QZaffre/Haleon_Cloud · Datasets at Hugging Face

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fPost hoc analysis: WURSS-21 individual symptom factor (Q11).
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.

The median time to resolution for ‘alertness’ (slow in response) was day 2, followed by ‘motivation’ with a median time to resolution by day 3 and ‘energy’ with a median time to resolution by day 4 (Figure 4).

Physical activity
The QoL factors under the physical activity category were ‘breathe easily’ (Q14), ‘walk, climb stairs exercise’ (Q15), and ‘accomplish daily activities’ (Q16) from the WURSS-21 questionnaire. The score range for the physical activity category was calculated by adding the maximum score of each factor, resulting in a range of 0–21. At baseline, the physical activity mean (±SE) score was 13.1 (±0.36), which was considered mild (score = 9) to moderate (score = 15) in severity level.

Significant improvement in physical activity was observed by day 2 (p < 0.0001) (Table 8). The ‘breathe easily’ factor was found to significantly improve by day 1 (p = 0.0449) and had the strongest correlation with nasal congestion (‘plugged nose’ symptom) factor (r = 0.72; p < 0.0001) (Table 12). The other two QoL factors ‘walk, climb stairs, exercise’ and ‘accomplish daily activities’, improved significantly by day 2 (Table 8). At the last dose administered for all participants who completed the study, physical activity improved significantly by 70.7% to a mean (±SE) score of 3.8 (±0.46), which indicates an impact closer to a very mild (score = 3) severity level. After last dose, the percentage of improvement in ‘breathe easily’, ‘walk, climb stairs, exercise’, and ‘accomplish daily activities’ was >70% for all (Table 8). The median time to resolution was day 4 for ‘walk, climb stairs, exercise’, and ‘accomplish daily activities’ and day 5 for ‘breathe easily’ (Figure 4).

Table 8.
Overview of changes observed in the physical activity 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 99 98 92 82 59 39 30 100
Physical activity c Mean ± SE 13.1 ± 0.36 12.4 ± 0.43 9.8 ± 0.44 7.6 ± 0.53 6.3 ± 0.54 5.9 ± 0.65 5.5 ± 0.80 3.9 ± 0.79 3.8 ± 0.46
95% CI (−1.37 to −0.08) (−4.22 to −2.37) (−6.61 to −4.37) (−8.16 to −5.60) (−8.58 to −5.39) (−9.48 to −5.81) (−11.51 to −8.09) (−10.40 to −8.12)
Difference −0.65 −3.30 −5.49 −6.88 −6.98 −7.64 −9.80 −9.26
p-Value 0.0808 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 4.94 25.14 41.87 52.32 54.14 58.09 71.53 70.74
Breathe easily d Mean ± SE 5.3 ± 0.14 4.9 ± 0.15 4 ± 0.15 3 ± 0.19 2.5 ± 0.18 2.3 ± 0.23 2.2 ± 0.27 1.6 ± 0.32 1.6 ± 0.17
95% CI (−0.64 to −0.01) (−1.66 to −0.87) (−2.73 to −1.80) (−3.20 to −2.21) (−3.51 to −2.19) (−3.51 to −2.24) (−4.30 to −2.83) (−4.18 to −3.26)
Difference −0.32 −1.27 −2.26 −2.71 −2.85 −2.87 −3.57 −3.72
p-Value 0.0449 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 6.13 24.03 43.06 51.99 55.26 56.28 68.59 70.45
Walk, climb stairs, exercise d Mean ± SE 3.9 ± 0.16 3.7 ± 0.19 2.9 ± 0.18 2.3 ± 0.19 2.0 ± 0.21 1.8 ± 0.25 1.7 ± 0.31 1.2 ± 0.30 1.2 ± 0.17
95% CI (−0.56 to 0.04) (−1.43 to −0.71) (−2.05 to −1.19) (−2.51 to −1.51) (−2.70 to −1.50) (−3.15 to −1.68) (−3.92 to −2.34) (−3.20 to −2.32)
Difference −0.26 −1.07 −1.62 −2.01 −2.10 −2.41 −3.13 −2.76
p-Value 0.0851 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 6.70 27.20 41.05 50.77 53.22 58.39 72.87 70.41
Accomplish daily activities d Mean ± SE 3.9 ± 0.16 3.8 ± 0.17 2.9 ± 0.19 2.3 ± 0.19 1.8 ± 0.19 1.8 ± 0.23 1.6 ± 0.29 1.1 ± 0.27 1.1 ± 0.15
95% CI (−0.40 to −0.28) (−1.32 to −0.60) (−2.02 to −1.20) (−2.61 to −1.71) (−2.57 to −1.50) (−3.08 to −1.64) (−3.75 to −2.45) (−3.19 to −2.37)
Difference −0.06 −0.96 −1.61 −2.16 −2.03 −2.36 −3.10 −2.78
p-Value 0.7256 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 1.56 24.54 41.11 54.29 53.57 60.13 73.81 71.47
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Individual scores ranged from 0 (not at all) to 7 (severely). The ‘physical activity’ category scores were calculated by adding the individual QoL factors scores grouped in this category. The ‘physical activity’ category score ranged from 0 (not at all) to 21 (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 in this category.
bLast dose includes all subjects’ last day of treatment regardless of study day.
cPost hoc analysis: QoL categories.
dPost hoc analysis: WURSS-21 individual QoL factors (Q14–Q16).
CI, confidence interval; Q, question; QoL, quality of life; SE, standard error; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

Social activity
The social activity category grouped the ‘interact with others’ factor from the WURSS-21 questionnaire (Q19) and ‘being self-conscious around people’ from the additional QoL questions (Q6). The sum of the individual scores determined the range of severity for the social activity category of 0–14. The individual QoL factors were both mildly (score = 3) to moderately (score = 5) impacted at baseline (Table 9).

Table 9.
Overview of changes observed in the social activity 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
Social activity c Mean ± SE 8.2 ± 0.32 5.9 ± 0.30 4.4 ± 0.32 3.8 ± 0.33 2.8 ± 0.32 2.7 ± 0.36 2.8 ± 0.48 1.8 ± 0.48 1.6 ± 0.24
95% CI (−2.75 to −1.64) (−4.442 to −3.13) (−5.05 to −3.58) (−6.06 to −4.50) (−6.20 to −4.44) (−6.47 to −4.25) (−7.80 to −5.13) (−7.31 to −5.85)
Difference −2.19 −3.78 −4.32 −5.28 −5.32 −5.36 −6.47 −6.58
p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 29.94 46.16 52.93 65.31 65.97 65.52 78.23 80.05
Self-conscious around people d Mean ± SE 4.3 ± 0.20 2.3 ± 0.20 1.7 ± 0.18 1.6 ± 0.18 1.1 ± 0.18 1.0 ± 0.18 1.0 ± 0.24 0.8 ± 0.25 0.7 ± 0.13
Difference −1.93 −2.60 −2.65 −3.07 −3.25 −3.41 −3.47 −3.63
p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 45.76 60.72 62.72 73.68 76.19 76.88 80.62 84.81
n e 102 99 98 92 82 59 39 30 100
Interact with others f Mean ± SE 3.9 ± 0.17 3.7 ± 0.17 2.7 ± 0.19 2.3 ± 0.19 1.7 ± 0.19 1.7 ± 0.23 1.8 ± 0.30 1.0 ± 0.29 1.0 ± 0.15
95% CI (−0.56 to −0.06) (−1.58 to −0.81) (−2.09 to −1.23) (−2.69 to −1.73) (−2.60 to −1.53) (−2.64 to −1.26) (−3.73 to −2.27) (−3.40 to −2.50)
Difference −0.25 −1.19 −1.66 −2.21 −2.07 −1.95 −3.00 −2.95
p-Value 0.1106 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 6.41 30.55 42.38 56.39 54.46 52.05 75.63 74.87
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Individual scores ranged from 0 (not at all) to 7 (severely). The ‘social activity category’ scores were calculated by adding the individual QoL factors grouped in this category. The ‘social activity’ 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 in this category 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 factor (Q6).
eNumber of participants who answered the WURSS-21 questionnaire.
fPost hoc analysis: WURSS-21 individual QoL factor (Q19).
CI, confidence interval; Q, question; QoL, quality of life; SE, standard error; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

