Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
Recruiting
Phase 4Interventional Study
Asthma
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Sally E. Wenzel MD · Other
Who this trial is looking for
This trial is looking for adults with moderate to severe asthma to see how a treatment called dupilumab affects a specific way the body clears mucus. Participants will receive either the treatment or a placebo to compare results.
Are You a Good Fit for This Trial?
Must be takingInhaled corticosteroids
Rules you outChronic Obstructive Pulmonary Disease
You may be able to join if
I am over 18 years old.
I have moderate to severe asthma and am using inhaled corticosteroids.
I have low lung function with an FEV1 under 90% predicted.
I have high levels of eosinophils in my blood.
I have a specific symptom score below 20.
I have a history of asthma reversibility.
I have elevated levels of exhaled nitric oxide.
I have a low FEV1/FVC ratio.
You may not be able to join if
I am pregnant or nursing.
I am a current smoker or have a significant smoking history.
My BMI is over 37.
I've had a respiratory infection in the last 30 days.
I've used antibiotics or oral prednisone in the last 30 days.
I have previously taken dupilumab.
I have been diagnosed with other lung diseases.
I have a history of cancer in the last 5 years.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.
Trial Locations
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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 …
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
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