Mepolizumab Treatment for Rhinovirus-induced Asthma Exacerbations (MATERIAL)
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|ClinicalTrials.gov Identifier: NCT01520051|
Recruitment Status : Unknown
Verified February 2012 by Suzanne Bal, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was: Recruiting
First Posted : January 27, 2012
Last Update Posted : February 7, 2012
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 from exacerbations, which can be triggered by allergens and, in particular, viral respiratory infections. It has recently been shown that mepolizumab, a humanized monoclonal antibody that neutralizes interleukin(IL)-5, markedly reduces the exacerbation rate in asthma patients with eosinophilic airway inflammation. Previous studies have indicated that in a mixed population (eosinophilic and non eosinophilic) of mild asthma patients, mepolizumab did not have an impact on lung function and asthma symptom scores upon allergen provocation, although it did on markers such as sputum and blood eosinophils. Together, these observations led to the hypothesis that mepolizumab treatment reduces the exacerbation rate by limiting virus-induced asthma exacerbations.
The investigators hypothesize that neutralization of IL-5 during virus infection in patients with allergic asthma:
- Reduces virus-induced bronchial inflammation
- Attenuates virus-induced asthma symptoms, airflow limitation and bronchial hyperresponsiveness.
- Enhances cellular immune responses to the virus.
The aims of this study are to:
- To investigate whether IL-5 neutralization reduces the inflammatory response to viral airway infections in allergic asthma patients
- To investigate whether IL-5 neutralization prevents or reduces asthma symptoms during virus-induced asthma exacerbations
- To investigate whether IL-5 neutralization affects the cellular immune response to viral airway infections in allergic asthma patients
|Condition or disease||Intervention/treatment||Phase|
|Asthma Viral Infection||Drug: Mepolizumab Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy of Mepolizumab Treatment on Rhinovirus Induced Asthma Exacerbations|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||March 2014|
3 monthly intravenous infusions of 750 mg
Other Name: Mepolizumab, SB240563
|Placebo Comparator: Saline||
3 monthly intravenous infusions with saline
- FEV1 [ Time Frame: 1 day prior and 6 days after RV16 challenge ]Change in pre-bronchodilator FEV1 between day 70 and day 77, i.e. 1 day prior and 6 days after RV16 challenge.
- Questionnaire to score asthma and common cold complaints [ Time Frame: During 14 days following viral infection ]
- Viral load [ Time Frame: Day 6 after viral infection ]Viral load in nasal swab and bronchial brushes
- Sputum eosinophils [ Time Frame: Before and after mepolizumab infusion ]Change in sputum eosinophils
- Cell influx in bronchoalveolar lavage fluid [ Time Frame: 6 days after viral infection ]Influx of neutrophils, eosinophils, macrophages, monocytes, T en B lymphocytes into the lungs
- Pro-inflammatory cytokines in bronchoalveolar lavage fluid [ Time Frame: 6 days after viral infection ]Measurement of IL-6, IL-8 and IFN-y in bronchoaveolar lavage fluid
- Antibody production [ Time Frame: 6 weeks after infection ]Anti RV-16 antibodies are measured in serum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520051
|Contact: Suzanne M Bal, PhD||+31 email@example.com|
|Contact: Koenraad F van der Sluijs, PhD||+31 firstname.lastname@example.org|
|Academic Medical Center||Recruiting|
|Amsterdam, Netherlands, 1105 AZ|
|Principal Investigator: René Lutter, PhD|
|Principal Investigator:||René Lutter, PhD||Academic Medical Center, Respiratory Medicine|
|Study Director:||Elisabeth H Bel, MD, PhD||Academic Medical Center, Respiratory Medicine|
|Study Director:||Peter J Sterk, PhD||Academic Medical Center, Respiratory Medicine|