Efficacy and Safety Comparison of Tiotropium Daily + Salmeterol Daily or Twice Daily Versus Tiotropium Daily in Patients With COPD

PHASE3CompletedINTERVENTIONAL
Enrollment

147

Participants

Timeline

Start Date

April 15, 2008

Primary Completion Date

July 22, 2009

Study Completion Date

July 22, 2009

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

Tiotropium (Tio18GEL)

18 µg Tiotropium (Tio18GEL) inhalation powder

DRUG

Salmeterol MDPI (Salm50DPI)

50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID)

DRUG

Tiotropium (T18GEL) + Salmeterol MDPI (S_DPI)

18 µg Tiotropium (T18GEL) inhalation powder plus 50 µg Salmeterol MDPI (S\_DPI) twice daily (BID)

DRUG

Tiotropium/Salmeterol (T+S_PE)

Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) inhalation powder

Trial Locations (12)

Unknown

1184.13.1302 Boehringer Ingelheim Investigational Site, Berlin

1184.13.1309 Boehringer Ingelheim Investigational Site, Berlin

1184.13.1308 Boehringer Ingelheim Investigational Site, Cottbus

1184.13.1311 Boehringer Ingelheim Investigational Site, Großhansdorf

1184.13.1312 Boehringer Ingelheim Investigational Site, Hamburg

1184.13.1305 Boehringer Ingelheim Investigational Site, Mainz

1184.13.1301 Boehringer Ingelheim Investigational Site, Mannheim

1184.13.1306 Boehringer Ingelheim Investigational Site, Rodgau-Dudenhofen

1184.13.1310 Boehringer Ingelheim Investigational Site, Rüdersdorf

1184.13.1307 Boehringer Ingelheim Investigational Site, Schwerin

1184.13.1304 Boehringer Ingelheim Investigational Site, Wiesbaden

1184.13.1303 Boehringer Ingelheim Investigational Site, Wiesloch

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT00662792 - Efficacy and Safety Comparison of Tiotropium Daily + Salmeterol Daily or Twice Daily Versus Tiotropium Daily in Patients With COPD | Biotech Hunter | Biotech Hunter