CClinicalTrials.gg
CompletedNCT00540163Updated Nov 28, 2013

Observational Non-interventional Study With Spiriva in Chronic Obstructive Pulmonary Disease Patients With Exercise-induced Dyspnoea

An observational study in Chronic Obstructive Pulmonary Disease, sponsored by Boehringer Ingelheim. Completed at 177 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-28.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
1,296
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

Study Design:

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Conditions studied

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In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 1,296 is above the median of 157 across 929 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients of office-based pulmonology practices

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

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.
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Study design

Time perspective
Prospective
Enrollment
1,296 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 weeks

Secondary outcomes

  1. The secondary endpoint was the change in the standardised PF-10 score within 6 weeks of treatment with Spiriva® 18 Microgram

    Time frame: 6 weeks

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Study locations

177 sites
  • 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
    Gotha, Germany
  • Boehringer Ingelheim Investigational Site
    Greiz, Germany
  • Boehringer Ingelheim Investigational Site
    Gummersbach, Germany
  • Boehringer Ingelheim Investigational Site
    Göppingen, 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
    Konstanz, Germany
  • Boehringer Ingelheim Investigational Site
    Krefeld, Germany
  • Boehringer Ingelheim Investigational Site
    Köln, 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
    Ludwigsburg, Germany
  • Boehringer Ingelheim Investigational Site
    Lörrach, Germany
  • Boehringer Ingelheim Investigational Site
    Lüdenscheid, Germany

Showing the first 100 of 177 sites.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00540163
Lead sponsor
Boehringer Ingelheim
First posted
Oct 5, 2007
Start date
Apr 2007
Primary completion
Nov 2007
Last update
Nov 28, 2013

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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