Effects of Interleukin (IL)- 4R-alpha Inhibition on Respiratory Microbiome and Immunologic Correlates in Severe Asthma

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT05036733
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Participants will receive 8 doses of Dupilumab. The initial loading dose (visit 1) of 600 milligrams (two 300 milligram injections) will be given subcutaneously (SQ). Then the participants will receive 300 milligrams SQ every other week (q 2 weeks) either at a study visit or self-administered at home between visits. Additionally, participants will complete questionnaires, have specimens collected, as well as perform breathing procedures at various timepoints.

Study Details

The overall goal of this study is to understand biological responses related to dupilumab treatment among severe asthma patients. Not all asthma is the same, and characteristics of asthma vary from person to person. The study will investigate whether the study drug can help to improve the health of participants lungs, boost immune response, as well as improve quality of life.

Key Dates

Start date
Feb 22, 2022
Status verified
Oct 2024
Primary completion
Jun 29, 2023
Completion
Jun 29, 2023

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Dupilumab

Primary Outcome Measure

Changes in Alpha-diversity of Respiratory Microbiota [ Time Frame: Baseline (before dupilumab), 1 month ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109-

Find similar trials in Ann Arbor, MI

By condition

Related Studies