This is a 1-treatment arm, open label design. This 1-day study includes a screening on day of attendance at clinic, followed by a washout period of 30 minutes to 8 hours (if participants are eligible for dosing the same day). The study also includes a supervised dosing with 10 mL oral solution and a 1 hour in-clinic evaluation period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle.
GSK Investigational Site
Erfurt, Thuringia, Germany
Onset of Warming Sensation
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.
Time frame: 10 minutes post-dose
Duration of Warming Sensation
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
Time frame: 10 minutes post-dose
Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose
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.
Time frame: Pre-dose and 60 sec post-dose
Number of Participants With Acceptability of Warming Sensation
Acceptability of strength of warming sensation was measured by a scale: 5= Much too strong; 4=Too strong (too warming); 3= Just about right (pleasant warming); 2= Too weak (not warming enough); 1= Much too weak
Time frame: 10 minutes post-dose
Number of Participants With Overall Opinion of Warming Sensation
Overall opinion of warming sensation was measured by scale: 9= Like extremely; 8= Like very much; 7= Like moderately; 6= Like slightly; 5= Neither like nor dislike; 4= Dislike slightly; 3= Dislike moderately; 2= Dislike very much; 1= Dislike extremely
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 10 minutes post-dose
Number of Participants With Overall Opinion of Oral Solution
Overall opinion of oral solution was measured by scale: 4 = Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = Unacceptable.
Time frame: 1 hour post-dose
Local Oral Tolerability
Local oral tolerability was assessed by performing oropharyngeal examination as follows: Results of oropharyngeal examination (Normal and abnormal); If abnormal, any signs of lesion on oral mucosa or irritation of oral mucosa.
Time frame: Day 1 (at screening and end of study)