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Recruiting NCT04743791

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

Phase IV Interventional Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dupilumab, Placebo.
Who it may be relevant to
Registry conditions: Asthma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Drug Dupilumab
    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.
  • Other Placebo
    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).

Primary outcome measures

  • Change in mucociliary clearance (MCC) rate [Time frame: Measured at 12 weeks after the start of treatment]
Secondary outcome measures (6)
  • Change in FEV1% predicted [Time frame: Measured from baseline to 12 weeks after start of treatment]
  • Change in ACT score [Time frame: Measured from baseline to 12 weeks after start of treatment]
  • Change in sputum eosinophils and T2 gene mean [Time frame: Measured from baseline to 12 weeks after start of treatment]
  • Change in mucus plugging score by CT [Time frame: Measured from baseline to 12 weeks after start of treatment]
  • Whole lung MCC90, AAC90 [Time frame: Measured from baseline to 12 weeks after start of treatment]
  • Peripheral and central lung MCC90, MCC240, AAC90 [Time frame: Measured from baseline to 12 weeks after start of treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Pittsburgh Asthma Institute at UPMC — Pittsburgh

Identifiers

NCT: NCT04743791 · STUDY20020131

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