The effect of beclomethasone dipropionate in ultrafine particles on bronchial hyper-reactivity in young children.
OBJECTIVE
Bronchial hyper-reactivity (BHR) provides a tool for asthma diagnosis, assessment of severity and response to treatment. The effect of beclomethasone dipropionate in ultrafine particles (BDP-HFA) on BHR as measured by the adenosine challenge test in young children has not yet been determined. Our aim was to determine the effect of BDP-HFA (100 μg twice daily) on BHR as evaluated by a reduction of 20% from baseline FEV1 (PC20-FEV1) values in young asthmatic children.


METHODS
Twenty-one young children (13 males), mean age 4.95 ± 1.05 years, with partially controlled or controlled asthma completed a double-blind randomized, placebo-controlled, cross-over study. Each child received 4 weeks of treatment with either 100 μg BDP-HFA twice daily or placebo, and after a 2-week washout period the other way around. Primary outcomes were PC20-FEV1 concentration, and the stage number at which FEV1 values dropped by 20%.


RESULTS
Following 4 weeks of treatment, median PC20-FEV1 was 81.28 mg/mL while on BDP-HFA, compared with 9.64 mg/mL on placebo (p < 0.001). The median increase in stages required to achieve PC20 on BDP-HFA compared with placebo was three (95% CI 2.28-4.86).


CONCLUSIONS
Four weeks of treatment with BDP-HFA resulted in significantly decreased BHR in young children.
Pediatric Pulmonary Unit, Meyer Children's Hospital, The Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
Claudia L
CL
Costa-Katz
Galit
G
Livnat
Fahed
F
Hakim
Daphna
D
Vilozni
Yedidia
Y
Bentur
Lea
L
Bentur
D000249:Adenosine Monophosphate; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001507:Beclomethasone / Q000008:administration & dosage / Q000627:therapeutic use*; D016535:Bronchial Hyperreactivity / Q000175:diagnosis / Q000188:drug therapy*; D002675:Child, Preschool; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010316:Particle Size
D018927:Anti-Asthmatic Agents; D000249:Adenosine Monophosphate; D001507:Beclomethasone