Common Cold
Conditions
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.
Interventions
DRUGOtrivine Congestion Relief
0.1% Nasal Spray (Xylometazoline Hydrochloride)
Sponsors
HALEON
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired | Baseline (Day 0) up to Day 7 | 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. |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose | Baseline (Day 0) up to Day 7 | 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. |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing | Baseline (Day 0) up to Day 7 | 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. |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat | Baseline (Day 0) up to Day 7 | 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. |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat | Baseline (Day 0) up to Day 7 | 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. |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough | Baseline (Day 0) up to Day 7 | 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. |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness | Baseline (Day 0) up to Day 7 | 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. |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion | Baseline (Day 0) up to Day 7 | 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. |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion | Baseline (Day 0) up to Day 7 | 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. |
| Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Baseline (Day 0) up to Day 7 | 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. |
| Change From Baseline in WURSS-21 Total Symptom Domains Score | Baseline (Day 0) up to Day 7 | 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. |
| Change From Baseline in WURSS-21 Total QoL Domains Score | Baseline (Day 0) up to Day 7 | 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. |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose | Baseline (Day 0) up to Day 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness | Days 1, 2, 3, 4, 5, 6, and 7 | 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. |
| Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound | Days 1, 2, 3, 4, 5, 6, and 7 | 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. |
| Post Otrivine Use Score for Additional Health Related QoL Factors: Smell | Days 1, 2, 3, 4, 5, 6 and 7 | 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. |
| Post Otrivine Use Score for Additional Health Related QoL Factors: Taste | Days 1, 2, 3, 4, 5, 6 and 7 | 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. |
| Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People | Day 1, 2, 3, 4, 5, 6 and 7 | 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. |
| Post Otrivine Use Score for Additional Health Related QoL Factors: Energy | Days 1, 2, 3, 4, 5, 6 and 7 | 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. |
| Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation | Days 1, 2, 3, 4, 5, 6 and 7 | 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. |
| Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring | Days 1, 2, 3, 4, 5, 6, and 7 | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
This was a decentralized study in participants with common cold using Otrivine nasal spray (xylometazoline hydrochloride 0.1 percent \[%\]), in a real-world setting. Participants were recruited through targeted advertising on social media channels. All study data were collected remotely through a study app using the participant's own mobile device.
Pre-assignment details
A total of 172 participants were screened of which 136 were enrolled and 100 completed the study. A total of 36 participants were discontinued from the study.
Participants by arm
| Arm | Count |
|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) Participants were instructed to use Otrivine congestion relief 0.1% nasal spray (xylometazoline hydrochloride) per label and leaflet instructions. Participants administered 1 spray in each nostril up to 3 times per day until resolution of symptoms or up to a maximum of 7 days, whichever occurred first. | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Bacterial Conjunctivitis | 1 |
| Overall Study | Baseline Tasks Expired | 4 |
| Overall Study | Early Termination | 29 |
| Overall Study | Family Emergency: Could no longer take part | 1 |
| Overall Study | No Longer Wished to Participate | 1 |
Baseline characteristics
| Characteristic | Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) |
|---|---|
| Age, Continuous | 35.9 years STANDARD_DEVIATION 12.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized Asian or Asian British | 18 Participants |
| Race/Ethnicity, Customized Black, Black British, Caribbean or African | 1 Participants |
| Race/Ethnicity, Customized Mixed or Multiple Ethnic Groups | 3 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White | 78 Participants |
| Sex/Gender, Customized Female | 73 Participants |
| Sex/Gender, Customized Male | 25 Participants |
| Sex/Gender, Customized Other | 2 Participants |
| Sex/Gender, Customized Prefer not to tell | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 136 |
| other Total, other adverse events | 6 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
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.
Time frame: Baseline (Day 0) up to Day 7
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion | Baseline | 2.6 score on a scale | Standard Deviation 2.07 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion | Change from Baseline at Day 1 | 0.4 score on a scale | Standard Deviation 1.17 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion | Change from Baseline at Day 2 | -0.1 score on a scale | Standard Deviation 1.53 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion | Change from Baseline at Day 3 | -0.6 score on a scale | Standard Deviation 1.77 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion | Change from Baseline at Day 4 | -0.8 score on a scale | Standard Deviation 1.9 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion | Change from Baseline at Day 5 | -1.2 score on a scale | Standard Deviation 1.83 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion | Change from Baseline at Day 6 | -1.4 score on a scale | Standard Deviation 2.11 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion | Change from Baseline at Day 7 | -2.1 score on a scale | Standard Deviation 2.18 |
Comparison: Change from Baseline at Day 1p-value: 0.000395% CI: [0.21, 0.68]Student's paired t-test
Comparison: Change from Baseline at Day 2p-value: 0.64695% CI: [-0.38, 0.24]Student's paired t-test
Comparison: Change from Baseline at Day 3p-value: 0.002195% CI: [-0.95, -0.22]Student's paired t-test
Comparison: Change from Baseline at Day 4p-value: 0.000295% CI: [-1.25, -0.41]Student's paired t-test
Comparison: Change from Baseline at Day 5p-value: <0.000195% CI: [-1.68, -0.73]Student's paired t-test
Comparison: Change from Baseline at Day 6p-value: 0.000395% CI: [-2.04, -0.68]Student's paired t-test
Comparison: Change from Baseline at Day 7p-value: <0.000195% CI: [-2.95, -1.32]Student's paired t-test
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.
Time frame: Baseline (Day 0) up to Day 7
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough | Baseline | 3.3 score on a scale | Standard Deviation 2.04 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough | Change from Baseline at Day 1 | 0.0 score on a scale | Standard Deviation 1.41 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough | Change from Baseline at Day 2 | -0.4 score on a scale | Standard Deviation 1.85 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough | Change from Baseline at Day 3 | -0.8 score on a scale | Standard Deviation 2.14 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough | Change from Baseline at Day 4 | -1.0 score on a scale | Standard Deviation 2.11 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough | Change from Baseline at Day 5 | -1.2 score on a scale | Standard Deviation 2.07 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough | Change from Baseline at Day 6 | -1.1 score on a scale | Standard Deviation 1.96 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough | Change from Baseline at Day 7 | -1.3 score on a scale | Standard Deviation 2.23 |
Comparison: Change from Baseline at Day 1p-value: 0.831195% CI: [-0.25, 0.31]Student's paired t-test
Comparison: Change from Baseline at Day 2p-value: 0.031395% CI: [-0.78, -0.04]Student's paired t-test
Comparison: Change from Baseline at Day 3p-value: 0.000395% CI: [-1.28, -0.39]Student's paired t-test
Comparison: Change from Baseline at Day 4p-value: <0.000195% CI: [-1.51, -0.59]Student's paired t-test
Comparison: Change from Baseline at Day 5p-value: <0.000195% CI: [-1.74, -0.66]Student's paired t-test
Comparison: Change from Baseline at Day 6p-value: 0.001895% CI: [-1.69, -0.42]Student's paired t-test
Comparison: Change from Baseline at Day 7p-value: 0.004195% CI: [-2.1, -0.43]Student's paired t-test
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.
Time frame: Baseline (Day 0) up to Day 7
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired | Baseline | 4.9 score on a scale | Standard Deviation 1.6 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired | Change from Baseline at Day 1 | 0.2 score on a scale | Standard Deviation 1.24 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired | Change from Baseline at Day 2 | -0.3 score on a scale | Standard Deviation 1.62 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired | Change from Baseline at Day 3 | -1.3 score on a scale | Standard Deviation 1.84 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired | Change from Baseline at Day 4 | -1.8 score on a scale | Standard Deviation 2.05 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired | Change from Baseline at Day 5 | -2.2 score on a scale | Standard Deviation 2.1 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired | Change from Baseline at Day 6 | -2.1 score on a scale | Standard Deviation 1.92 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired | Change from Baseline at Day 7 | -3.0 score on a scale | Standard Deviation 2.33 |
Comparison: Change from Baseline at Day 1p-value: 0.107495% CI: [-0.04, 0.45]Student's paired t-test
Comparison: Change from Baseline at Day 2p-value: 0.036495% CI: [-0.67, -0.02]Student's paired t-test
Comparison: Change from Baseline at Day 3p-value: <0.000195% CI: [-1.68, -0.91]Student's paired t-test
Comparison: Change from Baseline at Day 4p-value: <0.000195% CI: [-2.25, -1.36]Student's paired t-test
Comparison: Change from Baseline at Day 5p-value: <0.000195% CI: [-2.78, -1.69]Student's paired t-test
Comparison: Change from Baseline at Day 6p-value: <0.000195% CI: [-2.7, -1.45]Student's paired t-test
Comparison: Change from Baseline at Day 7p-value: <0.000195% CI: [-3.84, -2.1]Student's paired t-test
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.
Time frame: Baseline (Day 0) up to Day 7
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion | Baseline | 4.7 score on a scale | Standard Deviation 1.57 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion | Change from Baseline at Day 1 | 0.0 score on a scale | Standard Deviation 1.45 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion | Change from Baseline at Day 2 | -0.8 score on a scale | Standard Deviation 1.85 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion | Change from Baseline at Day 3 | -1.6 score on a scale | Standard Deviation 2.1 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion | Change from Baseline at Day 4 | -2.3 score on a scale | Standard Deviation 1.98 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion | Change from Baseline at Day 5 | -2.5 score on a scale | Standard Deviation 1.99 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion | Change from Baseline at Day 6 | -2.6 score on a scale | Standard Deviation 2.22 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion | Change from Baseline at Day 7 | -3.2 score on a scale | Standard Deviation 2.64 |
Comparison: Change from Baseline at Day 1p-value: 0.782195% CI: [-0.25, 0.33]Student's paired t-test
Comparison: Change from Baseline at Day 2p-value: <0.000195% CI: [-1.14, -0.39]Student's paired t-test
Comparison: Change from Baseline at Day 3p-value: <0.000195% CI: [-2.05, -1.19]Student's paired t-test
Comparison: Change from Baseline at Day 4p-value: <0.000195% CI: [-2.73, -1.86]Student's paired t-test
Comparison: Change from Baseline at Day 5p-value: <0.000195% CI: [-2.98, -1.94]Student's paired t-test
Comparison: Change from Baseline at Day 6p-value: <0.000195% CI: [-3.36, -1.92]Student's paired t-test
Comparison: Change from Baseline at Day 7p-value: <0.000195% CI: [-4.19, -2.21]Student's paired t-test
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.
Time frame: Baseline (Day 0) up to Day 7
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness | Baseline | 2.9 score on a scale | Standard Deviation 2.06 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness | Change from Baseline at Day 1 | 0.0 score on a scale | Standard Deviation 1.29 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness | Change from Baseline at Day 2 | -0.4 score on a scale | Standard Deviation 1.76 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness | Change from Baseline at Day 3 | -1.0 score on a scale | Standard Deviation 1.61 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness | Change from Baseline at Day 4 | -1.2 score on a scale | Standard Deviation 1.91 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness | Change from Baseline at Day 5 | -1.8 score on a scale | Standard Deviation 1.88 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness | Change from Baseline at Day 6 | -1.7 score on a scale | Standard Deviation 1.98 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness | Change from Baseline at Day 7 | -2.3 score on a scale | Standard Deviation 2.09 |
Comparison: Change from Baseline at Day 1p-value: 0.93895% CI: [-0.25, 0.27]Student's paired t-test
Comparison: Change from Baseline at Day 2p-value: 0.041695% CI: [-0.72, -0.01]Student's paired t-test
Comparison: Change from Baseline at Day 3p-value: <0.000195% CI: [-1.29, -0.62]Student's paired t-test
Comparison: Change from Baseline at Day 4p-value: <0.000195% CI: [-1.6, -0.76]Student's paired t-test
Comparison: Change from Baseline at Day 5p-value: <0.000195% CI: [-2.25, -1.27]Student's paired t-test
Comparison: Change from Baseline at Day 6p-value: <0.000195% CI: [-2.33, -1.05]Student's paired t-test
Comparison: Change from Baseline at Day 7p-value: <0.000195% CI: [-3.08, -1.52]Student's paired t-test
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.
Time frame: Baseline (Day 0) up to Day 7
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose | Change From Baseline at Day 3 | -2.0 score on a scale | Standard Deviation 1.99 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose | Baseline | 5.5 score on a scale | Standard Deviation 0.92 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose | Change From Baseline at Day 1 | -0.4 score on a scale | Standard Deviation 1.25 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose | Change From Baseline at Day 2 | -1.5 score on a scale | Standard Deviation 1.75 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose | Change From Baseline at Day 4 | -2.4 score on a scale | Standard Deviation 1.95 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose | Change From Baseline at Day 5 | -3.0 score on a scale | Standard Deviation 1.94 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose | Change From Baseline at Day 6 | -2.8 score on a scale | Standard Deviation 1.83 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose | Change From Baseline at Day 7 | -3.3 score on a scale | Standard Deviation 2.06 |
Comparison: Change from Baseline at Day 1p-value: 0.002395% CI: [-0.64, -0.14]Student's paired t-test
Comparison: Change from Baseline at Day 2p-value: <0.000195% CI: [-1.82, -1.12]Student's paired t-test
Comparison: Change from Baseline at Day 3p-value: <0.000195% CI: [-2.4, -1.58]Student's paired t-test
Comparison: Change from Baseline at Day 4p-value: <0.000195% CI: [-2.86, -2]Student's paired t-test
Comparison: Change from Baseline at Day 5p-value: <0.000195% CI: [-3.51, -2.49]Student's paired t-test
Comparison: Change from Baseline at Day 6p-value: <0.000195% CI: [-3.36, -2.18]Student's paired t-test
Comparison: Change from Baseline at Day 7p-value: <0.000195% CI: [-4.1, -2.57]Student's paired t-test
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.
