Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis
- Conditions
- Recurrent Acute Rhinosinusitis
- Registration Number
- NCT06264141
- Lead Sponsor
- Sanotize Research and Development corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 162
Inclusion Criteria:<br><br> 1. At least aged 18 years old at the time of consent (19 years depending on the age of<br> majority in the Canadian province/territory).<br><br> 2. History of recurrent acute bacterial sinusitis (ABS) with at least three episodes in<br> the previous 12 months with at least two episodes requiring ATB therapy (with<br> symptom-free periods between infections).<br><br> 3. History of at least two moderately severe symptoms of acute rhinosinusitis (anterior<br> (nasal) and posterior (postnasal drip) secretions, nasal obstruction (congestion),<br> headache or facial pain/pressure during a typical RARS episode.<br><br> 4. If female, be surgically sterile or post-menopausal (no menses for at least 12<br> months), or if of childbearing potential, must be using an acceptable method of<br> contraception such as a combination estrogen/progestin hormonal contraceptive (oral<br> or injected) for at least 1 month prior to Screening, or such items as an<br> intrauterine device (IUD), intrauterine system (IUS), transdermal hormonal implant,<br> vaginal hormonal ring, or 2 forms of the following: diaphragm, cervical cap, patch,<br> condom, spermicide, or sponge. Total abstinence is permitted. Must agree to agree<br> continue using contraception for the duration of the study medication treatment.<br><br> 5. If male, be surgically sterile, or agree to use appropriate contraception (latex<br> condom with spermicide) when engaging in sexual activity and agree to not donate<br> sperm for the duration of the study medication treatment.<br><br> 6. Be reasonable stable health (i.e., diagnosed chronic illnesses that are not deemed<br> stable by the participant's primary care physician), or in the opinion of the<br> Investigator, based on medical history (i.e., absence of any clinically relevant<br> abnormality) during Screening.<br><br> 7. Be able to understand and provide written, informed consent.<br><br> 8. Must be able to attend on-site and virtual study visits.<br><br>Exclusion Criteria:<br><br> 1. Complicated RARS (orbital or intracranial involvement).<br><br> 2. Symptoms attributed to sinus disease for longer than 4 weeks.<br><br> 3. RARS with multiple courses of antimicrobial therapy failures (in previous 2 years, 3<br> or more episodes treated with 2 or more ATBs).<br><br> 4. Disease history consistent with severe allergic or seasonal rhinitis (requiring oral<br> cortico-steroids to manage intractable nasal symptoms).<br><br> 5. Isolated frontal and sphenoidal clinical disease (given the different<br> pathophysiology and etiologic pathogens).<br><br> 6. History of nasal polyposis.<br><br> 7. History of abnormal sinus pathology.<br><br> 8. Previous sinus surgery.<br><br> 9. Participants with cystic fibrosis.<br><br> 10. Recurrent moderate epistaxis.<br><br> 11. Participants with chronic obstructive pulmonary disease (COPD).<br><br> 12. Participants with severe asthma (per European Respiratory Society (ERS)/American<br> Thoracic Society (ATS) 2014).<br><br> 13. Immunocompromised participants or participants with other medical conditions that<br> may affect interpretation of the effect of trial drugs.<br><br> 14. Allergic to any of the trial drugs.<br><br> 15. Females who are breastfeeding, pregnant, or attempting to become pregnant.<br><br> 16. Participants who have conditions that participation is not in their best interest.<br><br> 17. Participants whose participation in the study, in the opinion of the Investigator,<br> have a condition which would interfere with their ability to adhere to the protocol<br> (e.g., participants whom are mentally or neurologically disabled and whom are<br> considered not fit to their participation in the study), interfere with the<br> assessment of the investigational product, or compromise the safety of the<br> participant or the quality of the data.<br><br> 18. Participants who are unable to sign the informed consent.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is the time to sinus symptoms resolution
- Secondary Outcome Measures
Name Time Method Time (days) to full recovery from sinusitis (participant reported);Time (days) to sinus symptoms resolution, i.e., being cured or much improved (participant reported clinical success);Time (days) to the initiation of rescue oral ATB(s), i.e., treatment failure i.e., treatment failure;Time (days) to initiation of INCS;Proportion of participants requiring INCS;Proportion of participants requiring rescue oral ATBs;Proportion of participants recovered from sinusitis;Proportion of participants with rapidly worsening symptoms requiring the use of INCS and oral ATBs;Proportion of participants achieving at least a 9-point improvement change from baseline in Sinonasal Outcome Test (SNOT)-22;Tolerability and safety of NONS;Proportion of participants with clinically significant changes from baseline in vital signs;Proportion of participants with clinically significant changes from baseline in laboratory parameters;Number of participants with clinically significant changes from Baseline in physical examinations