Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma
NCT ID: NCT00152984
Last Updated: 2017-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
472 participants
INTERVENTIONAL
2004-12-31
2006-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tiotropium inhalation capsules
Placebo inhalation capsules
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Current or ex-smokers with a cigarette smoking history of at least 10 pack-years
* Treatment with inhaled steroids at least 1 year before study entry
* FEV1 increase of more than 12% 30 min. after 400 mcg salbutamol or documented reversibility of 12% documented during the past 5 years
* FEV1 increase of more than 200 mL 30 min. after 400 mcg salbutamol or documented increase of 200 mL after reversibility test within the last 5 years
* Post bronchodilator FEV1 less than 80% predicted normal (ECCS) at visit 1
* Post bronchodilator FEV1 less than 70% of FVC at visit 1
Exclusion Criteria
* Significant diseases other than COPD or asthma
* Myocardial infarction within the last 6 months
* Unstable or life-threatening cardiac arrhythmia requiring intervention or change in therapy in the last year
* Hospitalisation for heart failure (NYHA Class III or IV) within the last year
* History of life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
* Known active tuberculosis
* History of thoracotomy with pulmonary resection
* History of cancer within the last 5 years (excluding treated basal cell carcinoma)
* Patients requiring oxygen therapy for more than 1 hour per day
* Patients currently in a pulmonary rehabilitation programme or who have completed such a programme within 4 weeks before Visit 1
* Known hypersensitivity to anticholinergic drugs or lactose
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
B.I. Pharma GmbH & Co. KG
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Sart Tilman
Angleur, , Belgium
A.Z. VUB
Brussels, , Belgium
Boehringer Ingelheim Investigational Site
Genk, , Belgium
Boehringer Ingelheim Investigational Site
Hasselt, , Belgium
St. Elisabethziekenhuis
Herentals, , Belgium
Clinique Reine Astrid
Malmedy, , Belgium
Sint-Elisabethziekenhuis
Turnhout, , Belgium
VGH Research Pavillion
Vancouver, British Columbia, Canada
BG 034, Room C2027
Winnipeg, Manitoba, Canada
Department of Medicine, Health Sciences Centre
Hamilton, Ontario, Canada
Boehringer Ingelheim Investigational Site
Mississauga, Ontario, Canada
Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Respiratory Research Lab
Toronto, Ontario, Canada
Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Department of Respiratory Medicine
Toronto, Ontario, Canada
Centre de Recherche Clinique -CUSE
Sherbrooke, Quebec, Canada
Hopital Laval
Ste-Foy, Quebec, Canada
Lungemedicinsk Forskning 2B
Aarhus, , Denmark
Lungemedicinsk afdeling Y
Hellerup, , Denmark
Medicinsk afdeling B0642
Hiller?d, , Denmark
Lungemedicinsk Klinik
Hvidovre, , Denmark
H:S Bispebjerg Hospital
K?benhavn NV, , Denmark
Lungemedicinsk Forskning
Odense C, , Denmark
Hopital d'Annecy
Annecy, , France
Hopital Prive Antony
Antony, , France
Boehringer Ingelheim Investigational Site
Chamalières, , France
Hopital Gabriel Montpied
Clermont-Ferrand, , France
Hopital Ambroise Pare
Marseille, , France
Hopital Notre Dame de Bon Secours
Metz, , France
Boehringer Ingelheim Investigational Site
Montpellier, , France
Hopital Arnaud de Villeneuve
Montpellier, , France
Boehringer Ingelheim Investigational Site
Nantes, , France
Centre Medical Erdre St Augustin
Nantes, , France
Boehringer Ingelheim Investigational Site
Nice, , France
Hopital Maison blanche
Reims, , France
Boehringer Ingelheim Investigational Site
Berlin, , Germany
Boehringer Ingelheim Investigational Site
Berlin, , Germany
MEDARS GmbH
Berlin, , Germany
Boehringer Ingelheim Investigational Site
Bonn, , Germany
Med. Einrichtung der Universitat zu Koln
Cologne, , Germany
Boehringer Ingelheim Investigational Site
Frankfurt am Main, , Germany
Boehringer Ingelheim Investigational Site
Fürth, , Germany
Inamed Research GmbH & Co. KG
Gauting, , Germany
Boehringer Ingelheim Investigational Site
Gelnhausen, , Germany
ClinPharm Internat. GmbH & Co. KG
Görlitz, , Germany
Pneumologisches Forschungsinstitut GmbH am Krankenhaus
Hamburg, , Germany
Boehringer Ingelheim Investigational Site
Minden, , Germany
Boehringer Ingelheim Investigational Site
München, , Germany
Boehringer Ingelheim Investigational Site
Rudersdorf, , Germany
A. O. Universitaria di Ferrara - Arcispedale S. Anna
Ferrara, , Italy
A.O. S. Martino e Cliniche Universitarie di Genova
Genova, , Italy
Universita di Genova
Genova, , Italy
A.O. Pisana
Pisa, , Italy
Ziekenhuisgroep Twent
Almelo, , Netherlands
Amphia ziekenhuis
Breda, , Netherlands
Atrium medisch centrum
Heerlen, , Netherlands
Ziekenhuigroep Twente
Hengelo, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Antonius Ziekenhuis
Sneek, , Netherlands
Maxima Medisch Centrum
Velthoven, , Netherlands
Boehringer Ingelheim Investigational Site
Bellville, , South Africa
Boehringer Ingelheim Investigational Site
Cape Town, , South Africa
Boehringer Ingelheim Investigational Site
Cape Town, , South Africa
Boehringer Ingelheim Investigational Site
Durban, , South Africa
Boehringer Ingelheim Investigational Site
George, , South Africa
Boehringer Ingelheim Investigational Site
Paarl, , South Africa
Boehringer Ingelheim Investigational Site
Pretoria, , South Africa
Boehringer Ingelheim Investigational Site
Somerset West, , South Africa
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
205.301
Identifier Type: -
Identifier Source: org_study_id