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

Status Completed

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 ;

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT04780984
• Study type: Interventional
• Source: Nephron Pharmaceuticals Corporation
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2020
• Completion date: April 26, 2021