Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03051698
Status:
TERMINATED
Last Update Posted:
2020-06-24
First Post:
2017-02-07
Brief Title:
C1-inhibitor in Allergic ASThma Patients
Sponsor:
T van der Poll
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis showed no differences between groups
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAST
Brief 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
Detailed Description:
Intravenous administration of C1-inhibitor n20 or vehicle n20 One group of patients n20 will receive broad spectrum antibiotics vancomycin ciprofloxacin metronidazole for 7 days washout 36 hours before study day This group will receive the same vehicle as the control group 2 hours prior to challenge HDM will be administered together with the environmental pollutant LPS in a lung subsegment via a bronchoscope mimicking environmental exposure to HDM a contralateral lung subsegment will be administered with saline control side After 7 hours bronchoalveolar lavage BAL fluid will be harvested by a second bronchoscopy Blood samples will be collected before administration of C1-inhibitor or vehicle and before both bronchoscopies Faeces will be collected prior to antibiotic administration as well as prior to HDMLPS challenge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None