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

Common Cold Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822287
• Other study ID #: 205034
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2016
• Last updated: June 29, 2016
• Start date: February 2016
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Cold
• Respiratory Tract Infections

Intervention

Drug:
• Acetylcystine
Clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle.

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Erfurt	Thueringen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset and Duration of Action of Warming Sensation	Onset and Duration of Action of Warming Sensation will be measured by the two stop watches. Two stop watches will be started when the participant takes the oral solution (time zero). The participants will be advised to stop the first stop watch (labeled start of warming) as soon as he/she notices the onset of a warming sensation. The participant will be advised to stop the second stop watch (labeled end of warming) when he/she no longer feels the warming sensation. The labels "start of warming" and "end of warming" will totally cover the faces of the stop watches.	Up to 10 min. Post dose	No
Primary	Warming Sensation Intensity at Pre-Dose	Warming Sensation Intensity will be Measured on 100 mm 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). Participants will be asked to swallow and indicate with a vertical mark on this scale the intensity of the warming sensation, defined as "feeling of warmth mainly in the throat and at the back of the mouth". This will be measured at pre-dose following ingestion of 10 ml of water at room temperature.	Pre-dose	No
Primary	Warming Sensation Intensity at 60 sec (Seconds) Post-Dose	Warming Sensation Intensity will be Measured on 100 mm 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). Participants will be asked to swallow and indicate with a vertical mark on this scale the intensity of the warming sensation, defined as "feeling of warmth mainly in the throat and at the back of the mouth". This will be measured at 60 sec after dosing, with a window up to 75 seconds.	60 sec Post-Dose	No
Secondary	Acceptability of Strength of Warming Sensation	Acceptability of strength of warming sensation will be 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	No
Secondary	Overall Opinion of Warming Sensation	Overall opinion of warming sensation will be 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	No
Secondary	Overall Opinion of Taste	Overall opinion of taste will be measured to assess participant's acceptability to treatment. This will be measured by score: 4= Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = Unacceptable	1 hour post-dose	No
Secondary	Overall Opinion of the Texture of Oral Solution	Overall opinion of the texture of oral solution will be measured by scale: 4 = Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = Unacceptable.	1 hour post-dose	No
Secondary	Overall Opinion of Oral Solution	Overall opinion of oral solution will be measured by scale: 4 = Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = Unacceptable.	1 hour post-dose	No