Eosinophilic Airway Inflammation and Mepolizumab

NCT ID: NCT00802438

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-01
• Study Completion Date: 2013-03-01

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.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Mepolizumab

up to 3 monthly doses of 750mg i.v. mepolizumab

Group Type: EXPERIMENTAL

mepolizumab

Intervention Type: BIOLOGICAL

up to three monthly doses of 750mg i.v. mepolizumab

Interventions

mepolizumab

up to three monthly doses of 750mg i.v. mepolizumab

Intervention Type: BIOLOGICAL

Other Intervention Names

anti-interleukin 5

Eligibility 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,
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nizar N Jarjour, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin- Madison

Madison, Wisconsin, United States

Countries

United States

References

Kelly EA, Esnault S, Liu LY, Evans MD, Johansson MW, Mathur S, Mosher DF, Denlinger LC, Jarjour NN. Mepolizumab Attenuates Airway Eosinophil Numbers, but Not Their Functional Phenotype, in Asthma. Am J Respir Crit Care Med. 2017 Dec 1;196(11):1385-1395. doi: 10.1164/rccm.201611-2234OC.

Reference Type: DERIVED

PMID: 28862877 (View on PubMed)

Other Identifiers

H-2007-0311

Identifier Type: -

Identifier Source: org_study_id