- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00802438
Eosinophilic Airway Inflammation and Mepolizumab
March 27, 2019 updated by: University of Wisconsin, Madison
Eosinophilic Airway Inflammation: Relationship to Remodeling and Modulation by 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792-9988
- University of Wisconsin- Madison
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mepolizumab
up to 3 monthly doses of 750mg i.v.
mepolizumab
|
up to three monthly doses of 750mg i.v.
mepolizumab
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Percent of eosinophils was determined in the bronchoalveolar lavage fluid collected from the participant after segmental allergen challenge.
This was done via differential cell count using Hema-3 stain.
Cell differentials were determined by counting a total of 1000 cells on two cytospin preparations.
The percent eosinophils were done before and after administration of mepolizumab for a specified amount of time (up to 3 months of administration).
|
before and after up to 3 months of Mepo.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of Mepolizumab on Bronchoalveolar Lavage Fluid Concentrations of IL-5 Cytokine Before and After Mepolizumab
Time Frame: before and after up to 3 months of Mepo
|
IL-5 was measured via ELISA on bronchoalveolar lavage fluid before and after mepolizumab administration (up to 3 months of administration).
Fluid was prepared in LowCross-Buffer to minimize potential matrix effects.
A 1/2 dilution of 1X bronchoalveolar fluid was used for IL-5 detection.
Data are expressed as pg/mL and are extrapolated to 1X.
|
before and after up to 3 months of Mepo
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2008
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
March 1, 2013
Study Registration Dates
First Submitted
December 4, 2008
First Submitted That Met QC Criteria
December 4, 2008
First Posted (ESTIMATE)
December 5, 2008
Study Record Updates
Last Update Posted (ACTUAL)
April 10, 2019
Last Update Submitted That Met QC Criteria
March 27, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2007-0311
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
Johann Wolfgang Goethe University HospitalCompleted
-
Universita di VeronaCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
-
Johann Wolfgang Goethe University HospitalCompletedExercise-induced AsthmaGermany
Clinical Trials on mepolizumab
-
GlaxoSmithKlineCompletedAsthmaUnited States, Argentina, Australia, Germany, Poland, Romania, Russian Federation, Ukraine, Canada, Chile, France, Korea, Republic of, United Kingdom
-
Academisch Medisch Centrum - Universiteit van Amsterdam...GlaxoSmithKline; The Netherlands Asthma FoundationUnknownAsthma | Viral InfectionNetherlands
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingChronic Rhinosinusitis With Nasal PolypsItaly
-
GlaxoSmithKlineRecruitingEosinophilic Granulomatosis With PolyangiitisCanada, France, Italy, Spain, Belgium, Korea, Republic of, United States, Japan, China, Czechia, Hungary, Israel, Portugal, Poland, Netherlands, United Kingdom, Austria, Argentina, Australia, Brazil, Germany, Sweden
-
GlaxoSmithKlineCompletedAsthmaUnited States, Argentina, Australia, Canada, France, Germany, Japan, Russian Federation, Spain, Ukraine, Belgium, Chile, Korea, Republic of, Mexico, Italy, United Kingdom
-
St. Paul's Sinus CentreNot yet recruiting
-
Policlinico Universitario, CataniaRecruitingBronchiectasis | Bronchial AsthmaItaly
-
GlaxoSmithKlineRecruitingHypereosinophilic SyndromeUnited States, Argentina, Spain, Turkey, Israel, Brazil, Mexico, United Kingdom
-
GlaxoSmithKlineCompletedHypereosinophilic Syndrome | HypereosinophiliaUnited States, Belgium, Canada, Germany, Italy, France, Switzerland, Australia
-
GlaxoSmithKlineCompletedAsthmaJapan, United States, United Kingdom, Poland