Use of Broncho-Vaxom in private practice: phase IV trial in 587 children.

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.