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NCT04131686: NOTUS

NAC Inhalation in the Treatment Of Symptomatic acuTe rhinosinUSitis

Completed Results posted Last updated 8 January 2025
What this trial tests

trial in Acute Rhinosinusitis in 294 participants. Completed in 17 September 2021.

Timeline
30 September 2019
Primary endpoint
17 September 2021
17 September 2021

Quick facts

Lead sponsorBoryung Pharmaceutical Co., Ltd
StatusCompleted
Study typeOBSERVATIONAL
Enrollment294
Start date30 September 2019
Primary completion17 September 2021
Estimated completion17 September 2021
Sites1 location across South Korea

Conditions studied

Sponsor

Boryung Pharmaceutical Co., Ltd — full company profile →

Who can join

18 and older, any sex, with Acute Rhinosinusitis or Recurrent Acute Rhinosinusitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in the Total Score of the Investigator's Symptomatic Severity Assessment (Day 0, Day 14) Primary · Day 0(enrollment) and Day 14 after treatment for rhinosinusitis

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

GroupValue95% CI
Control Sites-4.37± 2.04
Test Sites-3.56± 1.74

Adverse events — posted to ClinicalTrials.gov

Time frame: 14days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Sites
Serious: 0/138 (0%)
Deaths: 0/138
Test Sites
Serious: 0/143 (0%)
Deaths: 0/143
Other adverse events (4 terms — click to expand)

ReactionSystemControl SitesTest Sites
coughRespiratory, thoracic and mediastinal disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
Chest painGeneral disorders
Eye painEye disorders

Data from ClinicalTrials.gov NCT04131686 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Boryung Pharmaceutical Co., Ltd trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04131686.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing