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

NCT00540163 | Completed

• 1 other identifier: 205.402
• Study Type: observational
• Target: 1,296
• Locations: 1 country
• Sites: 177

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

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

  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

  6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients of office-based pulmonology practices

You may qualify if:

• Men or women with COPD and a thoracic gas volume (TGV) of \< 140% at rest, MRC value of 2 or more.

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.
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (177)

Boehringer Ingelheim Investigational Site

Amberg, Germany

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Boehringer Ingelheim Investigational Site

Anklam, Germany

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Boehringer Ingelheim Investigational Site

Aschau, Germany

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Boehringer Ingelheim Investigational Site

Auerbach, Germany

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Boehringer Ingelheim Investigational Site

Augsburg, Germany

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Boehringer Ingelheim Investigational Site

Backnang, Germany

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Bad Doberan, Germany

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Bad Lippspringe, Germany

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Bad Oeynhausen, Germany

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Boehringer Ingelheim Investigational Site

Bad Soden, Germany

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Bad Wörishofen, Germany

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Boehringer Ingelheim Investigational Site

Beelitz, Germany

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Boehringer Ingelheim Investigational Site

Bensheim, Germany

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Boehringer Ingelheim Investigational Site

Bergisch Gladbach, Germany

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Boehringer Ingelheim Investigational Site

Berlin, Germany

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Biberach, Germany

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Bochum, Germany

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Bonn, Germany

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Braunschweig, Germany

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Breisach, Germany

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Bremen, Germany

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Bremerhaven, Germany

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Bruchsal, Germany

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Buchholz, Germany

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Bünde, Germany

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Calw, Germany

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Castrop-Rauxel, Germany

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Celle, Germany

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Chemnitz, Germany

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Coburg, Germany

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Cologne, Germany

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Cottbus, Germany

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Darmstadt, Germany

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Dillenburg, Germany

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Dinslaken, Germany

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Dortmund, Germany

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Dresden, Germany

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Duisburg, Germany

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Düren, Germany

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Düsseldorf, Germany

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Eisenhüttenstadt, Germany

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Emden, Germany

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Erbach im Odenwald, Germany

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Erfurt, Germany

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Essen, Germany

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Esslingen am Neckar, Germany

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Euskirchen, Germany

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Fellbach, Germany

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Flensburg, Germany

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Forchheim, Germany

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Frankfurt, Germany

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Freising, Germany

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Fürstenfeldbruck, Germany

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Fürth, Germany

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Gadebusch, Germany

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Geilenkirchen, Germany

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Gelnhausen, Germany

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Gelsenkirchen, Germany

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Germering, Germany

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Giessen, Germany

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Gifhorn, Germany

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Gotha, Germany

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Göppingen, Germany

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Greiz, Germany

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Gummersbach, Germany

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Gütersloh, Germany

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Halberstadt, Germany

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Halle, Germany

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Hamburg, Germany

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Hamelin, Germany

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Hamm, Germany

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Hanover, Germany

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Heidelberg, Germany

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Heilbronn, Germany

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Herne, Germany

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Hilden, Germany

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Hildesheim, Germany

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Hoyerswerda, Germany

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Ibbenbueren, Germany

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Ingolstadt, Germany

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Iserlohn, Germany

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Kaiserslautern, Germany

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Kamen, Germany

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Karlsruhe, Germany

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Kaufbeuren, Germany

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Kempten, Germany

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Kevelaer, Germany

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Kiel, Germany

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Konstanz, Germany

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Krefeld, Germany

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Landshut, Germany

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Langenfeld, Germany

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Leipzig, Germany

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Limburg, Germany

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Lindenberg, Germany

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Linz, Germany

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Lippstadt, Germany

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Loerrach, Germany

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Ludwigsburg, Germany

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Lüdenscheid, Germany

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Lüneburg, Germany

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Magdeburg, Germany

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Mainz, Germany

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Marburg, Germany

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Markkleeberg, Germany

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Memmingen, Germany

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Menden, Germany

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Minden, Germany

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Moers, Germany

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Mönchengladbach, Germany

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Mühldorf, Germany

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Mülheim, Germany

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München, Germany

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Neu-Ulm, Germany

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Neunkirchen, Germany

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Norderstedt, Germany

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Nordhausen, Germany

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Nuremberg, Germany

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Oberursel, Germany

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Olpe, Germany

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Oschersleben, Germany

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Osnabrück, Germany

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Papenburg, Germany

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Peine, Germany

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Plauen, Germany

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Potsdam, Germany

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Pulheim, Germany

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Rastatt, Germany

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Rathenow, Germany

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Regensburg, Germany

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Remscheid, Germany

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Rendsburg, Germany

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Rostock, Germany

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Rüdersdorf, Germany

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Rüsselsheim am Main, Germany

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Saarbrücken, Germany

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Saarlouis, Germany

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Salzgitter, Germany

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Schenefeld, Germany

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Schleswig, Germany

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Schmölln, Germany

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Schwalmstadt, Germany

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Schwalmtal, Germany

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Schwerin, Germany

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Sebnitz, Germany

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Seevetal, Germany

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Siegen, Germany

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Singen, Germany

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Sinsheim, Germany

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Solingen, Germany

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Sonneberg, Germany

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Spremberg, Germany

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Stade, Germany

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Starnberg, Germany

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Steinbach, Germany

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Straelen, Germany

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Strausberg, Germany

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Stuttgart, Germany

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Teltow, Germany

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Teterow, Germany

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Troisdorf, Germany

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Unna, Germany

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Uttenreuth, Germany

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Verden an der Aller, Germany

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Waiblingen, Germany

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Waren, Germany

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Warendorf, Germany

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Weiden, Germany

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Weißenhorn, Germany

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Wetzlar, Germany

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Wiesloch, Germany

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Wilhelmshaven, Germany

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Witten, Germany

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Worms, Germany

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Wuppertal, Germany

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Zella-Mehlis, Germany

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Boehringer Ingelheim Investigational Site

Zossen, Germany

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: October 5, 2007
• Study Start: April 1, 2007
• Primary Completion: November 1, 2007
• Last Updated: November 28, 2013

Record last verified: 2013-10

Locations

DE (177)