Clinical trial NCT04743791: Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Asthma
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change in mucociliary clearance (MCC) rate
timeFrame: Measured at 12 weeks after the start of treatment
Secondary outcomes:
measure: Change in FEV1% predicted
timeFrame: Measured from baseline to 12 weeks after start of treatment
measure: Change in ACT score
timeFrame: Measured from baseline to 12 weeks after start of treatment
measure: Change in sputum eosinophils and T2 gene mean
timeFrame: Measured from baseline to 12 weeks after start of treatment
measure: Change in mucus plugging score by CT
timeFrame: Measured from baseline to 12 weeks after start of treatment
measure: Whole lung MCC90, AAC90
timeFrame: Measured from baseline to 12 weeks after start of treatment
measure: Peripheral and central lung MCC90, MCC240, AAC90
timeFrame: Measured from baseline to 12 weeks after start of treatment
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: The University of Pittsburgh Asthma Institute at UPMC
state: Pennsylvania
Study officials:
References: