Evidence map›Paper›PMID 25212745›Full record

Trial reportThe Lancet. Respiratory medicine2014

Intermittent montelukast in children aged 10 months to 5 years with wheeze (WAIT trial): a multicentre, randomised, placebo-controlled trial.

Chinedu Nwokoro, Hitesh Pandya, Stephen Turner, Sandra Eldridge, Christopher J Griffiths, Tom Vulliamy, David Price, Marek Sanak, John W Holloway, Rossa Brugha and 4 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Respiratory medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01142505 (Parent-determined Oral Montelukast Therapy for Preschool Wheeze With Stratification for Arachidonate-5-Lipoxygenase), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
6.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01142505 phase3completednot on this map

Parent-determined Oral Montelukast Therapy for Preschool Wheeze With Stratification for Arachidonate-5-Lipoxygenase (ALOX5) Promoter Genotype

TypeinterventionalSponsorQueen Mary University of LondonRan2010 to 2014Enrolled1,358ConditionsWheezingArmsMannitol, Montelukast
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 82 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
  6. Article
  7. Management of preschool recurrent wheezing and asthma: a phenotype-based approach.Current opinion in allergy and clinical immunology · 2017
    Review
  8. EMC. Pediatria · 2016
    Review
  9. Review
  10. Review
  11. Article
  12. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 6 institutions in 2 countries.

Chinedu NwokoroAsthma UK Centre for Applied Research, Queen Mary University of London, London, UK.
Hitesh PandyaDepartment of Infection, Immunity and Inflammation, University of Leicester, Leicester, UK.
Stephen TurnerInstitute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
Sandra EldridgeAsthma UK Centre for Applied Research, Queen Mary University of London, London, UK.
Christopher J GriffithsAsthma UK Centre for Applied Research, Queen Mary University of London, London, UK.
Tom VulliamyAsthma UK Centre for Applied Research, Queen Mary University of London, London, UK.
David PriceAsthma UK Centre for Applied Research, Queen Mary University of London, London, UK.
Marek SanakDepartment of Medicine, Jagiellonian University Medical School, Krakow, Poland.
John W HollowayHuman Development and Health, University of Southampton, Southampton General Hospital, UK.
Rossa BrughaAsthma UK Centre for Applied Research, Queen Mary University of London, London, UK.
Lee KohAsthma UK Centre for Applied Research, Queen Mary University of London, London, UK.
Iain DicksonAsthma UK Centre for Applied Research, Queen Mary University of London, London, UK.
Clare RutterfordCentre for Primary Care and Public Health, Blizard Institute, Queen Mary University of London, London, UK.
Jonathan GriggAsthma UK Centre for Applied Research, Queen Mary University of London, London, UK. Electronic address: j.grigg@qmul.ac.uk.
Queen Mary University of London · GBAsthma UK · GBJagiellonian University · PLUniversity of Aberdeen · GBUniversity of Leicester · GBUniversity of Southampton · GB

Funding

Medical Research Council G0400473Medical Research Council G0800766Medical Research Council G0900453Medical Research Council MC_G1002451
6 · The paper itself

Abstract

backgroundThe effectiveness of intermittent montelukast for wheeze in young children is unclear. We aimed to assess whether intermittent montelukast is better than placebo for treatment of wheeze in this age group. Because copy numbers of the Sp1-binding motif in the arachidonate 5-lipoxygenase (ALOX5) gene promoter (either 5/5, 5/x, or x/x, where x does not equal 5) modifies response to montelukast in adults, we stratified by this genotype.

methodsWe did this multicentre, parallel-group, randomised, placebo-controlled trial between Oct 1, 2010, and Dec 20, 2013, at 21 primary care sites and 41 secondary care sites in England and Scotland. Children aged 10 months to 5 years with two or more wheeze episodes were allocated to either a 5/5 or 5/x+x/x ALOX5 promoter genotype stratum, then randomly assigned (1:1) via a permuted block schedule (size ten), to receive intermittent montelukast or placebo given by parents at each wheeze episode over a 12 month period. Clinical investigators and parents were masked to treatment group and genotype strata. The primary outcome was number of unscheduled medical attendances for wheezing episodes. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01142505.

findingsWe randomly assigned 1358 children to receive montelukast (n=669) or placebo (n=677). Consent was withdrawn for 12 (1%) children. Primary outcome data were available for 1308 (96%) children. There was no difference in unscheduled medical attendances for wheezing episodes between children in the montelukast and placebo groups (mean 2·0 [SD 2·6] vs 2·3 [2·7]; incidence rate ratio [IRR] 0·88, 95% CI: 0·77-1·01; p=0·06). Compared with placebo, unscheduled medical attendances for wheezing episodes were reduced in children given montelukast in the 5/5 stratum (2·0 [2·7] vs 2·4 [3·0]; IRR 0·80, 95% CI 0·68-0·95; p=0·01), but not in those in the 5/x+x/x stratum (2·0 [2·5] vs 2·0 [2·3]; 1·03, 0·83-1·29; p=0·79, pinteraction=0·08). We recorded one serious adverse event, which was a skin reaction in a child allocated to placebo.

interpretationOur findings show no clear benefit of intermittent montelukast in young children with wheeze. However, the 5/5 ALOX5 promoter genotype might identify a montelukast-responsive subgroup.

fundingMedical Research Council (UK) and National Institute for Health Research.

Indexed as

AcetatesAnti-Asthmatic AgentsAppointments and SchedulesArachidonate 5-LipoxygenaseAsthmaChild, PreschoolCyclopropanesCysteineDrug Administration ScheduleFemaleGenotypeHumansInfantLeukotrienesMaleQuinolinesAcetatesALOX5 protein, humanAnti-Asthmatic AgentsArachidonate 5-LipoxygenaseCyclopropanesCysteinecysteinyl-leukotrieneLeukotrienesmontelukastQuinolinesSulfides

Identifiers

PMID25212745
PMCPMC4189104
OpenAlexW2140553643

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.