CompletedNot Applicable

NAC Inhalation in the Treatment Of Symptomatic acuTe rhinosinUSitis

South Korea294 participantsStarted 2019-09-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 a…

What they're measuring

Change in the Total Score of the Investigator's Symptomatic Severity Assessment (Day 0, Day 14)

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

Trial details

NCT IDNCT04131686

SponsorBoryung Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-09-17

Results submitted2022-07-21