Status:
COMPLETED
Eosinophilic Airway Inflammation and Mepolizumab
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Asthma
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00802438
Start Date
June 1 2008
End Date
March 1 2013
Last Update
April 10 2019
Active Locations (1)
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1
University of Wisconsin- Madison
Madison, Wisconsin, United States, 53792-9988