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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  01/10/2008
 
Trade Name:  Alvesco Inhalation Aerosol, 80 mcg & 160 mcg
 
Generic or Proper Name (*):  ciclesonide
 
Indications Studied:  Treatment of asthma in patients 12 years of age and older.
 
Therapeutic Category:  Antiasthmatic
 
Ages Studied:  4-11 years
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Placebo/Parallel Group/Dose Response
 
No Patients:  514
 
No Centers:  67
 
No Countries:  2
 
BPCA(B), PREA(P):  P
 
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