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

April 11, 2012 updated by: Col·legi de Farmacèutics de la Província de Barcelona

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

3600

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08009
        • Col·legi Oficial de Farmacèutics de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: High Risk Customers
Pharmacy customers with GOLD COPD Criteria of high-risk subjects.
Other: Spirometry
Spirometry done in high-risk customers of community-pharmacies to detect airflow limitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COPD Case Finding
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Col·legi de Farmacèutics de la Província de Barcelona

Collaborators

Hospital Clinic of Barcelona
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Catalan Society of Family Medicine
Spanish Respiratory Society

Investigators

  • Principal Investigator: Diego Castillo, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

April 11, 2012

First Posted (Estimate)

April 12, 2012

Study Record Updates

Last Update Posted (Estimate)

April 12, 2012

Last Update Submitted That Met QC Criteria

April 11, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/3128/I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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