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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  03/26/2008
 
Trade Name:  Ventolin HFA
 
Generic or Proper Name (*):  albuterol
 
Indications Studied:  Treatment of symptoms of bronchospasm associated with obstructive airway disease
 
Therapeutic Category:  Antiasthmatic
 
Ages Studied:  birth - less than 4 years
 
Study #:  2
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  86
 
No Centers:  33
 
No Countries:  1
 
BPCA(B), PREA(P):  B
 
Asian:  0
 
Black:  18
 
Other:  1
 
White:  45
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  22
 
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