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• W2908648314 abstract "Children with episodes of severe wheezing are often treated with oral corticosteroids (OCSs) based on their efficacy in the management of asthma in older children. However, the benefit of OCS use remains unclear,1Beigelman A. Durrani S. Guilbert T.W. Should a preschool child with acute episodic wheeze be treated with oral corticosteroids? A pro/con debate.J Allergy Clin Immunol Pract. 2016; 4: 27-35Abstract Full Text Full Text PDF PubMed Scopus (18) Google Scholar, 2Tal A. Levy N. Bearman J.E. Methylprednisolone therapy for acute asthma in infants and toddlers: a controlled clinical trial.Pediatrics. 1990; 86: 350-356PubMed Google Scholar and the adverse reactions have been well described.3Aljebab F. Choonara I. Conroy S. Systematic review of the toxicity of short-course oral corticosteroids in children.Arch Dis Child. 2016; 101: 365-370Crossref PubMed Scopus (65) Google Scholar Thus identifying which children with recurrent wheezing are most likely to benefit from OCS use during acute severe wheezing episodes is warranted. The Oral Corticosteroids for Treating Episodes of Significant Lower respiratory Tract Symptoms (OCELOT) trial was a multisite clinical trial conducted by AsthmaNet to assess the efficacy of OCSs in preschool-aged children with recurrent severe wheezing. The OCELOT trial and its companion trial, Azithromycin for Preventing the Development of Upper Respiratory Tract Illness into Lower Respiratory Tract symptoms in Children (APRIL),4Bacharier L.B. Guilbert T.W. Mauger D.T. Boehmer S. Beigelman A. Fitzpatrick A.M. et al.Early administration of azithromycin and prevention of severe lower respiratory tract illnesses in preschool children with a history of such illnesses: a randomized clinical trial.JAMA. 2015; 314: 2034-2044Crossref PubMed Scopus (198) Google Scholar were 2 separate but linked trials conducted in 607 children 12 to 71 months of age with a history of clinically significant wheezing in the prior year (see Fig E1 in this article's Online Repository at www.jacionline.org). These studies began enrollment in April 2011. The APRIL trial examined the efficacy of the macrolide azithromycin versus placebo administered at the early signs of a respiratory tract illness (RTI).4Bacharier L.B. Guilbert T.W. Mauger D.T. Boehmer S. Beigelman A. Fitzpatrick A.M. et al.Early administration of azithromycin and prevention of severe lower respiratory tract illnesses in preschool children with a history of such illnesses: a randomized clinical trial.JAMA. 2015; 314: 2034-2044Crossref PubMed Scopus (198) Google Scholar The OCELOT trial was a randomized, double-blind, placebo-controlled trial in children enrolled in the APRIL trial, who were randomized to receive either an OCS (1 mg/kg prednisolone administered twice daily for 5 days; maximum dose, 60 mg/d) or placebo when an RTI had progressed to a significant lower respiratory tract illness (LRTI). Families were instructed to contact either the study staff during the day or a centralized telephone triage center after hours when the child had specific LRTI symptoms, including respiratory symptoms that had not improved after 3 albuterol treatments in 1 hour, symptoms that required 2 albuterol treatments within 4 hours, use of 7 or more albuterol treatments in 24 hours, or concerning cough or wheeze for several days. Nurses at the telephone triage center used an algorithm to determine the appropriateness of initiating OCELOT therapy, followed by a research physician's confirmation by telephone. Albuterol and blinded trial medications were available at home, and OCELOT therapy was started based on this telephone assessment. The primary outcome measure of the OCELOT trial was the Pediatric Respiratory Assessment Measure (PRAM) score (score range, 0-12),5Ducharme F.M. Chalut D. Plotnick L. Savdie C. Kudirka D. Zhang X. et al.The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers.J Pediatr. 