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

Assessment of Severity and Prognosis in Elderly Patients With Chronic Obstructive Pulmonary Disease (COPD) and Complex Chronic Comorbidities

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.

Study Overview

• Status: Unknown
• Conditions: COPD

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy, 41100
    • Recruiting
    • Azienda Ospedaliero-Universitaria di Modena
    • Contact: Bianca Beghé, MD PhD; Phone Number: +39 059 4225814; Email: bianca.beghe@unimore.it
    • Contact: Alessia Verduri, MD PhD; Phone Number: +39 059 4225769; Email: alessia.verduri@unimore.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

100 patients older than 65 years with diagnosis of COPD, current smokers or ex-smokers with more than 20 pack/years, in stable condition.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
COPD patients; COPD patients, males and females, older than 65 years, with smoking history > 20 pack/years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of chronic comorbidities associated to COPD	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.	0-3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formulation of a severity score	A severity score will be developed on the basis of lung function impairment, different clinical phenotypes (chronic bronchitis and/or emphysema), and systemic inflammation.	0-3 years

Collaborators and Investigators

• Sponsor: University of Modena and Reggio Emilia
• Investigators: Principal Investigator: Leonardo M Fabbri, MD, University of Modena and Reggio Emilia

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: February 1, 2013
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (Estimate): July 9, 2013

Study Record Updates

• Last Update Posted (Estimate): July 9, 2013
• Last Update Submitted That Met QC Criteria: July 2, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Smoking; Dyspnea
• Other Study ID Numbers: CCM147/10