The phase 4 VESTIGE trial (ClinicalTrials.gov Identifier: NCT04400318) represents the largest study to date that uses functional respiratory imaging (FRI) to assess the effects of dupilumab, an asthma biologic, on lung function and airway volume changes in moderate-to-severe asthma, according to a study protocol being presented at the American College of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting, held in New Orleans, LA, from November 4 to 8, 2021.

According to the researchers of the VESTIGE trial, fully human monoclonal antibody dupilumab blocks key drivers of type 2 inflammation in several diseases. In the randomized, double-blind trial, the researchers plan to assess the effect of dupilumab on bronchodynamics and lung structure with FRI endpoints.

The researchers note that FRI, a novel quantitative computed tomography (CT) technology, obtains information on functional as well as structural changes from high-resolution CT of the lungs. Additionally, the investigators note that FRI features “high sensitivity to detect changes associated with disease progression or treatment which are not apparent with spirometry,” a mainstay in asthma treatment.

Key FRI endpoints included in the VESTIGE trial will include airway volume, airway resistance, and the presence of mucus plugs to quantify how airway remodeling affects respiratory mechanics. The investigators will assess the findings to see if FRI provides novel information in regard to asthma management, particularly as it relates to moderate-to-severe disease. Conventional endpoints including disease biomarkers, clinical outcomes, and patient-reported outcomes will also be included.

“By coupling novel imaging with conventional endpoints, VESTIGE may provide further insight into dupilumab’s mechanism of action and effect on lung function, airway inflammation, and airway remodeling,” the investigators concluded.

Disclosure: Multiple authors declared affiliations with the pharmaceutical industry. Please refer to the original article for a full list of disclosures.

Visit Pulmonology Advisor’s conference section for complete coverage of ACAAI 2021 Annual Scientific Meeting.

 

Reference

Cox J, Fogarty C, Papi A, et al. Functional respiratory imaging in patients with moderate-to-severe asthma: the VESTIGE trial. Presented at: the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting; November 4-8, 2021; New Orleans, LA. Abstract P072.

Source link