Trial · NCT06716645
A Clinical Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin
NCT06716645, Phase 4, Completed, HALEON; results first posted 2026-02-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin. Trials, record NCT06716645. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06716645
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin
- NCT number
- NCT06716645
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 244 participants, actual
- Lead sponsor
- HALEON
- Conditions
- Common Cold, Cough
- Interventions
- Robitussin Maximum Strength Cough and Chest Congestion DM, Robitussin Maximum Strength Cough and Chest Congestion DM, Robitussin Maximum Strength Nighttime Cough DM
- First posted
- 2024-12-04
- Last updated
- 2026-02-20
- Results first posted
- 2026-02-20
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Baseline and up to Day 7 or End of Treatment (EOT) | The WURSS was an evaluative illness-specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. Participants rated their cold symptoms (10 questions) and Quality of Life (QoL) related 9 questions using WURSS-21. The responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms/Not at all and 7=Severe symptoms/Severely. Thus, the minimum and maximum possible total scores were 0 and 133 respectively, where higher total scores indicated more negative impact on symptoms and quality of life. Change from Baseline was calculated as each post-Baseline value minus Baseline value. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). |
| Primary | Adjusted Mean Change From Baseline in WURSS-21 Total Symptom Domain Score | Baseline and up to Day 7 or EOT | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The symptom domain of WURSS-21 consisted of 10 questions. Participants rated their cold symptoms related questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms and 7=Severe. Thus, the minimum and maximum possible total score was 0 and 70 respectively, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. |
| Primary | Adjusted Mean Change From Baseline in WURSS-21 Total QoL Domain Score | Baseline and up to Day 7 or EOT | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated their QoL related questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 63 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. |
| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Cough | Baseline and up to Day 7 or EOT | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. |
| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Runny Nose | Baseline and up to Day 7 or EOT | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. |
| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Plugged Nose | Baseline and up to Day 7 or EOT | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. |
| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sneezing | Baseline and up to Day 7 or EOT | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. |
| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sore Throat | Baseline and up to Day 7 or EOT | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. |
| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Scratchy Throat | Baseline and up to Day 7 or EOT | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. |
| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Hoarseness | Baseline and up to Day 7 or EOT | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms include runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Baseline and up to Day 7 or End of Treatment (EOT) | The modified Intent-To-Treat (mITT) population included all participants who used study product at least once and had data from at least one post baseline QoL questionnaire to support at least one of the primary endpoint assessments. Only those participants with data available at the specified timepoint were analyzed. | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Adjusted Mean Change From Baseline in WURSS-21 Total Symptom Domain Score | Baseline and up to Day 7 or EOT | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Adjusted Mean Change From Baseline in WURSS-21 Total QoL Domain Score | Baseline and up to Day 7 or EOT | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Cough | Baseline and up to Day 7 or EOT | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Runny Nose | Baseline and up to Day 7 or EOT | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | score on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Plugged Nose | Baseline and up to Day 7 or EOT | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | score on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sneezing | Baseline and up to Day 7 or EOT | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | score on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sore Throat | Baseline and up to Day 7 or EOT | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | score on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Scratchy Throat | Baseline and up to Day 7 or EOT | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | score on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Hoarseness | Baseline and up to Day 7 or EOT | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | score on a scale | MEAN |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group528
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Robitussin Cough Syrup (Daytime) | Day 1 | -9.56 | 95% Confidence Interval -14.45 to -4.66 | score on a scale |
| Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | Day 1 | -9.11 | 95% Confidence Interval -13.49 to -4.73 | score on a scale |
| Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Robitussin Cough Syrup (Daytime) | Day 2 | -26.49 | 95% Confidence Interval -31.51 to -21.47 | score on a scale |
| Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | Day 2 | -22.97 | 95% Confidence Interval -27.43 to -18.51 | score on a scale |
| Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Robitussin Cough Syrup (Daytime) | Day 3 | -40.99 | 95% Confidence Interval -46.09 to -35.89 | score on a scale |
| Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | Day 3 | -36.71 | 95% Confidence Interval -41.28 to -32.14 | score on a scale |
| Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Robitussin Cough Syrup (Daytime) | Day 4 | -47.63 | 95% Confidence Interval -53.07 to -42.18 | score on a scale |
| Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | Day 4 | -47.20 | 95% Confidence Interval -52.00 to -42.40 | score on a scale |
| Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Robitussin Cough Syrup (Daytime) | Day 5 | -51.20 | 95% Confidence Interval -57.14 to -45.25 | score on a scale |
| Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | Day 5 | -55.05 | 95% Confidence Interval -60.13 to -49.96 | score on a scale |
1 to 10 of 528Source ClinicalTrials.gov
See all 528 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Robitussin Cough Syrup (Daytime) | 122 | |
| Overall Study | STARTED | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | 122 | |
| Overall Study | COMPLETED | Robitussin Cough Syrup (Daytime) | 110 | |
| Overall Study | COMPLETED | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | 109 | |
| Overall Study | NOT COMPLETED | Robitussin Cough Syrup (Daytime) | 12 | |
| Overall Study | NOT COMPLETED | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | 13 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Robitussin Cough Syrup (Daytime) | 1 | 115 | |
| other | Diarrhoea | Gastrointestinal disorders | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | 0 | 112 | |
| other | Nausea | Gastrointestinal disorders | Robitussin Cough Syrup (Daytime) | 1 | 115 | |
| other | Nausea | Gastrointestinal disorders | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | 0 | 112 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Robitussin Cough Syrup (Daytime) | 0 | 115 |
| Total, all-cause mortality | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | 0 | 112 |
| Total, other adverse events | Robitussin Cough Syrup (Daytime) | 2 | 115 |
| Total, other adverse events | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | 0 | 112 |
| Total, serious adverse events | Robitussin Cough Syrup (Daytime) | 0 | 115 |
| Total, serious adverse events | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | 0 | 112 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Robitussin Cough Syrup (Daytime) vs Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime): deaths from any cause | Trial comparisons |
| Robitussin Cough Syrup (Daytime) vs Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06716645
GET https://conductscience.org/api/trials/v1/NCT06716645/registered?page=2