Common Cold
Conditions
Brief summary
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.
Interventions
DRUGAcetylcystine
Clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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 males or females ≥ 12 years. * Willingness and ability to communicate, to comply with all study requirements and to complete the study. * Productive cough of less than 7 days duration, rated based on interview with the participant as mild to moderate severity on a four- point ordinal scale (not present, mild, moderate, severe) due to upper respiratory tract infection.
Exclusion criteria
* Use of other investigational drugs before enrollment, or within 30 days or 5 half-lives before enrollment, whichever is longer. * Pre-dose productive cough or sore throat rated as severe on a four-point ordinal scale (not present, mild, moderate, severe) based on interview with the participant. * Pre-dose temperature equal or above 39.4°C at screening measured by oral thermometer. * History of hypersensitivity to any of the study drugs and the listed excipients or to drugs of similar chemical classes. * Pregnant , nursing (lactating women) or women with child bearing potential UNLESS they are using effective methods of contraception. * Use of any medication for sore throat containing a local anaesthetic, methanol or any topical products containing menthol, peppermint, spearmint or within the 6 hours prior to dosing. * Use of any paracetamol, non-steroidal anti-inflammatory drug (NSAID) or any oral/nasal decongestant within 6 hours prior to dosing. * Use of substances of abuse, herbal medications, or antihistamines within 48 hours of dosing. * Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, or heart disease. * Drinking of tea, coffee or other caffeinated beverages 1 hour prior to dosing. * Drinking of any hot beverages 1 hour prior to dosing. * Participant is a current smoker of ≥10 cigarettes per day (or reports equivalent smoking habits using other tobacco products) or smoked or chewed tobacco products within 12 hours before dosing. * Participant is taking nitroglycerin and nitrate drug treatments. * Participants who took antibiotic treatments such as semisynthetic penicillins, tetracyclines, cephalosporins and aminoglycosides within 2 hours of dosing. Amoxicillin, doxycycline, erythromycin, thiamphenicol and cefuroxime are allowed without this restriction. * Participants with gastroduodenal (peptic) ulcers, asthma. * Participants with intolerance to histamines. * Participants who have used antitussives (e.g., dextromethorphan, codeine), anticholinergic drugs (atropine-like) within the past 24 hours. * Participants who have taken heavy metal salts such as calcium, gold and iron within 2 hours of enrollment. * A history of alcohol abuse or an admission by the participant that they regularly consume alcohol in excess of the recommended weekly limits of 21 units for females and 28 units for males. * History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Onset of Warming Sensation | 10 minutes post-dose | 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 Warming Sensation | 10 minutes post-dose | 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 at Pre-Dose and 60 Sec (Seconds) Post-Dose | Pre-dose and 60 sec 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acceptability of Warming Sensation | 10 minutes post-dose | 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 |
| Local Oral Tolerability | Day 1 (at screening and end of study) | 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. |
| Number of Participants With Overall Opinion of Warming Sensation | 10 minutes post-dose | 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 With Overall Opinion of Oral Solution | 1 hour post-dose | Overall opinion of oral solution was measured by scale: 4 = Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = Unacceptable. |
Countries
Germany
Participant flow
Recruitment details
Participant were recruited at 1 center in Germany
Pre-assignment details
A total of 58 potential participants were screened and 57 participants were included in the study. All 57 participants received the investigational product.
Participants by arm
| Arm | Count |
|---|---|
| 2% Acetylcystine Solution Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution. | 57 |
| Total | 57 |
Baseline characteristics
| Characteristic | 2% Acetylcystine Solution |
|---|---|
| Age, Continuous | 38.7 Years STANDARD_DEVIATION 13.88 |
| Gender Female | 33 Participants |
| Gender Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 |
Outcome results
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
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2% Acetylcystine Solution | Duration of Warming Sensation | 2.833 Minutes |
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2% Acetylcystine Solution | Onset of Warming Sensation | 0.233 Minutes |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% Acetylcystine Solution | Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose | Pre-dose | 6.8 Millimeters (mm) | Standard Deviation 8.69 |
| 2% Acetylcystine Solution | Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose | Post-dose (Observed) | 36.1 Millimeters (mm) | Standard Deviation 26.93 |
| 2% Acetylcystine Solution | Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose | Post-dose (Change) | 29.2 Millimeters (mm) | Standard Deviation 27.84 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2% Acetylcystine Solution | Local Oral Tolerability | Oropharyngeal examination at screening (Normal) | 52 Participants |
| 2% Acetylcystine Solution | Local Oral Tolerability | Oropharyngeal examination at study end (Normal) | 52 Participants |
| 2% Acetylcystine Solution | Local Oral Tolerability | Oropharyngeal examination at screening (Abnormal) | 5 Participants |
| 2% Acetylcystine Solution | Local Oral Tolerability | Oropharyngeal examination at study end (Abnormal) | 5 Participants |
| 2% Acetylcystine Solution | Local Oral Tolerability | Abnormal (lesions on oral mucosa) | 0 Participants |
| 2% Acetylcystine Solution | Local Oral Tolerability | Abnormal (No lesions on oral mucosa) | 5 Participants |
| 2% Acetylcystine Solution | Local Oral Tolerability | Abnormal (Irritation of oral Mucosa) | 0 Participants |
| 2% Acetylcystine Solution | Local Oral Tolerability | Abnormal (No irritation of oral Mucosa) | 5 Participants |
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
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2% Acetylcystine Solution | Number of Participants With Acceptability of Warming Sensation | Much too strong | 0 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Acceptability of Warming Sensation | Too strong | 2 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Acceptability of Warming Sensation | Just about right | 30 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Acceptability of Warming Sensation | Too Weak | 16 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Acceptability of Warming Sensation | Much too weak | 9 Number of Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2% Acetylcystine Solution | Number of Participants With Overall Opinion of Oral Solution | Excellent | 2 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Overall Opinion of Oral Solution | Good | 21 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Overall Opinion of Oral Solution | Fair | 29 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Overall Opinion of Oral Solution | Poor | 5 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Overall Opinion of Oral Solution | Unacceptable | 0 Number of Participants |
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
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2% Acetylcystine Solution | Number of Participants With Overall Opinion of Warming Sensation | Like extremely | 1 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Overall Opinion of Warming Sensation | Like very Much | 21 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Overall Opinion of Warming Sensation | Like moderately | 11 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Overall Opinion of Warming Sensation | Like slightly | 7 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Overall Opinion of Warming Sensation | Neither Like nor Dislike | 10 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Overall Opinion of Warming Sensation | Dislike slightly | 3 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Overall Opinion of Warming Sensation | Dislike Moderately | 1 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Overall Opinion of Warming Sensation | Dislike Very Much | 3 Number of Participants |
| 2% Acetylcystine Solution | Number of Participants With Overall Opinion of Warming Sensation | Dislike extremely | 0 Number of Participants |