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Broncho-Vaxom in children with rhinosinusitis: a double-blind clinical trial
1Hospital for Tuberculosis and Pulmonary Diseases of Children and Adolescents, Zagreb, Yugoslavia.
Insights
Broncho-Vaxom (BV) significantly reduced infectious episodes and treatment duration in children with chronic rhinosinusitis. Clinical improvements correlated with increased serum IgA levels, showing BV
Area of Science:
- Pediatrics
- Immunology
- Otolaryngology
Background:
- Chronic rhinosinusitis (CRS) is a common condition in children, often leading to recurrent infections and significant morbidity.
- Current treatments for pediatric CRS focus on symptom management and reducing inflammation, but effective long-term prophylactic strategies are needed.
Purpose of the Study:
- To evaluate the efficacy of Broncho-Vaxom (BV), an immunomodulator, in treating acute episodes of chronic rhinosinusitis in children.
- To assess the impact of BV on clinical symptoms, treatment requirements, and serum immunoglobulin A (IgA) levels.
Main Methods:
- A double-blind, randomized, placebo-controlled trial was conducted involving 51 children aged 4-12 years with acute CRS.
- Participants received either BV or placebo for 6 months, with efficacy assessed through clinical symptom evaluation, recording of concomitant treatments, and measurement of serum IgA levels.
Main Results:
- Children treated with BV experienced a significant decrease in the incidence and duration of infectious episodes compared to the placebo group.
- The number and duration of concomitant treatments (antibiotics, secretolytics, antitussives) were also significantly reduced in the BV group.
- A positive correlation was observed between clinical response and increased serum IgA levels in patients receiving BV.
Conclusions:
- Broncho-Vaxom demonstrated both curative and prophylactic efficacy in managing acute episodes of chronic rhinosinusitis in children.
- BV treatment may enhance immune response, as indicated by increased serum IgA levels, contributing to its therapeutic benefits.
Abstract:
Fifty-one children aged 4-12 years, presenting with an acute epidose of chronic rhinosinusitis, were treated for 6 months with either Broncho-Vaxom (BV; marketed in Yugoslavia under the trade mark of Broncho-Munal) or placebo under double-blind randomized conditions. The efficacy of BV was assessed on the basis of clinical symptoms (cough, nasal discharge, congestion of nasal mucosa), number and duration of concomitant treatments (antibiotics, secretolytics, antitussives), number and duration of acute episodes during the trial and serum IgA levels. In BV treated patients the incidence and duration of infectious episodes and the number and duration of concomitant treatments decreased significantly in comparison with the placebo group, and the clinical response correlated positively with an increase in the serum levels of IgA. The results of treatment of acute episodes of chronic rhinosinusitis in children demonstrated the curative and prophylactic efficacy of BV.