A Phase 3 interventional study of Acetylcystine in Common Cold, sponsored by GlaxoSmithKline. Completed at 1 site in Germany. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-01-31.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
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.
184 studies on the registry are indexed under Common Cold; 21 are open to participants now.
This study's enrollment of 58 is below the median of 161 across 155 interventional studies indexed under Common Cold.
Browse Common Cold studies →GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.
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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.
Drug: Acetylcystine
Clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle.
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
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)
Participant were recruited at 1 center in Germany
| Milestone | 2% Acetylcystine Solution |
|---|---|
| Started | 57 |
| Completed | 57 |
| Not completed | 0 |
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.
| Minutes | 2% Acetylcystine Solution |
|---|---|
| Onset of Warming Sensation | 0.233 (0.067 to 10.00) |
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
| Minutes | 2% Acetylcystine Solution |
|---|---|
| Duration of Warming Sensation | 2.833 (0.150 to 9.783) |
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.
| Millimeters (mm) | 2% Acetylcystine Solution |
|---|---|
| Pre-dose | 6.8 ± 8.69 |
| Post-dose (Observed) | 36.1 ± 26.93 |
| Post-dose (Change) | 29.2 ± 27.84 |
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
| Number of Participants | 2% Acetylcystine Solution |
|---|---|
| Much too strong | 0 |
| Too strong | 2 |
| Just about right | 30 |
| Too Weak | 16 |
| Much too weak | 9 |
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
| Number of Participants | 2% Acetylcystine Solution |
|---|---|
| Like extremely | 1 |
| Like very Much | 21 |
| Like moderately | 11 |
| Like slightly | 7 |
| Neither Like nor Dislike | 10 |
| Dislike slightly | 3 |
| Dislike Moderately | 1 |
| Dislike Very Much | 3 |
| Dislike extremely | 0 |
Overall opinion of oral solution was measured by scale: 4 = Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = Unacceptable.
| Number of Participants | 2% Acetylcystine Solution |
|---|---|
| Excellent | 2 |
| Good | 21 |
| Fair | 29 |
| Poor | 5 |
| Unacceptable | 0 |
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.
| Participants | 2% Acetylcystine Solution |
|---|---|
| Oropharyngeal examination at screening (Normal) | 52 |
| Oropharyngeal examination at study end (Normal) | 52 |
| Oropharyngeal examination at screening (Abnormal) | 5 |
| Oropharyngeal examination at study end (Abnormal) | 5 |
| Abnormal (lesions on oral mucosa) | 0 |
| Abnormal (No lesions on oral mucosa) | 5 |
| Abnormal (Irritation of oral Mucosa) | 0 |
| Abnormal (No irritation of oral Mucosa) | 5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 2% Acetylcystine Solution | — | 0/57 (0%) | 0/57 (0%) |
The Safety Population was the primary population. The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug.
| Age, Continuous(Years) | 2% Acetylcystine Solution |
|---|---|
| Mean | 38.7 ± 13.88 |
| Gender(Participants) | 2% Acetylcystine Solution |
|---|---|
| Female | 33 |
| Male | 24 |
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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