C1-inhibitor in Allergic ASThma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-16

Study Completion Date

2019-10-23

Brief Summary

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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

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Detailed Description

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Intravenous administration of C1-inhibitor (n=20) or vehicle (n=20). One group of patients (n=20) 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 HDM+LPS challenge.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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C1-inhibitor

One gift of intravenous administration of C1-inhibitor (Cinryze, 100U/kg) during one hour

Group Type EXPERIMENTAL

C1-inhibitor

Intervention Type DRUG

100 Unit/kg IV, one gift prior to broncho provocation.

Saline

One gift of intravenous administration of 0.9% NaCl during one hour.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

0.9% NaCl

Antibiotics

broad spectrum antibiotics (vancomycin, ciprofloxacin, metronidazole) for 7 days (washout 36 hours before study day).

Group Type EXPERIMENTAL

Antibiotics

Intervention Type DRUG

vancomycin, ciprofloxacin, metronidazole

Interventions

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C1-inhibitor

100 Unit/kg IV, one gift prior to broncho provocation.

Intervention Type DRUG

Saline

0.9% NaCl

Intervention Type OTHER

Antibiotics

vancomycin, ciprofloxacin, metronidazole

Intervention Type DRUG

Other Intervention Names

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Cinryze vancomycin, ciprofloxacin, metronidazole

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No