Supervised Asthma Medication in Schools (SAMS)

NCT01997463 ↗

Phase 4 Completed 442 enrolled University of Arizona National Heart, Lung, and Blood Institute (NHLBI) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators hypothesize that school-based, direct supervision of daily controller therapy will result in more effective asthma control, as assessed by the Asthma Control Questionnaire than usual care. Additionally, as the result of enhanced asthma control and resulting decrease in health care utilization, school-based, direct supervision of daily controller therapy will result in lower cost per quality-adjusted life year (QALY) gained than usual care.

Timeline

Start: 2014-08
Primary completion: 2016-06
Completion: 2016-06

Outcome

Missed primary endpoint

paper Compared with usual care, supervised therapy did not improve asthma control among this population of Latino students. PMID 30118728 ↗

paper The estimated treatment effect was -0.08 (95% CI, -0.31 to 0.14). PMID 30118728 ↗

Publications

Gerald JK, Fisher JM, Brown MA, Clemens CJ, Moore MA, Carvajal SC, Bryson D, Stefan N, Billheimer D, Gerald LB. School-supervised use of a once-daily inhaled corticosteroid regimen: A cluster randomized trial. J Allergy Clin Immunol. 2019 Feb;143(2):755-764. doi: 10.1016/j.jaci.2018.06.048. Epub 2018 Aug 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mometasone furoate	Other / unclassified	—	—
Background	Salbutamol	Unknown	—	—