Efficacy and safety of bacterial lysate OM-85 in the treatment of uncomplicated acute respiratory infections: a double-blind, placebo-controlled, multicenter, randomized trial

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Abstract

Aim. To evaluate the efficacy and safety of OM-85 in the treatment of uncomplicated acute respiratory infections (ARI) in adults.

Materials and methods. A double-blind, placebo-controlled, multicenter, randomized trial included 556 patients (18–60 years old) with mild and moderate ARI and negative results of polymerase chain reaction analysis for SARS-CoV-2 RNA and rapid test for influenza A and B viruses. Patients were randomized into two groups: in the first group (n=278), patients received OM-85 (Broncho-munal®) one capsule 7 mg/day for 10 days, while the second group (n=278) was treated with placebo in the same regimen. The primary endpoint was the dynamics of the severity of symptoms over 3, 5, 7 and 10 days of treatment according to the 21-item Wisconsin Upper Respiratory Symptom Survey (WURSS-21), which was assessed by the area under the curve. Secondary efficacy criteria were the dynamics of the severity of symptoms according to the Common Cold Questionnaire (CCQ), the time to the resolution of symptoms according to WURSS-21 and CCQ, the proportion of patients with body temperature below 37°C on each day of treatment, frequency of the need for systemic antibacterial therapy.

Results. The superiority of OM-85 over placebo by primary endpoint was observed on the 5th, 7th and 10th days of treatment. OM-85 efficacy has also been proven by secondary criteria. OM-85 shortened the time until the symptoms of ARI resolved according to the WURSS-21 and CCQ, increased the proportion of patients with body temperature below 37°C by 2–9 days. The time needed to resolve the symptoms of disease in 20% of patients according to WURSS-21 was 7 and 9 days in patients taking OM-85 and placebo, respectively. Bacterial lysate increased the probability of complete disappearance of symptoms according to CCQ by 45.7% compared to placebo. The analysis of the frequency and severity of adverse events, laboratory tests, physical and instrumental examination results during treatment confirmed the good tolerability and safety of OM-85.

Conclusion. The study confirmed the efficacy and safety of OM-85 in the complex treatment of ARI in adults.

About the authors

Oleg V. Kalyuzhin

Sechenov First Moscow State Medical University (Sechenov University)

Author for correspondence.
Email: kalyuzhin@list.ru
ORCID iD: 0000-0003-3628-2436

д-р мед. наук, проф., проф. каф. клинической иммунологии и аллергологии Института клинической медицины им. Н.В. Склифосовского ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова»

Russian Federation, Moscow

Aleksandr V. Gorelov

Sechenov First Moscow State Medical University (Sechenov University); Central Research Institute of Epidemiology; Yevdokimov Moscow State University of Medicine and Dentistry

Email: kalyuzhin@list.ru
ORCID iD: 0000-0001-9257-0171

акад. РАН, д-р мед. наук, проф., проф. каф. детских болезней Клинического института детского здоровья им. Н.Ф. Филатова ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова», зам. дир. по науч. работе ФБУН «ЦНИИ эпидемиологии», зав. каф. инфекционных болезней и эпидемиологии ФГБОУ ВО «МГМСУ им. А.И. Евдокимова»

Moscow; Moscow; Moscow

Andrey G. Malyavin

Yevdokimov Moscow State University of Medicine and Dentistry

Email: kalyuzhin@list.ru
ORCID iD: 0000-0002-6128-5914

д-р мед. наук, проф., проф. каф. фтизиатрии и пульмонологии лечебного фак-та ФГБОУ ВО «МГМСУ им. А.И. Евдокимова»

Russian Federation, Moscow

Andrey A. Zaytsev

Burdenko Main Military Clinical Hospital; Russian Biotechnological University (ROSBIOTECH)

Email: kalyuzhin@list.ru
ORCID iD: 0000-0002-0934-7313

д-р мед. наук, проф., гл. пульмонолог ФГБУ «ГВКГ им. акад. Н.Н. Бурденко», зав. каф. пульмонологии (с курсом аллергологии) Медицинского института непрерывного образования ФГБОУ ВО «РОСБИОТЕХ»

Russian Federation, Moscow; Moscow

Elena V. Esaulenko

Saint Petersburg State Pediatric Medical University

Email: kalyuzhin@list.ru
ORCID iD: 0000-0003-3669-1993

д-р мед. наук, проф., зав. каф. инфекционных болезней взрослых и эпидемиологии ФГБОУ ВО СПбГПМУ

Russian Federation, Saint Petersburg

Ksenia E. Novak

Saint Petersburg State Pediatric Medical University

Email: kalyuzhin@list.ru
ORCID iD: 0000-0001-9633-4328

канд. мед. наук, доц. каф. инфекционных болезней взрослых и эпидемиологии ФГБОУ ВО СПбГПМУ

Russian Federation, Saint Petersburg

Anatoliy S. Bykov

Sechenov First Moscow State Medical University (Sechenov University)

Email: kalyuzhin@list.ru
ORCID iD: 0000-0002-8099-6201

д-р мед. наук, проф. каф. микробиологии, вирусологии и иммунологии им. акад. А.А. Воробьева Института общественного здоровья им. Ф.Ф. Эрисмана ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова»

Russian Federation, Moscow

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2. Fig. 1. Effect of OM-85 vs placebo on the severity ARI clinical manifestations (sum of WURSS-21 symptom domain scores) (M±SD).

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3. Fig. 2. Kaplan–Meier curves for time to resolution of ARI symptoms according to the WURSS-21 score in groups of patients treated with OM-85 vs placebo.

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4. Fig. 3. Kaplan–Meier curves for time to resolution of ARI symptoms according to the CCQ score in groups of patients treated with OM-85 vs placebo.

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