Phase 4
N=244
A Clinical Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin
Common Cold · Cough
Bottom Line
View on ClinicalTrials.gov: NCT06716645 ↗Enrolled (actual)
244
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score — -9.56; -9.11; -26.49; -22.97 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Robitussin Maximum Strength Cough and Chest Congestion DM (Drug); Robitussin Maximum Strength Nighttime Cough DM (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HALEON
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score |
-9.56; -9.11; -26.49; -22.97; -40.99; -36.71 | — |
| PRIMARY Adjusted Mean Change From Baseline in WURSS-21 Total Symptom Domain Score |
-6.48; -5.89; -14.59; -13.58; -22.56; -21.26 | — |
| PRIMARY Adjusted Mean Change From Baseline in WURSS-21 Total QoL Domain Score |
-3.06; -3.28; -11.87; -9.44; -18.40; -15.49 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Cough |
-0.87; -0.96; -1.91; -1.77; -2.91; -2.78 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Runny Nose |
-0.65; -0.33; -1.29; -1.02; -2.05; -1.61 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Plugged Nose |
-0.58; -0.22; -1.25; -1.01; -1.94; -1.65 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sneezing |
-0.65; -0.59; -1.43; -1.09; -1.88; -1.60 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sore Throat |
-0.84; -0.70; -1.65; -1.53; -2.23; -2.26 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Scratchy Throat |
-0.72; -1.10; -1.49; -1.91; -2.28; -2.61 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Hoarseness |
-0.73; -0.54; -1.66; -1.03; -2.28; -1.91 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Head Congestion |
-0.54; -0.41; -1.31; -0.92; -1.95; -1.81 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Chest Congestion |
-0.55; -0.49; -1.30; -1.01; -1.95; -1.98 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Feeling Tired |
-0.63; -0.68; -1.65; -1.42; -2.69; -2.20 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Think Clearly |
-0.29; -0.34; -1.11; -0.97; -1.78; -1.55 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Sleep Well |
-0.92; -0.83; -1.91; -1.57; -2.58; -2.35 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Breathe Easily |
-0.47; -0.48; -1.40; -0.92; -2.27; -1.66 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Walk, Climb Stairs, Exercise |
-0.43; -0.14; -1.23; -0.66; -1.70; -1.29 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Accomplish Daily Activities |
-0.44; -0.23; -1.46; -0.87; -2.17; -1.46 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Work Outside the Home |
-0.35; -0.32; -1.25; -0.78; -2.01; -1.46 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Work Inside the Home |
-0.29; -0.27; -1.21; -0.88; -1.98; -1.40 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Interact With Others |
-0.28; -0.45; -1.31; -1.12; -2.16; -1.82 | — |
| PRIMARY Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Live Your Personal Life |
-0.15; -0.55; -1.42; -1.05; -2.30; -1.89 | — |
| SECONDARY Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Social Activities |
-2.51; -2.70; -3.15; -2.97; -3.58; -3.49 | — |
| SECONDARY Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Self-conscious Around People |
-1.91; -2.03; -2.65; -2.78; -3.19; -3.37 | — |
| SECONDARY Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Coughing in Public |
-2.03; -2.23; -2.93; -2.96; -3.44; -3.63 | — |
| SECONDARY Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Falling Asleep |
-2.86; -3.40; -3.35; -3.54; -4.19; -4.27 | — |
| SECONDARY Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Sleeping Through the Night |
-3.05; -3.51; -3.40; -3.73; -4.08; -4.28 | — |
| SECONDARY Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Energy |
-2.33; -2.39; -3.17; -2.75; -3.70; -3.42 | — |
| SECONDARY Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Motivation |
-2.21; -2.34; -2.97; -2.52; -3.50; -3.41 | — |
| SECONDARY Mean Change From Baseline in Categorized QoL Questions Score: Sleep Quality |
-6.85; -7.72; -8.65; -8.87; -10.82; -10.90 | — |
| SECONDARY Mean Change From Baseline in Categorized QoL Questions Score: Vitality |
-5.12; -5.36; -7.76; -6.74; -9.88; -9.04 | — |
| SECONDARY Mean Change From Baseline in Categorized QoL Questions Score: Physical Activities |
-1.35; -0.84; -4.09; -2.45; -6.14; -4.41 | — |
| SECONDARY Mean Change From Baseline in Categorized QoL Questions Score: Social Activities |
-6.70; -7.38; -9.99; -9.90; -12.36; -12.34 | — |
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 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:
- 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.
- 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:
- 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).
- Are taking medication(s) to treat - psychiatric / mental health conditions (example, anxiety, depression) or Parkinson's disease. Medications such as:
- 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:
- cough accompanied by fever, rash, or persistent headache OR
- cough with too much phlegm.
- Participant who is an employee of Lindus Health, either directly involved in the conduct of
Data sourced from ClinicalTrials.gov (NCT06716645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.