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

NCT01893918 | Unknown DMC

• 1 other identifier: CCM147/10
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

Smoking; Dyspnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Formulation of a severity score

  0-3 years

Study Arms (1)

COPD patients

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria di Modena

Modena, 41100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling for complete blood count, fasting glucose, bilirubin, creatinine, blood urea, uric acid, electrolytes (magnesium, sodium, potassium, chloride), total cholesterol, cholesterol high-density lipoprotein (HDL), triglycerides, serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase, gamma-glutamyl transpeptidase, creatine phosphokinase, hemoglobin A1c, serum insulin. Urine sampling for microalbuminuria and urine creatinine. Measurement of arterial blood gas. Blood sampling for biomarkers (NT-proBNP, high-sensitive C-Reactive Protein, IL-1β, IL-6).

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Leonardo M Fabbri, MD

  University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bianca Beghé, MD PhD

CONTACT

+39 059 4225814; bianca.beghe@unimore.it

Alessia Verduri, MD PhD

CONTACT

+39 059 4225769; alessia.verduri@unimore.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: July 9, 2013
• Study Start: March 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

IT (1)