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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000060-20 | EudraCT Number |
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The trial was conducted as a prospective, randomized, multinational, multicenter, double-blind study in 4 parallel groups of patients.
The study was the prospective, randomized, multinational, multicenter, double-blind study in 4 parallel groups of patients.
Patients underwent screening examinations at Visit 1. Patients who met all inclusion/ no exclusion criteria were randomized at the baseline visit (Day 1) to the double-blind treatment for a duration of 14 days but in case of delayed final visit (Day 15) the patient could voluntarily take reserve study medication for a maximum of 3 additional days.
After the end of the double-blind treatment phase, the patients underwent an end-of-treatment (EOT) examinations on Day 15 (+3).
A follow-up phone call within 7 days after Day 15 (or earlier in case of premature termination) was performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: 600 mg acetylcysteine | Experimental | one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
|
| Group B: 1200 mg acetylcysteine | Experimental | two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
|
| Group C: 2400 mg acetylcysteine | Experimental | four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily) |
|
| Group D: Placebo | Placebo Comparator | four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetylcysteine | Drug | 600 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set | 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. | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set | 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. | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of Action, Full Analysis Set | 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. | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Time to Onset of Action, Per-Protocol Set |
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Inclusion Criteria:
Male or female subjects aged between 14 and 75 years inclusive on the date of consent
Diagnosis of acute, uncomplicated rhinosinusitis defined at screening visit 1 and at Visit 2 as:
For adults (≥18 years): Informed consent to participate in the trial provided in written form; For adolescents (≥14 - <18 years): own subject informed consent/ assent to participate in the trial and the informed consent from all parent(s)/ legal guardian(s) provided in written form.
Exclusion Criteria:
History of hypersensitivity or intolerance to the active substance or any of the excipients of the trial medication
Patient with history of hereditary fructose intolerance, galactose intolerance, lactase deficiency or glucose-galactose malabsorption
Chronic rhinosinusitis (symptoms lasting longer than 3 months)
Subjects who have undergone sinus or nasal surgery for chronic rhinosinusitis in the 6 months prior to screening visit
Sinus lavage within 7 days prior to screening visit
Odontogenic rhinosinusitis
Allergic (perennial or seasonal) rhinitis
Bronchial asthma or chronic obstructive pulmonary disease
Nasal polyposis or clinically relevant nasal septum deviation
Concomitant otitis
Intranasal or systemic use of corticosteroids within 30 days prior to screening visit
Intranasal or systemic use of antibiotics within 30 days prior to screening visit
Use of nasal decongestants within 2 days prior to screening visit
Concomitant treatment of common cold-like symptoms within 7 days prior to screening visit with any of the following:
Concomitant use of intranasal saline irrigation
Use of immunosuppressive agents within 30 days prior to screening visit
Immunocompromised state
Suspicion for acute bacterial rhinosinusitis (defined as presence of purulence for 3 to 4 days with fever ≥ 38.3°C)
Pregnant or breast-feeding female patient
Female patient of childbearing potential (not surgically sterilized/hysterectomized or postmenopausal for at least 1 year) who is not currently using (documented at screening visit) and not willing to use medically reliable methods of contraception for the entire trial duration such as oral, injectable or implantable contraceptives, intrauterine contraceptive devices (IUD), sexual abstinence or vasectomized partner
Any other condition of the patient (e.g. serious or unstable medical or psychological condition, acute psychosis) that in the opinion of the investigator may compromise evaluation of the trial treatment or may jeopardize patient's safety, compliance or adherence to protocol requirements
Participation in ANY research study involving another investigational medicinal product (IMP) within 30 days prior to screening visit, or simultaneous participation in another clinical study or previous participation in present study
Suspected alcohol/ drug dependence or abuse (including heavy smoking: ≥ 20 cigarettes daily)
Use of snuff tobacco
Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial
Subjects who are known or suspected:
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| Name | Affiliation | Role |
|---|---|---|
| Sandoz | Sandoz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandoz Investigative Site | Burgas | 8000 | Bulgaria | |||
| Sandoz Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Participants were randomized in 1:1:1:1 ratio
Participants were enrolled from 42 clinical centers located in Bulgaria, Germany, Moldova and Russia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: 600 mg Acetylcysteine | one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
| FG001 | Group B: 1200 mg Acetylcysteine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 14, 2020 | Oct 20, 2021 |
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| Placebo | Drug | Placebo to acetylcysteine |
|
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. |
| Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set | 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. | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set | 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. | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| Sino-Nasal Outcome Test (SNOT-22) by Visit, Full Analysis Set | 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. | Baseline (Day 1), Day 7 and Day 14 |
| Sino-Nasal Outcome Test (SNOT-22) by Visit, Per Protocol Set | 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. | Baseline (Day 1), Day 7 and Day 14 |
| Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Full Analysis Set | 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. | Baseline (Day 1), Day 7 and Day 14 |
| Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Per Protocol Set | 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. | Baseline (Day 1), Day 7 and Day 14 |
| Number of Responders and Non-responders to Treatment, Full Analysis Set | Number of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator were reported. | Day 4, 7, 10 and 15 |
| Number of Responders and Non-responders to Treatment, Per-Protocol Set | Number of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator were reported. | Day 4, 7, 10 and 15 |
| Gabrovo |
| 5300 |
| Bulgaria |
| Sandoz Investigative Site | Plovdiv | 4000 | Bulgaria |
| Sandoz Investigative Site | Sliven | 8800 | Bulgaria |
| Sandoz Investigative Site | Sofia | 1000 | Bulgaria |
| Sandoz Investigative Site | Sofia | 1408 | Bulgaria |
| Sandoz Investigative Site | Sofia | 1527 | Bulgaria |
