Evidence map›Paper›PMID 31112386›Full record

Trial reportThe New England journal of medicine2019

Controlled Trial of Budesonide-Formoterol as Needed for Mild Asthma.

Richard Beasley, Mark Holliday, Helen K Reddel, Irene Braithwaite, Stefan Ebmeier, Robert J Hancox, Tim Harrison, Claire Houghton, Karen Oldfield, Alberto Papi and 4 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06568445 (Efficacy of Regular ICS/LABA Sequential As-Needed Therapy in Newly Diagnosed Mild Asthma Patients), which is not on this map. Cited by 175 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
175citing papers in PubMed, 11 pooled it
35.9field-weighted citation impact, top 1% 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.

NCT06568445 phase4not yet recruitingnot on this mapstarted 2024, after this paper: background citation

Efficacy of Regular ICS/LABA Sequential As-Needed Therapy in Newly Diagnosed Mild Asthma Patients: A Randomized, Parallel, Positive-Control Study

TypeinterventionalSponsorShanghai General Hospital, Shanghai Jiao Tong University School of MedicineRan2024 to 2027Enrolled90ConditionsBronchial AsthmaArmsMaintenance at initial treatment sequential as-needed therapy with inhaled budesonide-formoterol(Symbicort 160/4.5) ®）, as-needed therapy with inhaled budesonide-formoterol (Symbicort 160/4.5) ®）
3 · Its place in the literature

Who cites it

175 citing papers in PubMed, 11 syntheses or guidelines pooled it, 447 citations in OpenAlex.

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  10. Does the use of inhaled corticosteroids in asthma benefit lung function in the long-term? A systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2021
    Pooled it
  11. 2020 Brazilian Thoracic Association recommendations for the management of asthma.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia
    Guideline
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  18. Mechanisms and therapeutic strategies of asthma: from bench to bedside.Signal transduction and targeted therapy · 2026
    Review
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115 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 6 institutions in 4 countries.

Richard BeasleyFrom the Medical Research Institute of New Zealand (R.B., M.H., I.B., S.E., C.H., K.O., M. Williams), the Capital and Coast District Health Board (R.B.), and the University of Otago Wellington (M. Weatherall), Wellington, the Department of Respiratory Medicine, Waikato Hospital, Hamilton (R.J.H.), and the Department of Preventive and Social Medicine, University of Otago, Dunedin (R.J.H.) - all in New Zealand; Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); the Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham (T.H.), and the Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford (I.D.P.) - both in the United Kingdom; and the Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy (A.P.).ORCID 0000-0003-0337-406X
Mark HollidayFrom the Medical Research Institute of New Zealand (R.B., M.H., I.B., S.E., C.H., K.O., M. Williams), the Capital and Coast District Health Board (R.B.), and the University of Otago Wellington (M. Weatherall), Wellington, the Department of Respiratory Medicine, Waikato Hospital, Hamilton (R.J.H.), and the Department of Preventive and Social Medicine, University of Otago, Dunedin (R.J.H.) - all in New Zealand; Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); the Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham (T.H.), and the Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford (I.D.P.) - both in the United Kingdom; and the Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy (A.P.).
Helen K ReddelFrom the Medical Research Institute of New Zealand (R.B., M.H., I.B., S.E., C.H., K.O., M. Williams), the Capital and Coast District Health Board (R.B.), and the University of Otago Wellington (M. Weatherall), Wellington, the Department of Respiratory Medicine, Waikato Hospital, Hamilton (R.J.H.), and the Department of Preventive and Social Medicine, University of Otago, Dunedin (R.J.H.) - all in New Zealand; Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); the Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham (T.H.), and the Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford (I.D.P.) - both in the United Kingdom; and the Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy (A.P.).
Irene BraithwaiteFrom the Medical Research Institute of New Zealand (R.B., M.H., I.B., S.E., C.H., K.O., M. Williams), the Capital and Coast District Health Board (R.B.), and the University of Otago Wellington (M. Weatherall), Wellington, the Department of Respiratory Medicine, Waikato Hospital, Hamilton (R.J.H.), and the Department of Preventive and Social Medicine, University of Otago, Dunedin (R.J.H.) - all in New Zealand; Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); the Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham (T.H.), and the Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford (I.D.P.) - both in the United Kingdom; and the Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy (A.P.).ORCID 0000-0001-5327-3027
Stefan EbmeierFrom the Medical Research Institute of New Zealand (R.B., M.H., I.B., S.E., C.H., K.O., M. Williams), the Capital and Coast District Health Board (R.B.), and the University of Otago Wellington (M. Weatherall), Wellington, the Department of Respiratory Medicine, Waikato Hospital, Hamilton (R.J.H.), and the Department of Preventive and Social Medicine, University of Otago, Dunedin (R.J.H.) - all in New Zealand; Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); the Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham (T.H.), and the Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford (I.D.P.) - both in the United Kingdom; and the Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy (A.P.).
Robert J HancoxFrom the Medical Research Institute of New Zealand (R.B., M.H., I.B., S.E., C.H., K.O., M. Williams), the Capital and Coast District Health Board (R.B.), and the University of Otago Wellington (M. Weatherall), Wellington, the Department of Respiratory Medicine, Waikato Hospital, Hamilton (R.J.H.), and the Department of Preventive and Social Medicine, University of Otago, Dunedin (R.J.H.) - all in New Zealand; Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); the Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham (T.H.), and the Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford (I.D.P.) - both in the United Kingdom; and the Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy (A.P.).
Tim HarrisonFrom the Medical Research Institute of New Zealand (R.B., M.H., I.B., S.E., C.H., K.O., M. Williams), the Capital and Coast District Health Board (R.B.), and the University of Otago Wellington (M. Weatherall), Wellington, the Department of Respiratory Medicine, Waikato Hospital, Hamilton (R.J.H.), and the Department of Preventive and Social Medicine, University of Otago, Dunedin (R.J.H.) - all in New Zealand; Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); the Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham (T.H.), and the Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford (I.D.P.) - both in the United Kingdom; and the Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy (A.P.).ORCID 0000-0002-3065-8247
Claire HoughtonFrom the Medical Research Institute of New Zealand (R.B., M.H., I.B., S.E., C.H., K.O., M. Williams), the Capital and Coast District Health Board (R.B.), and the University of Otago Wellington (M. Weatherall), Wellington, the Department of Respiratory Medicine, Waikato Hospital, Hamilton (R.J.H.), and the Department of Preventive and Social Medicine, University of Otago, Dunedin (R.J.H.) - all in New Zealand; Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); the Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham (T.H.), and the Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford (I.D.P.) - both in the United Kingdom; and the Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy (A.P.).
Karen OldfieldFrom the Medical Research Institute of New Zealand (R.B., M.H., I.B., S.E., C.H., K.O., M. Williams), the Capital and Coast District Health Board (R.B.), and the University of Otago Wellington (M. Weatherall), Wellington, the Department of Respiratory Medicine, Waikato Hospital, Hamilton (R.J.H.), and the Department of Preventive and Social Medicine, University of Otago, Dunedin (R.J.H.) - all in New Zealand; Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); the Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham (T.H.), and the Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford (I.D.P.) - both in the United Kingdom; and the Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy (A.P.).
Alberto PapiFrom the Medical Research Institute of New Zealand (R.B., M.H., I.B., S.E., C.H., K.O., M. Williams), the Capital and Coast District Health Board (R.B.), and the University of Otago Wellington (M. Weatherall), Wellington, the Department of Respiratory Medicine, Waikato Hospital, Hamilton (R.J.H.), and the Department of Preventive and Social Medicine, University of Otago, Dunedin (R.J.H.) - all in New Zealand; Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); the Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham (T.H.), and the Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford (I.D.P.) - both in the United Kingdom; and the Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy (A.P.).
Ian D PavordFrom the Medical Research Institute of New Zealand (R.B., M.H., I.B., S.E., C.H., K.O., M. Williams), the Capital and Coast District Health Board (R.B.), and the University of Otago Wellington (M. Weatherall), Wellington, the Department of Respiratory Medicine, Waikato Hospital, Hamilton (R.J.H.), and the Department of Preventive and Social Medicine, University of Otago, Dunedin (R.J.H.) - all in New Zealand; Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); the Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham (T.H.), and the Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford (I.D.P.) - both in the United Kingdom; and the Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy (A.P.).
Mathew WilliamsFrom the Medical Research Institute of New Zealand (R.B., M.H., I.B., S.E., C.H., K.O., M. Williams), the Capital and Coast District Health Board (R.B.), and the University of Otago Wellington (M. Weatherall), Wellington, the Department of Respiratory Medicine, Waikato Hospital, Hamilton (R.J.H.), and the Department of Preventive and Social Medicine, University of Otago, Dunedin (R.J.H.) - all in New Zealand; Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); the Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham (T.H.), and the Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford (I.D.P.) - both in the United Kingdom; and the Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy (A.P.).
Mark WeatherallFrom the Medical Research Institute of New Zealand (R.B., M.H., I.B., S.E., C.H., K.O., M. Williams), the Capital and Coast District Health Board (R.B.), and the University of Otago Wellington (M. Weatherall), Wellington, the Department of Respiratory Medicine, Waikato Hospital, Hamilton (R.J.H.), and the Department of Preventive and Social Medicine, University of Otago, Dunedin (R.J.H.) - all in New Zealand; Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); the Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham (T.H.), and the Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford (I.D.P.) - both in the United Kingdom; and the Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy (A.P.).
Novel START Study Team
Medical Research Institute of New Zealand · NZThe University of Sydney · AUUniversity of Ferrara · ITUniversity of Nottingham · GBUniversity of Oxford · GBWaikato Hospital · NZ

