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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. april 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1328

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Polen
      • Andrychow, Polen
        • Boehringer Ingelheim Investigational Site 236
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      • Bialystok, Polen
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        • Boehringer Ingelheim Investigational Site 240
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        • Boehringer Ingelheim Investigational Site 44
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        • Boehringer Ingelheim Investigational Site 84
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        • Boehringer Ingelheim Investigational Site 33
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        • Boehringer Ingelheim Investigational Site 222
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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 108
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        • Boehringer Ingelheim Investigational Site 225
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        • Boehringer Ingelheim Investigational Site 243
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        • Boehringer Ingelheim Investigational Site 212
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        • Boehringer Ingelheim Investigational Site 13
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        • Boehringer Ingelheim Investigational Site 49
      • Konin, Polen
        • Boehringer Ingelheim Investigational Site 219
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        • Boehringer Ingelheim Investigational Site 51
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        • Boehringer Ingelheim Investigational Site 122
      • Krakow, Polen
        • Boehringer Ingelheim Investigational Site 135
      • Krakow, Polen
        • Boehringer Ingelheim Investigational Site 143
      • Krakow, Polen
        • Boehringer Ingelheim Investigational Site 146
      • Krakow, Polen
        • Boehringer Ingelheim Investigational Site 171
      • Krakow, Polen
        • Boehringer Ingelheim Investigational Site 177
      • Krakow, Polen
        • Boehringer Ingelheim Investigational Site 214
      • Krakow, Polen
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        • Boehringer Ingelheim Investigational Site 129
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        • Boehringer Ingelheim Investigational Site 204
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        • Boehringer Ingelheim Investigational Site 207
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        • Boehringer Ingelheim Investigational Site 192
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        • Boehringer Ingelheim Investigational Site 198
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        • Boehringer Ingelheim Investigational Site 206
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        • Boehringer Ingelheim Investigational Site 57
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        • Boehringer Ingelheim Investigational Site 58
      • Lowicz, Polen
        • Boehringer Ingelheim Investigational Site 186
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        • Boehringer Ingelheim Investigational Site 158
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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
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        • Boehringer Ingelheim Investigational Site 17
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        • Boehringer Ingelheim Investigational Site 110
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        • Boehringer Ingelheim Investigational Site 159
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        • Boehringer Ingelheim Investigational Site 150
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        • Boehringer Ingelheim Investigational Site 25
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        • Boehringer Ingelheim Investigational Site 128
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        • Boehringer Ingelheim Investigational Site 109
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        • Boehringer Ingelheim Investigational Site 154
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        • Boehringer Ingelheim Investigational Site 72
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        • Boehringer Ingelheim Investigational Site 36
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        • Boehringer Ingelheim Investigational Site 245
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        • Boehringer Ingelheim Investigational Site 114
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        • Boehringer Ingelheim Investigational Site 145
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        • Boehringer Ingelheim Investigational Site 237
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        • Boehringer Ingelheim Investigational Site 182
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        • Boehringer Ingelheim Investigational Site 203
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        • Boehringer Ingelheim Investigational Site 59
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        • Boehringer Ingelheim Investigational Site 227
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        • Boehringer Ingelheim Investigational Site 228
      • Poznan, Polen
        • Boehringer Ingelheim Investigational Site 231
      • Prabuty, Polen
        • Boehringer Ingelheim Investigational Site 126
      • Proszowice, Polen
        • Boehringer Ingelheim Investigational Site 218
      • Pruszcz Gdanski, Polen
        • Boehringer Ingelheim Investigational Site 131
      • Przemysl, Polen
        • Boehringer Ingelheim Investigational Site 191
      • Rabka Zdroj, Polen
        • Boehringer Ingelheim Investigational Site 169
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        • Boehringer Ingelheim Investigational Site 117
      • Radom, Polen
        • Boehringer Ingelheim Investigational Site 118
      • Ruda Slaska, Polen
        • Boehringer Ingelheim Investigational Site 151
      • Ruda Slaska, Polen
        • Boehringer Ingelheim Investigational Site 152
      • Ruda Slaska, Polen
        • Boehringer Ingelheim Investigational Site 230
      • Ruda Slaska, Polen
        • Boehringer Ingelheim Investigational Site 82
      • Rumia, Polen
        • Boehringer Ingelheim Investigational Site 180
      • Rumia, Polen
        • Boehringer Ingelheim Investigational Site 239
      • Rumia, Polen
        • Boehringer Ingelheim Investigational Site 5
      • Rybnik, Polen
        • Boehringer Ingelheim Investigational Site 104
      • Rybnik, Polen
        • Boehringer Ingelheim Investigational Site 183
      • Rybnik, Polen
        • Boehringer Ingelheim Investigational Site 83
      • Rzeszow, Polen
        • Boehringer Ingelheim Investigational Site 175
      • Rzeszow, Polen
        • Boehringer Ingelheim Investigational Site 178
      • Sanok, Polen
        • Boehringer Ingelheim Investigational Site 190
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        • Boehringer Ingelheim Investigational Site 73
      • Sejny, Polen
        • Boehringer Ingelheim Investigational Site 78
      • Siewierz, Polen
        • Boehringer Ingelheim Investigational Site 160
      • Skarzysko Kamienna, Polen
        • Boehringer Ingelheim Investigational Site 241
      • Skawina, Polen
        • Boehringer Ingelheim Investigational Site 157
      • Skoczow, Polen
        • Boehringer Ingelheim Investigational Site 10
      • Skrzyszow, Polen
        • Boehringer Ingelheim Investigational Site 167
      • Slawno, Polen
        • Boehringer Ingelheim Investigational Site 53
      • Slubice, Polen
        • Boehringer Ingelheim Investigational Site 96
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        • Boehringer Ingelheim Investigational Site 205
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        • Boehringer Ingelheim Investigational Site 14
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        • Boehringer Ingelheim Investigational Site 113
      • Sosnowiec, Polen
        • Boehringer Ingelheim Investigational Site 166
      • Sosnowiec, Polen
        • Boehringer Ingelheim Investigational Site 24
      • Srem, Polen
        • Boehringer Ingelheim Investigational Site 107
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        • Boehringer Ingelheim Investigational Site 213
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        • Boehringer Ingelheim Investigational Site 54
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        • Boehringer Ingelheim Investigational Site 55
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        • Boehringer Ingelheim Investigational Site 66
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        • Boehringer Ingelheim Investigational Site 70
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        • Boehringer Ingelheim Investigational Site 121
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        • Boehringer Ingelheim Investigational Site 28
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        • Boehringer Ingelheim Investigational Site 81
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        • Boehringer Ingelheim Investigational Site 211

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Patients Maintaining or Improving Their Health Status
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the Total CAT Score (Value Baseline Minus 3 Months)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Samarbejdspartnere

Pfizer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2011

Primær færdiggørelse (Faktiske)

1. marts 2013

Studieafslutning (Faktiske)

1. marts 2013

Datoer for studieregistrering

Først indsendt

17. juli 2012

Først indsendt, der opfyldte QC-kriterier

18. juli 2012

Først opslået (Skøn)

19. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 205.502

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Spiriva HandiHaler

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uruguay

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner