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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Common Cold

Intervention / Treatment
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* Drug: Otrivine Congestion Relief


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Otrivine Congestion Relief<br>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. | Drug: Otrivine Congestion Relief<br>* 0.1% Nasal Spray (Xylometazoline Hydrochloride)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | The WURSS is an evaluative illness- specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). Participants will be asked to rate their cold symptoms and QoL related questionnaire using WURSS-21. It consists of 20 such questionnaire, the responses of which will be evaluated on a scale ranging from 0 to 7, where 0=No symptoms and 7=Severe symptoms. Thus, the minimum and maximum possible total score will be 0 and 140 respectively, where lower score indicates improvement. | Up to Day 7 | 
| WURSS-21 Total Symptom Domains Score | The WURSS is an evaluative illness-specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). The symptom domain of WURSS-21 consists of 10 questionnaires. Participants will be asked to rate their cold symptoms related questionnaire, the responses will be evaluated on a scale ranging from 0 to 7, where 0=No symptoms and 7=Severe symptoms. Thus, the minimum and maximum possible total score will be 0 and 70 respectively, where lower score indicates improvement. | Up to Day 7 | 
| WURSS-21 Total QoL Domains Score | The WURSS is an evaluative illness-specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). The QoL domain of WURSS-21 consists of 10 questionnaires. Participants will be asked to rate their QoL related questionnaire, the responses of which will be evaluated on a scale ranging from 0 to 7, where 0=No symptoms and 7=Severe symptoms. Thus, the minimum and maximum possible total score will be 0 and 70 respectively, where lower score indicates improvement. | Up to Day 7 | 
| Each of the WURSS-21 Symptom Domains Score | The WURSS is an evaluative illness-specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). The symptom domain of WURSS-21 consists of 10 questionnaires. Participants will be asked to rate their cold symptoms related questionnaire, the responses will be evaluated on a scale ranging from 0 to 7, where 0=No symptoms and 7=Severe symptoms. Thus, the minimum and maximum score will be 0 to 70 respectively, where lower score indicates improvement. | Up to Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Otrivine Use Score for Each Health Related QoL Factors | Health related QOL factors were assessed using a questionnaire related to snoring, morning alertness, feeling self-conscious about how you sound, smell, taste, feeling self-conscious around people, energy, and motivation. Participants will be asked to rate their response to questionnaire on a scale ranging from 0 to 7, where 0= not at all and 7= severe. The minimum and maximum score for each questionnaire will be 0 and 7 respectively, where lower score indicates improvement. | Up to Day 7 |