title: Efficacy and safety of budesonide/formoterol pMDI vs budesonide pMDI in asthmatic children (6-<12 years).
abstract: The efficacy and safety of budesonide/formoterol pressurized metered-dose inhaler (pMDI) have been demonstrated in patients with asthma at least 12 years old.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov Identifier: NCT02091986.
authors.affiliation: Colorado Allergy & Asthma Centers, P.C., Denver, Colorado. Electronic address: ds.pearlman@coloradoallergy.com.
authors.forename: David S
authors.initials: DS
authors.lastname: Pearlman
authors.affiliation: AstraZeneca R&D, Gothenburg, Sweden.
authors.forename: Göran
authors.initials: G
authors.lastname: Eckerwall
authors.affiliation: AstraZeneca, Gaithersburg, Maryland.
authors.forename: Julie
authors.initials: J
authors.lastname: McLaren
authors.affiliation: AstraZeneca, Barcelona, Spain.
authors.forename: Rosa
authors.initials: R
authors.lastname: Lamarca
authors.affiliation: AstraZeneca R&D, Gothenburg, Sweden.
authors.forename: Margareta
authors.initials: M
authors.lastname: Puu
authors.affiliation: AstraZeneca, Wilmington, Delaware.
authors.forename: Ileen
authors.initials: I
authors.lastname: Gilbert
authors.affiliation: AstraZeneca R&D, Gothenburg, Sweden.
authors.forename: Carin
authors.initials: C
authors.lastname: Jorup
authors.affiliation: AstraZeneca R&D, Gothenburg, Sweden.
authors.forename: Kristina
authors.initials: K
authors.lastname: Sandin
authors.affiliation: Allergy, Asthma & Immunology, AAADRS Clinical Research Center, Coral Gables, Florida.
authors.forename: Miguel J
authors.initials: MJ
authors.lastname: Lanz
mesh_terms: D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D019819:Budesonide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005541:Forced Expiratory Volume; D000068759:Formoterol Fumarate / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D018927:Anti-Asthmatic Agents; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate