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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylcystine | Drug | Clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | Pre-dose and 60 sec post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 minutes post-dose |
| Number of Participants With Overall Opinion of Warming Sensation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Erfurt | Thuringia | 99084 | Germany |
A total of 58 potential participants were screened and 57 participants were included in the study. All 57 participants received the investigational product.
Participant were recruited at 1 center in Germany
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| ID | Title | Description |
|---|---|---|
| FG000 | 2% Acetylcystine Solution | Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2% Acetylcystine Solution | Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis. | Posted | Median | Full Range | Minutes | 10 minutes post-dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2% Acetylcystine Solution | Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C030905 | N-monoacetylcystine |
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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 |
| 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. | 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. | Day 1 (at screening and end of study) |
| Years |
|
| Gender | Count of Participants | Participants |
|
|
|
| Primary | 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 | The safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint and safety analysis. Of the 57 subjects in the Safety Population, 53 reported an onset of a warming sensation within10 minutes after dosing. | Posted | Median | Full Range | Minutes | 10 minutes post-dose |
|
|
|
| Primary | 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. | The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis. | Posted | Mean | Standard Deviation | Millimeters (mm) | Pre-dose and 60 sec post-dose |
|
|
|
| Secondary | 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 | The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis. | Posted | Number | Number of Participants | 10 minutes post-dose |
|
|
|
| Secondary | 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 | The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis. | Posted | Number | Number of Participants | 10 minutes post-dose |
|
|
|
| Secondary | 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. | The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis. | Posted | Number | Number of Participants | 1 hour post-dose |
|
|
|
| Secondary | 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. | The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis. | Posted | Number | Participants | Day 1 (at screening and end of study) |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Too Weak |
|
| Much too weak |
|
| Title | Measurements |
|---|---|
|
| Like slightly |
|
| Neither Like nor Dislike |
|
| Dislike slightly |
|
| Dislike Moderately |
|
| Dislike Very Much |
|
| Dislike extremely |
|
| Title | Measurements |
|---|
|
| Poor |
|
| Unacceptable |
|
|
| Oropharyngeal examination at study end (Abnormal) |
|
| Abnormal (lesions on oral mucosa) |
|
| Abnormal (No lesions on oral mucosa) |
|
| Abnormal (Irritation of oral Mucosa) |
|
| Abnormal (No irritation of oral Mucosa) |
|