A Phase 4 interventional study of Robitussin Maximum Strength Cough and Chest Congestion DM and Robitussin Maximum Strength Cough and Chest Congestion DM in Common Cold and Cough, sponsored by HALEON. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by HALEON · Phase 4, Interventional, and Treatment
The purpose of this Real-World Evidence study is to generate real world data from participants with cough associated with the common cold, evaluating the effects in two arms with commercially available cough syrups on health-related quality of life (QoL). Arm 1 includes one cough syrup (which can be used day or night) and Arm 2 includes the daytime cough syrup and a nighttime cough syrup.
This is a longitudinal, randomized, decentralized, open-label study evaluating the effect on QoL factors in participants with cough associated with the common cold in two arms using Robitussin Maximum Strength in a real-world setting. A sufficient number of adult participants (approximately 372) with symptoms of common cold will be screened for eligibility. The study expects to enroll approximately 260 eligible participants with a total of 200 participants expected to complete the study, approximately 100 in each study group. Participants will be randomized into one of two study groups (at a 1:1 ratio). Participants will be recruited through targeted advertising on social media channels and participants will not be required to physically attend any on-site visits.
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's enrollment of 244 is above the median of 150 across 184 interventional studies indexed under Common Cold.
Browse Common Cold studies →HALEON is the lead sponsor of 64 studies on the registry; 9 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Have a history of allergies (example, rash, hives, difficulty breathing, swelling of face, lips, tongue, or throat) to any medication or any kind or sensitivity to ingredients in pain, cough, cold, and flu products; including the following active ingredients found in the Research products:
Have previously been diagnosed with:
Are taking medication(s) to treat - psychiatric / mental health conditions (example, anxiety, depression) or Parkinson's disease. Medications such as:
1. Monoamine oxidase inhibitor (MAOI) [example, Azilect, Emsam, Marplan, Nardil] or have stopped them within the last 2 weeks per their doctor's advice.
Participant who is currently experiencing:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be instructed to take up to 20 milliliters (ml) of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurs first.
Drug: Robitussin Maximum Strength Cough and Chest Congestion DM
Participants will be instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup and up to 20 ml of Robitussin Maximum Strength Nighttime Cough DM syrup orally (not to exceed 4 doses of daytime + 1 dose of nighttime or 3 doses of daytime + 2 doses of nighttime in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurs first.
Drug: Robitussin Maximum Strength Cough and Chest Congestion DM · Drug: Robitussin Maximum Strength Nighttime Cough DM
Dextromethorphan Hydrobromide, United States Pharmacopeia (USP) 20 milligram (mg) and Guaifenesin, USP 400 mg
Dextromethorphan Hydrobromide, USP 20 mg and Guaifenesin, USP 400 mg
Dextromethorphan Hydrobromide, USP 30 mg and Doxylamine Succinate, USP 12.5 mg
Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score
The WURSS was 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 was the short version of this validated survey. Participants rated their cold symptoms (10 questions) and Quality of Life (QoL) related 9 questions using WURSS-21. The responses 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. Change from Baseline was calculated as each post-Baseline value minus Baseline value. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information).
Time frame: Baseline and up to Day 7 or End of Treatment (EOT)
Adjusted Mean Change From Baseline in WURSS-21 Total Symptom Domain Score
The WURSS was 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 was the short version of this validated survey. The symptom domain of WURSS-21 consisted of 10 questions. Participants rated their cold symptoms related questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms and 7=Severe. Thus, the minimum and maximum possible total score was 0 and 70 respectively, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Adjusted Mean Change From Baseline in WURSS-21 Total QoL Domain Score
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated their QoL related questions and the responses 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 more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Cough
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Runny Nose
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Plugged Nose
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sneezing
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sore Throat
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Scratchy Throat
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Hoarseness
The WURSS was 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 was the short version of this validated survey. The individual symptoms include 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Head Congestion
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Chest Congestion
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Feeling Tired
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Think Clearly
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Sleep Well
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicate more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Breathe Easily
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Walk, Climb Stairs, Exercise
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Accomplish Daily Activities
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Work Outside the Home
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Work Inside the Home
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Interact With Others
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Live Your Personal Life
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Social Activities
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, 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. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Self-conscious Around People
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, 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. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Coughing in Public
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, 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. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Falling Asleep
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, 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. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Sleeping Through the Night
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, 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. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Energy
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, 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. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Motivation
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, 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. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Categorized QoL Questions Score: Sleep Quality
The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Sleep quality category included 3 individual questions - Sleep well (WURSS-21: Question 13), Falling asleep (QoL: Question 4) and Sleep through the night (QoL: Question 5). Participants rated each question, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total scores was 0 and 21 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Categorized QoL Questions Score: Vitality
The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Vitality category was assessed using 3 individual questions - Energy (QoL: Question 6), Motivation (QoL: Question 7), and Feel tired (WURSS-21: Question 11). Participants rated each question, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total score was 0 and 21 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Categorized QoL Questions Score: Physical Activities
The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Physical Activities were assessed using 3 individual questions - Breathe easily (WURSS-21: Question 14), Walk, climb stairs, exercise (WURSS-21: Question 15) and Accomplish daily activities (WURSS-21: Question 16). Participants rated each question, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total score was 0 and 21 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Categorized QoL Questions Score: Social Activities
The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Social Activities were assessed using 4 individual questions - Interact with others (WURSS-21: Question 19), Less comfortable in social activities (QoL: Question 1), Self-conscious around others (QoL: Question 2) and Coughing in public (QoL: Question 3). Participants rated each question and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total score was 0 and 28 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 7 or EOT
This study was conducted at a single center in United States of America.
| Milestone | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Started | 122 | 122 |
| Completed | 110 | 109 |
| Not completed | 12 | 13 |
| Withdrew: Unable to deliver study product | 4 | 7 |
| Withdrew: Lost to follow-up | 6 | 2 |
| Withdrew: Ineligibility | 2 | 2 |
| Withdrew: Non-compliance | 0 | 2 |
The WURSS was 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 was the short version of this validated survey. Participants rated their cold symptoms (10 questions) and Quality of Life (QoL) related 9 questions using WURSS-21. The responses 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. Change from Baseline was calculated as each post-Baseline value minus Baseline value. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information).
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -9.56 (-14.45 to -4.66) | -9.11 (-13.49 to -4.73) |
| Day 2 | -26.49 (-31.51 to -21.47) | -22.97 (-27.43 to -18.51) |
| Day 3 | -40.99 (-46.09 to -35.89) | -36.71 (-41.28 to -32.14) |
| Day 4 | -47.63 (-53.07 to -42.18) | -47.20 (-52.00 to -42.40) |
| Day 5 | -51.20 (-57.14 to -45.25) | -55.05 (-60.13 to -49.96) |
| Day 6 | -58.29 (-64.83 to -51.75) | -64.12 (-69.53 to -58.72) |
| Day 7 | -61.58 (-69.87 to -53.30) | -64.69 (-72.62 to -56.76) |
| EOT | -55.64 (-60.25 to -51.03) | -53.62 (-57.70 to -49.55) |
The WURSS was 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 was the short version of this validated survey. The symptom domain of WURSS-21 consisted of 10 questions. Participants rated their cold symptoms related questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms and 7=Severe. Thus, the minimum and maximum possible total score was 0 and 70 respectively, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -6.48 (-9.00 to -3.95) | -5.89 (-8.27 to -3.51) |
| Day 2 | -14.59 (-17.18 to -12.00) | -13.58 (-15.99 to -11.16) |
| Day 3 | -22.56 (-25.19 to -19.93) | -21.26 (-23.73 to -18.79) |
| Day 4 | -25.97 (-28.79 to -23.16) | -26.58 (-29.16 to -24.00) |
| Day 5 | -28.05 (-31.13 to -24.98) | -30.46 (-33.19 to -27.74) |
| Day 6 | -31.76 (-35.15 to -28.37) | -35.40 (-38.28 to -32.52) |
| Day 7 | -32.41 (-36.72 to -28.11) | -37.07 (-41.21 to -32.93) |
| EOT | -30.03 (-32.40 to -27.66) | -30.14 (-32.34 to -27.95) |
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated their QoL related questions and the responses 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 more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -3.06 (-5.71 to -0.40) | -3.28 (-5.73 to -0.83) |
| Day 2 | -11.87 (-14.59 to -9.16) | -9.44 (-11.94 to -6.93) |
| Day 3 | -18.40 (-21.16 to -15.63) | -15.49 (-18.07 to -12.91) |
| Day 4 | -21.56 (-24.52 to -18.60) | -20.61 (-23.34 to -17.87) |
| Day 5 | -23.05 (-26.29 to -19.81) | -24.54 (-27.46 to -21.62) |
| Day 6 | -26.40 (-29.98 to -22.83) | -28.63 (-31.76 to -25.50) |
| Day 7 | -28.99 (-33.54 to -24.44) | -27.55 (-32.31 to -22.80) |
| EOT | -25.57 (-28.08 to -23.05) | -23.54 (-25.86 to -21.23) |
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.87 (-1.20 to -0.54) | -0.96 (-1.25 to -0.68) |
| Day 2 | -1.91 (-2.26 to -1.57) | -1.77 (-2.06 to -1.48) |
| Day 3 | -2.91 (-3.26 to -2.57) | -2.78 (-3.08 to -2.48) |
| Day 4 | -3.34 (-3.71 to -2.96) | -3.46 (-3.78 to -3.14) |
| Day 5 | -3.66 (-4.07 to -3.25) | -3.78 (-4.12 to -3.43) |
| Day 6 | -4.01 (-4.47 to -3.55) | -4.44 (-4.80 to -4.07) |
| Day 7 | -4.29 (-4.88 to -3.70) | -4.54 (-5.10 to -3.97) |
| EOT | -3.96 (-4.26 to -3.66) | -3.92 (-4.19 to -3.65) |
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.65 ± 1.49 | -0.33 ± 1.51 |
| Day 2 | -1.29 ± 1.85 | -1.02 ± 1.70 |
| Day 3 | -2.05 ± 1.93 | -1.61 ± 1.69 |
| Day 4 | -2.33 ± 1.89 | -1.97 ± 2.11 |
| Day 5 | -2.23 ± 2.05 | -2.29 ± 1.67 |
| Day 6 | -2.33 ± 1.88 | -2.71 ± 1.84 |
| Day 7 | -2.48 ± 1.63 | -2.47 ± 2.50 |
| EOT | -2.80 ± 1.93 | -2.60 ± 1.89 |
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.58 ± 1.63 | -0.22 ± 1.37 |
| Day 2 | -1.25 ± 1.88 | -1.01 ± 1.79 |
| Day 3 | -1.94 ± 2.08 | -1.65 ± 1.95 |
| Day 4 | -2.09 ± 2.03 | -1.84 ± 2.10 |
| Day 5 | -2.15 ± 2.13 | -2.02 ± 2.04 |
| Day 6 | -2.15 ± 2.12 | -2.82 ± 1.64 |
| Day 7 | -2.14 ± 2.13 | -2.67 ± 2.16 |
| EOT | -2.52 ± 2.28 | -2.52 ± 1.93 |
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.65 ± 1.61 | -0.59 ± 1.53 |
| Day 2 | -1.43 ± 1.92 | -1.09 ± 1.77 |
| Day 3 | -1.88 ± 2.03 | -1.60 ± 1.80 |
| Day 4 | -2.10 ± 2.18 | -1.83 ± 1.80 |
| Day 5 | -2.06 ± 2.10 | -1.75 ± 1.64 |
| Day 6 | -2.05 ± 1.78 | -2.04 ± 1.51 |
| Day 7 | -1.86 ± 1.65 | -2.00 ± 1.96 |
| EOT | -2.64 ± 1.93 | -2.24 ± 1.95 |
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.84 ± 1.68 | -0.70 ± 1.57 |
| Day 2 | -1.65 ± 1.91 | -1.53 ± 1.61 |
| Day 3 | -2.23 ± 2.08 | -2.26 ± 1.78 |
| Day 4 | -2.36 ± 2.04 | -2.86 ± 1.87 |
| Day 5 | -2.42 ± 2.13 | -2.70 ± 1.76 |
| Day 6 | -2.72 ± 1.92 | -3.56 ± 1.63 |
| Day 7 | -2.48 ± 1.99 | -3.27 ± 1.67 |
| EOT | -2.96 ± 1.98 | -3.23 ± 1.87 |
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.72 ± 1.64 | -1.10 ± 1.44 |
| Day 2 | -1.49 ± 1.99 | -1.91 ± 1.87 |
| Day 3 | -2.28 ± 2.27 | -2.61 ± 1.79 |
| Day 4 | -2.42 ± 2.23 | -3.11 ± 1.69 |
| Day 5 | -2.62 ± 2.20 | -3.04 ± 1.77 |
| Day 6 | -2.85 ± 2.01 | -3.73 ± 1.54 |
| Day 7 | -3.05 ± 2.09 | -3.80 ± 1.66 |
| EOT | -3.06 ± 1.99 | -3.58 ± 1.82 |
The WURSS was 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 was the short version of this validated survey. The individual symptoms include 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.73 ± 1.48 | -0.54 ± 1.58 |
| Day 2 | -1.66 ± 1.78 | -1.03 ± 1.59 |
| Day 3 | -2.28 ± 2.06 | -1.91 ± 1.59 |
| Day 4 | -2.38 ± 2.11 | -2.41 ± 1.86 |
| Day 5 | -2.67 ± 2.10 | -2.62 ± 2.06 |
| Day 6 | -2.72 ± 2.08 | -3.22 ± 1.96 |
| Day 7 | -2.67 ± 1.80 | -3.07 ± 2.09 |
| EOT | -3.15 ± 2.00 | -2.95 ± 2.06 |
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.54 ± 1.68 | -0.41 ± 1.78 |
| Day 2 | -1.31 ± 1.98 | -0.92 ± 1.77 |
| Day 3 | -1.95 ± 2.31 | -1.81 ± 1.71 |
| Day 4 | -2.17 ± 2.37 | -1.94 ± 2.29 |
| Day 5 | -2.21 ± 2.25 | -2.32 ± 2.07 |
| Day 6 | -2.51 ± 1.99 | -3.00 ± 1.75 |
| Day 7 | -2.38 ± 2.42 | -3.00 ± 2.45 |
| EOT | -2.91 ± 2.06 | -2.67 ± 2.09 |
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.55 ± 1.57 | -0.49 ± 1.66 |
| Day 2 | -1.30 ± 1.88 | -1.01 ± 1.65 |
| Day 3 | -1.95 ± 1.78 | -1.98 ± 1.87 |
| Day 4 | -2.13 ± 1.76 | -2.16 ± 2.00 |
| Day 5 | -2.33 ± 2.02 | -2.34 ± 1.71 |
| Day 6 | -2.31 ± 1.76 | -2.87 ± 1.44 |
| Day 7 | -2.33 ± 1.65 | -3.07 ± 2.19 |
| EOT | -2.75 ± 1.94 | -2.82 ± 1.92 |
The WURSS was 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 was 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 and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.63 ± 1.65 | -0.68 ± 1.52 |
| Day 2 | -1.65 ± 2.04 | -1.42 ± 1.64 |
| Day 3 | -2.69 ± 1.95 | -2.20 ± 1.93 |
| Day 4 | -2.93 ± 2.26 | -2.61 ± 1.96 |
| Day 5 | -2.87 ± 2.00 | -2.95 ± 1.80 |
| Day 6 | -3.49 ± 1.96 | -3.51 ± 1.74 |
| Day 7 | -2.81 ± 1.94 | -3.47 ± 2.03 |
| EOT | -3.47 ± 2.02 | -3.50 ± 1.78 |
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.29 ± 1.76 | -0.34 ± 1.67 |
| Day 2 | -1.11 ± 2.02 | -0.97 ± 1.96 |
| Day 3 | -1.78 ± 1.86 | -1.55 ± 2.22 |
| Day 4 | -1.81 ± 2.43 | -1.97 ± 2.26 |
| Day 5 | -1.90 ± 2.31 | -1.88 ± 2.27 |
| Day 6 | -2.41 ± 2.04 | -2.62 ± 2.05 |
| Day 7 | -2.24 ± 1.87 | -2.13 ± 3.50 |
| EOT | -2.62 ± 1.91 | -2.41 ± 2.35 |
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicate more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.92 ± 2.22 | -0.83 ± 2.35 |
| Day 2 | -1.91 ± 2.37 | -1.57 ± 2.40 |
| Day 3 | -2.58 ± 2.40 | -2.35 ± 2.50 |
| Day 4 | -2.74 ± 2.85 | -2.66 ± 2.39 |
| Day 5 | -2.83 ± 2.66 | -3.09 ± 2.10 |
| Day 6 | -3.10 ± 2.82 | -3.47 ± 2.31 |
| Day 7 | -2.24 ± 2.51 | -3.87 ± 2.36 |
| EOT | -3.63 ± 2.34 | -3.27 ± 2.54 |
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.47 ± 1.80 | -0.48 ± 1.67 |
| Day 2 | -1.40 ± 2.02 | -0.92 ± 1.88 |
| Day 3 | -2.27 ± 1.88 | -1.66 ± 1.81 |
| Day 4 | -2.48 ± 2.36 | -2.04 ± 1.99 |
| Day 5 | -2.38 ± 2.09 | -2.21 ± 1.98 |
| Day 6 | -2.41 ± 2.02 | -2.87 ± 1.85 |
| Day 7 | -1.86 ± 2.03 | -2.00 ± 1.89 |
| EOT | -2.90 ± 2.06 | -2.52 ± 2.11 |
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.43 ± 1.80 | -0.14 ± 1.93 |
| Day 2 | -1.23 ± 1.93 | -0.66 ± 2.15 |
| Day 3 | -1.70 ± 1.96 | -1.29 ± 2.11 |
| Day 4 | -2.00 ± 2.37 | -1.76 ± 2.13 |
| Day 5 | -1.87 ± 2.13 | -2.09 ± 2.04 |
| Day 6 | -1.95 ± 1.50 | -2.60 ± 1.84 |
| Day 7 | -2.10 ± 1.61 | -2.40 ± 2.03 |
| EOT | -2.55 ± 2.03 | -2.14 ± 2.25 |
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.44 ± 1.81 | -0.23 ± 1.52 |
| Day 2 | -1.46 ± 1.83 | -0.87 ± 1.86 |
| Day 3 | -2.17 ± 1.96 | -1.46 ± 1.85 |
| Day 4 | -2.28 ± 2.27 | -1.84 ± 1.84 |
| Day 5 | -2.13 ± 1.85 | -2.12 ± 1.83 |
| Day 6 | -2.38 ± 1.63 | -2.78 ± 1.64 |
| Day 7 | -2.43 ± 1.69 | -2.80 ± 1.52 |
| EOT | -2.94 ± 2.00 | -2.56 ± 1.93 |
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.35 ± 2.22 | -0.32 ± 1.84 |
| Day 2 | -1.25 ± 2.04 | -0.78 ± 2.08 |
| Day 3 | -2.01 ± 2.05 | -1.46 ± 2.00 |
| Day 4 | -2.06 ± 2.53 | -1.71 ± 2.09 |
| Day 5 | -2.10 ± 2.21 | -2.11 ± 2.07 |
| Day 6 | -2.26 ± 1.96 | -2.47 ± 2.07 |
| Day 7 | -2.33 ± 2.73 | -2.40 ± 2.06 |
| EOT | -2.64 ± 2.38 | -2.51 ± 2.28 |
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.29 ± 1.72 | -0.27 ± 1.77 |
| Day 2 | -1.21 ± 1.80 | -0.88 ± 1.88 |
| Day 3 | -1.98 ± 1.90 | -1.40 ± 2.00 |
| Day 4 | -2.01 ± 2.34 | -1.86 ± 1.91 |
| Day 5 | -2.10 ± 2.14 | -2.21 ± 1.93 |
| Day 6 | -2.21 ± 1.87 | -2.78 ± 1.92 |
| Day 7 | -2.29 ± 2.19 | -2.40 ± 1.76 |
| EOT | -2.65 ± 2.07 | -2.41 ± 2.10 |
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.28 ± 2.12 | -0.45 ± 1.97 |
| Day 2 | -1.31 ± 2.04 | -1.12 ± 2.07 |
| Day 3 | -2.16 ± 2.07 | -1.82 ± 2.11 |
| Day 4 | -2.20 ± 2.30 | -2.01 ± 2.10 |
| Day 5 | -2.40 ± 2.14 | -2.43 ± 1.85 |
| Day 6 | -2.36 ± 1.98 | -3.07 ± 1.98 |
| Day 7 | -2.52 ± 1.97 | -3.07 ± 1.67 |
| EOT | -2.88 ± 2.15 | -2.77 ± 2.21 |
The WURSS was 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 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses 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 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -0.15 ± 2.11 | -0.55 ± 1.82 |
| Day 2 | -1.42 ± 1.95 | -1.05 ± 2.07 |
| Day 3 | -2.30 ± 2.02 | -1.89 ± 2.08 |
| Day 4 | -2.29 ± 2.19 | -1.94 ± 2.09 |
| Day 5 | -2.29 ± 1.95 | -2.61 ± 2.15 |
| Day 6 | -2.46 ± 1.92 | -3.09 ± 2.00 |
| Day 7 | -2.38 ± 1.75 | -2.73 ± 2.09 |
| EOT | -2.93 ± 2.07 | -2.76 ± 2.30 |
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, 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. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -2.51 ± 2.15 | -2.70 ± 1.95 |
| Day 2 | -3.15 ± 2.13 | -2.97 ± 2.04 |
| Day 3 | -3.58 ± 1.88 | -3.49 ± 2.01 |
| Day 4 | -3.99 ± 1.94 | -3.79 ± 1.85 |
| Day 5 | -3.84 ± 2.12 | -4.00 ± 1.81 |
| Day 6 | -4.11 ± 1.97 | -4.40 ± 1.86 |
| Day 7 | -3.57 ± 1.99 | -4.86 ± 2.41 |
| EOT | -4.29 ± 1.90 | -4.34 ± 2.07 |
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, 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. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -1.91 ± 1.93 | -2.03 ± 1.94 |
| Day 2 | -2.65 ± 2.10 | -2.78 ± 1.85 |
| Day 3 | -3.19 ± 1.87 | -3.37 ± 2.11 |
| Day 4 | -3.55 ± 2.14 | -3.55 ± 2.22 |
| Day 5 | -3.53 ± 2.09 | -3.68 ± 1.93 |
| Day 6 | -3.55 ± 2.13 | -4.31 ± 1.83 |
| Day 7 | -3.48 ± 2.48 | -4.64 ± 1.45 |
| EOT | -3.97 ± 1.86 | -4.21 ± 2.01 |
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, 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. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -2.03 ± 2.09 | -2.23 ± 1.76 |
| Day 2 | -2.93 ± 2.09 | -2.96 ± 2.08 |
| Day 3 | -3.44 ± 1.98 | -3.63 ± 2.21 |
| Day 4 | -3.83 ± 2.20 | -3.73 ± 2.19 |
| Day 5 | -3.86 ± 2.17 | -4.09 ± 1.95 |
| Day 6 | -3.89 ± 2.20 | -4.48 ± 2.09 |
| Day 7 | -3.57 ± 2.23 | -4.93 ± 2.20 |
| EOT | -4.29 ± 2.18 | -4.64 ± 1.93 |
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, 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. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -2.86 ± 1.88 | -3.40 ± 2.08 |
| Day 2 | -3.35 ± 1.93 | -3.54 ± 1.91 |
| Day 3 | -4.19 ± 1.75 | -4.27 ± 1.91 |
| Day 4 | -4.35 ± 1.99 | -4.39 ± 1.89 |
| Day 5 | -4.02 ± 2.19 | -4.43 ± 1.58 |
| Day 6 | -4.26 ± 2.11 | -4.90 ± 1.82 |
| Day 7 | -4.33 ± 1.80 | -5.21 ± 1.93 |
| EOT | -4.86 ± 1.66 | -5.07 ± 1.66 |
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, 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. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -3.05 ± 1.95 | -3.51 ± 2.06 |
| Day 2 | -3.40 ± 1.92 | -3.73 ± 2.03 |
| Day 3 | -4.08 ± 1.86 | -4.28 ± 1.93 |
| Day 4 | -4.16 ± 2.06 | -4.40 ± 1.92 |
| Day 5 | -3.92 ± 2.09 | -4.47 ± 1.60 |
| Day 6 | -4.11 ± 2.04 | -4.88 ± 1.58 |
| Day 7 | -4.19 ± 1.83 | -5.00 ± 1.66 |
| EOT | -4.91 ± 1.64 | -5.12 ± 1.55 |
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, 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. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -2.33 ± 2.21 | -2.39 ± 1.95 |
| Day 2 | -3.17 ± 2.12 | -2.75 ± 2.00 |
| Day 3 | -3.70 ± 1.94 | -3.42 ± 1.89 |
| Day 4 | -4.14 ± 2.05 | -3.79 ± 1.89 |
| Day 5 | -3.84 ± 1.90 | -3.83 ± 1.41 |
| Day 6 | -4.11 ± 1.96 | -4.21 ± 1.69 |
| Day 7 | -3.81 ± 1.86 | -4.36 ± 1.82 |
| EOT | -4.53 ± 1.73 | -4.38 ± 1.71 |
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, 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. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -2.21 ± 2.12 | -2.34 ± 1.94 |
| Day 2 | -2.97 ± 2.14 | -2.52 ± 1.94 |
| Day 3 | -3.50 ± 2.10 | -3.41 ± 1.77 |
| Day 4 | -3.93 ± 2.12 | -3.67 ± 1.83 |
| Day 5 | -3.76 ± 1.96 | -4.02 ± 1.35 |
| Day 6 | -4.00 ± 2.00 | -4.29 ± 1.53 |
| Day 7 | -3.86 ± 2.06 | -4.64 ± 1.39 |
| EOT | -4.37 ± 1.79 | -4.27 ± 1.77 |
The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Sleep quality category included 3 individual questions - Sleep well (WURSS-21: Question 13), Falling asleep (QoL: Question 4) and Sleep through the night (QoL: Question 5). Participants rated each question, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total scores was 0 and 21 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -6.85 ± 4.60 | -7.72 ± 4.93 |
| Day 2 | -8.65 ± 5.38 | -8.87 ± 4.99 |
| Day 3 | -10.82 ± 4.90 | -10.90 ± 5.03 |
| Day 4 | -11.25 ± 6.15 | -11.43 ± 4.75 |
| Day 5 | -10.78 ± 6.25 | -11.98 ± 4.07 |
| Day 6 | -11.47 ± 6.09 | -13.17 ± 4.62 |
| Day 7 | -10.76 ± 4.91 | -14.00 ± 5.32 |
| EOT | -13.40 ± 4.89 | -13.43 ± 4.82 |
The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Vitality category was assessed using 3 individual questions - Energy (QoL: Question 6), Motivation (QoL: Question 7), and Feel tired (WURSS-21: Question 11). Participants rated each question, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total score was 0 and 21 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -5.12 ± 5.00 | -5.36 ± 4.22 |
| Day 2 | -7.76 ± 5.21 | -6.74 ± 4.49 |
