N/A
N=294
NAC Inhalation in the Treatment Of Symptomatic acuTe rhinosinUSitis
Acute Rhinosinusitis · Recurrent Acute Rhinosinusitis · Chronic Rhinosinusitis
Bottom Line
View on ClinicalTrials.gov: NCT04131686 ↗Enrolled (actual)
294
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Change in the Total Score of the Investigator's Symptomatic Severity Assessment (Day 0, Day 14) — -4.37; -3.56 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Total Score of the Investigator's Symptomatic Severity Assessment (Day 0, Day 14) |
-4.37; -3.56 | — |
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). 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04131686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.