Mepolizumab Treatment for Rhinovirus-induced Asthma Exacerbations

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 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:

1. Reduces virus-induced bronchial inflammation
2. Attenuates virus-induced asthma symptoms, airflow limitation and bronchial hyperresponsiveness.
3. Enhances cellular immune responses to the virus.

The aims of this study are to:

1. To investigate whether IL-5 neutralization reduces the inflammatory response to viral airway infections in allergic asthma patients
2. To investigate whether IL-5 neutralization prevents or reduces asthma symptoms during virus-induced asthma exacerbations
3. To investigate whether IL-5 neutralization affects the cellular immune response to viral airway infections in allergic asthma patients

Conditions

• Asthma
• Viral Infection

Interventions

DRUG

Mepolizumab

3 monthly intravenous infusions of 750 mg

DRUG

Placebo

3 monthly intravenous infusions with saline

Sponsors & Collaborators

• The Netherlands Asthma Foundation

  collaborator OTHER

• GlaxoSmithKline

  collaborator INDUSTRY

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  lead OTHER

Principal Investigators

• René Lutter, PhD · Academic Medical Center, Respiratory Medicine

• Elisabeth H Bel, MD, PhD · Academic Medical Center, Respiratory Medicine

• Peter J Sterk, PhD · Academic Medical Center, Respiratory Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2013-12-31

Completion

2014-03-31

Countries

• Netherlands

Study Locations