Observational Non-Interventional Study With Spiriva Respimat in COPD Patients
Assessment of Physical Activity (PF10 Sub Domain of SF-36 Activity Score) and Tolerability in COPD Patients During Treatment With Spiriva® Respimat®
1 other identifier
observational
1,280
1 country
188
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
188 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 17, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedResults Posted
Study results publicly available
March 12, 2010
CompletedApril 10, 2014
March 1, 2014
7 months
June 17, 2008
January 13, 2010
March 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Change From Baseline in the PF-10 Score After 6 Weeks
Baseline and after 6 weeks of treatment
Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety
Baseline and after 6 weeks of treatment
Patients' Satisfaction After 6 Weeks of Treatment
6 weeks
Eligibility Criteria
Patients
You may qualify if:
- COPD patients who require treatment with longacting anticholinergic
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (188)
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 im Odenwald, Germany
Boehringer Ingelheim Investigational Site
Erfurt, Germany
Boehringer Ingelheim Investigational Site
Esslingen am Neckar, 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
Hanover, Germany
Boehringer Ingelheim Investigational Site 2
Hanover, Germany
Boehringer Ingelheim Investigational Site 3
Hanover, 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
Ibbenbueren, 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
Konstanz, Germany
Boehringer Ingelheim Investigational Site
Königs Wusterhausen, 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
Nuremberg, Germany
Boehringer Ingelheim Investigational Site 2
Nuremberg, Germany
Boehringer Ingelheim Investigational Site 3
Nuremberg, 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 am Main, 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
Saint Ingbert, Germany
Boehringer Ingelheim Investigational Site
Salzgitter, Germany
Boehringer Ingelheim Investigational Site
Schleswig, Germany
Boehringer Ingelheim Investigational Site
Schmölln, Germany
Boehringer Ingelheim Investigational Site
Schwandorf in Bayern, 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
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, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 17, 2008
First Posted
June 18, 2008
Study Start
June 1, 2008
Primary Completion
January 1, 2009
Last Updated
April 10, 2014
Results First Posted
March 12, 2010
Record last verified: 2014-03