NCT02822287

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

Completed Phase 3 Results posted Last updated 5 December 2016

What this trial tests

Phase 3 trial testing Acetylcystine in Common Cold in 58 participants. Completed in 1 March 2016.

Timeline

1 February 2016

Primary endpoint
1 March 2016

1 March 2016

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	1 February 2016
Primary completion	1 March 2016
Estimated completion	1 March 2016
Sites	1 location across Germany

Drugs / interventions tested

• Acetylcystine — full drug profile →

Conditions studied

• Common Cold — all drugs for Common Cold →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

12 and older, any sex, with Common Cold. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Onset of Warming Sensation
  Time frame: 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
  Time frame: 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 minut
• Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose
  Time frame: 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.

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluation of the warming sensation, acceptability, and local tolerability of an acetylcysteine oral solution containing the flavoring agent IFF flavor 316282 in the treatment of productive cough
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   Donath F, Grinienko A, Mallefet P, Ozun MJ, et al · · 2018 · PMID 29451469 · DOI 10.5414/cp203125