Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Improvement in Physical Functioning (SF-36 Activity Score) in COPD Patients With Exercise-induced Dyspnoea on Treatment With Spiriva® 18 Microgram (Capsules Containing 18 μg Tiotropium).
| NCT number | NCT00540163 |
| Other study ID # | 205.402 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | September 21, 2007 |
| Last updated | November 27, 2013 |
| Start date | April 2007 |
This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients with exercise-induced dyspnoea on treatment with Spiriva (tiotropium 18 µg capsules) and allows adverse events to be recorded and evaluated.
| Status | Completed |
| Enrollment | 1296 |
| Est. completion date | |
| Est. primary completion date | November 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: Men or women with COPD and a thoracic gas volume (TGV) of < 140% at rest, MRC value of 2 or more. Exclusion Criteria: - Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies. - Tiotropium bromide inhalation powder is contraindicated in patients with a hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to the excipient lactose monohydrate which contains milk protein. |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Boehringer Ingelheim Investigational Site | Amberg | |
| Germany | Boehringer Ingelheim Investigational Site | Anklam | |
| Germany | Boehringer Ingelheim Investigational Site | Aschau | |
| Germany | Boehringer Ingelheim Investigational Site | Auerbach | |
| Germany | Boehringer Ingelheim Investigational Site | Augsburg | |
| Germany | Boehringer Ingelheim Investigational Site | Backnang | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Doberan | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Lippspringe | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Oeynhausen | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Soden | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Wörishofen | |
| Germany | Boehringer Ingelheim Investigational Site | Beelitz | |
| Germany | Boehringer Ingelheim Investigational Site | Bensheim | |
| Germany | Boehringer Ingelheim Investigational Site | Bergisch Gladbach | |
| Germany | Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | Boehringer Ingelheim Investigational Site | Biberach | |
| Germany | Boehringer Ingelheim Investigational Site | Bochum | |
| Germany | Boehringer Ingelheim Investigational Site | Bonn | |
| Germany | Boehringer Ingelheim Investigational Site | Braunschweig | |
| Germany | Boehringer Ingelheim Investigational Site | Breisach | |
| Germany | Boehringer Ingelheim Investigational Site | Bremen | |
| Germany | Boehringer Ingelheim Investigational Site | Bremerhaven | |
| Germany | Boehringer Ingelheim Investigational Site | Bruchsal | |
| Germany | Boehringer Ingelheim Investigational Site | Buchholz | |
| Germany | Boehringer Ingelheim Investigational Site | Bünde | |
| Germany | Boehringer Ingelheim Investigational Site | Calw | |
| Germany | Boehringer Ingelheim Investigational Site | Castrop-Rauxel | |
| Germany | Boehringer Ingelheim Investigational Site | Celle | |
| Germany | Boehringer Ingelheim Investigational Site | Chemnitz | |
| Germany | Boehringer Ingelheim Investigational Site | Coburg | |
| Germany | Boehringer Ingelheim Investigational Site | Cottbus | |
| Germany | Boehringer Ingelheim Investigational Site | Darmstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Dillenburg | |
| Germany | Boehringer Ingelheim Investigational Site | Dinslaken | |
| Germany | Boehringer Ingelheim Investigational Site | Dortmund | |
| Germany | Boehringer Ingelheim Investigational Site | Dresden | |
| Germany | Boehringer Ingelheim Investigational Site | Duisburg | |
| Germany | Boehringer Ingelheim Investigational Site | Düren | |
| Germany | Boehringer Ingelheim Investigational Site | Düsseldorf | |
| Germany | Boehringer Ingelheim Investigational Site | Eisenhüttenstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Emden | |
| Germany | Boehringer Ingelheim Investigational Site | Erbach | |
| Germany | Boehringer Ingelheim Investigational Site | Erfurt | |
| Germany | Boehringer Ingelheim Investigational Site | Essen | |
| Germany | Boehringer Ingelheim Investigational Site | Esslingen | |
| Germany | Boehringer Ingelheim Investigational Site | Euskirchen | |
| Germany | Boehringer Ingelheim Investigational Site | Fellbach | |
| Germany | Boehringer Ingelheim Investigational Site | Flensburg | |
| Germany | Boehringer Ingelheim Investigational Site | Forchheim | |
| Germany | Boehringer Ingelheim Investigational Site | Frankfurt | |
