Back to resultsChronic Obstructive Pulmonary Disease Case Finding in Community-pharmacies by Spirometry (FARMAEPOC)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Early Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Spirometry
Sponsored by
About this trial
This is an interventional screening trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Pharmacy, Spirometry, Case finding
Eligibility 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
Sites / Locations
- Col·legi Oficial de Farmacèutics de Barcelona
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
High Risk Customers
Arm Description
Pharmacy customers with GOLD COPD Criteria of high-risk subjects.
Outcomes
Primary Outcome Measures
COPD Case Finding
Proportion of high-risk customers with spirometry showing a FEV1/FVC under 0,7.
Secondary Outcome Measures
Full Information
NCT ID
NCT01576068
First Posted
February 29, 2012
Last Updated
April 11, 2012
Sponsor
Col·legi de Farmacèutics de la Província de Barcelona
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
1. Study Identification
Unique Protocol Identification Number
NCT01576068
Brief Title
Chronic Obstructive Pulmonary Disease Case Finding in Community-pharmacies by Spirometry
Acronym
FARMAEPOC
Official Title
Efficiency of COPD Case Finding Program by Spirometry in High-risk Customers of Urban Community Pharmacies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Col·legi de Farmacèutics de la Província de Barcelona
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
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Pharmacy, Spirometry, Case finding
7. Study Design
Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Risk Customers
Arm Type
Other
Arm Description
Pharmacy customers with GOLD COPD Criteria of high-risk subjects.
Intervention Type
Other
Intervention Name(s)
Spirometry
Intervention Description
Spirometry done in high-risk customers of community-pharmacies to detect airflow limitation
Primary Outcome Measure Information:
Title
COPD Case Finding
Description
Proportion of high-risk customers with spirometry showing a FEV1/FVC under 0,7.
Time Frame
During 15 months pharmacies will include subjects with possible COPD through spirometry.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego Castillo, MD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Col·legi Oficial de Farmacèutics de Barcelona
City
Barcelona
ZIP/Postal Code
08009
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
19200706
Citation
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.
Results Reference
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Chronic Obstructive Pulmonary Disease Case Finding in Community-pharmacies by Spirometry
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