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

University of Michigan

Status and phase

Completed

Phase 4

Conditions

Asthma

Treatments

Drug: Dupilumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05036733

HUM00196809

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Physician-diagnosed/managed severe asthma patients that are clinically eligible for dupilumab
Current treatment with a medium-to-high-dose inhaled glucocorticoid (fluticasone propionate at a total daily dose of greater or equal (≥) 440 μg or equipotent equivalent) plus up to at least one additional controller (e.g., a long-acting β2-agonist or leukotriene receptor antagonist)
Eosinophilic asthma phenotype (blood eosinophil level >300) or asthma requiring daily oral corticosteroids
Asthma that is uncontrolled, as defined by a score on the Asthma Control Test of 19 or lower, or a worsening of asthma in the past year that led to an asthma hospitalization, Emergency Department visit, or 3 days of oral corticosteroids
Severity of asthma that, in the opinion of the subject's asthma care specialist, requires dupilumab for control
For women of childbearing age: agree to use birth control or remain abstinent during the duration of the study.

Exclusion criteria

Patients with diagnosis of other chronic lung diseases (e.g. Chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis, Churg-Strauss syndrome, Allergic bronchopulmonary aspergillosis, etc.)
Current smoker or reported smoking within 1 month of the screening visit (tobacco or any inhaled recreational product)
Greater than 10 total pack-year of cigarette smoking history
Treatment with oral corticosteroids for an asthma exacerbation 1 month prior to screening or during the screening period
Use of any biologic therapy for asthma within the past 3 months
Respiratory or Gastrointestinal illness within 1 month prior to screening or during the screening period
Treatment with antibiotics for acute infections within six weeks prior to screening or during the screening period.
Pregnancy at enrollment or during the study
Known hypersensitivity to dupilumab or its excipients