Guideline topic: Pharmacological management of asthma
Evidence table 4.8c: Children with poor asthma control on ICS – Is addition of leukotriene receptor antagonists helpful?

Author

Simons FER et al¹

2001

RCT, multicentered, placebo controlled, crossover study

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279 Asthmatic children 6-14 years, with symptoms despite BUD 400mcg/day.

Children given montelukast 5mg OD or placebo for 4 weeks and then ‘crossed over’ treatments

1] FEV1 compared with baseline

2] Home PEFR monitoring

3] asthma attack rates

4] beta2 agonist usage

5]QOLY

6] parent’s global assessment

7] physician’s global assessment

8] blood eosinophils

*Compared with placebo
1] difference FEV1 1.3% , p=0.06
(1.9%, p=0.01 – per protocol)

2] difference PEFR am 9.7L/min, p=0.023, and PEFR pm 10.7L/min, p=0.012

3] montelukast 12.2 % versus 15.9% for placebo, p<0.001

4] montelukast reduced beta2 use by mean 0.33puffs/day, p=0.013

5] NS different from placebo

6] NS different from placebo

7] NS different from placebo

8] 8% reduction greater than placebo

1] 95%ci –(0.1,2.7)

2] 95%ci; (1.4,18.1) for am and (2.4,1

9) for pm

P<0.001

No washout period in crossover study but outcome measured in 2^nd half of each study period.

Benefits of additional montelukast while statistically significant are at best modest

Bisgaard Hans et al²

1999

RCT, crossover, double blind

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26 asthmatic children, 6-15 years, 11 on ICS, 15 ICS naïve

Given 2 weeks montelukast 5mg or placebo then crossover

1] Exhaled NO

2] FEV1 and MMEF

*only those on ICS (n=11)

1] 22% fall ENO (placebo)

23.6% fall ENO (monte)

2] NS tendency for better values with montelukast

Small subgroup analysis for children on ICS