Efficacy and safety of budesonide/formoterol pMDI vs budesonide pMDI in asthmatic children (6- David S Pearlman 1 , Göran Eckerwall 2 , Julie McLaren 3 , Rosa Lamarca 4 , Margareta Puu 2 , Ileen Gilbert 5 , Carin Jorup 2 , Kristina Sandin 2 , Miguel J Lanz 6 Affiliations Expand Affiliations 1 Colorado Allergy & Asthma Centers, P.C., Denver, Colorado. Electronic address: ds.pearlman@coloradoallergy.com. 2 AstraZeneca R&D, Gothenburg, Sweden. 3 AstraZeneca, Gaithersburg, Maryland. 4 AstraZeneca, Barcelona, Spain. 5 AstraZeneca, Wilmington, Delaware. 6 Allergy, Asthma & Immunology, AAADRS Clinical Research Center, Coral Gables, Florida. PMID: 28256307 DOI: 10.1016/j.anai.2017.01.020 Free article Item in Clipboard
David S Pearlman, Göran Eckerwall, Julie McLaren, Rosa Lamarca, Margareta Puu, Ileen Gilbert, Carin Jorup, Kristina Sandin, Miguel J Lanz, David S Pearlman, Göran Eckerwall, Julie McLaren, Rosa Lamarca, Margareta Puu, Ileen Gilbert, Carin Jorup, Kristina Sandin, Miguel J Lanz
Abstract
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 β2-agonist. Children symptomatic during a 7-28-day run-in on low-dose ICS, 1 inhalation of budesonide dry powder inhaler 90 μg twice daily (BID), were randomized to receive 2 inhalations of budesonide/formoterol pMDI 80/4.5 μg (160/9 μg) BID (n = 92), budesonide/formoterol pMDI 80/2.25 μg (160/4.5 μg) BID (n = 95), or budesonide pMDI 80 μg (160 μg) 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 flow 1 hour after dosing at week 12 were statistically significantly greater for budesonide/formoterol 160/9 μg vs budesonide (P ≤ .015 for all comparisons), but not for budesonide/formoterol 160/4.5 μg 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 μg showed statistically significant and clinically meaningful lung function improvements vs budesonide pMDI 160 μg, 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.
Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed