Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-27 @ 5:17 PM
Study NCT ID:
NCT05912192
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2023-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy Of Elonide Nasal Corticosteroids In Managing 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068656', 'term': 'Mometasone Furoate'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2023-06-12', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Symptoms Score on Allergic Rhinitis at Week 4', 'timeFrame': 'Baseline and week 4', 'description': 'The Visual Analogue Score (VAS) is a validated, self-reported instrument assessing average scoring of overall allergic rhinitis symptoms in the last 7 days period from treatment date. Possible score range from 0 (no symptoms) to 100 (worst possible symptoms). Maximum number of change from baseline indicate improvement of symptoms.\n\nChange= (Baseline score - Week 4 score)'}, {'measure': 'Mean difference from Baseline in Quality of Life Questionnaire on several domains at Week 4', 'timeFrame': 'Baseline and week 4', 'description': 'Rhinoconjunctivitis Quality of Life Questionnaire (RQOLQ) contains several domains score to access patient quality of life for a 7 days period from treatment date. The domains include activities, sleep, non-hay symptoms, practical problems, nasal symptoms, eye symptoms and emotional. Possible scoring from 0 (not trouble) to 6 (extremely troubled).\n\nChange= (Baseline score - Week 4 score)'}, {'measure': 'Change from Baseline in Total Nasal Resistance while normal breathing at Week 4', 'timeFrame': 'Baseline and week 4', 'description': 'Total Nasal Resistance is performed using Rhinomanometry device that provides a functional measure if pressure during a breathing cycle. Normal values for total nasal resistance is below 0.2 and to 0.3 Pa cm3/s. Worst case will be higher than 0.3 Pa cm3/s indicate nasal obstruction.\n\nChange= (Baseline score - Week 4 score)'}], 'secondaryOutcomes': [{'measure': 'Adverse effect of Nasal Spray', 'timeFrame': 'Baseline to week 4', 'description': 'Any kind of side effect experience by patients in the period of using nasal spray'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical study is to compare the efficacy of Elonide Nasal Spray to Nasonex Nasal Spray and Placebo (non-active ingredient) in the management of allergic rhinitis.\n\nThere are two hypotheses of this study:\n\n1. Elonide nasal spray is same efficacy to Nasonex nasal spray.\n2. Elonide nasal spray is more efficient to placebo.', 'detailedDescription': 'There are several objectives of the study:\n\n1. To compare the efficacy of Elonide to Nasonex and Placebo in treating allergic rhinitis via Quality of life assessments and nasal airflow improvements.\n2. To compare the efficacy of Elonide to Nasonex and Placebo in treating allergic rhinitis via symptomatics improvement.\n3. To assess the side effect of Nasal spray given.\n\nPatients who meet the criteria to join the study will be randomized in a double-blind manner (patients and investigators). Patients will be given information about the study and consent form, patients will be randomized to 3 treatment group(Elonide, Nasonex, Placebo). Patients will be evaluated before and after treatment in one month time. Patients will be advised to use the nasal spray twice daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adults patients 18 years and above\n* Newly diagnosed mild, moderate to severe, intermittent and persistent allergic rhinitis\n* Positive skin prick test or serum Immunoglobulin E\n\nExclusion Criteria:\n\n* Patients who have been on allergic rhinitis treatment\n* Below 18 years old\n* Patients diagnosed with asthma or immunodeficiency diseases\n* Pregnancy\n* Other concomitant rhinology disease\n* Smokers\n* Severe deviated nasal septum'}, 'identificationModule': {'nctId': 'NCT05912192', 'briefTitle': 'The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'National University of Malaysia'}, 'officialTitle': 'The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis', 'orgStudyIdInfo': {'id': 'FF-2021-421'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elonide Nasal Spray', 'description': 'Elonide is generic nasal spray Dose: 50 mcg/dose mometasone furoate 140 sprays per nasal spray One pump for both nostrils twice daily', 'interventionNames': ['Drug: Elonide Nasal Spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nasonex Nasal Spray', 'description': 'Nasonex Aqueous Nasal Spray Dose: 50 mcg/dose mometasone furoate 140 sprays per nasal spray The usual recommended dose for prophylaxis and treatment is two sprays (50 micrograms/spray) in each nostril once daily (total dose 200 micrograms) One pump for both nostrils twice daily', 'interventionNames': ['Drug: Nasonex Nasal Spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'Placebo used is 0.9% sodium chloride Dose: 50 mcg/dose of 0.9% sodium chloride One pump for both nostrils twice daily', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Elonide Nasal Spray', 'type': 'DRUG', 'otherNames': ['Elonide'], 'description': '50mcg/dose One puff for each nostrils twice daily', 'armGroupLabels': ['Elonide Nasal Spray']}, {'name': 'Nasonex Nasal Spray', 'type': 'DRUG', 'description': '50mcg/dose One puff for each nostrils twice daily', 'armGroupLabels': ['Nasonex Nasal Spray']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': '50mcg/dose of 0.9% sodium chloride One puff for each nostrils twice daily', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Cheras', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia'}], 'overallOfficials': [{'name': 'Hardip Singh Gendeh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Universiti Kebangsaan Malaysia'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data can be assess 6 months after publication', 'ipdSharing': 'YES', 'description': 'Data obtained through this study may be provided to qualified researchers with academic interest in allergic rhinitis.', 'accessCriteria': 'Access to trial IPD can be access by qualified researchers engaging in independent scientific research.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Malaysia', 'class': 'OTHER'}, 'collaborators': [{'name': 'HOE pharmaceuticals Sdn. Bhd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}