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Tiotropium Bromide Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:
A Phase 2, Randomized, Partially-blinded, Parallel Group, Dose-ranging Study to Assess the Pharmacodynamics, Relative Bioavailability, and Safety of of Tiotropium Bromide Inhalation Solution in Subjects With COPD

Clinical Trial Summary

A Phase 2, Randomized, Partially-blinded, Parallel Group, Dose-ranging Study to Assess the Pharmacodynamics, Relative Bioavailability, and Safety of Three Doses of Tiotropium Bromide Inhalation Solution in Subjects with Chronic Obstructive Pulmonary Disease

Clinical Trial Description

Objectives: Primary: • To determine the effect of once daily dosing with tiotropium bromide inhalation solution for 22 consecutive days on trough forced expiratory volume in 1 second (FEV1) change from baseline compared with that of placebo inhalation solution in subjects with chronic obstructive pulmonary disease (COPD). Secondary: - To determine the effect of once daily dosing with tiotropium bromide inhalation solution for 22 consecutive days on trough FEV1 change from baseline compared with that of Spiriva Respimat; area under the curve (AUC) FEV10-6 change from baseline compared with that of placebo and Spiriva Respimat; and trough forced vital capacity (FVC) change from baseline compared with that of placebo and Spiriva Respimat - To assess the safety and tolerability of tiotropium bromide inhalation solution in subjects with COPD - To assess the relative bioavailability of tiotrop ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04780984
Study type Interventional
Source Nephron Pharmaceuticals Corporation
Contact
Status Completed
Phase Phase 2
Start date November 1, 2020
Completion date April 26, 2021
View Details
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