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

NCT02822287 | Completed Phase 3 Results

• 1 other identifier: 205034
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Cold

Outcome Measures

Primary Outcomes (3)

• 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.

  10 minutes post-dose

• 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

  10 minutes post-dose

• 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.

  Pre-dose and 60 sec post-dose

Secondary Outcomes (4)

• Number of Participants With Acceptability of Warming Sensation

  10 minutes post-dose

• Number of Participants With Overall Opinion of Warming Sensation

  10 minutes post-dose

• Number of Participants With Overall Opinion of Oral Solution

  1 hour post-dose

• Local Oral Tolerability

  Day 1 (at screening and end of study)

Study Arms (1)

2% Acetylcystine Solution

EXPERIMENTAL

Participants will be orally administered with the clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle over 1 minute or less using an oral syringe.

Drug: Acetylcystine

Interventions

Acetylcystine DRUG

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

2% Acetylcystine Solution

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Erfurt, Thuringia, 99084, Germany

Location

MeSH Terms

Conditions

Common Cold

Interventions

N-monoacetylcystine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: July 4, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 31, 2017
• Results First Posted: January 31, 2017

Record last verified: 2016-09

Locations

DE (1)