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

Description

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

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Study Overview

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Study Details

Study 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.

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

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

Condition
Asthma
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

The University of Pittsburgh Asthma Institute at UPMC, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sally E. Wenzel MD,

Study Record Dates

2025-09