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
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