Clinical trial NCT00699699: Observational Non-Interventional Study With Spiriva Respimat in COPD Patients
Official title: Assessment of Physical Activity (PF10 Sub Domain of SF-36 Activity Score) and Tolerability in COPD Patients During Treatment With Spiriva® Respimat®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 1280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks
timeFrame: Baseline and after 6 weeks of treatment
Secondary outcomes:
measure: Change From Baseline in the PF-10 Score After 6 Weeks
timeFrame: Baseline and after 6 weeks of treatment
measure: Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety
timeFrame: Baseline and after 6 weeks of treatment
measure: Patients' Satisfaction After 6 Weeks of Treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Amberg
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 1
city: Augsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Augsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Backnang
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Doberan
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Kötzing
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Lippspringe
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Nauheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Reichenhall
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Baden-Baden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bergisch Gladbach
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Bergisch Gladbach
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 5
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 6
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 7
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 8
city: Bochum
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Bonn
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Bottrop
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Braunschweig
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Braunschweig
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Braunschweig
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Bremen
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Bremen
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Bremerhaven
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Bremerhaven
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Burg
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: Cottbus
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Detmold
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dillenburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Donauwörth
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dormagen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dorsten
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 1
city: Dresden
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Dresden
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
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 1
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: Emden
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Emden
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Erbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Erfurt
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: Flensbrug
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Flensburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Frankenthal
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: Fürstenfeldbruck
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Fürstenwalde
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Fürth
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Geilenkirchen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Giessen
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Giessen
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Grimma
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gütersloh
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Gütersloh
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Hainburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 5
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 6
city: Hamm
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Heidelberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Heidelberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Heilbronn
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Heilbronn
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Herne
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hildburghausen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hilden
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: Karlsruhe
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kiel
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Kiel
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Koblenz
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Koblenz
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Konstanz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kyritz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Königs Wusterhausen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Leverkusen
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Leverkusen
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Limbach-Oberfrohna
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 1
city: Magdeburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Magdeburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Mannheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Markkleeberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Menden
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: Mühlheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 5
city: Nauen
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: Nordhorn
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Nürnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Nürnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Oberhausen
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Oberhausen
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Oberursel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Offenbach
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Offenbach
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Offenburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Olpe
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Oranienburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Osnabrück
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Peine
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Pforzheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rastatt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ratingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Ratingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Recklinghausen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Remscheid
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rostock
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Roth
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rottach-Egern
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rudolstadt
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 1
city: Saarbrücken
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Saarbrücken
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Saarlouis
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Salzgitter
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: Schwandorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Sebnitz
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: Solingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Solingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Solingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Solingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: St. Ingbert
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Stadthagen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Steinhagen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Strausberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Stremberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Tauberbischofsheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Tübingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ulm
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Ulm
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Ulm
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Velbert
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Waren
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Wiesbaden
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Wiesloch
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wilhelmshaven
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Wilhelmshaven
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Witten
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wittstock
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wolfsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Zirndorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: