C1-inhibitor in Allergic ASThma Patients (CAST)
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ClinicalTrials.gov Identifier: NCT03051698 |
Recruitment Status :
Terminated
(Interim analysis showed no differences between groups)
First Posted : February 14, 2017
Last Update Posted : June 24, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: C1-inhibitor Other: Saline Drug: Antibiotics | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 16, 2016 |
Actual Primary Completion Date : | October 23, 2019 |
Actual Study Completion Date : | October 23, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: C1-inhibitor
One gift of intravenous administration of C1-inhibitor (Cinryze, 100U/kg) during one hour
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Drug: C1-inhibitor
100 Unit/kg IV, one gift prior to broncho provocation.
Other Name: Cinryze |
Placebo Comparator: Saline
One gift of intravenous administration of 0.9% NaCl during one hour.
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Other: Saline
0.9% NaCl |
Experimental: Antibiotics
broad spectrum antibiotics (vancomycin, ciprofloxacin, metronidazole) for 7 days (washout 36 hours before study day).
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Drug: Antibiotics
vancomycin, ciprofloxacin, metronidazole
Other Name: vancomycin, ciprofloxacin, metronidazole |
- Influx of inflammatory cells in the lung [ Time Frame: 7 hours after bronchial instillation of house dust mite (HDM) and lipopolyssacharide(LPS) ]Most important cell types are the eosinophils and neutrophils in bronchoaveolar fluid
- Interleukin-4 in pg/ml. [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- Interleukin-5 in pg/ml. [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- IL-13 in pg/ml. [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- IL-10 in pg/ml. [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- IFN-Y in pg/ml. [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- TNF-α in pg/ml. [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- CCL11 in pg/ml. [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- Interleukin-6 in pg/ml. [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- C4bc u/ml [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- C3bc u/ml [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- iC3b u/ml [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- C5a ng/ml [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- C5b-9 u/ml. [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- C3a in ng/ml [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- FXIIa activity in OD [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- FXIa in OD [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- FXIIa- C1-inhibitor complexes u/ml [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- kallikrein-C1-inhibitor complexes u/ml [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- high-molecular weight kininogen in AU [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- thrombin-antithrombin complexes in ng/ml. [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]
- C1-inhibitor activity in bronchoalveolar lavage [ Time Frame: 7 hours after bronchial instillation of HDM and LPS ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051698
Netherlands | |
Academic Medical Center | |
Amsterdam, Noord-Holland, Netherlands, 1105 AZ |
Principal Investigator: | Tom vd Poll, Prof, dr, MD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Responsible Party: | T. van der Poll, Prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
ClinicalTrials.gov Identifier: | NCT03051698 |
Other Study ID Numbers: |
2015_024 |
First Posted: | February 14, 2017 Key Record Dates |
Last Update Posted: | June 24, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
C1-inhibitor house dust mite complement system |
Asthma Angioedemas, Hereditary Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Angioedema Vascular Diseases Cardiovascular Diseases Genetic Diseases, Inborn Urticaria |
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