Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination Dry Powder Inhalers (DPI) in Chronic Obstructive Pulmonary Disease (COPD)
15. oktober 2012 opdateret af: AstraZeneca
Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination DPI in COPD
The aim of this study is to describe patient preferences on budesonide/formoterol fix dose combination for the treatment of their COPD, and to find those factors more strongly associated to a better attitude to medication.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Validation of questionnaire and assessment of patient satisfaction for budesonide/formoterol fix combination DPI in COPD
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
446
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Adana, Kalkun
- Research Site
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Afyon, Kalkun
- Research Site
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Ankara, Kalkun
- Research Site
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Ayd?n, Kalkun
- Research Site
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Balikesir, Kalkun
- Research Site
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Bartin, Kalkun
- Research Site
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Cankiri, Kalkun
- Research Site
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Elazig, Kalkun
- Research Site
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Gaziantep, Kalkun
- Research Site
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Istanbul, Kalkun
- Research Site
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Izmir, Kalkun
- Research Site
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Kayseri, Kalkun
- Research Site
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Kocaeli, Kalkun
- Research Site
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Konya, Kalkun
- Research Site
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Manisa, Kalkun
- Research Site
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Mersin, Kalkun
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Rize, Kalkun
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Sakarya, Kalkun
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Samsun, Kalkun
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Yozgat, Kalkun
- Research Site
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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
40 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients of both sexes ≥ 40 years of age, diagnosed with COPD (according to ICD-10 criteria) and receiving budesonide/formoterol fix dose combination treatment by means of inhaler devices.
The first prescription must be given at least 3 months prior to the study start and patient inclusion.
Beskrivelse
Inclusion Criteria:
- Provision of subject informed consent and to be an outpatient
- Clinical diagnosis of COPD according to ICD-10 classification, females and males, aged ≥ 40 years
- To be prescribed a fixed dose combination of inhaled budesonide/formoterol fix combination at least 3 months before the study start
Exclusion Criteria:
- Pregnancy for women
- Use of inhaled medication via a metered dose inhaler (pMDI)
- Currently participating in randomized clinical trials and being included in this study once
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Feeling of Satisfaction with Inhaler (FSI-10) Questionnaire in COPD Turkish population.
Tidsramme: During 1 month, up to September 2012
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The FSI-10 is a self-completed 10-item questionnaire to assess patient opinions regarding ease or difficulty of use, portability, and usability of devices for delivery of inhaled medications.
Each of the 10 items has 5 response options from poorer to greater ease of use, scored 1 to 5, respectively.
The minimum score is 10 whereas the maximum is 50.
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During 1 month, up to September 2012
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Socio-demographics profile
Tidsramme: During 1 month, up to September 2012
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Socio-demographics parameters: Age; Gender; Educational level; Place of residence (urban / rural); Living alone or accompanied.
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During 1 month, up to September 2012
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Clinical characteristics
Tidsramme: During 1 month, up to September 2012
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Clinical characteristics parameters:Current disease grade; Date of COPD diagnosis
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During 1 month, up to September 2012
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Treatment-related information
Tidsramme: During 1 month, up to September 2012
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Date of first prescription for Turbuhaler; Concomitant treatments for COPD
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During 1 month, up to September 2012
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Inhaler use
Tidsramme: During 1 month, up to September 2012
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Specifically for evaluating real-life patterns of use and usage knowledge of the dry-powder inhaler (Turbuhaler) that delivers budesonide / formoterol fix combination, a specific checklist of the key features of the inhalation technique.Preference with the inhaler she/he is using will be assessed based on patient reported outcomes.
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During 1 month, up to September 2012
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Site characteristics
Tidsramme: During 1 month, up to September 2012
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Type of the hospital: state, university, private
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During 1 month, up to September 2012
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Mujgan Ates, DR, AZ MC Turkey
- Ledende efterforsker: Akin Kaya, PROF.DR., Ankara University Faculty of Medicine, Chest Diseases Department
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. august 2012
Primær færdiggørelse (Faktiske)
1. september 2012
Studieafslutning (Faktiske)
1. september 2012
Datoer for studieregistrering
Først indsendt
19. juli 2012
Først indsendt, der opfyldte QC-kriterier
19. juli 2012
Først opslået (Skøn)
20. juli 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. oktober 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. oktober 2012
Sidst verificeret
1. oktober 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NIS-RTR-XXX-2012/1
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 .