Assessment of Severity and Prognosis in Elderly Patients With COPD and Complex Chronic Comorbidities

• Conditions: COPD

• Registration Number: NCT01893918
• Lead Sponsor: University of Modena and Reggio Emilia

Brief Summary

Cigarette smoking, the major risk factor for Chronic Obstructive Pulmonary Disease (COPD), causes systemic effects, such as systemic cellular and humoral inflammation, that could substantially contribute to the development of chronic diseases, other than COPD, mainly cardiovascular diseases and metabolic disorders. Such chronic comorbidities affect health outcomes in COPD, particularly in terms of disease severity and prognosis. The aim of the project is to investigate the prevalence of chronic comorbidities associated with COPD and their impact on prognosis in elderly patients.

Detailed Description

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-02-01
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted QC: 2013-07-02
• Last Update Submitted: 2013-07-02
• Study First Posted: 2013-07-09
• Last Update Posted: 2013-07-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Caucasians
• Age > 65 years
• Smoking history > 20 pack/years (current or former smokers)
• Diagnosis of COPD according to GOLD 2010
• Stable condition

Exclusion Criteria

• History of bronchial asthma
• Other chronic diseases such as interstitial lung disease, bronchiectasis, bronchiolitis obliterans organizing pneumonia (BOOP), pulmonary tuberculosis, cystic fibrosis
• Malignancies for which patient is being treated with radiotherapy or chemotherapy
• Acute events and/or hospitalization within 12 weeks prior to screening

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of chronic comorbidities associated to COPD	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.

Secondary Outcome Measures

Name	Time	Method
Formulation of a severity score	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.

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria di Modena; 🇮🇹 Modena, Italy