protocolSection identificationModule nctId: NCT06264141, orgStudyIdInfo id: NONS-RARS-01, briefTitle: Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis, acronym: NONS-RARS-01, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-16, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Sanotize Research and Development corp., class: INDUSTRY, descriptionModule briefSummary: A two-week therapy of nitric oxide nasal spray (NONS) vs Placebo (saline nasal spray) initiated immediately after the onset of a new Recurrent Acute Rhinosinusitis (RARS) episode to assess the acceleration to clinical success (cured/much improved symptoms), lack of use of intranasal corticosteroids (INCS) (Day 5, or thereafter) and rescue oral antibiotics (ATBs) (Day 8, or thereafter) after initiation of nitric oxide releasing solution (NORS) platform therapy., conditionsModule conditions: Recurrent Acute Rhinosinusitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A two-week therapy of NONS vs Placebo (saline nasal spray) initiated immediately after the onset of a new RARS episode to assess the acceleration to clinical success (cured/much-improved symptoms), lack of use of INCS (Day 5, or thereafter) and rescue oral antibiotics (ATBs) (Day 8, or thereafter) after initiation of nitric oxide-releasing solution (NORS) platform therapy., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: A blinded participant number will be assigned to each randomized participant. Site staff/ physician will then dispense a kit labelled with the authorization number generated during randomization to the individual participant. No study investigators, associates performing assessments or participants will be aware of the study medication in the assigned treatments., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 186, type: ESTIMATED, armsInterventionsModule interventions name: Nitric Oxide Releasing Solution, interventions name: Nasal spray with isotonic saline, outcomesModule primaryOutcomes measure: Primary endpoint is the time to sinus symptoms resolution, secondaryOutcomes measure: Time (days) to full recovery from sinusitis (participant reported), secondaryOutcomes measure: Time (days) to sinus symptoms resolution, i.e., being cured or much improved (participant reported clinical success), secondaryOutcomes measure: Time (days) to the initiation of rescue oral ATB(s), i.e., treatment failure i.e., treatment failure, secondaryOutcomes measure: Time (days) to initiation of INCS, secondaryOutcomes measure: Proportion of participants requiring INCS, secondaryOutcomes measure: Proportion of participants requiring rescue oral ATBs, secondaryOutcomes measure: Proportion of participants recovered from sinusitis, secondaryOutcomes measure: Proportion of participants with rapidly worsening symptoms requiring the use of INCS and oral ATBs, secondaryOutcomes measure: Proportion of participants achieving at least a 9-point improvement change from baseline in Sinonasal Outcome Test (SNOT)-22, secondaryOutcomes measure: Tolerability and safety of NONS, secondaryOutcomes measure: Proportion of participants with clinically significant changes from baseline in vital signs, secondaryOutcomes measure: Proportion of participants with clinically significant changes from baseline in laboratory parameters, secondaryOutcomes measure: Number of participants with clinically significant changes from Baseline in physical examinations, otherOutcomes measure: Number of ATB courses required as a rescue treatment, otherOutcomes measure: Time (days) to the initiation of NSAIDs, otherOutcomes measure: Proportion of participants requiring NSAIDs, otherOutcomes measure: Time (days) to each symptom being cured or much improved, otherOutcomes measure: Proportion of participants being cured or much improved for each symptom, otherOutcomes measure: Proportion of participants achieving at least a 50% reduction in sinusitis symptoms (by MRSS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Okanegan Clinical Trials, status: RECRUITING, city: Kelowna, state: British Columbia, zip: V1Y 1Z9, country: Canada, contacts name: Cora Withers, role: CONTACT, phone: 250-862-8141, email: cora@oktrials.ca, contacts name: Colleen Maytham, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.88307, lon: -119.48568, locations facility: Richmond Clinical Trials (Okanagan Clinical Trials Satelite Site), status: RECRUITING, city: Richmond, state: British Columbia, zip: V6V 2L1, country: Canada, contacts role: CONTACT, phone: 604-373-4954, contacts name: Colleen Maytham, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.17003, lon: -123.13683, locations facility: Cliantha Research, status: RECRUITING, city: Mississauga, state: Ontario, zip: L4W 1V7, country: Canada, contacts name: Patricia Couroux, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.5789, lon: -79.6583, locations facility: Clinical Research of Ontario, status: NOT_YET_RECRUITING, city: Scarborough, state: Ontario, zip: M1S 4T7, country: Canada, contacts name: Jemilat Smith, role: CONTACT, phone: 18002474525, phoneExt: 1, email: jemilatsmith@gmail.com, geoPoint lat: 43.77223, lon: -79.25666, locations facility: Intermed Groupe Santé, status: RECRUITING, city: Chicoutimi, state: Quebec, zip: G7H 7Y8, country: Canada, contacts name: Nancu Lavoie, role: CONTACT, phone: 418-602-6620, email: n.lavoie@intermedgs.ca, contacts name: Doria Grimard, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.41963, lon: -71.06369, locations facility: Alpha Recherche Clinique LeBourneuf, status: RECRUITING, city: Québec City, state: Quebec, zip: G2J 0C4, country: Canada, contacts name: Amélie Boulay, role: CONTACT, phone: 418.704.1112, email: aboulay@alpha-recherche.ca, contacts name: Anne-Marie Beaulieu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, locations facility: Alpha Recherche Clinique Val-Belair, status: RECRUITING, city: Québec City, state: Quebec, zip: G3K 2P8, country: Canada, contacts name: Jessica M. M. Petit, role: CONTACT, phone: 418.847.1112, email: jpetit@alpha-recherche.ca, contacts name: Melanie Gauvin, role: CONTACT, email: mgauvin@alpha-recherche.ca, contacts name: Camille Walsh, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False