A Cross Sectional Disease/Condition Focused Observational Study on Chronic Obstructive Pulmonary Disease (COPD) (PREFER)
2. december 2016 opdateret af: AstraZeneca
Prevalence of Comorbidities of COPD in the Exacerbator Phenotype - A Cross Sectional Disease/Condition Focused Observational Study on COPD
The purpose of this study is to establish the prevalence of comorbidities in Italian patients with chronic bronchitis with at least 2 exacerbations per year, and to document the appropriateness of instrumental diagnostic tests, such as spirometry of these patients.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
This is an observational study so participants will only take medication that is presently prescribed by their regular healthcare provider. No additional study medication will be administered. This study will enroll patients who have been previously diagnosed with COPD. This study will look at the medical history and other diseases that have been diagnosed in people who also have COPD.
The study will enroll approximately 3000 patients.
This multi-centre trial will be conducted in Italy. The overall time to participate in this study is at a single, regularly scheduled visit at the pulmonologists office. There will not be any follow up assessments.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
860
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Veruno (Novara), Italien
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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
45 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients with COPD will be enrolled at hospital and pulmonology departments in Italy.
Beskrivelse
Inclusion Criteria:
- Age 45-85, of either gender.
- Signed informed consent.
- Known COPD documented by spirometric exams showing fixed non reversible respiratory obstruction.
- Forced Expired Volume measured after 1 second expiration (FEV-1) < 50% in a previous test (no time limits).
- Symptoms of chronic bronchitis : chronic productive cough for 3 months at least in each of the 2 years prior to the index visits.
- On treatment of bronchodilators (no restrictions) for the last 12 months at least.
- History of at least 2 exacerbations (moderate/severe) in the last 12 months prior to index visit.
Exclusion Criteria:
- None
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Chronic obstructive pulmonary disease
Patients with chronic obstructive pulmonary disease will undergo a single visit with the collection of data from his/her records.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Prevalence of Comorbidities
Tidsramme: Comorbidities captured at the index visit and related to 12 Months Prior to Study Index Visit
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The following comorbidities were accounted for (from the patient records): arterial hypertension, ischemic heart disease, other cardiac disorders, arrhythmia, congestive heart failure, diabetes, metabolic syndrome, known osteoporosis, depression, and chronic renal insufficiency.
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Comorbidities captured at the index visit and related to 12 Months Prior to Study Index Visit
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Percentage of Participants having Annual Spirometric Tests
Tidsramme: 12 months prior and up to the Study Index Visit
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12 months prior and up to the Study Index Visit
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 2012
Primær færdiggørelse (Faktiske)
1. juli 2014
Studieafslutning (Faktiske)
1. juli 2014
Datoer for studieregistrering
Først indsendt
6. februar 2014
Først indsendt, der opfyldte QC-kriterier
26. marts 2014
Først opslået (Skøn)
31. marts 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. december 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. december 2016
Sidst verificeret
1. september 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RO-2455-402-IT
- U1111-1152-9289 (Registry Identifier: WHO (UTN))
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 .