Trial · NCT04123405
Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis
NCT04123405, Phase 3, Completed, Sandoz; results first posted 2021-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis. Trials, record NCT04123405. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04123405
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis
- NCT number
- NCT04123405
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 944 participants, actual
- Lead sponsor
- Sandoz
- Conditions
- Rhinosinusitis
- Interventions
- acetylcysteine, Placebo
- First posted
- 2019-10-10
- Last updated
- 2021-11-19
- Other registries' IDs
- eudract:2019-000060-20
- Results first posted
- 2021-11-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15. Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement. |
| Primary | Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15. Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement. |
| Secondary | Time to Onset of Action, Full Analysis Set | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Time to onset of action was defined as first day of active treatment on which MSS showed statistically significant (p value\<0.05) improvement from placebo. |
| Secondary | Time to Onset of Action, Per-Protocol Set | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Time to onset of action was defined as first day of active treatment on which MSS showed statistically significant (p value\<0.05) improvement from placebo. |
| Secondary | Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15. Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement. |
| Secondary | Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15. Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement. |
| Secondary | Sino-Nasal Outcome Test (SNOT-22) by Visit, Full Analysis Set | Baseline (Day 1), Day 7 and Day 14 | SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. |
| Secondary | Sino-Nasal Outcome Test (SNOT-22) by Visit, Per Protocol Set | Baseline (Day 1), Day 7 and Day 14 | SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. |
| Secondary | Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Full Analysis Set | Baseline (Day 1), Day 7 and Day 14 | SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. A negative change from baseline in SNOT-22 is considered a favorable outcome. |
| Secondary | Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Per Protocol Set | Baseline (Day 1), Day 7 and Day 14 | SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. A negative change from baseline in SNOT-22 is considered a favorable outcome. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period. | Score on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation. | Score on a scale | MEAN |
| SECONDARY | Time to Onset of Action, Full Analysis Set | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period. | Days | NUMBER |
| SECONDARY | Time to Onset of Action, Per-Protocol Set | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation. | Days | NUMBER |
| SECONDARY | Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period. | Score on a scale | MEAN |
| SECONDARY | Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation. | Score on a scale | MEAN |
| SECONDARY | Sino-Nasal Outcome Test (SNOT-22) by Visit, Full Analysis Set | Baseline (Day 1), Day 7 and Day 14 | Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period. | Score on a scale | MEAN |
| SECONDARY | Sino-Nasal Outcome Test (SNOT-22) by Visit, Per Protocol Set | Baseline (Day 1), Day 7 and Day 14 | Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation. | Score on a scale | MEAN |
| SECONDARY | Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Full Analysis Set | Baseline (Day 1), Day 7 and Day 14 | Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period. | Score on a scale | MEAN |
| SECONDARY | Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Per Protocol Set | Baseline (Day 1), Day 7 and Day 14 | Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation. | Score on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group238
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set | Group A: 600 mg Acetylcysteine | -4.8213 | Standard Deviation 1.98247 | Score on a scale | |
| Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set | Group B: 1200 mg Acetylcysteine | -4.7394 | Standard Deviation 1.99090 | Score on a scale | |
| Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set | Group C: 2400 mg Acetylcysteine | -4.7758 | Standard Deviation 1.96938 | Score on a scale | |
| Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set | Group D: Placebo | -5.0180 | Standard Deviation 1.98262 | Score on a scale | |
| Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set | Group A: 600 mg Acetylcysteine | -4.9085 | Standard Deviation 1.92431 | Score on a scale | |
| Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set | Group B: 1200 mg Acetylcysteine | -4.8688 | Standard Deviation 1.84448 | Score on a scale | |
| Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set | Group C: 2400 mg Acetylcysteine | -4.8002 | Standard Deviation 1.90569 | Score on a scale | |
| Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set | Group D: Placebo | -5.1256 | Standard Deviation 1.95072 | Score on a scale | |
| Time to Onset of Action, Full Analysis Set | Group A: 600 mg Acetylcysteine | NA | Days | ||
| Time to Onset of Action, Full Analysis Set | Group B: 1200 mg Acetylcysteine | NA | Days |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A: 600 mg Acetylcysteine | 235 | |
| Overall Study | STARTED | Group B: 1200 mg Acetylcysteine | 238 | |
| Overall Study | STARTED | Group C: 2400 mg Acetylcysteine | 238 | |
| Overall Study | STARTED | Group D: Placebo | 233 | |
| Overall Study | Full Analysis Set | Group A: 600 mg Acetylcysteine | 235 | |
| Overall Study | Full Analysis Set | Group B: 1200 mg Acetylcysteine | 236 | |
| Overall Study | Full Analysis Set | Group C: 2400 mg Acetylcysteine | 238 | |
| Overall Study | Full Analysis Set | Group D: Placebo | 230 | |
| Overall Study | Per-protocol Set | Group A: 600 mg Acetylcysteine | 213 | |
| Overall Study | Per-protocol Set | Group B: 1200 mg Acetylcysteine | 215 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events136
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ear congestion | Ear and labyrinth disorders | Group A: 600 mg Acetylcysteine | 0 | 235 | |
| other | Ear congestion | Ear and labyrinth disorders | Group B: 1200 mg Acetylcysteine | 2 | 238 | |
| other | Ear congestion | Ear and labyrinth disorders | Group C: 2400 mg Acetylcysteine | 0 | 238 | |
| other | Ear congestion | Ear and labyrinth disorders | Group D: Placebo | 0 | 233 | |
| other | Abdominal distension | Gastrointestinal disorders | Group A: 600 mg Acetylcysteine | 0 | 235 | |
| other | Abdominal distension | Gastrointestinal disorders | Group B: 1200 mg Acetylcysteine | 0 | 238 | |
| other | Abdominal distension | Gastrointestinal disorders | Group C: 2400 mg Acetylcysteine | 1 | 238 | |
| other | Abdominal distension | Gastrointestinal disorders | Group D: Placebo | 0 | 233 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Group A: 600 mg Acetylcysteine | 1 | 235 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Group B: 1200 mg Acetylcysteine | 2 | 238 |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A: 600 mg Acetylcysteine | 0 | 235 |
| Total, all-cause mortality | Group B: 1200 mg Acetylcysteine | 0 | 238 |
| Total, all-cause mortality | Group C: 2400 mg Acetylcysteine | 0 | 238 |
| Total, all-cause mortality | Group D: Placebo | 0 | 233 |
| Total, other adverse events | Group A: 600 mg Acetylcysteine | 9 | 235 |
| Total, other adverse events | Group B: 1200 mg Acetylcysteine | 15 | 238 |
| Total, other adverse events | Group C: 2400 mg Acetylcysteine | 15 | 238 |
| Total, other adverse events | Group D: Placebo | 8 | 233 |
| Total, serious adverse events | Group A: 600 mg Acetylcysteine | 0 | 235 |
| Total, serious adverse events | Group B: 1200 mg Acetylcysteine | 0 | 238 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04123405
GET https://conductscience.org/api/trials/v1/NCT04123405/results?page=2