| Day 3 | -9.88 ± 5.07 | -9.04 ± 4.53 |
| Day 4 | -11.00 ± 5.80 | -10.12 ± 4.84 |
| Day 5 | -10.43 ± 5.31 | -10.75 ± 3.96 |
| Day 6 | -11.53 ± 5.14 | -11.95 ± 4.42 |
| Day 7 | -10.48 ± 5.27 | -12.36 ± 4.36 |
| EOT | -12.37 ± 4.74 | -12.15 ± 4.45 |
The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Physical Activities were assessed using 3 individual questions - Breathe easily (WURSS-21: Question 14), Walk, climb stairs, exercise (WURSS-21: Question 15) and Accomplish daily activities (WURSS-21: Question 16). Participants rated each question, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total score was 0 and 21 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -1.35 ± 4.56 | -0.84 ± 4.11 |
| Day 2 | -4.09 ± 4.76 | -2.45 ± 5.04 |
| Day 3 | -6.14 ± 5.03 | -4.41 ± 4.89 |
| Day 4 | -6.75 ± 6.37 | -5.64 ± 5.06 |
| Day 5 | -6.38 ± 5.56 | -6.43 ± 4.69 |
| Day 6 | -6.74 ± 4.18 | -8.24 ± 4.24 |
| Day 7 | -6.38 ± 4.24 | -7.20 ± 4.41 |
| EOT | -8.39 ± 5.37 | -7.23 ± 5.49 |
The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Social Activities were assessed using 4 individual questions - Interact with others (WURSS-21: Question 19), Less comfortable in social activities (QoL: Question 1), Self-conscious around others (QoL: Question 2) and Coughing in public (QoL: Question 3). Participants rated each question and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total score was 0 and 28 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
| score on a scale | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| Day 1 | -6.70 ± 6.05 | -7.38 ± 5.13 |
| Day 2 | -9.99 ± 6.77 | -9.90 ± 6.19 |
| Day 3 | -12.36 ± 6.48 | -12.34 ± 6.80 |
| Day 4 | -13.57 ± 7.43 | -13.12 ± 6.90 |
| Day 5 | -13.61 ± 7.50 | -14.13 ± 6.40 |
| Day 6 | -13.87 ± 7.14 | -16.21 ± 6.84 |
| Day 7 | -13.14 ± 7.86 | -17.50 ± 7.10 |
| EOT | -15.43 ± 6.67 | -15.93 ± 6.88 |
Collected over Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (approximately up to 10 days).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Robitussin Cough Syrup (Daytime) | 0/115 (0%) | 0/115 (0%) | 2/115 (1.7%) |
| Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | 0/112 (0%) | 0/112 (0%) | 0/112 (0%) |
| Event | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/115 | 0/112 |
| NauseaGastrointestinal disorders | 1/115 | 0/112 |
Safety Population included all participants who used the study product at least once.
| Age, Continuous(years) | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | Total |
|---|---|---|---|
| Mean | 40.7 ± 11.4 | 39.4 ± 11.2 | 40.1 ± 11.3 |
| Sex: Female, Male(Participants) | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | Total |
|---|---|---|---|
| Female | 73 | 71 | 144 |
| Male | 42 | 41 | 83 |
| Ethnicity (NIH/OMB)(Participants) | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 12 | 25 |
| Not Hispanic or Latino | 102 | 99 | 201 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race/Ethnicity, Customized(Participants) | Robitussin Cough Syrup (Daytime) | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | Total |
|---|---|---|---|
| Asian | 8 | 5 | 13 |
| Black or African American | 23 | 28 | 51 |
| Hispanic | 1 | 2 | 3 |
| Latino | 1 | 0 | 1 |
| Middle Eastern | 0 | 1 | 1 |
| Mixed | 1 | 1 | 2 |
| Multiple | 6 | 7 | 13 |
| Native Hawaiian / Other Pacific Islander | 1 | 0 | 1 |
| White | 74 | 67 | 141 |
| Missing | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.