Effect of Intravenous Administration of C1-inhibitor on Inflammation and Coagulation after Bronchial Instillation of House Dust Mite Allergen and Lipopolysaccharide in Allergic Asthma Patients
- Conditions
- Asthma10006436
- Registration Number
- NL-OMON47623
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
- Mild asthma patients between 18 and 45 years
- Allergy for house dust mite
- Spirometry FEV1 more than 70% of predicted value
- A PC20 between 1.2 * 9.6 mg/ml
- Stable asthma without the use of asthma medication 2 weeks prior to the study day
- No current smoking for at least 1 year and less than 10 pack years of smoking history
- No clinically significant findings during physical examination and hematological and biochemical screening
- Normal defecation pattern (defined as *3x/ day and *3x/week)
- Relevant comorbidity, pregnancy and/or recent surgical procedures.
- A history of smoking within the last 12 months, or regular consumption of greater than three units of alcohol per day
- Exacerbation and/ or the use of asthma medication within 2 weeks before start
- Administration of any investigational drug within 30 days of study initiation
- Donation of blood within 60 days, or loss of greater than 400 ml of blood within 12 weeks of study initiation
- Inability to maintain stable without the use of asthma medication 2 weeks before start.
- History of venous or arterial thromboembolic disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>De primary outcome is the difference in leukocytes counts in the BAL fluid. </p><br>
- Secondary Outcome Measures
Name Time Method <p>In the obtained BAL fluid and blood plasma activation of the complement system,<br /><br>activation of the cytokines and chemokines network, activation of coagulation<br /><br>and fibrinolyse wil be determined. Changes in RNA profiles will be exposed in<br /><br>epithelial cells. Microbiota diversity and composition in BAL fluid and feces. </p><br>