Evidence map›Paper›PMID 28069068›Full record

ArticleTrials2017

The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given 'as needed' in mild asthma: study protocols for two randomised controlled trials.

Paul M O'Byrne, J Mark FitzGerald, Nanshan Zhong, Eric Bateman, Peter J Barnes, Christina Keen, Gun Almqvist, Kristine Pemberton, Carin Jorup, Stefan Ivanov and 1 more

2 registry-linked trialsOpen access · goldAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
4.5field-weighted citation impact, top 5% 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.

NCT02149199 phase3completednot on this map

A Clinical Study Comparing Symbicort® 'as Needed' With Terbutaline 'as Needed' and With Pulmicort® Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma.

TypeinterventionalSponsorAstraZenecaRan2014 to 2017Enrolled3,850ConditionsAsthmaArmsbudesonide/formoterol 'as needed' + budesonide placebo bid, terbutaline 'as needed' + placebo budesonide bid, budesonide bid + terbutaline 'as needed'
NCT02224157 phase3completednot on this map

A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma

TypeinterventionalSponsorAstraZenecaRan2014 to 2017Enrolled4,215ConditionsAsthmaArmsbudesonide/formoterol 'as needed' + budesonide placebo bid, budesonode bid + terbutaline 'as needed'
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Clinician and family perspectives on the use of single maintenance and reliever therapy for children.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2026
    Article
  4. Article
  5. Article
  6. Respiratory Reviews in Asthma 2022.Tuberculosis and respiratory diseases · 2022
    Review
  7. Treatment Adherence in Adolescents with Asthma.Journal of asthma and allergy · 2020
    Review
  8. Exercise and Asthma.Advances in experimental medicine and biology · 2020
    Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 6 countries.

Paul M O'ByrneMichael G DeGroote School of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada. obyrnep@mcmaster.ca.
J Mark FitzGeraldInstitute for Heart and Lung Health, University of British Columbia, Vancouver, BC, Canada.
Nanshan ZhongState Key Laboratory of Respiratory Diseases, First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.
Eric BatemanDepartment of Medicine, University of Cape Town, Cape Town, South Africa.
Peter J BarnesAirway Disease Section, National Heart and Lung Institute, Imperial College, London, UK.
Christina KeenAstraZeneca R&D, Gothenburg, Sweden.
Gun AlmqvistAstraZeneca R&D, Gothenburg, Sweden.
Kristine PembertonAstraZeneca, Alderley Park, Macclesfield, UK.
Carin JorupAstraZeneca R&D, Gothenburg, Sweden.
Stefan IvanovAstraZeneca R&D, Gothenburg, Sweden.
Helen K ReddelClinical Management Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.
AstraZeneca (Sweden) · SEAstraZeneca (United Kingdom) · GBImperial College London · GBMcMaster University · CAState Key Laboratory of Respiratory Disease · CNThe University of Sydney · AUUniversity of British Columbia · CAUniversity of Cape Town · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn many patients with mild asthma, the low frequency of symptoms and the episodic nature of exacerbations make adherence to regular maintenance treatment difficult. This often leads to over-reliance on short-acting β METHODS/

designThe SYmbicort Given as needed in Mild Asthma (SYGMA) programme consists of two 52-week, double-blind, randomised, multicentre, parallel-group, phase 3 trials of patients aged 12 years and older with a clinical diagnosis of asthma for at least 6 months, who would qualify for treatment with regular inhaled corticosteroids (ICS). SYGMA1 aims to recruit 3750 patients who will be randomised to placebo twice daily (bid) plus as-needed budesonide/formoterol 160/4.5 μg, placebo bid plus as-needed terbutaline 0.4 mg, or budesonide 200 μg bid plus as-needed terbutaline 0.4 mg. The primary objective is to demonstrate the superiority of as-needed budesonide/formoterol over as-needed terbutaline for asthma control, as measured by well-controlled asthma weeks; a secondary objective is to establish the noninferiority of as-needed budesonide/formoterol versus maintenance budesonide plus as-needed terbutaline using the same outcome measure. SYGMA2 aims to recruit 4114 patients who will be randomised to placebo bid plus as-needed budesonide/formoterol 160/4.5 μg, or budesonide 200 μg bid plus as-needed terbutaline 0.4 mg. The primary objective is to demonstrate the noninferiority of as-needed budesonide/formoterol over budesonide bid plus as-needed terbutaline as measured by the annualised severe exacerbation rate. In both studies, use of all blinded study inhalers will be recorded electronically using Turbuhaler® Usage Monitors. DISCUSSION: Given the known risks of mild asthma, and known poor adherence with regular inhaled corticosteroids, the results of the SYGMA programme will help to determine the efficacy and safety of as-needed budesonide/formoterol therapy in mild asthma. Patient recruitment is complete, and completion of the phase 3 studies is planned in 2017.

trial registrationClinicalTrials.gov identifiers: NCT02149199 SYGMA1 and NCT02224157 SYGMA2. Registered on 16 May 2014 and 19 August 2014, respectively.

Indexed as

Clinical ProtocolsAsthmaBudesonideClinical Trials, Phase III as TopicDouble-Blind MethodFormoterol FumarateHumansRandomized Controlled Trials as TopicSample SizeBudesonideFormoterol FumarateAs-neededAsthma controlBudesonide/formoterolExacerbationsMild asthmaPrnRescue inhalerSYGMA

Identifiers

PMID28069068
PMCPMC5223341
OpenAlexW2571258660

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.