NL-OMON35983
Completed
N/A
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 - ACHILLES study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 28
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility 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
- •\* 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.
Outcomes
Primary Outcomes
Not specified
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