Significant improvement in ‘being self-conscious around people’ was observed from day 1 (p < 0.0001). The social activity category score and the individual factor of ‘interacting with others’ score significantly improved from day 1 (p < 0.0001) (Table 9). The time to resolution was day 3 for ‘being self-conscious around people’ and the median time to resolution for the ‘interact with others’ factor was day 4 (Figure 4). At last dose, social activity and both individual factors improved by at least by 70% (Table 9). Finally, the individual factor of ‘interacting with others’ showed a positive correlation with relief of nasal congestion (‘plugged nose’ symptom) (r = 0.60; p < 0.0001) (Table 12).

Sensation
The QoL category of sensation incorporates the senses of ‘smell’ (Q4) and ‘taste’ (Q5) from the additional QoL questions (Table 10). The sum of the individual scores determined the range of severity for the sensation category of 0–14. The ‘smell’ factor had a baseline mean (±SE) score of 4.8 (±0.16), considered to be moderate in severity level. The ‘taste’ factor had a mean (±SE) score of 4.2 (±0.19), considered mild (score = 3) to moderate (score = 5) in severity level. After day 1 of xylometazoline hydrochloride 0.1% use, the ‘smell’ and ‘taste’ senses improved significantly (p < 0.0001) (Table 10). Significant improvements continued throughout the study, and, at the last dose of treatment, the category of sensation had an improvement of 81%; the sense of ‘smell’ and the sense of ‘taste’ improved by 82.2% and 79.7%, respectively. The median time to resolution was day 3 for the sense of ‘taste’ and day 4 for the sense of ‘smell’ (Figure 4). A positive correlation with the symptom of ‘plugged nose’ and the sense of ‘smell’ was also observed (r = 0.61; p < 0.0001) (Table 12).

Table 10.
Overview of changes observed in the sensation 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
Sensation c Mean ± SE 9.0 ± 0.33 5.2 ± 0.38 4.5 ± 0.40 3.6 ± 0.38 2.8 ± 0.36 2.5 ± 0.41 2.8 ± 0.57 2.6 ± 0.61 1.7 ± 0.27
95% CI (−4.47 to −2.96) (−5.28 to −3.75) (−6.21 to −4.55) (−6.98 to −5.19) (−7.07 to −5.10) (−7.38 to −4.83) (−8.41 to −5.39) (−8.08 to −6.54)
Difference −3.71 −4.52 −5.38 −6.09 −6.08 −6.10 −6.90 −7.31
p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 41.60 50.17 59.93 68.36 71.09 68.39 72.38 81.04
Smell d Mean ± SE 4.8 ± 0.16 2.8 ± 0.19 2.4 ± 0.20 1.8 ± 0.19 1.5 ± 0.18 1.2 ± 0.21 1.5 ± 0.29 1.3 ± 0.31 0.9 ± 0.14
Difference −1.96 −2.42 −2.97 −3.34 −3.36 −3.23 −3.70 −3.98
p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 40.94 50.54 61.76 69.72 73.33 68.48 74.00 82.23
Taste d Mean ± SE 4.2 ± 0.19 2.4 ± 0.20 2.1 ± 0.21 1.8 ± 0.20 1.4 ± 0.18 1.3 ± 0.21 1.3 ± 0.29 1.3 ± 0.30 0.9 ± 0.14
Difference −1.76 −2.09 −2.41 −2.74 −2.73 −2.87 −3.20 −3.33
p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

fPost hoc analysis: WURSS-21 individual symptom factor (Q11).

