Clinical trial NCT06716645: A Clinical Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin
Official title: A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Common Cold
Cough
Lead sponsor: HALEON
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score
timeFrame: Baseline and up to Day 8
measure: Change from Baseline in WURSS-21 Total Symptom Domain Score
timeFrame: Baseline and up to Day 8
measure: Change from Baseline in WURSS-21 Total QoL Domain Score
timeFrame: Baseline and up to Day 8
measure: Change from Baseline in Each of the WURSS-21 Symptom Scores (10 Items in Total)
timeFrame: Baseline and up to Day 8
measure: Change from Baseline in Each of the WURSS-21 QoL Questions Scores (9 Items in Total)
timeFrame: Baseline and up to Day 8
Secondary outcomes:
measure: Change from Baseline in QoL Factors Assessed Using Specific QoL Questions
timeFrame: Baseline and up to Day 8
measure: Change from Baseline in Categorized QoL Questions Score: Sleep Quality
timeFrame: Baseline and up to Day 8
measure: Change from Baseline in Categorized QoL Questions Score: Vitality
timeFrame: Baseline and up to Day 8
measure: Change from Baseline in Categorized QoL Questions Score: Physical Activities
timeFrame: Baseline and up to Day 8
measure: Change from Baseline in Categorized QoL Questions Score: Social Activities
timeFrame: Baseline and up to Day 8
Other outcomes:
Locations:
city: New York
country: United States
facility: Lindus Health Limited
state: New York
Study officials:
References: