Clinical trial NCT01893918: Assessment of Severity and Prognosis in Elderly Patients With COPD and Complex Chronic Comorbidities
Official title: Assessment of Severity and Prognosis in Elderly Patients With Chronic Obstructive Pulmonary Disease (COPD) and Complex Chronic Comorbidities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Keywords: Smoking
Dyspnea
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2013-07-09
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Number of chronic comorbidities associated to COPD
timeFrame: 0-3 years
Secondary outcomes:
measure: Formulation of a severity score
timeFrame: 0-3 years
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena
Study officials:
affiliation: University of Modena and Reggio Emilia
name: Leonardo M Fabbri, MD
role: PRINCIPAL_INVESTIGATOR
References: