NCT04780984

Tiotropium Bromide Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Nephron Pharmaceuticals Corporation · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Tiotropium bromide inhalation solution	Tiotropium bromide inhalation solution
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-04-20
• Completion: 2021-04-26
• First posted: 2021-03-04
• Last updated: 2021-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study