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

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ClinicalTrials.gov Identifier: NCT01893918
Recruitment Status : Unknown
Verified July 2013 by Leonardo M. Fabbri, University of Modena and Reggio Emilia.
Recruitment status was:  Recruiting
First Posted : July 9, 2013
Last Update Posted : July 9, 2013
Sponsor:
Information provided by (Responsible Party):
Leonardo M. Fabbri, University of Modena and Reggio Emilia

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.

Condition or disease
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 [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Assessment of Severity and Prognosis in Elderly Patients With Chronic Obstructive Pulmonary Disease (COPD) and Complex Chronic Comorbidities
Study Start Date : March 2011
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

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



Primary Outcome Measures :
  1. Number of chronic comorbidities associated to COPD [ Time Frame: 0-3 years ]
    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.


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


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).


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893918


Contacts
Contact: Bianca Beghé, MD PhD +39 059 4225814 bianca.beghe@unimore.it
Contact: Alessia Verduri, MD PhD +39 059 4225769 alessia.verduri@unimore.it

Locations
Italy
Azienda Ospedaliero-Universitaria di Modena Recruiting
Modena, Italy, 41100
Contact: Bianca Beghé, MD PhD    +39 059 4225814    bianca.beghe@unimore.it   
Contact: Alessia Verduri, MD PhD    +39 059 4225769    alessia.verduri@unimore.it   
Sponsors and Collaborators
University of Modena and Reggio Emilia
Investigators
Principal Investigator: Leonardo M Fabbri, MD University of Modena and Reggio Emilia

Responsible Party: Leonardo M. Fabbri, Professor, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT01893918     History of Changes
Other Study ID Numbers: CCM147/10
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: July 2013

Keywords provided by Leonardo M. Fabbri, University of Modena and Reggio Emilia:
Smoking
Dyspnea

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases