Pulmonary Disease, Chronic ObstructiveNCT01036763
Assessment of Chronic Obstructive Pulmonary Disease (COPD) Therapy From the Physicians Perspective Using Tiotropium as an Example
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 352 sites in Germany.
Trial summary
Documentation of successful therapy with tiotropium (Spiriva Respimat; Spiriva (tiotropium 18 mcg capsules)) in COPD patients requiring long-acting bronchodilators: description of the most important outcome parameters according to the physicians assessment to determine the success of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- Not given
- Where
- 352 sitesGermany
- Study dates
- Jan 2010to Aug 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients
Inclusion criteria COPD patients requiring long-acting bronchodilators according to approved Summary of Product Characteristics (SPC) and guidelines
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.
Trial locations and contacts
352 sites in 1 country.
300 sites in 1 country
Germany300 sites
Boehringer Ingelheim Investigational Site 1
Ahrensburg
Boehringer Ingelheim Investigational Site 2
Amberg
Boehringer Ingelheim Investigational Site 3
Arnstadt
Boehringer Ingelheim Investigational Site 4
Auerbach
Boehringer Ingelheim Investigational Site 10
Augsburg
Boehringer Ingelheim Investigational Site 5
Augsburg
Boehringer Ingelheim Investigational Site 6
Augsburg
Boehringer Ingelheim Investigational Site 7
Augsburg
Boehringer Ingelheim Investigational Site 8
Augsburg
Boehringer Ingelheim Investigational Site 9
Augsburg
Boehringer Ingelheim Investigational Site 11
Backnang
Boehringer Ingelheim Investigational Site 12
Bad Doberan
Boehringer Ingelheim Investigational Site 13
Bad Kissingen
Boehringer Ingelheim Investigational Site 15
Bad Kötzting
Boehringer Ingelheim Investigational Site 16
Bad Kötzting
Boehringer Ingelheim Investigational Site 14
Bad Krozingen
Boehringer Ingelheim Investigational Site 17
Bad Lippspringe
Boehringer Ingelheim Investigational Site 18
Bad Neuenahr-Ahrweiler
Boehringer Ingelheim Investigational Site 19
Bad Neustadt an der Saale
Boehringer Ingelheim Investigational Site 20
Bad Reichenhall
Boehringer Ingelheim Investigational Site 21
Bad Reichenhall
Boehringer Ingelheim Investigational Site 22
Bad Sachsa
Boehringer Ingelheim Investigational Site 23
Bad Wörishofen
Boehringer Ingelheim Investigational Site 24
Baden-Baden
Boehringer Ingelheim Investigational Site 25
Ballenstedt
Boehringer Ingelheim Investigational Site 26
Bamberg
Boehringer Ingelheim Investigational Site 27
Bautzen
Boehringer Ingelheim Investigational Site 28
Beelitz
Boehringer Ingelheim Investigational Site 29
Bensheim
Boehringer Ingelheim Investigational Site 30
Bergisch Gladbach
Boehringer Ingelheim Investigational Site 31
Berlin
Boehringer Ingelheim Investigational Site 32
Berlin
Boehringer Ingelheim Investigational Site 33
Berlin
Boehringer Ingelheim Investigational Site 34
Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
Boehringer Ingelheim Investigational Site 53
Bernau
Boehringer Ingelheim Investigational Site 54
Bitterfeld-Wolfen
Boehringer Ingelheim Investigational Site 55
Bochum
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Bochum
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Bonn
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Bonn
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Bonn
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Bonn
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Bottrop
Boehringer Ingelheim Investigational Site 62
Braunschweig
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Braunschweig
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Bremen
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Bremen
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Bremen
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Bremen
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Bremerhaven
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Bremerhaven
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Bruchsal
Boehringer Ingelheim Investigational Site 71
Buchholz
Boehringer Ingelheim Investigational Site 72
Castrop-Rauxel
Boehringer Ingelheim Investigational Site 73
Celle
Boehringer Ingelheim Investigational Site 74
Celle
Boehringer Ingelheim Investigational Site 75
Chemnitz
Boehringer Ingelheim Investigational Site 76
Coburg
Boehringer Ingelheim Investigational Site 77
Coburg
Boehringer Ingelheim Investigational Site 200
Cologne
Boehringer Ingelheim Investigational Site 201
Cologne
Boehringer Ingelheim Investigational Site 202
Cologne
Boehringer Ingelheim Investigational Site 78
Cottbus
Boehringer Ingelheim Investigational Site 79
Cottbus
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Dachau
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Darmstadt
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Deggendorf
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Delitzsch
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Dessau
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Dillingen
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Dillingen
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Donaueschingen
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Dorsten
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Dortmund
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Dresden
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Dresden
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Dresden
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Dresden
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Dresden
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Dresden
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Dresden
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Düren
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Düren
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Düsseldorf
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Düsseldorf
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Düsseldorf
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Düsseldorf
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Eichstätt
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Emden
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Erbach im Odenwald
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Erfurt
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Erfurt
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Erfurt
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Erlangen
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Eschwege
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Esslingen am Neckar
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Esslingen am Neckar
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Euskirchen
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Fellbach
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Flensburg
Boehringer Ingelheim Investigational Site 123
Föhren
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Forchheim
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Frankenthal
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Frankfurt
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Frankfurt
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Frankfurt
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Frankfurt
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Freising
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Fürstenfeldbruck
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Fürth
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Fürth
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Ganderkesee
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Gauting
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Geilenkirchen
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Gelsenkirchen
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Gelsenkirchen
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Gera
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Germering
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Giessen
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Giessen
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Göppingen
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Göttingen
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Göttingen
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Göttingen
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Greiz
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Grevesmühlen
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Großenhain
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Gummersbach
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Günzburg
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Gütersloh
Boehringer Ingelheim Investigational Site 146
Gütersloh
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Gütersloh
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Hagen
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Halberstadt
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Halle
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Halle
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Hamburg
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Hamburg
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Hamburg
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Hamburg
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Hamburg
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Hamburg
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Hamburg
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Hamburg
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Hamburg
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Hamburg
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Hamburg
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Hamm
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Hanover
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Hanover
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Hanover
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Hanover
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Hartha
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Heidelberg
Boehringer Ingelheim Investigational Site 170
Heidelberg
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Heidelberg
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Heidelberg
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Heilbronn
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Heilbronn
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Hemmingen
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Hemmingen
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Herne
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Hettstedt
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Hilden
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Husum
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Itzehoe
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Itzehoe
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Kaiserslautern
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Kaiserslautern
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Kamen
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Karlsruhe
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Karlsruhe
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Kempten
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Kiel
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Kiel
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Kiel
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Kirchheim
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Koblenz
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Koblenz
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Koblenz
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Koblenz
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Königs Wusterhausen
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Konstanz
Boehringer Ingelheim Investigational Site 204
Köthen
Boehringer Ingelheim Investigational Site 198
Krefeld
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Krefeld
Boehringer Ingelheim Investigational Site 205
Landshut
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Langen
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Langenfeld
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Langenfeld
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Leipzig
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Leipzig
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Leipzig
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Leonberg
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Leverkusen
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Leverkusen
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Lichtenfels
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Limburg
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Lippstadt
Boehringer Ingelheim Investigational Site 221
Loerrach
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Ludwigshafen
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Ludwigshafen
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Lüneburg
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Lüneburg
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Lützen
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Magdeburg
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Magdeburg
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Mainz
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Mainz
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Mannheim
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Mannheim
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Marburg
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Markkleeberg
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Marktredwitz
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Menden
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Minden
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Minden
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Mönchengladbach
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Mönchengladbach
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Mönchengladbach
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Mühlhausen
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München
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München
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München
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München
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München
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München
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München
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München
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Münster
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Münster
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Münster
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Neu-Ulm
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Neumarkt
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Neuwied
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Niesky
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Norderstedt
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Norderstedt
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Nordhausen
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Nuremberg
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Nuremberg
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Nuremberg
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Nuremberg
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Oberursel
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Offenburg
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Olpe
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Oranienburg
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Oschatz
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Oschersleben
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Osnabrück
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Parsberg
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Peine
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Pforzheim
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Plauen
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Plauen
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Plauen
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Potsdam
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Pulheim
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Rathenow
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Ratingen
Boehringer Ingelheim Investigational Site 280
Raubach
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Regensburg
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Remscheid
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Remscheid
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Rostock
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Rostock
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Roth
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Rottach-Egern
Boehringer Ingelheim Investigational Site 288
Rüsselsheim am Main
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Rüsselsheim am Main
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Saalfeld
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Saarbrücken
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Saarbrücken
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Saarbrücken
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Saarbrücken
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Saarbrücken
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Saarlouis
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Saarlouis
Boehringer Ingelheim Investigational Site 314
Saint Ingbert
Boehringer Ingelheim Investigational Site 298
Salzgitter
Boehringer Ingelheim Investigational Site 299
Schmallenberg
Boehringer Ingelheim Investigational Site 300
Schmölln
About this study
Official title: Assessment of COPD Therapy From the Physicians Perspective Using Tiotropium as an Example
Documentation of successful therapy with tiotropium (Spiriva Respimat; Spiriva (tiotropium 18 mcg capsules)) in COPD patients requiring long-acting bronchodilators: description of the most important outcome parameters according to the physicians assessment to determine the success of therapy. Such data are not yet available.