Time frame: Baseline (Day 0) up to Day 7
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose | Baseline | 4.0 score on a scale | Standard Deviation 1.86 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose | Change from Baseline at Day 1 | 0.0 score on a scale | Standard Deviation 1.53 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose | Change from Baseline at Day 2 | -0.6 score on a scale | Standard Deviation 1.68 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose | Change from Baseline at Day 3 | -1.1 score on a scale | Standard Deviation 1.93 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose | Change from Baseline at Day 4 | -1.7 score on a scale | Standard Deviation 2.2 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose | Change from Baseline at Day 5 | -1.7 score on a scale | Standard Deviation 2.24 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose | Change from Baseline at Day 6 | -1.9 score on a scale | Standard Deviation 1.9 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose | Change from Baseline at Day 7 | -2.5 score on a scale | Standard Deviation 2.21 |
Comparison: Change from Baseline at Day 1p-value: 195% CI: [-0.31, 0.31]Student's paired t-test
Comparison: Change from Baseline at Day 2p-value: 0.000395% CI: [-0.97, -0.3]Student's paired t-test
Comparison: Change from Baseline at Day 3p-value: <0.000195% CI: [-1.5, -0.7]Student's paired t-test
Comparison: Change from Baseline at Day 4p-value: <0.000195% CI: [-2.2, -1.24]Student's paired t-test
Comparison: Change from Baseline at Day 5p-value: <0.000195% CI: [-2.33, -1.16]Student's paired t-test
Comparison: Change from Baseline at Day 6p-value: <0.000195% CI: [-2.51, -1.28]Student's paired t-test
Comparison: Change from Baseline at Day 7p-value: <0.000195% CI: [-3.29, -1.64]Student's paired t-test
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.
Time frame: Baseline (Day 0) up to Day 7
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat | Change from Baseline at Day 2 | -0.7 score on a scale | Standard Deviation 1.86 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat | Baseline | 3.2 score on a scale | Standard Deviation 2.11 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat | Change from Baseline at Day 1 | -0.0 score on a scale | Standard Deviation 1.6 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat | Change from Baseline at Day 3 | -1.3 score on a scale | Standard Deviation 1.92 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat | Change from Baseline at Day 4 | -1.4 score on a scale | Standard Deviation 2.04 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat | Change from Baseline at Day 5 | -2.0 score on a scale | Standard Deviation 1.99 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat | Change from Baseline at Day 6 | -1.9 score on a scale | Standard Deviation 2.03 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat | Change from Baseline at Day 7 | -2.4 score on a scale | Standard Deviation 2.31 |
Comparison: Change from Baseline at Day 1p-value: 0.801795% CI: [-0.36, 0.28]Student's paired t-test
Comparison: Change from Baseline at Day 2p-value: 0.000595% CI: [-1.05, -0.3]Student's paired t-test
Comparison: Change from Baseline at Day 3p-value: <0.000195% CI: [-1.69, -0.89]Student's paired t-test
Comparison: Change from Baseline at Day 4p-value: <0.000195% CI: [-1.86, -0.97]Student's paired t-test
Comparison: Change from Baseline at Day 5p-value: <0.000195% CI: [-2.5, -1.47]Student's paired t-test
Comparison: Change from Baseline at Day 6p-value: <0.000195% CI: [-2.61, -1.29]Student's paired t-test
Comparison: Change from Baseline at Day 7p-value: <0.000195% CI: [-3.26, -1.54]Student's paired t-test
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.
Time frame: Baseline (Day 0) up to Day 7
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing | Baseline | 3.6 score on a scale | Standard Deviation 1.8 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing | Change From Baseline at Day 1 | -0.1 score on a scale | Standard Deviation 1.46 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing | Change From Baseline at Day 2 | -0.9 score on a scale | Standard Deviation 1.62 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing | Change From Baseline at Day 3 | -1.2 score on a scale | Standard Deviation 1.86 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing | Change From Baseline at Day 4 | -1.6 score on a scale | Standard Deviation 2.14 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing | Change From Baseline at Day 5 | -1.9 score on a scale | Standard Deviation 2.05 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing | Change From Baseline at Day 6 | -1.8 score on a scale | Standard Deviation 1.87 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing | Change From Baseline at Day 7 | -2.5 score on a scale | Standard Deviation 1.93 |
Comparison: Change from Baseline at Day 1p-value: 0.449595% CI: [-0.4, 0.18]Student's paired t-test
Comparison: Change from Baseline at Day 2p-value: <0.000195% CI: [-1.19, -0.54]Student's paired t-test
Comparison: Change from Baseline at Day 3p-value: <0.000195% CI: [-1.59, -0.82]Student's paired t-test
Comparison: Change from Baseline at Day 4p-value: <0.000195% CI: [-2.05, -1.12]Student's paired t-test
Comparison: Change from Baseline at Day 5p-value: <0.000195% CI: [-2.4, -1.33]Student's paired t-test
Comparison: Change from Baseline at Day 6p-value: <0.000195% CI: [-2.45, -1.24]Student's paired t-test
Comparison: Change from Baseline at Day 7p-value: <0.000195% CI: [-3.19, -1.75]Student's paired t-test
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.
Time frame: Baseline (Day 0) up to Day 7
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat | Change from Baseline to Day 3 | -1.2 score on a scale | Standard Deviation 2.12 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat | Baseline | 3.5 score on a scale | Standard Deviation 2.05 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat | Change from Baseline to Day 1 | 0.1 score on a scale | Standard Deviation 1.54 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat | Change from Baseline to Day 2 | -0.6 score on a scale | Standard Deviation 1.86 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat | Change from Baseline to Day 4 | -1.7 score on a scale | Standard Deviation 2.33 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat | Change from Baseline to Day 5 | -2.0 score on a scale | Standard Deviation 1.81 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat | Change from Baseline to Day 6 | -2.1 score on a scale | Standard Deviation 2.13 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat | Change from Baseline to Day 7 | -2.9 score on a scale | Standard Deviation 2.1 |
Comparison: Change from Baseline at Day 1p-value: 0.475895% CI: [-0.2, 0.42]Student's paired t-test
Comparison: Change from Baseline at Day 2p-value: 0.001695% CI: [-0.99, -0.24]Student's paired t-test
Comparison: Change from Baseline at Day 3p-value: <0.000195% CI: [-1.67, -0.79]Student's paired t-test
Comparison: Change from Baseline at Day 4p-value: <0.000195% CI: [-2.18, -1.16]Student's paired t-test
Comparison: Change from Baseline at Day 5p-value: <0.000195% CI: [-2.46, -1.51]Student's paired t-test
Comparison: Change from Baseline at Day 6p-value: <0.000195% CI: [-2.77, -1.39]Student's paired t-test
Comparison: Change from Baseline at Day 7p-value: <0.000195% CI: [-3.65, -2.08]Student's paired t-test
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.
Time frame: Baseline (Day 0) up to Day 7
Population: The mITT population included all participants who used study product at least once and had data from at least one post-baseline QoL questionnaire to support at least one of the primary endpoint assessments. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Baseline | 75.8 score on a scale | Standard Deviation 20.23 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Change from Baseline at Day 1 | -1.5 score on a scale | Standard Deviation 14.57 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Change from Baseline at Day 2 | -15.4 score on a scale | Standard Deviation 22 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Change from Baseline at Day 3 | -27.3 score on a scale | Standard Deviation 27.94 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Change from Baseline at Day 4 | -35.0 score on a scale | Standard Deviation 30.21 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Change from Baseline at Day 5 | -38.5 score on a scale | Standard Deviation 28.31 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Change from Baseline at Day 6 | -39.7 score on a scale | Standard Deviation 27.12 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Change from Baseline at Day 7 | -52.6 score on a scale | Standard Deviation 29.7 |
Comparison: Change from Baseline at Day 1p-value: 0.296895% CI: [-4.44, 1.37]Student's paired t-test
Comparison: Change from Baseline at Day 2p-value: <0.000195% CI: [-19.77, -10.95]Student's paired t-test
Comparison: Change from Baseline at Day 3p-value: <0.000195% CI: [-33.06, -21.49]Student's paired t-test
Comparison: Change from Baseline at Day 4p-value: <0.000195% CI: [-41.69, -28.41]Student's paired t-test
Comparison: Change from Baseline at Day 5p-value: <0.000195% CI: [-45.87, -31.11]Student's paired t-test
Comparison: Change from Baseline at Day 6p-value: <0.000195% CI: [-48.46, -30.88]Student's paired t-test
Comparison: Change from Baseline at Day 7p-value: <0.000195% CI: [-63.69, -41.51]Student's paired t-test
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.
Time frame: Baseline (Day 0) up to Day 7
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total QoL Domains Score | Baseline | 37.5 score on a scale | Standard Deviation 11.61 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total QoL Domains Score | Change From Baseline at Day 1 | -1.8 score on a scale | Standard Deviation 9.09 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total QoL Domains Score | Change From Baseline at Day 2 | -9.1 score on a scale | Standard Deviation 12.95 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total QoL Domains Score | Change From Baseline at Day 3 | -15.2 score on a scale | Standard Deviation 15.84 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total QoL Domains Score | Change From Baseline at Day 4 | -19.1 score on a scale | Standard Deviation 17.17 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total QoL Domains Score | Change From Baseline at Day 5 | -19.1 score on a scale | Standard Deviation 16.5 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total QoL Domains Score | Change From Baseline at Day 6 | -20.3 score on a scale | Standard Deviation 16.62 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total QoL Domains Score | Change From Baseline at Day 7 | -27.2 score on a scale | Standard Deviation 14.14 |
Comparison: Change from Baseline at Day 1p-value: 0.048195% CI: [-3.64, -0.02]Student's paired t-test
Comparison: Change from Baseline at Day 2p-value: <0.000195% CI: [-11.74, -6.55]Student's paired t-test
Comparison: Change from Baseline at Day 3p-value: <0.000195% CI: [-18.44, -11.88]Student's paired t-test
Comparison: Change from Baseline at Day 4p-value: <0.000195% CI: [-22.84, -15.3]Student's paired t-test
Comparison: Change from Baseline at Day 5p-value: <0.000195% CI: [-23.35, -14.75]Student's paired t-test
Comparison: Change from Baseline at Day 6p-value: <0.000195% CI: [-25.7, -14.92]Student's paired t-test
Comparison: Change from Baseline at Day 7p-value: <0.000195% CI: [-32.48, -21.92]Student's paired t-test
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.
Time frame: Baseline (Day 0) up to Day 7
Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total Symptom Domains Score | Baseline | 38.3 score on a scale | Standard Deviation 11.35 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total Symptom Domains Score | Change from Baseline at Day 1 | 0.3 score on a scale | Standard Deviation 7.85 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total Symptom Domains Score | Change from Baseline at Day 2 | -6.2 score on a scale | Standard Deviation 11.44 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total Symptom Domains Score | Change from Baseline at Day 3 | -12.1 score on a scale | Standard Deviation 13.96 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total Symptom Domains Score | Change from Baseline at Day 4 | -16.0 score on a scale | Standard Deviation 14.88 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total Symptom Domains Score | Change from Baseline at Day 5 | -19.4 score on a scale | Standard Deviation 14.77 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total Symptom Domains Score | Change from Baseline at Day 6 | -19.4 score on a scale | Standard Deviation 14.4 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Change From Baseline in WURSS-21 Total Symptom Domains Score | Change from Baseline at Day 7 | -25.4 score on a scale | Standard Deviation 17.32 |
Comparison: Change from Baseline at Day 1p-value: 0.711295% CI: [-1.27, 1.86]Student's paired t-test
Comparison: Change from Baseline at Day 2p-value: <0.000195% CI: [-8.51, -3.92]Student's paired t-test
Comparison: Change from Baseline at Day 3p-value: <0.000195% CI: [-15, -9.22]Student's paired t-test
Comparison: Change from Baseline at Day 4p-value: <0.000195% CI: [-19.24, -12.71]Student's paired t-test
Comparison: Change from Baseline at Day 5p-value: <0.000195% CI: [-23.29, -15.59]Student's paired t-test
Comparison: Change from Baseline at Day 6p-value: <0.000195% CI: [-24.03, -14.69]Student's paired t-test
Comparison: Change from Baseline at Day 7p-value: <0.000195% CI: [-31.87, -18.93]Student's paired t-test
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.
Time frame: Days 1, 2, 3, 4, 5, 6, and 7
Population: mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness | Day 1 | 2.1 score on a scale | Standard Deviation 1.94 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness | Day 2 | 1.8 score on a scale | Standard Deviation 1.81 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness | Day 3 | 1.6 score on a scale | Standard Deviation 1.8 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness | Day 4 | 1.1 score on a scale | Standard Deviation 1.61 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness | Day 5 | 0.8 score on a scale | Standard Deviation 1.17 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness | Day 6 | 0.8 score on a scale | Standard Deviation 1.14 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness | Day 7 | 0.8 score on a scale | Standard Deviation 1.18 |
Comparison: Day 1p-value: <0.000195% CI: [-2.14, -1.31]Student's paired t-test
Comparison: Day 2p-value: <0.000195% CI: [-2.55, -1.7]Student's paired t-test
Comparison: Day 3p-value: <0.000195% CI: [-2.71, -1.9]Student's paired t-test
Comparison: Day 4p-value: <0.000195% CI: [-3.23, -2.29]Student's paired t-test
Comparison: Day 5p-value: <0.000195% CI: [-3.31, -2.39]Student's paired t-test
Comparison: Day 6p-value: <0.000195% CI: [-3.72, -2.64]Student's paired t-test
Comparison: Day 7p-value: <0.000195% CI: [-3.9, -2.43]Student's paired t-test
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.
