Chronic Obstructive Pulmonary Disease Case Finding in Community-pharmacies by Spirometry (FARMAEPOC)
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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 |
- 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 |
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| Spain | |
| Col·legi Oficial de Farmacèutics de Barcelona | |
| Barcelona, Spain, 08009 | |
| 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 May 21, 2013