QZaffre/Haleon_Cloud · Datasets at Hugging Face

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Baseline characteristics of study participants are shown in Table 4. Most of the participants were female (71.57%), white (76.47%), and the mean age was 35.9 ± 12.04 years old. Medical history of the participants revealed that the most common reported conditions were related to respiratory/thoracic disorders (11.80%) followed by musculoskeletal and connective tissue disorders (7.80%), gastrointestinal disorders (6.90%), and immune system disorders (5.90%). A total of 134 concomitant medications usages were reported by 63 participants (Table 4 and Figure 2). Of these concomitant medications, 15 were reported for cold-related symptoms as defined by questions 2–11 on the WURSS-21 (Table 1); 29 were reported for non-cold related indications that may have affected common cold symptoms; and 90 concomitant medications were reported for indications unrelated to the common cold (Supplemental Table 3).

Table 4.
Demographic and other baseline characteristics.

Characteristic Participants included in data analyses (N = 102)
Age (mean ± SD) 35.9 ± 12.04 years
Female n (%) 73 (71.57)
Male n (%) 25 (24.51)
Other n (%) 2 (1.96)
Prefer not to tell n (%) 2 (1.96)
Caucasian n (%) 78 (76.47)
Asian or Asian British n (%) 18 (17.65)
Black, Black British, Caribbean, or African n (%) 1 (0.98)
Mixed or multiple ethnic groups n (%) 3 (2.94)
Other n (%) 2 (1.96)
Non-Hispanic/Latino n (%) 99 (97.06)
Hispanic or Latino n (%) 2 (1.96)
Not reported n (%) 1 (0.98)
Respiratory/thoracic disorders n (%) 12 (11.80)
Musculoskeletal and connective tissue disorders n (%) 8 (7.80)
Surgical/medical procedures n (%) 8 (7.80)
GI disorders n (%) 7 (6.90)
Immune system disorders n (%) 6 (5.90)
Concomitant medications 134 (reported by 63 participants)
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GI, gastrointestinal; N, number of subjects in the safety population; n, number of subjects in this category; SD, standard deviation.

WURSS-21 total score
WURSS-21 total score ranges from 0 to 133, in which higher scores indicate higher severity. At baseline, the mean [±standard error (SE)] of the WURSS-21 total score of the mITT population (n = 102) was 75.8 (±2.00), which represents mild (score = 57) to moderate (score = 95) severity level. Statistically significant decreases in the WURSS-21 total score were observed consistently from day 2 to day 7 of treatment with the study product (p < 0.0001 for all). At the last dose administered for all participants that completed the study (n = 100), a statistically significant difference in WURSS-21 total score indicated a significant improvement in symptoms and QoL factors [−51.09 (95% CI: −56.82 to −45.36; p < 0.0001)] compared with baseline [Figure 3(a) and Supplemental Table 2], with a 67.6% improvement from baseline to the last dose (Supplemental Table 2).

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Object name is 10.1177_17534666241228927-fig3.jpg
Figure 3.
Over-time mean scores for the primary endpoint measures for the mITT population (N = 102). (a) Total score is the sum of questions 2 through 20, ranging from 0 to 133. (b) Total symptom domain score is a sum of questions 2 through 11 ranging from 0 to 70. (c) Total QoL domain score is a sum of questions 12–20 ranging from 0 to 63. (d) WURSS-21 plugged nose symptom score range from 0 to 7. Last dose refers to all participants’ last day if prior to day 7.

Subjects answered 10 symptom questions and 9 QoL questions scored from 0 (not at all) to 7 (severely). Higher scores indicate more negative impact of symptoms and QoL. Values presented are mean ± SE, and p-value calculated using Student’s paired t-test.

mITT, modified intention-to-treat; QoL, quality of life; SE, standard error; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21 items. p < 0.05, p < 0.01, **p < 0.0001.

WURSS-21 total symptom domain score
WURSS-21 total symptom domain score ranges from 0 to 70, in which higher scores indicate higher severity. At baseline, the mean (±SE) of the WURSS-21 symptom domain score of the mITT population observed was 38.3 (±1.12), which represents a mild (score = 30) to moderate (score = 50) severity level [Figure 3(b) and Supplemental Table 2]. Statistically significant decreases in the WURSS-21 total symptom domain were observed consistently from day 2 to day 7 (p < 0.0001) (Supplemental Table 2).

