Trial Outcomes & Findings for Warming Sensation and Tolerability Study of Acetylcysteine 2% Oral Solution for Productive Cough (NCT NCT02822287)

NCT ID: NCT02822287

Last Updated: 2017-01-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 58 participants
• Primary outcome timeframe: 10 minutes post-dose
• Results posted on: 2017-01-31

Participant Flow

Participant were recruited at 1 center in 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 milestones

Measure	2% Acetylcystine Solution Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
Overall Study STARTED	57
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Warming Sensation and Tolerability Study of Acetylcysteine 2% Oral Solution for Productive Cough

Baseline characteristics by cohort

Measure	2% Acetylcystine Solution n=57 Participants Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
Age, Continuous	38.7 Years STANDARD_DEVIATION 13.88 • n=5 Participants
Gender Female	33 Participants n=5 Participants
Gender Male	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes post-dose

Population: 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.

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.

Outcome measures

Measure	2% Acetylcystine Solution n=57 Participants Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
Onset of Warming Sensation	0.233 Minutes Interval 0.067 to 10.0

PRIMARY outcome

Timeframe: 10 minutes post-dose

Population: 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.

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

Outcome measures

Measure	2% Acetylcystine Solution n=53 Participants Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
Duration of Warming Sensation	2.833 Minutes Interval 0.15 to 9.783

PRIMARY outcome

Timeframe: Pre-dose and 60 sec post-dose

Population: 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.

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.

Outcome measures

Measure	2% Acetylcystine Solution n=57 Participants Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose Pre-dose	6.8 Millimeters (mm) Standard Deviation 8.69
Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose Post-dose (Observed)	36.1 Millimeters (mm) Standard Deviation 26.93
Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose Post-dose (Change)	29.2 Millimeters (mm) Standard Deviation 27.84

SECONDARY outcome

Timeframe: 10 minutes post-dose

Population: 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.

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

Outcome measures

Measure	2% Acetylcystine Solution n=57 Participants Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
Number of Participants With Acceptability of Warming Sensation Much too strong	0 Number of Participants
Number of Participants With Acceptability of Warming Sensation Too strong	2 Number of Participants
Number of Participants With Acceptability of Warming Sensation Just about right	30 Number of Participants
Number of Participants With Acceptability of Warming Sensation Too Weak	16 Number of Participants
Number of Participants With Acceptability of Warming Sensation Much too weak	9 Number of Participants

SECONDARY outcome

Timeframe: 10 minutes post-dose

Population: 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.

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

Outcome measures

Measure	2% Acetylcystine Solution n=57 Participants Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
Number of Participants With Overall Opinion of Warming Sensation Like extremely	1 Number of Participants
Number of Participants With Overall Opinion of Warming Sensation Like very Much	21 Number of Participants
Number of Participants With Overall Opinion of Warming Sensation Like moderately	11 Number of Participants
Number of Participants With Overall Opinion of Warming Sensation Like slightly	7 Number of Participants
Number of Participants With Overall Opinion of Warming Sensation Neither Like nor Dislike	10 Number of Participants
Number of Participants With Overall Opinion of Warming Sensation Dislike slightly	3 Number of Participants
Number of Participants With Overall Opinion of Warming Sensation Dislike Moderately	1 Number of Participants
Number of Participants With Overall Opinion of Warming Sensation Dislike Very Much	3 Number of Participants
Number of Participants With Overall Opinion of Warming Sensation Dislike extremely	0 Number of Participants

SECONDARY outcome

Timeframe: 1 hour post-dose

Population: 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.

Overall opinion of oral solution was measured by scale: 4 = Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = Unacceptable.

Outcome measures

Measure	2% Acetylcystine Solution n=57 Participants Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
Number of Participants With Overall Opinion of Oral Solution Good	21 Number of Participants
Number of Participants With Overall Opinion of Oral Solution Excellent	2 Number of Participants
Number of Participants With Overall Opinion of Oral Solution Fair	29 Number of Participants
Number of Participants With Overall Opinion of Oral Solution Poor	5 Number of Participants
Number of Participants With Overall Opinion of Oral Solution Unacceptable	0 Number of Participants

SECONDARY outcome

Timeframe: Day 1 (at screening and end of study)

Population: 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.

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.

Outcome measures

Measure	2% Acetylcystine Solution n=57 Participants Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
Local Oral Tolerability Oropharyngeal examination at screening (Normal)	52 Participants
Local Oral Tolerability Oropharyngeal examination at study end (Normal)	52 Participants
Local Oral Tolerability Oropharyngeal examination at screening (Abnormal)	5 Participants
Local Oral Tolerability Oropharyngeal examination at study end (Abnormal)	5 Participants
Local Oral Tolerability Abnormal (lesions on oral mucosa)	0 Participants
Local Oral Tolerability Abnormal (No lesions on oral mucosa)	5 Participants
Local Oral Tolerability Abnormal (Irritation of oral Mucosa)	0 Participants
Local Oral Tolerability Abnormal (No irritation of oral Mucosa)	5 Participants

Adverse Events

2% Acetylcystine Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER