Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-30 @ 7:40 PM
Study NCT ID:
NCT03369132
Status:
UNKNOWN
Last Update Posted:
2017-12-22
First Post:
2017-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010612', 'term': 'Pharyngitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-21', 'studyFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sore Throat Relief', 'timeFrame': 'Over the first three days', 'description': 'Evaluation of sore throat relief using the 7-point sore throat relief scale (STRS)'}], 'secondaryOutcomes': [{'measure': 'Sore Throat Individual Symptoms Relief', 'timeFrame': 'Day 1, 2, 3, 4, 5, 5, 7 to 8.', 'description': 'Evaluation of relief of sore throat individual symptoms (dry throat, burning/painful sensation, hoarseness/husky voice, painful talk, painful swallowing, irritation, prickly sensation/tingle, scratchy/itchy throat) using a 10-point rating scale'}, {'measure': 'Sore Throat Pain Intensity', 'timeFrame': 'Day 1, 2, 3, 4, 5, 5, 7 to 8.', 'description': 'Change from baseline of the Sore Throat Pain Intensity using a Visual Analog Scale (VAS) (STPIS)'}, {'measure': 'Difficulty Swallowing', 'timeFrame': 'Day 1, 2, 3, 4, 5, 5, 7 to 8.', 'description': 'Change from baseline of the difficulty of swallowing using a VAS (DSS)'}, {'measure': 'Swollen Throat', 'timeFrame': 'Day 1, 2, 3, 4, 5, 5, 7 to 8.', 'description': 'Change from baseline of the swollen throat using a VAS (SwoTS)'}, {'measure': 'Overall efficacy assessed by the physician', 'timeFrame': 'Day 8', 'description': 'Overall efficacy assessed by the physician using a 5-point descriptive scale'}, {'measure': 'Compliance: assessment of the number of use per day and the number of spray per use', 'timeFrame': 'Day 1, 2, 3, 4, 5, 5, 7 to 8.', 'description': 'Assessment of the patient usage: frequency per day and number of spray per use'}, {'measure': 'Product Satisfaction', 'timeFrame': 'Day 8', 'description': 'Assessment of the overall satisfaction using a 5-point descriptive scale'}, {'measure': 'Incidence of adverse events occuring during the study', 'timeFrame': 'Day 1, 2, 3, 4, 5, 5, 7 to 8.', 'description': 'Number of adverse events and serious events occuring during the study and evaluation of the severity and causality.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sore Throat']}, 'descriptionModule': {'briefSummary': 'Prospective, randomized, double-blind, placebo-controlled, multicentre clinical trial to assess the efficacy and tolerability of natural seawater based throat spray among adult patients with acute sore throat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Adults (male or female) aged ≥ 18 years old.\n* 2\\. Patients with complaint of sore throat ≤ 72h.\n* 3\\. Sore throat exclusively due to upper respiratory tract infection (tonsillitis, pharyngitis, rhinopharyngitis).\n* 4\\. Clinical confirmation by the physician for the presence of typical signs (spontaneous pain, local inflammation) of acute pharyngitis or tonsillitis.\n* 5\\. Pain intensity scored by patient on the 5-point descriptive pain intensity scale as slight, mild or moderate.\n* 6\\. Willingness to provide written informed consent prior to perform of any study related procedure.\n* 7\\. Subjects agreeing to follow the study requirements during the whole study period (including forbidden medication and food supplements).\n* 8\\. Subjects agreeing not to modify their lifestyle habits during the whole study period (diet, physical activity).\n* 9\\. Subject affiliated to social security.\n* 10\\. Subject able to understand verbal and written local language and in capacity to fill-in patient diary by himself/herself.\n\nExclusion Criteria:\n\n* 1\\. Previous history of allergy or known intolerance to one of the following formulation ingredients: seawater, vegetable glycerin, mint, lemon, acacia honey, propolis, essential oils.\n* 2\\. Active Smokers.\n* 3\\. Fever \\> 38°C at randomization.\n* 4\\. Past or current throat phlegmon.\n* 5\\. Past or current seasonal allergy.\n* 6\\. Past or current asthma.\n* 7\\. Past or current chronic rhinosinusitis.\n* 8\\. Past or current chronic obstructive pulmonary disease (COPD).\n* 9\\. Past or current ENT (Ear, Nose and Throat) cancer.\n* 10\\. Acute rhinosinusitis.\n* 11\\. Controlled or uncontrolled diabetes.\n* 12\\. Gastroesophageal reflux disease (GERD).\n* 13\\. Known immunodeficiency.\n* 14\\. Any painful condition that may distract attention from sore throat pain (ex: mouth ulcers etc.) or that requires analgesic usage.\n* 15\\. Any disease that may interfere with the study aim from investigator's opinion.\n* 16\\. Evidence of mouth breathing or severe coughing.\n* 17\\. Patient with severe pain intensity on 5-point descriptive pain intensity scale.\n* 18\\. Subjects taking:\n\n * chronic treatment for throat or other ENT pathology,\n * current antibiotherapy or stopped less than 2 weeks before inclusion,\n * chronic treatment (\\>3 months) with local or systemic corticotherapy, or immunotherapy,\n * local or systemic antihistaminic.\n* 19\\. Subjects refusing to stop at entry into the study:\n\n * throat spray, lozenge, pastille,\n * local throat or systemic analgesic,\n * medicated confectionary,\n * nasal wash and spray,\n * nasal corticosteroid or antihistaminic nasal spray,\n * medication to gargle,\n * honey, propolis, or any sore throat home remedies.\n* 20\\. Known liver disease or hypersensitivity to paracetamol.