Safety of budesonide inhalation suspension (Pulmicort Respules) after up to 52 weeks of treatment in infants and young children with persistent asthma.
Three open-label extension trials evaluated the safety of budesonide inhalation suspension (BIS; Pulmicort Respules) in 670 children (8 months-9 years of age) with mild-to-severe persistent asthma. Patients were randomized to receive either BIS or conventional asthma therapy (CAT) for 52 weeks. The percentage of patients who discontinued because of clinical adverse events was low and similar among the CAT (0.4%) and BIS (0.7%) groups. After adjusting for length of time in the studies, there were no clinically relevant differences between the BIS and CAT groups in the type, incidence, or intensity of adverse events; vital signs or physical examination outcomes; or changes in clinical laboratory evaluations or oral fungal cultures.
Leflein
J G
JG
Allergy and Immunology Associates of Ann Arbor, P.C., Reichert Health Building, Suite R-1018, 5333 McAuley Drive, Ann Arbor, MI 48106, USA.
Gawchik
S M
SM
Galant
S P
SP
Lyzell
E
E
Young
M
M
Cruz-Rivera
M
M
Walton-Bowen
K
K
Smith
J A
JA
Fitzpatrick
S
S
D000280:Administration, Inhalation; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019819:Budesonide / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002669:Child Welfare; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007229:Infant Welfare; D008297:Male; D012720:Severity of Illness Index; D013995:Time; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D028761:Withholding Treatment
D001993:Bronchodilator Agents; D019819:Budesonide