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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43072

Enrollment

120

Registered

2016-04-25

Start date

2016-10-03

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

asthma reactive airway disease

Interventions

None listed

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with proven asthma (airway responsiveness proven by reversibility and histamine PC20 1.5 despite maintenance medication

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
Number of astma exacerbations within 18 months after initiation of intervention.	—

Secondary

Measure	Time frame
Number of respiratory tract infections within 18 months after initiation of intervention, change in pulmonary function from baseline, use of antibiotics, oral corticosteroids and 2-agonists, quality of life, outpatient doctors visits and hospitalisation, adverse events, viral colonisation dynamics in time, bacterial colonisation dynamics in time, sputum and blood-inflammatory parameters (especially TH1/Th2 and ILC2) dynamics in time and during RTI.	—

Measure

Time frame

Number of respiratory tract infections within 18 months after initiation of intervention, change in pulmonary function from baseline, use of antibiotics, oral corticosteroids and *2-agonists, quality of life, outpatient doctor*s visits and hospitalisation, adverse events, viral colonisation dynamics in time, bacterial colonisation dynamics in time, sputum and blood-inflammatory parameters (especially TH1/Th2 and ILC2) dynamics in time and during RTI.

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Countries

Netherlands

Outcome results