A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control

PHASE3CompletedINTERVENTIONAL
Enrollment

169

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DRUG

Indacaterol

Indacaterol 150 μg or 300 μg, delivered via SDDPI

DRUG

Tiotropium

Tiotropium 18 μg once daily delivered via inhalation device

DRUG

Placebo

Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)

Trial Locations (20)

Unknown

Novartis Investigative site, Camperdown

Novartis Investigator Site, Gauting

Novartis Investigator Site, Großhansdorf

Novartis Investigator Site, Mainz

Novartis Investigator site, Marburg

Novartis Investigator Site, Wiesbaden

Novartis Investigator Site, Almelo

Novartis Investigator Site, Breda

Novartis Investigator Site, Eindhoven

Novartis Investigator Site, Harderwijk

Novartis Investigator Site, Helmond

Novartis Investigator Site, Wellington

Novartis Investigator Site, Katowice

Novartis Investigator Site, Warsaw

Novartis Investigator Site, Durban

Novartis Investigator Site, A Coruña

Novartis Investigative site, Alicante

Novartis Investigative Site, Cacenes

Novartis Investigative Site, Madrid

Novartis Investigator Site, Ourense

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY

NCT00615459 - A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control | Biotech Hunter | Biotech Hunter