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.

The median time to resolution for ‘alertness’ (slow in response) was day 2, followed by ‘motivation’ with a median time to resolution by day 3 and ‘energy’ with a median time to resolution by day 4 (Figure 4).

Physical activity

The QoL factors under the physical activity category were ‘breathe easily’ (Q14), ‘walk, climb stairs exercise’ (Q15), and ‘accomplish daily activities’ (Q16) from the WURSS-21 questionnaire. The score range for the physical activity category was calculated by adding the maximum score of each factor, resulting in a range of 0–21. At baseline, the physical activity mean (±SE) score was 13.1 (±0.36), which was considered mild (score = 9) to moderate (score = 15) in severity level.

Significant improvement in physical activity was observed by day 2 (p < 0.0001) (Table 8). The ‘breathe easily’ factor was found to significantly improve by day 1 (p = 0.0449) and had the strongest correlation with nasal congestion (‘plugged nose’ symptom) factor (r = 0.72; p < 0.0001) (Table 12). The other two QoL factors ‘walk, climb stairs, exercise’ and ‘accomplish daily activities’, improved significantly by day 2 (Table 8). At the last dose administered for all participants who completed the study, physical activity improved significantly by 70.7% to a mean (±SE) score of 3.8 (±0.46), which indicates an impact closer to a very mild (score = 3) severity level. After last dose, the percentage of improvement in ‘breathe easily’, ‘walk, climb stairs, exercise’, and ‘accomplish daily activities’ was >70% for all (Table 8). The median time to resolution was day 4 for ‘walk, climb stairs, exercise’, and ‘accomplish daily activities’ and day 5 for ‘breathe easily’ (Figure 4).

Table 8.

Overview of changes observed in the physical activity 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 99 98 92 82 59 39 30 100

Physical activity c Mean ± SE 13.1 ± 0.36 12.4 ± 0.43 9.8 ± 0.44 7.6 ± 0.53 6.3 ± 0.54 5.9 ± 0.65 5.5 ± 0.80 3.9 ± 0.79 3.8 ± 0.46

95% CI (−1.37 to −0.08) (−4.22 to −2.37) (−6.61 to −4.37) (−8.16 to −5.60) (−8.58 to −5.39) (−9.48 to −5.81) (−11.51 to −8.09) (−10.40 to −8.12)

Difference −0.65 −3.30 −5.49 −6.88 −6.98 −7.64 −9.80 −9.26

p-Value 0.0808 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

% Improvement 4.94 25.14 41.87 52.32 54.14 58.09 71.53 70.74

Breathe easily d Mean ± SE 5.3 ± 0.14 4.9 ± 0.15 4 ± 0.15 3 ± 0.19 2.5 ± 0.18 2.3 ± 0.23 2.2 ± 0.27 1.6 ± 0.32 1.6 ± 0.17

95% CI (−0.64 to −0.01) (−1.66 to −0.87) (−2.73 to −1.80) (−3.20 to −2.21) (−3.51 to −2.19) (−3.51 to −2.24) (−4.30 to −2.83) (−4.18 to −3.26)

Difference −0.32 −1.27 −2.26 −2.71 −2.85 −2.87 −3.57 −3.72

p-Value 0.0449 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

% Improvement 6.13 24.03 43.06 51.99 55.26 56.28 68.59 70.45

Walk, climb stairs, exercise d Mean ± SE 3.9 ± 0.16 3.7 ± 0.19 2.9 ± 0.18 2.3 ± 0.19 2.0 ± 0.21 1.8 ± 0.25 1.7 ± 0.31 1.2 ± 0.30 1.2 ± 0.17

95% CI (−0.56 to 0.04) (−1.43 to −0.71) (−2.05 to −1.19) (−2.51 to −1.51) (−2.70 to −1.50) (−3.15 to −1.68) (−3.92 to −2.34) (−3.20 to −2.32)

Difference −0.26 −1.07 −1.62 −2.01 −2.10 −2.41 −3.13 −2.76

p-Value 0.0851 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

% Improvement 6.70 27.20 41.05 50.77 53.22 58.39 72.87 70.41

Accomplish daily activities d Mean ± SE 3.9 ± 0.16 3.8 ± 0.17 2.9 ± 0.19 2.3 ± 0.19 1.8 ± 0.19 1.8 ± 0.23 1.6 ± 0.29 1.1 ± 0.27 1.1 ± 0.15

95% CI (−0.40 to −0.28) (−1.32 to −0.60) (−2.02 to −1.20) (−2.61 to −1.71) (−2.57 to −1.50) (−3.08 to −1.64) (−3.75 to −2.45) (−3.19 to −2.37)

Difference −0.06 −0.96 −1.61 −2.16 −2.03 −2.36 −3.10 −2.78

p-Value 0.7256 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

% Improvement 1.56 24.54 41.11 54.29 53.57 60.13 73.81 71.47

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Individual scores ranged from 0 (not at all) to 7 (severely). The ‘physical activity’ category scores were calculated by adding the individual QoL factors scores grouped in this category. The ‘physical activity’ category score ranged from 0 (not at all) to 21 (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 in this category.

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

cPost hoc analysis: QoL categories.

dPost hoc analysis: WURSS-21 individual QoL factors (Q14–Q16).

CI, confidence interval; Q, question; QoL, quality of life; SE, standard error; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

Social activity

The social activity category grouped the ‘interact with others’ factor from the WURSS-21 questionnaire (Q19) and ‘being self-conscious around people’ from the additional QoL questions (Q6). The sum of the individual scores determined the range of severity for the social activity category of 0–14. The individual QoL factors were both mildly (score = 3) to moderately (score = 5) impacted at baseline (Table 9).

Table 9.

Overview of changes observed in the social activity 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

Social activity c Mean ± SE 8.2 ± 0.32 5.9 ± 0.30 4.4 ± 0.32 3.8 ± 0.33 2.8 ± 0.32 2.7 ± 0.36 2.8 ± 0.48 1.8 ± 0.48 1.6 ± 0.24

95% CI (−2.75 to −1.64) (−4.442 to −3.13) (−5.05 to −3.58) (−6.06 to −4.50) (−6.20 to −4.44) (−6.47 to −4.25) (−7.80 to −5.13) (−7.31 to −5.85)

Difference −2.19 −3.78 −4.32 −5.28 −5.32 −5.36 −6.47 −6.58

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

% Improvement 29.94 46.16 52.93 65.31 65.97 65.52 78.23 80.05

Self-conscious around people d Mean ± SE 4.3 ± 0.20 2.3 ± 0.20 1.7 ± 0.18 1.6 ± 0.18 1.1 ± 0.18 1.0 ± 0.18 1.0 ± 0.24 0.8 ± 0.25 0.7 ± 0.13

Difference −1.93 −2.60 −2.65 −3.07 −3.25 −3.41 −3.47 −3.63

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

% Improvement 45.76 60.72 62.72 73.68 76.19 76.88 80.62 84.81

n e 102 99 98 92 82 59 39 30 100

Interact with others f Mean ± SE 3.9 ± 0.17 3.7 ± 0.17 2.7 ± 0.19 2.3 ± 0.19 1.7 ± 0.19 1.7 ± 0.23 1.8 ± 0.30 1.0 ± 0.29 1.0 ± 0.15

95% CI (−0.56 to −0.06) (−1.58 to −0.81) (−2.09 to −1.23) (−2.69 to −1.73) (−2.60 to −1.53) (−2.64 to −1.26) (−3.73 to −2.27) (−3.40 to −2.50)

Difference −0.25 −1.19 −1.66 −2.21 −2.07 −1.95 −3.00 −2.95

p-Value 0.1106 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

% Improvement 6.41 30.55 42.38 56.39 54.46 52.05 75.63 74.87

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Individual scores ranged from 0 (not at all) to 7 (severely). The ‘social activity category’ scores were calculated by adding the individual QoL factors grouped in this category. The ‘social activity’ 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 in this category 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 factor (Q6).

eNumber of participants who answered the WURSS-21 questionnaire.

fPost hoc analysis: WURSS-21 individual QoL factor (Q19).

