monthly intervals for 4 years, with measurements of peak expiratory flow (over 2 weeks), symptoms, inhaled beta2-agonist use, exacerbations and a quality of life assessment.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Budesonide
Primary outcome measure(s)	To measure risks we will measure the growth in children and bone density in children and adults. A cost-effectiveness analysis will also be performed.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	29/05/1998
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	400
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	30/11/1995
Date of final enrolment	29/05/1998

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of London

London
SW3 6LY
United Kingdom

Results and Publications

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

Editorial Notes

09/08/2017: Internal review
31/07/2017: PI confirmed that the study has been stopped and there have been no resulting publications.
28/07/2017: No publications found in PubMed, verifying study status with principal investigator.