Condition category
Respiratory
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
21/04/2015
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

Prof Peter Barnes

ORCID ID

Contact details

University of London
London
SW3 6LY
United Kingdom
+44 (0)20 7351 8174
p.j.barnes@ic.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 93/14/06

Study information

Scientific title

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

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 names

Budesonide

Primary outcome measures

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.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/11/1995

Overall trial end date

29/05/1998

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 adults and 200 children

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

30/11/1995

Recruitment end date

29/05/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of London
London
SW3 6LY
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes