Comparative Potency Evaluation of Salbutamol via HFA-152a and HFA-134a Propellant Metered Dose Inhalers in Adults with Mild Asthma

The primary objective of this study is to compare the **relative potency** of **salbutamol** when administered via metered dose inhalers containing different propellants, specifically HFA-152a and HFA-134a, in individuals with **mild asthma** aged 18 to 65 years. This comparison is clinically relevant as it may inform the selection of propellants in inhalers, potentially impacting the efficacy and safety of asthma management in this patient population.

The clinical trial involves a total of **91 participants** diagnosed with **mild asthma**. The study population includes both male and female subjects, with an age range spanning from 18 to 65 years. Participants were selected to ensure a representative sample of the general population affected by mild asthma, with consideration given to the inclusion of vulnerable populations. The trial does not specify particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the main objective of the trial or specific inclusion criteria.

The clinical trial is designed to evaluate the **relative potency** of salbutamol when administered via metered dose inhalers containing different propellants, specifically HFA-152a compared to HFA-134a, in individuals with **mild asthma**. This study is structured as a randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know which treatment is being administered, thereby minimizing bias. The trial is categorized as a Phase 3 study, indicating that it is conducted to confirm the effectiveness of the treatment, monitor side effects, and collect information that will allow the treatment to be used safely.

The trial is expected to commence recruitment on June 7, 2024, and is estimated to conclude by December 9, 2024. Participants will be involved in the study for a duration that aligns with the trial's timeline, from the initial screening to the end-of-study visit. The sequence of study visits begins with an inclusion visit, where potential participants are screened to ensure they meet the eligibility criteria. This is followed by a series of follow-up visits, which are scheduled to monitor the participants' response to the treatment and to collect necessary data. The study concludes with an end-of-study visit, where final assessments are conducted to evaluate the overall outcomes of the trial.

Participants are expected to remain in the study for its entire duration unless specific conditions arise that necessitate early termination. Such conditions may include adverse reactions to the treatment, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial's design and procedures are meticulously planned to ensure the collection of reliable data while prioritizing the safety and well-being of the participants.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the **experimental medication**, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on June 7, 2024, with an estimated end date of December 9, 2024. 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 provided data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The study will adhere to rigorous standards typical of Phase 3 trials, focusing on evaluating the treatment's effectiveness in a larger patient population. The trial's design will likely include validated scales, laboratory tests, or patient-reported outcomes to measure efficacy, consistent with standard practices in clinical research. The results will contribute to understanding the treatment's potential benefits and inform future clinical and regulatory decisions.