| Germany | Boehringer Ingelheim Investigational Site | Freising | |
| Germany | Boehringer Ingelheim Investigational Site | Fürstenfeldbruck | |
| Germany | Boehringer Ingelheim Investigational Site | Fürth | |
| Germany | Boehringer Ingelheim Investigational Site | Gadebusch | |
| Germany | Boehringer Ingelheim Investigational Site | Geilenkirchen | |
| Germany | Boehringer Ingelheim Investigational Site | Gelnhausen | |
| Germany | Boehringer Ingelheim Investigational Site | Gelsenkirchen | |
| Germany | Boehringer Ingelheim Investigational Site | Germering | |
| Germany | Boehringer Ingelheim Investigational Site | Gießen | |
| Germany | Boehringer Ingelheim Investigational Site | Gifhorn | |
| Germany | Boehringer Ingelheim Investigational Site | Göppingen | |
| Germany | Boehringer Ingelheim Investigational Site | Gotha | |
| Germany | Boehringer Ingelheim Investigational Site | Greiz | |
| Germany | Boehringer Ingelheim Investigational Site | Gummersbach | |
| Germany | Boehringer Ingelheim Investigational Site | Gütersloh | |
| Germany | Boehringer Ingelheim Investigational Site | Halberstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Halle | |
| Germany | Boehringer Ingelheim Investigational Site | Hamburg | |
| Germany | Boehringer Ingelheim Investigational Site | Hameln | |
| Germany | Boehringer Ingelheim Investigational Site | Hamm | |
| Germany | Boehringer Ingelheim Investigational Site | Hannover | |
| Germany | Boehringer Ingelheim Investigational Site | Heidelberg | |
| Germany | Boehringer Ingelheim Investigational Site | Heilbronn | |
| Germany | Boehringer Ingelheim Investigational Site | Herne | |
| Germany | Boehringer Ingelheim Investigational Site | Hilden | |
| Germany | Boehringer Ingelheim Investigational Site | Hildesheim | |
| Germany | Boehringer Ingelheim Investigational Site | Hoyerswerda | |
| Germany | Boehringer Ingelheim Investigational Site | Ibbenbüren | |
| Germany | Boehringer Ingelheim Investigational Site | Ingolstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Iserlohn | |
| Germany | Boehringer Ingelheim Investigational Site | Kaiserslautern | |
| Germany | Boehringer Ingelheim Investigational Site | Kamen | |
| Germany | Boehringer Ingelheim Investigational Site | Karlsruhe | |
| Germany | Boehringer Ingelheim Investigational Site | Kaufbeuren | |
| Germany | Boehringer Ingelheim Investigational Site | Kempten | |
| Germany | Boehringer Ingelheim Investigational Site | Kevelaer | |
| Germany | Boehringer Ingelheim Investigational Site | Kiel | |
| Germany | Boehringer Ingelheim Investigational Site | Köln | |
| Germany | Boehringer Ingelheim Investigational Site | Konstanz | |
| Germany | Boehringer Ingelheim Investigational Site | Krefeld | |
| Germany | Boehringer Ingelheim Investigational Site | Landshut | |
| Germany | Boehringer Ingelheim Investigational Site | Langenfeld | |
| Germany | Boehringer Ingelheim Investigational Site | Leipzig | |
| Germany | Boehringer Ingelheim Investigational Site | Limburg | |
| Germany | Boehringer Ingelheim Investigational Site | Lindenberg | |
| Germany | Boehringer Ingelheim Investigational Site | Linz | |
| Germany | Boehringer Ingelheim Investigational Site | Lippstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Lörrach | |
| Germany | Boehringer Ingelheim Investigational Site | Lüdenscheid | |
| Germany | Boehringer Ingelheim Investigational Site | Ludwigsburg | |
| Germany | Boehringer Ingelheim Investigational Site | Lüneburg | |
| Germany | Boehringer Ingelheim Investigational Site | Magdeburg | |
| Germany | Boehringer Ingelheim Investigational Site | Mainz | |
| Germany | Boehringer Ingelheim Investigational Site | Marburg | |
| Germany | Boehringer Ingelheim Investigational Site | Markkleeberg | |
| Germany | Boehringer Ingelheim Investigational Site | Memmingen | |
| Germany | Boehringer Ingelheim Investigational Site | Menden | |
| Germany | Boehringer Ingelheim Investigational Site | Minden | |
| Germany | Boehringer Ingelheim Investigational Site | Moers | |
| Germany | Boehringer Ingelheim Investigational Site | Mönchengladbach | |
| Germany | Boehringer Ingelheim Investigational Site | Mühldorf | |
| Germany | Boehringer Ingelheim Investigational Site | Mülheim | |
| Germany | Boehringer Ingelheim Investigational Site | München | |
| Germany | Boehringer Ingelheim Investigational Site | Neu-Ulm | |
| Germany | Boehringer Ingelheim Investigational Site | Neunkirchen | |
| Germany | Boehringer Ingelheim Investigational Site | Norderstedt | |
| Germany | Boehringer Ingelheim Investigational Site | Nordhausen | |
