Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Assessment of Physical Activity (PF10 Sub Domain of SF-36 Activity Score) and Tolerability in COPD Patients During Treatment With Spiriva® Respimat®
| NCT number | NCT00699699 |
| Other study ID # | 205.426 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | June 17, 2008 |
| Last updated | March 12, 2014 |
| Start date | June 2008 |
This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients on treatment with Spiriva Respimat and allows adverse events to be recorded and evaluated.
| Status | Completed |
| Enrollment | 1280 |
| Est. completion date | |
| Est. primary completion date | January 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: COPD patients who require treatment with longacting anticholinergic 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. Spiriva® Respimat® is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients. |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Boehringer Ingelheim Investigational Site | Aachen | |
| Germany | Boehringer Ingelheim Investigational Site | Amberg | |
| Germany | Boehringer Ingelheim Investigational Site | Auerbach | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Augsburg | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Augsburg | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Augsburg | |
| Germany | Boehringer Ingelheim Investigational Site | Backnang | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Doberan | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Kötzing | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Lippspringe | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Nauheim | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Reichenhall | |
| Germany | Boehringer Ingelheim Investigational Site | Baden-Baden | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Bergisch Gladbach | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Bergisch Gladbach | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Berlin | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Berlin | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Berlin | |
| Germany | Boehringer Ingelheim Investigational Site 4 | Berlin | |
| Germany | Boehringer Ingelheim Investigational Site 5 | Berlin | |
| Germany | Boehringer Ingelheim Investigational Site 6 | Berlin | |
| Germany | Boehringer Ingelheim Investigational Site 7 | Berlin | |
| Germany | Boehringer Ingelheim Investigational Site 8 | Berlin | |
| Germany | Boehringer Ingelheim Investigational Site | Bochum | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Bonn | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Bonn | |
| Germany | Boehringer Ingelheim Investigational Site | Bottrop | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Braunschweig | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Braunschweig | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Braunschweig | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Bremen | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Bremen | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Bremerhaven | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Bremerhaven | |
| Germany | Boehringer Ingelheim Investigational Site | Burg | |
| Germany | Boehringer Ingelheim Investigational Site | Castrop-Rauxel | |
| Germany | Boehringer Ingelheim Investigational Site | Celle | |
| Germany | Boehringer Ingelheim Investigational Site | Cottbus | |
| Germany | Boehringer Ingelheim Investigational Site | Detmold | |
| Germany | Boehringer Ingelheim Investigational Site | Dillenburg | |
| Germany | Boehringer Ingelheim Investigational Site | Donauwörth | |
| Germany | Boehringer Ingelheim Investigational Site | Dormagen | |
| Germany | Boehringer Ingelheim Investigational Site | Dorsten | |
| Germany | Boehringer Ingelheim Investigational Site | Dortmund | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Dresden | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Dresden | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Dresden | |
| Germany | Boehringer Ingelheim Investigational Site | Duisburg | |
| Germany | Boehringer Ingelheim Investigational Site | Düren | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Düsseldorf | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Düsseldorf | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Düsseldorf | |
| Germany | Boehringer Ingelheim Investigational Site 4 | Düsseldorf | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Emden | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Emden | |
| Germany | Boehringer Ingelheim Investigational Site | Erbach | |
| Germany | Boehringer Ingelheim Investigational Site | Erfurt | |
| Germany | Boehringer Ingelheim Investigational Site | Esslingen | |
| Germany | Boehringer Ingelheim Investigational Site | Euskirchen | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Flensbrug | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Flensburg | |
| Germany | Boehringer Ingelheim Investigational Site | Frankenthal | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Frankfurt | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Frankfurt | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Frankfurt | |
| Germany | Boehringer Ingelheim Investigational Site 4 | Frankfurt | |
| Germany | Boehringer Ingelheim Investigational Site | Fürstenfeldbruck | |
| Germany | Boehringer Ingelheim Investigational Site | Fürstenwalde | |
| Germany | Boehringer Ingelheim Investigational Site | Fürth | |
| Germany | Boehringer Ingelheim Investigational Site | Geilenkirchen | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Giessen | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Giessen | |
| Germany | Boehringer Ingelheim Investigational Site | Grimma | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Gütersloh | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Gütersloh | |
| Germany | Boehringer Ingelheim Investigational Site | Hainburg | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Hamburg | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Hamburg | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Hamburg | |
| Germany | Boehringer Ingelheim Investigational Site 4 | Hamburg | |
| Germany | Boehringer Ingelheim Investigational Site 5 | Hamburg | |
| Germany | Boehringer Ingelheim Investigational Site 6 | Hamburg | |
| Germany | Boehringer Ingelheim Investigational Site | Hamm | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Hannover | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Hannover | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Hannover | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Heidelberg | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Heidelberg | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Heilbronn | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Heilbronn | |
| Germany | Boehringer Ingelheim Investigational Site | Herne | |
| Germany | Boehringer Ingelheim Investigational Site | Hildburghausen | |
| Germany | Boehringer Ingelheim Investigational Site | Hilden | |
| Germany | Boehringer Ingelheim Investigational Site | Hoyerswerda | |
| Germany | Boehringer Ingelheim Investigational Site | Ibbenbüren | |
| Germany | Boehringer Ingelheim Investigational Site | Karlsruhe | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Kiel | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Kiel | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Koblenz | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Koblenz | |
| Germany | Boehringer Ingelheim Investigational Site | Königs Wusterhausen | |
| Germany | Boehringer Ingelheim Investigational Site | Konstanz | |
| Germany | Boehringer Ingelheim Investigational Site | Kyritz | |
| Germany | Boehringer Ingelheim Investigational Site | Leipzig | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Leverkusen | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Leverkusen | |
| Germany | Boehringer Ingelheim Investigational Site | Limbach-Oberfrohna | |
| Germany | Boehringer Ingelheim Investigational Site | Lüdenscheid | |
| Germany | Boehringer Ingelheim Investigational Site | Lüneburg | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Magdeburg | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Magdeburg | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Magdeburg | |
| Germany | Boehringer Ingelheim Investigational Site | Mannheim | |
| Germany | Boehringer Ingelheim Investigational Site | Markkleeberg | |
| Germany | Boehringer Ingelheim Investigational Site | Menden | |
| Germany | Boehringer Ingelheim Investigational Site | Moers | |
| Germany | Boehringer Ingelheim Investigational Site | Mönchengladbach | |
| Germany | Boehringer Ingelheim Investigational Site | Mühlheim | |
| Germany | Boehringer Ingelheim Investigational Site 1 | München | |
| Germany | Boehringer Ingelheim Investigational Site 2 | München | |
| Germany | Boehringer Ingelheim Investigational Site 3 | München | |
| Germany | Boehringer Ingelheim Investigational Site 4 | München | |
| Germany | Boehringer Ingelheim Investigational Site 5 | München | |
| Germany | Boehringer Ingelheim Investigational Site | Nauen | |
| Germany | Boehringer Ingelheim Investigational Site | Norderstedt | |
| Germany | Boehringer Ingelheim Investigational Site | Nordhausen | |
| Germany | Boehringer Ingelheim Investigational Site | Nordhorn | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Nürnberg | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Nürnberg | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Nürnberg | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Oberhausen | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Oberhausen | |
