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.

Phase 1

• Conditions: Asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-001213-24-NL
• Lead Sponsor: Franciscus Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-25
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with proven asthma (airway responsiveness proven by reversibility and histamine PC20 < 8 mg/ml)) who have recurrent airway signs and symptoms despite optimal maintenance medication (medium/high dose inhalation corticosteroid and long-acting ß2-agonist; GINA 4).

Specific inclusion criteria
-= 2 documented asthma exacerbations in the past winter season (see definition below)
-and Asthma Control Questionnaire (ACQ) > 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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)<br>-Duration of asthma exacerbations<br>-Time to first asthma exacerbation<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, ß2-agonist treatment and antibiotics<br>-Change in sputum- and blood inflammatory markers (cytokines, chemokines, lymfocyte populations)<br>-Change in airway & gut microbiome<br>-Quality of life/ACQ<br>-Number of outpatient doctor’s visits and hospitalisation<br>- Cost-effectiveness<br>-Number of adverse and serious adverse events<br>