NCT03137992 - Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness | Biotech Hunter

Enrollment

377

Participants

Timeline

Start Date

November 21, 2017

Primary Completion Date

January 31, 2018

Study Completion Date

April 30, 2018

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

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.

Trial Locations (34)

23606

Investigational Research Center Site #1031, Newport News

27607

Investigational Research Center Site #1032, Raleigh

29303

Investigational Research Center Site #1020, Spartanburg

Investigational Research Center Site #1025, Spartanburg

29340

Investigational Research Center Site #1012, Gaffney

29379

Investigational Research Center Site #1027, Union

29640

Investigational Research Center Site #1015, Easley

29678

Investigational Research Center Site #1024, Seneca

29732

Investigational Research Center Site #1023, Rock Hill

32825

Investigational Research Center Site #1036, Orlando

33756

Investigational Research Center Site #1026, Clearwater

33765

Investigational Research Center Site #1019, Clearwater

Investigational Research Center Site #1035, Clearwater

35501

Investigational Research Center Site #1003, Jasper

36420

Investigational Research Center Site #1017, Andalusia

37909

Investigational Research Center Site #1004, Knoxville

43215

Investigational Research Center Site #1037, Columbus

55432

Investigational Research Center Site #1011, Fridley

63141

Investigational Research Center Site #1029, St Louis

73034

Investigational Research Center Site #1018, Edmond

73103

Investigational Research Center Site #1009, Oklahoma City

74136

Investigational Research Center Site #1033, Tulsa

75069

Investigational Research Center Site #1002, McKinney

78130

Investigational Research Center Site #1030, New Braunfels

79903

Investigational Research Center Site #1013, El Paso

80907

Investigational Research Center Site #1016, Colorado Springs

85306

Investigational Research Center Site #1008, Glendale

89119

Investigational Research Center Site #1007, Las Vegas

90025

Investigational Research Center Site #1034, Los Angeles

92506

Investigational Research Center Site #1028, Riverside

92683

Investigational Research Center Site #1010, Westminster

97202

Investigational Research Center Site #1006, Portland

97504

Investigational Research Center Site #1005, Medford

02747

Investigational Research Center Site #1001, North Dartmouth

All Listed Sponsors

lead

Lupin, Inc.

INDUSTRY