Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-11 @ 10:24 PM
Study NCT ID:
NCT02632851
Status:
COMPLETED
Last Update Posted:
2016-06-21
First Post:
2015-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D003371', 'term': 'Cough'}, {'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-20', 'studyFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2015-12-14', 'lastUpdatePostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Bronchitis Severity Score on physician´s evaluation (5 point IMOS scale)', 'timeFrame': 'day 7', 'description': 'Assessment of bronchits severity score on a 5 point IMOS scale (complete recovery, major improvement, slight to moderate improvement, no change, deterioration) of symptoms:\n\nCough, sputum production, rales/rhonchi, chest pain during coughing, dyspnoea'}], 'secondaryOutcomes': [{'measure': 'Change in bronchitis symptoms evaluated on patients´ diaries (5 point scale)', 'timeFrame': 'day 14', 'description': 'Assessment of bronchits symptoms on a 5 point scale (absent, mild, moderate, severe, very severe) of symptoms:\n\nCough, sputum production, rales/rhonchi, chest pain during coughing, dyspnoea'}, {'measure': 'patients´ evaluation of tolerability (4 point scale)', 'timeFrame': 'day7', 'description': 'assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)'}, {'measure': 'physicians´ evaluation of tolerability (4 point scale)', 'timeFrame': 'day 7', 'description': 'assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)'}, {'measure': 'patients´ evaluation of efficacy (five point IMOS scale)', 'timeFrame': 'day 7', 'description': 'assessment of tolerability on a five point IMOS scale (complete recovery, major improvement, slight to moderate improvement, no change, deterioration)'}, {'measure': 'physicians´ evaluation of efficacy (five point IMOS scale)', 'timeFrame': 'day 7', 'description': 'assessment of tolerability on a five point IMOS scale (complete recovery, major improvement, slight to moderate improvement, no change, deterioration)'}, {'measure': 'Change in number and type of adverse events', 'timeFrame': 'day 7', 'description': 'incidence of adverse events and correlation with the therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['inhalation', 'isotonic saline', 'NaCl solution 0.9 %', 'Ectoin', 'bronchitis', 'respiratory tract infection'], 'conditions': ['Bronchitis', 'Cough', 'Sputum, Cellular Atypia', 'Dyspnoea']}, 'referencesModule': {'references': [{'pmid': '23927521', 'type': 'BACKGROUND', 'citation': 'Matthys H, Kamin W. Positioning of the Bronchitis Severity Score (BSS) for standardised use in clinical studies. Curr Med Res Opin. 2013 Oct;29(10):1383-90. doi: 10.1185/03007995.2013.832183. Epub 2013 Aug 23.'}]}, 'descriptionModule': {'briefSummary': 'This observational, non-interventional multicentric study compares the inhalation therapy on patients suffering on respiratory tract infections and/or acute bronchitis between Ectoin inhalation solution and Pari NaCl (0.9%) inhalation solution', 'detailedDescription': 'The assessment focuses on the bronchitis Severity Score (BSS) for standardized use in clinical studies with the outcome criteria of cough, sputum production, rales/rhonchi, chest pain during coughing and dysnoea'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care or ENT units study the therapeutic process in this obvservational trial in total of 120 patients suffering on respiratory tract infection and/or acute bronchitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* according to instruction for use\n\nExclusion Criteria:\n\n* according to instruction for use'}, 'identificationModule': {'nctId': 'NCT02632851', 'briefTitle': 'Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bitop AG'}, 'officialTitle': 'Non-interventional Multicentric Study on Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution', 'orgStudyIdInfo': {'id': 'EIL/aBr/2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ectoin inhalation solution', 'description': 'treatment according to instructions for use'}, {'label': 'Pari NaCl inhalation solution (0.9%)', 'description': 'treatment according to instructions for use'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Facharzt für HNO, Allergologie', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'R Mösges, Prof Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bitop AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}