title: The safety and clinical benefit of budesonide/formoterol pressurized metered-dose inhaler versus budesonide alone in children.
abstract: Few studies have evaluated inhaled corticosteroid (ICS)/long-acting beta(2)-adrenergic agonist combination therapy in asthmatic children. This study was designed to evaluate the safety (primary) and clinical benefits (secondary) of budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus budesonide dry powder inhaler (DPI) in children with persistent asthma. This was a 26-week, multicenter, randomized, open-label U.S. study of 187 children 6-11 years of age previously receiving ICS. After 1 week of usual ICS therapy, subjects received twice-daily budesonide/formoterol pMDI 160/4.5 micrograms x 2 inhalations (320/9 micrograms; n = 124) or budesonide DPI 200 micrograms x 2 inhalations (400 micrograms [320 micrograms delivered ex-mouthpiece]; n = 63). Budesonide/formoterol and budesonide were well tolerated with a similar incidence of adverse events (AEs) (84.6% and 85.7%, respectively), most of mild or moderate intensity. Treatment-related AE incidence was low (5.4%) and similar across groups (budesonide/formoterol, 4.9%; budesonide, 6.3%). No clinically important treatment differences were observed for 12-lead electrocardiograms, hematology, serum glucose and potassium, and 24-hour urinary cortisol. Compared with budesonide, budesonide/formoterol decreased health care use (urgent care visits and interference with daily activities [child] or work [caregiver]; p < or = 0.012) and improved health-related quality of life (Pediatric Asthma Quality of Life Questionnaire [standardized] and Pediatric Asthma Caregiver Quality of Life Questionnaire overall scores; p < or = 0.006) and pulmonary function (predose forced expiratory volume in 1 second and forced expiratory flow during the middle half of exhalation; p < or = 0.007). In this 26-week study of asthmatic children (6-11 years), safety profiles were similar and clinical benefits were greater with budesonide/formoterol than with budesonide.
authors.affiliation: Allergy and Asthma Associates of Southern California, 27800 Medical Center Road Number 244, Mission Viejo, CA 29691-6410, USA. Weberger@uci.edu
authors.forename: William E
authors.initials: WE
authors.lastname: Berger
authors.forename: Jeffrey G
authors.initials: JG
authors.lastname: Leflein
authors.forename: David E
authors.initials: DE
authors.lastname: Geller
authors.forename: Bhash
authors.initials: B
authors.lastname: Parasuraman
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Miller
authors.forename: Christopher D
authors.initials: CD
authors.lastname: O'Brien
authors.forename: Liza
authors.initials: L
authors.lastname: O'Dowd
mesh_terms: D000280:Administration, Inhalation; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000009:adverse effects / Q000627:therapeutic use; D019819:Budesonide / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D004359:Drug Therapy, Combination; D004562:Electrocardiography; D004983:Ethanolamines / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate