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Interleukin-5 Receptor Expression in COPD

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ClinicalTrials.gov Identifier: NCT03984799
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Larry Borish, MD, University of Virginia

Brief Summary:
At visit one, after the subject has signed the consent form, subjects will answer questions and have maximum reversibility lung function test to determine if they are eligible to proceed with the study. Once the study team has proven that the subject is eligible to proceed the study team will collect a sputum sample and blood sample to study their cells. At visit two the subjects will undergo a research bronchoscopy at this point the study team will collect more samples including a BAL sample and another blood sample. Three follow up phone calls will be conducted after the procedure to ensure subject safety, the study team will record any symptoms that they are experiencing at that time. Throughout this study the samples will be analyzed to see if a larger subset of COPD patients could benefit from using the drug mepolizumab.

Condition or disease Intervention/treatment Phase
COPD Procedure: Bronchoscopy Not Applicable

Detailed Description:
During this study the subjects will have a bronchoscopy where the study team will collect airway samples to see how the subjects express certain cells. The subjects will also have two blood draws to provide information on the number of inflammatory cells that are present in their blood. This will help the study team determine if mepolizumab might be able to be used in more patients with COPD. The use of mepolizumab in COPD subjects with elevated blood eosinophils has been proven effective. However, the cellular mechanisms in the COPD population are unknown, including the extent to which these subjects express IL-5 in their airway and whether eosinophils are the sole target. Through this study the study team plans to provide proof of concept that mepolizumab could target additional IL-5-expressing immune cells in the airway, including especially PMNs. The study team will also investigate additional feasible biomarkers that could be utilized to predict mepolizumab responsiveness in COPD. The study team is hoping to determine if COPD patients with elevated blood eosinophils will demonstrate increased concentrations of IL-5 in their bronchoalveolar lavage (BAL) fluid and increased expression in their BAL of CD125+ PMNs. To address this hypothesis, the following specific aims will be addressed: To define the expression of IL-5R on PMNs in COPD and to demonstrate elevated concentrations of IL-5 in BALF obtained from COPD subjects with blood eosinophils (≥300/µL).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Interleukin-5 Receptor Expression in COPD
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Intervention Details:
  • Procedure: Bronchoscopy
    Samples obtained during bronchoscopy and blood samples will be evaluated to define inflammatory markers of COPD
    Other Name: Blood Draw


Primary Outcome Measures :
  1. IL-5R expression on bronchial neutrophils [ Time Frame: within 24 hours ]
    IL-5R will be quantified on neutrophils purified from bronchoalveolar lavage fluid

  2. IL-5 concentration in BALF [ Time Frame: within 24 hours ]
    IL-5 will be quantified in bronchoalveolar lavage fluid



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Age ≥40 and ≤80.

    • COPD according to ATS-ERS guidelines
    • Current or former smokers (≥10 pack-years) / non-smokers without a history of asthma
    • FEV1/FVC ratio 0.70 before and after bronchodilator
    • FEV1 after bronchodilator ≥50% predicted and <80% predicted
    • No recent exacerbation within 30 days of bronchoscopy
    • No symptoms of recent symptomatic infection (change in sputum volume or color in the previous 30 days).
    • Absolute eosinophil count >300/µL within one month of the research bronchoscopy.

Exclusion Criteria:

  • • Current diagnosis of asthma

    • Non-smokers with a history of asthma
    • Recent exacerbation within 30 days of bronchoscopy
    • Major medical co-morbid or primary disorder including systemic disorders involving the heart, CNS, renal, and endocrine systems
    • Positive pregnancy test at time of bronchoscopy in women of child-bearing years
    • Recent change in COPD control regimen (within 60 days). Stable orally-dosed CCS will not be a contraindication to study as long as the dose was not changed within 60 days.
    • Recent (with 1-year) administration of a biologic agent
    • Presence of allergic sensitization (atopy) (if obtained) will not be considered an exclusion.
    • Presence of hypereosinophil syndrome (HES), eosinophilic granulomatous polyangiitis (EGPA), nasal polyposis, helminth infection, or any other medical condition associated with eosinophilia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984799


Contacts
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Contact: Kristen Wavell 4349246874 KWW7D@hscmail.mcc.virginia.edu
Contact: Larry Borish, MD 4349245917 lb4m@virginia.edu

Locations
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United States, Virginia
University of Virginia Not yet recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kristen Wavell    434-924-6874    KWW7D@hscmail.mcc.virginia.edu   
Contact: Larry Borish    14349245917    lb4m@virginia.edu   
Sponsors and Collaborators
University of Virginia
GlaxoSmithKline

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Responsible Party: Larry Borish, MD, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT03984799     History of Changes
Other Study ID Numbers: 21547
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No