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

NCT ID: NCT05556148

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2022-12-20

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Otrivine Congestion Relief

Participants will be instructed to use the product per label and leaflet instructions: 1 spray in each nostril up to 3 times per day until resolution of symptoms or up to a maximum of 7 days, whichever occurs first.

Group Type: EXPERIMENTAL

Otrivine Congestion Relief

Intervention Type: DRUG

0.1% Nasal Spray (Xylometazoline Hydrochloride)

Interventions

Otrivine Congestion Relief

0.1% Nasal Spray (Xylometazoline Hydrochloride)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant's provision of a signed and dated electronic informed consent (eIC) form indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
• Participant reporting a nasal congestion, and at least another common cold symptom among runny nose, sore throat, cough.
• Participant reporting a minimum score of 5 (moderate) for plugged nose associated with common cold symptoms and at least one other symptom of common cold (at least mild score of 3) as per the WURSS-21 questionnaire at screening.
• Participant reporting initiation of cold symptoms within no longer than 24 hours of prior to initiation of screening.
• Participants confirm common cold symptoms within 24 hours of study product receipt of minimum score of 5 (moderate) for plugged nose associated with common cold symptoms and at least one other symptom of common cold (at least mild score of 3) as per the WURSS-21 questionnaire.
• Male and female Participants.
• Participant that owns a smart device and willing to download the study app.
• Participant who is willing and able to complete all activities as shown in the Schedule of Activities independently on own smart devices.
• Participant is in good general and mental health.
• Participant who has a self-reported medical diagnosis of cardiovascular disease (including those with long QT syndrome), hyperthyroidism or diabetes mellitus, may be included if deemed acceptable by a medically qualified investigator.
• Participant who is showing a strong reaction to adrenergic substances, as manifested by signs of insomnia, dizziness, tremor, cardiac arrhythmias, or elevated blood pressure, may be included if deemed acceptable by a medically qualified investigator.

Exclusion Criteria

• Participants under 18 years of age.
• Participants who are allergic to xylometazoline hydrochloride or any of the other ingredients in the spray (see product label).
• Participants who have had recent neurosurgery.
• Participants who self-report narrow angle glaucoma, chronic nasal inflammation with very dry nasal passages (rhinitis sicca or atrophic rhinitis), or enlarged prostate gland.
• Participants who self-report a rare tumor of the adrenal gland that produces high amounts of adrenaline and noradrenaline (phaeochromocytoma).
• Participants who are taking monoamine oxidase inhibitors (MAOIs) or have stopped taking them in the last 14 days.
• Participants who are pregnant, lactating, or plan to be pregnant or lactating during the course of the study.
• Participant who is currently using or has used a nasal decongestant (for example, adrenergic, steroids) within the last 7 days (or for more than 7 days) prior to initiating study treatment.
• Participants who have tested positive for COVID-19 within one month prior to enrollment into the study.
• Participants who have taken a vaccine one week prior to enrollment into the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HALEON

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The VCTC

Swadlincote, Derbyshire, United Kingdom

Countries

United Kingdom

References

Hagen M, Clark K, Kalita P, Serra G, Sanchez E, Varbiro G, Albasser MM. A real-world study of quality of life following treatment with xylometazoline hydrochloride in individuals with common cold. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241228927. doi: 10.1177/17534666241228927.

Reference Type: DERIVED

PMID: 38372128 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

218317

Identifier Type: -

Identifier Source: org_study_id