School-supervised use of a once-daily inhaled corticosteroid regimen: A cluster randomized trial - 19/09/18
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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.
Le texte complet de cet article est disponible en PDF.Graphical abstract |
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. |
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Disclosure of potential conflict of interest: The authors declare that they have no relevant conflicts of interest. |
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Trial registration: NCT01997463. |
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