Chronic Obstructive Pulmonary Disease Case Finding in Community-pharmacies by Spirometry

Early Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT01576068
• Lead Sponsor: Col·legi de Farmacèutics de la Província de Barcelona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-02-29
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-11
• Last Update Submitted: 2012-04-11
• Study First Posted: 2012-04-12
• Last Update Posted: 2012-04-12
• Primary Completion: 2012-07
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
COPD Case Finding	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.

Trial Locations

Locations (1)

Col·legi Oficial de Farmacèutics de Barcelona; 🇪🇸 Barcelona, Spain