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

NCT04743791 — Phase 4, Recruiting, 30 participants, Sally E. Wenzel MD

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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

Registry	NCT04743791
Status	Recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	30 (Estimated)
Sponsor	Sally E. Wenzel MD (Other)
Conditions	Asthma
Interventions	Dupilumab, Placebo (Drug, other)
Dates	start 2022-10-17, primary completion 2027-12-01 (estimated), completion 2028-06-01 (estimated), first posted 2021-02-08, last updated 2026-08-06
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Dupilumab	Active comparator	Drug: Dupilumab	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.
Placebo	Placebo comparator	Other: Placebo	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.

Dupilumab (Drug): 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.
Placebo (Other), also known as Sucrose: 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).

+Outcome measures

Primary outcomes

Change in mucociliary clearance (MCC) rate [Measured at 12 weeks after the start of treatment]: MCC is measured using an aerosol-based nuclear imaging technique

Secondary outcomes

Change in FEV1% predicted [Measured from baseline to 12 weeks after start of treatment]: Assessed using spirometry after bronchodilator administration.
Change in ACT score [Measured from baseline to 12 weeks after start of treatment]: Measured via the Asthma Control Test questionnaire. Scores range from 5 (poor control of asthma) to 25 (complete control of asthma).
Change in sputum eosinophils and T2 gene mean [Measured from baseline to 12 weeks after start of treatment]: Measured via sputum induction to obtain airway cells and fluid from patients.
Change in mucus plugging score by CT [Measured from baseline to 12 weeks after start of treatment]: Radiologists will visually assess the presence or absence of mucus plugging in segmental airways and will provide a mucus plugging score
Whole lung MCC90, AAC90 [Measured from baseline to 12 weeks after start of treatment]: Measured via mucociliary clearance imaging
Peripheral and central lung MCC90, MCC240, AAC90 [Measured from baseline to 12 weeks after start of treatment]: Measured via mucociliary clearance imaging

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
The University of Pittsburgh Asthma Institute at UPMC	Pittsburgh, Pennsylvania	United States	Recruiting