C1-inhibitor in Allergic ASThma Patients

• Status: Terminated
• Trial end date: 2019-10-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this proof-of-concept study is to determine the effect of Intestinal Microbiota Depletion or Intravenous Administration of C1-inhibitor on Inflammation and Coagulation after Bronchial Instillation of House Dust Mite Allergen and Lipopolysaccharide in Allergic Asthma Patients

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: T. van der Poll
• Collaborators: Sanquin; Sanquin Plasma Products BV; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ciprofloxacin; Complement C1 Inactivator Proteins; Metronidazole; Vancomycin

Criteria

Inclusion Criteria:

• Intermittent to mild asthma 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 0.3 - 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. As documented by the Juniper's Asthma control questionnaire (ACQ) score < 1,2.

• Written informed consent

• No current smoking for at least 1 year and less than 10 pack years of smoking history

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 venous or arterial thromboembolic disease

• 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 of the study