Effect of Intravenous Administration of Recombinant Human Activated Protein C on Local Inflammation and Coagulation after Bronchial Instillation of House Dust Mite Allergen and Lipopolysaccharide in Asthma Patients
- Conditions
- Asthma10006436
- Registration Number
- NL-OMON35983
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
* Intermittent to mild asthmatics between 18 and 45 years of age according to the Global Initiative for Asthma (GINA) criteria
* Allergy for HDM documented by a positive RAST and a positive skin prick test.
* No clinically significant findings during physical examination and hematological and biochemical screening
* At spirometry FEV1 more than 70% of predicted value
* Able to communicate well with the investigator and to comply with the requirements of the study
* Stable asthma withouth the use of asthma medication 2 weeks prior to the study day.
* Written informed consent
* No current smoking for at least 1 year and less than 10 pack years of smoking history
* Both male and female subjects are eligible for the study. Female subjects of child bearing potential will use adequate anti-conceptive precautions and will be tested for pregnancy.
* 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
* History of enhanced bleeding tendency or abnormal clotting test results.
* History of heparin-induced thrombocytopenia
* History of serious drug-related reactions, including hypersensitivity
* Inability to maintain stable without the use of asthma medication 2 weeks before start.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Eight hours after instillation of HDM and LPS (t = 8 hours) a second<br /><br>bronchoscopy will be performed and the challenged segments will be lavaged.<br /><br>Primary outcome is leukocyte difference in obtained lavage fluid.</p><br>
- Secondary Outcome Measures
Name Time Method <p>In BAL fluid and blood, obtained directly before bronchoscopies, leukocyte<br /><br>responses, the response of alveolar macrophages, activation of the cytokine and<br /><br>chemokine network, complement and activation of coagulation and fibrinolysis<br /><br>will be determined. </p><br>