Trial Outcomes & Findings for Effect of Paracetamol on the Common Cold (NCT NCT01277081)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

200 participants

Primary outcome timeframe

Baseline to 15 minutes

Results posted on

2015-02-18

Participant Flow

Participants were recruited at the clinical site.

A total of 200 participants were screened and all were randomized into the study.

Participant milestones

Participant milestones
Measure	Mentholated Paracetamol Hot Drink Mentholated paracetamol hot drink prepared by dissolving 500 milligram (mg) of paracetamol in 200 milliliter (mL) of boiled mineral water was taken orally by participants within a time period of 15 minutes.	Paracetamol Tablet Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
Overall Study STARTED	100	100
Overall Study COMPLETED	100	100
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Paracetamol on the Common Cold

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mentholated Paracetamol Hot Drink n=100 Participants 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.	Paracetamol Tablet n=100 Participants Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.	Total n=200 Participants Total of all reporting groups
Age, Continuous	20.0 Years STANDARD_DEVIATION 1.85 • n=5 Participants	20.0 Years STANDARD_DEVIATION 1.98 • n=7 Participants	20.0 Years STANDARD_DEVIATION 1.92 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	63 Participants n=7 Participants	128 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 15 minutes

Population: Intent to Treat (ITT) Population: All randomized participants who had at least one post-baseline efficacy evaluation.

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.

Outcome measures

Outcome measures
Measure	Mentholated Paracetamol Hot Drink n=100 Participants 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.	Paracetamol Tablet n=100 Participants Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
Breathing Scores Post 15 Minutes	0.83 Score on a Scale Interval 0.73 to 0.93	0.11 Score on a Scale Interval 0.01 to 0.21

SECONDARY outcome

Timeframe: Baseline to 60 minutes

Population: ITT population: All randomized participants who had at least one post-baseline efficacy evaluation.

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.

Outcome measures

Outcome measures
Measure	Mentholated Paracetamol Hot Drink n=100 Participants 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.	Paracetamol Tablet n=100 Participants Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
Breathing Score Post 60 Minutes	0.92 Score on a scale Interval 0.81 to 1.02	0.34 Score on a scale Interval 0.23 to 0.44

SECONDARY outcome

Timeframe: Baseline to 15 minutes

Population: ITT Population: all randomized participants who had at least one post-baseline efficacy evaluation.

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.

Outcome measures

Outcome measures
Measure	Mentholated Paracetamol Hot Drink n=100 Participants 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.	Paracetamol Tablet n=100 Participants Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
Cold Symptoms Score Post 15 Minutes	0.64 Score on a scale Interval 0.52 to 0.75	0.13 Score on a scale Interval 0.02 to 0.25

SECONDARY outcome

Timeframe: Baseline to 60 minutes

Population: ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.

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.

Outcome measures

Outcome measures
Measure	Mentholated Paracetamol Hot Drink n=100 Participants 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.	Paracetamol Tablet n=100 Participants Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
Cold Symptoms Score Post 60 Minutes	0.87 Score on a scale Interval 0.76 to 0.99	0.35 Score on a scale Interval 0.24 to 0.46

SECONDARY outcome

Timeframe: Baseline to 15 and 60 minutes

Population: ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.

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'.

Outcome measures

Outcome measures
Measure	Mentholated Paracetamol Hot Drink n=100 Participants 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.	Paracetamol Tablet n=100 Participants Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
Soothing Attribute Scores Average effect over first 15 minutes	2.3 Score on a scale Standard Deviation 0.80	1.2 Score on a scale Standard Deviation 0.88
Soothing Attribute Scores Average effect over 60 minutes	2.4 Score on a scale Standard Deviation 0.72	1.3 Score on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: Baseline to 15 and 60 minutes

Population: ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.

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'.

Outcome measures

Outcome measures
Measure	Mentholated Paracetamol Hot Drink n=100 Participants 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.	Paracetamol Tablet n=100 Participants Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
Overall Cold Symptoms Score Average effect over first 15 minutes	1.8 Score on a scale Standard Error 0.86	0.9 Score on a scale Standard Error 0.63
Overall Cold Symptoms Score Average effect over 60 minutes	2.1 Score on a scale Standard Error 0.75	1.3 Score on a scale Standard Error 0.62

Adverse Events

Mentholated Paracetamol Hot Drink

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Paracetamol Tablets

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER