Stepping down inhaled corticosteroids in asthma: randomised controlled trialBMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7399.1115 (Published 22 May 2003) Cite this as: BMJ 2003;326:1115
- Gillian Hawkins, clinical research fellow1,
- Alex D McMahon, senior statistician2,
- Sara Twaddle, head of research and development3,
- Stuart F Wood, senior lecturer1,
- Ian Ford, professor2,
- Neil C Thomson, professor ()4
- 1 Department of General Practice, University of Glasgow, Glasgow G12 0RR
- 2 Robertson Centre for Biostatistics, University of Glasgow, Glasgow G12 8QQ
- 3 Department of Research and Development, Stobhill Hospital, Glasgow G21 3UT
- 4 Department of Respiratory Medicine, University of Glasgow, Western Infirmary, Glasgow G11 6NT
- Correspondence to: N C Thomson
- Accepted 24 March 2003
Objectives To determine whether the dose of inhaled corticosteroids can be stepped down in patients with chronic stable asthma while maintaining control. Design One year, randomised controlled, double blind, parallel group trial.
Setting General practices throughout western and central Scotland.
Participants 259 adult patients with asthma receiving regular treatment with inhaled corticosteroids at high dose (mean dose 1430 μg beclomethasone dipropionate).
Interventions Participants were allocated to receive either no alteration to their dose of inhaled corticosteroid (control) or a 50% reduction in their dose if they met criteria for stable asthma (stepdown).
Main outcome measures Comparison of asthma exacerbation rates, asthma related visits to general practice and hospital, health status measures, and corticosteroid dosage between the two groups.
Results The proportions of subjects with asthma exacerbations were not significantly different (stepdown 31%, control 26%, P=0.354). Similarly, the numbers of visits to general practice or hospital and the disease specific and generic measures of health status over the one year period were not significantly different. On average the stepdown group received 348 μg (95% confidence interval 202 μgto494 μg) of beclomethasone dipropionate less per day than the controls (a difference of 25%), with no difference in the annual dose of oral corticosteroids between the two treatment regimens.
Conclusions By adopting a stepdown approach to the use of inhaled steroids at high doses in asthma a reduction in the dose can be achieved without compromising asthma control.
Funding NHS R&D Programme on Asthma Management.
Conflict of interest NCT has been reimbursed by AstraZeneca (AZ), GlaxoSmithKline (GSK), and Schering Plough (SP), the manufacturers of budesonide, beclomethasone and fluticasone, and mometasone, respectively, for attending several conferences and has acted as a consultant to GSK and Altana. His department has received research funds for clinical trials from AZ, GSK, Novartis, and Merck; SFW has received fees for speaking, chairing, or advising from GSK, AZ, SP, and Aventis; IF has received research funding and committee honorariums from GSK and a committee honorarium and speaking fee from AZ.
Ethical approval was granted by the multicentre research ethics committee for Scotland and appropriate local research ethics committees.
- Accepted 24 March 2003