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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Col·legi de Farmacèutics de la Província de Barcelona.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Clinic of Barcelona
Spanish Respiratory Society
Catalan Society of Family Medicine
Information provided by (Responsible Party):
Col·legi de Farmacèutics de la Província de Barcelona
ClinicalTrials.gov Identifier:
NCT01576068
First received: February 29, 2012
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Other: Spirometry
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Efficiency of COPD Case Finding Program by Spirometry in High-risk Customers of Urban Community Pharmacies

Resource links provided by NLM:


Further study details as provided by Col·legi de Farmacèutics de la Província de Barcelona:

Primary Outcome Measures:
  • COPD Case Finding [ Time Frame: During 15 months pharmacies will include subjects with possible COPD through spirometry. ] [ Designated as safety issue: No ]
    Proportion of high-risk customers with spirometry showing a FEV1/FVC under 0,7.


Estimated Enrollment: 3600
Study Start Date: October 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576068

Locations
Spain
Col·legi Oficial de Farmacèutics de Barcelona
Barcelona, Spain, 08009
Sponsors and Collaborators
Col·legi de Farmacèutics de la Província de Barcelona
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Clinic of Barcelona
Spanish Respiratory Society
Catalan Society of Family Medicine
Investigators
Principal Investigator: Diego Castillo, MD Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
  More Information

Publications:
Responsible Party: Col·legi de Farmacèutics de la Província de Barcelona
ClinicalTrials.gov Identifier: NCT01576068     History of Changes
Other Study ID Numbers: 2008/3128/I
Study First Received: February 29, 2012
Last Updated: April 11, 2012
Health Authority: Spain: Departament de Salut de la Generalitat de Catalunya

Keywords provided by Col·legi de Farmacèutics de la Província de Barcelona:
COPD
Pharmacy
Spirometry
Case finding

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2014