COPDEARLY COPDNCT02352220
Determinants of Onset and Progression of COPD in Young Adults
An observational study of COPD, run by Borja Cosio at 1 site in Spain.
Trial summary
COPD (Chronic Obstructive Pulmonary Disease) is a Public Health problem due to its impact in the patient's quality of life, high prevalence, growing incidence and socioeconomic implication. COPD natural history and first stages determinants are unknown. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 310 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Dec 2020
- 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 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Smokers from 35 to 50 years who ever performed a spirometry in the selected primary care centers. Selected subjects will not have exacerbation symptoms (fever, new onset or increased cough, increase sputum volume and/or purulence, acute rhinitis) within 8 weeks prior to the recruitment (from beginning of the symptoms).
Who may be able to join
- COPD case:
- Subjects between 35 and 50 years
- Post-bronchodilator spirometry with FEV1/FVC <70%
- Smoker or ex-smoker with total cumulative exposure > 10 pack-years
- Smoking control:
- Subjects between 35 and 50 years
- Post-bronchodilator spirometry with FEV1/FVC >=70%
- Smoker or ex-smoker with total cumulative exposure> 10 pack-years
Who cannot join
- For cases:
- Chronic inflammatory diseases including autoimmune diseases under treatment.
- HIV
- Active cancer
- Cystic or saccular bronchiectasis
- Conditions that may interfere with follow-up: frequent change of residence, psychiatric disorders, dementia…
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- For controls:
- Chronic inflammatory diseases including autoimmune diseases under treatment
- HIV
- Active cancer
- Chronic respiratory diseases:
- active tuberculosis
- interstitial lung diseases
- cystic or saccular bronchiectasis
- ever diagnosed asthma
- deficit of alpha1-antitrypsin
- Conditions that may interfere with follow-up: frequent change of residence, psychiatric disorders, dementia …
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early COPD: Determinants of Onset and Progression of COPD in Young Adults
COPD (Chronic Obstructive Pulmonary Disease) is a Public Health problem due to its impact in the patient's quality of life, high prevalence, growing incidence and socioeconomic implication. COPD natural history and first stages determinants are unknown. Knowing them will help to understand the natural history of the disease and to design interventions that can modify the prognosis of the disease.
Study objectives: (1) To characterize an early COPD population from a multidimensional point of view including demographic, social, family and clinical data, lung function, exercise capacity, image, microbiology, quality of life, exacerbations, comorbidities and blood and sputum biomarkers. (2) To compare this patients with smoking subjects, with normal lung function, matched by age, sex and site. (3) To create an early COPD cohort to be followed in the future to understand the complete natural history of the disease.
Methods: Design: multicenter cross-sectional study that will allow establishing a well-characterized cohort of early COPD patients for later follow-up. Recruitment will be done in Primary Care settings. Subjects: smokers (> 10 packs year) between 35-50 years old with a spirometry (normal or obstructive) done in the last year. Diagnosis of COPD will be based on the smoking history and a postbronchodilator test FEV1(Forced Expiratory Volume in the first second) / FVC(Forced Vital Capacity) < 70%. Age, sex and site matched 'healthy' smoker controls will be compared with the COPD cases. Variables that will be collected in the reference hospitals are: health questionnaires, lung function test, exercise capacity, blood and sputum samples, and low dose CT-scan. Statistical analysis: early COPD patient's characteristics will be described and then, will be compared, with control subjects through a conditional multiple logistic regression analysis.