| Germany | Boehringer Ingelheim Investigational Site | Nürnberg | |
| Germany | Boehringer Ingelheim Investigational Site | Oberursel | |
| Germany | Boehringer Ingelheim Investigational Site | Olpe | |
| Germany | Boehringer Ingelheim Investigational Site | Oschersleben | |
| Germany | Boehringer Ingelheim Investigational Site | Osnabrück | |
| Germany | Boehringer Ingelheim Investigational Site | Papenburg | |
| Germany | Boehringer Ingelheim Investigational Site | Peine | |
| Germany | Boehringer Ingelheim Investigational Site | Plauen | |
| Germany | Boehringer Ingelheim Investigational Site | Potsdam | |
| Germany | Boehringer Ingelheim Investigational Site | Pulheim | |
| Germany | Boehringer Ingelheim Investigational Site | Rastatt | |
| Germany | Boehringer Ingelheim Investigational Site | Rathenow | |
| Germany | Boehringer Ingelheim Investigational Site | Regensburg | |
| Germany | Boehringer Ingelheim Investigational Site | Remscheid | |
| Germany | Boehringer Ingelheim Investigational Site | Rendsburg | |
| Germany | Boehringer Ingelheim Investigational Site | Rostock | |
| Germany | Boehringer Ingelheim Investigational Site | Rüdersdorf | |
| Germany | Boehringer Ingelheim Investigational Site | Rüsselsheim | |
| Germany | Boehringer Ingelheim Investigational Site | Saarbrücken | |
| Germany | Boehringer Ingelheim Investigational Site | Saarlouis | |
| Germany | Boehringer Ingelheim Investigational Site | Salzgitter | |
| Germany | Boehringer Ingelheim Investigational Site | Schenefeld | |
| Germany | Boehringer Ingelheim Investigational Site | Schleswig | |
| Germany | Boehringer Ingelheim Investigational Site | Schmölln | |
| Germany | Boehringer Ingelheim Investigational Site | Schwalmstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Schwalmtal | |
| Germany | Boehringer Ingelheim Investigational Site | Schwerin | |
| Germany | Boehringer Ingelheim Investigational Site | Sebnitz | |
| Germany | Boehringer Ingelheim Investigational Site | Seevetal | |
| Germany | Boehringer Ingelheim Investigational Site | Siegen | |
| Germany | Boehringer Ingelheim Investigational Site | Singen | |
| Germany | Boehringer Ingelheim Investigational Site | Sinsheim | |
| Germany | Boehringer Ingelheim Investigational Site | Solingen | |
| Germany | Boehringer Ingelheim Investigational Site | Sonneberg | |
| Germany | Boehringer Ingelheim Investigational Site | Spremberg | |
| Germany | Boehringer Ingelheim Investigational Site | Stade | |
| Germany | Boehringer Ingelheim Investigational Site | Starnberg | |
| Germany | Boehringer Ingelheim Investigational Site | Steinbach | |
| Germany | Boehringer Ingelheim Investigational Site | Straelen | |
| Germany | Boehringer Ingelheim Investigational Site | Strausberg | |
| Germany | Boehringer Ingelheim Investigational Site | Stuttgart | |
| Germany | Boehringer Ingelheim Investigational Site | Teltow | |
| Germany | Boehringer Ingelheim Investigational Site | Teterow | |
| Germany | Boehringer Ingelheim Investigational Site | Troisdorf | |
| Germany | Boehringer Ingelheim Investigational Site | Unna | |
| Germany | Boehringer Ingelheim Investigational Site | Uttenreuth | |
| Germany | Boehringer Ingelheim Investigational Site | Verden | |
| Germany | Boehringer Ingelheim Investigational Site | Waiblingen | |
| Germany | Boehringer Ingelheim Investigational Site | Waren | |
| Germany | Boehringer Ingelheim Investigational Site | Warendorf | |
| Germany | Boehringer Ingelheim Investigational Site | Weiden | |
| Germany | Boehringer Ingelheim Investigational Site | Weißenhorn | |
| Germany | Boehringer Ingelheim Investigational Site | Wetzlar | |
| Germany | Boehringer Ingelheim Investigational Site | Wiesloch | |
| Germany | Boehringer Ingelheim Investigational Site | Wilhelmshaven | |
| Germany | Boehringer Ingelheim Investigational Site | Witten | |
| Germany | Boehringer Ingelheim Investigational Site | Worms | |
| Germany | Boehringer Ingelheim Investigational Site | Wuppertal | |
| Germany | Boehringer Ingelheim Investigational Site | Zella-Mehlis | |
| Germany | Boehringer Ingelheim Investigational Site | Zossen |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary endpoint was the proportion of patients with an improvement by =10 points in the standardised PF-10 score after 6 weeks of treatment with Spiriva® 18 Microgram | 6 weeks | Yes | |
| Secondary | The secondary endpoint was the change in the standardised PF-10 score within 6 weeks of treatment with Spiriva® 18 Microgram | 6 weeks | No |
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