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NCT Number: NCT04743791

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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).

Other names: Sucrose

Primary outcomes

  1. Change in mucociliary clearance (MCC) rate

    Time frame: Measured at 12 weeks after the start of treatment

    MCC is measured using an aerosol-based nuclear imaging technique

Secondary outcomes

  1. Change in FEV1% predicted

    Time frame: Measured from baseline to 12 weeks after start of treatment

    Assessed using spirometry after bronchodilator administration.

  2. Change in ACT score

    Time frame: 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).

  3. Change in sputum eosinophils and T2 gene mean

    Time frame: Measured from baseline to 12 weeks after start of treatment

    Measured via sputum induction to obtain airway cells and fluid from patients.

  4. Change in mucus plugging score by CT

    Time frame: 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

  5. Whole lung MCC90, AAC90

    Time frame: Measured from baseline to 12 weeks after start of treatment

    Measured via mucociliary clearance imaging

  6. Peripheral and central lung MCC90, MCC240, AAC90

    Time frame: Measured from baseline to 12 weeks after start of treatment

    Measured via mucociliary clearance imaging

Study contacts

Contact information is provided by the study sponsor or research team.

John Moore

CONTACT

[email protected]

412-648-6726

Sponsors and collaborators

Lead sponsor

Sally E. Wenzel MD

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2021
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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