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

Common Cold Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05556148
• Other study ID #: 218317
• Status: Completed
• Phase: Phase 4
• Start date: November 7, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: May 2024
• Source: HALEON
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Common Cold

Intervention

Drug:
• Otrivine Congestion Relief
0.1% Nasal Spray (Xylometazoline Hydrochloride)

Locations

Country	Name	City	State
United Kingdom	The VCTC	Swadlincote	Derbyshire

Sponsors (1)

Lead Sponsor	Collaborator
HALEON

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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