Contact information
Type
Scientific
Primary contact
Prof Neil Thomson
ORCID ID
Contact details
Department of Respiratory Medicine
West Glasgow Hospitals University NHS Trust
1053 Gt. Western Road
Glasgow
G12 0YN
United Kingdom
+44 (0)141 211 3241
n.c.thomson@clinmed.gla.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The UK national guidelines for asthma management recommend a slow stepwise reduction of treatment in patients with chronic asthma which has been stable for a three to six month period. Inhaled steroids are highly effective in treating asthma, although, a plateau in the therapeutic response may exist for many asthmatic patients at doses below 1000 mcg daily. Concerns have been raised that some patients may be receiving inappropriately high doses of inhaled steroids. The aims of this study are to assess the clinical and economic implications of stepping down inhaled steroid treatment over a one year period on patients with chronic stable asthma receiving more than 1000 mcg inhaled steroid daily.
The primary objectives are:
1. To compare the number of exacerbations of asthma in the group in whom the dose of inhaled steroid is reduced by up to 50% with those in whom the dose is unaltered over a one year period;
2. To perform an economic evaluation of the two management plans. The benefit the proposed investigation may bring to the National Health Service (NHS) is the cost-effective use of inhaled steroid treatment in asthma.
Ethics approval
Ethical approval obtained in 1998.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Respiratory tract diseases: Asthma
Intervention
Step down inhaled steroid over one year
Intervention type
Drug
Phase
Not Specified
Drug names
Inhaled steroid
Primary outcome measure
Exacerbation rate
Secondary outcome measures
Inhaled steroid dose
Overall trial start date
02/01/1999
Overall trial end date
31/12/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult asthmatic patients
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
250
Participant exclusion criteria
1. Chronic Obstructive Pulmonary Disease (COPD)
2. Low dose inhaled steroids
Recruitment start date
02/01/1999
Recruitment end date
31/12/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Respiratory Medicine
Glasgow
G12 0YN
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Asthma National Research and Development Programme (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
Basic results (scientific)
Publication list
Publication citations
-
Results
Hawkins G, McMahon AD, Twaddle S, Wood SF, Ford I, Thomson NC, Stepping down inhaled corticosteroids in asthma: randomised controlled trial., BMJ, 2003, 326, 7399, 1115, doi: 10.1136/bmj.326.7399.1115.