QZaffre/Haleon_Cloud · Datasets at Hugging Face

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Difference −1.88 −2.45 −2.90 −3.30 −2.95 −3.26 −3.12 −3.78
p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 39.83 50.88 60.79 70.53 67.98 69.84 72.22 80.00
n 102 99 98 92 82 59 39 30 100
Sleep well e Mean ± SE 4.9 ± 0.16 4.4 ± 0.17 3.8 ± 0.19 3.0 ± 0.22 2.6 ± 0.21 2.6 ± 0.27 2.2 ± 0.31 1.7 ± 0.30 1.7 ± 0.18
95% CI (−0.94 to −0.01) (−1.48 to −0.74) (−2.40 to −1.45) (−2.81 to −1.76) (−2.83 to −1.61) (−3.37 to −1.81) (−4.12 to −2.48) (−3.72 to −2.82)
Difference −0.57 −1.11 −1.92 −2.28 −2.22 −2.59 −3.30 −3.27
p-Value 0.0039 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 11.45 22.66 39.25 46.87 46.45 53.72 66.0 66.3
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Individual QoL factors scores ranged from 0 (not at all) to 7 (severely). The ‘sleep quality’ category scores were calculated by adding the individual QoL factors scores grouped in this category. Sleeping quality category score ranged from 0 (not at all) to 14 (severely). Higher scores indicate more negative impact of QoL domains. % Improvement is calculated as −100 * (mean change from baseline)/(baseline mean). p-Value presented using Student’s paired t-test.

aNumber of participants who lived with partners and could score the snoring factor.
bLast dose includes all subjects’ last day of treatment regardless of study day.
cPost hoc analysis: QoL category.
dSecondary endpoint: additional QoL factor (Q1).
ePost hoc analysis: WURSS-21 Individual QoL factor (Q13).
CI, confidence interval; n, number of subjects in this category; Q, question; QoL, quality of life; SE, standard error; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

‘Sleep well’ and ‘snoring’ were found to be moderately affected at baseline with a mean score (±SE) of 4.9 (±0.16) and 4.7 (±0.19), respectively. Statistically significant improvements in the ‘sleep well’ factor (p = 0.0039) and ‘snoring’ factor (p < 0.0001) (Table 6) were observed by day 1 following the use of xylometazoline hydrochloride 0.1%. Continued improvements were seen throughout the study for both factor scores (p < 0.0001). By the last dose of treatment, improvements of 66.3% and 80.0% were observed for the ‘sleep well’ and ‘snoring’ scores, respectively (Table 6).

The median days to resolution for ‘snoring’ and ‘sleep well’ were day 4 and day 5, respectively (Figure 4).

An external file that holds a picture, illustration, etc.
Object name is 10.1177_17534666241228927-fig4.jpg
Figure 4.
Median days to resolution for the QoL factors grouped by QoL categories and for other QoL factors for the mITT population.

Symptom resolution occurred when a subject selected ‘0-not at all’ or answered ‘No’ to the question ‘Do you have nasal congestion associated with your cold from which you seek relief?’

mITT, modified intention-to-treat; QoL, quality of life.

The observed improvements may be attributed to the relief of nasal congestion, as shown by a moderate positive correlation observed between the ‘plugged nose’ and ‘sleep well’ factors [Pearson correlation coefficient (r = 0.60; p < 0.0001)] (Table 12).

Table 12.
Correlation analysis of the plugged nose symptom with WURSS-21 QoL individual factors and the additional QoL factors for the mITT population.

Question Correlation (r) p-Value
Breathe easily 0.72 <0.0001
Smell 0.61 <0.0001
Sleep well 0.60 <0.0001
Interact with others 0.60 <0.0001
Live your personal life 0.60 <0.0001
Motivation 0.59 <0.0001
Energy 0.58 <0.0001
Accomplish daily activities 0.58 <0.0001
Self-conscious about how you sound 0.57 <0.0001
Think clearly 0.57 <0.0001
Walk, climb stairs, exercise 0.56 <0.0001
Taste 0.56 <0.0001
Self-conscious about people 0.55 <0.0001
Work outside the home 0.53 <0.0001
Work inside the home 0.52 <0.0001
Snoring 0.51 <0.0001
Alertness (slow in your responses) 0.47 <0.0001
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r = Pearson correlation coefficient. A positive correlation indicates the question changes in the same direction as plugged nose.

mITT, modified intention-to-treat; QoL, quality of life; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

Vitality
QoL factors grouped in the vitality category correspond to ‘alertness’ (slow in responses, Q2), ‘energy’ (Q7), ‘motivation’ (Q8) factors of the additional QoL questionnaire, and the ‘feeling tired’ symptom factor (Q11) from the WURSS-21 questionnaire. The score range of the vitality category was calculated by adding the maximum score for each factor resulting in a range of 0–28, where higher scores indicate higher severity.