| Sandoz Investigative Site | Sofia | 1606 | Bulgaria |
| Sandoz Investigative Site | Yambol | 8600 | Bulgaria |
| Sandoz Investigative Site | Aachen | 52074 | Germany |
| Sandoz Investigative Site | Dresden | 01139 | Germany |
| Sandoz Investigative Site | Duisburg | 47051 | Germany |
| Sandoz Investigative Site | Chisinau | 2012 | Moldova |
| Sandoz Investigative Site | Chisinau | 2025 | Moldova |
| Sandoz Investigative Site | Chisinau | 2032 | Moldova |
| Sandoz Investigative Site | Chisinau | 2044 | Moldova |
| Sandoz Investigative Site | Chisinau | 2051 | Moldova |
| Sandoz Investigative Site | Chisinau | 37 | Moldova |
| Sandoz Investigative Site | Orhei | 3005 | Moldova |
| Sandoz Investigative Site | Kazan' | 420029 | Russia |
| Sandoz Investigative Site | Kemerovo | 650066 | Russia |
| Sandoz Investigative Site | Moscow | 117552 | Russia |
| Sandoz Investigative Site | Moscow | 119571 | Russia |
| Sandoz Investigative Site | Moscow | 123184 | Russia |
| Sandoz Investigative Site | Moscow | 142190 | Russia |
| Sandoz Investigative Site | Novosibirsk | 630051 | Russia |
| Sandoz Investigative Site | Ryazan | 390026 | Russia |
| Sandoz Investigative Site | Saint Petersburg | 191025 | Russia |
| Sandoz Investigative Site | Saint Petersburg | 191186 | Russia |
| Sandoz Investigative Site | Saint Petersburg | 192283 | Russia |
| Sandoz Investigative Site | Saint Petersburg | 194291 | Russia |
| Sandoz Investigative Site | Saint Petersburg | 195197 | Russia |
| Sandoz Investigative Site | Saint Petersburg | 196084 | Russia |
| Sandoz Investigative Site | Saint Petersburg | 196158 | Russia |
| Sandoz Investigative Site | Saint Petersburg | 197376 | Russia |
| Sandoz Investigative Site | Smolensk | 214031 | Russia |
| Sandoz Investigative Site | Yaroslavl | 150000 | Russia |
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
| FG002 | Group C: 2400 mg Acetylcysteine | four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily) |
| FG003 | Group D: Placebo | four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily). |
| Full Analysis Set | 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 |
|
| Per-protocol Set | all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation |
|
| Safety Set | all randomized patients who received at least one dose of the trial medication |
|
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: 600 mg Acetylcysteine | one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
| BG001 | Group B: 1200 mg Acetylcysteine | two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
| BG002 | Group C: 2400 mg Acetylcysteine | four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily) |
| BG003 | Group D: Placebo | four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
|
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| Primary | Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Time to Onset of Action, Full Analysis Set | 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. | 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. | Posted | Number | Days | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Time to Onset of Action, Per-Protocol Set | 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. | 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. | Posted | Number | Days | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
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| Secondary | Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Sino-Nasal Outcome Test (SNOT-22) by Visit, Full Analysis Set | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 1), Day 7 and Day 14 |
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| Secondary | Sino-Nasal Outcome Test (SNOT-22) by Visit, Per Protocol Set | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 1), Day 7 and Day 14 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Full Analysis Set | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 1), Day 7 and Day 14 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Per Protocol Set | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 1), Day 7 and Day 14 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Responders and Non-responders to Treatment, Full Analysis Set | Number of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator were reported. | 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. | Posted | Count of Participants | Participants | Day 4, 7, 10 and 15 |
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| Secondary | Number of Responders and Non-responders to Treatment, Per-Protocol Set | Number of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator were reported. | 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. | Posted | Count of Participants | Participants | Day 4, 7, 10 and 15 |
|
Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: 600 mg Acetylcysteine | one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) | 0 | 235 | 0 | 235 | 9 | 235 |
| EG001 | Group B: 1200 mg Acetylcysteine | two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) | 0 | 238 | 0 | 238 | 15 | 238 |
| EG002 | Group C: 2400 mg Acetylcysteine | four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily) | 0 | 238 | 0 | 238 | 15 | 238 |
| EG003 | Group D: Placebo | four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily). | 0 | 233 | 1 | 233 | 8 | 233 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concussion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear congestion | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Otitis media bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Human chorionic gonadotropin increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nasal crusting | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2020 | Oct 20, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000096825 | Rhinosinusitis |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012852 | Sinusitis |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Unknown |
|
| OG002 | Group C: 2400 mg Acetylcysteine | four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily) |
| OG003 | Group D: Placebo | four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| OG002 | Group C: 2400 mg Acetylcysteine | four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily) |
| OG003 | Group D: Placebo | four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
|
|
| OG002 | Group C: 2400 mg Acetylcysteine | four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily) |
| OG003 | Group D: Placebo | four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
|
|
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
| OG003 | Group D: Placebo | four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
|
|
| OG003 | Group D: Placebo | four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
|
|
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily) |
| OG003 | Group D: Placebo | four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
|
|
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily) |
| OG003 | Group D: Placebo | four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
|
|
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily) |
|
|
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Non-responders |
|
| Title | Measurements |
|---|---|
| Responders |
|
| Non-responders |
|
| Title | Measurements |
|---|---|
| Responders |
|
| Non-responders |
|
| Title | Measurements |
|---|---|
| Responders |
|
| Non-responders |
|
| Non-responders |
|
| Non-responders |
|
| Non-responders |
|