Mild asthmatics with house dust mite allergy MedDRA version: 19.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Cinryze
Product Name: Human C1-inhibitor
Pharmaceutical Form: Powder and solvent for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration
Sponsors
Academic Medical Center, University of Amsterdam
Eligibility
Sex/Gender
All
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 • A PC20 between 1.2 – 9.6 mg/ml (corresponding with increased airway hyperreactivity) • Able to communicate well with the investigator and to comply with the requirements of the study • Stable asthma without 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 • Normal defecation pattern (defined as =3x/ day and =3x/week) • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 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 |
|---|---|
| Main Objective: The primary objective is to determine the effect of C1-inhibitor or modulation of the intestinal microbiota on HDM-LPS induced allergic lung inflammation.;Secondary Objective: In the obtained BAL fluid and blood plasma activation of the complement system, activation of the cytokines and chemokines network, activation of coagulation and fibrinolyse wil be determined. Changes in RNA profiles will be explored in epithelial cells. Microbiota diversity and composition will be determined in BAL fluid and feces.;Primary end point(s): The primary outcome is the difference in leukocytes counts in the BAL fluid.;Timepoint(s) of evaluation of this end point: Samples will be collected at t=-2, t=0 and t=7 hours and analysed later | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In the obtained BAL fluid and blood plasma activation of the complement system, activation of the cytokines and chemokines network, activation of coagulation and fibrinolyse wil be determined. Changes in RNA profiles will be explored in epithelial cells. Microbiota diversity and composition will be determined in BAL fluid and feces.;Timepoint(s) of evaluation of this end point: Samples will be collected at t=-2, t=0 and t=7 hours and analysed later | — |
Countries
Netherlands
Contacts
Public ContactTom van der Poll
Academic Medical Center, University of Amsterdam
Outcome results
None listed