REGULAR INHALED SALBUTAMOL AND

ASTHMA CONTROL : THE TRUST RANDOMISED

TRIALSarah M Dennis et al.

The Therapy Working Group of the National Asthma Task Force and the MRC General Practice Research Framework

นสภ.ศุภนุช ดวงสนิท มหาวทิยาลัยศรนีครนิทรวโิรฒนสภ.สรินิพร ศิรกิลุ มหาวทิยาลัยพะเยา

OUTLINE

Background & Rationale Objective Study design & Method Study Outcome Results Conclusion

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.

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

Inclusion criteria

Patients

Study design & Method

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-

agonists at least twice/week, either alone, or in combination with inhaled steroids (≤ 2 mg) ≥ 6 months

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 medicationpregnantHad any other major illness

Exclusion criteria

STUDY DESIGN & METHOD

DesignA randomised, double-blind, placebo-controlled

trial

N = 497 (400 µg salbutamol)

N = 486 (placebo)1 year

1 year

Run in

Duration 1 year and Follow up monthly

STUDY DESIGN & METHOD

STUDY DESIGN & METHOD

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

BASELINE CHARACTERISTIC

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

Secondary outcome Use of rescue inhaled Beta 2 agonistsDiurnal variation in PEFSymptom score Days lost from work or normal activities

and quality of life.

STUDY OUTCOME

STATISTICAL ANALYSIS

Primary outcome: Non-parametric Wilcoxon rank sum

test

Secondary outcomeChis-quare test.Analysis of covarain

RESULTS : PRIMARY OUTCOME

RESULT : SECONDARY OUTCOME

RESULT : SECONDARY OUTCOME

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

THANK YOU

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