- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01644734
Assessment of Health-status of Patients With Chronic Obstructive Pulmonary Disease (COPD) on Maintenance Therapy With Spiriva HH Measured by COPD Assessment Test (CAT) Test
April 30, 2014 updated by: Boehringer Ingelheim
MATHS: Assessment of Health-status of Patients With COPD on MAintenance THerapy With Spiriva® HH Measured by CAT Test
To evaluate the early (3-month) impact of the long-acting anticholinergic Spiriva HH maintenance treatment on the COPD symptoms using the novel COPD Assessment test (CAT) in the real life setting of COPD patients, previously treated with short-acting bronchodilator on regular or as-needed basis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1328
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Andrychow, Poland
- Boehringer Ingelheim Investigational Site 236
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Bialystok, Poland
- Boehringer Ingelheim Investigational Site 170
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Bialystok, Poland
- Boehringer Ingelheim Investigational Site 184
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Bialystok, Poland
- Boehringer Ingelheim Investigational Site 240
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Bialystok, Poland
- Boehringer Ingelheim Investigational Site 44
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Bialystok, Poland
- Boehringer Ingelheim Investigational Site 84
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Bielsko-Biala, Poland
- Boehringer Ingelheim Investigational Site 33
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Bielsko-Biala, Poland
- Boehringer Ingelheim Investigational Site 34
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Bielsko-Biala, Poland
- Boehringer Ingelheim Investigational Site 35
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Biskupiec, Poland
- Boehringer Ingelheim Investigational Site 79
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Bochnia, Poland
- Boehringer Ingelheim Investigational Site 116
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Brzesko, Poland
- Boehringer Ingelheim Investigational Site 115
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Brzesko, Poland
- Boehringer Ingelheim Investigational Site 138
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Brzeziny, Poland
- Boehringer Ingelheim Investigational Site 185
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Brzozow, Poland
- Boehringer Ingelheim Investigational Site 90
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Bydgoszcz, Poland
- Boehringer Ingelheim Investigational Site 105
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Bydgoszcz, Poland
- Boehringer Ingelheim Investigational Site 119
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Bydgoszcz, Poland
- Boehringer Ingelheim Investigational Site 123
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Bydgoszcz, Poland
- Boehringer Ingelheim Investigational Site 222
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Bydgoszcz, Poland
- Boehringer Ingelheim Investigational Site 27
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Chelm, Poland
- Boehringer Ingelheim Investigational Site 21
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Chelm, Poland
- Boehringer Ingelheim Investigational Site 22
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Chelmsko Slaskie, Poland
- Boehringer Ingelheim Investigational Site 11
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Chodziez, Poland
- Boehringer Ingelheim Investigational Site 233
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Chojnice, Poland
- Boehringer Ingelheim Investigational Site 226
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Chorzow, Poland
- Boehringer Ingelheim Investigational Site 149
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Chorzow, Poland
- Boehringer Ingelheim Investigational Site 153
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Ciechanow, Poland
- Boehringer Ingelheim Investigational Site 88
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Czarnkow, Poland
- Boehringer Ingelheim Investigational Site 232
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Czestochowa, Poland
- Boehringer Ingelheim Investigational Site 229
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Czestochowa, Poland
- Boehringer Ingelheim Investigational Site 4
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Dabrowa Gornicza, Poland
- Boehringer Ingelheim Investigational Site 23
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Domaradz, Poland
- Boehringer Ingelheim Investigational Site 92
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Dziergowice, Poland
- Boehringer Ingelheim Investigational Site 246
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Gdansk, Poland
- Boehringer Ingelheim Investigational Site 133
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Gdansk, Poland
- Boehringer Ingelheim Investigational Site 134
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Gdansk, Poland
- Boehringer Ingelheim Investigational Site 136
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Gdansk, Poland
- Boehringer Ingelheim Investigational Site 155
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Gdansk, Poland
- Boehringer Ingelheim Investigational Site 156
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Gdansk, Poland
- Boehringer Ingelheim Investigational Site 20
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Gdansk, Poland
- Boehringer Ingelheim Investigational Site 234
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Gdansk, Poland
- Boehringer Ingelheim Investigational Site 31
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Gdynia, Poland
- Boehringer Ingelheim Investigational Site 41
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Gliwice, Poland
- Boehringer Ingelheim Investigational Site 217
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Glucholazy, Poland
- Boehringer Ingelheim Investigational Site 247
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Gora, Poland
- Boehringer Ingelheim Investigational Site 85
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Gorzow Wielkopolski, Poland
- Boehringer Ingelheim Investigational Site 50
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Grodzisk Mazowiecki, Poland
- Boehringer Ingelheim Investigational Site 174
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Grodzisk Mazowiecki, Poland
- Boehringer Ingelheim Investigational Site 176
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Gryfice, Poland
- Boehringer Ingelheim Investigational Site 56
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Jaroslaw, Poland
- Boehringer Ingelheim Investigational Site 179
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Jaslo, Poland
- Boehringer Ingelheim Investigational Site 108
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Jaslo, Poland
- Boehringer Ingelheim Investigational Site 225
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Jaslo, Poland
- Boehringer Ingelheim Investigational Site 8
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Jedrzejow, Poland
- Boehringer Ingelheim Investigational Site 243
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Jelenia Gora, Poland
- Boehringer Ingelheim Investigational Site 148
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Katowice, Poland
- Boehringer Ingelheim Investigational Site 162
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Katowice, Poland
- Boehringer Ingelheim Investigational Site 163
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Katowice, Poland
- Boehringer Ingelheim Investigational Site 164
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Katowice, Poland
- Boehringer Ingelheim Investigational Site 212
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Kcynia, Poland
- Boehringer Ingelheim Investigational Site 69
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Kielce, Poland
- Boehringer Ingelheim Investigational Site 112
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Kielce, Poland
- Boehringer Ingelheim Investigational Site 18
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Kielce, Poland
- Boehringer Ingelheim Investigational Site 19
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Klodzko, Poland
- Boehringer Ingelheim Investigational Site 13
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Kolobrzeg, Poland
- Boehringer Ingelheim Investigational Site 49
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Konin, Poland
- Boehringer Ingelheim Investigational Site 219
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Konskie, Poland
- Boehringer Ingelheim Investigational Site 141
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Konskie, Poland
- Boehringer Ingelheim Investigational Site 142
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Koszalin, Poland
- Boehringer Ingelheim Investigational Site 51
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Koszalin, Poland
- Boehringer Ingelheim Investigational Site 52
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Krakow, Poland
- Boehringer Ingelheim Investigational Site 122
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Krakow, Poland
- Boehringer Ingelheim Investigational Site 135
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Krakow, Poland
- Boehringer Ingelheim Investigational Site 143
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Krakow, Poland
- Boehringer Ingelheim Investigational Site 146
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Krakow, Poland
- Boehringer Ingelheim Investigational Site 171
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Krakow, Poland
- Boehringer Ingelheim Investigational Site 177
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Krakow, Poland
- Boehringer Ingelheim Investigational Site 214
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Krakow, Poland
- Boehringer Ingelheim Investigational Site 87
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Krakow, Poland
- Boehringer Ingelheim Investigational Site 94
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Krasnik, Poland
- Boehringer Ingelheim Investigational Site 129
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Krasnik, Poland
- Boehringer Ingelheim Investigational Site 204
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Krasnik, Poland
- Boehringer Ingelheim Investigational Site 207
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Krosno, Poland
- Boehringer Ingelheim Investigational Site 192
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Kutno, Poland
- Boehringer Ingelheim Investigational Site 194
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Ledziny, Poland
- Boehringer Ingelheim Investigational Site 86
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Legionowo, Poland
- Boehringer Ingelheim Investigational Site 97
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Lisnik Duzy, Poland
- Boehringer Ingelheim Investigational Site 127
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Lodz, Poland
- Boehringer Ingelheim Investigational Site 187
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Lodz, Poland
- Boehringer Ingelheim Investigational Site 188
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Lodz, Poland
- Boehringer Ingelheim Investigational Site 193
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Lodz, Poland
- Boehringer Ingelheim Investigational Site 198
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Lodz, Poland
- Boehringer Ingelheim Investigational Site 206
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Lomza, Poland
- Boehringer Ingelheim Investigational Site 57
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Lomza, Poland
- Boehringer Ingelheim Investigational Site 58
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Lowicz, Poland
- Boehringer Ingelheim Investigational Site 186
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Luban, Poland
- Boehringer Ingelheim Investigational Site 158
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Lubartow, Poland
- Boehringer Ingelheim Investigational Site 37
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Lubin, Poland
- Boehringer Ingelheim Investigational Site 172
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Lubin, Poland
- Boehringer Ingelheim Investigational Site 173
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Lubin, Poland
- Boehringer Ingelheim Investigational Site 196
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Lublin, Poland
- Boehringer Ingelheim Investigational Site 124
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Lublin, Poland
- Boehringer Ingelheim Investigational Site 17
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Lublin, Poland
- Boehringer Ingelheim Investigational Site 29
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Lublin, Poland
- Boehringer Ingelheim Investigational Site 7
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Lubliniec, Poland
- Boehringer Ingelheim Investigational Site 242
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Lubon, Poland
- Boehringer Ingelheim Investigational Site 209
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Ludwikowo, Poland
- Boehringer Ingelheim Investigational Site 106
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Lukow, Poland
- Boehringer Ingelheim Investigational Site 30
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Makow Mazowiecki, Poland
- Boehringer Ingelheim Investigational Site 45
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Malbork, Poland
- Boehringer Ingelheim Investigational Site 168
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Mielec, Poland
- Boehringer Ingelheim Investigational Site 110
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Milicz, Poland
- Boehringer Ingelheim Investigational Site 159
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Myslowice, Poland
- Boehringer Ingelheim Investigational Site 150
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Myszkow, Poland
- Boehringer Ingelheim Investigational Site 25
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Nisko, Poland
- Boehringer Ingelheim Investigational Site 215
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Nowy Dwor Gdanski, Poland
- Boehringer Ingelheim Investigational Site 128
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Nowy Sacz, Poland
- Boehringer Ingelheim Investigational Site 109
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Olawa, Poland
- Boehringer Ingelheim Investigational Site 154
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Olecko, Poland
- Boehringer Ingelheim Investigational Site 72
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Olsztyn, Poland
- Boehringer Ingelheim Investigational Site 36
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Opatow, Poland
- Boehringer Ingelheim Investigational Site 245
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Ostrowiec Swietokrzyski, Poland
- Boehringer Ingelheim Investigational Site 114
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Ostrowiec Swietokrzyski, Poland
- Boehringer Ingelheim Investigational Site 145
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Pabianice, Poland
- Boehringer Ingelheim Investigational Site 237
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Papowo Biskupie, Poland
- Boehringer Ingelheim Investigational Site 182
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Pawonkow, Poland
- Boehringer Ingelheim Investigational Site 216
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Piekary Slaskie, Poland
- Boehringer Ingelheim Investigational Site 189
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Pietrzykowice, Poland
- Boehringer Ingelheim Investigational Site 32
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Pila, Poland
- Boehringer Ingelheim Investigational Site 40
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Piotrkow Trybunalski, Poland
- Boehringer Ingelheim Investigational Site 203
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Plock, Poland
- Boehringer Ingelheim Investigational Site 59
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Pniewy, Poland
- Boehringer Ingelheim Investigational Site 93
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Poniatowa, Poland
- Boehringer Ingelheim Investigational Site 130
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Poznan, Poland
- Boehringer Ingelheim Investigational Site 201
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Poznan, Poland
- Boehringer Ingelheim Investigational Site 208
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Poznan, Poland
- Boehringer Ingelheim Investigational Site 227
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Poznan, Poland
- Boehringer Ingelheim Investigational Site 228
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Poznan, Poland
- Boehringer Ingelheim Investigational Site 231
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Prabuty, Poland
- Boehringer Ingelheim Investigational Site 126
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Proszowice, Poland
- Boehringer Ingelheim Investigational Site 218
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Pruszcz Gdanski, Poland
- Boehringer Ingelheim Investigational Site 131
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Przemysl, Poland
- Boehringer Ingelheim Investigational Site 191
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Rabka Zdroj, Poland
- Boehringer Ingelheim Investigational Site 169
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Radom, Poland
- Boehringer Ingelheim Investigational Site 117
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Radom, Poland
- Boehringer Ingelheim Investigational Site 118
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Ruda Slaska, Poland
- Boehringer Ingelheim Investigational Site 151
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Ruda Slaska, Poland
- Boehringer Ingelheim Investigational Site 152
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Ruda Slaska, Poland
- Boehringer Ingelheim Investigational Site 230
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Ruda Slaska, Poland
- Boehringer Ingelheim Investigational Site 82
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Rumia, Poland
- Boehringer Ingelheim Investigational Site 180
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Rumia, Poland
- Boehringer Ingelheim Investigational Site 239
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Rumia, Poland
- Boehringer Ingelheim Investigational Site 5
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Rybnik, Poland
- Boehringer Ingelheim Investigational Site 104
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Rybnik, Poland
- Boehringer Ingelheim Investigational Site 183
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Rybnik, Poland
- Boehringer Ingelheim Investigational Site 83
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Rzeszow, Poland
- Boehringer Ingelheim Investigational Site 175
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Rzeszow, Poland
- Boehringer Ingelheim Investigational Site 178
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Sanok, Poland
- Boehringer Ingelheim Investigational Site 190
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Sawin, Poland
- Boehringer Ingelheim Investigational Site 73
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Sejny, Poland
- Boehringer Ingelheim Investigational Site 78
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Siewierz, Poland
- Boehringer Ingelheim Investigational Site 160
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Skarzysko Kamienna, Poland
- Boehringer Ingelheim Investigational Site 241
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Skawina, Poland
- Boehringer Ingelheim Investigational Site 157
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Skoczow, Poland
- Boehringer Ingelheim Investigational Site 10
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Skrzyszow, Poland
- Boehringer Ingelheim Investigational Site 167
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Slawno, Poland
- Boehringer Ingelheim Investigational Site 53
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Slubice, Poland
- Boehringer Ingelheim Investigational Site 96
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Slupca, Poland
- Boehringer Ingelheim Investigational Site 205
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Sokolowsko, Poland
- Boehringer Ingelheim Investigational Site 14
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Sopot, Poland
- Boehringer Ingelheim Investigational Site 113
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Sosnowiec, Poland
- Boehringer Ingelheim Investigational Site 166
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Sosnowiec, Poland
- Boehringer Ingelheim Investigational Site 24
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Srem, Poland
- Boehringer Ingelheim Investigational Site 107
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Srem, Poland
- Boehringer Ingelheim Investigational Site 213
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Stalowa Wola, Poland
- Boehringer Ingelheim Investigational Site 125
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Starachowice, Poland
- Boehringer Ingelheim Investigational Site 144
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Starachowice, Poland
- Boehringer Ingelheim Investigational Site 80
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Stargard Szczecinski, Poland
- Boehringer Ingelheim Investigational Site 120
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Sucha Beskidzka, Poland
- Boehringer Ingelheim Investigational Site 95
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Suprasl, Poland
- Boehringer Ingelheim Investigational Site 16
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Suwalki, Poland
- Boehringer Ingelheim Investigational Site 54
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Suwalki, Poland
- Boehringer Ingelheim Investigational Site 55
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Swidnik, Poland
- Boehringer Ingelheim Investigational Site 1
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Swiecie, Poland
- Boehringer Ingelheim Investigational Site 181
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Sycow, Poland
- Boehringer Ingelheim Investigational Site 76
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Szczecin, Poland
- Boehringer Ingelheim Investigational Site 43
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Szczecin, Poland
- Boehringer Ingelheim Investigational Site 48
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Szczecin, Poland
- Boehringer Ingelheim Investigational Site 61
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Szczecin, Poland
- Boehringer Ingelheim Investigational Site 66
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Szczecin, Poland
- Boehringer Ingelheim Investigational Site 67
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Szczecinek, Poland
- Boehringer Ingelheim Investigational Site 26
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Tarnobrzeg, Poland
- Boehringer Ingelheim Investigational Site 111
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Tarnobrzeg, Poland
- Boehringer Ingelheim Investigational Site 224
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Tarnow, Poland
- Boehringer Ingelheim Investigational Site 139
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Tarnow, Poland
- Boehringer Ingelheim Investigational Site 140
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Tarnowskie Gory, Poland
- Boehringer Ingelheim Investigational Site 200
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Torun, Poland
- Boehringer Ingelheim Investigational Site 101
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Torun, Poland
- Boehringer Ingelheim Investigational Site 70
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Torun, Poland
- Boehringer Ingelheim Investigational Site 71
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Trzcianka Lubuska, Poland
- Boehringer Ingelheim Investigational Site 220
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Twardogora, Poland
- Boehringer Ingelheim Investigational Site 103
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Tychy, Poland
- Boehringer Ingelheim Investigational Site 147
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Tychy, Poland
- Boehringer Ingelheim Investigational Site 244
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Uchanie, Poland
- Boehringer Ingelheim Investigational Site 38
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Walcz, Poland
- Boehringer Ingelheim Investigational Site 39
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 100
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 121
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 137
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 161
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 165
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 210
