Assessment of long-term efficacy of early introduction of inhaled steroids in asthma
ISRCTN | ISRCTN00922609 |
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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
Scientific
University of London
London
SW3 6LY
United Kingdom
Phone | +44 (0)20 7351 8174 |
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p.j.barnes@ic.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Budesonide |
Primary outcome measure | 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 study start date | 30/11/1995 |
Completion date | 29/05/1998 |
Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 200 adults and 200 children |
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
- England
- United Kingdom
Study participating centre
University of London
London
SW3 6LY
United Kingdom
SW3 6LY
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Phone | +44 (0)1132 545 843 |
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Sheila.Greener@doh.gsi.gov.uk | |
Website | http://www.dh.gov.uk/en/index.htm |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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.