NCT05320939

Immunological Basis for Mepolizumab Activity in COPD

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The current literature suggests that the mode of action of mepolizumab is to bind with Interleukin (IL)-5 and block the interaction of IL-5 with the IL-5Ra receptor on eosinophils. This removal of IL-5 may not explain all of the effects of mepolizumab. The investigators propose a set of studies to systematically examine the spectrum of effects of this drug on the immune system.

Detailed description

The investigators will recruit a total of 30 Chronic Obstructive Pulmonary Disease (COPD) participants from the Temple University Hospital Lung Center Clinic. All participants will have moderate to severe COPD and have a history of 2 or more acute exacerbations in the past year, and eosinophil counts of greater than 300 cells/ul. The investigators studies will include an analysis of the status of the systemic and lung inflammatory phenotype of the major leukocyte populations, using multiparameter flow cytometry. The investigators will couple these studies with an analysis of a panel of inflammatory and anti-inflammatory biomarkers in both the blood and bronchoalveolar lavage fluid. Very importantly, the investigators will characterize the functional capacity of T cells, B cells, monocytes, and granulocytes during drug therapy. By using this approach, the investigators believe a more complete understanding of the scope of activity of mepolizumab at the level of immune competence will be developed.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Mepolizumab 100 MG	30 subjects (≥ 300 eosinophils/ul) will receive mepolizumab 100 mg subcutaneously every 4 weeks for 5 complete doses.

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-04-01
• Completion: 2025-05-01
• First posted: 2022-04-11
• Last updated: 2023-04-07

Regulatory

• FDA-regulated drug study