Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

PHASE3CompletedINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

August 31, 2008

Study Completion Date

August 31, 2008

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

Indacaterol

Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)

DRUG

Salmeterol/fluticasone (50/500 μg)

Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

DRUG

Salbutamol (200 µg)

Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

DRUG

Placebo to Indacaterol

Placebo to indacaterol delivered via SDDPI

DRUG

Placebo to Salmeterol/fluticasone

Placebo to salmeterol/fluticasone delivered via MDDPI

DRUG

Placebo to salbutamol

Placebo to salbutamol delivered via MDDPI

Trial Locations (17)

15009

Novartis Investigative Site, Beaver

28150

Novartis Investigative site, Shelby

33321

Novartis Investigative Site, Tamarac

70503

Novartis Investigator Site, Lafayette

63301-2847

Novartis Investigative Site, Saint Charles

Unknown

Novartis Investigative Site, Antwerp

Novartis Investigative Site, Berlin

Novartis Investigator Site, Borstel

Novartis Investigative site, Dortmund

Novartis Investigative site, Hamburg

Novartis Investigative site, Hanover

Novartis Investigative site, Mainz

Novartis Investigator Site, Potsdam

Novartis Investigative site, Wiesbaden

Novartis Investigative site, Debrecen

Novartis Investigative site, Deszk

Novartis Investigative Site, Nyíregyháza

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY