Evidence map›Paper›PMID 20197425›Full record

Trial reportThe New England journal of medicine2010

Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids.

Robert F Lemanske, David T Mauger, Christine A Sorkness, Daniel J Jackson, Susan J Boehmer, Fernando D Martinez, Robert C Strunk, Stanley J Szefler, Robert S Zeiger, Leonard B Bacharier and 8 more

3 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 151 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
151citing papers in PubMed, 16 pooled it
27.7field-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.

NCT00395304 phase3completednot on this map

Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER)

TypeinterventionalSponsorMilton S. Hershey Medical CenterRan2007 to 2011Enrolled182ConditionsAsthmaArmsfluticasone propionate + montelukast, fluticasone propionate, fluticasone propionate + salmeterol
NCT02758873 nacompletednot on this mapstarted 2016, after this paper: background citation

Prescribing Asthma Controller Medication According to Gene Status to Improve Quality of Life in Young People With Asthma

TypeinterventionalSponsorUniversity of SussexRan2016 to 2019Enrolled241ConditionsAsthmaArmsPersonalised medicine (Salmeterol), Personalised medicine (Montelukast), Standard care
NCT04129931 phase2completednot on this mapstarted 2019, after this paper: background citation

PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2019 to 2025Enrolled950ConditionsAsthmaArmsMCT, Clazakizumab, Broncho-Vaxom, Imatinib Mesylate, Cavosonstat
3 · Its place in the literature

Who cites it

151 citing papers in PubMed, 16 syntheses or guidelines pooled it, 441 citations in OpenAlex.

  1. Pooled it
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  4. Genome-wide association studies of exacerbations in children using long-acting beta2-agonists.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2021
    Pooled it
  5. Uncovering Outcome Disparities of βJournal of the National Medical Association · 2021
    Pooled it
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  16. Guideline
  17. Trial
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  19. Individualized therapy for persistent asthma in young children.The Journal of allergy and clinical immunology · 2016
    Trial
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91 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 4 institutions in 1 country.

Robert F LemanskeUniversity of Wisconsin School of Medicine and Public Health, Madison, USA. rfl@medicine.wisc.edu
David T Mauger
Christine A Sorkness
Daniel J Jackson
Susan J Boehmer
Fernando D Martinez
Robert C Strunk
Stanley J Szefler
Robert S Zeiger
Leonard B Bacharier
Ronina A Covar
Theresa W Guilbert
Gary Larsen
Wayne J Morgan
Mark H Moss
Joseph D Spahn
Lynn M Taussig
Childhood Asthma Research and Education (CARE) Network of the National Heart, Lung, and Blood Institute
University of California, San Diego · USUniversity of Colorado Denver · USKaiser Permanente · USWisconsin Division of Public Health · US

