Assessment of Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol in BGF MDI HFO vs. BGF MDI HFA with and without Spacer in Healthy Volunteers

The primary objective of this study is 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. This evaluation is clinically relevant as it aims to determine if the new formulation with a spacer provides similar lung deposition and therapeutic effects as the existing formulation, which is crucial for ensuring consistent treatment efficacy in respiratory conditions. Additionally, the study seeks to compare the lung exposure of BGF MDI HFO with a spacer to BGF MDI HFO without a spacer, which is important for understanding the impact of spacer use on drug delivery to the lungs.

The clinical trial involves **healthy volunteers** with an age range of 18 to 65 years, encompassing both male and female participants. The study population includes individuals who are not affected by any specific medical condition, as the trial is designed for healthy subjects. The sponsor has not provided the total number of participants involved in the trial. Participants were selected without specific lifestyle considerations such as diet or physical activity being highlighted. The trial includes a vulnerable population, although specific details regarding this aspect are not disclosed. The sponsor has not provided detailed information on key inclusion or exclusion criteria for this study.

The clinical trial is designed as a **randomized**, partial **double-blind**, single-dose, 3-way cross-over study. The primary aim is 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. Additionally, the study will compare the lung exposure of BGF MDI HFO with a spacer to BGF MDI HFO without a spacer. The trial will involve healthy volunteers and is expected to commence recruitment on June 17, 2024, with an estimated completion date of October 26, 2024.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive the study interventions in a cross-over manner. Each participant will attend multiple follow-up visits to monitor safety, collect pharmacokinetic data, and ensure adherence to the study protocol. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted to evaluate the outcomes of the trial.

The expected duration of participant involvement will span the entire trial period, from the initial screening to the end-of-study visit. Conditions that may lead to early termination from the study include non-compliance with the study protocol, adverse events that compromise participant safety, or withdrawal of consent. The trial is structured to maintain scientific rigor and ensure the reliability of the data collected, adhering to ethical standards and regulatory requirements throughout its duration.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to commence recruitment on June 17, 2024, with an estimated completion date of October 26, 2024. The efficacy assessment will be conducted using predefined primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The efficacy parameters will be measured at various timepoints throughout the study duration, utilizing appropriate tools and instruments as per the trial protocol. The data collected will be analyzed to determine the efficacy of the intervention under investigation, adhering to the rigorous standards of clinical research.