RecruitingPhase 4NCT04743791

Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma

A Randomized, Placebo-controlled, Parallel Group Study Designed to Assess the Change in Mucociliary Clearance After 12 Weeks of Treatment With Dupilumab in Patients With Moderate to Severe Asthma

Sponsor

Sally E. Wenzel MD

Enrollment

30 participants

Start Date

Oct 17, 2022

Study Type

INTERVENTIONAL

Conditions

Asthma

Summary

Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

Moderate - Severe Th2 (Type 2) High asthma, as defined by Forced Expiratory Volume in one second (FEV1) \<90% predicted, on medium to high dose inhaled corticosteroids (ICS) with or without a second controller
Age \> 18
Inhaled steroid doses of 500micrograms (mcg) per day or more (Fluticasone equivalent)
Reversibility \>/= 12% at screening or within the past 2 years, or a positive methacholine challenge test within the past 2 years, or a positive methacholine challenge during screening
FEV1/Forced Vital Capacity (FVC)\<75%
Blood Eosinophils (EOS) \>300 cells per mm3
Exhaled Nitric Oxide (FeNO) \>25 parts per billion (ppb)
Asthma Control Test (ACT) score \<20

Exclusion Criteria12

Pregnant, nursing, or unwilling to test for pregnancy
Current smoker or \>10 pack year smoking history
Body Mass Index (BMI)\>37
Respiratory infection in the last 30 days
Use of antibiotics or oral prednisone in the last 30 days
Current or previous use of dupilumab
Current or recent use of anti-IL-5 therapies
Any other criteria that place the subject at unnecessary risk
Diagnosis of other lung diseases including Chronic Obstructive Pulmonary Disease (COPD)
History of non-skin cell cancer in the last 5 years
Drug or alcohol addiction in the last 5 years
Any other uncontrolled disease

Interventions

DRUGDupilumab

Dupilumab is supplied as a sterile aqueous solution for SC injection at the concentration of 175 mg/mL in glass pre-filled syringe to deliver 200 mg in 1.14mL.

OTHERPlacebo

Sterile placebo for dupilumab will be provided in identically matched glass pre-filled syringe to deliver 200 mg in 1.14mL, which will match dupilumab 200 mg (1.14mL).