Bioequivalence Study of Indacaterol/Glycopyrronium Inhalation Powder in Adult COPD Patients: PG341 vs. Ultibro Breezhaler

The primary objective of this study is to evaluate the **bioequivalence** of indacaterol/glycopyrronium (85/43 mcg inhalation powder hard capsules) produced by Celon Pharma (PG341) compared to Ultibro Breezhaler by Novartis. This is clinically relevant as it aims to establish whether the two formulations can be used interchangeably for the maintenance bronchodilator treatment to relieve symptoms in adult patients with **chronic obstructive pulmonary disease (COPD)**. The study is designed as a randomized, single dose, cross-over, replicated, open-label trial. No secondary objectives are specified.

The clinical trial involves a study population comprising adult patients diagnosed with **chronic obstructive pulmonary disease (COPD)**, requiring maintenance bronchodilator treatment to alleviate symptoms. The trial includes both male and female participants, with an age range classified under category code 3, indicating adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. Additionally, details on the selection process for the trial population, as well as key inclusion or exclusion criteria, have not been disclosed.

The clinical trial is designed as a **randomized**, single-dose, cross-over, replicated, open-label bioequivalence study. The primary objective is to compare the bioequivalence of indacaterol/glycopyrronium (85/43mcg inhalation powder hard capsules) with Ultibro Breezhaler in the maintenance bronchodilator treatment for adult patients with **chronic obstructive pulmonary disease (COPD)**. The trial is categorized as a Phase 2 study and is expected to commence recruitment on November 1, 2024, with an estimated completion date of January 31, 2025.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive the study treatments in a cross-over manner. The study design includes multiple follow-up visits to monitor safety, efficacy, and pharmacokinetic parameters. The end-of-study visit will conclude the participant's involvement, ensuring all necessary data is collected and any post-treatment assessments are completed.

The expected length of participant involvement is determined by the study's cross-over design, which requires participants to receive both treatments with appropriate washout periods in between. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The study aims to ensure rigorous adherence to protocol to maintain the integrity and validity of the collected data.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to commence recruitment on November 1, 2024, with an estimated completion date of January 31, 2025. The efficacy assessment will be conducted through a series of pre-defined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The study will adhere to rigorous clinical standards to evaluate the therapeutic impact of the investigational product. The trial's design and execution will be aligned with regulatory requirements to ensure the reliability and validity of the efficacy outcomes.