Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04123405 | Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis | PHASE3 | COMPLETED | 944 | — | — | Oct 22, 2020 | Apr 20, 2021 | Nov 19, 2021 | 37 | Bulgaria, Germany +2 |
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| acetylcysteine | DRUG | 600 mg tablet |
| Placebo | DRUG | Placebo to acetylcysteine |
Inclusion Criteria: 1. Male or female subjects aged between 14 and 75 years inclusive on the date of consent 2. Diagnosis of acute, uncomplicated rhinosinusitis defined at screening visit 1 and at Visit 2 as: 1. major symptom score (MSS) assessed by the patient ≥8 and ≤12 points for the followi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Itepekimab, Mometasone furoate, lunsekimig |
| AstraZeneca PLC | AZN | 4 | PHASE3 | Tezepelumab |
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | — | Undisclosed |