- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01576068
Chronic Obstructive Pulmonary Disease Case Finding in Community-pharmacies by Spirometry (FARMAEPOC)
Efficiency of COPD Case Finding Program by Spirometry in High-risk Customers of Urban Community Pharmacies
Chronic Obstructive Pulmonary Disease (COPD) is a prevalent disease. In the investigators country, underdiagnosis has been estimated in around 80% of subjects. Early detection is done mainly in primary care but due to actual situation new alternatives have been proposed to decrease underdiagnosis.
This present study promote by a multidisciplinary research team (respiratory medicine, primary care, nurse and pharmacist) raise the objective of evaluate the effect of a COPD case finding program guide by spirometry in community-pharmacies.
From the results of a pilot-study conducted in 13 community-pharmacies in Barcelona, in which the investigators showed the feasibility of spirometry in community-pharmacies for the early detection of COPD, the investigators have design a second phase to evaluate the effect of this strategy. 100 Barcelona's community-pharmacies during 6 months will select high risk customers and will conduct a spirometry in agreement with the design protocol. 3600 spirometries is the establish objective. Participants hospitals will train pharmacist in spirometry and also control spirometry quality daily by a telematic pathway. Spirometry results will be evaluate in terms of effect and costs. The investigators will also evaluate the impact of this program in the health system by numbers of subjects diagnosed and follow up in primary care.
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Tidlig fase 1
Kontakter og plasseringer
Studiesteder
-
-
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Barcelona, Spania, 08009
- Col·legi Oficial de Farmacèutics de Barcelona
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age over 40 years.
- Current or former smoker
- Chronic respiratory symptoms(cough, shortness of breath, expectoration)
Exclusion Criteria:
- Previous diagnosed chronic lung disease
- Use of inhalers
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: High Risk Customers
Pharmacy customers with GOLD COPD Criteria of high-risk subjects.
|
Spirometry done in high-risk customers of community-pharmacies to detect airflow limitation
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
COPD Case Finding
Tidsramme: During 15 months pharmacies will include subjects with possible COPD through spirometry.
|
Proportion of high-risk customers with spirometry showing a FEV1/FVC under 0,7.
|
During 15 months pharmacies will include subjects with possible COPD through spirometry.
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Diego Castillo, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2008/3128/I
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