Clinical and economic implications of stepping down inhaled corticosteroids in patients with chronic stable asthma

ISRCTN ISRCTN12335748
DOI https://doi.org/10.1186/ISRCTN12335748
Secondary identifying numbers N/A
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
19/03/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Neil Thomson
Scientific

Department of Respiratory Medicine
West Glasgow Hospitals University NHS Trust
1053 Gt. Western Road
Glasgow
G12 0YN
United Kingdom

Phone +44 (0)141 211 3241
Email n.c.thomson@clinmed.gla.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThe 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(s)Ethical approval obtained in 1998.
Health condition(s) or problem(s) studiedRespiratory tract diseases: Asthma
InterventionStep down inhaled steroid over one year
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Inhaled steroid
Primary outcome measureExacerbation rate
Secondary outcome measuresInhaled steroid dose
Overall study start date02/01/1999
Completion date31/12/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants250
Key inclusion criteriaAdult asthmatic patients
Key exclusion criteria1. Chronic Obstructive Pulmonary Disease (COPD)
2. Low dose inhaled steroids
Date of first enrolment02/01/1999
Date of final enrolment31/12/2001

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Department of Respiratory Medicine
Glasgow
G12 0YN
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Asthma National Research and Development Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 24/05/2003 Yes No