Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-03 @ 10:45 PM
Study NCT ID:
NCT01664767
Status:
COMPLETED
Last Update Posted:
2013-12-30
First Post:
2012-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Sulfur Thermal Water Inhalation on Airway Oxidative Stress in COPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-27', 'studyFirstSubmitDate': '2012-08-10', 'studyFirstSubmitQcDate': '2012-08-13', 'lastUpdatePostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Superoxide anion levels in exhaled breath condensate', 'timeFrame': '12 days', 'description': 'Levels of superoxide anion levels will be measured at recruitment (day 0) and after 12 days of inhalation. Changes between day 12 and day 0 will be evaluated.'}], 'secondaryOutcomes': [{'measure': 'Superoxide anion levels in exhaled breath condensate', 'timeFrame': '42 day', 'description': 'Levels of superoxide anion will be measured at recruitment (day 0), after 12 days of inhalation (day 12) and one month after the last day oh inhalation (day 42). Changes between day 42, day 12 and day 0 will be evaluated.'}, {'measure': 'Inflammatory cell counts in induced sputum', 'timeFrame': '42 days', 'description': 'Inflammatory cell counts in induced sputum will be measured at recruitment (day 0), after 12 days of inhalation (day 12) and one month after the last day of inhalation (day 42). Changes between day 42, day 12 and day 0 will be evaluated.'}, {'measure': 'Clinical outcomes', 'timeFrame': '42 days', 'description': 'Spirometry and the impact of COPD on patient quality of life (performed by the COPD Assessment Test (CAT)) will be measured at recruitment (day 0), after 12 days of inhalation (day 12) and one month after the last day of inhalation (day 42). Changes between day 42, day 12 and day 0 will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Thermal water', 'Oxidative stress', 'Inflammation'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '24453924', 'type': 'DERIVED', 'citation': 'Contoli M, Gnesini G, Forini G, Marku B, Pauletti A, Padovani A, Casolari P, Taurino L, Ferraro A, Chicca M, Ciaccia A, Papi A, Pinamonti S. Reducing agents decrease the oxidative burst and improve clinical outcomes in COPD patients: a randomised controlled trial on the effects of sulphurous thermal water inhalation. ScientificWorldJournal. 2013 Dec 23;2013:927835. doi: 10.1155/2013/927835. eCollection 2013.'}]}, 'descriptionModule': {'briefSummary': 'The chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways characterized by fixed airflow obstruction, with important systemic co-morbidities. The obstruction is usually progressive and irreversible despite chronic therapy. Cigarette smoking is the major cause of this disease. COPD is an important cause of morbidity and mortality worldwide. Numerous studies have shown that oxidative stress plays a key role in the pathogenesis of COPD. In particular, the active metabolites of oxygen such as superoxide anion and the hydroxyl radical are unstable molecules that can trigger significant oxidative processes at the cellular level. These molecules can alter the extracellular matrix remodeling, cell respiration, cell proliferation, cellular repair and the immune response in the lung. All these events are key elements in the pathogenesis of COPD.\n\nCurrently available treatments for COPD (i.e. long-acting bronchodilators and inhaled corticosteroids) have not demonstrated a significant in vivo antioxidant effect. The thermal inhalation treatments are a therapeutic strategy used since many years in an empirical way in patients with COPD. Indeed, the evidence of effectiveness of spa treatment in patients with COPD are very limited.\n\nThe aim of this in vivo study is to evaluate the modulatory effects of sulfur thermal water inhalation on oxidant stress in the airways of stable COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Forty stable moderate to severe COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2 and 3), according to international guidelines.\n* FEV1/FVC ratio post-bronchodilator \\<70%\n* 30% \\< FEV1 \\< 80%\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': 'NCT01664767', 'briefTitle': 'Effects of Sulfur Thermal Water Inhalation on Airway Oxidative Stress in COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Ferrara'}, 'officialTitle': 'Placebo Controlled Study Evaluating the Modulatory Effects of Sulfur Thermal Water Inhalation on Superoxide Anion Levels in Exhaled Breath Condensate in COPD Patients', 'orgStudyIdInfo': {'id': 'RTUNIFE01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thermal water inhalation', 'description': 'Patients will perform 12 days of sulfur thermal water inhalation', 'interventionNames': ['Other: Sulfur Thermal water']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Isotonic saline inhalation', 'description': 'Patients will perform 12 days of isotonic saline inhalation', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Sulfur Thermal water', 'type': 'OTHER', 'armGroupLabels': ['Thermal water inhalation']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Isotonic saline inhalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44121', 'city': 'Ferrara', 'country': 'Italy', 'facility': 'Research Centre on Asthma and COPD, University of Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Ferrara', 'class': 'OTHER'}, 'collaborators': [{'name': 'Terme di Riolo Spa', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alberto Papi, MD', 'investigatorAffiliation': 'Università degli Studi di Ferrara'}}}}