Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD)

PHASE3CompletedINTERVENTIONAL
Enrollment

335

Participants

Timeline

Start Date

August 17, 2022

Primary Completion Date

August 11, 2023

Study Completion Date

August 14, 2023

Conditions
COPD
Interventions
COMBINATION_PRODUCT

Test Product - Tiotropium Bromide Inhalation Powder 18 mcg

Test Product

COMBINATION_PRODUCT

Spiriva Handihaler (Tiotropium Bromide) 18 mcg

RLD

COMBINATION_PRODUCT

Placebo

Placebo Product

Trial Locations (33)

13057

Velocity clinical Research Syracuse (East North)), Syracuse

29204

Velocity Clinical Research Columbia, Columbia

29303

Velocity Clinical Research Spartanburg, Spartanburg

29340

Velocity Clinical Research Gaffney, Gaffney

29379

Velocity Clinical Research Union, Union

29615

Velocity Clinical Research Greenville, Greenville

29621

Velocity Clinical Research Anderson, Anderson

32132

Velocity Clinical Research - New Smyrna Beach, New Smyrna Beach

32607

SIMED Health, Gainesville

33145

Clintex Research Group, Inc., Miami

33173

Research Institue of South Florida, Miami

33176

Vista Health Research, Miami

33907

Southwest General Heathcare, Fort Myers

34744

Clinical Research Solutions, Kissimmee

45242

Velocity Clinical Research-Cincinnati, Cincinnati

70791

Southern Clinical Research, Zachary

77433

Inquest Clinical Research, Cypress

77479

Mt. Olympus Medical Research, Houston

78028

Sante Clinical Research, Kerrville

84088

Velocity Clinical Research-Utah, West Jordan

90017

DownTown LA Research (West Coast), Los Angeles

97504

Velocity Clinical Research Medford, Medford

97527

Velocity Clinical Research Grants Pass (W Coast), Grants Pass

02920

Greater Providence Clinical Research (East North), Cranston

Unknown

Anand Surgical Hospital Pvt. Ltd, Ahmedabad

Care and Cure Multispeciality Hospital, Ahmedabad

Hope Medicare Centre, Ahmedabad

Divine Multispeciality Hopsital, Gandhinagar

Maharaja Agrasen Superspeciality Hospital, Jaipur

Shree Hospital & Critical Care Centre, Nagpur

Chest Disease Hospital, Srinagar

Global Hospital, Surat

Dhawal Multispeciality Hospital, Vadodara

Sponsors
All Listed Sponsors
collaborator

Exeltis

INDUSTRY

collaborator

Laboratorios Liconsa

INDUSTRY

lead

Xiromed LLC

INDUSTRY