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

Last updated: February 25, 2025
Sponsor: HALEON
Overall Status: Completed

Phase

4

Condition

Common Cold

Acute Rhinitis

Treatment

Robitussin Maximum Strength Cough and Chest Congestion DM

Robitussin Maximum Strength Nighttime Cough DM

Clinical Study ID

NCT06716645
300233
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant provides a signed and dated electronic informed consent documentindicating that the participant has been informed of and consents to all pertinentaspects of the study, before any assessment is performed and participant hasreviewed and is willing to follow the product label.

  • Participant aged 18 years or older at the time of electronic consent, inclusive ofall ethnicities, races and gender identities.

  • Participant reporting initiation of cough symptoms within 48 hours prior toinitiation of the virtual visit.

  • Participant reporting a minimum score of 5 (moderate) for cough associated withcommon cold symptoms and at least one other symptom of common cold (at least mildscore 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 andis willing to use their device to complete study surveys and assessments per theschedule of events.

  • Participant who has not taken any cough products containing dextromethorphan,guaifenesin, or doxylamine (example, Robitussin, Delsym, Vicks, Mucinex), or coughdrops/lozenges containing benzocaine or menthol (example, Cepacol, Halls, Ricola) orany natural cough products during the study.

Exclusion

Exclusion Criteria:

  • Have a history of allergies (example, rash, hives, difficulty breathing, swelling offace, lips, tongue, or throat) to any medication or any kind or sensitivity toingredients in pain, cough, cold, and flu products; including the following activeingredients 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, naturaland 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 studyproducts.

  • Participant who is pregnant, lactating, or plans to be pregnant or lactating duringthe course of the study (self-report).

  • Participant who has taken any cough products containing dextromethorphan,guaifenesin, or doxylamine (example, Robitussin, Delsym, Vicks, Mucinex), or coughdrops/lozenges containing benzocaine or menthol (example, Cepacol, Halls, Ricola) orany 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 (difficultyin 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 ashaloperidol 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 theconduct of the study or a member of their immediate family; or a Haleon employeedirectly 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 inthis study.

  • Participant who, in the opinion of the investigator or delegate, should notparticipate in the study, including a participant who meets any of the "stop use"criteria recommended by the label.

Study Design

Total Participants: 244
Treatment Group(s): 2
Primary Treatment: Robitussin Maximum Strength Cough and Chest Congestion DM
Phase: 4
Study Start date:
December 04, 2024
Estimated Completion Date:
February 14, 2025

Study 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.

Connect with a study center

  • Lindus Health Limited

    London, England SE1 0NW
    United Kingdom

    Site Not Available

  • Lindus Health Limited

    New York, New York 10017
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.