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
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT01644734
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1328
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of Patients Maintaining or Improving Their Health Status 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.
- Secondary Outcome Measures
Name Time Method Change in the Total CAT Score (Value Baseline Minus 3 Months) 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.
Trial Locations
- Locations (247)
Boehringer Ingelheim Investigational Site 44
🇵🇱Bialystok, Poland
Boehringer Ingelheim Investigational Site 153
🇵🇱Chorzow, Poland
Boehringer Ingelheim Investigational Site 88
🇵🇱Ciechanow, Poland
Boehringer Ingelheim Investigational Site 50
🇵🇱Gorzow Wielkopolski, Poland
Boehringer Ingelheim Investigational Site 212
🇵🇱Katowice, Poland
Boehringer Ingelheim Investigational Site 112
🇵🇱Kielce, Poland
Boehringer Ingelheim Investigational Site 21
🇵🇱Chelm, Poland
Boehringer Ingelheim Investigational Site 229
🇵🇱Czestochowa, Poland
Boehringer Ingelheim Investigational Site 174
🇵🇱Grodzisk Mazowiecki, Poland
Boehringer Ingelheim Investigational Site 243
🇵🇱Jedrzejow, Poland
Boehringer Ingelheim Investigational Site 13
🇵🇱Klodzko, Poland
Boehringer Ingelheim Investigational Site 219
🇵🇱Konin, Poland
Boehringer Ingelheim Investigational Site 185
🇵🇱Brzeziny, Poland
Boehringer Ingelheim Investigational Site 4
🇵🇱Czestochowa, Poland
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🇵🇱Gora, Poland
Boehringer Ingelheim Investigational Site 184
🇵🇱Bialystok, Poland
Boehringer Ingelheim Investigational Site 34
🇵🇱Bielsko-Biala, Poland
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🇵🇱Chelmsko Slaskie, Poland
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🇵🇱Dabrowa Gornicza, Poland
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🇵🇱Gryfice, Poland
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🇵🇱Jaslo, Poland
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🇵🇱Katowice, Poland
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🇵🇱Kcynia, Poland
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🇵🇱Kielce, Poland
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🇵🇱Krakow, Poland
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🇵🇱Krasnik, Poland
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🇵🇱Legionowo, Poland
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🇵🇱Tychy, Poland
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🇵🇱Bialystok, Poland
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🇵🇱Czarnkow, Poland
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🇵🇱Gdynia, Poland
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🇵🇱Glucholazy, Poland
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🇵🇱Kielce, Poland
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🇵🇱Koszalin, Poland
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🇵🇱Krakow, Poland
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🇵🇱Lubon, Poland
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🇵🇱Olawa, Poland
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🇵🇱Pietrzykowice, Poland
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🇵🇱Piotrkow Trybunalski, Poland
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🇵🇱Rybnik, Poland
Boehringer Ingelheim Investigational Site 178
🇵🇱Rzeszow, Poland
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🇵🇱Slawno, Poland
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🇵🇱Sokolowsko, Poland
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🇵🇱Tarnobrzeg, Poland
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🇵🇱Warszawa, Poland
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🇵🇱Wodzislaw Slaski, Poland
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🇵🇱Wroclaw, Poland
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🇵🇱Srem, Poland
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🇵🇱Jaslo, Poland
Boehringer Ingelheim Investigational Site 163
🇵🇱Katowice, Poland
Boehringer Ingelheim Investigational Site 141
🇵🇱Konskie, Poland
Boehringer Ingelheim Investigational Site 135
🇵🇱Krakow, Poland
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🇵🇱Krakow, Poland
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🇵🇱Krakow, Poland
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🇵🇱Krasnik, Poland
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🇵🇱Lublin, Poland
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🇵🇱Mielec, Poland
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🇵🇱Myszkow, Poland
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🇵🇱Nisko, Poland
Boehringer Ingelheim Investigational Site 182
🇵🇱Papowo Biskupie, Poland
Boehringer Ingelheim Investigational Site 227
🇵🇱Poznan, Poland
Boehringer Ingelheim Investigational Site 120
🇵🇱Stargard Szczecinski, Poland
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🇵🇱Swidnik, Poland
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🇵🇱Sycow, Poland
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🇵🇱Szczecin, Poland
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🇵🇱Warszawa, Poland
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🇵🇱Wieliczna, Poland
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🇵🇱Witonia, Poland
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🇵🇱Wejherowo, Poland
Boehringer Ingelheim Investigational Site 63
🇵🇱Wroclaw, Poland
Boehringer Ingelheim Investigational Site 129
🇵🇱Krasnik, Poland
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🇵🇱Lowicz, Poland
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🇵🇱Lubin, Poland
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🇵🇱Ostrowiec Swietokrzyski, Poland
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🇵🇱Poniatowa, Poland
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🇵🇱Poznan, Poland
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🇵🇱Szczecin, Poland
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🇵🇱Warszawa, Poland
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🇵🇱Zielona Gora, Poland
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🇵🇱Zielonka k/Warszawy, Poland
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🇵🇱Koszalin, Poland
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🇵🇱Krakow, Poland
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Boehringer Ingelheim Investigational Site 188
🇵🇱Lodz, Poland
Boehringer Ingelheim Investigational Site 206
🇵🇱Lodz, Poland
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🇵🇱Lomza, Poland
Boehringer Ingelheim Investigational Site 124
🇵🇱Lublin, Poland
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🇵🇱Lukow, Poland
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🇵🇱Olsztyn, Poland
Boehringer Ingelheim Investigational Site 237
🇵🇱Pabianice, Poland
Boehringer Ingelheim Investigational Site 201
🇵🇱Poznan, Poland
Boehringer Ingelheim Investigational Site 126
🇵🇱Prabuty, Poland
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🇵🇱Proszowice, Poland
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🇵🇱Rumia, Poland
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🇵🇱Skarzysko Kamienna, Poland
Boehringer Ingelheim Investigational Site 167
🇵🇱Skrzyszow, Poland
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Boehringer Ingelheim Investigational Site 125
🇵🇱Stalowa Wola, Poland
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🇵🇱Szczecin, Poland
Boehringer Ingelheim Investigational Site 224
🇵🇱Tarnobrzeg, Poland
Boehringer Ingelheim Investigational Site 200
🇵🇱Tarnowskie Gory, Poland
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🇵🇱Torun, Poland
Boehringer Ingelheim Investigational Site 38
🇵🇱Uchanie, Poland
Boehringer Ingelheim Investigational Site 121
🇵🇱Warszawa, Poland
Boehringer Ingelheim Investigational Site 2
🇵🇱Warszawa, Poland
Boehringer Ingelheim Investigational Site 61
🇵🇱Szczecin, Poland
Boehringer Ingelheim Investigational Site 127
🇵🇱Lisnik Duzy, Poland
Boehringer Ingelheim Investigational Site 198
🇵🇱Lodz, Poland
Boehringer Ingelheim Investigational Site 57
🇵🇱Lomza, Poland
Boehringer Ingelheim Investigational Site 159
🇵🇱Milicz, Poland
Boehringer Ingelheim Investigational Site 109
🇵🇱Nowy Sacz, Poland
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🇵🇱Olecko, Poland
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🇵🇱Opatow, Poland
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🇵🇱Ostrowiec Swietokrzyski, Poland
Boehringer Ingelheim Investigational Site 189
🇵🇱Piekary Slaskie, Poland
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🇵🇱Pila, Poland
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🇵🇱Pruszcz Gdanski, Poland
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🇵🇱Rabka Zdroj, Poland
Boehringer Ingelheim Investigational Site 230
🇵🇱Ruda Slaska, Poland
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🇵🇱Rumia, Poland
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🇵🇱Rzeszow, Poland
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🇵🇱Sawin, Poland
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🇵🇱Siewierz, Poland
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🇵🇱Sosnowiec, Poland
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🇵🇱Suprasl, Poland
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🇵🇱Suwalki, Poland
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🇵🇱Szczecinek, Poland
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🇵🇱Walcz, Poland
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🇵🇱Warszawa, Poland
Boehringer Ingelheim Investigational Site 91
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🇵🇱Wroclaw, Poland
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🇵🇱Zabkowice Slaskie, Poland
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🇵🇱Zabrze, Poland
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🇵🇱Zagoty, Poland
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🇵🇱Zabrze, Poland
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🇵🇱Zielona Gora, Poland
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