A Phase 2 clinical trial proposal describes a planned study of 49 obese asthma subjects. The intervention involves using hyperpolarized 129XeMRI for 3D functional imaging combined with single-cell RNA sequencing to examine mechanisms driving regional airway remodeling and fibrosis. The study also mentions preclinical models of obese asthma. The primary outcomes listed are the percentage of neutrophils and eosinophils in peripheral blood. No comparator, setting, or follow-up duration is reported.
No main results are available, as this is a study record describing a proposal. The record states that very little research has been conducted in obese animals or obese asthmatics, resulting in a major knowledge deficit that this study aims to address. Safety and tolerability data, including adverse events, serious adverse events, and discontinuations, are not reported.
Key limitations include the absence of reported results and the preliminary nature of the proposal. The practice relevance is not reported. Given that this is a study record without results, no clinical conclusions can be drawn. The findings, when available, will require careful evaluation in the context of the full study design and outcomes.
View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): Asthma, Obesity
Intervention(s): Hyperpolarized 129XeMRI (DRUG)
40% of all asthma patients in the US are obese. Obese asthmatics have more severe disease than lean asthmatics and do not respond as well to conventional anti-inflammatory therapies. This proposal will utilize 3D functional imaging with 129XeMRI and single cell RNA sequencing to study mechanisms driving regional airway remodeling and fibrosis in obese asthma subjects and in preclinical models of obese asthma.
Detailed: ABSTRACT
Obesity, a major comorbidity and a potential modulator of asthma, affects nearly 40% of asthmatics in the U.S., and increases its severity. Obese asthmatics do not respond as well to conventional anti-inflammatory therapies and new biologics targeting asthma are less effective in obese asthmatics compared to lean. Very little research has been conducted in obese animals or obese asthmatics, resulting in a major knowledge deficit.
A key feature of asthma is airway remodeling and fibrosis, broadly defined as a change in distribution, thickness, composition, mass or volume of structural components of the airway wall of patients relative to healthy patients. Airway remodeling is difficult to diagnose in obese patients as mechanical changes in chest wall compliance can contribute to
Primary Outcome(s): Percentage of Neutrophils in Peripheral Blood; Percentage of Eosinophils in Peripheral Blood
Enrollment: 49 (ACTUAL)
Lead Sponsor: Bastiaan Driehuys
Start: 2021-04-01 | Primary Completion: 2025-01-31
Results posted: 2026-03-23