Chronic Obstructive Pulmonary DiseaseEarly Phase 1FARMAEPOCNCT01576068
Chronic Obstructive Pulmonary Disease Case Finding in Community-pharmacies by Spirometry
A Early Phase 1 study testing Spirometry in people with Chronic Obstructive Pulmonary Disease, run by Col·legi de Farmacèutics de la Província de Barcelona at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Spirometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2010to Jun 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 40 years.
- Current or former smoker
- Chronic respiratory symptoms(cough, shortness of breath, expectoration)
Who cannot join
- Previous diagnosed chronic lung disease
- Use of inhalers
Trial locations and contacts
1 site in 1 country.
Spain1 site
Col·legi Oficial de Farmacèutics de Barcelona
Barcelona, Barcelona, 08009
About this study
Official title: Efficiency of COPD Case Finding Program by Spirometry in High-risk Customers of Urban Community Pharmacies
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
- Being tested
- Spirometry
- Keywords
- COPD, Pharmacy, Spirometry, Case finding
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryOther
Spirometry done in high-risk customers of community-pharmacies to detect airflow limitation
| Study group | Role | What they receive |
|---|---|---|
| High Risk Customers | Other | Pharmacy customers with GOLD COPD Criteria of high-risk subjects. Receives: Other: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Case Finding
Proportion of high-risk customers with spirometry showing a FEV1/FVC under 0,7.
Measured: During 15 months pharmacies will include subjects with possible COPD through spirometry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startOct 2010
- Primary completionJul 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Col·legi de Farmacèutics de la Província de Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona, Spanish Respiratory Society, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
- Responsible party
- Sponsor
- Investigators
- Diego Castillo, MD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576068
- Sponsor's protocol ID
- 2008/3128/I
- Acronym
- FARMAEPOC
- Status last verified
- Apr 2012
- First submitted
- 29 Feb 2012
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19200706
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of COPD Case Finding Program by Spirometry in High-risk Customers of Urban Community Pharmacies
- ClinicalTrials.gov ID
- NCT01576068
- Acronym / sponsor ID
- FARMAEPOC / 2008/3128/I
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Pharmacy, Spirometry, Case finding
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Col·legi de Farmacèutics de la Província de BarcelonaUniversity, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona, Spanish Respiratory Society, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
- Study start
- Oct 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Risk Customers | Other | Other: SpirometryPharmacy customers with GOLD COPD Criteria of high-risk subjects. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 40 years.
- Current or former smoker
- Chronic respiratory symptoms(cough, shortness of breath, expectoration)
Key exclusion criteria (2 listed)
- Previous diagnosed chronic lung disease
- Use of inhalers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpirometrySpirometry done in high-risk customers of community-pharmacies to detect airflow limitation | Other | High Risk Customers |
Primary outcome
COPD Case Finding
Time frame: During 15 months pharmacies will include subjects with possible COPD through spirometry.
Proportion of high-risk customers with spirometry showing a FEV1/FVC under 0,7.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
- Background: PubMed 19200706Castillo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Castillo, MD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Spirometry in people with Chronic Obstructive Pulmonary Disease, run by Col·legi de Farmacèutics de la Província de Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD Case Finding (time frame: During 15 months pharmacies will include subjects with possible COPD through spirometry.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01576068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2012.