Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-16

Study Completion Date

2025-02-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS)

NCT04163978

Chronic Sinusitis

COMPLETED PHASE2

Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection

NCT05109611

SARS-CoV-2 Infection

TERMINATED PHASE3

Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Phase 3 Study)(Study P02692)

NCT00751075

Acute Rhinosinusitis

COMPLETED PHASE3

Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Study P02683)

NCT00750750

Acute Rhinosinusitis

COMPLETED PHASE2

Oxymetazoline Hydrochloride in Combination With Nasal Glucocorticosteroid for Perennial Allergic and Non-allergic Rhinitis in Subjects With Persistent Nasal Congestion

NCT00584662

Chronic Rhinitis

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study Design:

This is a multicenter, randomized, double-blind placebo-controlled, two-arm, parallel-group, phase 2 clinical trial to determine the efficacy and safety of NONS to treat recurrent acute (bacterial) rhinosinusitis (RARS).

Nitric oxide-releasing solution (NORS) therapy administered as NONS, has the potential to shorten RARS episodes and may reduce the concomitant use of INCS, oral non-steroidal anti-inflammatory drugs (NSAIDS) and oral ATBs used to manage this condition. Suitable candidates will be randomized to a 2-week course of nitric oxide nasal spray (NONS) compared to saline nasal spray (1:1 ratio, administered as five doses daily). RARS symptoms efficacy response will be measured twice daily, after initiation of study medication (Day 1 to Day 15), then once daily to the end of the study (Day 16 to Day 29). The goal of NONS therapy is to accelerate the time to achieve RARS symptoms resolution, defined as a clinical success (cured or much improved sinusitis symptoms; primary endpoint assessment at Day 8), minimize the use of INCS and the avoidance of rescue oral ATBs (both secondary endpoints) over the study period (Day 1 to Day 29). Participants will be enrolled between RARS episodes while asymptomatic, and on study for up to 4 months or until their next recurrence of RARS at which time study procedures and medication begin.

Adults (18 years or older) presenting with a history of mild to severe RARS symptoms (nasal obstruction (congestion), purulent nasal discharge, postnasal drip, headache, facial pain), signs (such as facial swelling), and other nonspecific signs/symptoms of fever and malaise are eligible.

The primary endpoint is is the time to sinus symptoms resolution, i.e., being cured or much improved (participant reported clinical success) after 7 days of therapy,

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Acute Rhinosinusitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nitric Oxide Releasing Solution

Nasal spray with nitric oxide releasing solution (NORS) delivered five times per day spaced 1 to 4 hours between each dose while awake.

Maximum volume delivered: 0.56 mL NORS @ 0.11ppm\*hrs

Group Type ACTIVE_COMPARATOR

Nitric Oxide Releasing Solution

Intervention Type DRUG

The Sponsor designed a dual chamber nasal spray bottle for NORS administration. Components are mixed from two chambers to create the final NO-producing formulation. The liquid contains NO at 0.11 ppm\*hour, which acts as a viricidal agent. Instructions for storing, preparing, and administering the study treatment will be provided to participants.

Placebo

Nasal spray with isotonic saline delivered five times per day spaced 1 to 4 hours between each dose while awake.

Maximum volume delivered: 0.56 mL Saline @ 0.9%

Group Type PLACEBO_COMPARATOR

Nasal spray with isotonic saline

Intervention Type DEVICE

The Sponsor designed a dual-chamber nasal spray bottle for NORS administration. The bottle will be filled with normal saline before being provided to the participant.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nitric Oxide Releasing Solution

The Sponsor designed a dual chamber nasal spray bottle for NORS administration. Components are mixed from two chambers to create the final NO-producing formulation. The liquid contains NO at 0.11 ppm\*hour, which acts as a viricidal agent. Instructions for storing, preparing, and administering the study treatment will be provided to participants.

Intervention Type DRUG

Nasal spray with isotonic saline

The Sponsor designed a dual-chamber nasal spray bottle for NORS administration. The bottle will be filled with normal saline before being provided to the participant.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nitric Oxide Nasal Spray Normal saline, 0.9% saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. At least aged 18 years old at the time of consent (19 years depending on the age of majority in the Canadian province/territory).
2. History of recurrent acute bacterial sinusitis (ABS) with at least three episodes in the previous 12 months with at least two episodes requiring ATB therapy (with symptom-free periods between infections).
3. History of at least two moderately severe symptoms of acute rhinosinusitis (anterior (nasal) and posterior (postnasal drip) secretions, nasal obstruction (congestion), headache or facial pain/pressure during a typical RARS episode.
4. If female, be surgically sterile or post-menopausal (no menses for at least 12 months), or if of childbearing potential, must be using an acceptable method of contraception such as a combination estrogen/progestin hormonal contraceptive (oral or injected) for at least 1 month prior to Screening, or such items as an intrauterine device (IUD), intrauterine system (IUS), transdermal hormonal implant, vaginal hormonal ring, or 2 forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge. Total abstinence is permitted. Must agree to agree continue using contraception for the duration of the study medication treatment.
5. If male, be surgically sterile, or agree to use appropriate contraception (latex condom with spermicide) when engaging in sexual activity and agree to not donate sperm for the duration of the study medication treatment.
6. Be reasonable stable health (i.e., diagnosed chronic illnesses that are not deemed stable by the participant's primary care physician), or in the opinion of the Investigator, based on medical history (i.e., absence of any clinically relevant abnormality) during Screening.
7. Be able to understand and provide written, informed consent.
8. Must be able to attend on-site and virtual study visits.

Exclusion Criteria

1. Complicated RARS (orbital or intracranial involvement).
2. Symptoms attributed to sinus disease for longer than 4 weeks.
3. RARS with multiple courses of antimicrobial therapy failures (in previous 2 years, 3 or more episodes treated with 2 or more ATBs).
4. Disease history consistent with severe allergic or seasonal rhinitis (requiring oral cortico-steroids to manage intractable nasal symptoms).
5. Isolated frontal and sphenoidal clinical disease (given the different pathophysiology and etiologic pathogens).
6. History of nasal polyposis.
7. History of abnormal sinus pathology.
8. Previous sinus surgery.
9. Participants with cystic fibrosis.
10. Recurrent moderate epistaxis.
11. Participants with chronic obstructive pulmonary disease (COPD).
12. Participants with severe asthma (per European Respiratory Society (ERS)/American Thoracic Society (ATS) 2014).
13. Immunocompromised participants or participants with other medical conditions that may affect interpretation of the effect of trial drugs.
14. Allergic to any of the trial drugs.
15. Females who are breastfeeding, pregnant, or attempting to become pregnant.
16. Participants who have conditions that participation is not in their best interest.
17. Participants whose participation in the study, in the opinion of the Investigator, have a condition which would interfere with their ability to adhere to the protocol (e.g., participants whom are mentally or neurologically disabled and whom are considered not fit to their participation in the study), interfere with the assessment of the investigational product, or compromise the safety of the participant or the quality of the data.
18. Participants who are unable to sign the informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No