[Protective effect of oxatomide in infantile bronchial asthma. Double-blind study vs placebo].
BACKGROUND
This study has been designed to assess the protective effect of oxatomide in allergic bronchial asthma of the seasonal type in young children.


METHODS
The study was carried out in a paediatric clinic; sixteen children divided into two balanced groups took oxatomide in an oral suspension at the dosage of 1 mg/kg/day, or placebo for a period of 2 months. Eight patients (7 males, 1 female), aged 22 months +/- 2.83 (mean +/- SD) took oxatomide in an oral suspension at the dosage of 1 mg/kg/day, while the other eight (3 males, 5 females; 22.13 months +/- 3.48) took placebo. Efficacy was assessed by monitoring cough, dyspnea at rest, dyspnea following exercise, wheezing, sleep disorders at baseline and after 15, 30 and 60 days of treatment, on the basis of a semiquantitative scale. All side effects were recorded.


RESULTS
Persistent coughing was significantly reduced (p < 0.05) after two weeks' treatment with oxatomide. Sleep disorders and other symptoms remarkably improved. Dyspnea at rest and following exercise disappeared after 15 days' therapy, while the intensity of wheezing decreased after 30 days' active treatment. In all parameters examined, oxatomide was significantly more active than placebo at the first examination (p < 0.05 and p < 0.01). Oxatomide was well tolerated and only 2 patients complained of drowsiness which required a reduction in dosage.


CONCLUSIONS
Oxatomide, at the dose of 1 mg/kg/day, obtained a good control of respiratory symptoms.
Giorgi
P L
PL
Istituto di Clinica Pediatrica, Università degli Studi, Ancona.
Oggiano
N
N
Kantar
A
A
Coppa
G V
GV
Nicora
M
M
D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010879:Piperazines / Q000627:therapeutic use*; D010919:Placebos; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy / Q000276:immunology*