Evidence map›Paper›PMID 22111718›Full record

Trial reportThe New England journal of medicine2011

Daily or intermittent budesonide in preschool children with recurrent wheezing.

Robert S Zeiger, David Mauger, Leonard B Bacharier, Theresa W Guilbert, Fernando D Martinez, Robert F Lemanske, Robert C Strunk, Ronina Covar, Stanley J Szefler, Susan Boehmer and 15 more

2 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2011. 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 75 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 5 pooled it
13.5field-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.

NCT00675584 phase3completednot on this map

Childhood Asthma Research and Education (CARE) Network Trial - Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST)

TypeinterventionalSponsorMilton S. Hershey Medical CenterRan2008 to 2010Enrolled278ConditionsAsthmaArmsBudesonide, Placebo Budesonide
NCT02148796 phase2completednot on this mapstarted 2017, after this paper: background citation

Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of ORal Bacterial EXtract for the Prevention of Wheezing Lower Respiratory Tract Illness (ORBEX)

TypeinterventionalSponsorUniversity of ArizonaRan2017 to 2026Enrolled822ConditionsAsthma, WheezingArmsBroncho-Vaxom (BV), Placebo
3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 5 syntheses or guidelines pooled it, 213 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Guideline
  6. Trial
  7. Trial
  8. Trial
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  10. Individualized therapy for persistent asthma in young children.The Journal of allergy and clinical immunology · 2016
    Trial
  11. Trial
  12. Discrepancies between medical record data and parent reported use of preventive asthma medications.The Journal of asthma : official journal of the Association for the Care of Asthma · 2014
    Trial
  13. Trial
  14. Article
  15. Article
  16. Questions in Mild Asthma: An Official American Thoracic Society Research Statement.American journal of respiratory and critical care medicine · 2023
    Article
  17. Blood Eosinophils for Prediction of Exacerbation in Preschool Children With Recurrent Wheezing.The journal of allergy and clinical immunology. In practice · 2023
    Article
  18. Article
  19. Diagnosis and management of asthma in infants and preschoolers.Clinical and experimental pediatrics · 2022
    Article
  20. Observational

15 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 10 institutions in 1 country.

Robert S ZeigerDepartment of Allergy, Kaiser Permanente Southern California, San Diego, CA 92111, USA. robert.s.zeiger@kp.org
David Mauger
Leonard B Bacharier
Theresa W Guilbert
Fernando D Martinez
Robert F Lemanske
Robert C Strunk
Ronina Covar
Stanley J Szefler
Susan Boehmer
Daniel J Jackson
Christine A Sorkness
James E Gern
H William Kelly
Noah J Friedman
Michael H Mellon
Michael Schatz
Wayne J Morgan
Vernon M Chinchilli
Hengameh H Raissy
Elizabeth Bade
Jonathan Malka-Rais
Avraham Beigelman
Lynn M Taussig
CARE Network of the National Heart, Lung, and Blood Institute
University of Wisconsin–Madison · USKaiser Permanente · USPennsylvania State University · USSt. Louis Children's Hospital · USUniversity of Colorado Denver · USUniversity of Arizona · USUniversity of New Mexico · USNational Jewish Health · USUniversity of California, San Diego · USUniversity of Wisconsin–Milwaukee · 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 KOSMISKI, LISA 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
ZUNI KIDNEY PROJECT STUDY I--POPULATION BASED SURVEY OF RENAL DISEASEM01RR000997 · NCRR · UNIVERSITY OF NEW MEXICO · PI ROLDAN, CARLOS A · 1985 to 2010
$30.0M
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 NEWCOMER, JOHN W. · 1985 to 2007
$25.4M
Colorado Clinical and Translational Science Institute (UL1)UL1TR000154 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2012 to 2013
$20.4M
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
CHILDHOOD ASTHMA: INITIATION AND INTERVENTIONU10HL064305 · NHLBI · UNIVERSITY OF WISCONSIN-MADISON · PI LEMANSKE, ROBERT F · 1999 to 2008
$5.8M
NCATS NIH HHS UL1 TR000154NCATS NIH HHS UL1 TR000448NCRR NIH HHS 1UL1RR025011NCRR NIH HHS 5M01 RR00997NCRR NIH HHS 5UL1RR02499204NCRR NIH HHS M01 RR000036NCRR NIH HHS M01 RR000051NCRR NIH HHS M01 RR00036NCRR NIH HHS M01 RR00051NCRR NIH HHS M01 RR000997NCRR NIH HHS UL1 RR024992NCRR NIH HHS UL1 RR025011NCRR NIH HHS UL1 RR025780NCRR NIH HHS UL1RR025780NHLBI NIH HHS 5U10HL064287NHLBI NIH HHS 5U10HL064288NHLBI NIH HHS 5U10HL064295NHLBI NIH HHS 5U10HL064305NHLBI NIH HHS 5U10HL064307NHLBI NIH HHS 5U10HL064313NHLBI NIH HHS U10 HL064287NHLBI NIH HHS U10 HL064288NHLBI NIH HHS U10 HL064295NHLBI NIH HHS U10 HL064305NHLBI NIH HHS U10 HL064307NHLBI NIH HHS U10 HL064313
6 · The paper itself

Abstract

backgroundDaily inhaled glucocorticoids are recommended for young children at risk for asthma exacerbations, as indicated by a positive value on the modified asthma predictive index (API) and an exacerbation in the preceding year, but concern remains about daily adherence and effects on growth. We compared daily therapy with intermittent therapy.

methodsWe studied 278 children between the ages of 12 and 53 months who had positive values on the modified API, recurrent wheezing episodes, and at least one exacerbation in the previous year but a low degree of impairment. Children were randomly assigned to receive a budesonide inhalation suspension for 1 year as either an intermittent high-dose regimen (1 mg twice daily for 7 days, starting early during a predefined respiratory tract illness) or a daily low-dose regimen (0.5 mg nightly) with corresponding placebos. The primary outcome was the frequency of exacerbations requiring oral glucocorticoid therapy.

resultsThe daily regimen of budesonide did not differ significantly from the intermittent regimen with respect to the frequency of exacerbations, with a rate per patient-year for the daily regimen of 0.97 (95% confidence interval [CI], 0.76 to 1.22) versus a rate of 0.95 (95% CI, 0.75 to 1.20) for the intermittent regimen (relative rate in the intermittent-regimen group, 0.99; 95% CI, 0.71 to 1.35; P=0.60). There were also no significant between-group differences in several other measures of asthma severity, including the time to the first exacerbation, or adverse events. The mean exposure to budesonide was 104 mg less with the intermittent regimen than with the daily regimen.

conclusionsA daily low-dose regimen of budesonide was not superior to an intermittent high-dose regimen in reducing asthma exacerbations. Daily administration led to greater exposure to the drug at 1 year. (Funded by the National Heart, Lung, and Blood Institute and others; MIST ClinicalTrials.gov number, NCT00675584.).

Indexed as

Administration, InhalationAdministration, OralAsthmaBronchodilator AgentsBudesonideChild, PreschoolDrug Administration ScheduleFemaleGlucocorticoidsHumansInfantMalePrednisoloneRespiratory SoundsSeverity of Illness IndexTreatment FailureBronchodilator AgentsBudesonideGlucocorticoidsPrednisolone

Identifiers

PMID22111718
PMCPMC3247621
OpenAlexW2124283091

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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.