Last updated: 11/03/2018 23:04:24
Warming Sensation and Tolerability Study of Acetylcysteine 2% Oral Solution for Productive Cough
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open label study to assess the warming sensation, acceptability and local oral tolerability of NCH-GSK Acetylcysteine 2% Oral Solution, given as a single dose in subjects suffering from productive cough due to upper respiratory tract infection
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Onset of Warming Sensation
Timeframe: 10 minutes post-dose
Duration of Warming Sensation
Timeframe: 10 minutes post-dose
Warming Sensation Intensity at Pre-Dose and 60 sec (Seconds) Post-Dose
Timeframe: Pre-dose and 60 sec post-dose
Secondary outcomes:
Number of participants with Acceptability of Warming Sensation
Timeframe: 10 minutes post-dose
Number of participants with overall opinion of warming sensation
Timeframe: 10 minutes post-dose
Number of participants with overall opinion of oral solution
Timeframe: 1 hour post-dose
Local oral tolerability
Timeframe: Day 1 (at screening and end of study)
Interventions:
Enrollment:
58
Primary completion date:
2016-22-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Common cold
Product
acetylcysteine
Collaborators
Not applicable
Study date(s)
February 2016 to March 2016
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- 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
- 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
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2016-22-03
Actual study completion date
2016-22-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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