Trial Outcomes & Findings for Otrivine: Quality of Life (QoL) Impact in a Real-World Setting (NCT NCT05556148)
NCT ID: NCT05556148
Last Updated: 2024-05-17
Results Overview
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.
COMPLETED
PHASE4
136 participants
Baseline (Day 0) up to Day 7
2024-05-17
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
136
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|
Overall Study
Modified Intent-To-Treat (mITT) Population
|
102
|
|
Overall Study
COMPLETED
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100
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Early Termination
|
29
|
|
Overall Study
Baseline Tasks Expired
|
4
|
|
Overall Study
Family Emergency: Could no longer take part
|
1
|
|
Overall Study
No Longer Wished to Participate
|
1
|
|
Overall Study
Bacterial Conjunctivitis
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1
|
Baseline Characteristics
Otrivine: Quality of Life (QoL) Impact in a Real-World Setting
Baseline characteristics by cohort
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 Participants
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.
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|---|---|
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Age, Continuous
|
35.9 years
STANDARD_DEVIATION 12.04 • n=5 Participants
|
|
Sex/Gender, Customized
Female
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73 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
25 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Prefer not to tell
|
2 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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99 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Asian British
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18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, Black British, Caribbean or African
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed or Multiple Ethnic Groups
|
3 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Other
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2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to Day 7Population: 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.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 Participants
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 occured first.
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|---|---|
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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
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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
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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
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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
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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
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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
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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
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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
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PRIMARY outcome
Timeframe: Baseline (Day 0) up to Day 7Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 Participants
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 occured first.
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|---|---|
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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
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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
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Change From Baseline in WURSS-21 Total Symptom Domains Score
Baseline
|
38.3 score on a scale
Standard Deviation 11.35
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Change From Baseline in WURSS-21 Total Symptom Domains Score
Change from Baseline at Day 2
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-6.2 score on a scale
Standard Deviation 11.44
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Change From Baseline in WURSS-21 Total Symptom Domains Score
Change from Baseline at Day 3
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-12.1 score on a scale
Standard Deviation 13.96
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Change From Baseline in WURSS-21 Total Symptom Domains Score
Change from Baseline at Day 4
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-16.0 score on a scale
Standard Deviation 14.88
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Change From Baseline in WURSS-21 Total Symptom Domains Score
Change from Baseline at Day 5
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-19.4 score on a scale
Standard Deviation 14.77
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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
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PRIMARY outcome
Timeframe: Baseline (Day 0) up to Day 7Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 Participants
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 occured first.
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|---|---|
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Change From Baseline in WURSS-21 Total QoL Domains Score
Change From Baseline at Day 5
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-19.1 score on a scale
Standard Deviation 16.5
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Change From Baseline in WURSS-21 Total QoL Domains Score
Baseline
|
37.5 score on a scale
Standard Deviation 11.61
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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
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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
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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
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Change From Baseline in WURSS-21 Total QoL Domains Score
Change From Baseline at Day 4
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-19.1 score on a scale
Standard Deviation 17.17
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Change From Baseline in WURSS-21 Total QoL Domains Score
Change From Baseline at Day 6
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-20.3 score on a scale
Standard Deviation 16.62
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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
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to Day 7Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 Participants
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 occured first.
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|---|---|
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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 2.20
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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
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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
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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
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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
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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
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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 1.90
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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
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to Day 7Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 Participants
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 occured first.
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|---|---|
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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
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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
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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
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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
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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
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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
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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
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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
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to Day 7Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 Participants
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 occured first.
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|---|---|
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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
|
|
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
|
|
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
|
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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
|
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Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing
Baseline
|
3.6 score on a scale
Standard Deviation 1.80
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to Day 7Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 Participants
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 occured first.
|
|---|---|
|
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
|
|
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 2.10
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to Day 7Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 Participants
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 occured first.
|
|---|---|
|
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
|
|
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 1.60
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to Day 7Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 Participants
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 occured first.
|
|---|---|
|
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough
Baseline
|
3.3 score on a scale
Standard Deviation 2.04
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to Day 7Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 Participants
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 occured first.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness
Baseline
|
2.9 score on a scale
Standard Deviation 2.06
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to Day 7Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 Participants
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 occured first.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 2.10
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to Day 7Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 Participants
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 occured first.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 1.90
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to Day 7Population: mITT population. Only those participants with data available at the indicated timepoints were analyzed.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 Participants
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 occured first.
|
|---|---|
|
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired
Baseline
|
4.9 score on a scale
Standard Deviation 1.60
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 2.10
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, 5, 6, and 7Population: 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.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=73 Participants
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 occured first.
|
|---|---|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring
Day 1
|
2.8 score on a scale
Standard Deviation 2.11
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring
Day 2
|
2.4 score on a scale
Standard Deviation 2.04
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring
Day 3
|
1.9 score on a scale
Standard Deviation 1.95
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring
Day 4
|
1.4 score on a scale
Standard Deviation 1.79
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring
Day 5
|
1.4 score on a scale
Standard Deviation 1.63
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring
Day 6
|
1.4 score on a scale
Standard Deviation 1.58
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring
Day 7
|
1.2 score on a scale
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, 5, 6, and 7Population: 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.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=98 Participants
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 occured first.
