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Otrivine Real-World Evidence Study in Common Cold

NCT05556148Phase 4

Key facts

Status: Completed
Start: Nov 2022
Primary completion: Dec 2022
Countries: 1
Sponsor: Haleon
Modality: Small Molecules

Drugs: xylometazoline
Conditions: common cold

Overview

Phase 4, open-label, single-arm trial of xylometazoline in common cold, sponsored by Haleon. Primary endpoints: Wisconsin Upper Respiratory Symptom Survey-21 Total Score, Wisconsin Upper Respiratory Symptom Survey-21 Total Symptom Domains Score and 11 more. Started Nov 2022; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Otrivine Congestion Relief
Otrivine nasal spray (xylometazoline hydrochloride 0.1%)

Who it enrols

Adults with common cold symptoms (moderate plugged nose and at least one other mild symptom) with symptom onset within 24 hours. Excludes pregnant/lactating women, recent COVID-19 cases, recent vaccine recipients, and those with narrow angle glaucoma, enlarged prostate, or recent MAOI/decongestant use.

Endpoints

Primary

Wisconsin Upper Respiratory Symptom Survey-21 Total ScoreDay 0 to Day 7
Wisconsin Upper Respiratory Symptom Survey-21 Total Symptom Domains ScoreDay 0 to Day 7
Wisconsin Upper Respiratory Symptom Survey-21 Total Quality of Life Domains ScoreDay 0 to Day 7
WURSS-21 Symptom Domain: Runny NoseDay 0 to Day 7
WURSS-21 Symptom Domain: Plugged NoseDay 0 to Day 7

Secondary

Post Otrivine Use Score: SnoringDays 1-7
Post Otrivine Use Score: AlertnessDays 1-7
Post Otrivine Use Score: Self-conscious About SoundDays 1-7
Post Otrivine Use Score: SmellDays 1-7
Post Otrivine Use Score: TasteDays 1-7
Post Otrivine Use Score: Self-conscious Around PeopleDays 1-7
Post Otrivine Use Score: EnergyDays 1-7
Post Otrivine Use Score: MotivationDays 1-7

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