Overview

This trial is active, not recruiting.

Condition asthma
Treatment mepolizumab
Sponsor University of Wisconsin, Madison
Start date June 2008
End date March 2013
Trial size 20 participants
Trial identifier NCT00802438, H-2007-0311

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
up to 3 monthly doses of 750mg i.v. mepolizumab
mepolizumab anti-interleukin 5
up to three monthly doses of 750mg i.v. mepolizumab

Primary Outcomes

Measure
The primary endpoint of the study is the percent of eosinophils in the bronchoalveolar lavage fluid after segmental allergen challenge, before and after mepolizumab administration (bronchoscopy #2 vs. bronchoscopy #4).
time frame: before and after up to 3 months of Mepo.

Secondary Outcomes

Measure
Segmental allergen challenge induced bronchoalveolar lavage fluid cytokines and chemokines before and after mepolizumab as markers of lymphocyte activation patterns
time frame: before and after up to 3 months of Mepo

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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.

Additional Information

Official title Eosinophilic Airway Inflammation: Relationship to Remodeling and Modulation by Mepolizumab
Principal investigator Nizar N Jarjour, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.