PMID- 10518847
OWN - NLM
STAT- MEDLINE
DCOM- 19991115
LR  - 20190723
IS  - 0091-6749 (Print)
IS  - 0091-6749 (Linking)
VI  - 104
IP  - 4 Pt 2
DP  - 1999 Oct
TI  - Short-term and long-term safety of budesonide inhalation suspension in infants 
      and young children with persistent asthma.
PG  - 200-9
AB  - This article reviews the short-term and long-term safety profile of budesonide 
      inhalation suspension (BIS) for nebulization in infants and young children with 
      persistent asthma. Short-term safety (12 weeks) was assessed by pooling the 
      results from the 3 randomized, double-blind, placebo-controlled, multicenter 
      studies (studies A, B, and C) on the efficacy and safety of once- and twice-daily 
      BIS. Long-term safety of BIS and conventional asthma therapy (CAT) was assessed 
      in 52-week extension studies of the 12-week double-blind trials. CAT consisted of 
      any available therapy for asthma; in 2 studies, CAT could have included treatment 
      with inhaled glucocorticosteroids. Safety was assessed by monitoring adverse 
      events (AEs), physical examinations, and basal and ACTH-stimulated plasma 
      cortisol levels (in a subset of subjects). In the 52-week open-label extensions, 
      the effects of BIS on growth velocity and skeletal age also were determined. In 
      the 12-week studies, a total of 1017 subjects was evaluated for safety; totals of 
      231, 185, 229, 327, and 45 subjects were randomized to receive placebo or BIS at 
      total daily doses of 0.25 mg, 0.5 mg, 1.0 mg, and 2.0 mg, respectively. Subject 
      demographics and baseline asthma characteristics were similar across treatment 
      groups, except that age, weight, height, and duration of asthma appeared higher 
      in the 2. 0-mg daily dose group. For BIS groups, mean age was 58.9 months; mean 
      weight was 20.3 kg; mean height was 108.9 cm, and mean duration of asthma was 3.2 
      years. There were no differences in the incidence, severity, or types of AEs 
      reported among the BIS and placebo groups. There were no significant differences 
      between placebo and BIS treatment groups in basal or ACTH-stimulated cortisol 
      levels, physical examinations, clinical laboratory values, or fungal cultures. A 
      total of 670 subjects completed the 52-week extension studies; 223 subjects 
      received CAT and 447 received BIS. Median total daily doses of BIS ranged from 
      0.50 mg to 1.0 mg in the 3 studies, and the mean duration of treatment exposure 
      was 304 +/- 119 days and 342 +/- 83 days in CAT and BIS groups, respectively. 
      During the 52-week treatment period, the incidences of reported AEs were 
      comparable between treatment groups and were mild-to-moderate in intensity; no 
      new AEs occurred during the 52-week studies compared with 12-week studies. No 
      significant differences were observed between BIS and CAT in basal or 
      ACTH-stimulated cortisol levels, physical examinations, clinical laboratory 
      values, or fungal cultures. There was a small but statistically significant 
      reduction in growth velocity (a difference of 0.8 cm) in the BIS-treated group 
      compared with the CAT group in study A. In studies B and C, growth velocity was 
      not different between BIS and CAT groups. In pooled analyses, no statistically 
      significant differences in growth velocity, standard median heights, or skeletal 
      age were observed between BIS and CAT groups. Short-term and long-term treatment 
      with BIS, over a wide range of doses, was well tolerated for the treatment of 
      persistent asthma in infants and young children.
FAU - Scott, M B
AU  - Scott MB
AD  - Fairfield County Allergy, Asthma, and Immunology Associates, Norwalk, CT 06851, 
      USA.
FAU - Skoner, D P
AU  - Skoner DP
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Allergy Clin Immunol
JT  - The Journal of allergy and clinical immunology
JID - 1275002
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Placebos)
RN  - 51333-22-3 (Budesonide)
SB  - IM
MH  - Administration, Inhalation
MH  - Adolescent
MH  - Anti-Asthmatic Agents/*administration & dosage/*adverse effects
MH  - Asthma/*drug therapy
MH  - Budesonide/*administration & dosage/*adverse effects
MH  - Child
MH  - Child, Preschool
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Growth/drug effects
MH  - Humans
MH  - Hypothalamo-Hypophyseal System/drug effects
MH  - Infant
MH  - Male
MH  - Nebulizers and Vaporizers
MH  - Pituitary-Adrenal System/drug effects
MH  - Placebos
MH  - Time Factors
EDAT- 1999/10/16 00:00
MHDA- 1999/10/16 00:01
CRDT- 1999/10/16 00:00
PHST- 1999/10/16 00:00 [pubmed]
PHST- 1999/10/16 00:01 [medline]
PHST- 1999/10/16 00:00 [entrez]
AID - S0091-6749(99)70062-X [pii]
AID - 10.1016/s0091-6749(99)70062-x [doi]
PST - ppublish
SO  - J Allergy Clin Immunol. 1999 Oct;104(4 Pt 2):200-9. doi: 
      10.1016/s0091-6749(99)70062-x.