Appendix 1
Summary of evidence for the efficacy of montelukast in children with each clinical pattern of asthma
| |
Author |
Design |
Key findings |
| Persistent asthma |
| Randomised placebo-controlled trials |
Knorr et al., 200113
|
Montelukast 4 mg once daily at bedtime for 12 weeks in pre-school children with mild-to-moderate persistent asthma (n=689) |
Montelukast superior to placebo on: percentage asthma-free days, daytime asthma symptoms, night-time asthma symptoms, days with asthma symptoms, need for SABA or oral corticosteroids, physician's global evaluation
No significant difference vs placebo in exacerbations rate, caregiver's global evaluation, quality of life
Benefits observed from first day
No difference vs placebo in adverse event rate
|
| Knorr et al., 199814
Becker et al., 200417
|
Montelukast 5 mg once daily at bedtime for 8 weeks in school children with persistent asthma (n=336)
Included children with moderately severe (FEV150-85% predicted) asthma
One-third taking ICS
|
Montelukast superior to placebo on: FEV1improvement, SABA use, days with asthma exacerbations (21% vs 26%), quality of life
No significant difference vs placebo on: absenteeism from school, nocturnal awakening, daytime asthma symptom score.
Onset of action rapid and sustained
No difference vs placebo in adverse event rate
In subgroup with milder asthma (FEV1> 75% predicted), montelukast superior to placebo on: FEV1improvement, PEF, night-time wakening, quality of life
|
| Phipatanakul et al., 200242
|
School children with asthma triggered by exposure to cat allergens (n=18)
|
Montelukast superior on: FEV1response to allergen exposure, duration of challenge tolerated
No significant difference vs placebo for upper respiratory
response
|
| Phipatanakul et al., 200343
|
24-week trial of montelukast during planned ICS tapering in children with
stable persistent asthma taking low-to-moderate ICS doses (n=36)
|
Montelukast superior to placebo on: number of rescue-free days, ICS dose reduction achieved
ICS requirement increased in placebo control group
|
| Randomised
comparative trials
|
Garcia Garcia
et al., 200516
|
Montelukast 5 mg once daily vs
fluticasone 100 mcg twice daily in school children with mild persistent asthma for 12 months (n=994)
Designed to demonstrate non-inferiority for primary outcome: change
from baseline in % days free of rescue
medications (e.g. SABA, systemic
corticosteroids)
|
Montelukast not inferior to ICS on primary outcome
Fluticasone superior on: FEV1, days without SABA, quality of life, systemic corticosteroid requirement, acute asthma episodes
Both montelukast and fluticasone well tolerated
|
| Luskin et al.,
200319
|
Montelukast vs fluticasone in school
children with mild persistent asthma
(n=104)
12-month prospective open-label
observational study
|
Montelukast and fluticasone equally effective on:
emergency visits, hospitalisation, symptoms at study completion, SABA use, oral prednisolone use.
Montelukast superior on adherence
|
| Sorkness et al., 200720 |
Montelukast once daily vs fluticasone 100 mcg twice daily for 48 weeks in school children with mild-to-moderate persistent asthma |
Fluticasone superior on: symptom-free days, SABA use, improvement in number of asthma control days, improvement in episode-free days, FEV1, morning and evening PEF
No difference for growth over 48 weeks
|
| Zeiger et al., 200621
|
Montelukast vs fluticasone for 16 weeks in school children with mild-to-
moderate persistent asthma
|
Fluticasone superior to montelukast on: number of asthma control days, Asthma Control Questionnaire,
SABA use, FEV1, peak expiratory flow
|
| Ostrom et al., 200522 |
Montelukast 5 mg once daily vs fluticasone 50 mcg twice daily for 12 weeks in school children (n=342) with moderate-to-severe persistent asthma (baseline FEV160-85% predicted) |
Fluticasone superior to montelukast on: FEV1, morning and evening PEF, percentage rescue-free days, night-time symptom score, mean total symptom score, SABA use |
| Jat et al., 200623 |
Combination montelukast 5 mg once + budesonide 200 mcg daily vs budesonide 400 mcg/day alone in children with moderate persistent asthma |
Similar efficacy on: FEV1, asthma symptom scores Budesonide 400 mcg/day markedly superior to montelukast plus low-dose budesonide on exacerbation rate (33.3% vs 9.1%; P < 0.01) |
| Peroni et al.,
200544
|
Montelukast vs budesonide in children with mild asthma exposed to known allergen trigger (house dust mite) |
Both budesonide and montelukast protected against fall in FEV1on allergen challenge Budesonide, but not montelukast, protected against increase in bronchial hyperresponsiveness after allergen challenge |
| Intermittent asthma |
| Randomised placebo-controlled trials
|
Bisgaard et al., 200325 |
Long-term (12 months) montelukast in pre-school children with intermittent asthma and a history of recurrent viral-induced exacerbations taking ICS (n=549) |
Montelukast superior to placebo on: exacerbation rate, ICS requirement Number of positive viral tests too low to permit correlation of reduction exacerbations with prevention of viral-induced episodes |
| Robertson et al., 20073 |
12-month study of parent-initiated montelukast course commenced at onset of viral infection or asthma symptoms in school children with intermittent asthma |
Montelukast superior to placebo on: reduction in symptoms, days off school, need for doctor visits Non-significant trend favouring montelukast for: specialist attendances and hospitalisations, duration of episode, SABA use, prednisolone use |
| Bisgaard et al.,
200345
|
28-day course montelukast in infants
(3-36 months) hospitalised with acute
RSV bronchiolitis
|
Montelukast superior to placebo on: proportion of symptom-free days and nights, cough rate, delayed acute respiratory episodes |
| Exercise-induced asthma |
| Randomised placebo-
controlled trials
|
Melo et al.,
200330
|
Montelukast taken for 1 week in
atopic school children with exercise-
induced bronchoconstriction
|
Montelukast superior to placebo on: reduction in
immediate-phase and late-phase bronchoconstriction
following exercise challenge
Montelukast abolished late-phase bronchoconstriction
|
| Kemp et al.,
199831
|
Montelukast 5 mg once daily in school
children
|
Montelukast superior to placebo on protection against
exercise-induced bronchoconstriction
Protective effect seen after 2 days' treatment
|
| Kim et al.,
200532
|
Montelukast taken for 8 weeks in
children with exercise-induced asthma
(n=64)
|
Montelukast superior to placebo on protection against
exercise-induced bronchoconstriction
Bronchoprotective effect sustained for 8 weeks after cessation of treatment
|
Appendix 2
Search Strategy
A. Medline 1996 to Present with Daily Update (Ovid) Search strategy:
1 montelukast.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (843)
2 leukotriene receptor antagonist$.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (784)
3 1 or 2 (1373)
4 limit 3 to (humans and English language and (clinical trial, all or guideline or meta analysis or practice guideline or randomized controlled trial or “review”)) (590)
B. Medline 1996 to Present with Daily Update (Ovid)
Search strategy:
1 Asthma, Exercise-Induced/ (1313)
2 montelukast.mp. [mp=title, original title, abstract, name of substance word, subject heading word] (846)
3 1 and 2 (32)
C. Pubmed clinical queries
1 montelukast + therapy + narrow (specific) (249)
2 Limit 1 to: (human + English + [meta-analysis or RTC] + age 0–18 years) (141)
Content Updated June 2007
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