At the time of the last dose administered, the difference in WURSS-21 total symptom domain score was −24.7 (95% CI: −27.73 to −21.67; p < 0.0001) compared with baseline, which represents a drop to a severity level between very mild and mild. A 64.8% improvement from baseline in WURSS-21 total symptom domain score was observed at the last dose of treatment needed for all participants completing the study (n = 100) [Figure 3(b) and Supplemental Table 2].

WURSS-21 total QoL domain score
The WURSS-21 total QoL domain score ranges from 0 to 63, in which higher scores indicate higher severity. At baseline, the mean (±SE) of the WURSS-21 total QoL domain score of the mITT population observed was 37.5 (±1.15), which represents a mild (score = 27) to moderate (score = 45) severity level [Figure 3(c) and Supplemental Table 2]. Statistically significant decreases in the WURSS-21 total QoL domain score were observed consistently from day 1 (p = 0.0481) to day 7 (p < 0.0001) (Supplemental Table 2). By the last dose administered, the difference in WURSS-21 QoL domain score was −26.39 (95% CI: −29.75 to −23.03; p < 0.0001) compared with baseline, representing a 70.4% improvement from baseline in WURSS-21 total QoL domain score at the last dose of the treatment needed for all participants who completed the study (n = 100) [Figure 3(c) and Supplemental Table 2].

Individual WURSS-21 symptom domain scores
The individual WURSS-21 symptom domain score ranges from 0 to 7 (Table 1), in which higher scores indicate higher severity. Of the 10 individual symptoms assessed using the WURSS-21 questionnaire, ‘plugged nose’, ‘runny nose’, ‘head congestion’, and ‘feeling tired’ scored a mean baseline score of at least 4, representing a mild (score = 3) to moderate (score = 5) severity level. These individual symptoms generally showed the greatest percentage improvement by the last day of dose administered (Supplemental Table 2). A statistically significant improvement in ‘plugged nose’ (p = 0.0023) was observed from day 1 post-treatment [Figure 3(d) and Supplemental Table 2]. The mean ± SE score for ‘plugged nose’ at baseline was 5.5 (±0.09), which represents a moderate to severe level for this symptom. By the last dose of xylometazoline hydrochloride 0.1% was used, the ‘plugged nose’ symptom improved by 68.1% and dropped to a mean (±SE) score of 1.8 (±0.16), which represents a very mild-to-absent severity level. All 10 symptom scores improved by at least 50% from baseline at the last dose (Supplemental Table 2).

Safety
Treatment-emergent AEs (TEAEs) are shown in Table 5. Six participants reported 10 TEAEs, 5 of which were treatment-related in 5 participants (two events of epistaxis, two events of headache, and one event of sinusitis). No new significant safety information was identified from these AEs. There were no severe TEAEs, and no participants withdrew from the study due to AEs. Participants who reported using the product more than three times a day did not report any safety issues.

Table 5.
TEAEs by system organ class and preferred term.

System organ class a
Preferred term b Overall c , N = 102, n (%) Total events, M = 10, m (%)
TEAE 6 (5.9) 10 (100)
Respiratory, thoracic, and mediastinal disorders 3 (2.9) 4 (40.0)
Epistaxis 2 (2.0) 2 (20.0)
Cough 1 (1.0) 1 (10.0)
Oropharyngeal pain 1 (1.0) 1 (10.0)
Eye disorders 1 (1.0) 2 (20.0)
Eye pruritus 1 (1.0) 1 (10.0)
Lacrimation increased 1 (1.0) 1 (10.0)
Nervous system disorders 2 (2.0) 2 (20.0)
Headache 2 (2.0) 2 (20.0)
Gastrointestinal disorders 1 (1.0) 1 (10.0)
Nausea 1 (1.0) 1 (10.0)
Infections and infestations 1 (1.0) 1 (10.0)
Sinusitis 1 (1.0) 1 (10.0)
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AEs are coded with the MedDRA version 25.1.

aSubjects with multiple occurrences of AEs in the same system organ class are counted only once within that preferred term.
bSubjects with multiple occurrences of AEs in the same preferred term are counted only once within that system organ class.
cOverall is the number of subjects who had at least one TEAE. System organ classes are listed in descending order of frequency and preferred terms are listed in descending order of frequency within each system organ class.
AE, adverse event; M, number of AEs; m (%), number (percentage) of AEs in this category; MedDRA, Medical Dictionary for Regulatory Activities N, number of subjects in the safety population; n (%), number (percentage) of subjects in this category; TEAE, treatment-emergent adverse event.

QoL categories
The over-time effects of xylometazoline hydrochloride 0.1% on five QoL categories were evaluated. Each category grouped similar QoL factors from the WURSS-21 questionnaire and the additional QoL factors. Other QoL factors that were not included in a category were analyzed individually.

Sleep quality
The sleep quality category was defined by grouping the ‘sleep well’ factor from the WURSS-21 questionnaire (Q13) and the ‘snoring’ factor from the additional QoL questions (Q1). The severity scale for sleep quality was calculated by adding the two individual QoL scores included; the resulting range was 0–14, where 14 represented the highest severity. Because the ‘snoring’ factor could only be measured in participants who lived with a partner, the analyses for sleep quality category were assessed on an initial n of 80 participants, and not on the full mITT population (n = 102).

At baseline, the mean (±SE) score for ‘sleep quality’ was 9.7 (±0.30), which was considered a moderate severity level (score = 10). However, a significant improvement was seen on day 1 of treatment (p = 0.0001), with a mean score of 7.3 (±0.37), which was closer to mild severity level (score = 6). At the last dose administered sleep quality improved by 72.5% (Table 6).

Table 6.
Overview of changes observed in the sleep quality category.

QoL category/factor n a Baseline Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Last dose b
80 73 71 69 61 41 27 25 74
Sleep quality c Mean ± SE 9.7 ± 0.30 7.3 ± 0.37 6.3 ± 0.39 4.9 ± 0.42 3.7 ± 0.38 3.8 ± 0.42 3.8 ± 0.55 3.0 ± 0.55 2.6 ± 0.34
95% CI (−3.08 to −1.72) (−4.17 to −2.81) (−5.53 to −3.94) (−6.75 to −5.05) (−6.45 to −4.53) (−7.19 to −4.44) (−7.78 to −4.46) (−7.85 to −6.18)
Difference −2.40 −3.49 −4.74 −5.90 −5.49 −5.81 −6.12 −7.01
p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
% Improvement 24.75 35.41 48.79 61.46 59.21 60.38 66.81 72.52
Snoring d Mean ± SE 4.7 ± 0.19 2.8 ± 0.25 2.4 ± 0.24 1.9 ± 0.23 1.4 ± 0.23 1.4 ± 0.25 1.4 ± 0.30 1.2 ± 0.29 0.9 ± 0.19

Baseline characteristics of study participants are shown in Table 4. Most of the participants were female (71.57%), white (76.47%), and the mean age was 35.9 ± 12.04 years old. Medical history of the participants revealed that the most common reported conditions were related to respiratory/thoracic disorders (11.80%) followed by musculoskeletal and connective tissue disorders (7.80%), gastrointestinal disorders (6.90%), and immune system disorders (5.90%). A total of 134 concomitant medications usages were reported by 63 participants (Table 4 and Figure 2). Of these concomitant medications, 15 were reported for cold-related symptoms as defined by questions 2–11 on the WURSS-21 (Table 1); 29 were reported for non-cold related indications that may have affected common cold symptoms; and 90 concomitant medications were reported for indications unrelated to the common cold (Supplemental Table 3).

Table 4.

Demographic and other baseline characteristics.

Characteristic Participants included in data analyses (N = 102)

Age (mean ± SD) 35.9 ± 12.04 years

Female n (%) 73 (71.57)

Male n (%) 25 (24.51)

Other n (%) 2 (1.96)

Prefer not to tell n (%) 2 (1.96)

Caucasian n (%) 78 (76.47)

Asian or Asian British n (%) 18 (17.65)

Black, Black British, Caribbean, or African n (%) 1 (0.98)

Mixed or multiple ethnic groups n (%) 3 (2.94)

Other n (%) 2 (1.96)

Non-Hispanic/Latino n (%) 99 (97.06)

Hispanic or Latino n (%) 2 (1.96)

Not reported n (%) 1 (0.98)

Respiratory/thoracic disorders n (%) 12 (11.80)

Musculoskeletal and connective tissue disorders n (%) 8 (7.80)

Surgical/medical procedures n (%) 8 (7.80)

GI disorders n (%) 7 (6.90)

Immune system disorders n (%) 6 (5.90)

Concomitant medications 134 (reported by 63 participants)

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GI, gastrointestinal; N, number of subjects in the safety population; n, number of subjects in this category; SD, standard deviation.