CI, confidence interval; Q, question; QoL, quality of life; SE, standard error; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

Significant improvement in ‘being self-conscious around people’ was observed from day 1 (p < 0.0001). The social activity category score and the individual factor of ‘interacting with others’ score significantly improved from day 1 (p < 0.0001) (Table 9). The time to resolution was day 3 for ‘being self-conscious around people’ and the median time to resolution for the ‘interact with others’ factor was day 4 (Figure 4). At last dose, social activity and both individual factors improved by at least by 70% (Table 9). Finally, the individual factor of ‘interacting with others’ showed a positive correlation with relief of nasal congestion (‘plugged nose’ symptom) (r = 0.60; p < 0.0001) (Table 12).

Sensation

The QoL category of sensation incorporates the senses of ‘smell’ (Q4) and ‘taste’ (Q5) from the additional QoL questions (Table 10). The sum of the individual scores determined the range of severity for the sensation category of 0–14. The ‘smell’ factor had a baseline mean (±SE) score of 4.8 (±0.16), considered to be moderate in severity level. The ‘taste’ factor had a mean (±SE) score of 4.2 (±0.19), considered mild (score = 3) to moderate (score = 5) in severity level. After day 1 of xylometazoline hydrochloride 0.1% use, the ‘smell’ and ‘taste’ senses improved significantly (p < 0.0001) (Table 10). Significant improvements continued throughout the study, and, at the last dose of treatment, the category of sensation had an improvement of 81%; the sense of ‘smell’ and the sense of ‘taste’ improved by 82.2% and 79.7%, respectively. The median time to resolution was day 3 for the sense of ‘taste’ and day 4 for the sense of ‘smell’ (Figure 4). A positive correlation with the symptom of ‘plugged nose’ and the sense of ‘smell’ was also observed (r = 0.61; p < 0.0001) (Table 12).

Table 10.

Overview of changes observed in the sensation 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

Sensation c Mean ± SE 9.0 ± 0.33 5.2 ± 0.38 4.5 ± 0.40 3.6 ± 0.38 2.8 ± 0.36 2.5 ± 0.41 2.8 ± 0.57 2.6 ± 0.61 1.7 ± 0.27

95% CI (−4.47 to −2.96) (−5.28 to −3.75) (−6.21 to −4.55) (−6.98 to −5.19) (−7.07 to −5.10) (−7.38 to −4.83) (−8.41 to −5.39) (−8.08 to −6.54)

Difference −3.71 −4.52 −5.38 −6.09 −6.08 −6.10 −6.90 −7.31

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

% Improvement 41.60 50.17 59.93 68.36 71.09 68.39 72.38 81.04

Smell d Mean ± SE 4.8 ± 0.16 2.8 ± 0.19 2.4 ± 0.20 1.8 ± 0.19 1.5 ± 0.18 1.2 ± 0.21 1.5 ± 0.29 1.3 ± 0.31 0.9 ± 0.14

Difference −1.96 −2.42 −2.97 −3.34 −3.36 −3.23 −3.70 −3.98

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

% Improvement 40.94 50.54 61.76 69.72 73.33 68.48 74.00 82.23

Taste d Mean ± SE 4.2 ± 0.19 2.4 ± 0.20 2.1 ± 0.21 1.8 ± 0.20 1.4 ± 0.18 1.3 ± 0.21 1.3 ± 0.29 1.3 ± 0.30 0.9 ± 0.14

Difference −1.76 −2.09 −2.41 −2.74 −2.73 −2.87 −3.20 −3.33

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