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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1328

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Polen
      • Andrychow, Polen
        • Boehringer Ingelheim Investigational Site 236
      • Bialystok, Polen
        • Boehringer Ingelheim Investigational Site 170
      • Bialystok, Polen
        • Boehringer Ingelheim Investigational Site 184
      • Bialystok, Polen
        • Boehringer Ingelheim Investigational Site 240
      • Bialystok, Polen
        • Boehringer Ingelheim Investigational Site 44
      • Bialystok, Polen
        • Boehringer Ingelheim Investigational Site 84
      • Bielsko-Biala, Polen
        • Boehringer Ingelheim Investigational Site 33
      • Bielsko-Biala, Polen
        • Boehringer Ingelheim Investigational Site 34
      • Bielsko-Biala, Polen
        • Boehringer Ingelheim Investigational Site 35
      • Biskupiec, Polen
        • Boehringer Ingelheim Investigational Site 79
      • Bochnia, Polen
        • Boehringer Ingelheim Investigational Site 116
      • Brzesko, Polen
        • Boehringer Ingelheim Investigational Site 115
      • Brzesko, Polen
        • Boehringer Ingelheim Investigational Site 138
      • Brzeziny, Polen
        • Boehringer Ingelheim Investigational Site 185
      • Brzozow, Polen
        • Boehringer Ingelheim Investigational Site 90
      • Bydgoszcz, Polen
        • Boehringer Ingelheim Investigational Site 105
      • Bydgoszcz, Polen
        • Boehringer Ingelheim Investigational Site 119
      • Bydgoszcz, Polen
        • Boehringer Ingelheim Investigational Site 123
      • Bydgoszcz, Polen
        • Boehringer Ingelheim Investigational Site 222
      • Bydgoszcz, Polen
        • Boehringer Ingelheim Investigational Site 27
      • Chelm, Polen
        • Boehringer Ingelheim Investigational Site 21
      • Chelm, Polen
        • Boehringer Ingelheim Investigational Site 22
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        • Boehringer Ingelheim Investigational Site 11
      • Chodziez, Polen
        • Boehringer Ingelheim Investigational Site 233
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        • Boehringer Ingelheim Investigational Site 226
      • Chorzow, Polen
        • Boehringer Ingelheim Investigational Site 149
      • Chorzow, Polen
        • Boehringer Ingelheim Investigational Site 153
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        • Boehringer Ingelheim Investigational Site 88
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        • Boehringer Ingelheim Investigational Site 133
      • Gdansk, Polen
        • Boehringer Ingelheim Investigational Site 134
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        • Boehringer Ingelheim Investigational Site 136
      • Gdansk, Polen
        • Boehringer Ingelheim Investigational Site 155
      • Gdansk, Polen
        • Boehringer Ingelheim Investigational Site 156
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        • Boehringer Ingelheim Investigational Site 20
      • Gdansk, Polen
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        • Boehringer Ingelheim Investigational Site 174
      • Grodzisk Mazowiecki, Polen
        • Boehringer Ingelheim Investigational Site 176
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        • Boehringer Ingelheim Investigational Site 56
      • Jaroslaw, Polen
        • Boehringer Ingelheim Investigational Site 179
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        • Boehringer Ingelheim Investigational Site 108
      • Jaslo, Polen
        • Boehringer Ingelheim Investigational Site 225
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        • Boehringer Ingelheim Investigational Site 8
      • Jedrzejow, Polen
        • Boehringer Ingelheim Investigational Site 243
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        • Boehringer Ingelheim Investigational Site 148
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        • Boehringer Ingelheim Investigational Site 162
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        • Boehringer Ingelheim Investigational Site 163
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        • Boehringer Ingelheim Investigational Site 212
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        • Boehringer Ingelheim Investigational Site 69
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        • Boehringer Ingelheim Investigational Site 112
      • Kielce, Polen
        • Boehringer Ingelheim Investigational Site 18
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        • Boehringer Ingelheim Investigational Site 19
      • Klodzko, Polen
        • 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 141
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        • Boehringer Ingelheim Investigational Site 51
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        • Boehringer Ingelheim Investigational Site 52
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        • Boehringer Ingelheim Investigational Site 122
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        • Boehringer Ingelheim Investigational Site 143
      • Krakow, Polen
        • Boehringer Ingelheim Investigational Site 146
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        • Boehringer Ingelheim Investigational Site 171
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      • 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 86
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        • Boehringer Ingelheim Investigational Site 186
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      • Milicz, Polen
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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 189
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        • Boehringer Ingelheim Investigational Site 32
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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 130
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        • Boehringer Ingelheim Investigational Site 208
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        • Boehringer Ingelheim Investigational Site 227
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        • Boehringer Ingelheim Investigational Site 228
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        • Boehringer Ingelheim Investigational Site 231
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        • Boehringer Ingelheim Investigational Site 126
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        • Boehringer Ingelheim Investigational Site 218
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        • Boehringer Ingelheim Investigational Site 131
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        • Boehringer Ingelheim Investigational Site 191
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        • Boehringer Ingelheim Investigational Site 169
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        • Boehringer Ingelheim Investigational Site 117
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        • Boehringer Ingelheim Investigational Site 118
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        • Boehringer Ingelheim Investigational Site 230
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        • Boehringer Ingelheim Investigational Site 82
      • Rumia, Polen
        • Boehringer Ingelheim Investigational Site 180
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        • 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
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        • Boehringer Ingelheim Investigational Site 83
      • Rzeszow, Polen
        • Boehringer Ingelheim Investigational Site 175
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        • Boehringer Ingelheim Investigational Site 178
      • Sanok, Polen
        • Boehringer Ingelheim Investigational Site 190
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        • Boehringer Ingelheim Investigational Site 73
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        • Boehringer Ingelheim Investigational Site 78
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        • Boehringer Ingelheim Investigational Site 241
      • Skawina, Polen
        • Boehringer Ingelheim Investigational Site 157
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        • Boehringer Ingelheim Investigational Site 10
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        • Boehringer Ingelheim Investigational Site 167
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        • Boehringer Ingelheim Investigational Site 53
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        • Boehringer Ingelheim Investigational Site 96
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        • Boehringer Ingelheim Investigational Site 107
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        • Boehringer Ingelheim Investigational Site 55
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        • Boehringer Ingelheim Investigational Site 48
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Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Samarbeidspartnere

Pfizer

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2011

Primær fullføring (Faktiske)

1. mars 2013

Studiet fullført (Faktiske)

1. mars 2013

Datoer for studieregistrering

Først innsendt

17. juli 2012

Først innsendt som oppfylte QC-kriteriene

18. juli 2012

Først lagt ut (Anslag)

19. juli 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. mai 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. april 2014

Sist bekreftet

1. april 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 205.502

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Chile

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere