Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652776
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
The Italian Registry of Patients with Chronic Obstructive Pulmonary Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Italian COPD Registry the DescribinG BUrden of COPD and Occurrence of MortaLity in a Cohort of Italian Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICoRe
Brief Summary:
Chronic obstructive pulmonary disease COPD is a treatable but debilitating medical condition associated with persistent symptoms and chronic airflow obstruction Despite the availability of multiple therapeutic options COPD is the third leading cause of death worldwide and has a substantial socioeconomic impact
The present real life study is aimed at describing the clinical and functional characteristics treatment patterns impact of exacerbations and comorbidities and their association with mortality in a large cohort of Italian patients with COPD
The present real life study is aimed at describing the clinical and functional characteristics treatment patterns impact of exacerbations and comorbidities and their association with mortality in a large cohort of Italian patients with COPD
Detailed Description:
The temporal relationship of observation period to time of participant enrollment will be both retrospective and prospective
A digital dataset will be shared with the participating centers The following variables if available will be collected
Demographic and clinical variables
Age sex height weight BMI waist circumference
Pneumonia episodes in the last 12 months and number of hospitalizations for pneumonia
Number of pulmonary rehabilitation cycles performed
Vaccination status Flu SARS-CoV-2 pneumococcus human respiratory syncytial virus herpes zoster
COPD characteristics
Date of COPD diagnosis
COPD exacerbations in the year before the index date mild moderate severe exacerbations hospitalizations andor access to ICU
Type dosages and duration of antibiotic and systemic corticosteroid treatments during exacerbations
Respiratory symptoms evaluated with mMRC and CAT
Frequency and purulence of sputum cough frequency
Inhaled bronchodilatorcorticosteroid therapy and type of device used any treatment changes at index date or during follow up
Mucolytic agents active molecules and dosage
Chronic use of azithromycin
Therapy with roflumilast
Biological therapies type of active molecules duration switch
Long-term oxygen therapy FiO2 average flow presence of tracheostomy and any invasive or non-invasive ventilatory support
Comorbidities
Concomitant respiratory diseases history of exposure to risk factors smoking history active former and non-smoker
Cardiovascular comorbidities and complications in the last 12 months before index date and during follow up
Cardioactive pharmacological therapies
Charlson score
Other comorbidities
Biological and functional variables
Blood tests RBC Hb hematocrit MCV PLT WBC differential CRP glycemia creatinine uremia NT-proBNP cholesterol
Cardiopulmonary exercise test The variables collected will include VO2max WR max HRmax VE max VEmax VEVO2 ratio PET CO2 O2 pulse anaerobic threshold A-a gradient All values will be collected as absolute and as percentage of predicted values
Nocturnal oximetry FiO2 T-90 mean SpO2 ODI
Polysomnography type of support eg CPAP or NIMV FiO2 apnea-hypopnea index AHI obstructive central and mixed type AI oxygen desaturation index ODI T-90 Cheyne-Stokes respiration snoring and body position during the exam
6 minutes walking test FiO2 distance walked in meters and predicted value SpO2 at the beginning and end of the test desaturation if SpO2lt90 modified Borg dyspnea score at the beginning and end of the test
Gas exchange SpO2 FiO2 Blood Gas Analysis pH PaO2 PaCO2 HCO3- A-a gradient FiO2 PaO2FiO2
Lung function test pre- and post-bronchodilator FVC FEV1 FEV1FVC FEF 25-75 VC IC FEV1VC All values will be collected as absolute values ratio and percentage of predicted values
Body plethysmography pre- and post-bronchodilator TGV RV TLC RVTLC ICTLC sRAW All values will be collected as absolute values ratio and percentage of predicted values
Diffusion capacity of the lung for carbon monoxide DLCO KCO VA TLCVA
Fractional exhaled nitric oxide
Chest imaging radiography or CT scan presence of emphysema panlobular or centrolobular bronchiectasis or interstitial lung disease
Ecocardiography ejection fraction pathological signs PAPs left ventricular hypertrophy and left atrial right ventricular or left ventricular enlargement
Coronary angiography if pathological for stenosis and number of involved vessels PTCA or CABG
All these items will be also valued during the follow up period with an emphasis on COPD exacerbations and date and cause of death
A digital dataset will be shared with the participating centers The following variables if available will be collected
Demographic and clinical variables
Age sex height weight BMI waist circumference
Pneumonia episodes in the last 12 months and number of hospitalizations for pneumonia
Number of pulmonary rehabilitation cycles performed
Vaccination status Flu SARS-CoV-2 pneumococcus human respiratory syncytial virus herpes zoster
COPD characteristics
Date of COPD diagnosis
COPD exacerbations in the year before the index date mild moderate severe exacerbations hospitalizations andor access to ICU
Type dosages and duration of antibiotic and systemic corticosteroid treatments during exacerbations
Respiratory symptoms evaluated with mMRC and CAT
Frequency and purulence of sputum cough frequency
Inhaled bronchodilatorcorticosteroid therapy and type of device used any treatment changes at index date or during follow up
Mucolytic agents active molecules and dosage
Chronic use of azithromycin
Therapy with roflumilast
Biological therapies type of active molecules duration switch
Long-term oxygen therapy FiO2 average flow presence of tracheostomy and any invasive or non-invasive ventilatory support
Comorbidities
Concomitant respiratory diseases history of exposure to risk factors smoking history active former and non-smoker
Cardiovascular comorbidities and complications in the last 12 months before index date and during follow up
Cardioactive pharmacological therapies
Charlson score
Other comorbidities
Biological and functional variables
Blood tests RBC Hb hematocrit MCV PLT WBC differential CRP glycemia creatinine uremia NT-proBNP cholesterol
Cardiopulmonary exercise test The variables collected will include VO2max WR max HRmax VE max VEmax VEVO2 ratio PET CO2 O2 pulse anaerobic threshold A-a gradient All values will be collected as absolute and as percentage of predicted values
Nocturnal oximetry FiO2 T-90 mean SpO2 ODI
Polysomnography type of support eg CPAP or NIMV FiO2 apnea-hypopnea index AHI obstructive central and mixed type AI oxygen desaturation index ODI T-90 Cheyne-Stokes respiration snoring and body position during the exam
6 minutes walking test FiO2 distance walked in meters and predicted value SpO2 at the beginning and end of the test desaturation if SpO2lt90 modified Borg dyspnea score at the beginning and end of the test
Gas exchange SpO2 FiO2 Blood Gas Analysis pH PaO2 PaCO2 HCO3- A-a gradient FiO2 PaO2FiO2
Lung function test pre- and post-bronchodilator FVC FEV1 FEV1FVC FEF 25-75 VC IC FEV1VC All values will be collected as absolute values ratio and percentage of predicted values
Body plethysmography pre- and post-bronchodilator TGV RV TLC RVTLC ICTLC sRAW All values will be collected as absolute values ratio and percentage of predicted values
Diffusion capacity of the lung for carbon monoxide DLCO KCO VA TLCVA
Fractional exhaled nitric oxide
Chest imaging radiography or CT scan presence of emphysema panlobular or centrolobular bronchiectasis or interstitial lung disease
Ecocardiography ejection fraction pathological signs PAPs left ventricular hypertrophy and left atrial right ventricular or left ventricular enlargement
Coronary angiography if pathological for stenosis and number of involved vessels PTCA or CABG
All these items will be also valued during the follow up period with an emphasis on COPD exacerbations and date and cause of death
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