Time frame: Days 1, 2, 3, 4, 5, 6 and 7
Population: mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Energy | Day 1 | 3.1 score on a scale | Standard Deviation 2.02 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Energy | Day 2 | 2.5 score on a scale | Standard Deviation 2.06 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Energy | Day 3 | 2.1 score on a scale | Standard Deviation 1.87 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Energy | Day 4 | 1.8 score on a scale | Standard Deviation 1.94 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Energy | Day 5 | 1.4 score on a scale | Standard Deviation 1.54 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Energy | Day 6 | 1.2 score on a scale | Standard Deviation 1.44 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Energy | Day 7 | 1.0 score on a scale | Standard Deviation 1.3 |
Comparison: Day 1p-value: <0.000195% CI: [-2.49, -1.66]Student's paired t-test
Comparison: Day 2p-value: <0.000195% CI: [-3.2, -2.33]Student's paired t-test
Comparison: Day 3p-value: <0.000195% CI: [-3.63, -2.78]Student's paired t-test
Comparison: Day 4p-value: <0.000195% CI: [-3.98, -3]Student's paired t-test
Comparison: Day 5p-value: <0.000195% CI: [-4.33, -3.33]Student's paired t-test
Comparison: Day 6p-value: <0.000195% CI: [-4.65, -3.46]Student's paired t-test
Comparison: Day 7p-value: <0.000195% CI: [-4.81, -3.46]Student's paired t-test
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.
Time frame: Days 1, 2, 3, 4, 5, 6 and 7
Population: mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation | Day 7 | 1.1 score on a scale | Standard Deviation 1.49 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation | Day 1 | 2.9 score on a scale | Standard Deviation 2.19 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation | Day 2 | 2.4 score on a scale | Standard Deviation 1.92 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation | Day 3 | 2.0 score on a scale | Standard Deviation 1.9 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation | Day 4 | 1.7 score on a scale | Standard Deviation 1.89 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation | Day 5 | 1.4 score on a scale | Standard Deviation 1.61 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation | Day 6 | 1.2 score on a scale | Standard Deviation 1.54 |
Comparison: Day 1p-value: <0.000195% CI: [-2.66, -1.77]Student's paired t-test
Comparison: Day 2p-value: <0.000195% CI: [-3.15, -2.31]Student's paired t-test
Comparison: Day 3p-value: <0.000195% CI: [-3.6, -2.73]Student's paired t-test
Comparison: Day 4p-value: <0.000195% CI: [-4, -3.05]Student's paired t-test
Comparison: Day 5p-value: <0.000195% CI: [-4.19, -3.27]Student's paired t-test
Comparison: Day 6p-value: <0.000195% CI: [-4.55, -3.45]Student's paired t-test
Comparison: Day 7p-value: <0.000195% CI: [-4.74, -3.39]Student's paired t-test
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.
Time frame: Days 1, 2, 3, 4, 5, 6, and 7
Population: mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound | Day 6 | 1.3 score on a scale | Standard Deviation 1.69 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound | Day 7 | 0.9 score on a scale | Standard Deviation 1.28 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound | Day 1 | 2.2 score on a scale | Standard Deviation 1.85 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound | Day 2 | 2.0 score on a scale | Standard Deviation 1.99 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound | Day 3 | 1.6 score on a scale | Standard Deviation 1.76 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound | Day 4 | 1.4 score on a scale | Standard Deviation 1.75 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound | Day 5 | 1.1 score on a scale | Standard Deviation 1.56 |
Comparison: Day 1p-value: <0.000195% CI: [-2.39, -1.57]Student's paired t-test
Comparison: Day 2p-value: <0.000195% CI: [-2.66, -1.81]Student's paired t-test
Comparison: Day 3p-value: <0.000195% CI: [-3.14, -2.32]Student's paired t-test
Comparison: Day 4p-value: <0.000195% CI: [-3.4, -2.43]Student's paired t-test
Comparison: Day 5p-value: <0.000195% CI: [-3.68, -2.66]Student's paired t-test
Comparison: Day 6p-value: <0.000195% CI: [-4.02, -2.54]Student's paired t-test
Comparison: Day 7p-value: <0.000195% CI: [-4.24, -2.7]Student's paired t-test
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.
Time frame: Day 1, 2, 3, 4, 5, 6 and 7
Population: mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People | Day 1 | 2.3 score on a scale | Standard Deviation 1.96 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People | Day 2 | 1.7 score on a scale | Standard Deviation 1.76 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People | Day 3 | 1.6 score on a scale | Standard Deviation 1.7 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People | Day 4 | 1.1 score on a scale | Standard Deviation 1.61 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People | Day 5 | 1.0 score on a scale | Standard Deviation 1.4 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People | Day 6 | 1.0 score on a scale | Standard Deviation 1.5 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People | Day 7 | 0.8 score on a scale | Standard Deviation 1.37 |
Comparison: Day 1p-value: <0.000195% CI: [-2.35, -1.51]Student's paired t-test
Comparison: Day 2p-value: <0.000195% CI: [-3, -2.2]Student's paired t-test
Comparison: Day 3p-value: <0.000195% CI: [-3.09, -2.22]Student's paired t-test
Comparison: Day 4p-value: <0.000195% CI: [-3.53, -2.62]Student's paired t-test
Comparison: Day 5p-value: <0.000195% CI: [-3.76, -2.75]Student's paired t-test
Comparison: Day 6p-value: <0.000195% CI: [-4.04, -2.78]Student's paired t-test
Comparison: Day 7p-value: <0.000195% CI: [-4.3, -2.64]Student's paired t-test
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.
