Clinical trial NCT00540163: Observational Non-interventional Study With Spiriva in Chronic Obstructive Pulmonary Disease Patients With Exercise-induced Dyspnoea
Official title: Improvement in Physical Functioning (SF-36 Activity Score) in COPD Patients With Exercise-induced Dyspnoea on Treatment With Spiriva® 18 Microgram (Capsules Containing 18 μg Tiotropium).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-10-05
Enrollment: 1296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of office-based pulmonology practices

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.

Detailed description: Study Design:

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: 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
timeFrame: 6 weeks
Secondary outcomes:
measure: The secondary endpoint was the change in the standardised PF-10 score within 6 weeks of treatment with Spiriva® 18 Microgram
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Amberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Anklam
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Aschau
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Auerbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Augsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Backnang
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Doberan
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Lippspringe
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Oeynhausen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Soden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Wörishofen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Beelitz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bensheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bergisch Gladbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Biberach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bochum
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Braunschweig
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Breisach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bremen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bremerhaven
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bruchsal
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Buchholz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bünde
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Calw
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Castrop-Rauxel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Celle
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Chemnitz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Coburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Cottbus
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Darmstadt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dillenburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dinslaken
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dortmund
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Duisburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Düren
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Eisenhüttenstadt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Emden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Erbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Erfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Essen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Esslingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Euskirchen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Fellbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Flensburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Forchheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Freising
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Fürstenfeldbruck
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Fürth
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gadebusch
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Geilenkirchen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gelnhausen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gelsenkirchen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Germering
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gießen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gifhorn
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gotha
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Greiz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gummersbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Göppingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gütersloh
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Halberstadt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Halle
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hameln
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hamm
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Heidelberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Heilbronn
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Herne
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hilden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hildesheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hoyerswerda
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ibbenbüren
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ingolstadt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Iserlohn
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kaiserslautern
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kamen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Karlsruhe
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kaufbeuren
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kempten
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kevelaer
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kiel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Konstanz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Krefeld
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Landshut
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Langenfeld
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Limburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lindenberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Linz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lippstadt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ludwigsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lörrach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lüdenscheid
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lüneburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Magdeburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Marburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Markkleeberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Memmingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Menden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Minden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Moers
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mönchengladbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mühldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mülheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Neu-Ulm
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Neunkirchen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Norderstedt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Nordhausen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Oberursel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Olpe
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Oschersleben
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Osnabrück
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Papenburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Peine
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Plauen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Potsdam
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Pulheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rastatt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rathenow
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Regensburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Remscheid
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rendsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rostock
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rüdersdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rüsselsheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Saarbrücken
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Saarlouis
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Salzgitter
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Schenefeld
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Schleswig
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Schmölln
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Schwalmstadt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Schwalmtal
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Schwerin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Sebnitz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Seevetal
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Siegen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Singen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Sinsheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Solingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Sonneberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Spremberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Stade
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Starnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Steinbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Straelen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Strausberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Teltow
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Teterow
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Troisdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Unna
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Uttenreuth
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Verden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Waiblingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Warendorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Waren
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Weiden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Weißenhorn
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wetzlar
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wiesloch
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wilhelmshaven
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Witten
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Worms
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wuppertal
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Zella-Mehlis
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Zossen
country: Germany
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: