asthma virus-induced asthma exacerbation
Conditions
Interventions
Patients will receive three times an infusion with either mepolizumab or
placebo (on day 0, 28 and 56). Two weeks after the last infusion, all patients
will be infected with RV16.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age between 18 * 50 years Intermittent or mild persistent asthma according to the criteria by the Global Initiative for Asthma Non-smoking or stopped smoking more than 12 months ago and * 5 pack years Clinically stable, no history of exacerbations within the last 6 weeks prior to the study Steroid-naïve or those patients who are currently not on corticosteroids and have not taken any corticosteroids by any dosing-routes within 2 weeks prior to the study Baseline FEV1 at least 80% of predicted PC20histamine
Exclusion criteria
Exclusion criteria: Moderate to severe asthma patients (according to the GINA guidelines) Patients who have had an exacerbation during the past 6 months, as indicated by a course of systemic steroids or antibiotics Presence of antibodies directed against rhinovirus type 16 (titer > 4) Smokers or ex-smokers ( 6 pack years) Women who are pregnant, lactating or who have a positive urine pregnancy test at visit 1 Patients who are in close contact with young children (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lungfunction, determined by the difference in pre-bronchodilator FEV1 between day 70 and 77 (1 day prior and 6 days after inoculation with RV16). | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom scores for common cold and asthma will be recorded, as well as additional lungfunction parameters (PEF and FVC). The viral load in the nasal swabs and bronchial brushes will be determined by PCR. Additionally we will determine cell counts and phenotype of inflammatory cells in BALF and blood and the production of inflammatory mediators in BALF and blood. | — |
Countries
Netherlands
Outcome results
None listed