WURSS-21 total score

WURSS-21 total score ranges from 0 to 133, in which higher scores indicate higher severity. At baseline, the mean [±standard error (SE)] of the WURSS-21 total score of the mITT population (n = 102) was 75.8 (±2.00), which represents mild (score = 57) to moderate (score = 95) severity level. Statistically significant decreases in the WURSS-21 total score were observed consistently from day 2 to day 7 of treatment with the study product (p < 0.0001 for all). At the last dose administered for all participants that completed the study (n = 100), a statistically significant difference in WURSS-21 total score indicated a significant improvement in symptoms and QoL factors [−51.09 (95% CI: −56.82 to −45.36; p < 0.0001)] compared with baseline [Figure 3(a) and Supplemental Table 2], with a 67.6% improvement from baseline to the last dose (Supplemental Table 2).

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

Object name is 10.1177_17534666241228927-fig3.jpg

Figure 3.

Over-time mean scores for the primary endpoint measures for the mITT population (N = 102). (a) Total score is the sum of questions 2 through 20, ranging from 0 to 133. (b) Total symptom domain score is a sum of questions 2 through 11 ranging from 0 to 70. (c) Total QoL domain score is a sum of questions 12–20 ranging from 0 to 63. (d) WURSS-21 plugged nose symptom score range from 0 to 7. Last dose refers to all participants’ last day if prior to day 7.

Subjects answered 10 symptom questions and 9 QoL questions scored from 0 (not at all) to 7 (severely). Higher scores indicate more negative impact of symptoms and QoL. Values presented are mean ± SE, and p-value calculated using Student’s paired t-test.

mITT, modified intention-to-treat; QoL, quality of life; SE, standard error; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21 items. *p < 0.05, **p < 0.01, ***p < 0.0001.

WURSS-21 total symptom domain score

WURSS-21 total symptom domain score ranges from 0 to 70, in which higher scores indicate higher severity. At baseline, the mean (±SE) of the WURSS-21 symptom domain score of the mITT population observed was 38.3 (±1.12), which represents a mild (score = 30) to moderate (score = 50) severity level [Figure 3(b) and Supplemental Table 2]. Statistically significant decreases in the WURSS-21 total symptom domain were observed consistently from day 2 to day 7 (p < 0.0001) (Supplemental Table 2).

At the time of the last dose administered, the difference in WURSS-21 total symptom domain score was −24.7 (95% CI: −27.73 to −21.67; p < 0.0001) compared with baseline, which represents a drop to a severity level between very mild and mild. A 64.8% improvement from baseline in WURSS-21 total symptom domain score was observed at the last dose of treatment needed for all participants completing the study (n = 100) [Figure 3(b) and Supplemental Table 2].

WURSS-21 total QoL domain score

The WURSS-21 total QoL domain score ranges from 0 to 63, in which higher scores indicate higher severity. At baseline, the mean (±SE) of the WURSS-21 total QoL domain score of the mITT population observed was 37.5 (±1.15), which represents a mild (score = 27) to moderate (score = 45) severity level [Figure 3(c) and Supplemental Table 2]. Statistically significant decreases in the WURSS-21 total QoL domain score were observed consistently from day 1 (p = 0.0481) to day 7 (p < 0.0001) (Supplemental Table 2). By the last dose administered, the difference in WURSS-21 QoL domain score was −26.39 (95% CI: −29.75 to −23.03; p < 0.0001) compared with baseline, representing a 70.4% improvement from baseline in WURSS-21 total QoL domain score at the last dose of the treatment needed for all participants who completed the study (n = 100) [Figure 3(c) and Supplemental Table 2].

Individual WURSS-21 symptom domain scores

The individual WURSS-21 symptom domain score ranges from 0 to 7 (Table 1), in which higher scores indicate higher severity. Of the 10 individual symptoms assessed using the WURSS-21 questionnaire, ‘plugged nose’, ‘runny nose’, ‘head congestion’, and ‘feeling tired’ scored a mean baseline score of at least 4, representing a mild (score = 3) to moderate (score = 5) severity level. These individual symptoms generally showed the greatest percentage improvement by the last day of dose administered (Supplemental Table 2). A statistically significant improvement in ‘plugged nose’ (p = 0.0023) was observed from day 1 post-treatment [Figure 3(d) and Supplemental Table 2]. The mean ± SE score for ‘plugged nose’ at baseline was 5.5 (±0.09), which represents a moderate to severe level for this symptom. By the last dose of xylometazoline hydrochloride 0.1% was used, the ‘plugged nose’ symptom improved by 68.1% and dropped to a mean (±SE) score of 1.8 (±0.16), which represents a very mild-to-absent severity level. All 10 symptom scores improved by at least 50% from baseline at the last dose (Supplemental Table 2).

Safety

Treatment-emergent AEs (TEAEs) are shown in Table 5. Six participants reported 10 TEAEs, 5 of which were treatment-related in 5 participants (two events of epistaxis, two events of headache, and one event of sinusitis). No new significant safety information was identified from these AEs. There were no severe TEAEs, and no participants withdrew from the study due to AEs. Participants who reported using the product more than three times a day did not report any safety issues.

Table 5.

TEAEs by system organ class and preferred term.

System organ class a

Preferred term b Overall c , N = 102, n (%) Total events, M = 10, m (%)

TEAE 6 (5.9) 10 (100)

Respiratory, thoracic, and mediastinal disorders 3 (2.9) 4 (40.0)

Epistaxis 2 (2.0) 2 (20.0)

Cough 1 (1.0) 1 (10.0)

Oropharyngeal pain 1 (1.0) 1 (10.0)

Eye disorders 1 (1.0) 2 (20.0)

Eye pruritus 1 (1.0) 1 (10.0)

Lacrimation increased 1 (1.0) 1 (10.0)

Nervous system disorders 2 (2.0) 2 (20.0)

Headache 2 (2.0) 2 (20.0)

Gastrointestinal disorders 1 (1.0) 1 (10.0)

Nausea 1 (1.0) 1 (10.0)

Infections and infestations 1 (1.0) 1 (10.0)

Sinusitis 1 (1.0) 1 (10.0)

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AEs are coded with the MedDRA version 25.1.

aSubjects with multiple occurrences of AEs in the same system organ class are counted only once within that preferred term.

bSubjects with multiple occurrences of AEs in the same preferred term are counted only once within that system organ class.

cOverall is the number of subjects who had at least one TEAE. System organ classes are listed in descending order of frequency and preferred terms are listed in descending order of frequency within each system organ class.

AE, adverse event; M, number of AEs; m (%), number (percentage) of AEs in this category; MedDRA, Medical Dictionary for Regulatory Activities N, number of subjects in the safety population; n (%), number (percentage) of subjects in this category; TEAE, treatment-emergent adverse event.

QoL categories

The over-time effects of xylometazoline hydrochloride 0.1% on five QoL categories were evaluated. Each category grouped similar QoL factors from the WURSS-21 questionnaire and the additional QoL factors. Other QoL factors that were not included in a category were analyzed individually.

Sleep quality

The sleep quality category was defined by grouping the ‘sleep well’ factor from the WURSS-21 questionnaire (Q13) and the ‘snoring’ factor from the additional QoL questions (Q1). The severity scale for sleep quality was calculated by adding the two individual QoL scores included; the resulting range was 0–14, where 14 represented the highest severity. Because the ‘snoring’ factor could only be measured in participants who lived with a partner, the analyses for sleep quality category were assessed on an initial n of 80 participants, and not on the full mITT population (n = 102).

At baseline, the mean (±SE) score for ‘sleep quality’ was 9.7 (±0.30), which was considered a moderate severity level (score = 10). However, a significant improvement was seen on day 1 of treatment (p = 0.0001), with a mean score of 7.3 (±0.37), which was closer to mild severity level (score = 6). At the last dose administered sleep quality improved by 72.5% (Table 6).

Table 6.

Overview of changes observed in the sleep quality category.

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

80 73 71 69 61 41 27 25 74

Sleep quality c Mean ± SE 9.7 ± 0.30 7.3 ± 0.37 6.3 ± 0.39 4.9 ± 0.42 3.7 ± 0.38 3.8 ± 0.42 3.8 ± 0.55 3.0 ± 0.55 2.6 ± 0.34

95% CI (−3.08 to −1.72) (−4.17 to −2.81) (−5.53 to −3.94) (−6.75 to −5.05) (−6.45 to −4.53) (−7.19 to −4.44) (−7.78 to −4.46) (−7.85 to −6.18)

Difference −2.40 −3.49 −4.74 −5.90 −5.49 −5.81 −6.12 −7.01

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

% Improvement 24.75 35.41 48.79 61.46 59.21 60.38 66.81 72.52

Snoring d Mean ± SE 4.7 ± 0.19 2.8 ± 0.25 2.4 ± 0.24 1.9 ± 0.23 1.4 ± 0.23 1.4 ± 0.25 1.4 ± 0.30 1.2 ± 0.29 0.9 ± 0.19