Efficacy of Lyophilized Bacterial Lysates in Reducing Exacerbation Frequency in Patients with Chronic Obstructive Pulmonary Disease

The primary objective is to evaluate the efficacy of Broncho-Vaxom in reducing the frequency of moderate and severe COPD exacerbations during a 6-month treatment period and a subsequent 6-month observation phase. This assessment is clinically significant to determine the potential for decreasing hospitalizations and home-managed acute episodes. 5, 4

Secondary objectives include:

• Evaluation of the safety and efficacy in reducing patient-reported respiratory tract infections.
• Assessment of whether exacerbations were triggered by respiratory tract infections.
• Measurement of efficacy and safety regarding the 6-minute walk distance.
• Assessment of dyspnoea using the mMRC scale.
• Investigation of the effect of the bacterial lysate on exacerbation-related outcomes over 12 months, including:
  • Changes in lung function.
  • Immune status, specifically IgA and IgG levels.
  • Body composition.
  • Quality of life as measured by the CAT-COPD Assessment Test.
  • Physical activity via the CCQ-Chronic COPD Questionnaire.

The sponsor did not provide the total number of participants. The study population consists of male and female patients diagnosed with chronic obstructive pulmonary disease. The participants are between 40 and 80 years of age. Eligible individuals must have a documented history of at least two moderate exacerbations managed at home or one severe event requiring hospitalization. Clinical requirements include a forced expiratory volume in one second between 20% and 70% of the predicted value, which is not reversible by more than 12%. Inclusion criteria also involve a body mass index between 18 kg/m² and 40 kg/m² and a history of heavy smoking exceeding 20 years.

This Phase IV clinical trial is designed to evaluate the efficacy of Broncho-Vaxom in reducing the rate of moderate and severe COPD exacerbations. The study utilizes a placebo-controlled methodology to assess outcomes related to lung function, lung mechanics, immune state, body composition, quality of life, and physical activity. The research period consists of a 6-month treatment period followed by a 6-month observation phase. The sequence of study activities begins with a screening visit to confirm a diagnosis of chronic obstructive pulmonary disease and ensure adherence to specific inclusion criteria, such as FEV1 levels, BMI, and smoking history. During the course of the study, participants undergo assessments including body plethysmography, diffusion capacity tests, and the CAT-COPD Assessment Test. The total involvement of a participant spans 12 months. Early termination from the study may occur due to adverse events or study discontinuation related to safety concerns.

The experimental treatment consists of Broncho-Vaxom, administered as a hard capsule. The medicinal product contains lyophilized bacterial lysates of Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, and Moraxella catarrhalis. The oral administration of the active substance is conducted at a dosage of 40 mg.

The control group receives a placebo, which is defined as a powder without an active ingredient.

The efficacy of the intervention is evaluated by the reduction in the frequency of COPD exacerbations, specifically categorized as moderate exacerbations managed at home and severe exacerbations requiring hospitalization, measured over a 12-month period. The assessment includes a 6-month treatment period followed by a 6-month observation phase.

Secondary endpoints involve several clinical and physiological parameters:

• Reduction in respiratory tract infections reported by the patient and an assessment of whether these infections triggered exacerbations.
• Improvements in the 6-minute walk distance and dyspnea, as measured by the mMRC scale, comparing baseline to the end of the study.
• Changes in lung function and mechanics, assessed via body plethysmography and a diffusion capacity test, including parameters such as FEV1, FVC, FEV1/FVC, TLC, VC, FRC, RV, DL, and CO.
• Evaluation of body composition, specifically fat-free body mass, using an Omron BF511.
• Assessment of quality of life and COPD-associated symptoms using the CAT-COPD Assessment Test and the CCQ-Chronic COPD Questionnaire.
• Monitoring of adverse events and study discontinuation rates.