NCT02822287

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Acetylcystine	Clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle.

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2016-07-04
• Last updated: 2017-01-31
• Results posted: 2017-01-31

Locations

1 site across 1 country: Germany