AstraZeneca’s Clinical Study on BGF MDI: Recent Developments and Market Impact

AstraZeneca ((AZN)), Parexel International ((PRXL)), AstraZeneca plc ((GB:AZN)), AstraZeneca ((DE:ZEGA)), AstraZeneca plc US ((AZNCF)) announced an update on their ongoing clinical study.

AstraZeneca, in collaboration with Parexel International, initiated a clinical study titled A Phase I, Randomized, Partial Double-blind, Single Dose, 3 Way Cross Over Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol for BGF MDI HFO Compared With BGF MDI HFA Using an AeroChamber Plus Flow Vu Spacer and to Compare the Lung Exposure of BGF MDI HFO With a Spacer to BGF MDI HFO Without a Spacer. The study aims to evaluate the bioequivalence of a new formulation of a metered dose inhaler (MDI) using a next-generation propellant compared to the existing formulation, focusing on lung exposure.

The interventions being tested include three formulations: BGF MDI HFA with a spacer, BGF MDI HFO with a spacer, and BGF MDI HFO without a spacer. These treatments are designed to deliver medications for respiratory conditions, with the spacer intended to improve drug delivery to the lungs.

This Phase I study employs a randomized, crossover design with quadruple masking, meaning that participants, care providers, investigators, and outcomes assessors are all blinded to treatment allocations. The primary purpose is to assess treatment efficacy and safety in healthy participants.

The study was initially set to start on October 17, 2024, with an estimated completion date not specified. However, the study status is currently marked as withdrawn, with the last update submitted on August 12, 2025. This indicates potential delays or changes in study execution.

The withdrawal of this study could impact AstraZeneca’s stock performance and investor sentiment, especially as the company competes in the respiratory treatment market. Investors may need to adjust expectations based on this development, considering the competitive landscape and the importance of innovation in respiratory therapies.

The study is currently marked as withdrawn, with further details available on the ClinicalTrials portal.