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Eosinophilic Airway Inflammation and Mepolizumab
This study is currently recruiting participants.
Verified by University of Wisconsin, Madison, December 2008
First Received: December 4, 2008   No Changes Posted
Sponsored by: University of Wisconsin, Madison
Information provided by: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00802438
  Purpose

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.


Condition Intervention
Asthma
Biological: mepolizumab

MedlinePlus related topics: Asthma
Drug Information available for: Mepolizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Official Title: Eosinophilic Airway Inflammation: Relationship to Remodeling and Modulation by Mepolizumab

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • The primary endpoint of the study is the percent of BAL EOS after SBP, before and after mepolizumab administration (BAL#2 vs. BAL#4). [ Time Frame: before and after up to 3 months of Mepo. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • a) SBP-Ag induced BAL cytokines and chemokines before and after mepolizumab as markers of lymphocyte activation patterns [ Time Frame: before and after up to 3 mo of Mepo ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mepolizumab: Experimental
up to 3 monthly doses of 750mg i.v. mepolizumab
Biological: mepolizumab
up to three monthly doses of 750mg i.v. mepolizumab

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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,
  • FEV1 >70% predicted pre-albuterol, > 80% predicted post albuterol
  • >12% increase in FEV1 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 CBC with differential, BUN, creatinine, AST, ALT, PT, PTT 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-hIL-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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802438

Contacts
Contact: Mary Jo M Jackson, BSN (608) 263-0524 mmj@medicine.wisc.edu
Contact: Cheri A Swenson, BS (608) 262-5189 cas@medicine.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin- Madison Recruiting
Madison, Wisconsin, United States, 53792-9988
Contact: Cheri A Swenson, BS     608-262-5189     cas@medicine.wisc.edu    
Contact: Mary Jo Jackson, BSN     (608) 263-0524     mmj@medicine.wisc.edu    
Sub-Investigator: Loren Denlinger, MD, PhD            
Principal Investigator: Nizar N Jarjour, MD            
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Nizar N Jarjour, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin- Madison ( Board of Regents of the Universtiy of Wisconsin System )
Study ID Numbers: H-2007-0311
Study First Received: December 4, 2008
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00802438     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
asthma
allergic inflammation
IL-5

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity
Inflammation

Additional relevant MeSH terms:
Hypersensitivity
Lung Diseases, Obstructive
Pathologic Processes
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009