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

Sally E. Wenzel MD

Status and phase: Enrolling; Phase 4

Conditions: Asthma

Treatments: Drug: Dupilumab; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04743791

STUDY20020131

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Dupilumab

Active Comparator group

Description:

Two injections of Dupilumab will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of Dupilumab will be given every 2 weeks ± 3 days at home by the patient. The doses of investigational product must be separated by ≥11 days to avoid an overdose.

Treatment:

Drug: Dupilumab

Placebo

Placebo Comparator group

Description:

Two injections of placebo will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of placebo will be given every 2 weeks ± 3 days at home by the patient. The doses must be separated by ≥11 day.

Treatment:

Other: Placebo