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

PHASE2CompletedINTERVENTIONAL
Enrollment

155

Participants

Timeline

Start Date

March 24, 2017

Primary Completion Date

July 31, 2017

Study Completion Date

July 31, 2017

Conditions
Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
Interventions
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

Trial Locations (25)

28207

Glenmark Investigational Site 9, Charlotte

29303

Glenmark Investigational Site 15, Spartanburg

Glenmark Investigational Site 7, Spartanburg

29615

Glenmark Investigational Site 2, Greenville

Glenmark Investigational Site 4, Greenville

29640

Glenmark Investigational Site 3, Easley

29732

Glenmark Investigational Site 1, Rock Hill

32124

Glenmark Investigational Site 20, Ormond Beach

32132

Glenmark Investigational Site 19, Edgewater

32789

Glenmark Investigational Site 13, Winter Park

32825

Glenmark Investigational Site 6, Orlando

32960

Glenmark Investigational Site 21, Vero Beach

33016

Glenmark Investigational Site 10, Miami Lakes

33144

Glenmark Investigational Site 24, Miami

33186

Glenmark Investigational Site 16, Miami

36420

Glenmark Investigational Site 23, Andalusia

43016

Glenmark Investigational Site 8, Dublin

43213

Glenmark Investigational Site 5, Columbus

43215

Glenmark Investigational Site 22, Columbus

77375

Glenmark Investigational Site 25, Tomball

85006

Glenmark Investigational Site 12, Phoenix

85283

Glenmark Investigational Site 14, Tempe

89119

Glenmark Investigational Site 18, Las Vegas

92835

Glenmark Investigational Site 17, Fullerton

97504-9741

Glenmark Investigational Site 11, Medford

All Listed Sponsors
lead

Glenmark Specialty S.A.

INDUSTRY

NCT03118765 - Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter | Biotech Hunter