Evaluation of Tiotropium Bromide 2.5μg Soft Mist Inhaler Device in Patients with Chronic Obstructive Pulmonary Disease

The primary objective of this open-label study is to assess the effect of patient use and the robustness of the tiotropium bromide spray 2.5μg soft mist inhaler device in patients with chronic obstructive pulmonary disease. Evaluating device performance and user interaction is clinically relevant to ensure consistent drug delivery and therapeutic efficacy in managing this respiratory condition.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients diagnosed with chronic obstructive pulmonary disease. The cohort includes both male and female individuals. The age range for participants corresponds to specific age codes 3 and 4.

This Phase 3, open-label study is designed to assess the effect of patient use and the robustness of the Tiotropium Bromide Spray 2.5μg delivered via a Soft Mist Inhaler device in individuals with Chronic obstructive pulmonary disease. The research methodology involves a sequence of clinical assessments starting with a screening visit to determine eligibility. Subsequent follow-up visits will be conducted to monitor device performance and patient usage, concluding with an end-of-study visit. The total duration of participant involvement is determined by the study protocol, and early termination may occur based on predefined clinical criteria or withdrawal conditions. The recruitment period for this trial is estimated to occur between October 2025 and December 2025.

The assessment of efficacy in this Phase 3 clinical trial for chronic obstructive pulmonary disease is not specified in the provided documentation.