Status:
UNKNOWN
Mepolizumab Treatment for Rhinovirus-induced Asthma Exacerbations
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
The Netherlands Asthma Foundation
GlaxoSmithKline
Conditions:
Asthma
Viral Infection
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
Asthma is a chronic inflammatory disorder of the airways characterized by lower respiratory tract (LRT) symptoms such as wheeze, cough and airway obstruction. Patients with asthma frequently suffer fr...
Detailed Description
Mild allergic asthma subjects receive three times an infusion containing 750 mg of mepolizumab. Two weeks after the third infusion, subjects will be experimentally infected with RV16. One day before a...
Eligibility Criteria
Inclusion
- Age between 18 - 50 years
- History of episodic chest tightness and wheezing
- 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 (PY)
- 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. Occasional usage of inhaled short-acting beta2-agonists as rescue medication is allowed, prior and during the study
- Baseline FEV1 \> 80% of predicted
- Airway hyperresponsiveness, indicated by a positive acetyl-ß-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 of \> 3mm
- No other clinically significant abnormality on medical history and clinical examination
Exclusion
- Presence of antibodies directed against RV16 in serum (titer \> 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 within the preceding 3 months
- Ongoing use of tobacco products of any kind or previous usage with ≥ 6 total PY
- 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 patient
- People with young children (\< 2 years)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01520051
Start Date
January 1 2012
End Date
March 1 2014
Last Update
February 7 2012
Active Locations (1)
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1
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