Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT05639959
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2022-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of New Mometasone Furoate Nasal Spray Formulation in Acute Rhinosinusitis Patients: A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'targetDuration': '3 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-27', 'studyFirstSubmitDate': '2022-11-27', 'studyFirstSubmitQcDate': '2022-11-27', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'congestion', 'timeFrame': '3 weeks', 'description': "The primary end outcomes were change from baseline in the subject's congestion and/or blockage score averaged throughout the first month of treatment and change from baseline in the physician's assessment of Allergic rhinitis."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Rhinosinusitis']}, 'descriptionModule': {'briefSummary': 'Seasonal and perennial allergic rhinitis, acute rhino sinusitis, and nasal polyposis are examples of common inflammatory disorders of the airway that significantly reduce patient health and quality of life. Intranasal corticosteroids are advised as part of treatment plans for each of these illnesses since they help to reduce inflammation and thus symptoms.\n\nObjective In order to assess the effectiveness and safety of a new nano formulation of Mometasone furoate nano-nasal spray (FM-NNS) for the treatment of allergic rhinitis. Mometasone Furoate Nano-nasal spray (FM-NNS) was compared with commercial available nasal spray named as MFNS.', 'detailedDescription': 'Background Seasonal and perennial allergic rhinitis, acute rhino sinusitis, and nasal polyposis are examples of common inflammatory disorders of the airway that significantly reduce patient health and quality of life. Intranasal corticosteroids are advised as part of treatment plans for each of these illnesses since they help to reduce inflammation and thus symptoms.\n\nObjective In order to assess the effectiveness and safety of a new nano formulation of Mometasone furoate nano-nasal spray (FM-NNS) for the treatment of allergic rhinitis. Mometasone Furoate Nano-nasal spray (FM-NNS) was compared with commercial available nasal spray named as MFNS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ages Eligible for Study: 10 Years to 50 Years older Sexes Eligible for Study: All Accepts Healthy Volunteers: No Children and adults of any age who had a diagnosis of rhinitis sicca, symptoms of dry nose brought on by the use of specific drugs, or who were receiving concurrent treatment for allergies or rhinosinusitis were eligible for the study', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children and adults of age (10-50) who had a diagnosis of rhinitis\n2. Ability and willingness to understand and provide informed consent.\n\nExclusion Criteria:\n\n1. Known current pregnancy.\n2. Current hospitalization.\n3. Unable to complete online questionnaires or adhere to study requirements.\n4. Kidney failure or dialysis; severe liver disease or cirrhosis.\n5. Any parathyroid conditions.\n6. Known current pregnancy.\n7. History of SARS-CoV-2 infection.'}, 'identificationModule': {'nctId': 'NCT05639959', 'briefTitle': 'Efficacy and Safety of New Mometasone Furoate Nasal Spray Formulation in Acute Rhinosinusitis Patients: A Randomized Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Saffron Pharma'}, 'officialTitle': 'Efficacy and Safety of New Mometasone Furoate Nasal Spray Formulation in Acute Rhinosinusitis Patients: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'QA/CT/001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Commercial product group', 'description': 'group who are taking commercial nasal spray products', 'interventionNames': ['Drug: Mometasone Nasal 50 Mcg/Inh Nasal Spray', 'Device: Nasal spray']}, {'label': 'New formulation product group', 'description': 'who are taking new formulation nasal spray product with same strength', 'interventionNames': ['Drug: Mometasone Nasal 50 Mcg/Inh Nasal Spray', 'Device: Nasal spray']}], 'interventions': [{'name': 'Mometasone Nasal 50 Mcg/Inh Nasal Spray', 'type': 'DRUG', 'otherNames': ['Hivate'], 'description': 'Mometasone furoate nasal spray effectively reduced total and individual symptoms scores in patients with allergic rhinitis.', 'armGroupLabels': ['Commercial product group', 'New formulation product group']}, {'name': 'Nasal spray', 'type': 'DEVICE', 'description': 'device can work properly for actuation during trials', 'armGroupLabels': ['Commercial product group', 'New formulation product group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Faisalabad', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Saffron Pharmaceutical', 'geoPoint': {'lat': 31.41554, 'lon': 73.08969}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saffron Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Yasir Mehmood', 'investigatorFullName': 'Yasir Mehmood Mehmood', 'investigatorAffiliation': 'Saffron Pharma'}}}}