Asthma
Conditions
Interventions
28 asthma patients will start on intravenous treatment with rhAPC or placebo 4
hours before (t = -4 hours) bronchial instillation of HDM/LPS in a lung
subsegment and bronchial instillation of saline
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * 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.
Exclusion criteria
Exclusion criteria: * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eight hours after instillation of HDM and LPS (t = 8 hours) a second bronchoscopy will be performed and the challenged segments will be lavaged. Primary outcome is leukocyte difference in obtained lavage fluid. | — |
Secondary
| Measure | Time frame |
|---|---|
| In BAL fluid and blood, obtained directly before bronchoscopies, leukocyte responses, the response of alveolar macrophages, activation of the cytokine and chemokine network, complement and activation of coagulation and fibrinolysis will be determined. | — |
Countries
Netherlands
Outcome results
None listed