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 |