Clinical trial NCT01036763: Assessment of Chronic Obstructive Pulmonary Disease (COPD) Therapy From the Physicians Perspective Using Tiotropium as an Example
Official title: Assessment of COPD Therapy From the Physicians Perspective Using Tiotropium as an Example
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-12-21
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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Success of Treatment With Tiotropium According to Physician's Assessment
timeFrame: 6 - 12 weeks
measure: Assessment of Efficacy According to Physician
timeFrame: 6 - 12 weeks
measure: Assessment of Tolerability According to Physician
timeFrame: 6 - 12 weeks
measure: Assessment of Efficacy According to Patient
timeFrame: 6 - 12 weeks
measure: Assessment of Tolerability According to Patient
timeFrame: 6 - 12 weeks
Secondary outcomes:
measure: Physician's Global Evaluation at Visit 1
timeFrame: 0 weeks
measure: Physician's Global Evaluation at Visit 2
timeFrame: after 6 - 12 weeks
Other outcomes:
Locations:
city: Ahrensburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Amberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Arnstadt
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Auerbach
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: Augsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 10
city: Augsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 5
city: Augsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 6
city: Augsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 7
city: Augsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 8
city: Augsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 9
city: Backnang
country: Germany
facility: Boehringer Ingelheim Investigational Site 11
city: Bad Doberan
country: Germany
facility: Boehringer Ingelheim Investigational Site 12
city: Bad Kissingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 13
city: Bad Krozingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 14
city: Bad Kötzting
country: Germany
facility: Boehringer Ingelheim Investigational Site 15
city: Bad Kötzting
country: Germany
facility: Boehringer Ingelheim Investigational Site 16
city: Bad Lippspringe
country: Germany
facility: Boehringer Ingelheim Investigational Site 17
city: Bad Neuenahr-Ahrweiler
country: Germany
facility: Boehringer Ingelheim Investigational Site 18
city: Bad Neustadt
country: Germany
facility: Boehringer Ingelheim Investigational Site 19
city: Bad Reichenhall
country: Germany
facility: Boehringer Ingelheim Investigational Site 20
city: Bad Reichenhall
country: Germany
facility: Boehringer Ingelheim Investigational Site 21
city: Bad Sachsa
country: Germany
facility: Boehringer Ingelheim Investigational Site 22
city: Bad Wörishofen
country: Germany
facility: Boehringer Ingelheim Investigational Site 23
city: Baden-Baden
country: Germany
facility: Boehringer Ingelheim Investigational Site 24
city: Ballenstedt
country: Germany
facility: Boehringer Ingelheim Investigational Site 25
city: Bamberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 26
city: Bautzen
country: Germany
facility: Boehringer Ingelheim Investigational Site 27
city: Beelitz
country: Germany
facility: Boehringer Ingelheim Investigational Site 28
city: Bensheim
country: Germany
facility: Boehringer Ingelheim Investigational Site 29
city: Bergisch Gladbach
country: Germany
facility: Boehringer Ingelheim Investigational Site 30
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 31
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 32
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 33
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 34
city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Bernau
country: Germany
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city: Bitterfeld
country: Germany
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city: Bochum
country: Germany
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city: Bochum
country: Germany
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city: Bonn
country: Germany
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city: Bonn
country: Germany
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city: Bonn
country: Germany
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city: Bonn
country: Germany
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city: Bottrop
country: Germany
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city: Braunschweig
country: Germany
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city: Braunschweig
country: Germany
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city: Bremen
country: Germany
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city: Bremen
country: Germany
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city: Bremen
country: Germany
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city: Bremen
country: Germany
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city: Bremerhaven
country: Germany
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city: Bremerhaven
country: Germany
facility: Boehringer Ingelheim Investigational Site 69
city: Bruchsal
country: Germany
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city: Buchholz
country: Germany
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city: Castrop-Rauxel
country: Germany
facility: Boehringer Ingelheim Investigational Site 72
city: Celle
country: Germany
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city: Celle
country: Germany
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city: Chemnitz
country: Germany
facility: Boehringer Ingelheim Investigational Site 75
city: Coburg
country: Germany
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city: Coburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 77
city: Cottbus
country: Germany
facility: Boehringer Ingelheim Investigational Site 78
city: Cottbus
country: Germany
facility: Boehringer Ingelheim Investigational Site 79
city: Dachau
country: Germany
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city: Darmstadt
country: Germany
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city: Deggendorf
country: Germany
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city: Delitzsch
country: Germany
facility: Boehringer Ingelheim Investigational Site 83
city: Dessau-Roßlau
country: Germany
facility: Boehringer Ingelheim Investigational Site 84
city: Dillingen
country: Germany
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city: Dillingen
country: Germany
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city: Donaueschingen
country: Germany
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city: Dorsten
country: Germany
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city: Dortmund
country: Germany
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city: Dresden
country: Germany
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city: Dresden
country: Germany
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city: Dresden
country: Germany
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city: Dresden
country: Germany
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city: Dresden
country: Germany
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city: Dresden
country: Germany
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city: Dresden
country: Germany
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city: Düren
country: Germany
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city: Düren
country: Germany
