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

Chronic Obstructive Pulmonary Disease Clinical Trial

— FARMAEPOC  

Official title:

Efficiency of COPD Case Finding Program by Spirometry in High-risk Customers of Urban Community Pharmacies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01576068
• Other study ID #: 2008/3128/I
• Status: Active, not recruiting
• Phase: Phase 0
• First received: February 29, 2012
• Last updated: April 11, 2012
• Start date: October 2010
• Est. completion date: June 2013

Study information

• Verified date: April 2012
• Source: Col·legi de Farmacèutics de la Província de Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Departament de Salut de la Generalitat de Catalunya
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3600
• Est. completion date: June 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Spirometry
Spirometry done in high-risk customers of community-pharmacies to detect airflow limitation

Locations

Country	Name	City	State
Spain	Col·legi Oficial de Farmacèutics de Barcelona	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Col·legi de Farmacèutics de la Província de Barcelona	Catalan Society of Family Medicine, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona, Spanish Respiratory Society

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD Case Finding	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.	No