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 223
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 238
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 2
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 3
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 42
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 46
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 74
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 91
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Warszawa, Poland
- Boehringer Ingelheim Investigational Site 99
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Wejherowo, Poland
- Boehringer Ingelheim Investigational Site 6
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Wieliczna, Poland
- Boehringer Ingelheim Investigational Site 199
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Wielun, Poland
- Boehringer Ingelheim Investigational Site 235
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Witonia, Poland
- Boehringer Ingelheim Investigational Site 197
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Wloc³awek, Poland
- Boehringer Ingelheim Investigational Site 65
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Wodzislaw Slaski, Poland
- Boehringer Ingelheim Investigational Site 28
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Wolomin, Poland
- Boehringer Ingelheim Investigational Site 98
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Wroclaw, Poland
- Boehringer Ingelheim Investigational Site 102
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Wroclaw, Poland
- Boehringer Ingelheim Investigational Site 202
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Wroclaw, Poland
- Boehringer Ingelheim Investigational Site 221
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Wroclaw, Poland
- Boehringer Ingelheim Investigational Site 62
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Wroclaw, Poland
- Boehringer Ingelheim Investigational Site 63
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Wroclaw, Poland
- Boehringer Ingelheim Investigational Site 64
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Wroclaw, Poland
- Boehringer Ingelheim Investigational Site 89
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Zabkowice Slaskie, Poland
- Boehringer Ingelheim Investigational Site 12
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Zabkowice Slaskie, Poland
- Boehringer Ingelheim Investigational Site 9
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Zabrze, Poland
- Boehringer Ingelheim Investigational Site 68
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Zabrze, Poland
- Boehringer Ingelheim Investigational Site 75
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Zabrze, Poland
- Boehringer Ingelheim Investigational Site 77
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Zagoty, Poland
- Boehringer Ingelheim Investigational Site 60
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Zblewo, Poland
- Boehringer Ingelheim Investigational Site 132
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Zgierz, Poland
- Boehringer Ingelheim Investigational Site 195
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Zielona Gora, Poland
- Boehringer Ingelheim Investigational Site 15
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Zielona Gora, Poland
- Boehringer Ingelheim Investigational Site 47
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Zielonka k/Warszawy, Poland
- Boehringer Ingelheim Investigational Site 81
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Zyrardow, Poland
- Boehringer Ingelheim Investigational Site 211
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Male and female ambulatory outpatients being seen in a participating physicians office for routine care,
- Patients with a clinical diagnosis of COPD (all stages according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2010) being treated with long-acting anticholinergic (Tiotropium, Spiriva® HandiHaler® ) as maintenance therapy within the product label and a maximum of the last 4 weeks (0.-28. days before Visit 1),
- Patients previously treated with short-acting bronchodilators on regular or as-needed basis for at least 3 months before change to long-acting anticholinergic treatment,
- Patient fluent in language of questionnaire and having the cognitive and functional abilities required to fill in the questionnaire alone.
Exclusion criteria:
- Uncooperative patients as judged by the physician,
- Patients with any conditions excluded as per Country specific package insert,
- Patients currently enrolled in any clinical trial,
- Patients with COPD exacerbation or any acute disease in the last 3 months before Visit 1.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Maintaining or Improving Their Health Status
Time Frame: Baseline, 3 months
|
The health status was measured by the total COPD Assessment Test (CAT) score at baseline and at the end of the observation period after app. 3 months (visit 3).
Therefore, the total CAT score at baseline and at Visit 3 was calculated by adding up the scores of the single questions of the CAT questionnaire.
In the case of one or more missing items the total score was not determined for the specific visit.
The health status is considered to be maintained or improved if the change in the total CAT score from baseline at Visit 3 is ≥0.
|
Baseline, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Total CAT Score (Value Baseline Minus 3 Months)
Time Frame: Baseline, 3 months
|
The change represents the value at baseline minus the value after 3 months.
The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms.
Therefore, a positive value for the change in the total CAT score means an improvement.
|
Baseline, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
July 17, 2012
First Submitted That Met QC Criteria
July 18, 2012
First Posted (Estimate)
July 19, 2012
Study Record Updates
Last Update Posted (Estimate)
May 26, 2014
Last Update Submitted That Met QC Criteria
April 30, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases, Obstructive
- Lung Diseases
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Tiotropium Bromide
Other Study ID Numbers
- 205.502
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Phargentis SACompleted