Acute RhinosinusitisNOTUSNCT04131686
NAC Inhalation in the Treatment Of Symptomatic acuTe rhinosinUSitis
An observational study of Acute Rhinosinusitis and Recurrent Acute Rhinosinusitis, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
N-acetylcysteine (NAC), known to have mucolytic and antioxidant effects, is widely used to treat respiratory diseases and manage post-surgery pulmonary complications. It is also administered as a treatment for acetaminophen addiction and a preventive measure for contrast-induced nephropathy (CIN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Rhinosinusitis, Recurrent Acute Rhinosinusitis, Chronic Rhinosinusitis
- How many people
- 294 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Sep 2019to 17 Sep 2021
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic acute rhinosinusitis (including recurrent acute rhinosinusitis and symptomatic acute-on-chronic rhinosinusitis). Approximately 300 subjects (Re-enrollment is not allowed.)
Who may be able to join
- Patients are explained about the study objectives and methodologies, and shall express their consent by signing a written agreement for the use of their personal information.
- Male and female patients who are ≥ 18 years old.
- Symptomatic acute rhinosinusitis patients whose symptoms have been present for more than 1 week and less than 12 weeks; recurrent acute rhinosinusitis patients (acute rhinosinusitis relapsed 3 times or more within 6 months, sub-clinical symptoms between the relapses); or, symptomatic acute-on-chronic (12 weeks or more) rhinosinusitis patients. [Patients display 2 or more symptoms that imply rhinosinusitis infection. The displayed symptoms should include at least one or more cardinal symptoms (nasal congestion or nasal/postnasal discharge).]
- The total score of the investigator's symptomatic severity assessment for a patient is 4 or above, and four symptomatic aspects (nasal congestion, nasal/postnasal discharge, facial pain/sense of facial pressure, reduction/loss of smell) are rated in four categories (0=no symptom, 1=mild, 2=moderate, 3=severe).
- Patients have anterior rhinoscopy or nasal endoscopy results, and one or more of the following are observed: Redness, Edema or mucosal obstruction(mostly in the middle nasal), Mucopurulent discharge(mostly in the middle nasal), Nasal polyps
Who cannot join
- Patients with rhinosinusitis of dental origin.
- Patients with a known chronic pulmonary symptoms including bronchial asthma and chronic bronchitis.
- Patients with nasal obstruction to the extent that drug administration is difficult.
- Patients who have received endoscopic sinus surgery within the last 3 months.
- Patients who have shown hypersensitivity or are likely to show hypersensitivity to N-acetylcysteine inhalation components (for the test sites)
- Pregnant or breast-feeding patients.
- Patients who are currently participating in other clinical trials (clinical trials for drugs or medical devices) or are planning to participate in other clinical trials during the duration of this study.
- Patients who are not suitable for study participation upon the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul
About this study
Official title: A Cluster-randomized, Open, Prospective, Observational Study to Evaluate the Treatment Effectiveness and Safety of N-acetylcysteine(NAC) Inhalation Compared With Standard Treatment in Patients With Symptomatic Acute Rhinosinusitis
N-acetylcysteine (NAC), known to have mucolytic and antioxidant effects, is widely used to treat respiratory diseases and manage post-surgery pulmonary complications. It is also administered as a treatment for acetaminophen addiction and a preventive measure for contrast-induced nephropathy (CIN). While NAC inhalation is commonly used for mucolytic purpose for various respiratory disease because it has relatively less side effects compared to oral or injection administrations, it is more used as a part of allopathy than as a major therapy. As a result, there is neither enough relevant clinical data nor specific reference in treatment guidelines. Therefore, this study aims to evaluate the overall treatment effectiveness and safety of NAC inhalation compared with standard treatment, and to perform follow-up observations on administration cases, patient characteristics, and adverse events of NAC inhalation used in real clinical settings.
Read the detailed description
Study Methodology :
12 medical institutions in Korea that meet the inclusion criteria are cluster-randomized (test sites : control sites =1:1). Information about randomization is disclosed to both investigators and subjects. This means both study center investigators and subjects will be aware of the purpose of this study as well as the result of randomization (whether the subjects will receive NAC inhalation or not) from the beginning of the study.
Investigators shall obtain voluntary consent for participation in this research from patients who visit their medical institutions with symptomatic acute rhinosinusitis within the study duration. Patients who provided a written consent for the use of their personal information and who satisfy inclusion/exclusion criteria will be given a study enrollment number and available data on these patients will be collected among the predefined study relevant data in the case reports until Day 14 (±3 days) from the starting day of treatment.
Statistical Analysis Methods (Analysis of primary endpoints) :
Obtain descriptive statistics (average, standard deviation, median, minimum, quartile, and maximum) for the change in the total score of the investigator's symptomatic severity assessment by treatment group on Day 14 compared with each time point and baseline (Day 0). Paired t-test shall be used to check intra-group change difference and Two sample t-test shall be used to check inter-group change difference.
- Keywords
- rhinosinusitis, N-acetylcysteine
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control sites | Group of patients receiving standard treatment for symptomatic acute rhinosinusitis | |
| Test sites | Group of patients receiving NAC inhalation in addition to standard treatment for symptomatic acute rhinosinusitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Total Score of the Investigator's Symptomatic Severity Assessment (Day 0, Day 14)
Assessed symptoms: nasal congestion, nasal/postnasal discharge, facial pain/sense of facial pressure, reduction/loss of smell are rated in four categories [0=no symptom, 1=mild, 2=moderate, 3=severe] The total score is sum of the investigator's symptomatic assessment scores (on nasal congestion, nasal/postnasal discharge, facial pain/sense of facial pressure, and reduction/loss of smell); the maximum total score is 12 and minimum total score is 0
Measured: Day 0(enrollment) and Day 14 after treatment for rhinosinusitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start30 Sep 2019
- Primary completion17 Sep 2021
- Study completion17 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung-Sook Hong, Study director, Boryung Pharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131686
- Sponsor's protocol ID
- BR-NAC-OS-401
- Acronym
- NOTUS
- Status last verified
- Jan 2025
- First submitted
- 16 Oct 2019
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No