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Use of Broncho-Vaxom in private practice: phase IV trial in 587 children
A C Berber1, B E Del-Rio-Navarro
1Arzneimittelforschung BASF Pharma, Mexico City, Mexico.
Insights
Broncho-Vaxom significantly reduced respiratory infection duration and frequency in children. This immunomodulating agent proved safe and effective for treating acute infections and preventing recurrences.
Area of Science:
- Pediatrics
- Immunology
- Pharmacology
Background:
- Recurrent respiratory tract infections (RRTIs) pose a significant health burden in children.
- Effective management strategies for RRTIs are crucial to reduce morbidity and healthcare utilization.
Purpose of the Study:
- To evaluate the efficacy and safety of Broncho-Vaxom, an immunomodulating agent, in treating acute respiratory tract infections (ARTIs) and preventing recurrences in children.
- To assess the impact of Broncho-Vaxom on key clinical outcomes such as time to improvement, time to cure, infection frequency, absenteeism, and antibiotic use.
Main Methods:
- Phase IV, open-label clinical trial involving 587 children under 12 with ARTIs and a history of RRTIs.
- Patients received Broncho-Vaxom (one capsule daily, 10 days/month for 3 months) alongside antibiotics during acute phases.
- Data collected included time to improvement/cure, infection rates, absenteeism, and antibiotic prescriptions.
Main Results:
- Significant reduction in time to improvement (6.77 to 3.76 days) and time to cure (11.86 to 7.36 days) for acute infections.
- Marked decrease in the number of infections per month (1.79 to 0.24), absenteeism (3.17 to 0.16 days), and antibiotic treatments (1.71 to 0.16).
- In patients with RRTIs, time to improvement decreased from 5.46 to 2.79 days, and time to cure from 8.71 to 4.54 days.
Conclusions:
- Broncho-Vaxom is effective in reducing the duration and frequency of acute respiratory tract infections in children.
- The immunomodulating agent demonstrates significant efficacy in preventing recurrent respiratory tract infections.
- Broncho-Vaxom was found to be safe, with minimal adverse events reported during the trial.
Abstract:
We conducted a Phase IV, open-label clinical trial to test the efficacy and safety of the immunomodulating agent Broncho-Vaxom in private practice. The trial comprised 587 children younger than 12 years of age who had an acute respiratory tract infection at entry and a history of recurrent respiratory tract infections. The patients were given one capsule daily, 10 days per month, for 3 consecutive months. During the acute phase of the disease the patients also received antibiotic therapy. Comparing the infection present at entry with previous infections, the time to improvement (mean +/- SD) decreased from 6.77 +/- 4.42 days to 3.76 +/- 2.18 days, while the time to cure decreased from 11.86 +/- 8.41 days to 7.36 +/- 4.93 days. During the 3 months of therapy, the number of infections decreased from 1.79 +/- 0.96 1 month before treatment to 0.24 +/- 0.46 in the third month of treatment; absenteeism decreased from 3.17 +/- 3.07 days to 0.16 +/- 0.63 days; and the number of antibiotic treatments decreased from 1.71 +/- 1.06 to 0.16 +/- 0.51. In the patients who experienced a recurrent respiratory tract infection during the study, the time to improvement decreased from 5.46 +/- 3.28 days before treatment to 2.79 +/- 1.36 days after treatment, and the time to cure decreased from 8.71 +/- 3.96 days to 4.54 +/- 2.26 days. Adverse events included asthenia and adynamia in 3 patients, diarrhea in 3, rash in 2, fever in 2, exacerbation of symptoms in 2, adenitis in 1, and flulike syndrome in 1. We conclude that Broncho-Vaxom is effective and safe for the treatment of acute episodes of respiratory tract infections and for preventing recurrences.