Clinical trial NCT02822287: Warming Sensation and Tolerability Study of Acetylcysteine 2% Oral Solution for Productive Cough
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Cold
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-07-04
Enrollment: 58
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Onset of Warming Sensation
timeFrame: 10 minutes post-dose
measure: Duration of Warming Sensation
timeFrame: 10 minutes post-dose
measure: Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose
timeFrame: Pre-dose and 60 sec post-dose
Secondary outcomes:
measure: Number of Participants With Acceptability of Warming Sensation
timeFrame: 10 minutes post-dose
measure: Number of Participants With Overall Opinion of Warming Sensation
timeFrame: 10 minutes post-dose
measure: Number of Participants With Overall Opinion of Oral Solution
timeFrame: 1 hour post-dose
measure: Local Oral Tolerability
timeFrame: Day 1 (at screening and end of study)
Other outcomes:
Locations:
city: Erfurt
country: Germany
facility: GSK Investigational Site
state: Thueringen
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: