Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01893918
Status:
UNKNOWN
Last Update Posted:
2013-07-09
First Post:
2013-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Severity and Prognosis in Elderly Patients With COPD and Complex Chronic Comorbidities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '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).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-02', 'studyFirstSubmitDate': '2013-02-01', 'studyFirstSubmitQcDate': '2013-07-02', 'lastUpdatePostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of chronic comorbidities associated to COPD', 'timeFrame': '0-3 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Formulation of a severity score', 'timeFrame': '0-3 years', 'description': 'A severity score will be developed on the basis of lung function impairment, different clinical phenotypes (chronic bronchitis and/or emphysema), and systemic inflammation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Smoking', 'Dyspnea'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100 patients older than 65 years with diagnosis of COPD, current smokers or ex-smokers with more than 20 pack/years, in stable condition.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasians\n* Age \\> 65 years\n* Smoking history \\> 20 pack/years (current or former smokers)\n* Diagnosis of COPD according to GOLD 2010\n* Stable condition\n\nExclusion Criteria:\n\n* History of bronchial asthma\n* Other chronic diseases such as interstitial lung disease, bronchiectasis, bronchiolitis obliterans organizing pneumonia (BOOP), pulmonary tuberculosis, cystic fibrosis\n* Malignancies for which patient is being treated with radiotherapy or chemotherapy\n* Acute events and/or hospitalization within 12 weeks prior to screening'}, 'identificationModule': {'nctId': 'NCT01893918', 'briefTitle': 'Assessment of Severity and Prognosis in Elderly Patients With COPD and Complex Chronic Comorbidities', 'organization': {'class': 'OTHER', 'fullName': 'University of Modena and Reggio Emilia'}, 'officialTitle': 'Assessment of Severity and Prognosis in Elderly Patients With Chronic Obstructive Pulmonary Disease (COPD) and Complex Chronic Comorbidities', 'orgStudyIdInfo': {'id': 'CCM147/10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD patients', 'description': 'COPD patients, males and females, older than 65 years, with smoking history \\> 20 pack/years'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41100', 'city': 'Modena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Bianca Beghé, MD PhD', 'role': 'CONTACT', 'email': 'bianca.beghe@unimore.it', 'phone': '+39 059 4225814'}, {'name': 'Alessia Verduri, MD PhD', 'role': 'CONTACT', 'email': 'alessia.verduri@unimore.it', 'phone': '+39 059 4225769'}], 'facility': 'Azienda Ospedaliero-Universitaria di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}], 'centralContacts': [{'name': 'Bianca Beghé, MD PhD', 'role': 'CONTACT', 'email': 'bianca.beghe@unimore.it', 'phone': '+39 059 4225814'}, {'name': 'Alessia Verduri, MD PhD', 'role': 'CONTACT', 'email': 'alessia.verduri@unimore.it', 'phone': '+39 059 4225769'}], 'overallOfficials': [{'name': 'Leonardo M Fabbri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Modena and Reggio Emilia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Modena and Reggio Emilia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Leonardo M. Fabbri', 'investigatorAffiliation': 'University of Modena and Reggio Emilia'}}}}