|
|---|---|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness
Day 1
|
2.1 score on a scale
Standard Deviation 1.94
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness
Day 2
|
1.8 score on a scale
Standard Deviation 1.81
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness
Day 3
|
1.6 score on a scale
Standard Deviation 1.80
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness
Day 4
|
1.1 score on a scale
Standard Deviation 1.61
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness
Day 5
|
0.8 score on a scale
Standard Deviation 1.17
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness
Day 6
|
0.8 score on a scale
Standard Deviation 1.14
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness
Day 7
|
0.8 score on a scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, 5, 6, and 7Population: 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.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=98 Participants
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 occured first.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, 5, 6 and 7Population: 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.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=98 Participants
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 occured first.
|
|---|---|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Smell
Day 1
|
2.8 score on a scale
Standard Deviation 1.89
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Smell
Day 2
|
2.4 score on a scale
Standard Deviation 1.99
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Smell
Day 3
|
1.8 score on a scale
Standard Deviation 1.81
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Smell
Day 4
|
1.5 score on a scale
Standard Deviation 1.65
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Smell
Day 5
|
1.2 score on a scale
Standard Deviation 1.59
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Smell
Day 6
|
1.5 score on a scale
Standard Deviation 1.80
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Smell
Day 7
|
1.3 score on a scale
Standard Deviation 1.70
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, 5, 6 and 7Population: 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.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=98 Participants
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 occured first.
|
|---|---|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Taste
Day 1
|
2.4 score on a scale
Standard Deviation 2.01
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Taste
Day 2
|
2.1 score on a scale
Standard Deviation 2.03
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Taste
Day 3
|
1.8 score on a scale
Standard Deviation 1.91
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Taste
Day 4
|
1.4 score on a scale
Standard Deviation 1.67
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Taste
Day 5
|
1.3 score on a scale
Standard Deviation 1.65
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Taste
Day 6
|
1.3 score on a scale
Standard Deviation 1.78
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Taste
Day 7
|
1.3 score on a scale
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: Day 1, 2, 3, 4, 5, 6 and 7Population: 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.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=98 Participants
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 occured first.
|
|---|---|
|
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
|
|
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
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People
Day 3
|
1.6 score on a scale
Standard Deviation 1.70
|
|
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
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People
Day 5
|
1.0 score on a scale
Standard Deviation 1.40
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People
Day 6
|
1.0 score on a scale
Standard Deviation 1.50
|
|
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
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, 5, 6 and 7Population: 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.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=98 Participants
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 occured first.
|
|---|---|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Energy
Day 1
|
3.1 score on a scale
Standard Deviation 2.02
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Energy
Day 2
|
2.5 score on a scale
Standard Deviation 2.06
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Energy
Day 3
|
2.1 score on a scale
Standard Deviation 1.87
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Energy
Day 4
|
1.8 score on a scale
Standard Deviation 1.94
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Energy
Day 5
|
1.4 score on a scale
Standard Deviation 1.54
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Energy
Day 6
|
1.2 score on a scale
Standard Deviation 1.44
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Energy
Day 7
|
1.0 score on a scale
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, 5, 6 and 7Population: 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.
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.
Outcome measures
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=98 Participants
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 occured first.
|
|---|---|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation
Day 1
|
2.9 score on a scale
Standard Deviation 2.19
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation
Day 2
|
2.4 score on a scale
Standard Deviation 1.92
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation
Day 3
|
2.0 score on a scale
Standard Deviation 1.90
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation
Day 4
|
1.7 score on a scale
Standard Deviation 1.89
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation
Day 5
|
1.4 score on a scale
Standard Deviation 1.61
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation
Day 6
|
1.2 score on a scale
Standard Deviation 1.54
|
|
Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation
Day 7
|
1.1 score on a scale
Standard Deviation 1.49
|
Adverse Events
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)
n=102 participants at risk
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 occured first.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
2/102 • From first dose of study product administration up to Day 7
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). All-Cause Mortality included all randomized participants. Serious and Other AEs: Safety population included all participants who used study product at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.98%
1/102 • From first dose of study product administration up to Day 7
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). All-Cause Mortality included all randomized participants. Serious and Other AEs: Safety population included all participants who used study product at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.98%
1/102 • From first dose of study product administration up to Day 7
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). All-Cause Mortality included all randomized participants. Serious and Other AEs: Safety population included all participants who used study product at least once.
|
|
Eye disorders
Eye Pruritus
|
0.98%
1/102 • From first dose of study product administration up to Day 7
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). All-Cause Mortality included all randomized participants. Serious and Other AEs: Safety population included all participants who used study product at least once.
|
|
Eye disorders
Lacrimation Increased
|
0.98%
1/102 • From first dose of study product administration up to Day 7
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). All-Cause Mortality included all randomized participants. Serious and Other AEs: Safety population included all participants who used study product at least once.
|
|
Nervous system disorders
Headache
|
2.0%
2/102 • From first dose of study product administration up to Day 7
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). All-Cause Mortality included all randomized participants. Serious and Other AEs: Safety population included all participants who used study product at least once.
|
|
Gastrointestinal disorders
Nausea
|
0.98%
1/102 • From first dose of study product administration up to Day 7
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). All-Cause Mortality included all randomized participants. Serious and Other AEs: Safety population included all participants who used study product at least once.
|
|
Infections and infestations
Sinusitis
|
0.98%
1/102 • From first dose of study product administration up to Day 7
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). All-Cause Mortality included all randomized participants. Serious and Other AEs: Safety population included all participants who used study product at least once.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER