Back to resultsMeasuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
Primary Purpose
Asthma
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dupilumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
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
Sites / Locations
- The University of Pittsburgh Asthma Institute at UPMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dupilumab
Placebo
Arm Description
Two injections of Dupilumab will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of Dupilumab will be given every 2 weeks ± 3 days at home by the patient. The doses of investigational product must be separated by ≥11 days to avoid an overdose.
Two injections of placebo will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of placebo will be given every 2 weeks ± 3 days at home by the patient. The doses must be separated by ≥11 day.
Outcomes
Primary Outcome Measures
Change in mucociliary clearance (MCC) rate
MCC is measured using an aerosol-based nuclear imaging technique
Secondary Outcome Measures
Change in FEV1% predicted
Assessed using spirometry after bronchodilator administration.
Change in ACT score
Measured via the Asthma Control Test questionnaire. Scores range from 5 (poor control of asthma) to 25 (complete control of asthma).
Change in sputum eosinophils and T2 gene mean
Measured via sputum induction to obtain airway cells and fluid from patients.
Change in mucus plugging score by CT
Radiologists will visually assess the presence or absence of mucus plugging in segmental airways and will provide a mucus plugging score
Whole lung MCC90, AAC90
Measured via mucociliary clearance imaging
Peripheral and central lung MCC90, MCC240, AAC90
Measured via mucociliary clearance imaging
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04743791
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sally E. Wenzel MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Dupilumab and placebo will be provided in identically matched 1.14 mL pre-filled syringes. To protect the blind, each treatment kit of 1.14 mL (dupilumab / placebo) glass pre-filled syringes will be prepared such that the treatments (dupilumab and its matching placebo) are identical and indistinguishable and will be labeled with a treatment kit number. The randomized treatment kit number list will be generated by Sanofi Regeneron
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dupilumab
Arm Type
Active Comparator
Arm Description
Two injections of Dupilumab will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of Dupilumab will be given every 2 weeks ± 3 days at home by the patient. The doses of investigational product must be separated by ≥11 days to avoid an overdose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two injections of placebo will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of placebo will be given every 2 weeks ± 3 days at home by the patient. The doses must be separated by ≥11 day.
Intervention Type
Drug
Intervention Name(s)
Dupilumab
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sucrose
Intervention Description
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 Measure Information:
Title
Change in mucociliary clearance (MCC) rate
Description
MCC is measured using an aerosol-based nuclear imaging technique
Time Frame
Measured at 12 weeks after the start of treatment
Secondary Outcome Measure Information:
Title
Change in FEV1% predicted
Description
Assessed using spirometry after bronchodilator administration.
Time Frame
Measured from baseline to 12 weeks after start of treatment
Title
Change in ACT score
Description
Measured via the Asthma Control Test questionnaire. Scores range from 5 (poor control of asthma) to 25 (complete control of asthma).
Time Frame
Measured from baseline to 12 weeks after start of treatment
Title
Change in sputum eosinophils and T2 gene mean
Description
Measured via sputum induction to obtain airway cells and fluid from patients.
Time Frame
Measured from baseline to 12 weeks after start of treatment
Title
Change in mucus plugging score by CT
Description
Radiologists will visually assess the presence or absence of mucus plugging in segmental airways and will provide a mucus plugging score
Time Frame
Measured from baseline to 12 weeks after start of treatment
Title
Whole lung MCC90, AAC90
Description
Measured via mucociliary clearance imaging
Time Frame
Measured from baseline to 12 weeks after start of treatment
Title
Peripheral and central lung MCC90, MCC240, AAC90
Description
Measured via mucociliary clearance imaging
Time Frame
Measured from baseline to 12 weeks after start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Moore
Phone
412-648-6726
Email
mooreja6@upmc.edu
Facility Information:
Facility Name
The University of Pittsburgh Asthma Institute at UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sally Wenzel, MD
Phone
412-647-9955
Email
swenzel@pitt.edu
First Name & Middle Initial & Last Name & Degree
John Moore
Phone
412-648-6726
Email
mooreja6@upmc.edu
12. IPD Sharing Statement
Learn more about this trial
Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
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