Knemometric assessment of systemic activity of once daily intranasal dry-powder budesonide in children.
Systemic activity of the intranasal glucocorticosteroid budesonide administered once daily from a dry-powder inhaler (Turbuhaler) was assessed by knemometry. Lower leg length was measured weekly in 38 children aged 7-15 (mean 11.3) years with allergic or perennial rhinitis. The design was a randomized, double-blind, parallel-group study. After 4 weeks' run-in, the children were allocated to 4 weeks' treatment with either budesonide 200 or 400 micrograms or placebo. Fourteen children in the budesonide 200-micrograms group, 13 in the 400-micrograms group, and 10 in the placebo group completed the study. In the placebo and budesonide 200-micrograms groups, growth velocities during run-in (0.36 and 0.28 mm/week, respectively) and treatment periods (0.34 and 0.27 mm/week, respectively) were almost identical. In the budesonide 400-micrograms group (run-in: 0.40 mm/week), a nonsignificant reduction in mean growth velocity of 0.18 mm/week was seen (P = 0.11). There were no statistically significant differences among the run-in mean lower leg growth velocities (F = 1.12; P = 0.34), among growth velocities during treatment (F = 1.10; P = 0.34), or among the run-in and treatment growth velocities in the three groups (F = 1.19; P = 0.32). These results provide good evidence that systemic activity is low in children with allergic or perennial rhinitis treated with once daily budesonide in doses of 200- and 400-micrograms administered intranasally from a dry-powder inhaler.
Wolthers
O D
OD
Department of Paediatrics, Kolding Hospital, Denmark.
Pedersen
S
S
D000280:Administration, Inhalation; D000287:Administration, Topical; D000293:Adolescent; D000886:Anthropometry; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D019819:Budesonide; D002648:Child; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005938:Glucocorticoids; D006128:Growth / Q000187:drug effects*; D006801:Humans; D007866:Leg / Q000254:growth & development; D008297:Male; D011208:Powders; D011282:Pregnenediones / Q000008:administration & dosage* / Q000009:adverse effects*; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D011208:Powders; D011282:Pregnenediones; D019819:Budesonide