- Conditions
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in lung function measures between cases and controls
Measured: At time of visit 1 (cross-sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Borja Cosio
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Research Center for Respiratory Diseases, Hospital Son Espases, Hospital Clinic of Barcelona, Hospital del Mar, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Hospital Universitario 12 de Octubre, Parc Taulí Hospital Universitari, Hospitales Universitarios Virgen del Rocío, Hospital Universitari de Bellvitge, Hospital Arnau de Vilanova, Hospital Universitario Central de Asturias, University Hospital of the Nuestra Señora de Candelaria, University Hospital A Coruña, Barcelona Institute for Global Health, Boehringer Ingelheim
- Responsible party
- Sponsor-investigator, Borja Cosio, Hospital Son Espases
- Investigators
- Borja Cosio, Medical Doctor, Principal investigator, Spanish Research Center for Respiratory Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352220
- Sponsor's protocol ID
- PI13-02225
- Acronym
- EARLY COPD
- Status last verified
- Feb 2018
- First submitted
- 2 Dec 2014
- Last updated
- 27 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early COPD: Determinants of Onset and Progression of COPD in Young Adults
- ClinicalTrials.gov ID
- NCT02352220
- Acronym / sponsor ID
- EARLY COPD / PI13-02225
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Borja CosioUniversity, hospital or other
- Collaborators
- Spanish Research Center for Respiratory Diseases, Hospital Son Espases, Hospital Clinic of Barcelona, Hospital del Mar, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Hospital Universitario 12 de Octubre, Parc Taulí Hospital Universitari, Hospitales Universitarios Virgen del Rocío, Hospital Universitari de Bellvitge, Hospital Arnau de Vilanova, Hospital Universitario Central de Asturias, University Hospital of the Nuestra Señora de Candelaria, University Hospital A Coruña, Barcelona Institute for Global Health, Boehringer Ingelheim
- Study start
- Jan 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Feb 2015 (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.
COPD (Chronic Obstructive Pulmonary Disease) is a Public Health problem due to its impact in the patient's quality of life, high prevalence, growing incidence and socioeconomic implication. COPD natural history and first stages determinants are unknown. Knowing them will help to understand the natural history of the disease and to design interventions that can modify the prognosis of the disease.
Study objectives: (1) To characterize an early COPD population from a multidimensional point of view including demographic, social, family and clinical data, lung function, exercise capacity, image, microbiology, quality of life, exacerbations, comorbidities and blood and sputum biomarkers. (2) To compare this patients with smoking subjects, with normal lung function, matched by age, sex and site. (3) To create an early COPD cohort to be followed in the future to understand the complete natural history of the disease.
Methods: Design: multicenter cross-sectional study that will allow establishing a well-characterized cohort of early COPD patients for later follow-up. Recruitment will be done in Primary Care settings. Subjects: smokers (> 10 packs year) between 35-50 years old with a spirometry (normal or obstructive) done in the last year. Diagnosis of COPD will be based on the smoking history and a postbronchodilator test FEV1(Forced Expiratory Volume in the first second) / FVC(Forced Vital Capacity) < 70%. Age, sex and site matched 'healthy' smoker controls will be compared with the COPD cases. Variables that will be collected in the reference hospitals are: health questionnaires, lung function test, exercise capacity, blood and sputum samples, and low dose CT-scan. Statistical analysis: early COPD patient's characteristics will be described and then, will be compared, with control subjects through a conditional multiple logistic regression analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Smokers from 35 to 50 years who ever performed a spirometry in the selected primary care centers. Selected subjects will not have exacerbation symptoms (fever, new onset or increased cough, increase sputum volume and/or purulence, acute rhinitis) within 8 weeks prior to the recruitment (from beginning of the symptoms).
Key inclusion criteria (8 listed)
- Subjects between 35 and 50 years
- Post-bronchodilator spirometry with FEV1/FVC <70%
- Smoker or ex-smoker with total cumulative exposure > 10 pack-years
- Subjects between 35 and 50 years
- Post-bronchodilator spirometry with FEV1/FVC >=70%
Key exclusion criteria (17 listed)
- Chronic inflammatory diseases including autoimmune diseases under treatment.
- HIV
- Active cancer
- Cystic or saccular bronchiectasis
- Conditions that may interfere with follow-up: frequent change of residence, psychiatric disorders, dementia…
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
Differences in lung function measures between cases and controls
Time frame: At time of visit 1 (cross-sectional)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
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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.
Borja Cosio, Medical Doctor principal investigator
Spanish Research Center for Respiratory Diseases
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 COPD, run by Borja Cosio 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 8 inclusion and 17 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 27 Feb 2018. 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?
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?
Differences in lung function measures between cases and controls (time frame: At time of visit 1 (cross-sectional)). 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 27 Feb 2018.