The vitality category mean score (±SE) at baseline was 19.1 (±0.50) and considered as moderate severity level (score = 20). The individual factors had mean scores within the range of 3.8–5.2, indicating a moderate severity level (score = 5) for each score at baseline (Table 7). The overall vitality category and its corresponding QoL factors showed a statistically significant improvement from day 1 (p < 0.0001). ‘Feeling tired’, which is one of the WURSS-21 symptom factor, significantly improved by day 2 (p = 0.0364). At the time of the observed significance, the scores had dropped from moderate severity to a mild severity level. By the last dose used for all participants, ‘motivation’ improved by 83.2%, ‘energy’ by 83.1%, ‘alertness’ by 85.9%, and ‘feeling tired’ improved by 53.6%. By the last dose of treatment, the vitality category score improved by 76.1% (Table 7).

Table 7.
Overview of changes observed in the vitality category.

QoL category/factor n a Baseline Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Last dose b
102 98 97 92 82 59 39 30 100
Vitality c Mean ± SE 19.1 ± 0.50 13.2 ± 0.63 11.2 ± 0.62 9.3 ± 0.66 7.7 ± 0.68 6.5 ± 0.65 6.3 ± 0.77 5.3 ± 0.94 4.6 ± 0.50
95% CI (−6.96 to −4.67) (−9.19 to −6.67) (−11.32 to −8.61) (−13.16 to −9.99) (−14.22 to −11.07) (−15.01 to −11.60) (−16.77 to −11.89) (−15.86 to −13.28)
Difference −5.82 −7.93 −9.97 −11.57 −12.64 −13.31 −14.33 −14.57
p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 30.63 41.43 51.60 59.95 66.19 67.84 72.88 76.12
Energy d Mean ± SE 5.2 ± 0.14 3.1 ± 0.20 2.5 ± 0.21 2.1 ± 0.20 1.8 ± 0.21 1.4 ± 0.20 1.2 ± 0.23 1.0 ± 0.24 0.9 ± 0.15
Difference −2.07 −2.76 −3.21 −3.49 −3.83 −4.05 −4.13 −4.37
p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 39.73 52.76 60.70 66.36 73.86 76.70 81.05 83.08
Motivation d Mean ± SE 5.2 ± 0.14 2.9 ± 0.22 2.4 ± 0.19 2.0 ± 0.20 1.7 ± 0.21 1.4 ± 0.21 1.2 ± 0.25 1.1 ± 0.27 0.9 ± 0.14
Difference −2.21 −2.73 −3.16 −3.52 −3.73 −4.00 −4.07 −4.30
p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 43.23 53.21 60.75 68.0 72.85 76.85 78.71 83.17
Alertness d Mean ± SE 3.8 ± 0.17 2.1 ± 0.20 1.8 ± 0.18 1.6 ± 0.19 1.1 ± 0.18 0.8 ± 0.15 0.8 ± 0.18 0.8 ± 0.21 0.5 ± 0.11
Difference −1.72 −2.12 −2.30 −2.76 −2.85 −3.18 −3.17 −3.28
p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 45.31 54.64 59.55 71.52 77.06 78.98 79.17 85.86
n e 102 99 98 92 82 59 39 30 100
Feeling tired f Mean ± SE 4.9 ± 0.16 5.1 ± 0.17 4.5 ± 0.17 3.7 ± 0.20 3.2 ± 0.20 2.9 ± 0.24 3.0 ± 0.33 2.4 ± 0.41 2.3 ± 0.20
Difference 0.20 −0.35 −1.29 −1.80 −2.24 −2.08 −2.97 −2.62
p-Value 0.1074 0.0364 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 4.16 7.13 26.10 36.01 43.85 40.70 54.94 53.58
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Individual scores ranged from 0 (not at all) to 7 (severely). The scores of the ‘vitality’ category were calculated by adding the scores of the individual QoL factors grouped in this category. The ‘vitality’ category score ranged from 0 (not at all) to 28 (severely). Higher scores indicate more negative impact of QoL domains. % Improvement is calculated as −100 * (mean change from baseline)/(baseline mean). p-Value presented using Student’s paired t-test.

aNumber of participants who answered the additional QoL questionnaire.
bLast dose includes all subjects’ last day of treatment regardless of study day.
cPost hoc analysis: QoL categories.
dSecondary endpoint: additional QoL factors [Q2 (slow in response) and Q7–8].
eNumber of participants who answered the WURSS-21 questionnaire.

Difference −1.88 −2.45 −2.90 −3.30 −2.95 −3.26 −3.12 −3.78

p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

% Improvement 39.83 50.88 60.79 70.53 67.98 69.84 72.22 80.00

n 102 99 98 92 82 59 39 30 100

Sleep well e Mean ± SE 4.9 ± 0.16 4.4 ± 0.17 3.8 ± 0.19 3.0 ± 0.22 2.6 ± 0.21 2.6 ± 0.27 2.2 ± 0.31 1.7 ± 0.30 1.7 ± 0.18

95% CI (−0.94 to −0.01) (−1.48 to −0.74) (−2.40 to −1.45) (−2.81 to −1.76) (−2.83 to −1.61) (−3.37 to −1.81) (−4.12 to −2.48) (−3.72 to −2.82)

Difference −0.57 −1.11 −1.92 −2.28 −2.22 −2.59 −3.30 −3.27

p-Value 0.0039 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

% Improvement 11.45 22.66 39.25 46.87 46.45 53.72 66.0 66.3

Open in a separate window

Individual QoL factors scores ranged from 0 (not at all) to 7 (severely). The ‘sleep quality’ category scores were calculated by adding the individual QoL factors scores grouped in this category. Sleeping quality category score ranged from 0 (not at all) to 14 (severely). Higher scores indicate more negative impact of QoL domains. % Improvement is calculated as −100 * (mean change from baseline)/(baseline mean). p-Value presented using Student’s paired t-test.

aNumber of participants who lived with partners and could score the snoring factor.

bLast dose includes all subjects’ last day of treatment regardless of study day.

cPost hoc analysis: QoL category.

dSecondary endpoint: additional QoL factor (Q1).

ePost hoc analysis: WURSS-21 Individual QoL factor (Q13).

CI, confidence interval; n, number of subjects in this category; Q, question; QoL, quality of life; SE, standard error; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

‘Sleep well’ and ‘snoring’ were found to be moderately affected at baseline with a mean score (±SE) of 4.9 (±0.16) and 4.7 (±0.19), respectively. Statistically significant improvements in the ‘sleep well’ factor (p = 0.0039) and ‘snoring’ factor (p < 0.0001) (Table 6) were observed by day 1 following the use of xylometazoline hydrochloride 0.1%. Continued improvements were seen throughout the study for both factor scores (p < 0.0001). By the last dose of treatment, improvements of 66.3% and 80.0% were observed for the ‘sleep well’ and ‘snoring’ scores, respectively (Table 6).

The median days to resolution for ‘snoring’ and ‘sleep well’ were day 4 and day 5, respectively (Figure 4).

An external file that holds a picture, illustration, etc.

Object name is 10.1177_17534666241228927-fig4.jpg

Figure 4.

Median days to resolution for the QoL factors grouped by QoL categories and for other QoL factors for the mITT population.

Symptom resolution occurred when a subject selected ‘0-not at all’ or answered ‘No’ to the question ‘Do you have nasal congestion associated with your cold from which you seek relief?’

mITT, modified intention-to-treat; QoL, quality of life.

The observed improvements may be attributed to the relief of nasal congestion, as shown by a moderate positive correlation observed between the ‘plugged nose’ and ‘sleep well’ factors [Pearson correlation coefficient (r = 0.60; p < 0.0001)] (Table 12).

Table 12.

Correlation analysis of the plugged nose symptom with WURSS-21 QoL individual factors and the additional QoL factors for the mITT population.

Question Correlation (r) p-Value

Breathe easily 0.72 <0.0001

Smell 0.61 <0.0001

Sleep well 0.60 <0.0001

Interact with others 0.60 <0.0001

Live your personal life 0.60 <0.0001

Motivation 0.59 <0.0001

Energy 0.58 <0.0001

Accomplish daily activities 0.58 <0.0001

Self-conscious about how you sound 0.57 <0.0001

Think clearly 0.57 <0.0001

Walk, climb stairs, exercise 0.56 <0.0001

Taste 0.56 <0.0001

Self-conscious about people 0.55 <0.0001

Work outside the home 0.53 <0.0001

Work inside the home 0.52 <0.0001

Snoring 0.51 <0.0001

Alertness (slow in your responses) 0.47 <0.0001

Open in a separate window

r = Pearson correlation coefficient. A positive correlation indicates the question changes in the same direction as plugged nose.

mITT, modified intention-to-treat; QoL, quality of life; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

Vitality

QoL factors grouped in the vitality category correspond to ‘alertness’ (slow in responses, Q2), ‘energy’ (Q7), ‘motivation’ (Q8) factors of the additional QoL questionnaire, and the ‘feeling tired’ symptom factor (Q11) from the WURSS-21 questionnaire. The score range of the vitality category was calculated by adding the maximum score for each factor resulting in a range of 0–28, where higher scores indicate higher severity.

The vitality category mean score (±SE) at baseline was 19.1 (±0.50) and considered as moderate severity level (score = 20). The individual factors had mean scores within the range of 3.8–5.2, indicating a moderate severity level (score = 5) for each score at baseline (Table 7). The overall vitality category and its corresponding QoL factors showed a statistically significant improvement from day 1 (p < 0.0001). ‘Feeling tired’, which is one of the WURSS-21 symptom factor, significantly improved by day 2 (p = 0.0364). At the time of the observed significance, the scores had dropped from moderate severity to a mild severity level. By the last dose used for all participants, ‘motivation’ improved by 83.2%, ‘energy’ by 83.1%, ‘alertness’ by 85.9%, and ‘feeling tired’ improved by 53.6%. By the last dose of treatment, the vitality category score improved by 76.1% (Table 7).

Table 7.

Overview of changes observed in the vitality category.

QoL category/factor n a Baseline Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Last dose b

102 98 97 92 82 59 39 30 100

Vitality c Mean ± SE 19.1 ± 0.50 13.2 ± 0.63 11.2 ± 0.62 9.3 ± 0.66 7.7 ± 0.68 6.5 ± 0.65 6.3 ± 0.77 5.3 ± 0.94 4.6 ± 0.50

95% CI (−6.96 to −4.67) (−9.19 to −6.67) (−11.32 to −8.61) (−13.16 to −9.99) (−14.22 to −11.07) (−15.01 to −11.60) (−16.77 to −11.89) (−15.86 to −13.28)

Difference −5.82 −7.93 −9.97 −11.57 −12.64 −13.31 −14.33 −14.57

p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

% Improvement 30.63 41.43 51.60 59.95 66.19 67.84 72.88 76.12

Energy d Mean ± SE 5.2 ± 0.14 3.1 ± 0.20 2.5 ± 0.21 2.1 ± 0.20 1.8 ± 0.21 1.4 ± 0.20 1.2 ± 0.23 1.0 ± 0.24 0.9 ± 0.15

Difference −2.07 −2.76 −3.21 −3.49 −3.83 −4.05 −4.13 −4.37

p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

% Improvement 39.73 52.76 60.70 66.36 73.86 76.70 81.05 83.08

Motivation d Mean ± SE 5.2 ± 0.14 2.9 ± 0.22 2.4 ± 0.19 2.0 ± 0.20 1.7 ± 0.21 1.4 ± 0.21 1.2 ± 0.25 1.1 ± 0.27 0.9 ± 0.14

Difference −2.21 −2.73 −3.16 −3.52 −3.73 −4.00 −4.07 −4.30

p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

% Improvement 43.23 53.21 60.75 68.0 72.85 76.85 78.71 83.17

Alertness d Mean ± SE 3.8 ± 0.17 2.1 ± 0.20 1.8 ± 0.18 1.6 ± 0.19 1.1 ± 0.18 0.8 ± 0.15 0.8 ± 0.18 0.8 ± 0.21 0.5 ± 0.11

Difference −1.72 −2.12 −2.30 −2.76 −2.85 −3.18 −3.17 −3.28

p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

% Improvement 45.31 54.64 59.55 71.52 77.06 78.98 79.17 85.86

n e 102 99 98 92 82 59 39 30 100

Feeling tired f Mean ± SE 4.9 ± 0.16 5.1 ± 0.17 4.5 ± 0.17 3.7 ± 0.20 3.2 ± 0.20 2.9 ± 0.24 3.0 ± 0.33 2.4 ± 0.41 2.3 ± 0.20

Difference 0.20 −0.35 −1.29 −1.80 −2.24 −2.08 −2.97 −2.62

p-Value 0.1074 0.0364 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

% Improvement 4.16 7.13 26.10 36.01 43.85 40.70 54.94 53.58

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Individual scores ranged from 0 (not at all) to 7 (severely). The scores of the ‘vitality’ category were calculated by adding the scores of the individual QoL factors grouped in this category. The ‘vitality’ category score ranged from 0 (not at all) to 28 (severely). Higher scores indicate more negative impact of QoL domains. % Improvement is calculated as −100 * (mean change from baseline)/(baseline mean). p-Value presented using Student’s paired t-test.

aNumber of participants who answered the additional QoL questionnaire.

bLast dose includes all subjects’ last day of treatment regardless of study day.

cPost hoc analysis: QoL categories.

dSecondary endpoint: additional QoL factors [Q2 (slow in response) and Q7–8].

eNumber of participants who answered the WURSS-21 questionnaire.