Bronchovaxom therapy in patients with asthma: the effects of an old therapy on prevention of respiratory tract infections, colonization with viruses and bacteria and modification of the immune response.

Infection prevention and immune modulation by bacterial lysates: gaining insight into the mechanism of an old therapy in patients with asthma

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001213-24-NL

Enrollment

Unknown

Registered

2016-04-25

Start date

2016-05-25

Completion date

Unknown

Last updated

2017-01-31

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

Conditions

Asthma

Interventions

Trade Name: Bronchovaxom or OM-85 Product Name: Broncho-Vaxom Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with proven asthma (airway responsiveness proven by reversibility and histamine PC20 1.5 despite maintenance medication Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Other relevant respiratory conditions, e.g. OSAS, bronchiectasis - Systemic immunological diseases - Current smoking or past smoking > 10 pack years - Other untreated co-morbidity, such as gastro-esophageal reflux disease, ENT problems, psychological disorders - Non-compliance to current medication or inhalation technique - Communication difficulties - Pregnancy or planned pregnancy within 2 years

Design outcomes

Primary

Measure	Time frame
Main Objective: Do the number and duration of asthma exacerbations diminish with the regular use of a bacterial lysate?;Secondary Objective: - Do the number and duration of infectious asthma exacerbations diminish with the regular use of a bacterial lysate? - Do the number of clinical and laboratory proven respiratory tract infections (RTI) diminish with the regular use of a bacterial lysate? - Does regular bacterial lysate treatment improves health (pulmonary function, quality of life) - Does medication use and health care utility diminish with regular lysate treatrment? - How do the respiratory and gut microbial colonization dynamics change with the regular use of a bacterial lysate? - How do the airway– and blood immunological markers (T-cell dynamics; cytokine production, ILC2-activity) change with the regular use of a bacterial lysate? ;Primary end point(s): Total asthma exacerbations within 18 months after initiation of intervention;Timepoint(s) of evaluation of this end point: 18 months	—

Measure

Time frame

Main Objective: Do the number and duration of asthma exacerbations diminish with the regular use of a bacterial lysate?;Secondary Objective: - Do the number and duration of infectious asthma exacerbations diminish with the regular use of a bacterial lysate? - Do the number of clinical and laboratory proven respiratory tract infections (RTI) diminish with the regular use of a bacterial lysate? - Does regular bacterial lysate treatment improves health (pulmonary function, quality of life) - Does medication use and health care utility diminish with regular lysate treatrment? - How do the respiratory and gut microbial colonization dynamics change with the regular use of a bacterial lysate? - How do the airway– and blood immunological markers (T-cell dynamics; cytokine production, ILC2-activity) change with the regular use of a bacterial lysate? ;Primary end point(s): Total asthma exacerbations within 18 months after initiation of intervention;Timepoint(s) of evaluation of this end point: 18 months

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 18 months and 30 months;Secondary end point(s): - Number of suspected infectious asthma exacerbations (asthma exacerbation + symptoms of respiratory tract infection + proven new respiratory viral or bacterial pathogen) - Duration of asthma exacerbations - Time to first asthma exacerbation - Number of respiratory tract infections - Change in viral and bacterial colonization - Days free from asthma symptoms - Change in pulmonary function (spirometry parameters) from baseline - Use of oral corticosteroids, ß2-agonist treatment and antibiotics - Change in sputum- and blood inflammatory markers (cytokines, chemokines, lymfocyte populations) - Change in airway & gut microbiome - Quality of life/ACQ - Number of outpatient doctor’s visits and hospitalisation - Cost-effectiveness - Number of adverse and serious adverse events	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 18 months and 30 months;Secondary end point(s): - Number of suspected infectious asthma exacerbations (asthma exacerbation + symptoms of respiratory tract infection + proven new respiratory viral or bacterial pathogen) - Duration of asthma exacerbations - Time to first asthma exacerbation - Number of respiratory tract infections - Change in viral and bacterial colonization - Days free from asthma symptoms - Change in pulmonary function (spirometry parameters) from baseline - Use of oral corticosteroids, ß2-agonist treatment and antibiotics - Change in sputum- and blood inflammatory markers (cytokines, chemokines, lymfocyte populations) - Change in airway & gut microbiome - Quality of life/ACQ - Number of outpatient doctor’s visits and hospitalisation - Cost-effectiveness - Number of adverse and serious adverse events

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Countries

Netherlands

Contacts

Public ContactGerdien Tramper-Stranders

Franciscus Gasthuis

g.tramper@franciscus.nl

Outcome results

None listed

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