Robitussin for Cough

Recruiting at 1 trial location

Overseen By Haleon Response Center

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: HALEON

Must not be taking: Antidepressants, Antipsychotics, Sedatives, others

Disqualifiers: Pregnancy, Glaucoma, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 days

244 Participants Needed

Trial Summary

What is the purpose of this trial?

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

This trial is for adults over 18 in the US who started having a cough from a cold within the last 48 hours, with at least moderate severity and one other cold symptom. They must be in good health overall, have had sleep affected by the cold, agree to electronic consent, follow product labels, self-treat using study treatments, own a mobile device with internet for surveys and not have used certain cough medications recently.

Inclusion Criteria

I am willing to use the study treatment for my cough by myself.

Participant provides a signed and dated electronic informed consent document

I have not used any cough products or lozenges during the study.

Exclusion Criteria

Recent participation in other studies involving investigational products

I have a cough with specific symptoms.

Employment status with Lindus Health or Haleon

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Robitussin Maximum Strength Cough and Chest Congestion DM syrup for up to 8 days or until resolution of symptoms

8 days

Follow-up

Participants are monitored for changes in quality of life and symptom scores using WURSS-21 and other QoL assessments

Up to Day 8

Treatment Details

Interventions

• Robitussin

Trial Overview The study tests two Robitussin products on quality of life during a common cold: Arm 1 uses one syrup any time; Arm 2 uses separate day and night syrups. It's real-world evidence research comparing how these options help manage symptoms like sore throat and cough.

Participant Groups

Group I: Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) Experimental Treatment 2 Interventions

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.

Group II: Robitussin Cough Syrup (Daytime) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials

40

Recruited

6,000+