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School-supervised use of a once-daily inhaled corticosteroid regimen: A cluster randomized trial - 19/09/18

Doi : 10.1016/j.jaci.2018.06.048 
Joe K. Gerald, MD, PhD a, b, , Julia M. Fisher, PhD, MS c, Mark A. Brown, MD d, e, Conrad J. Clemens, MD, MPH f, Melissa A. Moore, MD f, Scott C. Carvajal, PhD, MPH g, Donna Bryson, RN, AE-C h, Nikki Stefan, RN, BSN i, Dean Billheimer, PhD c, j, Lynn B. Gerald, PhD, MSPH b, g
a Department of Community, Environment and Policy, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson 
b Asthma and Airways Disease Research Center, University of Arizona, Tucson 
c BIO5 Institute, University of Arizona, Tucson 
d Department of Pediatrics, University of Colorado, Denver 
e The Breathing Institute, Children's Hospital Colorado, Denver 
f Department of Pediatrics, University of Arizona College of Medicine, University of Arizona, Tucson 
g Department of Health Promotion Sciences, the Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson 
h American Lung Association of Southern Arizona, Tucson 
i Department of Health Services, Tucson Unified School District, Tucson 
j Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson 

Corresponding author: Joe K. Gerald, MD, PhD, Department of Community Environment and Policy, Mel and Enid Zuckerman College of Public Health, Asthma and Airways Disease Research Center, University of Arizona, 1295 N Martin Ave, PO Box 245210, Tucson, AZ 85724-5210.Department of Community Environment and PolicyMel and Enid Zuckerman College of Public HealthAsthma and Airways Disease Research CenterUniversity of Arizona1295 N Martin Ave, PO Box 245210TucsonAZ85724-5210
Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Wednesday 19 September 2018
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Abstract

Background

School-supervised use of a once-daily inhaled corticosteroid regimen (supervised therapy) can improve medication adherence and asthma control.

Objective

We sought to evaluate the effectiveness of supervised therapy in a unique setting and population.

Methods

We conducted a cluster randomized trial of supervised therapy in 20 elementary schools with a disproportionate enrollment of low-income Latino students. Schools were purposively selected, matched, and randomized to receive 9 months of supervised therapy with mometasone furoate or usual care. All English- or Spanish-speaking students with self-reported asthma were eligible. The Asthma Control Questionnaire (ACQ) was interviewer administered quarterly at school. Students in supervised therapy schools were hypothesized to have lower ACQ scores than students in usual-care schools.

Results

Of 393 enrolled students, 189 students receiving immediate intervention and 143 students receiving delayed intervention provided 1 or more ACQ data points, were between 6 and 10 years of age, and were included in the primary analysis. At baseline, 39% of students reported taking a controller medication, and 24% had well-controlled asthma. Eighty percent of students receiving immediate intervention were prescribed mometasone. Schools administered 98% of prescribed doses when students attended school. Absences, weekends, and holidays reduced calendar adherence to 53%. During the first year, the mean ACQ score for students receiving immediate and delayed intervention was 1.55 (95% CI, 1.41-1.70) and 1.64 (95% CI, 1.47-1.80), respectively. The estimated treatment effect was −0.08 (95% CI, −0.31 to 0.14).

Discussion

Compared with usual care, supervised therapy did not improve asthma control among this population of Latino students. Additional research is warranted to confirm these results.

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Graphical abstract




Le texte complet de cet article est disponible en PDF.

Key words : Schools, anti-inflammatory agent, medication adherence, asthma, child, directly observed therapy, randomized controlled trial, inhaled corticosteroid, cluster randomized trial

Abbreviations used : ACQ, ICS, MAR, MID, NSLP, OCS, SAMS, TUSD


Plan


 Supported by National Institutes of Health/National Heart, Lung, and Blood Institute grant 1R18HL110858-01A1; a research grant from the Investigator-Initiated Studies Program of Merck Sharp & Dohme Corporation who provided Asmanex (mometasone furoate) and Proventil (albuterol sulfate); and Thayer Medical Corporation, who provided disposable valved holding chambers (LiteAire). The opinions expressed in this paper are those of the authors and do not necessarily represent those of Merck Sharp & Dohme Corp.
 Disclosure of potential conflict of interest: The authors declare that they have no relevant conflicts of interest.
 Trial registration: NCT01997463.


© 2018  American Academy of Allergy, Asthma & Immunology. Publié par Elsevier Masson SAS. Tous droits réservés.
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