Regular inhaled salbutamol and asthma control : the TRUST randomised trial
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Transcript of Regular inhaled salbutamol and asthma control : the TRUST randomised trial
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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