Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-03-09 @ 7:22 AM
Study NCT ID:
NCT02131051
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2014-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Ectoine Containing Nasal Spray and Eye Drops in Patients With Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-05', 'studyFirstSubmitDate': '2014-04-25', 'studyFirstSubmitQcDate': '2014-05-05', 'lastUpdatePostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in primary allergic symptoms symptoms', 'timeFrame': 'Day1, Day 7', 'description': 'Change in the primary allergic nasal and ophthalmic symptoms:\n\nDegree of nasal breathing impairment, Rhinorrhea, Frequency of sneezing, Nasal itching,Eye itching, Watery eyes, Conjunctivitis score (eye redness)'}], 'secondaryOutcomes': [{'measure': 'Palatal itching score', 'timeFrame': 'day 1 and day 7'}, {'measure': 'Efficacy and tolerability assessment by the patients', 'timeFrame': 'day1 and day 7', 'description': 'Patients assess the efficacy and tolerability separately based on a general an Scale from 0 to 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ectoine', 'allergic rhinitis', 'bitop'], 'conditions': ['Allergic Rhinoconjunctivitis']}, 'descriptionModule': {'briefSummary': 'This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray and Eye drops. In addition the effectiveness and safety shall be compared to Azelastine containing nasal Sprays and Eye drops. The patient applied Ectoin® Rhinitis Nasal Spray / Eye drops or takes Azelastine nasals spray and eye drops according to the instructions for use. The observation takes place over a period of 7 days. Response to treatment is recorded at day 7 by the physician and in daily by the patient in a dairy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Care Clinic', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male or female patients\n* aged 18-70 years\n* Patients with proven allergy and acute symptoms in nose and eye which are treated with Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops or Azelastine Nasal Spray and Azelastine Eye Drops during the observational period\n\nExclusion Criteria:\n\n* pregnancy and nursing women,\n* drug addicts and persons unable to give consent to study participation,\n* patients with intolerance against ingredients of any of the study treatments,\n* previous eye or nose surgery,\n* concomitant treatment with anti-allergic drugs, and\n* diseases which might influence the output of the study according to the physicians' judgment.\n* contra indications according to the label"}, 'identificationModule': {'nctId': 'NCT02131051', 'briefTitle': 'Application of Ectoine Containing Nasal Spray and Eye Drops in Patients With Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bitop AG'}, 'officialTitle': 'Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray and Eye Drops in Patients With Allergic Rhinitis', 'orgStudyIdInfo': {'id': 'REP-85'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Azelastine group', 'description': 'Azelastine nasal spray Azelastine eye drops'}, {'label': 'Ectoin group', 'description': 'Ectoin Allergy Nasal Spray Ectoin Allergy Eye Drops'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Elmshorn', 'country': 'Germany', 'facility': 'HNO Praxis Elmshorn', 'geoPoint': {'lat': 53.74912, 'lon': 9.66176}}], 'overallOfficials': [{'name': 'Uwe Sonnemann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HNO Praxis Elmshorn'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bitop AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}