RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-10-17

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04743791

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

John Moore

CONTACT

412-648-6726

mooreja6@upmc.edu

Study Locations (Sites)

The University of Pittsburgh Asthma Institute at UPMC

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Sally E. Wenzel MD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-17

Study Completion Date2025-09

Study Record Updates

Study Start Date2022-10-17

Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

Asthma