Robitussin for Cough

No longer recruiting at 1 trial location
HR
Overseen ByHaleon Response Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well Robitussin cough syrups improve the quality of life for individuals with coughs from the common cold. Participants will use either a daytime syrup or a combination of daytime and nighttime syrups. The trial seeks individuals who have experienced a cough from a cold starting within the last 48 hours, with symptoms severe enough to disrupt sleep over the past two nights. Those who have not recently used any cough products and are in good health may be suitable for this study. As a Phase 4 trial, this research helps to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

Do I have to stop taking my current medications to join the trial?

Yes, you may need to stop taking certain medications, especially if they interact with the study products or contain specific ingredients like dextromethorphan, guaifenesin, or doxylamine. If you're taking medications for mental health, heart problems, or using sedatives, you might not be eligible to participate.

What is the safety track record for these treatments?

Previous studies have shown that Robitussin Maximum Strength Cough and Chest Congestion DM syrup is widely used and generally well-tolerated. The FDA has not raised safety concerns about its use. This syrup relieves cough and chest congestion, common cold symptoms.

The nighttime version, Robitussin Maximum Strength Nighttime Cough DM, controls cough and aids sleep. Like the daytime version, it is considered safe.

Both syrups include instructions to avoid exceeding the recommended doses in a 24-hour period to prevent side effects. As with many over-the-counter medicines, following the dosing guidelines carefully is important for safety. Overall, both daytime and nighttime Robitussin products are designed to be safe when used as directed.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Robitussin for cough relief because it offers a comprehensive approach to managing symptoms both during the day and at night. Unlike standard treatments that often focus solely on daytime relief, one arm of the trial combines Robitussin Maximum Strength Cough and Chest Congestion DM syrup with a nighttime formula, potentially providing round-the-clock symptom control. This dual approach could mean fewer disruptions to sleep due to coughing, which is a significant advantage over typical daytime-only options. Additionally, the maximum strength formulation aims to tackle both cough and chest congestion, addressing multiple symptoms simultaneously.

What is the effectiveness track record for Robitussin in treating cough associated with the common cold?

Research has shown that Robitussin Maximum Strength Cough and Chest Congestion DM effectively relieves coughs caused by minor throat and chest irritation, such as those from a common cold. In this trial, participants in one arm will receive the daytime syrup, which controls coughs and loosens mucus, easing breathing. Studies indicate that this formula provides quick and effective relief from coughing.

Participants in another arm will receive both the daytime and nighttime syrups. The nighttime syrup is similar but also includes ingredients to aid sleep, which can help manage symptoms at night. While the nighttime formula may cause drowsiness, it effectively reduces cough and chest congestion, promoting better sleep. Overall, Robitussin is well-known for relieving coughs and improving comfort during a cold.16789

Are You a Good Fit for This Trial?

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.
See 7 more

Exclusion Criteria

Recent participation in other studies involving investigational products
I have a cough with specific symptoms.
Employment status with Lindus Health or Haleon
See 10 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime)Experimental Treatment2 Interventions
Group II: Robitussin Cough Syrup (Daytime)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials
40
Recruited
6,000+

Citations

Maximum Strength Cough and Chest Congestion DMRobitussin Maximum Strength Nighttime Cough DM effectively relieves coughs with a tolerable taste, but be aware of significant drowsiness side effects.
Amazon.com: Robitussin Adult Maximum Strength Cough ...Cough suppressant for relief for cough and an expectorant for relief of chest congestion · Maximum-strength formula with expectorant that thins and loosens mucus ...
Label: ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS ...ADULT - Robitussin - MAXIMUM STRENGTH - Cough+Chest - Congestion DM - DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) Controls Cough - ...
Robitussin Maximum Strength Cough + Chest Congestion ...Fast, Effective Cough Relief. With a tough cough suppressant to help reduce the urge to cough, maximum strength Robitussin DM Max is formulated for adults and ...
Cough and Chest Congestion DMOverall this cough medicine is good. It works fast. The taste is not bad being raspberry and it helps break the stuff up and alleviates the cough. Would get ...
Robitussin Maximum Strength Nighttime Cough DMTry Robitussin Maximum Strength Nighttime Cough DM for your cold and flu symptoms. This great-tasting cough syrup controls your cough and helps you sleep.
Robitussin DM Adult Maximum Strength Cough + Chest ...Robitussin DM Adult Maximum Strength Cough + Chest Congestion & Nighttime Cough DM Max Raspberry, ... That includes making sure your data is safe and secure, and ...
Robitussin Maximum Strength Day & Night Cough + Chest ...The Robitussin DM Max controls cough, relieves chest congestion, and thins and loosens mucus; Robitussin Nighttime Cough Medicine controls cough and relieves ...
ROBITUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH ...Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold - temporarily relieves these symptoms due to hay fever or ...
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