Also collection of physicians assessments and patients assessments of efficacy and tolerability of Spiriva Respimat, Spiriva (tiotropium 18 mcg capsules).
Read the detailed description
Study Design:
observational
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Treatment With Tiotropium According to Physician's Assessment
Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful
Measured: 6 - 12 weeks
Assessment of Efficacy According to Physician
Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined
Measured: 6 - 12 weeks
Assessment of Tolerability According to Physician
Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined
Measured: 6 - 12 weeks
Assessment of Efficacy According to Patient
patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)
Measured: 6 - 12 weeks
Assessment of Tolerability According to Patient
Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)
Measured: 6 - 12 weeks
Secondary outcomes (2)
Physician's Global Evaluation at Visit 1
Physician's global evaluation (PGE) of the patients' general condition at Visit 1 evaluated on an 8-point scale with the scores "Poor (1, 2)", "Satisfactory (3, 4)", "Good (5, 6)" and "Excellent (7, 8)" prior to treatment with Spiriva.
Measured: 0 weeks
Physician's Global Evaluation at Visit 2
Physician's global evaluation (PGE) of the patients' general condition at Visit 2 evaluated on an 8-point scale after approximately 6-12 weeks of treatment with Spiriva.
Measured: after 6 - 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036763
- Sponsor's protocol ID
- 205.455
- Status last verified
- Feb 2014
- First submitted
- 18 Dec 2009
- Last updated
- 27 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Rau-Berger H, Kroker A, Mitfessel H, Schmidt H, Glaab T Assessment of COPD-therapy with tiotropium by the treating pneumologist. 53rd Cong of the German Respiratory Society, Nuremberg, 29 Mar - 1 Apr 2012 (Poster), (2012)
Glaab T, Kroker A, Mitfessel H, Schmdit H, Rau-Berger H Evaluation of COPD treatment success by office-based pneumologists using the example of tiotropium. 21st Ann Cong of the European Respiratory Society (ERS), Amsterdam, 24 - 28 Sep 2011 (Poster), (2011)
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of COPD Therapy From the Physicians Perspective Using Tiotropium as an Example
- ClinicalTrials.gov ID
- NCT01036763
- Acronym / sponsor ID
- 205.455
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Posted 22 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Documentation of successful therapy with tiotropium (Spiriva Respimat; Spiriva (tiotropium 18 mcg capsules)) in COPD patients requiring long-acting bronchodilators: description of the most important outcome parameters according to the physicians assessment to determine the success of therapy. Such data are not yet available.
Also collection of physicians assessments and patients assessments of efficacy and tolerability of Spiriva Respimat, Spiriva (tiotropium 18 mcg capsules).
Detailed description
Study Design:
observational
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Success of Treatment With Tiotropium According to Physician's Assessment
Time frame: 6 - 12 weeks
Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful
Assessment of Efficacy According to Physician
Time frame: 6 - 12 weeks
Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined
Assessment of Tolerability According to Physician
Time frame: 6 - 12 weeks
Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined
Assessment of Efficacy According to Patient
Time frame: 6 - 12 weeks
patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)
Assessment of Tolerability According to Patient
Time frame: 6 - 12 weeks
Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)
2 secondary outcomes
Physician's Global Evaluation at Visit 1
Time frame: 0 weeks
Physician's Global Evaluation at Visit 2
Time frame: after 6 - 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundRau-Berger H, Kroker A, Mitfessel H, Schmidt H, Glaab T Assessment of COPD-therapy with tiotropium by the treating pneumologist. 53rd Cong of the German Respiratory Society, Nuremberg, 29 Mar - 1 Apr 2012 (Poster), (2012)
- BackgroundGlaab T, Kroker A, Mitfessel H, Schmdit H, Rau-Berger H Evaluation of COPD treatment success by office-based pneumologists using the example of tiotropium. 21st Ann Cong of the European Respiratory Society (ERS), Amsterdam, 24 - 28 Sep 2011 (Poster), (2011)
- Related InfoLink provided by the sponsor.
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Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
352 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 352 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 352 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of Treatment With Tiotropium According to Physician's Assessment (time frame: 6 - 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01036763, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.