NL-OMON47623CompletedNot Applicable
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 - CAST-study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •- 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)
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
- •- Inability to maintain stable without the use of asthma medication 2 weeks before start.
- •- History of venous or arterial thromboembolic disease
Investigators
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