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

Phase 1

• Conditions: Mild asthmatics with house dust mite allergy; MedDRA version: 19.0Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-005611-16-NL
• Lead Sponsor: Academic Medical Center, University of Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-18
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified