Observational Non-Interventional Study With Spiriva Respimat in COPD Patients

March 12, 2014 updated by: Boehringer Ingelheim

Assessment of Physical Activity (PF10 Sub Domain of SF-36 Activity Score) and Tolerability in COPD Patients During Treatment With Spiriva® Respimat®

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • Boehringer Ingelheim Investigational Site
      • Amberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Auerbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Augsburg, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Augsburg, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Augsburg, Germany
        • Boehringer Ingelheim Investigational Site 3
      • 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
      • Bergisch Gladbach, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Bergisch Gladbach, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Berlin, Germany
        • Boehringer Ingelheim Investigational Site 4
      • Berlin, Germany
        • Boehringer Ingelheim Investigational Site 5
      • Berlin, Germany
        • Boehringer Ingelheim Investigational Site 8
      • Berlin, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Berlin, Germany
        • Boehringer Ingelheim Investigational Site 3
      • Berlin, Germany
        • Boehringer Ingelheim Investigational Site 6
      • Berlin, Germany
        • Boehringer Ingelheim Investigational Site 7
      • Berlin, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Bochum, Germany
        • Boehringer Ingelheim Investigational Site
      • Bonn, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Bonn, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Bottrop, Germany
        • Boehringer Ingelheim Investigational Site
      • Braunschweig, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Braunschweig, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Braunschweig, Germany
        • Boehringer Ingelheim Investigational Site 3
      • Bremen, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Bremen, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Bremerhaven, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Bremerhaven, Germany
        • Boehringer Ingelheim Investigational Site 2
      • 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
      • Dresden, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Dresden, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Dresden, Germany
        • Boehringer Ingelheim Investigational Site 3
      • Duisburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Düren, Germany
        • Boehringer Ingelheim Investigational Site
      • Düsseldorf, 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
      • Emden, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Emden, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Erbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Erfurt, Germany
        • Boehringer Ingelheim Investigational Site
      • Esslingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Euskirchen, Germany
        • Boehringer Ingelheim Investigational Site
      • Flensbrug, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Flensburg, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Frankenthal, Germany
        • Boehringer Ingelheim Investigational Site
      • Frankfurt, 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
      • Fürstenfeldbruck, Germany
        • Boehringer Ingelheim Investigational Site
      • Fürstenwalde, Germany
        • Boehringer Ingelheim Investigational Site
      • Fürth, Germany
        • Boehringer Ingelheim Investigational Site
      • Geilenkirchen, Germany
        • Boehringer Ingelheim Investigational Site
      • Giessen, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Giessen, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Grimma, Germany
        • Boehringer Ingelheim Investigational Site
      • Gütersloh, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Gütersloh, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Hainburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • Boehringer Ingelheim Investigational Site 6
      • Hamburg, Germany
        • Boehringer Ingelheim Investigational Site 3
      • Hamburg, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Hamburg, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Hamburg, Germany
        • Boehringer Ingelheim Investigational Site 4
      • Hamburg, Germany
        • Boehringer Ingelheim Investigational Site 5
      • Hamm, Germany
        • Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Hannover, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Hannover, Germany
        • Boehringer Ingelheim Investigational Site 3
      • Heidelberg, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Heidelberg, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Heilbronn, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Heilbronn, Germany
        • Boehringer Ingelheim Investigational Site 2
      • 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
      • Kiel, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Kiel, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Koblenz, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Koblenz, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Konstanz, Germany
        • Boehringer Ingelheim Investigational Site
      • Kyritz, Germany
        • Boehringer Ingelheim Investigational Site
      • Königs Wusterhausen, Germany
        • Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • Boehringer Ingelheim Investigational Site
      • Leverkusen, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Leverkusen, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Limbach-Oberfrohna, Germany
        • Boehringer Ingelheim Investigational Site
      • Lüdenscheid, Germany
        • Boehringer Ingelheim Investigational Site
      • Lüneburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Magdeburg, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Magdeburg, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Magdeburg, Germany
        • Boehringer Ingelheim Investigational Site 3
      • 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
      • München, Germany
        • Boehringer Ingelheim Investigational Site 3
      • München, Germany
        • Boehringer Ingelheim Investigational Site 1
      • München, Germany
        • Boehringer Ingelheim Investigational Site 2
      • München, Germany
        • Boehringer Ingelheim Investigational Site 4
      • München, Germany
        • Boehringer Ingelheim Investigational Site 5
      • Nauen, Germany
        • Boehringer Ingelheim Investigational Site
      • Norderstedt, Germany
        • Boehringer Ingelheim Investigational Site
      • Nordhausen, Germany
        • Boehringer Ingelheim Investigational Site
      • Nordhorn, Germany
        • Boehringer Ingelheim Investigational Site
      • Nürnberg, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Nürnberg, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Nürnberg, Germany
        • Boehringer Ingelheim Investigational Site 3
      • Oberhausen, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Oberhausen, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Oberursel, Germany
        • Boehringer Ingelheim Investigational Site
      • Offenbach, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Offenbach, Germany
        • Boehringer Ingelheim Investigational Site 2
      • 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
      • Ratingen, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Ratingen, Germany
        • Boehringer Ingelheim Investigational Site 2
      • 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
      • Saarbrücken, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Saarbrücken, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Saarbrücken, Germany
        • Boehringer Ingelheim Investigational Site 3
      • 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
      • Solingen, 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
      • 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
      • Ulm, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Ulm, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Ulm, Germany
        • Boehringer Ingelheim Investigational Site 3
      • Velbert, Germany
        • Boehringer Ingelheim Investigational Site
      • Waren, Germany
        • Boehringer Ingelheim Investigational Site
      • Wiesbaden, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Wiesbaden, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Wiesloch, Germany
        • Boehringer Ingelheim Investigational Site
      • Wilhelmshaven, Germany
        • Boehringer Ingelheim Investigational Site 1
      • Wilhelmshaven, Germany
        • Boehringer Ingelheim Investigational Site 2
      • Witten, Germany
        • Boehringer Ingelheim Investigational Site
      • Wittstock, Germany
        • Boehringer Ingelheim Investigational Site
      • Wolfsburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Zirndorf, Germany
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks
Time Frame: Baseline and after 6 weeks of treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the PF-10 Score After 6 Weeks
Time Frame: Baseline and after 6 weeks of treatment
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
Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety
Time Frame: Baseline and after 6 weeks of treatment
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
Patients' Satisfaction After 6 Weeks of Treatment
Time Frame: 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

April 10, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.426

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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