NCT03118765

Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Dose Ranging, Parallel Group, Active (Spiriva® Respimat®) And Placebo Controlled Study To Assess Relative Bioavailability, Pharmacodynamics And Safety Of Three Doses Of Tiotropium Bromide Inhalation Solution In Subjects With Mild To Moderate Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Glenmark Specialty S.A. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Conditions

• Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	GSP304 (tiotropium bromide) Inhalation Solution	Once daily (QD) oral inhalation using a nebulizer
DRUG	GSP304 Placebo Inhalation Solution	Once daily (QD) oral inhalation using a nebulizer
DRUG	Spiriva® Respimat® inhalation spray	Once daily (QD) oral inhalation

Timeline

• Start date: 2017-03-24
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2017-04-18
• Last updated: 2019-08-01
• Results posted: 2019-08-01

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study