The Impact of Budesonide/Formoterol pMDI Medication Reminders on Adherence in Chronic Obstructive Pulmonary Disease (COPD) Patients: Results of a Randomized, Phase 4, Clinical Study
Received 19 June 2020
Accepted for publication 1 February 2021
Published 4 March 2021 Volume 2021:16 Pages 563—577
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Richard Russell
Gerard J Criner,1 Therese Cole,2 Kristen A Hahn,3 Kari Kastango,3 James Eudicone,4 Ileen Gilbert4
1Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University Hospital, Philadelphia, PA, USA; 2IQVIA, Rockville, MD, USA; 3IQVIA, Cambridge, MA, USA; 4AstraZeneca, Wilmington, DE, USA
Correspondence: Gerard J Criner
Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University Hospital, Philadelphia, PA, 19140, USA
Tel +1 215 707 8113
Email [email protected]
Purpose: Among patients with chronic obstructive pulmonary disease (COPD), adherence to inhaled medication leads to fewer exacerbations and improved health status. The goal of the present study was to evaluate the effects of medication reminders via the BreatheMate device on adherence in patients with COPD.
Patients and Methods: A 6-month, phase 4, randomized, multicenter, open-label US study (NCT02864342) enrolled 138 patients aged ≥ 40 years with moderate to very severe COPD and ≥ 10 pack-year smoking history. Patients in the intervention (n = 68) and control (n = 70) groups received the BreatheMate device, smartphone application, and vouchers to redeem pressurized metered-dose inhalers (pMDIs) for the prescribed 2 puffs of budesonide/formoterol 160/4.5 μg twice daily. The intervention group also received twice-daily electronic reminders to take budesonide/formoterol. The primary endpoint was the mean number of sets of adherent puffs/day (4 puffs: 2 puffs within 60 minutes, twice daily) over 6 months. Secondary endpoints included adherence by three 60-day intervals, usage days, prescription refills, and Clinical COPD Questionnaire (CCQ) score. Study enrollment terminated early due to issues with inconsistent syncing.
Results: A higher mean proportion of adherent days (77.6% vs 60.2%; P < 0.001) and sets of adherent puffs/day (1.61 vs 1.33; P < 0.001) were recorded for the intervention group versus the control group. Intervention group adherence was higher than that of the control group for each 60-day interval (P < 0.001); the intervention group was 3.07 (95% confidence interval: 1.49– 6.52) times more likely than the control group to be adherent for ≥ 80% of study days. Overuse (> 2 sets of 2 puffs/day), underuse (< 2 sets of 2 puffs/day), and no use days were lower in the intervention group versus control (P < 0.05). Patients aged ≥ 65 years had higher adherence (P < 0.001).
Conclusion: Medication reminders through the BreatheMate device and application produced greater adherence to inhaled therapy in patients with COPD.
Keywords: chronic obstructive pulmonary disease, telemedicine, adherence, pressurized metered-dose inhaler
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