NCT03137992

Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover, Multicenter Clinical Study to Assess the Efficacy and Safety of Once Daily Administration of Lupin Tiotropium Bromide Inhalation Powder Compared to SPIRIVA® HANDIHALER® and Placebo in Patients With COPD Including a 12-Week Open Label Extension to Assess Inhaler Robustness

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 377 (actual)
• Sponsor: Lupin, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to show bioequivalence of test product to reference product based on baseline-adjusted forced expiratory volume in one second (FEV1).

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Placebo	Single dose of placebo inhalation powder administered by test and reference dry powder inhalers.
DRUG	Test Product (tiotropium bromide inhalation powder)	Double-Blind: Single dose of test product 18 mcg of test product Open-Label: once daily administration of test product (tiotropium bromide inhalation powder) 18 mcg administered by test dry powder inhaler.
DRUG	Reference Product (Spiriva®)	Reference product (Spiriva®) 18 mcg.

Timeline

• Start date: 2017-11-21
• Primary completion: 2018-01-31
• Completion: 2018-04-30
• First posted: 2017-05-03
• Last updated: 2021-04-05
• Results posted: 2021-04-05

Locations

34 sites across 1 country: United States

Regulatory

• FDA-regulated drug study