The efficacy of mepolizumab treatment on rhinovirus induced asthma exacerbations - MATERIA

Conditions: Asthma and more specifically virus-induced exacerbations in allergic asthma patients
MedDRA version: 12.1Level: LLTClassification code 10015575Term: Exacerbation of asthma
MedDRA version: 12.1Level: LLTClassification code 10001705Term: Allergic asthma
MedDRA version: 12.1Level: LLTClassification code 10049868Term: Asthma exacerbation prophylaxis

Registration Number: EUCTR2011-000586-12-NL

Lead Sponsor: Academic Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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