Trial reportBMJ (Clinical research ed.)2003
Montelukast and fluticasone compared with salmeterol and fluticasone in protecting against asthma exacerbation in adults: one year, double blind, randomised, comparative trial.
Trial report in BMJ (Clinical research ed.), 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 9 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
45 citing papers in PubMed, 9 syntheses or guidelines pooled it, 213 citations in OpenAlex.
- Montelukast in paediatric asthma and allergic rhinitis: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2023Pooled it
- Inhaled steroids with and without regular salmeterol for asthma: serious adverse events.The Cochrane database of systematic reviews · 2018Pooled it
- Comparative effectiveness of long term drug treatment strategies to prevent asthma exacerbations: network meta-analysis.BMJ (Clinical research ed.) · 2014Pooled it
- Addition to inhaled corticosteroids of long-acting beta2-agonists versus anti-leukotrienes for chronic asthma.The Cochrane database of systematic reviews · 2014Pooled it
- Addition of anti-leukotriene agents to inhaled corticosteroids in children with persistent asthma.The Cochrane database of systematic reviews · 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
- Addition of long-acting beta2-agonists to inhaled corticosteroids versus same dose inhaled corticosteroids for chronic asthma in adults and children.The Cochrane database of systematic reviews · 2010Pooled it
- Addition of inhaled long-acting beta2-agonists to inhaled steroids as first line therapy for persistent asthma in steroid-naive adults and children.The Cochrane database of systematic reviews · 2009Pooled it
- Add-on therapy options in asthma not adequately controlled by inhaled corticosteroids: a comprehensive review.Respiratory research · 2004Pooled it
- Fevipiprant, an oral prostaglandin DPThe European respiratory journal · 2017Trial
- Risk factors for montelukast treatment failure in step-down therapy for controlled asthma.The Journal of asthma : official journal of the Association for the Care of Asthma · 2011Trial
- Salmeterol plus fluticasone propionate versus fluticasone propionate plus montelukast: a randomised controlled trial investigating the effects on airway inflammation in asthma.Respiratory research · 2007Trial
- Montelukast as add-on therapy with inhaled corticosteroids alone or inhaled corticosteroids and long-acting beta-2-agonists in the management of patients diagnosed with asthma and concurrent allergic rhinitis (the RADAR trial).Canadian respiratory journalTrial
- Montelukast as add-on therapy to inhaled corticosteroids in the management of asthma (the SAS trial).Canadian respiratory journalTrial
- Effects of oral montelukast on pulmonary function and clinical symptoms in acute asthma exacerbations: a randomized, double-blind, placebo-controlled trial.Annals of medicine and surgery (2012) · 2024Article
- Cellular signalling pathways mediating the pathogenesis of chronic inflammatory respiratory diseases: an update.Inflammopharmacology · 2020Review
- Mechanisms of eosinophilic inflammation.Asia Pacific allergy · 2020Review
- Involvement and Possible Role of Eosinophils in Asthma Exacerbation.Frontiers in immunology · 2018Review
- Long-Term Fluticasone Propionate/Formoterol Fumarate Combination Therapy Is Associated with a Low Incidence of Severe Asthma Exacerbations.Journal of aerosol medicine and pulmonary drug delivery · 2016Article
- The Effect of Combined Therapy ICS/LABA and ICS/LABA plus Montelukast in Patients with Uncontrolled Severe Persistent Asthma Based on the Serum IL-13 and FEV1.Open access Macedonian journal of medical sciences · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 9 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo assess the effect of montelukast versus salmeterol added to inhaled fluticasone propionate on asthma exacerbation in patients whose symptoms are inadequately controlled with fluticasone alone. Design and setting A 52 week, two period, double blind, multicentre trial during which patients whose symptoms remained uncontrolled by inhaled corticosteroids were randomised to add montelukast or salmeterol.
participantsPatients (15-72 years; n = 1490) had a clinical history of chronic asthma for > or = 1 year, a baseline forced expiratory volume in one second (FEV1) value 50-90% predicted, and a beta agonist improvement of > or = 12% in FEV1.
main outcome measuresThe primary end point was the percentage of patients with at least one asthma exacerbation.
results20.1% of the patients in the group receiving montelukast and fluticasone had an asthma exacerbation compared with 19.1% in the group receiving salmeterol and fluticasone; the difference was 1% (95% confidence interval -3.1% to 5.0%). With a risk ratio (montelukast-fluticasone/salmeterol-fluticasone) of 1.05 (0.86 to 1.29), treatment with montelukast and fluticasone was shown to be non-inferior to treatment with salmeterol and fluticasone. Salmeterol and fluticasone significantly increased FEV1 before a beta agonist was used and morning peak expiratory flow compared with montelukast and fluticasone (P < or = 0.001), whereas FEV1 after a beta agonist was used and improvements in asthma specific quality of life and nocturnal awakenings were similar between the groups. Montelukast and fluticasone significantly (P = 0.011) reduced peripheral blood eosinophil counts compared with salmeterol and fluticasone. Both treatments were generally well tolerated.
conclusionThe addition of montelukast in patients whose symptoms remain uncontrolled by inhaled fluticasone could provide equivalent clinical control to salmeterol.
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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.