Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Acetylcystine · 1 trial · 1 indication
Onset and duration of action of warming sensation was measured by two stop watches started when the participants took the oral solution. First watch was stopped at the start of warming sensation and the second watch was stopped at the end. If onset had not occurred by 10 minutes then time to onset was censored at 10 minutes. 53 of the 57 participants had onset within 10 minutes after dosing.
Duration of action of warming sensation was measured by two stop watches started when the participants took the oral solution. First watch was stopped at the start of warming sensation and the second watch was stopped at the end. If onset of warming sensation occurred within 10 minutes of dosing but had not ended by the end of 10 minutes following dosing, then the duration was censored at 10 minutes minus the time to onset
Warming Sensation Intensity was measured on 100 mm visual analogue scale (VAS), marked as "no warming sensation" on the left hand side (= 0 mm) and "strongest possible warming sensation" at the right hand side (=100 mm) at pre-dose.
| Arm | Type | Description |
|---|---|---|
| 2% Acetylcystine Solution | EXPERIMENTAL | Participants will be orally administered with the clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle over 1 minute or less using an oral syringe. |
| Name | Type | Description |
|---|---|---|
| Acetylcystine | DRUG | Clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle. |
Inclusion Criteria: * Participants must give written informed consent before any assessment is performed. In the case of adolescents Informed Consent must be signed by one or both parents or legal guardian as per local regulations and an Informed Assent must be signed by the participant. * Must be ...
Acetylcystine is a small molecule being developed by GSK plc for the treatment of the common cold. It is currently in Phase 3 clinical development as an investigational drug and is not yet approved by regulatory authorities.
The molecular target of Acetylcystine has not been disclosed. It is being studied as a 2% oral solution for the management of productive cough associated with the common cold.
Acetylcystine is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK.
Acetylcystine is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies for the treatment of the common cold.
Acetylcystine has one completed Phase 3 clinical trial, identified as NCT02822287, titled 'Warming Sensation and Tolerability Study of Acetylcysteine 2% Oral Solution for Productive Cough'. The trial enrolled 58 participants in Germany and was not randomized or double-blinded.