Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD

PHASE4CompletedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

May 30, 2014

Primary Completion Date

January 26, 2016

Study Completion Date

January 26, 2016

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

Budesonide

Budesonide 400 mcg twice a day via Breezhaler® device

DRUG

Fluticasone

Fluticasone 250 mcg twice daily via Accuhaler® device

DRUG

Indacaterol

Indacaterol 150 mcg once daily via Breezhaler® device

DRUG

Salmeterol

Salmeterol 50 mcg twice daily via Diskus® device

Trial Locations (25)

412

Novartis Investigative Site, Guayaquil

1900

Novartis Investigative Site, La Plata

2800

Novartis Investigative Site, Zárate

4000

Novartis Investigative Site, Salta

10205

Novartis Investigative Site, Santo Domingo

14050

Novartis Investigative Site, Mexico City

21102

Novartis Investigative Site, San Pedro Sula

37000

Novartis Investigative Site, León

2841959

Novartis Investigative Site, Rancagua

8431633

Novartis Investigative Site, Santiago

C1125ABE

Novartis Investigative Site, Buenos Aires

C1056ABJ

Novartis Investigative Site, Caba

B1602DQD

Novartis Investigative Site, Florida

B1638AAI

Novartis Investigative Site, Vicente López

C1425FVH

Novartis Investigative Site, Ciudad Autonoma de Bs As

Unknown

Novartis Investigative Site, Santa Rosa

Novartis Investigative Site, Santo Domingo

Novartis Investigative Site, Tegucigalpa

Novartis Investigative Site, Panama City

021941-617

Novartis Investigative Site, Rio de Janeiro

90880-480

Novartis Investigative Site, Porto Alegre

09750-420

Novartis Investigative Site, São Bernardo do Campo

01244-030

Novartis Investigative Site, São Paulo

03310

Novartis Investigative Site, Mexico City

06760

Novartis Investigative Site, Mexico City

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY