Trial reportBritish journal of clinical pharmacology2003
Comparison of combination inhalers vs inhaled corticosteroids alone in moderate persistent asthma.
Trial report in British journal of clinical pharmacology, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 7 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
19 citing papers in PubMed, 7 syntheses or guidelines pooled it, 54 citations in OpenAlex.
- Regular treatment with formoterol and an inhaled corticosteroid versus regular treatment with salmeterol and an inhaled corticosteroid for chronic asthma: serious adverse events.The Cochrane database of systematic reviews · 2021Pooled it
- Inhaled steroids with and without regular salmeterol for asthma: serious adverse events.The Cochrane database of systematic reviews · 2018Pooled it
- Regular treatment with formoterol for chronic asthma: serious adverse events.The Cochrane database of systematic reviews · 2012Pooled it
- Regular treatment with formoterol versus regular treatment with salmeterol for chronic asthma: serious adverse events.The Cochrane database of systematic reviews · 2012Pooled it
- Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children.The Cochrane database of systematic reviews · 2011Pooled 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
- Regular treatment with salmeterol for chronic asthma: serious adverse events.The Cochrane database of systematic reviews · 2008Pooled it
- Overcoming beta-agonist tolerance: high dose salbutamol and ipratropium bromide. Two randomised controlled trials.Respiratory research · 2007Trial
- Tolerance to bronchodilation during treatment with long-acting beta-agonists, a randomised controlled trial.Respiratory research · 2005Trial
- Trial
- Agreement between self-reported asthma symptoms and exhaled nitric oxide levels: impact on inhaled corticosteroid prescribing in general practice. An observational study.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2019Article
- Tiotropium in asthma: what is the evidence and how does it fit in?The World Allergy Organization journal · 2016Review
- Emerging role of long acting muscarinic antagonists for asthma.British journal of clinical pharmacology · 2014Review
- New treatment regimes for virus-induced exacerbations of asthma.Pulmonary pharmacology & therapeutics · 2006Review
- Long-acting beta2-agonists in asthma: not so SMART?Drug safety · 2006Review
- Long-acting beta 2-adrenoceptor agonists and exercise-induced asthma: lessons to guide us in the future.Paediatric drugs · 2004Review
- Benefit-risk assessment of long-acting beta2-agonists in asthma.Drug safety · 2004Review
- Recovery from bronchoconstriction and bronchodilator tolerance.Clinical reviews in allergy & immunologyReview
- Interactions between corticosteroids and beta2-agonists.Clinical reviews in allergy & immunologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsInhalers combining long acting beta2-adrenoceptor agonists (LABA) and corticosteroids (ICS) are indicated at Step 3 of current asthma guidelines. We evaluated the relative effects of LABA + ICS combination vs ICS alone on pulmonary function, bronchoprotection, acute salbutamol recovery following methacholine bronchial challenge, and surrogate inflammatory markers in patients with moderate persistent asthma.
methodsTwenty-nine patients with mean FEV1 (+/- SEM) of 78 +/- 3% predicted completed a randomized, double-blind, double-dummy, cross-over study. Patients received either 4 weeks of budesonide 400 microg + formoterol 12 microg (BUD + FM) combination twice daily followed by 1 week of BUD 400 microg alone twice daily, or 4 weeks of fluticasone propionate 250 microg + salmeterol 50 microg (FP + SM) combination twice daily followed by 1 week of FP 250 microg alone twice daily. Measurements were made at baseline and following each randomized treatment.
resultsFEV1 increase from pretreatment baseline as mean (+/- SEM) % predicted was significantly higher (P < 0.05) for BUD + FM (8 +/- 1%) vs BUD (2 +/- 1%), and for FP + SM (8 +/- 1%) vs FP (2 +/- 1%). The fall in FEV1 following methacholine challenge as percentage change from prechallenge baseline FEV1 was not significantly different in all four groups; BUD + FM (22 +/- 1%), BUD (24 +/- 1%), FP + SM (23 +/- 1%) and FP (23 +/- 1%). Salbutamol recovery over 30 min following methacholine challenge as area under curve (AUC %.min) was significantly blunted (P < 0.05) with BUD + FM (486.7 +/- 35.5) vs BUD (281.1 +/- 52.8), and with FP + SM (553.1 +/- 34.1) vs FP (368.3 +/- 46.7). There were no significant differences between respective combination inhalers or between respective ICS alone. Decreases in exhaled nitric oxide (NO) and serum eosinophilic cationic protein (ECP) from baseline were not significantly different between treatments.
conclusionsCombination inhalers improve pulmonary function without potentiating anti-inflammatory effects on exhaled NO and serum ECP as compared with ICS alone, but delay acute salbutamol recovery after bronchoconstriction.
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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.