nctId: NCT06264141 id: NONS-RARS-01 briefTitle: Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis acronym: NONS-RARS-01 overallStatus: RECRUITING date: 2024-01-16 date: 2024-06 date: 2024-09 date: 2024-02-16 date: 2024-02-16 name: Sanotize Research and Development corp. class: INDUSTRY 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. conditions: Recurrent Acute Rhinosinusitis studyType: INTERVENTIONAL phases: PHASE2 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 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 count: 186 type: ESTIMATED name: Nitric Oxide Releasing Solution name: Nasal spray with isotonic saline measure: Primary endpoint is the time to sinus symptoms resolution measure: Time (days) to full recovery from sinusitis (participant reported) measure: Time (days) to sinus symptoms resolution, i.e., being cured or much improved (participant reported clinical success) measure: Time (days) to the initiation of rescue oral ATB(s), i.e., treatment failure i.e., treatment failure measure: Time (days) to initiation of INCS measure: Proportion of participants requiring INCS measure: Proportion of participants requiring rescue oral ATBs measure: Proportion of participants recovered from sinusitis measure: Proportion of participants with rapidly worsening symptoms requiring the use of INCS and oral ATBs measure: Proportion of participants achieving at least a 9-point improvement change from baseline in Sinonasal Outcome Test (SNOT)-22 measure: Tolerability and safety of NONS measure: Proportion of participants with clinically significant changes from baseline in vital signs measure: Proportion of participants with clinically significant changes from baseline in laboratory parameters measure: Number of participants with clinically significant changes from Baseline in physical examinations measure: Number of ATB courses required as a rescue treatment measure: Time (days) to the initiation of NSAIDs measure: Proportion of participants requiring NSAIDs measure: Time (days) to each symptom being cured or much improved measure: Proportion of participants being cured or much improved for each symptom measure: Proportion of participants achieving at least a 50% reduction in sinusitis symptoms (by MRSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Okanegan Clinical Trials status: RECRUITING city: Kelowna state: British Columbia zip: V1Y 1Z9 country: Canada name: Cora Withers role: CONTACT phone: 250-862-8141 email: cora@oktrials.ca name: Colleen Maytham, MD role: PRINCIPAL_INVESTIGATOR lat: 49.88307 lon: -119.48568 facility: Richmond Clinical Trials (Okanagan Clinical Trials Satelite Site) status: RECRUITING city: Richmond state: British Columbia zip: V6V 2L1 country: Canada role: CONTACT phone: 604-373-4954 name: Colleen Maytham, MD role: PRINCIPAL_INVESTIGATOR lat: 49.17003 lon: -123.13683 facility: Cliantha Research status: RECRUITING city: Mississauga state: Ontario zip: L4W 1V7 country: Canada name: Patricia Couroux, MD role: PRINCIPAL_INVESTIGATOR lat: 43.5789 lon: -79.6583 facility: Clinical Research of Ontario status: NOT_YET_RECRUITING city: Scarborough state: Ontario zip: M1S 4T7 country: Canada name: Jemilat Smith role: CONTACT phone: 18002474525 phoneExt: 1 email: jemilatsmith@gmail.com lat: 43.77223 lon: -79.25666 facility: Intermed Groupe Santé status: RECRUITING city: Chicoutimi state: Quebec zip: G7H 7Y8 country: Canada name: Nancu Lavoie role: CONTACT phone: 418-602-6620 email: n.lavoie@intermedgs.ca name: Doria Grimard, MD role: PRINCIPAL_INVESTIGATOR lat: 48.41963 lon: -71.06369 facility: Alpha Recherche Clinique LeBourneuf status: RECRUITING city: Québec City state: Quebec zip: G2J 0C4 country: Canada name: Amélie Boulay role: CONTACT phone: 418.704.1112 email: aboulay@alpha-recherche.ca name: Anne-Marie Beaulieu, MD role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 facility: Alpha Recherche Clinique Val-Belair status: RECRUITING city: Québec City state: Quebec zip: G3K 2P8 country: Canada name: Jessica M. M. Petit role: CONTACT phone: 418.847.1112 email: jpetit@alpha-recherche.ca name: Melanie Gauvin role: CONTACT email: mgauvin@alpha-recherche.ca name: Camille Walsh, MD role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False