Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma
- Conditions
- Pulmonary Disease, Chronic ObstructiveAsthma
- Registration Number
- NCT00152984
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this study is to demonstrate the superiority of tiotropium compared to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 472
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose) after 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method Change from baseline in Physical examination 12 weeks Forced vital capacity (FVC) 12 weeks AUC0-6hFVC defined in the same way as for FEV1. Day 1, week 4 Trough FVC defined in the same way as for FEV1. Day 1, week 4 Peak FVC defined in the same way as for FEV1 Day 1, week 4 Weekly average PEFR in the morning (a.m. pre-dose measurement) and in the evening (p.m. measurement). 12 weeks Weekly average number of puffs of rescue medication used 12 weeks Occurrence of adverse events 12 weeks Peak expiratory flow rate (PEFR) 12 weeks Use of rescue medication 12 weeks AUC0-6hFEV1 after first dose on Day 1 and after 4 weeks of treatment Change in trough FEV1 (i.e. trough response) from baseline. after 4 and 12 weeks of treatment Change in peak FEV1 from baseline (=peak response) after first dose after 4 and 12 weeks of treatment Change from baseline in pulse rate and systolic and diastolic blood pressure (seated) measured just before spirometry 12 weeks
Trial Locations
- Locations (43)
Clinique Reine Astrid
🇧🇪Malmedy, Belgium
Sint-Elisabethziekenhuis
🇧🇪Turnhout, Belgium
Hopital Notre Dame de Bon Secours
🇫🇷Metz cedex 1, France
Antonius Ziekenhuis
🇳🇱Sneek, Netherlands
VGH Research Pavillion
🇨🇦Vancouver, British Columbia, Canada
Respiratory Research Lab
🇨🇦Toronto, Ontario, Canada
Hopital Ambroise Pare
🇫🇷Marseille, France
Department of Medicine, Health Sciences Centre
🇨🇦Hamilton, Ontario, Canada
Amphia ziekenhuis
🇳🇱Breda, Netherlands
A.Z. VUB
🇧🇪Brussel, Belgium
CHU Sart Tilman
🇧🇪Angleur, Belgium
Department of Respiratory Medicine
🇨🇦Toronto, Ontario, Canada
Centre Medical Erdre St Augustin
🇫🇷Nantes, France
Ziekenhuigroep Twente
🇳🇱Hengelo, Netherlands
Ziekenhuisgroep Twent
🇳🇱Almelo, Netherlands
Atrium medisch centrum
🇳🇱Heerlen, Netherlands
BG 034, Room C2027
🇨🇦Winnipeg, Manitoba, Canada
Maxima Medisch Centrum
🇳🇱Velthoven, Netherlands
St. Elisabethziekenhuis
🇧🇪Herentals, Belgium
Hopital Laval
🇨🇦Ste-Foy, Quebec, Canada
Medicinsk afdeling B0642
🇩🇰Hiller?d, Denmark
Boehringer Ingelheim Investigational Site
🇿🇦Somerset West, South Africa
Hopital d'Annecy
🇫🇷Annecy, France
Lungemedicinsk afdeling Y
🇩🇰Hellerup, Denmark
Centre de Recherche Clinique -CUSE
🇨🇦Sherbrooke, Quebec, Canada
Hopital Prive Antony
🇫🇷Antony cedex, France
Hopital Gabriel Montpied
🇫🇷Clermont Ferrand cedex 1, France
Hopital Arnaud de Villeneuve
🇫🇷Montpellier, France
Lungemedicinsk Forskning 2B
🇩🇰Aarhus, Denmark
Lungemedicinsk Klinik
🇩🇰Hvidovre, Denmark
H:S Bispebjerg Hospital
🇩🇰K?benhavn NV, Denmark
Lungemedicinsk Forskning
🇩🇰Odense C, Denmark
Inamed Research GmbH & Co. KG
🇩🇪Gauting, Germany
ClinPharm Internat. GmbH & Co. KG
🇩🇪Gorlitz, Germany
Pneumologisches Forschungsinstitut GmbH am Krankenhaus
🇩🇪Hamburg, Germany
Hopital Maison blanche
🇫🇷Reims cedex, France
Universita di Genova
🇮🇹Genova, Italy
A.O. Pisana
🇮🇹Pisa, Italy
Med. Einrichtung der Universitat zu Koln
🇩🇪Koln, Germany
A. O. Universitaria di Ferrara - Arcispedale S. Anna
🇮🇹Ferrara, Italy
A.O. S. Martino e Cliniche Universitarie di Genova
🇮🇹Genova, Italy
MEDARS GmbH
🇩🇪Berlin, Germany
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands