Common Cold
Conditions
Keywords
Paracetamol, Common cold
Brief summary
The aim of this study is to subjectively assess symptoms in subjects suffering from the common cold following a single dose of paracetamol hot drink compared to paracetamol tablet
Interventions
DRUGParacetamol hot drink
Hot drink containing paracetamol
Paracetamol tablets
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptoms of the common cold of no more than 120 hours duration * Self-rating congestion of at least moderate severity * Suffering from at least four symptoms of common cold or flu
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breathing Scores Post 15 Minutes | Baseline to 15 minutes | A mean breathing score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes, derived from participant responses to questions relating to breathing i.e. my breathing feels easy, I feel airways are open, I feel a cooling sensation in my throat, I can feel the air flowing to my lungs easily, My nose feels less blocked and I feel my breathing is comfortable. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breathing Score Post 60 Minutes | Baseline to 60 minutes | A mean breathing score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes, derived from participant responses to questions relating to breathing i.e. my breathing feels easy, I feel airways are open, I feel a cooling sensation in my throat, I can feel the air flowing to my lungs easily, My nose feels less blocked and I feel my breathing is comfortable. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered. |
| Cold Symptoms Score Post 15 Minutes | Baseline to 15 minutes | A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes from participant responses to questions relating to cold symptoms i.e. My head feels clear, I feel soothing in my throat and I feel my cough is being soothed. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered. |
| Cold Symptoms Score Post 60 Minutes | Baseline to 60 minutes | A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes from participant responses to questions relating to cold symptoms i.e. My head feels clear, I feel soothing in my throat and I feel my cough is being soothed. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered. |
| Soothing Attribute Scores | Baseline to 15 and 60 minutes | Soothing attribute of test treatment was assessed by asking the question if the hot drink is soothing at baseline, 15 and 60 minutes. The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. |
| Overall Cold Symptoms Score | Baseline to 15 and 60 minutes | Overall cold symptom score was assessed by asking the question my cold symptoms are improved only post consuming the drink at baseline, 15 and 60 minutes . The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited at the clinical site.
Pre-assignment details
A total of 200 participants were screened and all were randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| Mentholated Paracetamol Hot Drink Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes. | 100 |
| Paracetamol Tablet Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water. | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Mentholated Paracetamol Hot Drink | Paracetamol Tablet | Total |
|---|---|---|---|
| Age, Continuous | 20.0 Years STANDARD_DEVIATION 1.85 | 20.0 Years STANDARD_DEVIATION 1.98 | 20.0 Years STANDARD_DEVIATION 1.92 |
| Sex: Female, Male Female | 65 Participants | 63 Participants | 128 Participants |
| Sex: Female, Male Male | 35 Participants | 37 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Breathing Scores Post 15 Minutes
A mean breathing score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes, derived from participant responses to questions relating to breathing i.e. my breathing feels easy, I feel airways are open, I feel a cooling sensation in my throat, I can feel the air flowing to my lungs easily, My nose feels less blocked and I feel my breathing is comfortable. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.
Time frame: Baseline to 15 minutes
Population: Intent to Treat (ITT) Population: All randomized participants who had at least one post-baseline efficacy evaluation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mentholated Paracetamol Hot Drink | Breathing Scores Post 15 Minutes | 0.83 Score on a Scale |
| Paracetamol Tablet | Breathing Scores Post 15 Minutes | 0.11 Score on a Scale |
Comparison: Null Hypothesis considered no difference in treatments being compared for breathing score over the first 15 minutes compared to baseline.p-value: <0.000195% CI: [0.58, 0.86]Repeated Measure Analysis
Secondary
Breathing Score Post 60 Minutes
A mean breathing score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes, derived from participant responses to questions relating to breathing i.e. my breathing feels easy, I feel airways are open, I feel a cooling sensation in my throat, I can feel the air flowing to my lungs easily, My nose feels less blocked and I feel my breathing is comfortable. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.
Time frame: Baseline to 60 minutes
Population: ITT population: All randomized participants who had at least one post-baseline efficacy evaluation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mentholated Paracetamol Hot Drink | Breathing Score Post 60 Minutes | 0.92 Score on a scale |
| Paracetamol Tablet | Breathing Score Post 60 Minutes | 0.34 Score on a scale |
Comparison: Null hypothesis considered no difference in treatments being compared for breathing score over 60 minutes.p-value: <0.000195% CI: [0.44, 0.72]Repeated measures analysis
Secondary
Cold Symptoms Score Post 15 Minutes
A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes from participant responses to questions relating to cold symptoms i.e. My head feels clear, I feel soothing in my throat and I feel my cough is being soothed. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.
Time frame: Baseline to 15 minutes
Population: ITT Population: all randomized participants who had at least one post-baseline efficacy evaluation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mentholated Paracetamol Hot Drink | Cold Symptoms Score Post 15 Minutes | 0.64 Score on a scale |
| Paracetamol Tablet | Cold Symptoms Score Post 15 Minutes | 0.13 Score on a scale |
Comparison: Null Hypothesis considered no difference in treatments being compared for cold symptoms score after 60 minutes.p-value: <0.000195% CI: [0.36, 0.65]Repeated measures analysis
Secondary
Cold Symptoms Score Post 60 Minutes
A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes from participant responses to questions relating to cold symptoms i.e. My head feels clear, I feel soothing in my throat and I feel my cough is being soothed. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.
Time frame: Baseline to 60 minutes
Population: ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mentholated Paracetamol Hot Drink | Cold Symptoms Score Post 60 Minutes | 0.87 Score on a scale |
| Paracetamol Tablet | Cold Symptoms Score Post 60 Minutes | 0.35 Score on a scale |
Comparison: Null hypothesis considered two treatments being compared to be equal for cold symptom score after 60 minutes.p-value: <0.000195% CI: [0.38, 0.67]Repeated measures analysis
Secondary
Overall Cold Symptoms Score
Overall cold symptom score was assessed by asking the question my cold symptoms are improved only post consuming the drink at baseline, 15 and 60 minutes . The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'.
Time frame: Baseline to 15 and 60 minutes
Population: ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mentholated Paracetamol Hot Drink | Overall Cold Symptoms Score | Average effect over first 15 minutes | 1.8 Score on a scale | Standard Error 0.86 |
| Mentholated Paracetamol Hot Drink | Overall Cold Symptoms Score | Average effect over 60 minutes | 2.1 Score on a scale | Standard Error 0.75 |
| Paracetamol Tablet | Overall Cold Symptoms Score | Average effect over first 15 minutes | 0.9 Score on a scale | Standard Error 0.63 |
| Paracetamol Tablet | Overall Cold Symptoms Score | Average effect over 60 minutes | 1.3 Score on a scale | Standard Error 0.62 |
Secondary
Soothing Attribute Scores
Soothing attribute of test treatment was assessed by asking the question if the hot drink is soothing at baseline, 15 and 60 minutes. The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'.
Time frame: Baseline to 15 and 60 minutes
Population: ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mentholated Paracetamol Hot Drink | Soothing Attribute Scores | Average effect over 60 minutes | 2.4 Score on a scale | Standard Deviation 0.72 |
| Mentholated Paracetamol Hot Drink | Soothing Attribute Scores | Average effect over first 15 minutes | 2.3 Score on a scale | Standard Deviation 0.8 |
| Paracetamol Tablet | Soothing Attribute Scores | Average effect over first 15 minutes | 1.2 Score on a scale | Standard Deviation 0.88 |
| Paracetamol Tablet | Soothing Attribute Scores | Average effect over 60 minutes | 1.3 Score on a scale | Standard Deviation 0.88 |