Infection prevention and immune modulation by bacterial lysates in patients with asthma: gaining insight into the mechanism of an old therapy
- Conditions
- asthmareactive airway disease1001981510006436
- Registration Number
- NL-OMON43072
- Lead Sponsor
- Sint Franciscus Gasthuis
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
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 *2-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
- 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
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Number of astma exacerbations within 18 months after initiation of<br /><br>intervention. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Number of respiratory tract infections within 18 months after initiation of<br /><br>intervention, change in pulmonary function from baseline, use of antibiotics,<br /><br>oral corticosteroids and *2-agonists, quality of life, outpatient doctor*s<br /><br>visits and hospitalisation, adverse events, viral colonisation dynamics in<br /><br>time, bacterial colonisation dynamics in time, sputum and blood-inflammatory<br /><br>parameters (especially TH1/Th2 and ILC2) dynamics in time and during RTI.</p><br>