Phase 4
Completed N=136
Otrivine: Quality of Life (QoL) Impact in a Real-World Setting
Source: ClinicalTrials.gov NCT05556148 ↗Enrolled (actual)
136
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score — 75.8; -1.5; -15.4; -27.3 score on a scale — p=0.2968
◆ Published Evidence
Emerging
1citation · ~1 / year
A real-world study of quality of life following treatment with xylometazoline hydrochloride in individuals with common cold.
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.
Linked Publications
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A real-world study of quality of life following treatment with xylometazoline hydrochloride in individuals with common cold.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score |
75.8; -1.5; -15.4; -27.3; -35.0; -38.5 | 0.2968 |
| PRIMARY Change From Baseline in WURSS-21 Total Symptom Domains Score |
38.3; 0.3; -6.2; -12.1; -16.0; -19.4 | 0.7112 |
| PRIMARY Change From Baseline in WURSS-21 Total QoL Domains Score |
37.5; -1.8; -9.1; -15.2; -19.1; -19.1 | 0.0481 sig |
| PRIMARY Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose |
4.0; 0.0; -0.6; -1.1; -1.7; -1.7 | 1.0000 |
| PRIMARY Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose |
5.5; -0.4; -1.5; -2.0; -2.4; -3.0 | 0.0023 sig |
| PRIMARY Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing |
3.6; -0.1; -0.9; -1.2; -1.6; -1.9 | 0.4495 |
| PRIMARY Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat |
3.5; 0.1; -0.6; -1.2; -1.7; -2.0 | 0.4758 |
| PRIMARY Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat |
3.2; -0.0; -0.7; -1.3; -1.4; -2.0 | 0.8017 |
| PRIMARY Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough |
3.3; 0.0; -0.4; -0.8; -1.0; -1.2 | 0.8311 |
| PRIMARY Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness |
2.9; 0.0; -0.4; -1.0; -1.2; -1.8 | 0.9380 |
| PRIMARY Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion |
4.7; 0.0; -0.8; -1.6; -2.3; -2.5 | 0.7821 |
| PRIMARY Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion |
2.6; 0.4; -0.1; -0.6; -0.8; -1.2 | 0.0003 sig |
| PRIMARY Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired |
4.9; 0.2; -0.3; -1.3; -1.8; -2.2 | 0.1074 |
| SECONDARY Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring |
2.8; 2.4; 1.9; 1.4; 1.4; 1.4 | <.0001 sig |
| SECONDARY Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness |
2.1; 1.8; 1.6; 1.1; 0.8; 0.8 | <.0001 sig |
| SECONDARY Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound |
2.2; 2.0; 1.6; 1.4; 1.1; 1.3 | <.0001 sig |
| SECONDARY Post Otrivine Use Score for Additional Health Related QoL Factors: Smell |
2.8; 2.4; 1.8; 1.5; 1.2; 1.5 | <.0001 sig |
| SECONDARY Post Otrivine Use Score for Additional Health Related QoL Factors: Taste |
2.4; 2.1; 1.8; 1.4; 1.3; 1.3 | <.0001 sig |
| SECONDARY Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People |
2.3; 1.7; 1.6; 1.1; 1.0; 1.0 | <.0001 sig |
| SECONDARY Post Otrivine Use Score for Additional Health Related QoL Factors: Energy |
3.1; 2.5; 2.1; 1.8; 1.4; 1.2 | <.0001 sig |
| SECONDARY Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation |
2.9; 2.4; 2.0; 1.7; 1.4; 1.2 | <.0001 sig |
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.
Data sourced from ClinicalTrials.gov (NCT05556148) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.