Chronic Obstructive Pulmonary DiseaseNCT01380470
Prevalence of Undiagnosed Chronic Obstructive Pulmonary Disease Sufferers in the Region of Murcia
An observational study of Chronic Obstructive Pulmonary Disease, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial summary
The purpose of this study is determine the prevalence of undiagnosed Chronic Obstructive Pulmonary Disease (COPD) in population served and with exposure to cigarettes in the Region of Murcia Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 1,052 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2010to Jun 2010
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group of patients seen in consultation not previously diagnosed with COPD, both sexes, aged between 40 and 70 years.
Who may be able to join
- Aged between 40 and 70 years of both sexes
- With a history of smoking (current or past)
- Do not diagnosed with COPD at the time of completion of study
- Subject treated in CS there is explicit evidence for the disease
Who cannot join
- Prior diagnosis of COPD or Asthma
- A condition prevents performing spirometry
- Patients displaced
- For those diagnosed with COPD:
- Subjects who at the time of the consultation arouse suspicion of previously undiagnosed COPD
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
Murcia, Murcia, 30003
About this study
Official title: Prevalence of Undiagnosed Sufferers in Murcia :Cross-sectional Study
The purpose of this study is determine the prevalence of undiagnosed Chronic Obstructive Pulmonary Disease (COPD) in population served and with exposure to cigarettes in the Region of Murcia
Read the detailed description
COPD is a serious, chronic and very disabling, associated with smoking and aging. Therefore it is a preventable and treatable process. It is know to be a pathology under diagnosed and when diagnosis, this is done in advanced stage, resulting to rise to more complication and more severe, in a addition to a high social and economic cost.
Therefore, take out an epidemiological study, observational, multicentre, whose main objective is estimate the prevalence of undiagnosed COPD in population served between 40 and 70 years and exposure to cigarettes in the Region of Murcia.
Other objectives are estimate the proportion of patients already diagnosed, identifying risk factors associated with not previous diagnosis of COPD and describe the history of symptoms in them. Description of therapeutic manage and motivation to give up smoking.
The study was carried out with 120 researcher doctors and 120 researcher nurses from 40 health centers in the Region of Murcia.
Each researcher will select 10 patients for the main objective and 10 for objectives related to manage of COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Diagnosis differential, Dyspnea/classification, Dyspnea/etiology
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | Group of patients seen in consultation not previously diagnosed with COPD, both sexes, aged between 40 and 70 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1/FVC,Forced Expiratory Volume 1/ Forced Vital Capacity
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- MurciaSalud, Public Health Service, Murcia, AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Asensio Lopez Santiago, MD, Principal investigator, Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380470
- Sponsor's protocol ID
- Brisa I
- Status last verified
- Jun 2011
- First submitted
- 22 Jun 2011
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Undiagnosed Sufferers in Murcia :Cross-sectional Study
- ClinicalTrials.gov ID
- NCT01380470
- Acronym / sponsor ID
- Brisa I
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Diagnosis differential, Dyspnea/classification, Dyspnea/etiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,052 participants (actual)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Collaborators
- MurciaSalud, Public Health Service, Murcia, AstraZeneca
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 27 Jun 2011 (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.
The purpose of this study is determine the prevalence of undiagnosed Chronic Obstructive Pulmonary Disease (COPD) in population served and with exposure to cigarettes in the Region of Murcia
Detailed description
COPD is a serious, chronic and very disabling, associated with smoking and aging. Therefore it is a preventable and treatable process. It is know to be a pathology under diagnosed and when diagnosis, this is done in advanced stage, resulting to rise to more complication and more severe, in a addition to a high social and economic cost.
Therefore, take out an epidemiological study, observational, multicentre, whose main objective is estimate the prevalence of undiagnosed COPD in population served between 40 and 70 years and exposure to cigarettes in the Region of Murcia.
Other objectives are estimate the proportion of patients already diagnosed, identifying risk factors associated with not previous diagnosis of COPD and describe the history of symptoms in them. Description of therapeutic manage and motivation to give up smoking.
The study was carried out with 120 researcher doctors and 120 researcher nurses from 40 health centers in the Region of Murcia.
Each researcher will select 10 patients for the main objective and 10 for objectives related to manage of COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | – | –Group of patients seen in consultation not previously diagnosed with COPD, both sexes, aged between 40 and 70 years. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group of patients seen in consultation not previously diagnosed with COPD, both sexes, aged between 40 and 70 years.
Key inclusion criteria (4 listed)
- Aged between 40 and 70 years of both sexes
- With a history of smoking (current or past)
- Do not diagnosed with COPD at the time of completion of study
- Subject treated in CS there is explicit evidence for the disease
Key exclusion criteria (5 listed)
- Prior diagnosis of COPD or Asthma
- A condition prevents performing spirometry
- Patients displaced
- Subjects who at the time of the consultation arouse suspicion of previously undiagnosed COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FEV1/FVC,Forced Expiratory Volume 1/ Forced Vital Capacity
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
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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.
Asensio Lopez Santiago, MD principal investigator
Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 Dec 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FEV1/FVC,Forced Expiratory Volume 1/ Forced Vital Capacity (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2017.