Multicentre, double-blind, placebo-controlled, randomised clinical study of Broncho-Vaxom® (Broncho-Munal®) for the protection from acute exacerbations of COPD - Broncho-Vaxom® in COPD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004702-27-DE

Enrollment

350

Registered

2007-12-07

Start date

2008-03-17

Completion date

Unknown

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute exacerbations in patients suffering from COPD (stage II - III according GOLD) MedDRA version: 9.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease

Interventions

Trade Name: Broncho-Vaxom® Erwachsene Pharmaceutical Form: Capsule* Current Sponsor code: OM-85 BV Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7- Pharmaceutical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Patients of either sex. • Patients aged >/= 40 years. • History of documented AECBs >/= 2 in the previous year, and COPD Stage II to III, respectively. •30% =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Patients with asthma. • Patients with mucoviscidosis. • Patients with bronchiectases. • Any known disseminated malignancy. • Known chronic systemic infections or inflammatory conditions (e.g. rheumatoid arthritis, systemic lupus erythematosis, active sarcoidosis). • Previous solid organ transplantation. • Myocardial infarction or cerebrovascular accident within the past 6 months prior to study enrolment. •Patients with a known allergy or previous intolerance to the study medication. •Female patients who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD).

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to show that Broncho-Vaxom® decreases significantly the rate of exacerbations by at least 20% when compared with placebo in patients suffering from Stage II and III of COPD, respectively. ;Secondary Objective: The secondary efficacy variables are: · Type, severity and duration of the acute exacerbations. · Type and duration of prescribed concomitant treatment(s). · Use of healthcare resources, hospitals and other institution. · The duration of absenteeism from work. · Number and duration of hospitalization. · Spirometry with FEV1/FVC will be performed for each participant at Visit 1 and 6. · St Georges Respiratory Questionnaire : the scores for each section including symptom score (frequency and severity), activity score (activities that cause or are limited by breathlessness), and impact score (social functioning, psychological disturbances resulting from airways disease), as well as a total score will be calculated using established methods. · The SGRQ has been translated into 27 languages and a validated translation is available for each patient. · Global assessment of efficacy. ;Primary end point(s): The primary efficacy variable is the rate of acute exacerbations recorded in the treatment period.	—

Measure

Time frame

Main Objective: The primary objective of the study is to show that Broncho-Vaxom® decreases significantly the rate of exacerbations by at least 20% when compared with placebo in patients suffering from Stage II and III of COPD, respectively. ;Secondary Objective: The secondary efficacy variables are: · Type, severity and duration of the acute exacerbations. · Type and duration of prescribed concomitant treatment(s). · Use of healthcare resources, hospitals and other institution. · The duration of absenteeism from work. · Number and duration of hospitalization. · Spirometry with FEV1/FVC will be performed for each participant at Visit 1 and 6. · St Georges Respiratory Questionnaire : the scores for each section including symptom score (frequency and severity), activity score (activities that cause or are limited by breathlessness), and impact score (social functioning, psychological disturbances resulting from airways disease), as well as a total score will be calculated using established methods. · The SGRQ has been translated into 27 languages and a validated translation is available for each patient. · Global assessment of efficacy. ;Primary end point(s): The primary efficacy variable is the rate of acute exacerbations recorded in the treatment period.

—

Countries

Austria, Belgium, Germany, Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026