Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
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.
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).
The University of Pittsburgh Asthma Institute at UPMC
Pittsburgh, Pennsylvania, United States
RECRUITINGChange in mucociliary clearance (MCC) rate
MCC is measured using an aerosol-based nuclear imaging technique
Time frame: Measured at 12 weeks after the start of treatment
Change in FEV1% predicted
Assessed using spirometry after bronchodilator administration.
Time frame: Measured from baseline to 12 weeks after start of treatment
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).
Time frame: Measured from baseline to 12 weeks after start of treatment
Change in sputum eosinophils and T2 gene mean
Measured via sputum induction to obtain airway cells and fluid from patients.
Time frame: Measured from baseline to 12 weeks after start of treatment
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
Time frame: Measured from baseline to 12 weeks after start of treatment
Whole lung MCC90, AAC90
Measured via mucociliary clearance imaging
Time frame: Measured from baseline to 12 weeks after start of treatment
Peripheral and central lung MCC90, MCC240, AAC90
Measured via mucociliary clearance imaging
Time frame: Measured from baseline to 12 weeks after start of treatment
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