PMID- 20167143
OWN - NLM
STAT- MEDLINE
DCOM- 20100518
LR  - 20161020
IS  - 1539-6304 (Electronic)
IS  - 1088-5412 (Linking)
VI  - 31
IP  - 1
DP  - 2010 Jan-Feb
TI  - The safety and clinical benefit of budesonide/formoterol pressurized metered-dose 
      inhaler versus budesonide alone in children.
PG  - 26-39
LID - 10.2500/aap.2010.31.3301 [doi]
AB  - 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.
FAU - Berger, William E
AU  - Berger WE
AD  - Allergy and Asthma Associates of Southern California, 27800 Medical Center Road 
      Number 244, Mission Viejo, CA 29691-6410, USA. Weberger@uci.edu
FAU - Leflein, Jeffrey G
AU  - Leflein JG
FAU - Geller, David E
AU  - Geller DE
FAU - Parasuraman, Bhash
AU  - Parasuraman B
FAU - Miller, Christopher J
AU  - Miller CJ
FAU - O'Brien, Christopher D
AU  - O'Brien CD
FAU - O'Dowd, Liza
AU  - O'Dowd L
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Allergy Asthma Proc
JT  - Allergy and asthma proceedings
JID - 9603640
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Ethanolamines)
RN  - 51333-22-3 (Budesonide)
RN  - W34SHF8J2K (Formoterol Fumarate)
SB  - IM
MH  - Administration, Inhalation
MH  - Asthma/*drug therapy/physiopathology
MH  - *Bronchodilator Agents/adverse effects/therapeutic use
MH  - *Budesonide/adverse effects/therapeutic use
MH  - Child
MH  - Drug Therapy, Combination
MH  - Electrocardiography
MH  - *Ethanolamines/adverse effects/therapeutic use
MH  - Female
MH  - Formoterol Fumarate
MH  - Humans
MH  - Male
MH  - Metered Dose Inhalers
MH  - Quality of Life
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
EDAT- 2010/02/20 06:00
MHDA- 2010/05/19 06:00
CRDT- 2010/02/20 06:00
PHST- 2010/02/20 06:00 [entrez]
PHST- 2010/02/20 06:00 [pubmed]
PHST- 2010/05/19 06:00 [medline]
AID - 10.2500/aap.2010.31.3301 [doi]
PST - ppublish
SO  - Allergy Asthma Proc. 2010 Jan-Feb;31(1):26-39. doi: 10.2500/aap.2010.31.3301.