VESTIGE was a phase 4, randomized, double-blind, placebo-controlled imaging study5

Study
population5

  • The study population consisted of patients aged 21 to 70 years with uncontrolled moderate-to-severe asthma (ACQ-5 score ≥1.5), percent predicted pre-bronchodilator FEV1 ≤80%, 1 exacerbation in prior year, blood EOS count ≥300 cells/uL, and FeNO ≥25 ppb

Baseline
characteristics5

DUPIXENT 300 mg group (n=72) and placebo group (n=37), respectively: mean ages 51 ± 13 and 49 ± 12 years; 64% and 59% female; mean FeNO 63 ppb ± 40 and 53 ppb ± 25; mucus plug score 7.2 ± 5.1 and 6.9 ± 5.0; pre-bronchodilator FEV1 1900 mL ± 700 mL and 1900 mL ± 700 mL.

Background therapy: medium-to-high dose ICS + second controller ± third controller

dCT scans.5

Primary endpoints: Proportion of patients achieving FeNO <25 ppb at Week 24, and percent change from baseline to Week 24 in (s)iVaw at TLC.5

Select secondary and other endpoints: Change from baseline in pre-bronchodilator FEV1 at Week 24, and change from baseline in mucus plug score at Week 24 and CT scans of mucus plug volume (exploratory).5

The primary imaging endpoint ([s]iVaw at TLC) did not reach statistical significance (P>0.05); therefore all subsequent endpoints are descriptive; definitive conclusions cannot be made.5

What is functional respiratory imaging (FRI)?

  • FRI is a novel computational modeling technique that combines high-resolution CT imaging with computational fluid dynamics to create patient-specific 3D models of lung structure and function5
  • FRI provides clinically relevant, patient-specific measurements, including airway volumes, airflow distribution, and resistance, with greater sensitivity compared to standard spirometry6

ACQ-5, Asthma Control Questionnaire, 5-item version; CT, computed tomography; EOS, eosinophil; EOT, end of treatment; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; OLE, open-label extension; Q2W, once every 2 weeks; (s)iVaw, specific image-based airway volume; TLC, total lung capacity.