| Germany | Boehringer Ingelheim Investigational Site | Oberursel | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Offenbach | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Offenbach | |
| Germany | Boehringer Ingelheim Investigational Site | Offenburg | |
| Germany | Boehringer Ingelheim Investigational Site | Olpe | |
| Germany | Boehringer Ingelheim Investigational Site | Oranienburg | |
| Germany | Boehringer Ingelheim Investigational Site | Osnabrück | |
| Germany | Boehringer Ingelheim Investigational Site | Peine | |
| Germany | Boehringer Ingelheim Investigational Site | Pforzheim | |
| Germany | Boehringer Ingelheim Investigational Site | Rastatt | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Ratingen | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Ratingen | |
| Germany | Boehringer Ingelheim Investigational Site | Recklinghausen | |
| Germany | Boehringer Ingelheim Investigational Site | Remscheid | |
| Germany | Boehringer Ingelheim Investigational Site | Rostock | |
| Germany | Boehringer Ingelheim Investigational Site | Roth | |
| Germany | Boehringer Ingelheim Investigational Site | Rottach-Egern | |
| Germany | Boehringer Ingelheim Investigational Site | Rudolstadt | |
| Germany | Boehringer Ingelheim Investigational Site | Rüsselsheim | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Saarbrücken | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Saarbrücken | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Saarbrücken | |
| Germany | Boehringer Ingelheim Investigational Site | Saarlouis | |
| Germany | Boehringer Ingelheim Investigational Site | Salzgitter | |
| Germany | Boehringer Ingelheim Investigational Site | Schleswig | |
| Germany | Boehringer Ingelheim Investigational Site | Schmölln | |
| Germany | Boehringer Ingelheim Investigational Site | Schwandorf | |
| Germany | Boehringer Ingelheim Investigational Site | Sebnitz | |
| Germany | Boehringer Ingelheim Investigational Site | Siegen | |
| Germany | Boehringer Ingelheim Investigational Site | Singen | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Solingen | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Solingen | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Solingen | |
| Germany | Boehringer Ingelheim Investigational Site 4 | Solingen | |
| Germany | Boehringer Ingelheim Investigational Site | St. Ingbert | |
| Germany | Boehringer Ingelheim Investigational Site | Stadthagen | |
| Germany | Boehringer Ingelheim Investigational Site | Steinhagen | |
| Germany | Boehringer Ingelheim Investigational Site | Strausberg | |
| Germany | Boehringer Ingelheim Investigational Site | Stremberg | |
| Germany | Boehringer Ingelheim Investigational Site | Stuttgart | |
| Germany | Boehringer Ingelheim Investigational Site | Tauberbischofsheim | |
| Germany | Boehringer Ingelheim Investigational Site | Tübingen | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Ulm | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Ulm | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Ulm | |
| Germany | Boehringer Ingelheim Investigational Site | Velbert | |
| Germany | Boehringer Ingelheim Investigational Site | Waren | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Wiesbaden | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Wiesbaden | |
| Germany | Boehringer Ingelheim Investigational Site | Wiesloch | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Wilhelmshaven | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Wilhelmshaven | |
| Germany | Boehringer Ingelheim Investigational Site | Witten | |
| Germany | Boehringer Ingelheim Investigational Site | Wittstock | |
| Germany | Boehringer Ingelheim Investigational Site | Wolfsburg | |
| Germany | Boehringer Ingelheim Investigational Site | Zirndorf |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks | Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition) | Baseline and after 6 weeks of treatment | No |
| Secondary | Change From Baseline in the PF-10 Score After 6 Weeks | Numerical changes in physical functioning (PF-10) after 6 weeks of treatment. PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition) | Baseline and after 6 weeks of treatment | No |
| Secondary | Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety | Changes in Physician's Global Evaluation in physical functioning from baseline after 6 weeks of treatment (measured as 8 point scale with classifications "poor" (1, 2), "satisfactory" (3, 4), "good" (5, 6), and "excellent" (7, 8)) | Baseline and after 6 weeks of treatment | No |
| Secondary | Patients' Satisfaction After 6 Weeks of Treatment | Patients' satisfaction with the Spiriva® Respimat® device after 6 weeks of treatment ("very satisfied", "satisfied", "rather satisfied", "neither satisfied nor "unsatisfied", "rather unsatisfied", "unsatisfied", and "very unsatisfied") | 6 weeks | No |
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