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

NCT ID: NCT01893918

Last Updated: 2013-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-07-31

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.

Conditions

COPD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD patients

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Modena and Reggio Emilia

OTHER

Sponsor Role: lead

Responsible Party

Leonardo M. Fabbri

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leonardo M Fabbri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Modena and Reggio Emilia

Locations

Azienda Ospedaliero-Universitaria di Modena

Modena, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Bianca Beghé, MD PhD

Role: CONTACT

bianca.beghe@unimore.it

+39 059 4225814

Alessia Verduri, MD PhD

Role: CONTACT

alessia.verduri@unimore.it

+39 059 4225769

Facility Contacts

Bianca Beghé, MD PhD

Role: primary

bianca.beghe@unimore.it

+39 059 4225814

Alessia Verduri, MD PhD

Role: backup

alessia.verduri@unimore.it

+39 059 4225769

Other Identifiers

CCM147/10

Identifier Type: -

Identifier Source: org_study_id