The efficacy of mepolizumab treatment on rhinovirus induced asthma exacerbations

Completed

Conditions: asthma
virus-induced asthma exacerbation
10001708
10047438
10006436

Registration Number: NL-OMON36480

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

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 < 9.8 mg/ml
Positive skin prick test to one or more of the 12 common aeroallergen extracts

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 (< 12 months or > 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 (< 2 years), either professional or family related
Participation in any clinical investigational drug treatment protocol within the preceding 3 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Lungfunction, determined by the difference in pre-bronchodilator FEV1 between<br /><br>day 70 and 77 (1 day prior and 6 days after inoculation with RV16). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Symptom scores for common cold and asthma will be recorded, as well as<br /><br>additional lungfunction parameters (PEF and FVC). The viral load in the nasal<br /><br>swabs and bronchial brushes will be determined by PCR. Additionally we will<br /><br>determine cell counts and phenotype of inflammatory cells in BALF and blood and<br /><br>the production of inflammatory mediators in BALF and blood.</p><br>