Ignite Creation Date:
2024-05-06 @ 3:42 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02352220
Status:
UNKNOWN
Last Update Posted:
2018-02-27
First Post:
2014-12-02
Brief Title:
Determinants of Onset and Progression of COPD in Young Adults
Sponsor:
Borja Cosio
Organization:
Hospital Son Espases
Study Overview
Official Title:
Early COPD Determinants of Onset and Progression of COPD in Young Adults
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EARLY COPD
Brief Summary:
COPD Chronic Obstructive Pulmonary Disease is a Public Health problem due to its impact in the patients 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 FEV1Forced Expiratory Volume in the first second FVCForced 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 patients characteristics will be described and then will be compared with control subjects through a conditional multiple logistic regression analysis
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 FEV1Forced Expiratory Volume in the first second FVCForced 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 patients characteristics will be described and then will be compared with control subjects through a conditional multiple logistic regression analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None