\n* 21\\. Pregnant, breastfeeding or seeking pregnancy women.\n* 22\\. Positive result from rapid strep throat test.\n* 23\\. Subjects already included once in this study.\n* 24\\. Subjects participating in another clinical trial or in the exclusion period to another study.\n* 25\\. Subjects having a member of his/her home who is currently participating to this study."}, 'identificationModule': {'nctId': 'NCT03369132', 'acronym': 'FLASH', 'briefTitle': 'Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoire de la Mer'}, 'officialTitle': 'Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief: a Prospective, Randomized, Double-blind, Placebo-controlled, Multicentre Clinical Study', 'orgStudyIdInfo': {'id': 'FLASH-CZ-2017-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Angiflash', 'interventionNames': ['Device: Angiflash']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'Angiflash', 'type': 'DEVICE', 'otherNames': ['Seawater based throat spray'], 'description': 'throat spray (20 ml) containing hypertonic seawater, vegetable glycerin, natural mint, acacia honey, propolis extract, essential oils of thyme linalool, ravintsara and wintergreen, natural lemon flavor.', 'armGroupLabels': ['Angiflash']}, {'name': 'Placebo', 'type': 'DEVICE', 'otherNames': ['Placebo throat spray'], 'description': 'water based throat spray matching Angiflash for posology, dispensed volume, shape and size.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '602 00', 'city': 'Brno', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Lenka Dybova, M. D.', 'role': 'CONTACT'}], 'facility': 'MUDr. Lenka Dybova', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '533 61', 'city': 'Choltice', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Libor Hemzsky, M. D.', 'role': 'CONTACT'}], 'facility': 'MUDr. Libor Hemzsky', 'geoPoint': {'lat': 49.98772, 'lon': 15.61941}}, {'zip': '160 00', 'city': 'Dejvice', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Krisitina Sadilkova, M. D.', 'role': 'CONTACT'}], 'facility': 'NEFROMED s.r.o.', 'geoPoint': {'lat': 50.10079, 'lon': 14.39071}}, {'zip': '500 09', 'city': 'Hradec Králové', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Ivana Skardova, M. D.', 'role': 'CONTACT'}, {'name': 'Jan Skarda, M. D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'MEDIGATE care s.r.o', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '500 09', 'city': 'Hradec Králové', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Petra Hoskova, M. D.', 'role': 'CONTACT'}], 'facility': 'MUDr. Petra Hoskova', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '500 11', 'city': 'Hradec Králové', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Jana Dvorakova, M. D.', 'role': 'CONTACT'}], 'facility': 'MUDr. Jana Dvorakova s.r.o.', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '360 17', 'city': 'Karlovy Vary', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'David Macharacek, M. D.', 'role': 'CONTACT'}], 'facility': 'MUDr. Danuse Mikeschova', 'geoPoint': {'lat': 50.23271, 'lon': 12.87117}}, {'zip': '108 00', 'city': 'Malšice', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Azita Gebauerova, M. D.', 'role': 'CONTACT'}], 'facility': 'Azita s.r.o.', 'geoPoint': {'lat': 49.36391, 'lon': 14.57868}}, {'zip': '143 00', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Tomas Fort, M. D.', 'role': 'CONTACT'}, {'name': 'Daniel Groh, M. D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fortmedica s.r.o.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '148 00', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'David Macharacek, M. D.', 'role': 'CONTACT'}], 'facility': 'GM ordinace s.r.o', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '160 00', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Sylva Kohoutova, M. D.', 'role': 'CONTACT'}], 'facility': 'MUDr Sylva Kohoutova', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '161 00', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Radka Majerova, M. D.', 'role': 'CONTACT'}], 'facility': 'Ordinace Optima s.r.o', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '164 00', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Lenka Fejfarova, M. D.', 'role': 'CONTACT'}], 'facility': 'MUDr. Lenka Fejfarova', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '356 01', 'city': 'Sokolov', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Zdenek Vlasak, M. D.', 'role': 'CONTACT'}], 'facility': 'Saniga s.r.o.', 'geoPoint': {'lat': 50.1813, 'lon': 12.6401}}, {'zip': '415 01', 'city': 'Teplice', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Jan Bartusek, M. D.', 'role': 'CONTACT'}], 'facility': 'MUDr. Jan Bartusek', 'geoPoint': {'lat': 50.6404, 'lon': 13.82451}}, {'zip': '760 01', 'city': 'Zlín', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Alena Malikova, M. D.', 'role': 'CONTACT'}], 'facility': 'A-MEDICOS s.r.o.', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}], 'centralContacts': [{'name': 'Gaelle Naelten, Pharm.D,Ph.D', 'role': 'CONTACT', 'email': 'gaelle.naelten@perrigo.com', 'phone': '+33 (0)299 215 387'}, {'name': 'Olivia Gavard, Ph.D.', 'role': 'CONTACT', 'email': 'olivia.gavard@perrigo.com', 'phone': '+33 (0)256 521 017'}], 'overallOfficials': [{'name': 'Ivana Skardova, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MEDIGATE care s.r.o'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoire de la Mer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}