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

• Status: Not yet recruiting
• Trial end date: 2023-02-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HALEON

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.