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

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 - CAST-study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47623

Enrollment

Registered

2019-05-22

Start date

2016-11-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

40 patients will receive either C1-inhibitor or a placebo intravenously. 20 patients will be pretreated with broad-spectrum antibiotics and receive placebo treatment. All 60 patients subsequently un

asthma

C1-inhibitor

house dust mite

inflammation

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Mild asthma patients between 18 and 45 years - Allergy for house dust mite - Spirometry FEV1 more than 70% of predicted value - A PC20 between 1.2 * 9.6 mg/ml - Stable asthma without the use of asthma medication 2 weeks prior to the study day - No current smoking for at least 1 year and less than 10 pack years of smoking history - No clinically significant findings during physical examination and hematological and biochemical screening - Normal defecation pattern (defined as *3x/ day and *3x/week)

Exclusion criteria

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 - Inability to maintain stable without the use of asthma medication 2 weeks before start. - History of venous or arterial thromboembolic disease

Design outcomes

Primary

Measure	Time frame
De primary outcome is the difference in leukocytes counts in the BAL fluid.	—

Secondary

Measure	Time frame
In the obtained BAL fluid and blood plasma activation of the complement system, activation of the cytokines and chemokines network, activation of coagulation and fibrinolyse wil be determined. Changes in RNA profiles will be exposed in epithelial cells. Microbiota diversity and composition in BAL fluid and feces.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)