Prevention of asthma exacerbations by the regular use of a bacterial lysate (Broncho-Vaxom).

Completed

Conditions: asthma, respiratory tract infections, bacterial lysates, inflammation

Registration Number: NL-OMON28868

Lead Sponsor: Investigator initiated trial by clinical researchers of the Department of Pediatrics and Department of Pulmonology; Franciscus Gasthuis & Vlietland, Rotterdam

Brief Summary: to follow

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

Subjects aged 12-60 years with proven asthma (airway responsiveness proven by reversibility or histamine PC20 < 8 mg/ml)) who have recurrent airway signs and symptoms despite optimal maintenance medication (medium/high dose inhalation corticosteroid and long-acting ¦Â2-agonist; GINA 4).

Exclusion Criteria

-Other relevant respiratory conditions, e.g. OSAS, bronchiectasis
-Systemic immunological diseases/systemic immunosuppression
-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total number of asthma exacerbations within 18 months after initiation of intervention.

Secondary Outcome Measures

Name	Time	Method
-Number of suspected infectious asthma exacerbations (asthma exacerbation + symptoms of <br>respiratory tract infection + proven new respiratory viral or bacterial pathogen)<br>-Duration of asthma exacerbations<br>-Time to first asthma exacerbation<br>-Time between first and second asthma exacerbation<br>-Number of asthma exacerbations within 3, 6, 12 months after initiation of intervention<br>-Number of respiratory tract infections<br>-Change in viral and bacterial colonization<br>-Days free from asthma symptoms<br>-Change in pulmonary function (spirometry parameters) from baseline<br>-Use of oral corticosteroids, B2-agonist treatment and antibiotics<br>-Change in sputum- and blood inflammatory markers (cytokines, chemokines, lymfocyte <br>populations)<br>-Change in airway & gut microbiome<br>-Asthma Quality of life/Asthma control questionairre<br>-Number of outpatient doctor's visits and hospitalisation<br>-Number of adverse and serious adverse events