Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT01213693
Status:
COMPLETED
Last Update Posted:
2016-04-08
First Post:
2010-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D014777', 'term': 'Virus Diseases'}], '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': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}], 'ancestors': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-06', 'studyFirstSubmitDate': '2010-10-01', 'studyFirstSubmitQcDate': '2010-10-01', 'lastUpdatePostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison between groups of bacterial load in sputum', 'timeFrame': '1 year', 'description': 'The primary outcome will measure changes in sputum bacterial load of COPD patients treated with inhaled corticosteroids in combination with long acting beta-2 bronchodilators (ICS/LABA group) compared with COPD treated only with long acting beta-2 bronchodilators (LABA group)'}], 'secondaryOutcomes': [{'measure': 'Correlations between clinical outcomes and sputum viral and/or bacterial load', 'timeFrame': '1 year', 'description': 'To evaluate whether sputum viral and/or bacterial load correlate with symptoms and need for rescue medication in stabile COPD.'}, {'measure': 'Sputum viral and/or bacterial load and exacerbation rate', 'timeFrame': '1 year', 'description': 'To evaluate whether changes in sputum viral and/or bacterial load (end of the study vs baseline) correlate with exacerbation rate in COPD patients'}, {'measure': 'Sputum viral and/or bacterial load and lung function', 'timeFrame': '1 year', 'description': 'To evaluate correlations between changes in sputum viral and/or bacterial load and changes in lung function over 1 year.'}, {'measure': 'Airway inflammation and viral/bacterial load in COPD', 'timeFrame': '1 year', 'description': 'To evaluate correlations between sputum inflammatory cell profiles and markers of airway inflammation (interleukin-6) and viral/bacterial load at stable stable conditions in COPD paetints.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Bacteria', 'Virus', 'Inhaled Corticosteroids'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '28982774', 'type': 'DERIVED', 'citation': 'Contoli M, Pauletti A, Rossi MR, Spanevello A, Casolari P, Marcellini A, Forini G, Gnesini G, Marku B, Barnes N, Rizzi A, Curradi G, Caramori G, Morelli P, Papi A. Long-term effects of inhaled corticosteroids on sputum bacterial and viral loads in COPD. Eur Respir J. 2017 Oct 5;50(4):1700451. doi: 10.1183/13993003.00451-2017. Print 2017 Oct.'}]}, 'descriptionModule': {'briefSummary': 'Exacerbations are important events in the natural history of chronic obstructive pulmonary disease (COPD). Beside the acute (and prolonged) clinical impact, there is evidence that exacerbations negatively affect the natural history of the disease; e.g. lung function decline is accelerated in patients with frequent exacerbations. Bacteria are considered the most relevant cause of exacerbations, but there is evidence that viral infections are equally contributing.\n\nEither alone or in combination with viruses, airway bacterial load in stable COPD correlates with both the frequency of exacerbations and the decline in lung function.\n\nA long-term clinical trial recently showed that the regular treatment with inhaled corticosteroids (ICS) increases the risk of infectious events such as pneumonia, whereas it reduces the frequency of acute COPD exacerbations in COPD.\n\nIn a recent study it was found that airway bacterial load increases over time (1 yr follow up) in stable COPD. In this study, virtually all patients (93%) were treated with ICS.\n\nThis study is designed to evaluate whether long-term (1 year) ICS treatment increases viral and/or bacterial load in the sputum of COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sixty stable moderate COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2) requiring regular treatment with long-acting bronchodilators, according to international guidelines.\n* GOLD stage 2 COPD patients will be enrolled providing they were steroid-free for the last 4 months\n\nExclusion Criteria:\n\n* Atopy\n* Asthma\n* Concomitant lung diseases (e.g. lung cancer)\n* Acute infections of the respiratory tree in the previous 3 months including COPD exacerbation.'}, 'identificationModule': {'nctId': 'NCT01213693', 'briefTitle': 'Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Ferrara'}, 'officialTitle': 'Long-term Effects of Inhaled Corticosteroids (ICS) Treatment on Sputum Bacterial and Viral Loads in Chronic Obstructive Pulmonary Disease (COPD) Patients', 'orgStudyIdInfo': {'id': 'LTEICSBV01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICS/LABA group', 'description': 'Patients assigned to this arm will take bid 50/500 mcg fluticasone/salmeterol combination', 'interventionNames': ['Drug: Salmeterol/Fluticasone combination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LABA group', 'description': 'Patients assigned to this arm will take bid 50 mcg salmeterol', 'interventionNames': ['Drug: Salmeterol']}], 'interventions': [{'name': 'Salmeterol/Fluticasone combination', 'type': 'DRUG', 'description': 'Salmeterol/Fluticasone 50/500 mcg 1 inhalation bid', 'armGroupLabels': ['ICS/LABA group']}, {'name': 'Salmeterol', 'type': 'DRUG', 'description': 'Salmeterol 50 mcg 1 inhalation bid', 'armGroupLabels': ['LABA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44121', 'city': 'Ferrara', 'country': 'Italy', 'facility': 'Research Centre on Asthma and COPD - Department of Clinical and Experimental Medicine - Section of Respiratory Disease - University of Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}], 'overallOfficials': [{'name': 'Alberto Papi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Ferrara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Ferrara', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Respiratory Medicine', 'investigatorFullName': 'Alberto Papi, MD', 'investigatorAffiliation': 'Università degli Studi di Ferrara'}}}}