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

ISRCTN ISRCTN00922609
DOI https://doi.org/10.1186/ISRCTN00922609
Secondary identifying numbers HTA 93/14/06
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific titleAssessment of long-term efficacy of early introduction of inhaled steroids in asthma
Study objectivesWe 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) studiedRespiratory tract diseases: Asthma
InterventionWe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Budesonide
Primary outcome measureTo 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 measuresNot provided at time of registration
Overall study start date30/11/1995
Completion date29/05/1998
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants200 adults and 200 children
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment30/11/1995
Date of final enrolment29/05/1998

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of London
London
SW3 6LY
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

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 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.