Clinical trial NCT05556148: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Common Cold
Lead sponsor: HALEON
Sponsor class: INDUSTRY
First posted: 2022-09-27
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score
timeFrame: Baseline (Day 0) up to Day 7
measure: Change From Baseline in WURSS-21 Total Symptom Domains Score
timeFrame: Baseline (Day 0) up to Day 7
measure: Change From Baseline in WURSS-21 Total QoL Domains Score
timeFrame: Baseline (Day 0) up to Day 7
measure: Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose
timeFrame: Baseline (Day 0) up to Day 7
measure: Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose
timeFrame: Baseline (Day 0) up to Day 7
measure: Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing
timeFrame: Baseline (Day 0) up to Day 7
measure: Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat
timeFrame: Baseline (Day 0) up to Day 7
measure: Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat
timeFrame: Baseline (Day 0) up to Day 7
measure: Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough
timeFrame: Baseline (Day 0) up to Day 7
measure: Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness
timeFrame: Baseline (Day 0) up to Day 7
measure: Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion
timeFrame: Baseline (Day 0) up to Day 7
measure: Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion
timeFrame: Baseline (Day 0) up to Day 7
measure: Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired
timeFrame: Baseline (Day 0) up to Day 7
Secondary outcomes:
measure: Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring
timeFrame: Days 1, 2, 3, 4, 5, 6, and 7
measure: Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness
timeFrame: Days 1, 2, 3, 4, 5, 6, and 7
measure: Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound
timeFrame: Days 1, 2, 3, 4, 5, 6, and 7
measure: Post Otrivine Use Score for Additional Health Related QoL Factors: Smell
timeFrame: Days 1, 2, 3, 4, 5, 6 and 7
measure: Post Otrivine Use Score for Additional Health Related QoL Factors: Taste
timeFrame: Days 1, 2, 3, 4, 5, 6 and 7
measure: Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People
timeFrame: Day 1, 2, 3, 4, 5, 6 and 7
measure: Post Otrivine Use Score for Additional Health Related QoL Factors: Energy
timeFrame: Days 1, 2, 3, 4, 5, 6 and 7
measure: Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation
timeFrame: Days 1, 2, 3, 4, 5, 6 and 7
Other outcomes:
Locations:
city: Swadlincote
country: United Kingdom
facility: The VCTC
state: Derbyshire
Study officials:
References: