Eosinophilic Airway Inflammation and Mepolizumab
Eosinophilic Airway Inflammation and Mepolizumab
A drug (mepolizumab) that reduces allergic inflammation will affect the function of allergy
 cells called eosinophils which are produced by the body in response to allergen exposure.
Inclusion Criteria:

 -  Males or females age 18 to 50 yrs,

 -  History of asthma based upon presence of asthma symptoms such as cough, shortness of
 breath, wheeze or chest tightness,

 -  positive skin-prick test to a House Dust Mite extract,

 -  Forced expiratory volume at one second >70% predicted pre-albuterol, > 80% predicted
 post albuterol

 -  >12% increase in Forced expiratory volume at one second following inhaled albuterol
 (180 µg) and/or

 -  airway responsiveness to methacholine (PC20 <8mg/ml).

 -  > 20% immediate drop in FEV1 following inhaled antigen challenge.

 -  Safety laboratory assessments within normal ranges (labs to include complete blood
 count with differential, blood urea nitrogen, creatinine, aspartate aminotransferase,
 alanine aminotransferase, Prothrombin time, Partial Thromboplastin Time, and platelet
 count)

 -  Female subjects of child-bearing potential must have a negative urine pregnancy test
 (urine HCG) within 48 hours of the methacholine challenge at Visit 2 and agree to use
 a reliable method of birth control for the duration of the study (reliable methods of
 birth control can include abstinence, barrier methods, oral contraceptives, injection
 contraceptives or skin absorption contraceptives).

 -  In the opinion of the investigator, capable and willing to grant written informed
 consent and cooperate with study procedures and requirements.

 Exclusion Criteria:

 -  Use of inhaled or systemic corticosteroids or leukotriene inhibitors within 1 month of
 screening.

 -  Treatment with Omalizumab (anti-IgE) within 9 months of screening visit

 -  Concomitant use of any other monoclonal antibody

 -  Respiratory infection within 4 weeks of study

 -  Unstable asthma as indicated by self-report of increased symptoms or increased
 beta-agonist use over the previous 2 weeks.

 -  Female subjects who are pregnant, nursing or have a pregnancy planned during the
 course of study

 -  Current smokers (defined as smoked within the last year) or a former smoker with a
 history of >5 pack years.

 -  Major health problems such as heart disease, type I and II diabetes or lung diseases
 other than asthma. Decisions regarding this criteria will be based upon the judgment
 of the investigator.

 -  Previous malignancy.

 -  Medication other than for asthma, allergies or contraception and that the investigator
 feels may interfere with the conduct of study (e.g. monoamine oxidase inhibitors and
 B-adrenergic antagonists in any form)

 -  Known history of allergic reaction to previous antibody administration.

 -  Prior treatment with an anti-interleukin-5 monoclonal antibody,

 -  Use of an investigational drug within 30 days of entering the study,

 -  History of noncompliance with medical regimens or subjects who are considered
 unreliable.