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city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 100
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 101
city: Düsseldorf
country: Germany
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city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 99
city: Eichstätt
country: Germany
facility: Boehringer Ingelheim Investigational Site 103
city: Emden
country: Germany
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city: Erbach
country: Germany
facility: Boehringer Ingelheim Investigational Site 105
city: Erfurt
country: Germany
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city: Erfurt
country: Germany
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city: Erfurt
country: Germany
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city: Erlangen
country: Germany
facility: Boehringer Ingelheim Investigational Site 109
city: Eschwege
country: Germany
facility: Boehringer Ingelheim Investigational Site 110
city: Esslingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 111
city: Esslingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 112
city: Euskirchen
country: Germany
facility: Boehringer Ingelheim Investigational Site 113
city: Fellbach
country: Germany
facility: Boehringer Ingelheim Investigational Site 114
city: Flensburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 115
city: Forchheim
country: Germany
facility: Boehringer Ingelheim Investigational Site 116
city: Frankenthal
country: Germany
facility: Boehringer Ingelheim Investigational Site 117
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 118
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 119
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 120
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 121
city: Freising
country: Germany
facility: Boehringer Ingelheim Investigational Site 122
city: Föhren
country: Germany
facility: Boehringer Ingelheim Investigational Site 123
city: Fürstenfeldbruck
country: Germany
facility: Boehringer Ingelheim Investigational Site 124
city: Fürth
country: Germany
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city: Fürth
country: Germany
facility: Boehringer Ingelheim Investigational Site 126
city: Ganderkesee
country: Germany
facility: Boehringer Ingelheim Investigational Site 127
city: Gauting
country: Germany
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city: Geilenkirchen
country: Germany
facility: Boehringer Ingelheim Investigational Site 129
city: Gelsenkirchen
country: Germany
facility: Boehringer Ingelheim Investigational Site 130
city: Gelsenkirchen
country: Germany
facility: Boehringer Ingelheim Investigational Site 131
city: Gera
country: Germany
facility: Boehringer Ingelheim Investigational Site 132
city: Germering
country: Germany
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city: Gießen
country: Germany
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city: Gießen
country: Germany
facility: Boehringer Ingelheim Investigational Site 135
city: Greiz
country: Germany
facility: Boehringer Ingelheim Investigational Site 136
city: Grevesmühlen
country: Germany
facility: Boehringer Ingelheim Investigational Site 137
city: Großenhain
country: Germany
facility: Boehringer Ingelheim Investigational Site 138
city: Gummersbach
country: Germany
facility: Boehringer Ingelheim Investigational Site 139
city: Göppingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 140
city: Göttingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 141
city: Göttingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 142
city: Göttingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 143
city: Günzburg
country: Germany
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city: Gütersloh
country: Germany
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city: Gütersloh
country: Germany
facility: Boehringer Ingelheim Investigational Site 146
city: Gütersloh
country: Germany
facility: Boehringer Ingelheim Investigational Site 147
city: Hagen
country: Germany
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city: Halberstadt
country: Germany
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city: Halle
country: Germany
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city: Halle
country: Germany
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city: Hamburg
country: Germany
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city: Hamburg
country: Germany
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city: Hamburg
country: Germany
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city: Hamburg
country: Germany
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city: Hamburg
country: Germany
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city: Hamburg
country: Germany
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city: Hamburg
country: Germany
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city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 159
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 160
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 161
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 162
city: Hamm
country: Germany
facility: Boehringer Ingelheim Investigational Site 163
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 164
city: Hannover
country: Germany
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city: Hannover
country: Germany
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city: Hannover
country: Germany
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city: Hartha
country: Germany
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city: Heidelberg
country: Germany
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city: Heidelberg
country: Germany
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city: Heidelberg
country: Germany
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city: Heidelberg
country: Germany
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city: Heilbronn
country: Germany
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city: Heilbronn
country: Germany
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city: Hemmingen
country: Germany
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city: Hemmingen
country: Germany
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city: Herne
country: Germany
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city: Hettstedt
country: Germany
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city: Hilden
country: Germany
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city: Husum
country: Germany
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city: Itzehoe
country: Germany
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city: Itzehoe
country: Germany
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city: Kaiserslautern
country: Germany
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city: Kaiserslautern
country: Germany
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city: Kamen
country: Germany
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city: Karlsruhe
country: Germany
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country: Germany
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city: Kempten
country: Germany
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city: Kiel
country: Germany
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city: Kiel
country: Germany
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city: Kiel
country: Germany
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city: Kirchheim
country: Germany
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city: Koblenz
country: Germany
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country: Germany
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city: Koblenz
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city: Koblenz
country: Germany
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city: Konstanz
country: Germany
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city: Krefeld
country: Germany
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city: Krefeld
country: Germany
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city: Köln
country: Germany
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city: Köln
country: Germany
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city: Köln
country: Germany
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city: Königs Wusterhausen
country: Germany
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city: Köthen
country: Germany
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city: Landshut
country: Germany
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city: Langenfeld
country: Germany
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city: Langenfeld
country: Germany
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city: Langen
country: Germany
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city: Leipzig
country: Germany
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city: Leipzig
country: Germany
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city: Leipzig
country: Germany
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city: Leonberg
country: Germany
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country: Germany
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city: Leverkusen
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country: Germany
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city: Ludwigshafen
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city: Lutherstadt Wittenberg
country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: Mainz
country: Germany
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country: Germany
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city: Mannheim
country: Germany
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country: Germany
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city: München
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city: Saarbrücken
country: Germany
facility: Boehringer Ingelheim Investigational Site 294
city: Saarbrücken
country: Germany
facility: Boehringer Ingelheim Investigational Site 295
city: Saarlouis
country: Germany
facility: Boehringer Ingelheim Investigational Site 296
city: Saarlouis
country: Germany
facility: Boehringer Ingelheim Investigational Site 297
city: Salzgitter
country: Germany
facility: Boehringer Ingelheim Investigational Site 298
city: Schmallenberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 299
city: Schmölln
country: Germany
facility: Boehringer Ingelheim Investigational Site 300
city: Schmölln
country: Germany
facility: Boehringer Ingelheim Investigational Site 301
city: Schwabach
country: Germany
facility: Boehringer Ingelheim Investigational Site 302
city: Schwandorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 303
city: Schwedt
country: Germany
facility: Boehringer Ingelheim Investigational Site 304
city: Schwäbisch Gmünd
country: Germany
facility: Boehringer Ingelheim Investigational Site 305
city: Sebnitz
country: Germany
facility: Boehringer Ingelheim Investigational Site 306
city: Seevetal
country: Germany
facility: Boehringer Ingelheim Investigational Site 307
city: Siegen
country: Germany
facility: Boehringer Ingelheim Investigational Site 308
city: Simmern
country: Germany
facility: Boehringer Ingelheim Investigational Site 309
city: Sinsheim
country: Germany
facility: Boehringer Ingelheim Investigational Site 310
city: Solingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 311
city: Sondershausen
country: Germany
facility: Boehringer Ingelheim Investigational Site 312
city: Sonneberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 313
city: St. Ingbert
country: Germany
facility: Boehringer Ingelheim Investigational Site 314
city: Stade
country: Germany
facility: Boehringer Ingelheim Investigational Site 315
city: Stadthagen
country: Germany
facility: Boehringer Ingelheim Investigational Site 316
city: Starnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 317
city: Starnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 318
city: Staufen
country: Germany
facility: Boehringer Ingelheim Investigational Site 319
city: Steinbach
country: Germany
facility: Boehringer Ingelheim Investigational Site 320
city: Steinhagen
country: Germany
facility: Boehringer Ingelheim Investigational Site 321
city: Steinhagen
country: Germany
facility: Boehringer Ingelheim Investigational Site 322
city: Strausberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 323
city: Straußfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 324
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site 325
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site 326
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site 327
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site 328
city: Teltow
country: Germany
facility: Boehringer Ingelheim Investigational Site 329
city: Teterow
country: Germany
facility: Boehringer Ingelheim Investigational Site 330
city: Teuchern
country: Germany
facility: Boehringer Ingelheim Investigational Site 331
city: Troisdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 332
city: Ulm
country: Germany
facility: Boehringer Ingelheim Investigational Site 333
city: Uttenreuth
country: Germany
facility: Boehringer Ingelheim Investigational Site 334
city: Waiblingen
country: Germany
facility: Boehringer Ingelheim Investigational Site 335
city: Waren
country: Germany
facility: Boehringer Ingelheim Investigational Site 336
city: Weilheim
country: Germany
facility: Boehringer Ingelheim Investigational Site 337
city: Weyhe
country: Germany
facility: Boehringer Ingelheim Investigational Site 338
city: Wiesbaden
country: Germany
facility: Boehringer Ingelheim Investigational Site 339
city: Wiesbaden
country: Germany
facility: Boehringer Ingelheim Investigational Site 340
city: Wiesloch
country: Germany
facility: Boehringer Ingelheim Investigational Site 341
city: Wilhelmshaven
country: Germany
facility: Boehringer Ingelheim Investigational Site 342
city: Wilhelmshaven
country: Germany
facility: Boehringer Ingelheim Investigational Site 343
city: Wilhelmshaven
country: Germany
facility: Boehringer Ingelheim Investigational Site 344
city: Witten
country: Germany
facility: Boehringer Ingelheim Investigational Site 345
city: Witten
country: Germany
facility: Boehringer Ingelheim Investigational Site 346
city: Witten
country: Germany
facility: Boehringer Ingelheim Investigational Site 347
city: Wolfsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 348
city: Wolfsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 349
city: Würzburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 350
city: Zerbst
country: Germany
facility: Boehringer Ingelheim Investigational Site 351
city: Zirndorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 352
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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)
citation: 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)