Clinical trial NCT01576068: Chronic Obstructive Pulmonary Disease Case Finding in Community-pharmacies by Spirometry
Official title: Efficiency of COPD Case Finding Program by Spirometry in High-risk Customers of Urban Community Pharmacies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Pharmacy
Spirometry
Case finding
Lead sponsor: Col·legi de Farmacèutics de la Província de Barcelona
Sponsor class: OTHER
Collaborators: name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Hospital Clinic of Barcelona
name: Spanish Respiratory Society
name: Catalan Society of Family Medicine
First posted: 2012-04-12
Enrollment: 3600
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: COPD Case Finding
timeFrame: During 15 months pharmacies will include subjects with possible COPD through spirometry.
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Col·legi Oficial de Farmacèutics de Barcelona
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Diego Castillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castillo D, Guayta R, Giner J, Burgos F, Capdevila C, Soriano JB, Barau M, Casan P; FARMAEPOC group. COPD case finding by spirometry in high-risk customers of urban community pharmacies: a pilot study. Respir Med. 2009 Jun;103(6):839-45. doi: 10.1016/j.rmed.2008.12.022. Epub 2009 Feb 5.