NCT03984799

Interleukin-5 Receptor Expression in COPD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• COPD

Interventions

Type	Name	Description
PROCEDURE	Bronchoscopy	Samples obtained during bronchoscopy and blood samples will be evaluated to define inflammatory markers of COPD

Timeline

• Start date: 2020-02-21
• Primary completion: 2022-03-31
• Completion: 2022-04-30
• First posted: 2019-06-13
• Last updated: 2022-05-18

Locations

1 site across 1 country: United States