Regular inhaled salbutamol and asthma control : the TRUST randomised trial

1. Regular inhaled salbutamol and asthma control : the TRUST randomisedtrial Sarah M Dennis et al. The Therapy Working Group of the National Asthma Task Force and the MRC General Practice Research Framework นสภ.ศุภนุช ดวงสนิท มหาวิทยาลัยศรีนครินทรวิโรฒ นสภ.สิรินพรศิริกุล มหาวิทยาลัยพะเยา

2. Outline • Background & Rationale • Objective • Study design & Method • Study Outcome • Results • Conclusion

3. Background & Rationale Previous work has suggested that : • The long-term regular use of inhaled β2-agonist bronchodilators • might lead to a deterioration in asthma control. Sears et al. : that regular treatment with the inhaled β2-agonist fenoterol resulted in worse control of asthma than when the drug was used on demand, although results of other studies do not all support this conclusion. Drazen et al. : patients with mild asthma taking β2-agonists only, regular short-term use of salbutamol over 16 weeks was not associated with a worsening of PEF.

4. Objective The aim of TRUST (The Regular Use of Salbutamol Trial) was to study the effects of regular use of inhaled salbutamol, the most widely prescribed bronchodilator in the UK, on the control of asthma

5. Study design & Method Patients • Aged ≥ 18 years • Had had asthma ≥ 1 year • treated at steps 1-3 of the British Thoracic Society Guidelines on asthma management • have been taking short-acting inhaled beta 2-agonistsat least twice/week, either alone, or in combination with inhaled steroids (≤ 2 mg) ≥ 6 months Inclusion criteria

6. Study design & Method Exclusion criteria • Had increased the dose of inhaled corticosteroids, taken a course of oral steroids, or had been admitted to hospital for asthma in the 6 weeks • Taken any other antiasthma medication • pregnant • Had any other major illness

7. Study design & Method Design A randomised, double-blind, placebo-controlled trial N = 486 (placebo) 1 year Run in N = 497 (400 µg salbutamol) 1 year Duration 1 year and Follow up monthly

8. Study design & Method

9. daily diary card recording : • Morning and evening PEF before bronchodilator use • Asthma symptoms during day and night • Use of beta 2-agonist inhaler • Days off work or college • Visits to the general practitioner or hospital because of asthma • Increased dose of inhaled corticosteroids, or courses of oral corticosteroids

10. Baseline Characteristic

11. Study Outcome • Primary outcome : exacerbation rate • use of oral corticosteroids • an increase in the dose of inhaled corticosteroids • at least 2 of 3 criteria on 2 consecutive days • Fall in PEF to less than 80% of median baseline level • Bronchodilator inhalations per 24 h increased by three or more over baseline level • Symptom-score increased during the day or at night, by two or more over median baseline level

12. Study Outcome • Secondary outcome • Use of rescue inhaled Beta 2 agonists • Diurnal variation in PEF • Symptom score • Days lost from work or normal activities and quality of life.

13. Statistical analysis Primary outcome: • Non-parametric Wilcoxon rank sum test Secondary outcome • Chis-quare test. • Analysis of covarain

14. Results : Primary outcome

15. Result : secondary outcome

16. Result : secondary outcome

17. Conclusion There was no evidence that regular use of inhaled salbutamol 400 µg 4 times daily for a year increased the exacerbation rate of asthma in the population studied Nevertheless, it should be emphasised that the need to use increased doses of inhaled β 2-agonist is an indication that asthma is not optimally controlled, and additional treatment should be considered

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