- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03984799
Interleukin-5 Receptor Expression in COPD
May 16, 2022 updated by: Larry Borish, MD, University of Virginia
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.
Study Overview
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).
Study Type
Interventional
Enrollment (Actual)
20
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
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia
-
-
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
40 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Bronchoscopy
Research bronchoscopy
|
Samples obtained during bronchoscopy and blood samples will be evaluated to define inflammatory markers of COPD
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IL-5R expression on bronchial neutrophils
Time Frame: within 24 hours
|
IL-5R will be quantified on neutrophils purified from bronchoalveolar lavage fluid
|
within 24 hours
|
IL-5 concentration in BALF
Time Frame: within 24 hours
|
IL-5 will be quantified in bronchoalveolar lavage fluid
|
within 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
February 21, 2020
Primary Completion (ACTUAL)
March 31, 2022
Study Completion (ACTUAL)
April 30, 2022
Study Registration Dates
First Submitted
June 10, 2019
First Submitted That Met QC Criteria
June 10, 2019
First Posted (ACTUAL)
June 13, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 16, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 21547
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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