Assessment of long-term efficacy of early introduction of inhaled steroids in asthma
| ISRCTN | ISRCTN34366936 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34366936 |
| Secondary identifying numbers | HTA 93/14/99 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 24/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
Dr Madge Vickers
Scientific
Scientific
MRC Epidemiology & Medical Care Unit
Wolfson Institute
Preventive Medicine
Charterhouse Square
London
NW1 2ND
United Kingdom
| Phone | +44 (0)20 7670 4851 |
|---|---|
| m.r.vickers@mds.qmw.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Assessment of long-term efficacy of early introduction of inhaled steroids in asthma |
| Study objectives | Asthma is one of the commonest chronic diseases in the UK and currently imposes a large economic burden on the NHS. Asthma is often a life-long disease but there are few studies of long-term therapy. Even in its mildest form asthma is associated with chronic inflammation of the airways. Inhaled steroids reduce this inflammation and are highly effective in controlling asthma. Recent evidence suggests that their early introduction may also reduce irreversible changes in airflow obstruction, but larger controlled trials are needed to assess this in both adults and children. The impact of early introduction of inhaled steroids on growth and bone density has not yet been studied adequately in a randomised controlled trial. We propose to study the efficacy 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 a large asthma study coordinated by the applicants. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory tract diseases: Asthma |
| Intervention | Children (3-8 yr) and adults will be randomised to receive either inhaled steroid (budesonide 100µg b.d. in children r 200 µg b.d. in adults) 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) FEV symptoms, inhaled beta-agonist use, exacerbations and a quality of life assessment. To measure risks we will measure growth in children and bone density in children and adults. A cost-effectiveness analysis will also be performed. A feasibility study and audit suggest that these patients can be identified and that the procedures are acceptable to both the doctors and patients. This long-term controlled study will provide information about whether very early introduction of inhaled steroids has advantages over the current policy of introducing inhaled steroids when symptoms occur on a daily basis. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | budesonide |
| Primary outcome measure | Not provided at time of registration. |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 01/02/1999 |
| Completion date | 30/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | Not provided at time of registration. |
| Key inclusion criteria | Not provided at time of registration. |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/02/1999 |
| Date of final enrolment | 30/04/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Epidemiology & Medical Care Unit
London
NW1 2ND
United Kingdom
NW1 2ND
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 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"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 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
24/05/2016: No publications found, study status unverified
