Efficacy and safety of budesonide/formoterol pMDI vs budesonide pMDI in asthmatic children (6–<12 years)

Background: The efficacy and safety of budesonide/formoterol pressurized metered-dose inhaler (pMDI) have been demonstrated in patients with asthma at least 12 years old. Objective: To evaluate the efficacy of 2 formoterol doses added to budesonide as fixed combinations vs budesonide alone in children 6 to younger than 12 years with asthma. Methods: This randomized, double-blinded, parallel-group, multicenter study (NCT02091986; CHASE 3) included children 6 to younger than 12 years with asthma previously receiving a medium-dose inhaled corticosteroid (ICS) or an ICS plus a long-acting beta(2)-agonist. Children symptomatic during a 7-28-day run-in on low-dose ICS, 1 inhalation of budesonide dry powder inhaler 90 mu g twice daily (BID), were randomized to receive 2 inhalations of budesonide/formoterol pMDI 80/4.5 mu g (160/9 mu g) BID (n = 92), budesonide/formoterol pMDI 80/2.25 mu g (160/4.5 mu g) BID (n = 95), or budesonide pMDI 80 mu g (160 mu g) BID (n = 92) for 12 weeks. Results: Change in forced expiratory volume in 1 second from baseline to 1 hour after dosing (primary end point), change in forced expiratory volume in 1 second 15 minutes after dosing, and peak expiratory flow1 hour after dosing at week 12 were statistically significantly greater forbudesonide/formoterol 160/9 mu g vs budesonide (P <= .015 for all comparisons), but not for budesonide/formoterol 160/4.5 mu g vs budesonide. Bronchodilator effects, evident 15 minutes after the dose on day 1, were maintained at week 12. Incidence of protocol-defined asthma exacerbations and improvements in asthma symptom-related and quality-of-life outcomes were similar across treatments. There were no notable safety differences among treatments. Conclusion: Budesonide/formoterol pMDI 160/9 mu g showed statistically significant and clinically meaningful lung function improvements vs budesonide pMDI 160 mu g, demonstrating appropriateness as a therapeutic option for children 6 to younger than 12 years with asthma symptomatic on ICS alone. Trial Registration: ClinicalTrials.gov Identifier: NCT02091986. (C) 2017 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).