CompletedPhase 4

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

United States244 participantsStarted 2024-12-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score

Timeframe: Baseline and up to Day 7 or End of Treatment (EOT)

Adjusted Mean Change From Baseline in WURSS-21 Total Symptom Domain Score

Timeframe: Baseline and up to Day 7 or EOT

Adjusted Mean Change From Baseline in WURSS-21 Total QoL Domain Score

Timeframe: Baseline and up to Day 7 or EOT

Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Cough

Timeframe: Baseline and up to Day 7 or EOT

Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Runny Nose

Timeframe: Baseline and up to Day 7 or EOT

Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Plugged Nose

Timeframe: Baseline and up to Day 7 or EOT

Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sneezing

Trial details

NCT IDNCT06716645

SponsorHALEON

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-14

Results submitted2026-02-02

View on ClinicalTrials.gov More Common Cold trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

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

What they're measuring

Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score

Timeframe: Baseline and up to Day 7 or End of Treatment (EOT)

Adjusted Mean Change From Baseline in WURSS-21 Total Symptom Domain Score

Timeframe: Baseline and up to Day 7 or EOT

Adjusted Mean Change From Baseline in WURSS-21 Total QoL Domain Score

Timeframe: Baseline and up to Day 7 or EOT

Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Cough

Timeframe: Baseline and up to Day 7 or EOT

Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Runny Nose

Timeframe: Baseline and up to Day 7 or EOT

Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Plugged Nose

Timeframe: Baseline and up to Day 7 or EOT

Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sneezing