A Clinical Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin

A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin

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.

Study Overview

• Status: Completed
• Conditions: Cough; Common Cold
• Intervention / Treatment: Drug: Robitussin Maximum Strength Cough and Chest Congestion DM; Drug: Robitussin Maximum Strength Cough and Chest Congestion DM; Drug: Robitussin Maximum Strength Nighttime Cough DM

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Lindus Health Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant provides a signed and dated electronic informed consent document indicating that the participant has been informed of and consents to all pertinent aspects of the study, before any assessment is performed and participant has reviewed and is willing to follow the product label.
• Participant aged 18 years or older at the time of electronic consent, inclusive of all ethnicities, races and gender identities.
• Participant reporting initiation of cough symptoms within 48 hours prior to initiation of the virtual visit.
• Participant reporting a minimum score of 5 (moderate) for cough associated with common cold symptoms and at least one other symptom of common cold (at least mild score of 3) as per the WURSS-21 symptom domains.
• Participant reporting at least one night's sleep has been disrupted in the previous 2 nights due to the symptoms of common cold.
• Participant who is willing to self-treat their cough using the study treatment.
• Participant who is in good general and mental health.
• Participant who resides in the United States (except for Hawaii and Alaska).
• Participant who owns a mobile device with access to stable internet connection and is willing to use their device to complete study surveys and assessments per the schedule of events.
• Participant who has not taken any cough products containing dextromethorphan, guaifenesin, or doxylamine (example, Robitussin, Delsym, Vicks, Mucinex), or cough drops/lozenges containing benzocaine or menthol (example, Cepacol, Halls, Ricola) or any natural cough products during the study.

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:

  1. Active Ingredients - dextromethorphan, guaifenesin, doxylamine.
  2. Inactive Ingredients - anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, xanthan gum.
• Participant who is currently taking medications that may interact with the study products.
• Participant who is pregnant, lactating, or plans to be pregnant or lactating during the course of the study (self-report).
• Participant who has taken any cough products containing dextromethorphan, guaifenesin, or doxylamine (example, Robitussin, Delsym, Vicks, Mucinex), or cough drops/lozenges containing benzocaine or menthol (example, Cepacol, Halls, Ricola) or any natural cough products within 7 days prior to the virtual visit.

• Have previously been diagnosed with:

  1. prostate gland enlargement or difficulty urinating.
  2. glaucoma (excessive pressure inside your eyes).
  3. asthma, chronic bronchitis, chronic cough or chronic lung disease (difficulty in breathing and cough that won't go away).
  4. Pneumonia (within the last 6 months).
  5. Coronavirus disease (COVID-19) (within the last month).

• 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.

• Are currently taking sedatives or tranquilizers (example, Ambien, Xanax, Klonopin).
• Are taking drugs for heart problems such as quinidine, amiodarone or metoprolol, antidepressants such as fluoxetine and paroxetine, or antipsychotics such as haloperidol and thioridazine.

• Participant who is currently experiencing:

  1. cough accompanied by fever, rash, or persistent headache OR
  2. cough with too much phlegm.
• Participant who is an employee of Lindus Health, either directly involved in the conduct of the study or a member of their immediate family; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
• Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry.
• Participant who has previously been enrolled in this study.
• Participant sharing the same address as another participant who has been enrolled in this study.
• Participant who, in the opinion of the investigator or delegate, should not participate in the study, including a participant who meets any of the "stop use" criteria recommended by the label.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robitussin Cough Syrup (Daytime); 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; Dextromethorphan Hydrobromide, United States Pharmacopeia (USP) 20 milligram (mg) and Guaifenesin, USP 400 mg; Drug: Robitussin Maximum Strength Cough and Chest Congestion DM; Dextromethorphan Hydrobromide, USP 20 mg and Guaifenesin, USP 400 mg
Experimental: Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime); 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; Dextromethorphan Hydrobromide, United States Pharmacopeia (USP) 20 milligram (mg) and Guaifenesin, USP 400 mg; Drug: Robitussin Maximum Strength Cough and Chest Congestion DM; Dextromethorphan Hydrobromide, USP 20 mg and Guaifenesin, USP 400 mg; Drug: Robitussin Maximum Strength Nighttime Cough DM; Dextromethorphan Hydrobromide, USP 30 mg and Doxylamine Succinate, USP 12.5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline and up to Day 7 or EOT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline and up to Day 7 or EOT

Collaborators and Investigators

• Sponsor: HALEON

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Actual): February 14, 2025
• Study Completion (Actual): February 14, 2025

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Respiration Disorders; Picornaviridae Infections; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cough; Common Cold; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Expectorants; Respiratory System Agents; Excitatory Amino Acid Agents; Excitatory Amino Acid Antagonists; Anti-Obesity Agents; Sympathomimetics; Vasoconstrictor Agents; Antitussive Agents; Nasal Decongestants; Appetite Depressants; Levomethorphan; Dextromethorphan; Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
• Other Study ID Numbers: 300233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No