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

NCT04743791 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY20020131
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change in mucociliary clearance (MCC) rate

  MCC is measured using an aerosol-based nuclear imaging technique

  Measured at 12 weeks after the start of treatment

Secondary Outcomes (6)

• Change in FEV1% predicted

  Measured from baseline to 12 weeks after start of treatment

• Change in ACT score

  Measured from baseline to 12 weeks after start of treatment

• Change in sputum eosinophils and T2 gene mean

  Measured from baseline to 12 weeks after start of treatment

• Change in mucus plugging score by CT

  Measured from baseline to 12 weeks after start of treatment

• Whole lung MCC90, AAC90

  Measured from baseline to 12 weeks after start of treatment

Study Arms (2)

Dupilumab

ACTIVE COMPARATOR

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.

Drug: Dupilumab

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

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.

Dupilumab

Placebo OTHER

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).

Also known as: Sucrose

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sally E. Wenzel MD: lead

Study Sites (1)

The University of Pittsburgh Asthma Institute at UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

dupilumab; Sucrose

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Central Study Contacts

John Moore

CONTACT

412-648-6726; mooreja6@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Dupilumab and placebo will be provided in identically matched 1.14 mL pre-filled syringes. To protect the blind, each treatment kit of 1.14 mL (dupilumab / placebo) glass pre-filled syringes will be prepared such that the treatments (dupilumab and its matching placebo) are identical and indistinguishable and will be labeled with a treatment kit number. The randomized treatment kit number list will be generated by Sanofi Regeneron
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: October 17, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)