Trial reportRespiratory research2012
The effect of budesonide/formoterol maintenance and reliever therapy on the risk of severe asthma exacerbations following episodes of high reliever use: an exploratory analysis of two randomised, controlled studies with comparisons to standard therapy.
Trial report in Respiratory research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04835961 (This Study Will Record the Use of Budesonide / Formoterol Either as Maintenance Treatment or / or as Needed According to Standard Clinical Practice and at the Discretion of the Treating Physician.), which is not on this map. Cited by 16 papers.
What it found
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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.
This Study Will Record the Use of Budesonide / Formoterol Either as Maintenance Treatment or / or as Needed According to Standard Clinical Practice and at the Discretion of the Treating Physician.
Who cites it
16 citing papers in PubMed, 50 citations in OpenAlex.
- Can severe asthmatic patients achieve asthma control? A systematic approach in patients with difficult to control asthma followed in a specialized clinic.BMC pulmonary medicine · 2016Trial
- Reliever salbutamol use as a measure of exacerbation risk in chronic obstructive pulmonary disease.BMC pulmonary medicine · 2015Trial
- Airway inflammation and asthma control in patients using salbutamol or budesonide/formoterol reliever: a randomised, controlled study.ERJ open research · 2026Article
- Sex-specific adverse event profiles of PDE4 inhibitors: a comparative big-data pharmacovigilance study of apremilast, crisaborole, and roflumilast in FAERS (2004-2025).Frontiers in pharmacology · 2026Article
- An anti-inflammatory reliever algorithm approach to asthma management in adults: an open-label, single-arm trial.EClinicalMedicine · 2025Article
- Patient response to the management during the acute presentation of cough variant Asthma: Retrospective cohort study.Saudi journal of biological sciences · 2023Article
- A Call for the United States to Accelerate the Implementation of Reliever Combination Inhaled Corticosteroid-Formoterol Inhalers in Asthma.American journal of respiratory and critical care medicine · 2023Article
- Asthma management in low and middle income countries: case for change.The European respiratory journal · 2022Review
- Global Initiative for Asthma Strategy 2021: Executive Summary and Rationale for Key Changes.American journal of respiratory and critical care medicine · 2022Article
- Global Initiative for Asthma Strategy 2021: executive summary and rationale for key changes.The European respiratory journal · 2022Review
- Efficacy and safety of as-needed albuterol/budesonide versus albuterol in adults and children aged ≥4 years with moderate-to-severe asthma: rationale and design of the randomised, double-blind, active-controlled MANDALA study.BMJ open respiratory research · 2021Article
- New insights from GINA 2019/2020-Focus on early anti-inflammatory therapy.Wiener klinische Wochenschrift · 2021Article
- Updated Australian guidelines for mild asthma: what's changed and why?Australian prescriber · 2020Review
- Variability in airway inflammation, symptoms, lung function and reliever use in asthma: anti-inflammatory reliever hypothesis and STIFLE study design.ERJ open research · 2020Article
- Real-Life Clinical Use of Symbicort® Maintenance and Reliever Therapy for Asthmatic Patients in Korea.Allergy, asthma & immunology research · 2018Article
- [What not to do in the therapeutic management of bronchial asthma. Delphi consensus recommendations for physicians who treat asthma].Atencion primariaArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDivergent strategies have emerged for the management of severe asthma. One strategy utilises high and fixed doses of maintenance treatment, usually inhaled corticosteroid/long-acting β2-agonist (ICS/LABA), supplemented by a short-acting β2-agonist (SABA) as needed. Alternatively, budesonide/formoterol is used as both maintenance and reliever therapy. The latter is superior to fixed-dose treatment in reducing severe exacerbations while achieving similar or better asthma control in other regards. Exacerbations may be reduced by the use of budesonide/formoterol as reliever medication during periods of unstable asthma. We examined the risk of a severe exacerbation in the period after a single day with high reliever use.
methodsEpisodes of high reliever use were quantified and exacerbations occurring post-index day with these episodes were examined post hoc in two double-blind studies comparing the efficacy and safety of budesonide/formoterol maintenance and reliever therapy (Symbicort SMART™, Turbuhaler®) 160/4.5 μg twice daily plus as needed with similar or higher maintenance doses of ICS/LABA plus SABA or formoterol.
resultsBudesonide/formoterol maintenance and reliever therapy significantly reduced the risk of episodes of high reliever use (>6 inhalations/day) vs. all alternative ICS/LABA regimens. With conventional fixed-dose treatment the need for exacerbation treatment within 21 days ranged from 6.0-10.1% of days post-index for all regimens compared with 2.5-3.4% of days with budesonide/formoterol maintenance and reliever therapy.
conclusionsBudesonide/formoterol maintenance and reliever therapy reduces the incidence of high reliever episodes and the exacerbation burden immediately following these episodes vs. alternative ICS/LABA plus SABA regimens at up to double the maintenance dose of ICS.
trial registrationThese studies do not have registration numbers as they were conducted before clinical trial registration was required.
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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.