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Double-blind placebo-controlled study of oxatomide in the treatment of childhood asthma
1Department of Pediatrics, Chang Gung Children's Hospital, Linko, Taiwan, R.O.C.
Insights
Oxatomide effectively treated childhood asthma by improving pulmonary function and reducing symptoms. This H1-histamine receptor antagonist was well-tolerated, showing potential for pediatric asthma management.
Area of Science:
- Pediatric Pulmonology
- Allergy and Immunology
- Clinical Pharmacology
Background:
- Oxatomide is an H1-histamine receptor antagonist with proven efficacy in adult allergic diseases.
- Asthma is a common chronic respiratory condition in children, necessitating effective and safe treatment options.
Purpose of the Study:
- To evaluate the efficacy and safety of oxatomide in treating asthma in children.
- To assess the impact of oxatomide on pulmonary function, asthma symptoms, and relevant biomarkers.
Main Methods:
- A 4-month, double-blind, placebo-controlled trial involving 64 children (5-16 years) with asthma.
- Patients received either oxatomide (1-2 mg/kg/day) or placebo, with clinical evaluations including pulmonary function tests and immunological studies.
- Patient-reported outcomes and adverse events were systematically recorded.
Main Results:
- Oxatomide treatment led to bronchodilatation and normalized pulmonary function within 2 months.
- Significant reductions were observed in eosinophil cationic protein levels and total asthma symptom scores.
- Adverse events were mild, including drowsiness (5.8%) and weight gain (2.9%), with no significant changes in IgE or IgG4 levels.
Conclusions:
- Oxatomide demonstrated good tolerability and potential efficacy in managing childhood asthma.
- The drug may offer a beneficial treatment option for pediatric asthma patients, warranting further investigation.
Abstract:
Oxatomide is an orally active H1-histamine receptor antagonist. It has been demonstrated to have therapeutic efficacy in the treatment of allergic diseases in adults. The aim of this study was to evaluate the efficacy and safety of oxatomide in the treatment of asthma in children. Sixty-four asthmatic children of both sexes, aged between 5 and 16 years, were enrolled in this double-blind, placebo-controlled trial with a duration of 4 months. Patients were randomized chosen to receive either oxatomide with a daily dose of 1 to 2 mg/kg body weight or a placebo twice daily. Clinical evaluations including pulmonary function tests and immunological studies. The patients' impression on the effect of treatment also were recorded during the study. The effects of bronchodilatation and normalizing pulmonary function were observed 2 months after oxatomide treatment. The levels of eosinophil cationic protein and total asthma symptom scores were significantly reduced during treatment with oxatomide. There was no significant change in total IgE or IgG4 before or after treatment in either the treatment or control groups. During the study, two (5.8%) oxatomide treated patients reported slight drowsiness and one (2.9%) reported body weight gain. Routine laboratory tests showed no significant alterations. In conclusion, oxatomide was generally well tolerated in this study and may have the potential of being an effective treatment for childhood asthma.