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

NCT01576068 | Unknown Early Phase 1

• 1 other identifier: 2008/3128/I
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Pharmacy; Spirometry; Case finding

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

High Risk Customers

OTHER

Pharmacy customers with GOLD COPD Criteria of high-risk subjects.

Other: Spirometry

Interventions

Spirometry OTHER

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

High Risk Customers

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 40 years.
• Current or former smoker
• Chronic respiratory symptoms(cough, shortness of breath, expectoration)

You may not qualify if:

• Previous diagnosed chronic lung disease
• Use of inhalers

Sponsors & Collaborators

• Col·legi de Farmacèutics de la Província de Barcelona: lead
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Hospital Clinic of Barcelona: collaborator
• Spanish Respiratory Society: collaborator
• Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC): collaborator

Study Sites (1)

Col·legi Oficial de Farmacèutics de Barcelona

Barcelona, Barcelona, 08009, Spain

Location

Related 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.

  PMID: 19200706 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Diego Castillo, MD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: April 12, 2012
• Study Start: October 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: June 1, 2013
• Last Updated: April 12, 2012

Record last verified: 2012-04

Locations

ES (1)