Status:
COMPLETED
NAC Inhalation in the Treatment Of Symptomatic acuTe rhinosinUSitis
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Acute Rhinosinusitis
Recurrent Acute Rhinosinusitis
Eligibility:
All Genders
18+ years
Brief 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 trea...
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 17 2021
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT04131686
Start Date
September 30 2019
End Date
September 17 2021
Last Update
January 8 2025
Active Locations (1)
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1
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul, South Korea