Trial reportThe Journal of allergy and clinical immunology2008
Azithromycin or montelukast as inhaled corticosteroid-sparing agents in moderate-to-severe childhood asthma study.
Trial report in The Journal of allergy and clinical immunology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00471809 (Childhood Asthma Research and Education), which is not on this map. Cited by 37 papers, 8 of them syntheses that pooled 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.
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.
Childhood Asthma Research and Education (CARE) Network Trial - Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS)
Who cites it
37 citing papers in PubMed, 8 syntheses or guidelines pooled it, 134 citations in OpenAlex.
- Establishing the best step-up treatments for children with uncontrolled asthma despite inhaled corticosteroids: the EINSTEIN systematic review, network meta-analysis and cost-effectiveness analysis using individual participant data.Health technology assessment (Winchester, England) · 2025Pooled it
- Macrolides versus placebo for chronic asthma.The Cochrane database of systematic reviews · 2021Pooled it
- Mobile direct observation of therapy (MDOT) - A rapid systematic review and pilot study in children with asthma.PloS one · 2018Pooled it
- The effects of macrolides in children with reactive airway disease: a systematic review and meta-analysis of randomized controlled trials.Drug design, development and therapy · 2018Pooled it
- Leukotriene-receptor antagonists versus placebo in the treatment of asthma in adults and adolescents: a systematic review and meta-analysis.Annals of internal medicine · 2015Pooled it
- A meta-analysis of genome-wide association studies for serum total IgE in diverse study populations.The Journal of allergy and clinical immunology · 2013Pooled it
- Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children.The Cochrane database of systematic reviews · 2012Pooled it
- Comparison between the health-related quality of life of children/adolescents with asthma and that of their caregivers: a systematic review and meta-analysis.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e TisilogiaPooled it
- Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations.The Journal of allergy and clinical immunology · 2015Trial
- Development of a population pharmacokinetic model to describe azithromycin whole-blood and plasma concentrations over time in healthy subjects.Antimicrobial agents and chemotherapy · 2013Trial
- Type 2-low Asthma: Epidemiology, Multiomics, and Emerging Therapies.Current allergy and asthma reports · 2026Review
- Evaluating Severe Therapy-Resistant Asthma in Children: Diagnostic and Therapeutic Strategies.Medicina (Kaunas, Lithuania) · 2024Review
- Review
- Severe and Difficult Asthma: Diagnosis and Management-Challenges for a Low-Resource Environment.Indian journal of pediatrics · 2022Review
- How to Choose the Correct Drug in Severe Pediatric Asthma.Frontiers in pediatrics · 2022Review
- Management of severe asthma: summary of the European Respiratory Society/American Thoracic Society task force report.Breathe (Sheffield, England) · 2020Review
- Which Child with Asthma is a Candidate for Biological Therapies?Journal of clinical medicine · 2020Review
- Severe Asthma-Perspectives From Adult and Pediatric Pulmonology.Frontiers in pediatrics · 2019Review
- Effects of Macrolide Treatment during the Hospitalization of Children with Childhood Wheezing Disease: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2018Article
- New Drugs for Pediatric Asthma.Frontiers in pediatrics · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 8 institutions in 2 countries.
Funding
Abstract
backgroundClinical trials in children with moderate-to-severe persistent asthma are limited.
objectiveWe sought to determine whether azithromycin or montelukast are inhaled corticosteroid sparing.
methodsThe budesonide dose (with salmeterol [50 microg] twice daily) necessary to achieve control was determined in children 6 to 17 years of age with moderate-to-severe persistent asthma. After a budesonide-stable period of 6 weeks, children were randomized in a double-masked, parallel, multicenter study to receive once-nightly azithromycin, montelukast, or matching placebos plus the established controlling dose of budesonide (minimum, 400 microg twice daily) and salmeterol twice daily. Primary outcome was time from randomization to inadequate asthma control after sequential budesonide dose reduction.
resultsOf 292 children screened, only 55 were randomized. Inadequate adherence to study medication (n = 80) and improved asthma control under close medical supervision (n = 49) were the major reasons for randomization failure. A futility analysis was requested by the Data Safety Monitoring Board. In data available for analyses, no differences were noted for either treatment compared with placebo in time to inadequate control status (median: azithromycin, 8.4 weeks [95% confidence limit, 4.3-17.3]; montelukast, 13.9 weeks [95% confidence limit, 4.7-20.6]; placebo, 19.1 weeks [95% confidence limit, 11.7-infinity]), with no difference between the groups (log-rank test, P = .49). The futility analysis indicated that even if the planned sample size was reached, the results of this negative study were unlikely to be different, and the trial was prematurely terminated.
conclusionBased on these results, neither azithromycin nor montelukast is likely to be an effective inhaled corticosteroid-sparing alternative in children with moderate-to-severe persistent asthma.
Indexed as
Identifiers
What OpenQuestion holds
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.