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Efficacy and Safety of OM-85 in Patients with Chronic Bronchitis and/or Chronic Obstructive Pulmonary Disease

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Abstract

Background

Recurrent acute exacerbations are generally associated with accelerated decline of lung function and characterized by reduced physical activity and worsening of clinical status in patients with chronic obstructive pulmonary disease (COPD). Effective practices and therapies aimed at preventing acute exacerbations are continuously under investigation by healthcare providers. This double-blind, placebo-control, randomized clinical trial sought to evaluate the preventive effect of a bacterial lysate (OM-85) on acute exacerbations in patients with COPD or chronic bronchitis in China.

Methods

A total of 428 patients were randomly assigned either to OM-85 treatment or to placebo. Patients received study drug or placebo for 10 days per month over 3 consecutive months, with a 10-week follow-up. Three hundred and eighty-four (384) patients completed the study (192 in the OM-85 group and 192 in the placebo group) and were included in the full analysis set (FAS). Thirty (30) patients, 21 in the OM-85 and 9 in the placebo groups, were excluded due to protocol violations and drop-outs, and the remaining 354 patients (171 in the OM-85 and 183 in the placebo groups) were included in the per protocol set (PPS).

Results

The proportion of patients with recurrent acute exacerbations in the OM-85 group was significantly lower than in the placebo group at the end of the treatment period, both, in the FAS (23.4 % vs. 33.3 %, p = 0.0311) and in the PPS (17.0 % vs. 31.2 %, p < 0.05). Throughout the entire 22-week study period, the proportion of patients with recurrent acute exacerbations in the OM-85 group was lower than in the placebo group in the FAS (32.8 % vs. 38.0 %, p = 0.277), while the difference is statistically significant in the PPS (26.3 % vs. 36.1 %, p < 0.05).

Conclusion

OM-85 significantly reduced the proportion of patients with acute exacerbation after 12 weeks of therapy and the benefit appeared to be maintained up to 22 weeks, and showed a favorable tolerability profile.

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Acknowledgments

This study was sponsored by OM Pharma, Geneva, Switzerland. We wish to thank the following members of the BV Study Group: Xin Zhou, Qiang Li, Huili Zhu, Zhaolong Cao, Xiaowen Han, Xixin Yan, Heping Yang, Changgui Wu, Xiuzhen Sun, Xiuhua Fu, Zhongguang Wen, and Shenghua Sun.

Conflict of interest

The study was designed and planned by the academic authors and the sponsor, OM Pharma. Data were held and analyzed by a contract research organization, TigerMed Consulting Co. Ltd., under the supervision of the study sponsor. All the authors assume responsibility for the integrity and completeness of the data and data analyses. All the authors had signed confidentiality agreements with the sponsor during the planning and conduct of the study. Gabriela P. Saborío is an employee of Vifor Pharma.

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Author notes

    Authors and Affiliations

    1. Department of Respiratory Medicine, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China

      Hao Tang, Zheng Fang & Qingyu Xiu

    2. Vifor Pharma SA, 22 rue du bois-du-Lan, Geneva, 1217, Switzerland

      Gabriela P. Saborío

    Authors
    1. Hao Tang
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    2. Zheng Fang
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    3. Gabriela P. Saborío
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    4. Qingyu Xiu
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    Corresponding author

    Correspondence to Qingyu Xiu.

    Additional information

    This study was conducted on behalf of the BV Study Group. The members of BV study group are listed in Appendix.

    Hao Tang and Zheng Fang contributed equally to this work.

    Electronic supplementary material

    Below is the link to the electronic supplementary material.

    Supplementary material 1 (DOCX 23 kb)

    Appendix

    Appendix

    The members of BV study group: Xin Zhou, Shanghai First People’s Hospital; Qiang Li, Shanghai Changhai Hospital; Huili Zhu, Shanghai Hua Dong Hospital; Zhaolong Cao, Peking University People’s Hospital; Xiaowen Han, the people’s Hospital of Hebei; Xixin Yan, the Second Hospital of Hebei Medical University; Heping Yang, Southwest Hospital, Third Military Medical University; Changgui Wu, Xijing Hospital, Fourth Military Medical University; Xiuzhen Sun, First Affiliated Hospital of Medical College of Xi’an Jiaotong University; Xiuhua Fu, the Affiliated Hospital of Inner Mongolia Medical College; Zhongguang Wen, No.1 Hospital affiliated to General Hospital of the Chinese People’s Liberation Army; Shenghua Sun, the Third Xiangya Hospital of Central South University.

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    Tang, H., Fang, Z., Saborío, G.P. et al. Efficacy and Safety of OM-85 in Patients with Chronic Bronchitis and/or Chronic Obstructive Pulmonary Disease. Lung 193, 513–519 (2015). https://doi.org/10.1007/s00408-015-9737-3

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    • DOI: https://doi.org/10.1007/s00408-015-9737-3

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