Adherence to Adding Inhaled Corticosteroids to Rescue Therapy in a Pragmatic Trial with Adults with Asthma– a Pilot Study

Abstract Background Underuse of guideline-recommended inhaled corticosteroids (ICS) controller therapy is a risk factor for greater asthma burden. ICS concomitantly-used with rescue inhalers [Patient-Activated Reliever-Triggered ICS(‘PARTICS’)] reduced asthma exacerbations in efficacy trials, but whether PARTICS is effective in pragmatic trials is unknown. Objective We conducted this pilot to determine the feasibility of executing a large-scale pragmatic PARTICS trial and to improve study protocols. Methods Four sites recruited 33 Hispanic or Black persistently asthmatic adults, randomized them ∼3:1 to intervention or usual care, and followed them for 12 weeks. All participants received asthma guideline-based educational videos; intervention participants received video-based instructions on implementing PARTICS plus usual medications. The study involved one randomization visit and monthly questionnaires. Timely questionnaire responses (+/-2 weeks) were monitored. Participants underwent qualitative phone interviews to assess self-reported adherence to PARTICS and understand barriers to completing study procedures. Results Timely questionnaire response rates were 61%, 64%, 70% at 4, 8 and 12 weeks, respectively. Self-reported adherence to PARTICS was 76% [95%CI 58-94%(n=21)], 88% [95%CI 72-100%(n=16)], and 62% [95%CI 36-88%(n=13)] at weeks 1, 6, and 12, respectively. Barriers to completing study procedures included difficulties with questionnaire access, remembering to use ICS and rescue inhalers together, and obtaining refills. Only 22% of participants recognized their short-acting bronchodilator as “reliever” or “rescue”. Conclusion Recruitment was feasible within the allocated period. Adherence to PARTICS was incomplete, questionnaire completion was suboptimal, and common rescue inhaler nomenclature usage was limited. We have modified the full study protocol to attempt to improve adherence to PARTICS and minimize barriers to study procedures.