NCT05556148

Otrivine: Quality of Life (QoL) Impact in a Real-World Setting

A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment With Otrivine (Xylometazoline Hydrochloride)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to generate real world data from participants with nasal congestion acquired from common cold following treatment with a marketed nasal spray. The main purpose of this study is to evaluate the effectiveness of a nasal spray on quality of life (QoL) factors.

Detailed description

This is a longitudinal, open-label study evaluating the effect on QoL factors in participants with the common cold using Otrivine nasal spray (xylometazoline hydrochloride 0.1 percent \[%\]), in a real-world setting. A sufficient number of adults aged 18 years and over with symptoms of common cold will be screened for eligibility. The study expects to enroll approximately 125 participants to ensure that 100 participants complete the study. All study data will be collected remotely through a study app using the participant's own mobile device.

Conditions

• Common Cold

Interventions

Type	Name	Description
DRUG	Otrivine Congestion Relief	0.1% Nasal Spray (Xylometazoline Hydrochloride)

Timeline

• Start date: 2022-11-07
• Primary completion: 2022-12-20
• Completion: 2022-12-20
• First posted: 2022-09-27
• Last updated: 2024-05-17
• Results posted: 2024-05-17

Locations

1 site across 1 country: United Kingdom