Assessment of Severity and Prognosis in Elderly Patients With COPD and Complex Chronic Comorbidities
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01893918|
Recruitment Status : Unknown
Verified July 2013 by Leonardo M. Fabbri, University of Modena and Reggio Emilia.
Recruitment status was: Recruiting
First Posted : July 9, 2013
Last Update Posted : July 9, 2013
|Condition or disease|
The investigators will recruit 100 outpatients, heavy smokers (20 pack/years), older than 65 years, diagnosed with COPD. COPD is defined by presence of fixed airflow limitation: post-bronchodilator forced expiratory volume at one second (FEV1)/forced vital capacity (FVC) less than 70% according to spirometry classification from Global Inititiative for Obstructive Lung Disease (GOLD) guidelines. Each patient will be characterized by medical history, physical examination, and smoking history. Each patient will perform pulmonary function test, including reversibility to inhaled bronchodilator (400 mcg albuterol), and 6-minute walk test. Arterial blood gases and routine blood test, including inflammatory biomarkers, will also examined. In addition, each patient will undergo chest X-ray, thorax CT scan, echocardiography, and carotid ultrasonography.
At enrollment, all patients will be in stable condition (no changes in medication dosage or frequency, no COPD exacerbation or hospital admissions in the previous 4 weeks). Clinical and biological follow-up will be prospectively followed for 3 years.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Assessment of Severity and Prognosis in Elderly Patients With Chronic Obstructive Pulmonary Disease (COPD) and Complex Chronic Comorbidities|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||July 2013|
COPD patients, males and females, older than 65 years, with smoking history > 20 pack/years
- Number of chronic comorbidities associated to COPD [ Time Frame: 0-3 years ]Number of comorbidities for the formulation of a severity score with predictive value to 3 years in terms of hospital admissions for acute events and mortality.
- Formulation of a severity score [ Time Frame: 0-3 years ]A severity score will be developed on the basis of lung function impairment, different clinical phenotypes (chronic bronchitis and/or emphysema), and systemic inflammation.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893918
|Contact: Bianca Beghé, MD PhD||+39 059 firstname.lastname@example.org|
|Contact: Alessia Verduri, MD PhD||+39 059 email@example.com|
|Azienda Ospedaliero-Universitaria di Modena||Recruiting|
|Modena, Italy, 41100|
|Contact: Bianca Beghé, MD PhD +39 059 4225814 firstname.lastname@example.org|
|Contact: Alessia Verduri, MD PhD +39 059 4225769 email@example.com|
|Principal Investigator:||Leonardo M Fabbri, MD||University of Modena and Reggio Emilia|