Dupilumab on Airway Hyper-responsiveness and Ventilation Heterogeneity in Patients With Asthma.

Sponsor
McMaster University
Study ID
NCT03884842
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab/Dupixent — BIOLOGICAL
    a monoclonal antibody designed for the treatment asthma and atopic dermatitis.
  • Placebo — BIOLOGICAL
    Matched placebo

Study Details

In asthmatics with airway hyperresponsiveness and a "T2 immune signature" (type 2), Dupilumab will suppress airway hyperresponsiveness (assessed by methacholine PC20 ≤ 4 mg/mL (PC20: provocative concentration causing a 20% fall in FEV1) OR ≥15% decreased in forced expired volume in 1 second (FEV1) during saline inhalation for sputum induction OR ≥25% improvement in FEV1 after bronchodilator) and airway eosinophilia (assessed by sputum eosinophils) and this will be associated with greater asthma control and improved ventilation heterogeneity.

Key Dates

Start date
Jul 1, 2019
Status verified
Jan 2023
Primary completion
Oct 12, 2022
Completion
Jan 17, 2023

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: dupilumab
    Dupilumab 300 mg subcutaneously (SC) every 2 weeks as an investigational drug. For those randomized to dupilumab, a loading dose of 600 mg will be given only at randomization/Visit 2. Sterile dupilumab of will be provided in 150 mg/mL in glass prefilled syringes (2.25 mL total volume) to deliver 300 mg in 2 mL.
  • Placebo Comparator: matched placebo
    Sterile placebo for dupilumab will be provided in identically matched glass prefilled syringes to deliver 2 mL.

Primary Outcome Measure

Proportion of patients that achieve at least one doubling dose improvement in PC20 methacholine and/or a 50% reduction in FEV1 reversibility after bronchodilator. [ Time Frame: Between screening (week -4) and week 16. ]

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