CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 377 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Test Product (tiotropium bromide inhalation powder) 18 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03137992
NCT03137992Phase 3Completed
CompareCT.gov

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

Lupin, Inc.·interventional·Posted May 3, 2017·Updated Apr 5, 2021

In Brief

A Phase 3 clinical trial evaluating Placebo, Test Product (tiotropium bromide inhalation powder), and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 377 participants across 34 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 3, 2017
Enrollment StartNov 21, 2017
Primary CompletionJan 31, 2018
Study CompletionApr 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.2 years ago

Interventions

Placebodrug

Single dose of placebo inhalation powder administered by test and reference dry powder inhalers.

Test Product (tiotropium bromide inhalation powder)drug

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.

Reference Product (Spiriva®)drug

Reference product (Spiriva®) 18 mcg.