Back to resultsOtrivine: Quality of Life (QoL) Impact in a Real-World Setting
Primary Purpose
Common Cold
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Otrivine Congestion Relief
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold
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.
Sites / Locations
- The VCTC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Otrivine Congestion Relief
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05556148
Brief Title
Otrivine: Quality of Life (QoL) Impact in a Real-World Setting
Official Title
A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment With Otrivine (Xylometazoline Hydrochloride)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HALEON
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Otrivine Congestion Relief
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Otrivine Congestion Relief
Intervention Description
0.1% Nasal Spray (Xylometazoline Hydrochloride)
Primary Outcome Measure Information:
Title
Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score
Description
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.
Time Frame
Up to Day 7
Title
WURSS-21 Total Symptom Domains Score
Description
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.
Time Frame
Up to Day 7
Title
WURSS-21 Total QoL Domains Score
Description
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.
Time Frame
Up to Day 7
Title
Each of the WURSS-21 Symptom Domains Score
Description
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.
Time Frame
Up to Day 7
Secondary Outcome Measure Information:
Title
Post Otrivine Use Score for Each Health Related QoL Factors
Description
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.
Time Frame
Up to Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The VCTC
City
Swadlincote
State/Province
Derbyshire
ZIP/Postal Code
DE11 7AQ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Otrivine: Quality of Life (QoL) Impact in a Real-World Setting
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