Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD

PHASE2CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

September 30, 2008

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

Tiotropium

Oral inhalation by HandiHaler® device

DRUG

Salmeterol

Oral inhalation from Diskus®

DRUG

Fluticasone

Oral inhalation from metered dose inhaler (MDI)

DRUG

Ciclesonide low

Oral inhalation from MDI

DRUG

Ciclesonide high

Oral inhalation from MDI

DRUG

Placebo

Oral inhalation from MDI

Trial Locations (12)

Unknown

1249.1.32003 Boehringer Ingelheim Investigational Site, Genk

1249.1.32001 Boehringer Ingelheim Investigational Site, Ghent

1249.1.32002 Boehringer Ingelheim Investigational Site, Hasselt

1249.1.32004 Boehringer Ingelheim Investigational Site, Ostend

1249.1.45001 Boehringer Ingelheim Investigational Site, Aarhus C

1249.1.49001 Boehringer Ingelheim Investigational Site, Großhansdorf

1249.1.49002 Boehringer Ingelheim Investigational Site, Mannheim

1249.1.49003 Boehringer Ingelheim Investigational Site, Weinheim

1249.1.31002 Boehringer Ingelheim Investigational Site, Eindhoven

1249.1.31003 Boehringer Ingelheim Investigational Site, Harderwijk

1249.1.31001 Boehringer Ingelheim Investigational Site, Heerlen

1249.1.31004 Boehringer Ingelheim Investigational Site, Veldhoven

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY