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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01893918
• Other study ID #: CCM147/10
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2013
• Last updated: July 2, 2013
• Start date: March 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: University of Modena and Reggio Emilia
• Contact: Bianca Beghé, MD PhD
• Phone: +39 059 4225814
• Email: bianca.beghe[@]unimore.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria di Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes