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

NCT ID: NCT01576068

Last Updated: 2012-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

3600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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High Risk Customers

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

Group Type OTHER

Spirometry

Intervention Type OTHER

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

Interventions

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Spirometry

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Spanish Respiratory Society

OTHER

Sponsor Role collaborator

Catalan Society of Family Medicine

OTHER

Sponsor Role collaborator

Col·legi de Farmacèutics de la Província de Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diego Castillo, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Col·legi Oficial de Farmacèutics de Barcelona

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 19200706 (View on PubMed)

Other Identifiers

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2008/3128/I

Identifier Type: -

Identifier Source: org_study_id

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