[Protective effect of oxatomide in infantile bronchial asthma. Double-blind study vs placebo]
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P L Giorgi1, N Oggiano, A Kantar
1Istituto di Clinica Pediatrica, Università degli Studi, Ancona.
Insights
Oxatomide effectively controlled seasonal allergic asthma symptoms in young children. This medication significantly reduced coughing, dyspnea, and wheezing, offering a safe and well-tolerated treatment option.
Area of Science:
- Pediatric Allergy and Immunology
- Pharmacology and Therapeutics
- Respiratory Medicine
Background:
- Seasonal allergic bronchial asthma affects young children.
- Assessing the efficacy of oxatomide in managing pediatric asthma is crucial.
Purpose of the Study:
- To evaluate the protective effects of oxatomide in children with seasonal allergic bronchial asthma.
- To compare the efficacy of oxatomide with a placebo in treating pediatric asthma symptoms.
Main Methods:
- A randomized, placebo-controlled study involving 16 children over 2 months.
- Participants received either oxatomide (1 mg/kg/day) or placebo orally.
- Efficacy assessed via semiquantitative scales for cough, dyspnea, wheezing, and sleep disturbances at regular intervals.
Main Results:
- Oxatomide significantly reduced persistent coughing within two weeks (p < 0.05).
- Improvements observed in sleep disorders, dyspnea (at rest and exercise), and wheezing intensity.
- Oxatomide demonstrated significantly greater efficacy than placebo across all measured parameters (p < 0.05 and p < 0.01).
Conclusions:
- Oxatomide at 1 mg/kg/day effectively controlled respiratory symptoms in pediatric asthma.
- The drug was well-tolerated, with mild drowsiness reported in two patients.
- Oxatomide presents a promising therapeutic option for managing seasonal allergic asthma in children.
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.
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