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

Academisch Medisch Centrum0 个研究点目标入组 28 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

Trial is onging in other countries

•* 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.

发起方