NAC Inhalation in the Treatment Of Symptomatic acuTe rhinosinUSitis

NCT04131686 | Completed Results

• 1 other identifier: BR-NAC-OS-401
• Study Type: observational
• Target: 294
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Acute Rhinosinusitis; Recurrent Acute Rhinosinusitis; Chronic Rhinosinusitis

Keywords

rhinosinusitis; N-acetylcysteine

Outcome Measures

Primary Outcomes (1)

• 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

  Day 0(enrollment) and Day 14 after treatment for rhinosinusitis

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

The Catholic University of Korea, Yeouido ST. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Ji-Yeon Kim
• Organization: Boryung

jiyeonkim@boryung.co.kr

82-2-708-8128

Study Officials

• Myung-Sook Hong

  Boryung Pharmaceutical Co., Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: September 30, 2019
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: January 8, 2025
• Results First Posted: February 20, 2024

Record last verified: 2025-01

Locations

KR (1)