NCT01520051

Trial name or title	Mepolizumab treatment for rhinovirus‐induced asthma exacerbations (MATERIAL)
Methods	Randomised, double‐blind trial
Participants	People with mild allergic asthma with viral airway infections Target recruitment = 48 participants Inclusion criteria Age: from 18‐50 years History of episodic chest tightness and wheezing Intermittent or mild persistent asthma according to the criteria of the Global Initiative for Asthma Non‐smoking or stopped smoking > 12 months ago and ≤ 5 pack‐years Clinically stable, no history of exacerbations within 6 weeks prior to the study Steroid‐naïve or those not currently on corticosteroids and who have not taken any corticosteroids by any dosing routes within 2 weeks prior to the study. Occasional usage of inhaled short‐acting beta2‐agonists as rescue medication is allowed, prior to and during the study Baseline FEV1 > 80% of predicted Airway hyperresponsiveness, indicated by a positive acetyl‐beta‐methylcholine bromide (MeBr) challenge with PC20 < 9.8 mg/mL Positive skin prick test (SPT) to one or more of the 12 common aeroallergen extracts, defined as a wheal with an average diameter over 3 mm No other clinically significant abnormality on medical history and clinical examination Exclusion criteria: Presence of antibodies directed against RV16 in serum (titre > 4), measured at visit 1 History of clinical significant hypotensive episodes or symptoms of fainting, dizziness, or light‐headedness Women who are pregnant, lactating or who have a positive urine pregnancy test at visit 1 Chronic use of any other medication for treatment of lung disease other than short‐acting beta2‐agonists Participation in any clinical investigational drug treatment protocol in previous 3 months Ongoing use of tobacco products of any kind or previous usage with ≥ 6 total pack‐years Concomitant disease or condition which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the participant People with young children (< 2 years)
Interventions	3 monthly intravenous infusions of 750 mg versus 3 monthly intravenous infusions with saline
Outcomes	Primary outcome measures FEV1 1 day prior and 6 days after RV16 challenge Questionnaire to score asthma and common cold complaints during 14 days following viral infection Secondary outcome measures: Viral load on day 6 after viral infection Sputum eosinophils before and after mepolizumab infusion Cell influx in bronchoalveolar lavage fluid 6 days after viral infection Pro‐inflammatory cytokines in bronchoalveolar lavage fluid 6 days after viral infection Antibody production 6 weeks after infection
Starting date	January 2012
Contact information	Suzanne Bal +31 205668043 s.m.bal@amc.uva.nl Koenraad van der Sluijs +31 205668224 kvandersluijs@amc.uva.nl Principal Investigator: René Lutter, Academisch Medisch Centrum ‐ Universiteit van Amsterdam (AMC‐UvA)
Notes	Also known as "MATERIAL" study. Clinicaltrials.gov website notes "The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years." Estimated study completion date March 2014