Trial Outcomes & Findings for NAC Inhalation in the Treatment Of Symptomatic acuTe rhinosinUSitis (NCT NCT04131686)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

294 participants

Primary outcome timeframe

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

Results posted on

2025-01-08

Participant Flow

Unit of analysis: hospitals (sites)

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	146 6	148 6
Overall Study COMPLETED	138 6	143 6
Overall Study NOT COMPLETED	8 0	5 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Sites n=138 Participants Group of patients receiving standard treatment for symptomatic acute rhinosinusitis	Test Sites n=143 Participants Group of patients receiving NAC inhalation in addition to standard treatment for symptomatic acute rhinosinusitis	Total n=281 Participants Total of all reporting groups
Age, Continuous	52.69 years STANDARD_DEVIATION 15.38 • n=138 Participants	50.45 years STANDARD_DEVIATION 15.20 • n=143 Participants	51.55 years STANDARD_DEVIATION 15.30 • n=281 Participants
Sex: Female, Male Female	78 Participants n=138 Participants	68 Participants n=143 Participants	146 Participants n=281 Participants
Sex: Female, Male Male	60 Participants n=138 Participants	75 Participants n=143 Participants	135 Participants n=281 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	24.14 kg/m^2 STANDARD_DEVIATION 3.61 • n=138 Participants	24.06 kg/m^2 STANDARD_DEVIATION 3.36 • n=143 Participants	24.11 kg/m^2 STANDARD_DEVIATION 3.50 • n=281 Participants

PRIMARY outcome

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

Population: Subject with investigator's symptomatic severity assessment was collected

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

Outcome measures

Outcome measures
Measure	Control Sites n=135 Participants Group of patients receiving standard treatment for symptomatic acute rhinosinusitis	Test Sites n=137 Participants Group of patients receiving NAC inhalation in addition to standard treatment for symptomatic acute rhinosinusitis
Change in the Total Score of the Investigator's Symptomatic Severity Assessment (Day 0, Day 14)	-4.37 score on a scale Standard Deviation 2.04	-3.56 score on a scale Standard Deviation 1.74

Adverse Events

Control Sites

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Sites

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control Sites n=138 participants at risk Group of patients receiving standard treatment for symptomatic acute rhinosinusitis	Test Sites n=143 participants at risk Group of patients receiving NAC inhalation in addition to standard treatment for symptomatic acute rhinosinusitis
Respiratory, thoracic and mediastinal disorders cough	0.00% 0/138 • 14days Adverse drug reaction related to NAC inhalation was collected in the test sites and serious adverse event was collected in the whole study sites.	2.1% 3/143 • Number of events 3 • 14days Adverse drug reaction related to NAC inhalation was collected in the test sites and serious adverse event was collected in the whole study sites.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/138 • 14days Adverse drug reaction related to NAC inhalation was collected in the test sites and serious adverse event was collected in the whole study sites.	1.4% 2/143 • Number of events 2 • 14days Adverse drug reaction related to NAC inhalation was collected in the test sites and serious adverse event was collected in the whole study sites.
General disorders Chest pain	0.00% 0/138 • 14days Adverse drug reaction related to NAC inhalation was collected in the test sites and serious adverse event was collected in the whole study sites.	1.4% 2/143 • Number of events 2 • 14days Adverse drug reaction related to NAC inhalation was collected in the test sites and serious adverse event was collected in the whole study sites.
Eye disorders Eye pain	0.00% 0/138 • 14days Adverse drug reaction related to NAC inhalation was collected in the test sites and serious adverse event was collected in the whole study sites.	0.70% 1/143 • Number of events 1 • 14days Adverse drug reaction related to NAC inhalation was collected in the test sites and serious adverse event was collected in the whole study sites.

Additional Information

Ji-Yeon Kim

Boryung

Phone: 82-2-708-8128

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place