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Background:
The motive behind conducting this study was to determine if better control
of asthma can be achieved by adding a second controller medication and to
assess its use to reduce the dose of inhaled steroids.
Objectives:
The study aimed to determine whether either oral sustained-release
theophylline or montelukast added to inhaled steroids improved clinical
symptoms and pulmonary function test parameters when compared to high-dose
steroids alone.
Methods:
Ninety patients with incompletely controlled asthma were allocated, in a
randomised, double-blind fashion, to one of three treatment groups: group A:
double dose of inhaled budesonide (400 mug b.i.d.), group B: 400 mg oral
sustained-release theophylline plus budesonide (200 mug b.i.d.) and group C:
10 mg montelukast plus budesonide (200 mug b.i.d.). The primary endpoints
were forced expiratory volume in 1 s (FEV(1)) and mean morning peak
expiratory flow rate (PEFR).
Results:
All three groups had improved FEV(1) and PEFR at 8 weeks (p < 0.001). Group
C increased their PEFR by 18.7 l/min (95% confidence interval, CI,
12.4-25.1) more than group A and by 19.8 l/min (95% CI 13.4-26.1) more than
group B (both p = 0.001). Similarly, group C had a 114 ml (95% CI 45-183 ml)
greater improvement in FEV(1) than group A and a 95 ml (95% CI 26-164 ml)
greater improvement than group B (both p = 0.01).
Conclusions:
Addition of montelukast to budesonide is safe and results in greater
improvement in pulmonary function test parameters than high-dose budesonide
treatment or addition of theophylline.
Reference:
Respiration. 2006 Jan 9 |