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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

30 aprile 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1328

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Andrychow, Polonia
        • Boehringer Ingelheim Investigational Site 236
      • Bialystok, Polonia
        • Boehringer Ingelheim Investigational Site 170
      • Bialystok, Polonia
        • Boehringer Ingelheim Investigational Site 184
      • Bialystok, Polonia
        • Boehringer Ingelheim Investigational Site 240
      • Bialystok, Polonia
        • Boehringer Ingelheim Investigational Site 44
      • Bialystok, Polonia
        • Boehringer Ingelheim Investigational Site 84
      • Bielsko-Biala, Polonia
        • Boehringer Ingelheim Investigational Site 33
      • Bielsko-Biala, Polonia
        • Boehringer Ingelheim Investigational Site 34
      • Bielsko-Biala, Polonia
        • Boehringer Ingelheim Investigational Site 35
      • Biskupiec, Polonia
        • Boehringer Ingelheim Investigational Site 79
      • Bochnia, Polonia
        • Boehringer Ingelheim Investigational Site 116
      • Brzesko, Polonia
        • Boehringer Ingelheim Investigational Site 115
      • Brzesko, Polonia
        • Boehringer Ingelheim Investigational Site 138
      • Brzeziny, Polonia
        • Boehringer Ingelheim Investigational Site 185
      • Brzozow, Polonia
        • Boehringer Ingelheim Investigational Site 90
      • Bydgoszcz, Polonia
        • Boehringer Ingelheim Investigational Site 105
      • Bydgoszcz, Polonia
        • Boehringer Ingelheim Investigational Site 119
      • Bydgoszcz, Polonia
        • Boehringer Ingelheim Investigational Site 123
      • Bydgoszcz, Polonia
        • Boehringer Ingelheim Investigational Site 222
      • Bydgoszcz, Polonia
        • Boehringer Ingelheim Investigational Site 27
      • Chelm, Polonia
        • Boehringer Ingelheim Investigational Site 21
      • Chelm, Polonia
        • Boehringer Ingelheim Investigational Site 22
      • Chelmsko Slaskie, Polonia
        • Boehringer Ingelheim Investigational Site 11
      • Chodziez, Polonia
        • Boehringer Ingelheim Investigational Site 233
      • Chojnice, Polonia
        • Boehringer Ingelheim Investigational Site 226
      • Chorzow, Polonia
        • Boehringer Ingelheim Investigational Site 149
      • Chorzow, Polonia
        • Boehringer Ingelheim Investigational Site 153
      • Ciechanow, Polonia
        • Boehringer Ingelheim Investigational Site 88
      • Czarnkow, Polonia
        • Boehringer Ingelheim Investigational Site 232
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        • Boehringer Ingelheim Investigational Site 229
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        • Boehringer Ingelheim Investigational Site 4
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        • Boehringer Ingelheim Investigational Site 23
      • Domaradz, Polonia
        • Boehringer Ingelheim Investigational Site 92
      • Dziergowice, Polonia
        • Boehringer Ingelheim Investigational Site 246
      • Gdansk, Polonia
        • Boehringer Ingelheim Investigational Site 133
      • Gdansk, Polonia
        • Boehringer Ingelheim Investigational Site 134
      • Gdansk, Polonia
        • Boehringer Ingelheim Investigational Site 136
      • Gdansk, Polonia
        • Boehringer Ingelheim Investigational Site 155
      • Gdansk, Polonia
        • Boehringer Ingelheim Investigational Site 156
      • Gdansk, Polonia
        • Boehringer Ingelheim Investigational Site 20
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        • Boehringer Ingelheim Investigational Site 234
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        • Boehringer Ingelheim Investigational Site 50
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        • Boehringer Ingelheim Investigational Site 174
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        • Boehringer Ingelheim Investigational Site 176
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        • Boehringer Ingelheim Investigational Site 56
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        • Boehringer Ingelheim Investigational Site 179
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        • Boehringer Ingelheim Investigational Site 225
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        • Boehringer Ingelheim Investigational Site 8
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        • Boehringer Ingelheim Investigational Site 243
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        • Boehringer Ingelheim Investigational Site 148
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        • Boehringer Ingelheim Investigational Site 13
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        • Boehringer Ingelheim Investigational Site 49
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        • Boehringer Ingelheim Investigational Site 219
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        • Boehringer Ingelheim Investigational Site 51
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        • Boehringer Ingelheim Investigational Site 52
      • Krakow, Polonia
        • Boehringer Ingelheim Investigational Site 122
      • Krakow, Polonia
        • Boehringer Ingelheim Investigational Site 135
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        • Boehringer Ingelheim Investigational Site 143
      • Krakow, Polonia
        • Boehringer Ingelheim Investigational Site 146
      • Krakow, Polonia
        • Boehringer Ingelheim Investigational Site 171
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      • Krakow, Polonia
        • Boehringer Ingelheim Investigational Site 214
      • Krakow, Polonia
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      • Krakow, Polonia
        • Boehringer Ingelheim Investigational Site 94
      • Krasnik, Polonia
        • Boehringer Ingelheim Investigational Site 129
      • Krasnik, Polonia
        • Boehringer Ingelheim Investigational Site 204
      • Krasnik, Polonia
        • Boehringer Ingelheim Investigational Site 207
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        • Boehringer Ingelheim Investigational Site 206
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        • Boehringer Ingelheim Investigational Site 37
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        • Boehringer Ingelheim Investigational Site 172
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        • Boehringer Ingelheim Investigational Site 196
      • Lublin, Polonia
        • Boehringer Ingelheim Investigational Site 124
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        • Boehringer Ingelheim Investigational Site 17
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        • Boehringer Ingelheim Investigational Site 29
      • Lublin, Polonia
        • Boehringer Ingelheim Investigational Site 7
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        • Boehringer Ingelheim Investigational Site 242
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        • Boehringer Ingelheim Investigational Site 30
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        • Boehringer Ingelheim Investigational Site 45
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        • Boehringer Ingelheim Investigational Site 168
      • Mielec, Polonia
        • Boehringer Ingelheim Investigational Site 110
      • Milicz, Polonia
        • Boehringer Ingelheim Investigational Site 159
      • Myslowice, Polonia
        • Boehringer Ingelheim Investigational Site 150
      • Myszkow, Polonia
        • Boehringer Ingelheim Investigational Site 25
      • Nisko, Polonia
        • Boehringer Ingelheim Investigational Site 215
      • Nowy Dwor Gdanski, Polonia
        • Boehringer Ingelheim Investigational Site 128
      • Nowy Sacz, Polonia
        • Boehringer Ingelheim Investigational Site 109
      • Olawa, Polonia
        • Boehringer Ingelheim Investigational Site 154
      • Olecko, Polonia
        • Boehringer Ingelheim Investigational Site 72
      • Olsztyn, Polonia
        • Boehringer Ingelheim Investigational Site 36
      • Opatow, Polonia
        • Boehringer Ingelheim Investigational Site 245
      • Ostrowiec Swietokrzyski, Polonia
        • Boehringer Ingelheim Investigational Site 114
      • Ostrowiec Swietokrzyski, Polonia
        • Boehringer Ingelheim Investigational Site 145
      • Pabianice, Polonia
        • Boehringer Ingelheim Investigational Site 237
      • Papowo Biskupie, Polonia
        • Boehringer Ingelheim Investigational Site 182
      • Pawonkow, Polonia
        • Boehringer Ingelheim Investigational Site 216
      • Piekary Slaskie, Polonia
        • Boehringer Ingelheim Investigational Site 189
      • Pietrzykowice, Polonia
        • Boehringer Ingelheim Investigational Site 32
      • Pila, Polonia
        • Boehringer Ingelheim Investigational Site 40
      • Piotrkow Trybunalski, Polonia
        • Boehringer Ingelheim Investigational Site 203
      • Plock, Polonia
        • Boehringer Ingelheim Investigational Site 59
      • Pniewy, Polonia
        • Boehringer Ingelheim Investigational Site 93
      • Poniatowa, Polonia
        • Boehringer Ingelheim Investigational Site 130
      • Poznan, Polonia
        • Boehringer Ingelheim Investigational Site 201
      • Poznan, Polonia
        • Boehringer Ingelheim Investigational Site 208
      • Poznan, Polonia
        • Boehringer Ingelheim Investigational Site 227
      • Poznan, Polonia
        • Boehringer Ingelheim Investigational Site 228
      • Poznan, Polonia
        • Boehringer Ingelheim Investigational Site 231
      • Prabuty, Polonia
        • Boehringer Ingelheim Investigational Site 126
      • Proszowice, Polonia
        • Boehringer Ingelheim Investigational Site 218
      • Pruszcz Gdanski, Polonia
        • Boehringer Ingelheim Investigational Site 131
      • Przemysl, Polonia
        • Boehringer Ingelheim Investigational Site 191
      • Rabka Zdroj, Polonia
        • Boehringer Ingelheim Investigational Site 169
      • Radom, Polonia
        • Boehringer Ingelheim Investigational Site 117
      • Radom, Polonia
        • Boehringer Ingelheim Investigational Site 118
      • Ruda Slaska, Polonia
        • Boehringer Ingelheim Investigational Site 151
      • Ruda Slaska, Polonia
        • Boehringer Ingelheim Investigational Site 152
      • Ruda Slaska, Polonia
        • Boehringer Ingelheim Investigational Site 230
      • Ruda Slaska, Polonia
        • Boehringer Ingelheim Investigational Site 82
      • Rumia, Polonia
        • Boehringer Ingelheim Investigational Site 180
      • Rumia, Polonia
        • Boehringer Ingelheim Investigational Site 239
      • Rumia, Polonia
        • Boehringer Ingelheim Investigational Site 5
      • Rybnik, Polonia
        • Boehringer Ingelheim Investigational Site 104
      • Rybnik, Polonia
        • Boehringer Ingelheim Investigational Site 183
      • Rybnik, Polonia
        • Boehringer Ingelheim Investigational Site 83
      • Rzeszow, Polonia
        • Boehringer Ingelheim Investigational Site 175
      • Rzeszow, Polonia
        • Boehringer Ingelheim Investigational Site 178
      • Sanok, Polonia
        • Boehringer Ingelheim Investigational Site 190
      • Sawin, Polonia
        • Boehringer Ingelheim Investigational Site 73
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        • Boehringer Ingelheim Investigational Site 78
      • Siewierz, Polonia
        • Boehringer Ingelheim Investigational Site 160
      • Skarzysko Kamienna, Polonia
        • Boehringer Ingelheim Investigational Site 241
      • Skawina, Polonia
        • Boehringer Ingelheim Investigational Site 157
      • Skoczow, Polonia
        • Boehringer Ingelheim Investigational Site 10
      • Skrzyszow, Polonia
        • Boehringer Ingelheim Investigational Site 167
      • Slawno, Polonia
        • Boehringer Ingelheim Investigational Site 53
      • Slubice, Polonia
        • Boehringer Ingelheim Investigational Site 96
      • Slupca, Polonia
        • Boehringer Ingelheim Investigational Site 205
      • Sokolowsko, Polonia
        • Boehringer Ingelheim Investigational Site 14
      • Sopot, Polonia
        • Boehringer Ingelheim Investigational Site 113
      • Sosnowiec, Polonia
        • Boehringer Ingelheim Investigational Site 166
      • Sosnowiec, Polonia
        • Boehringer Ingelheim Investigational Site 24
      • Srem, Polonia
        • Boehringer Ingelheim Investigational Site 107
      • Srem, Polonia
        • Boehringer Ingelheim Investigational Site 213
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        • Boehringer Ingelheim Investigational Site 125
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        • Boehringer Ingelheim Investigational Site 144
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        • Boehringer Ingelheim Investigational Site 80
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        • Boehringer Ingelheim Investigational Site 120
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        • Boehringer Ingelheim Investigational Site 95
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        • Boehringer Ingelheim Investigational Site 16
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        • Boehringer Ingelheim Investigational Site 54
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        • Boehringer Ingelheim Investigational Site 55
      • Swidnik, Polonia
        • Boehringer Ingelheim Investigational Site 1
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        • Boehringer Ingelheim Investigational Site 181
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        • Boehringer Ingelheim Investigational Site 76
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        • Boehringer Ingelheim Investigational Site 43
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        • Boehringer Ingelheim Investigational Site 48
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        • Boehringer Ingelheim Investigational Site 61
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        • Boehringer Ingelheim Investigational Site 66
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        • Boehringer Ingelheim Investigational Site 67
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        • Boehringer Ingelheim Investigational Site 224
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        • Boehringer Ingelheim Investigational Site 140
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        • Boehringer Ingelheim Investigational Site 200
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        • Boehringer Ingelheim Investigational Site 101
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        • Boehringer Ingelheim Investigational Site 70
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        • Boehringer Ingelheim Investigational Site 39
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        • Boehringer Ingelheim Investigational Site 121
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        • Boehringer Ingelheim Investigational Site 137
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        • Boehringer Ingelheim Investigational Site 161
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        • Boehringer Ingelheim Investigational Site 210
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        • Boehringer Ingelheim Investigational Site 238
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        • Boehringer Ingelheim Investigational Site 2
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        • Boehringer Ingelheim Investigational Site 3
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        • Boehringer Ingelheim Investigational Site 42
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        • Boehringer Ingelheim Investigational Site 46
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        • Boehringer Ingelheim Investigational Site 74
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        • Boehringer Ingelheim Investigational Site 91
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        • Boehringer Ingelheim Investigational Site 99
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        • Boehringer Ingelheim Investigational Site 6
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        • Boehringer Ingelheim Investigational Site 199
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        • Boehringer Ingelheim Investigational Site 235
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        • Boehringer Ingelheim Investigational Site 197
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        • Boehringer Ingelheim Investigational Site 65
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        • Boehringer Ingelheim Investigational Site 28
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        • Boehringer Ingelheim Investigational Site 98
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        • Boehringer Ingelheim Investigational Site 102
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        • Boehringer Ingelheim Investigational Site 202
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        • Boehringer Ingelheim Investigational Site 221
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        • Boehringer Ingelheim Investigational Site 62
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        • Boehringer Ingelheim Investigational Site 64
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        • Boehringer Ingelheim Investigational Site 89
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        • Boehringer Ingelheim Investigational Site 12
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        • Boehringer Ingelheim Investigational Site 9
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        • Boehringer Ingelheim Investigational Site 68
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        • Boehringer Ingelheim Investigational Site 15
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        • Boehringer Ingelheim Investigational Site 47
      • Zielonka k/Warszawy, Polonia
        • Boehringer Ingelheim Investigational Site 81
      • Zyrardow, Polonia
        • Boehringer Ingelheim Investigational Site 211

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Patients Maintaining or Improving Their Health Status
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in the Total CAT Score (Value Baseline Minus 3 Months)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2011

Completamento primario (Effettivo)

1 marzo 2013

Completamento dello studio (Effettivo)

1 marzo 2013

Date di iscrizione allo studio

Primo inviato

17 luglio 2012

Primo inviato che soddisfa i criteri di controllo qualità

18 luglio 2012

Primo Inserito (Stima)

19 luglio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 aprile 2014

Ultimo verificato

1 aprile 2014

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Spiriva HandiHaler

3
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