Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
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. |
Baseline (Day 0) up to Day 7 |
|
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. |
Baseline (Day 0) up to Day 7 |
|
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. |
Baseline (Day 0) up to Day 7 |
|
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. |
Baseline (Day 0) up to Day 7 |
|
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. |
Baseline (Day 0) up to Day 7 |
|
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. |
Baseline (Day 0) up to Day 7 |
|
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. |
Baseline (Day 0) up to Day 7 |
|
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. |
Baseline (Day 0) up to Day 7 |
|
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. |
Baseline (Day 0) up to Day 7 |
|
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. |
Baseline (Day 0) up to Day 7 |
|
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. |
Baseline (Day 0) up to Day 7 |
|
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. |
Baseline (Day 0) up to Day 7 |
|
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. |
Baseline (Day 0) up to Day 7 |
|
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. |
Days 1, 2, 3, 4, 5, 6, and 7 |
|
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. |
Days 1, 2, 3, 4, 5, 6, and 7 |
|
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. |
Days 1, 2, 3, 4, 5, 6, and 7 |
|
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. |
Days 1, 2, 3, 4, 5, 6 and 7 |
|
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. |
Days 1, 2, 3, 4, 5, 6 and 7 |
|
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. |
Day 1, 2, 3, 4, 5, 6 and 7 |
|
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. |
Days 1, 2, 3, 4, 5, 6 and 7 |
|
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. |
Days 1, 2, 3, 4, 5, 6 and 7 |
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