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Clinical Investigations: COUGH |

Immunostimulation With OM-85 in Children With Recurrent Infections of the Upper Respiratory Tract*: A Double-Blind, Placebo-Controlled Multicenter Study

Urs B. Schaad, MD; Ralph Mütterlein, MD; Heidi Goffin, MD; on behalf of the BV-Child Study Group
Author and Funding Information

Affiliations: *From the University Children’s Hospital of Basel (Dr. Schaad), Basel, Switzerland; the Regional Hospital of Parsberg (Dr. Mütterlein), Parsberg, Germany; and OM PHARMA (Dr. Goffin), Meyrin/Geneva, Switzerland.,  Members of the BV-Child Study Group are listed in the Appendix.

Correspondence to: Urs B. Schaad, MD, Department of Pediatrics, Universitäts-Kinderspital beider Basel, PO Box CH-4005, Basel, Switzerland; e-mail: urs-b.schaad@unibas.ch


Affiliations: *From the University Children’s Hospital of Basel (Dr. Schaad), Basel, Switzerland; the Regional Hospital of Parsberg (Dr. Mütterlein), Parsberg, Germany; and OM PHARMA (Dr. Goffin), Meyrin/Geneva, Switzerland.,  Members of the BV-Child Study Group are listed in the Appendix.


Chest. 2002;122(6):2042-2049. doi:10.1378/chest.122.6.2042
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Objective: Recurrent upper respiratory tract infections (URTIs) are common illnesses in young children. As the immunoactive bacterial extract OM-85 has been shown to prevent these infections in both adults and children, the aim of the present trial was to investigate further its efficacy and safety in infection-prone children.

Methods: This is a randomized, double-blind, placebo-controlled, multicenter study with OM-85 in 232 patients aged 36 to 96 months with recurrent URTIs. Treatment was one capsule daily during month 1 and during 10 days in months 3 to 5. URTI was defined by the presence of at least two of the following: rhinitis, pharyngitis, cough, hoarseness, temperature ≥ 38.5°C, or URTI-related prescription of an antibiotic.

Results: OM-85–treated patients had a lower rate of URTIs (p < 0.05). The cumulated difference in URTIs between the two groups reached − 0.40 URTIs per patient in 6 months, corresponding to a 16% reduction in the active-treatment group with respect to placebo. The largest difference was observed in the patients having had three or more URTIs during the study period; odds ratios for three or more URTIs were 0.51 (95% confidence interval, 0.29 to 0.91) and 0.65 (95% confidence interval, 0.37 to 1.11) after 5 months and 6 months, respectively. The difference between OM-85 and placebo was independent of age but was more important in patients reporting a larger number of URTIs in the previous year. Patients’ global assessment showed improvement in comparison to the previous season in the majority of the cases (OM-85, 78.4% of cases; placebo, 75.5%); however, there were more cases reporting worsening with placebo (6.4% vs 0.9%; p = 0.05).

Conclusions: OM-85 treatment significantly reduced the rate of URTIs, particularly in children with a history of frequent URTIs. Safety and tolerance of test medication were good, comparable to placebo.

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