Condition category
Respiratory
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
24/05/2016
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

Dr Madge Vickers

ORCID ID

Contact details

MRC Epidemiology & Medical Care Unit
Wolfson Institute
Preventive Medicine
Charterhouse Square
London
NW1 2ND
United Kingdom
+44 (0)20 7670 4851
m.r.vickers@mds.qmw.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 93/14/99

Study information

Scientific title

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

budesonide

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/02/1999

Overall trial end date

30/04/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Not provided at time of registration.

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/02/1999

Recruitment end date

30/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Epidemiology & Medical Care Unit
London
NW1 2ND
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

24/05/2016: No publications found, study status unverified