Funding

AstraZeneca ESR-14-10452
6 · The paper itself

Abstract

backgroundIn double-blind, placebo-controlled trials, budesonide-formoterol used on an as-needed basis resulted in a lower risk of severe exacerbation of asthma than as-needed use of a short-acting β

methodsWe conducted a 52-week, randomized, open-label, parallel-group, controlled trial involving adults with mild asthma. Patients were randomly assigned to one of three treatment groups: albuterol (100 μg, two inhalations from a pressurized metered-dose inhaler as needed for asthma symptoms) (albuterol group); budesonide (200 μg, one inhalation through a Turbuhaler twice daily) plus as-needed albuterol (budesonide maintenance group); or budesonide-formoterol (200 μg of budesonide and 6 μg of formoterol, one inhalation through a Turbuhaler as needed) (budesonide-formoterol group). Electronic monitoring of inhalers was used to measure medication use. The primary outcome was the annualized rate of asthma exacerbations.

resultsThe analysis included 668 of 675 patients who underwent randomization. The annualized exacerbation rate in the budesonide-formoterol group was lower than that in the albuterol group (absolute rate, 0.195 vs. 0.400; relative rate, 0.49; 95% confidence interval [CI], 0.33 to 0.72; P<0.001) and did not differ significantly from the rate in the budesonide maintenance group (absolute rate, 0.195 in the budesonide-formoterol group vs. 0.175 in the budesonide maintenance group; relative rate, 1.12; 95% CI, 0.70 to 1.79; P = 0.65). The number of severe exacerbations was lower in the budesonide-formoterol group than in both the albuterol group (9 vs. 23; relative risk, 0.40; 95% CI, 0.18 to 0.86) and the budesonide maintenance group (9 vs. 21; relative risk, 0.44; 95% CI, 0.20 to 0.96). The mean (±SD) dose of inhaled budesonide was 107±109 μg per day in the budesonide-formoterol group and 222±113 μg per day in the budesonide maintenance group. The incidence and type of adverse events reported were consistent with those in previous trials and with reports in clinical use.

conclusionsIn an open-label trial involving adults with mild asthma, budesonide-formoterol used as needed was superior to albuterol used as needed for the prevention of asthma exacerbations. (Funded by AstraZeneca and the Health Research Council of New Zealand; Novel START Australian New Zealand Clinical Trials Registry number, ACTRN12615000999538.).

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsAdultAgedAlbuterolAsthmaBronchodilator AgentsBudesonideDrug Therapy, CombinationFemaleFormoterol FumarateHumansMaleMetered Dose InhalersMiddle AgedAdrenergic beta-2 Receptor AgonistsAlbuterolBronchodilator AgentsBudesonideFormoterol Fumarate

Identifiers

PMID31112386
OpenAlexW2946771756

What OpenQuestion holds

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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.