A Six-week Study Comparing the Efficacy and Safety of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD)

PHASE4CompletedINTERVENTIONAL
Enrollment

605

Participants

Timeline

Start Date

November 30, 2003

Primary Completion Date

September 30, 2004

Study Completion Date

September 30, 2004

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

Test: Tiotropium 18 µg per day (one inhalation capsule) plus 12 µg formoterol twice daily (two times one inhalation capsule)

DRUG

Reference: Salmeterol MDI 50 µg (2 puffs of 25 µg each) b.i.d., plus fluticasone propionate MDI 500 µg (2 puffs of 250 µg each) b.i.d.

Trial Locations (56)

1120

Boehringer Ingelheim Investigational Site, Vienna

2018

Sint-Vincentius Ziekenhuis, Antwerp

2193

Boehringer Ingelheim Investigational Site, Johannesburg

2350

Boehringer Ingelheim Investigational Site, Vosselaar

4001

Boehringer Ingelheim Investigational Site, Durban

St. Augustine Hospital, Durban

4032

CHU Notre Dame des Bruyères, Chênée

4600

Klinikum Kreuzschwestern Wels, Wels

6529

QdotPharma, George

7530

Tiervlei Trial Centre, Bellville

7646

Boehringer Ingelheim Investigational Site, Paarl

7700

UCT Lung Institute, Cape Town

8001

Boehringer Ingelheim Investigational Site, Cape Town

8036

Med. Uni.-Klinik Graz, Graz

8930

Heilig Hartziekenhuis Campus Menen, Menen

9301

Boehringer Ingelheim Investigational Site, Bloemfontein

13597

Boehringer Ingelheim Investigational Site, Berlin

14057

MEDARS GmbH, Berlin

17140

Boehringer Ingelheim Investigational Site, Lagord

20535

Pneumologisches Forschungsinstitut GmbH, Hamburg

22927

am Krankenhaus Großhansdorf, Großhansdorf

24105

Boehringer Ingelheim Investigational Site, Kiel

30176

Boehringer Ingelheim Investigational Site, Hanover

32423

Boehringer Ingelheim Investigational Site, Minden

38100

Boehringer Ingelheim Investigational Site, Grenoble

39120

Otto-von-Guericke-Universtität Magdeburg, Magdeburg

44263

ClinGuard GmbH, Dortmund

44791

Klinikum der Ruhr-Universität Bochum, Bochum

50931

Klinikum der Universität zu Köln, Cologne

59042

Clinique de la Louvière, Lille

60323

Boehringer Ingelheim Investigational Site, Frankfurt am Main

62660

Centre Hospitalier Germon et Gauthier, Beuvry

63003

Hôpital Gabriel Montpied, Clermont-Ferrand

63571

Boehringer Ingelheim Investigational Site, Gelnhausen

80634

Boehringer Ingelheim Investigational Site, München

82131

Inamed Research GmbH & Co. KG, Gauting

DK-8000

Lungemedicinsk Forskning 2B, Aarhus

DK-2400

Bispebjerg Hospital, Copenhagen NV

DK-2900

Amtssygehuset i Gentofte, Hellerup

DK-2650

Hvidovre Hospital, Hvidovre

DK-5000

Odense Universitetshospital, Odense C

04229

ClinPharm International GmbH & Co. KG, Leipzig

7609 PP

Poli Longziekten, Almelo

4819 EV

lokatie Langendijk, Breda

5623 EJ

Catharina Hospital, Eindhoven

6419 PC

Polikliniek Longziekten, Heerlen

7555 DL

Poli Longziekten, Hengelo

6525 GA

UMC St Radboud ziekenhuis, Nijmegen

3045 PM

Sint Franciscus Gasthuis, Rotterdam

5504 DB

Afdeling CardioSearch, Veldhoven

0083

Boehringer Ingelheim Investigational Site, Pretoria

S-551 85

Lung- och allergikliniken, Länssjukhuset Ryhov, Jönköping

591 85

Endokrinologmott/Medicinkliniken, Motala

141 86

Lung och allergikliniken, Stockholm

171 76

Lung och allergikliniken, Stockholm

S-901 85

Lung- och allergikliniken, Universitetssjukhuset, Umeå

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT00239421 - A Six-week Study Comparing the Efficacy and Safety of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter | Biotech Hunter