2008; 152: 476-480.e1Abstract Full Text Full Text PDF PubMed Scopus (147) Google Scholar which was determined 15 minutes after bronchodilator and measured in the AsthmaNet clinic by a physician 36 to 72 hours after the initiation of OCELOT medication. Trial participation was terminated after 1 course of OCELOT therapy, and then the discharge care plan was prescribed by the research physician. Parents received asthma education and customized action plans. One hundred forty-nine of 607 children enrolled in the APRIL trial received either OCELOT treatment or open-label OCS treatment during the trial, and these occurred under one of 4 conditions (Fig 1). A total of 61 children received OCELOT treatment in a per-protocol fashion, whereas 88 received open-label OCS as part of clinical care outside of the trial (early terminators). Given the high rate of off-protocol use of open-label OCSs combined with the small number of children managed per-protocol and the potential for selection bias of children with more severe episodes being managed with open-label OCSs by providers outside the trial, the OCELOT Data Safety and Monitoring Board recommended premature termination of the trial because of a lack of feasibility in April 2013. Thus the primary outcome was not able to be evaluated. However, several important observations from the conduct of this trial warrant discussion and future consideration. Compared with children treated per-protocol, children who received open-label OCS treatment were more likely to have at least 1 positive aeroallergen skin prick test response, higher IgE levels, higher blood eosinophil counts, higher asthma-related hospitalization rates in the year before enrollment, and/or self-reported black race at baseline (Table I). However, both groups of children had similar rates of OCS courses and inhaled corticosteroid use in the year before enrollment (Table I). This suggests that children who received open-label OCSs might have been predisposed to experience an LRTI that rapidly progressed in severity because of greater baseline markers of type 2 inflammation and prior severe episodes requiring hospitalization. These children also share several of the criteria that predict wheezing exacerbations in children with asthma.6Teach S.J. Gergen P.J. Szefler S.J. Mitchell H.E. Calatroni A. Wildfire J. et al.Seasonal risk factors for asthma exacerbations among inner-city children.J Allergy Clin Immunol. 2015; 135: 1465-1473.e5Abstract Full Text Full Text PDF PubMed Scopus (119) Google Scholar, 7Hoch H.E. Calatroni A. West J.B. Liu A.H. Gergen P.J. Gruchalla R.S. et al.Can we predict fall asthma exacerbations? Validation of the seasonal asthma exacerbation index.J Allergy Clin Immunol. 2017; 140: 1130-1137.e5Abstract Full Text Full Text PDF PubMed Scopus (35) Google ScholarTable IBaseline characteristics at enrollmentBaseline characteristicEarly terminators (n = 88)∗Unless different sample sizes are noted below.Per-protocol (n = 61)∗Unless different sample sizes are noted below.Age (mo), mean ± SD41.1 ± 16.240.3 ± 16.8Male sex, no. (%)60 (68.2)41 (67.2)Family reported race, no. (%) White59 (67)44 (72.1) Black/African American19 (21.6)8 (13.1) Other4 (4.6)1 (1.6) >1 Race reported6 (6.8)8 (13.1)Family reported ethnicity, no. (%) Hispanic/Latino27 (30.7)16 (26.2)Family-reported highest education level No high school diploma4 (4.5)1 (1.7) GED or high school diploma13 (14.8)5 (8.8) Post–high school education71 (80.7)51 (89.5)Family-reported income, no. (%) <$25,00019 (21.6)16 (27.6) $25,000-$49,99919 (21.6)14 (24.1) $50,000-$99,99922 (25)17 (29.3) ≥$100,00020 (22.7)11 (19.0)No. of asthma-related hospitalizations in past year, mean ± SD0.25 ± 0.440.16 ± 0.37No. of OCS courses in past year, mean ± SD1.17 ± 0.961.36 ± 1.11ICS use in past year, no. (%)22 (25)26 (42.6)>1 Positive aeroallergen sensitivity, no. (%)46 (54.1), n = 8522 (36.7), n = 60Serum IgE (kU/L), median (quartile range)115.8 (19.7-307.6), n = 8177.6 (14.5-190.5), n = 56Blood eosinophil count (%), median (quartile range)3.8 (2-6.15), n = 843 (1.4-5), n = 58ICS, Inhaled corticosteroid.∗ Unless different sample sizes are noted below. Open table in a new tab ICS, Inhaled corticosteroid. Of the 61 children treated per-protocol, 54 had PRAM scores recorded, and 92.6% had mild symptoms (score < 4) at 36 to 72 hrs. During the visit, 27.8% had wheezing, 20.4% had poor air entry, and 3.7% had suprasternal retractions, and the mean oxygen saturation in room air was 97.1%. OCSs might be more effective in treating children with more severe respiratory symptoms during LRTIs; however, this could not be evaluated because the severity of the index episode could not be objectively evaluated. Adverse events reported within 4 days of initiation of OCELOT therapy included otitis media (1 participant), acute bronchitis (1 participant), asthma exacerbation (3 participants), respiratory abnormality (1 participant), fever (1 participant), chest pain (1 participant), vomiting (1 participant), and pneumonia (1 participant). Although the OCELOT trial was carefully designed by the AsthmaNet Steering Committee and reviewed by clinical trials experts, including the National Heart, Lung, and Blood Institute Protocol Review Committee and the Data Safety and Monitoring Board, the US Food and Drug Administration, and numerous institutional review boards, we encountered several problems that proved more challenging to deal with than we anticipated. The major barrier was frequent use of open-label OCSs despite careful informed consent with parental education to encourage communication with research staff during illness, written action plans, letters about trial medications to the primary care physician for parents to bring to the emergency department, and real-time support from triage nurses and experienced research personnel. The fact that the OCELOT trial was the first OCS efficacy trial that used a sequential trial design might have exacerbated these challenges by generating parent- or provider-perceived ineffectiveness of the first trial medication (APRIL treatment). This might have led them to seek open-label OCSs rather than to begin the OCELOT blinded treatment because OCSs were considered the accepted treatment for preschool wheezing at the time this study was conducted. There also might be a rapid course because of the child's inability to report symptoms and the parents' inability to detect symptoms in these young children, which leads to a more rapidly evolving course that does not allow time for an effective intervention at this stage of severity. Furthermore, the equipoise of this trial was compromised by the inertia of clinical practice relying on OCS treatment as the standard for rescue during such episodes rather than allowing for conduct of a placebo-controlled evaluation, despite the relatively low PRAM score these children exhibited at 36 to 72 hours of their LRTI. There are several lessons and implications for future studies. Ultimately, there remains a significant need to conduct efficacy trials evaluating OCS treatment in preschool-aged children with recurrent wheezing8Deshpande D.R. Martinez F.D. The dilemma of systemic steroids in preschool children with recurrent wheezing exacerbations.Pediatr Pulmonol. 2016; 51: 775-777Google Scholar targeting specific phenotypes. Large observational and pragmatic trials can provide valuable additional data on the comparative effectiveness and safety of OCSs in this population. It might be useful to compare OCSs in a randomized, double-blind, placebo-controlled trial with another active therapy, such as high-dose inhaled corticosteroids or azithromycin administered at doses previously shown to be effective in preschool-aged children. Children would be stratified by clearly defined clinical phenotypes that predict future wheezing LRTIs and response to these therapies.9Fitzpatrick A.M. Jackson D.J. Mauger D.T. Boehmer S.J. Phipatanakul W. Sheehan W.J. et al.Individualized therapy for persistent asthma in young children.J Allergy Clin Immunol. 2016; 138: 1608-1618.e12Abstract Full Text Full Text PDF PubMed Scopus (170) Google Scholar Finally, it might be helpful to conduct this study in a clinical setting to confirm that protocol-defined criteria for OCS intervention are met. Table E1AsthmaNet OCELOT grant support/acknowledgement rosterSite IDGrant supportCoordinator and investigator acknowledgementSite addressBoston 112HL098102Lisa Bartnikas, MDAlisha Bouzaher, MSChristopher Burke,Matthew Cavanaugh,Julia Chen, PA-CElizabeth Cunningham,Amparito Cunningham,James Friedlander, MDEnal Hindi, MDDavid Kantor MD,Perdita Permaul, MDDevako Rao, MDMelinda Rossi, MPHDoris Schierembergg, MSKynda Schneider, MDJennifer Troung,Dale Umetsu, MDJoseph Zhou, MDChildren's Hospital Boston, 333 Longwood Ave, Suite 403, Boston, MA 02115Phone: 857-218-5529Chicago 122HL098096Jill Chmielewski,Anna Fishbein,Iliana Flexas,Ramsay Fuleihan,Rajesh Kumar,James Lane,Melanie Makhija,Louis Martos,Brandon Parker,Benjamin Prince,Nashmia Qamar,Mary Riordan,Rachel Robinson,Waheeda Samady,Christine Szychlinski,Daniel TsangAnn & Robert H. Lurie Children's HospitalDivision of Allergy & Immunology, 225 East Chicago Ave #60, Chicago, IL 60611Phone: 312-227-6455 125HL098096Christopher Codispoti,Juan Fu, Grace Li,Diana Munoz-Mendoza,Benjamin ThompsonRush University Medical Center, 1725 W Harrison St, Ste 117, Chicago, IL 60612Phone: 312-942-8701Fax: 312-563-2201Denver 132HL098075UL1 TR001082Melanie Gleason, SakariGraves, Jonathan Malka,Melanie Phillips, GayleSpears, D. Sundstrom,Michael WhiteNational Jewish Health, Rm A303, 1400 Jackson St, Denver, CO 80206-2761Phone: 303-398-1721 133HL098075Christina Batson, BSLea Davies, MDFranceska Kelly, BS, CCRCEsmeralda Morales, MDAbby Redway, RRT, BOEMary Spicher, BSN, MSNUniversity of New Mexico Health Sciences Center, MSC 10-5590, 1 University of New Mexico, Albuquerque, NM 87131-0001Phone: 505-272-9889Madison 141HL098090Lauren Kaminski, BSMegan R. Knutson, MS, RCEPKelly Miller, BS, CCRCJennifer Promer, BSSheila Turcsanyi, BS, CCRCTanya Watson, RN, BSNUniversity of Wisconsin-Madison, K4/968 CSC, MC 9988, 600 Highland Ave, Madison, WI 53792Phone: 608-263-3360Pittsburgh 152HL098177ULITR000439Shean Aujla, MDJohn Broyles, CRNPHey Chong, MDPatricia Dubin, MDJonathan Finder, MDTodd D. Green, MDLori Holt, CRNPAdam Kufen, RNGeoffrey Kurland, MDRose Lanzo, RRTDavid Nash, MDJulianne Parente,Catherine Smith, RNJonathan Spahr, MDDaniel J. Weiner, MDDepartment of Pulmonary Medicine, Allergy and Immunology, Children's Hospital of Pittsburgh of UPMC, One Children's Hospital Dr, 4401 Penn Ave, AOB 3rd Fl, Ste 3300, Pittsburgh, PA 15224Phone: 412-692-5872 153HL098177Daniel Craven, MDDanielle Goetz,Meeghan Hart MDLeigh A. Kerns, MDLaurie Logan, RNRoss Myers, MDLaura Veri, RARainbow Babies and Children's Hospital, 11100 Euclid Ave, Ste 3001, MS 6006, Cleveland, OH 44106Phone: 216-844-7927 154HL098177Erica Butler, MBS, CCRCJennifer Maiolo, PA-CSara Misplay, MBA, CCRCDavid Skoner, MDGlennys SmithASRI/AGH Department of Allergy, Asthma and Immunology, 490 E North Ave, Suite 207, Pittsburgh, PA 15212Phone: 412-359-3328St Louis 162HL098098UL1 TR000448Wanda Caldwell, MBA, RRT, BHSCourtney Dula, MSAlysa Ellis, MDCaroline Horner, MDLila Kertz, PNPTina Norris, CRTKatherine Rivera-Spoljaric, MDOscar Rodriguez, MDRobert Strunk, MDWashington University School of Medicine, Campus Box 8116, 660 S Euclid Ave, St Louis, MO 63110Phone: 314-286-1173San Francisco 172HL098107Jessica Bowman,Vicky Bowyer,Judy Gonzales-Vargas,Sara Hawkey,Susannah McCormick,Michelle McKean,Dan Shapiro,Katherine TomUniversity of California–San Francisco, 3333 California St, Suite 245, San Francisco, CA 94118Phone: 415-476-2860 173HL098107Jason Decker, RNKeonna Harrison,Dayna Long, MDJyothi Marbin, MDRobert Mok, LVNCindy Nelson-Purdy, NP, MPHDennis Ren,Hollie Stessel, CPhTBenioff Children's Hospital–Oakland, 5220 Claremont Ave, Oakland, CA 94618Phone: 510-428-3885 x7492Tucson 181HL098112Valerie Bloss, BSMark Brown, MDKatherine Chee, BSCori Daines, MDClara S. Ehrman, BS, BSHSDima Ezmigna, MBBSJamie Goodwin, PhDRoni Grad, MDAnunya Hiranratta, MDSilvia Lopez, RNAndrea Paco,Janette Priefert,Natalie S. Provencio, BSElizabeth Ryan, BS, RRTMonica Varela, LPNMonica Vasquez, MPH, MEdRosemary Weese, RN, RRTJesus Wences, BSArizona Respiratory Center, University of Arizona, 1501 N Campbell Ave, Rm 2344, PO Box 245030, Tucson, AZ 85724-5030Phone: 520-626-4200WS/Charlottesville 192HL098103Deb Green,Denise Thompson-Batt,Kristin Wavell,Donna WolfUniversity of Virginia Health System, Pediatric Respiratory Medicine, PO Box 810386, 409 Lane Rd, Building MR4, Charlottesville, VA 22908-0386 194HL098103UL1 TR000454Timothy Beaty,Alice C. Bruce, BSKaren DeMuth,Jennifer Dodds,Shaneka Douglas,Dawn M. Simon,Denise Whitlock,Shanae Brown, RRTEmory University Department of Pediatrics, 2015 Uppergate Dr, Rm 326, Atlanta, GA 30322Phone: 404-727-5176DCCHL098115Susan Boehmer, MAMatthew Bowman,Loretta Doty, MSWLinda Ferrari, BSBeth Gern,Dave Mauger, PhDAimee Merchlinski,James Schmidt,Daniel Tekely,Lindsay Texter,Angela Updegrave,Ronald Zimmerman, Jr, MPAPennsylvania State University College of Medicine, Department of Public Health Sciences, 90 Hope Dr, Hershey, PA 17033Phone: 717-531-3663AsthmaNet Executive Steering Committee Members: Boston—Elliot Israel, Wanda Phipatanakul; Chicago—Lewis Smith, Jacqueline A. Pongracic, Julian Solway, Jerry A. Krishnan; Denver—Stanley J. Szefler, Michael Wechsler; Madison—Christine A. Sorkness, Robert Lemanske; Pittsburgh—Sally Wenzel, Fernando Holguin; St Louis—Mario Castro, Leonard B. Bacharier; San Francisco—Stephen C. Lazarus, Michael D. Cabana; Tucson—Monica Kraft, Fernando Martinez; Winston-Salem/Emory—Stephen P. Peters, Anne M. Fitzpatrick; Penn State Hershey DCC—David T. MaugerAsthmaNet Chair Person: William B. Busse Open table in a new tab AsthmaNet Executive Steering Committee Members: Boston—Elliot Israel, Wanda Phipatanakul; Chicago—Lewis Smith, Jacqueline A. Pongracic, Julian Solway, Jerry A. Krishnan; Denver—Stanley J. Szefler, Michael Wechsler; Madison—Christine A. Sorkness, Robert Lemanske; Pittsburgh—Sally Wenzel, Fernando Holguin; St Louis—Mario Castro, Leonard B. Bacharier; San Francisco—Stephen C. Lazarus, Michael D. Cabana; Tucson—Monica Kraft, Fernando Martinez; Winston-Salem/Emory—Stephen P. Peters, Anne M. Fitzpatrick; Penn State Hershey DCC—David T. Mauger AsthmaNet Chair Person: William B. Busse" @default.
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