Oral Immunotherapy of Chronic Bronchitis: a Double-Blind Placebo-Controlled Multicentre Study

Author(s): Ustar, M., Pardon, R., Palecek, I., Stipic-Markovic, A., Zimic, B.

Journal/Book: Respiration. 1989; 55: 129-135.

Abstract: 104 patients with chronic bronchitis were treated under randomized double-blind conditions with either Broncho-Vaxom® (BV) or a placebo over a period of 6 consecutive months. The beneficial effect of BV was manifested by a statistically significant reduction in the duration of acute episodes and of fever (p < 0.001) with respect to the placebo group. The consumption of antibiotics dropped significantly in the BV group (p < 0.05) but not in the placebo group. The serum IgA levels increased in the BV group and the difference with the placebo group was statistically significant (p < 0.05) from the 3rd month onwards. In the patients with bronchitis exacerbationÂ’s during the trial, T-lymphocyte counts increased steadily under BV therapy until 3 months after the exacerbation (p < 0.05), but not under the placebo. BV was generally well tolerated with the exception of 1 patient who reported nausea and upper abdominal pain. In their assessment of the overall therapeutic effect, the physician judged BV to be significantly superior (p < 0.001) to the placebo as regards both the curative and prophylactic efficacy.

Keyword(s): Bacterial lysate

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