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
ZOPOLRESTAT PHARMACOKINETICS IN DIABETICS WITH VARYING RENAL FUNCTIONM01RR000051 · NCRR · UNIVERSITY OF COLORADO DENVER · PI CAMPBELL, THOMAS A · 1985 to 2008
$52.6M
Washington University Institute of Clinical and Translational Sciences (UL1)UL1RR024992 · NCRR · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2007 to 2011
$45.4M
Washington University Institute of Clinical and Translational SciencesUL1TR000448 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$41.4M
INSTITUTIONAL CTSA (UW-MADISON): CLINICAL TRIALSUL1RR025011 · NCRR · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2007 to 2011
$29.5M
YOGA FOR THE MANAGEMENT OF HIV-METABOLIC SYNDROMESM01RR000036 · NCRR · WASHINGTON UNIVERSITY · PI CLIFFORD, DAVID B · 1985 to 2007
$25.4M
ZOSUQUIDAR TRIHYDROCHLORIDE IN NEWLY DIAGNOSED AMLM01RR003186 · NCRR · UNIVERSITY OF WISCONSIN-MADISON · PI GOLDEN, ROBERT NEAL · 1986 to 2007
$19.3M
PEDIATRIC ASTHMA NETWORK DATA COORDINATING CENTERU10HL064313 · NHLBI · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI MAUGER, DAVID T. · 1999 to 2008
$18.3M
CHILDHOOD ASTHMA: EARLY PREVENTION AND PHARMACOGENETICSU10HL064307 · NHLBI · UNIVERSITY OF ARIZONA · PI MARTINEZ, FERNANDO D · 1999 to 2008
$9.0M
EARLY INTERVENTION IN CHILDHOOD ASTHMAU10HL064288 · NHLBI · NATIONAL JEWISH HEALTH · PI SZEFLER, STANLEY J. · 1999 to 2008
$6.7M
Wisconsin Allergy Research Training (WISCART) ProgramT32AI007635 · NIAID · UNIVERSITY OF WISCONSIN-MADISON · PI James E. Gern, DANIEL J JACKSON · 2000 to 2026
$6.5M
CHILDHOOD ASTHMA: INITIATION AND INTERVENTIONU10HL064305 · NHLBI · UNIVERSITY OF WISCONSIN-MADISON · PI LEMANSKE, ROBERT F · 1999 to 2008
$5.8M
NCATS NIH HHS UL1 TR000448NCRR NIH HHS M01 RR000036NCRR NIH HHS M01 RR000051NCRR NIH HHS M01-RR00036NCRR NIH HHS M01-RR00051NCRR NIH HHS M01 RR003186NCRR NIH HHS M01-RR03186NCRR NIH HHS UL1 RR024992NCRR NIH HHS UL1-RR024992NCRR NIH HHS UL1 RR025011NCRR NIH HHS UL1-RR025011NCRR NIH HHS UL1 RR025780NCRR NIH HHS UL1-RR025780NHLBI NIH HHS HL064287NHLBI NIH HHS HL064288NHLBI NIH HHS HL064295NHLBI NIH HHS HL064305NHLBI NIH HHS HL064307NHLBI NIH HHS HL064313NHLBI NIH HHS U10 HL064287NHLBI NIH HHS U10 HL064288NHLBI NIH HHS U10 HL064295NHLBI NIH HHS U10 HL064305NHLBI NIH HHS U10 HL064307NHLBI NIH HHS U10 HL064313NIAID NIH HHS T32 AI007635NIAID NIH HHS T32AI007635
6 · The paper itself

Abstract

backgroundFor children who have uncontrolled asthma despite the use of low-dose inhaled corticosteroids (ICS), evidence to guide step-up therapy is lacking.

methodsWe randomly assigned 182 children (6 to 17 years of age), who had uncontrolled asthma while receiving 100 microg of fluticasone twice daily, to receive each of three blinded step-up therapies in random order for 16 weeks: 250 microg of fluticasone twice daily (ICS step-up), 100 microg of fluticasone plus 50 microg of a long-acting beta-agonist twice daily (LABA step-up), or 100 microg of fluticasone twice daily plus 5 or 10 mg of a leukotriene-receptor antagonist daily (LTRA step-up). We used a triple-crossover design and a composite of three outcomes (exacerbations, asthma-control days, and the forced expiratory volume in 1 second) to determine whether the frequency of a differential response to the step-up regimens was more than 25%.

resultsA differential response occurred in 161 of 165 patients who were evaluated (P<0.001). The response to LABA step-up therapy was most likely to be the best response, as compared with responses to LTRA step-up (relative probability, 1.6; 95% confidence interval [CI], 1.1 to 2.3; P=0.004) and ICS step-up (relative probability, 1.7; 95% CI, 1.2 to 2.4; P=0.002). Higher scores on the Asthma Control Test before randomization (indicating better control at baseline) predicted a better response to LABA step-up (P=0.009). White race predicted a better response to LABA step-up, whereas black patients were least likely to have a best response to LTRA step-up (P=0.005).

conclusionsNearly all the children had a differential response to each step-up therapy. LABA step-up was significantly more likely to provide the best response than either ICS or LTRA step-up. However, many children had a best response to ICS or LTRA step-up therapy, highlighting the need to regularly monitor and appropriately adjust each child's asthma therapy. (ClinicalTrials.gov number, NCT00395304.)

Indexed as

AcetatesAdministration, InhalationAdministration, OralAdolescentAdrenergic beta-AgonistsAlbuterolAndrostadienesAsthmaBronchodilator AgentsChildCross-Over StudiesCyclopropanesDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationEczemaAcetatesAdrenergic beta-AgonistsAlbuterolAndrostadienesBronchodilator AgentsCyclopropanesFluticasoneGlucocorticoidsLeukotriene AntagonistsmontelukastPrednisoneQuinolinesSalmeterol XinafoateSulfides

Identifiers

PMID20197425
PMCPMC2989902
OpenAlexW2139291708

What OpenQuestion holds

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Read underepoch 390

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.