Time frame: Days 1, 2, 3, 4, 5, 6 and 7
Population: mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Smell | Day 1 | 2.8 score on a scale | Standard Deviation 1.89 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Smell | Day 2 | 2.4 score on a scale | Standard Deviation 1.99 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Smell | Day 3 | 1.8 score on a scale | Standard Deviation 1.81 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Smell | Day 4 | 1.5 score on a scale | Standard Deviation 1.65 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Smell | Day 5 | 1.2 score on a scale | Standard Deviation 1.59 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Smell | Day 6 | 1.5 score on a scale | Standard Deviation 1.8 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Smell | Day 7 | 1.3 score on a scale | Standard Deviation 1.7 |
Comparison: Day 1p-value: <0.000195% CI: [-2.37, -1.55]Student's paired t-test
Comparison: Day 2p-value: <0.000195% CI: [-2.83, -2.01]Student's paired t-test
Comparison: Day 3p-value: <0.000195% CI: [-3.41, -2.53]Student's paired t-test
Comparison: Day 4p-value: <0.000195% CI: [-3.81, -2.87]Student's paired t-test
Comparison: Day 5p-value: <0.000195% CI: [-3.84, -2.87]Student's paired t-test
Comparison: Change from Baseline at Day 6p-value: <0.000195% CI: [-3.91, -2.56]Student's paired t-test
Comparison: Day 7p-value: <0.000195% CI: [-4.48, -2.92]Student's paired t-test
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.
Time frame: Days 1, 2, 3, 4, 5, 6, and 7
Population: mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring | Day 1 | 2.8 score on a scale | Standard Deviation 2.11 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring | Day 2 | 2.4 score on a scale | Standard Deviation 2.04 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring | Day 3 | 1.9 score on a scale | Standard Deviation 1.95 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring | Day 4 | 1.4 score on a scale | Standard Deviation 1.79 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring | Day 5 | 1.4 score on a scale | Standard Deviation 1.63 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring | Day 6 | 1.4 score on a scale | Standard Deviation 1.58 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring | Day 7 | 1.2 score on a scale | Standard Deviation 1.44 |
Comparison: Day 1p-value: <0.000195% CI: [-2.33, -1.43]Student's paired t-test
Comparison: Day 2p-value: <0.000195% CI: [-2.9, -2.01]Student's paired t-test
Comparison: Day 3p-value: <0.000195% CI: [-3.41, -2.39]Student's paired t-test
Comparison: Day 4p-value: <0.000195% CI: [-3.82, -2.77]Student's paired t-test
Comparison: Day 5p-value: <0.000195% CI: [-3.53, -2.37]Student's paired t-test
Comparison: Day 6p-value: <0.000195% CI: [-3.98, -2.53]Student's paired t-test
Comparison: Day 7p-value: <0.000195% CI: [-4.08, -2.16]Student's paired t-test
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.
Time frame: Days 1, 2, 3, 4, 5, 6 and 7
Population: mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Taste | Day 4 | 1.4 score on a scale | Standard Deviation 1.67 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Taste | Day 1 | 2.4 score on a scale | Standard Deviation 2.01 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Taste | Day 2 | 2.1 score on a scale | Standard Deviation 2.03 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Taste | Day 3 | 1.8 score on a scale | Standard Deviation 1.91 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Taste | Day 5 | 1.3 score on a scale | Standard Deviation 1.65 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Taste | Day 6 | 1.3 score on a scale | Standard Deviation 1.78 |
| Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Post Otrivine Use Score for Additional Health Related QoL Factors: Taste | Day 7 | 1.3 score on a scale | Standard Deviation 1.67 |
Comparison: Day 1p-value: <0.000195% CI: [-2.17, -1.34]Student's paired t-test
Comparison: Day 2p-value: <0.000195% CI: [-2.51, -1.67]Student's paired t-test
Comparison: Day 3p-value: <0.000195% CI: [-2.86, -1.97]Student's paired t-test
Comparison: Day 4p-value: <0.000195% CI: [-3.22, -2.27]Student's paired t-test
Comparison: Day 5p-value: <0.000195% CI: [-3.3, -2.16]Student's paired t-test
Comparison: Day 6p-value: <0.000195% CI: [-3.56, -2.19]Student's paired t-test
Comparison: Day 7p-value: <0.000195% CI: [-4.01, -2.39]Student's paired t-test