Asthma
Conditions
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.
Interventions
DRUGDupilumab
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.
OTHERPlacebo
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).
Sponsors
Sally E. Wenzel MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mucociliary clearance (MCC) rate | Measured at 12 weeks after the start of treatment | MCC is measured using an aerosol-based nuclear imaging technique |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in FEV1% predicted | Measured from baseline to 12 weeks after start of treatment | Assessed using spirometry after bronchodilator administration. |
| Change in ACT score | Measured from baseline to 12 weeks after start of treatment | 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 from baseline to 12 weeks after start of treatment | Measured via sputum induction to obtain airway cells and fluid from patients. |
| Change in mucus plugging score by CT | Measured from baseline to 12 weeks after start of treatment | 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 from baseline to 12 weeks after start of treatment | Measured via mucociliary clearance imaging |
| Peripheral and central lung MCC90, MCC240, AAC90 | Measured from baseline to 12 weeks after start of treatment | Measured via mucociliary clearance imaging |
Countries
United States
Contacts
CONTACTJohn Moore
Outcome results
None listed