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)

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.

Study Overview

• Status: Completed
• Conditions: Common Cold
• Intervention / Treatment: Drug: Otrivine Congestion Relief

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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Derbyshire
    • Swadlincote, Derbyshire, United Kingdom, DE11 7AQ
      • The VCTC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Otrivine Congestion Relief; 0.1% Nasal Spray (Xylometazoline Hydrochloride)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in 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). WURSS-21 is the short version of this validated survey. Participants rated their cold symptoms and QoL related questions using WURSS-21. It consisted of 10 symptoms questions and 9 QoL questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms/Not at all and 7=Severe symptoms/Severely. Thus, the minimum and maximum possible total scores were 0 and 133 respectively, where higher total scores indicated more negative impact on symptoms and quality of life. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptoms and quality of life.	Baseline (Day 0) up to Day 7
Change From Baseline in 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). WURSS-21 is the short version of this validated survey. The symptom domain of WURSS-21 consisted of 10 questions. Participants rated their cold symptoms related questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms and 7=Severely. Thus, the minimum and maximum possible total score were 0 and 70 respectively, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement of symptoms.	Baseline (Day 0) up to Day 7
Change From Baseline in 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). WURSS-21 is the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated their QoL related questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 63 respectively, where higher scores indicated a negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement of quality of life.	Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose	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). WURSS-21 is the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.	Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose	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). WURSS-21 is the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.	Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing	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). WURSS-21 is the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.	Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat	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). WURSS-21 is the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on each individual symptom. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptoms.	Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat	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). WURSS-21 is the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.	Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough	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). WURSS-21 is the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.	Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness	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). WURSS-21 is the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.	Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion	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). WURSS-21 is the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.	Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion	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). WURSS-21 is the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.	Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired	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). WURSS-21 is the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.	Baseline (Day 0) up to Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring	Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.	Days 1, 2, 3, 4, 5, 6, and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness	Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.	Days 1, 2, 3, 4, 5, 6, and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound	Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.	Days 1, 2, 3, 4, 5, 6, and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Smell	Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.	Days 1, 2, 3, 4, 5, 6 and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Taste	Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.	Days 1, 2, 3, 4, 5, 6 and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People	Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.	Day 1, 2, 3, 4, 5, 6 and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Energy	Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.	Days 1, 2, 3, 4, 5, 6 and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation	Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.	Days 1, 2, 3, 4, 5, 6 and 7

Collaborators and Investigators

• Sponsor: HALEON

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: 218317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No