QZaffre/Haleon_Cloud · Datasets at Hugging Face

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19. Interact with others
20. Live your personal life
Compared to yesterday, I feel that my cold is. . ..
21. Very much better – Somewhat better – A little better – The same – A little worse – Somewhat worse – Very much worse
Additional QoL questionnaire
Considering the past 24 h, please read each question and choose the answera that best reflects your experience with Otrivin use and your nasal congestion:
1. After using Otrivin, is your nasal congestion/cold making you snore during the night? (aFor those with sleeping partners only)
2. After using Otrivin, is your nasal congestion/cold making you slow in your responses?
3. After using Otrivin, is your nasal congestion/cold making you self-conscious about how you sound?
4. After using Otrivin, is your nasal congestion/cold affecting your sense of smell?
5. After using Otrivin, is your nasal congestion/cold affecting your sense of taste?
6. After using Otrivin, is your nasal congestion/cold making you self-conscious around people?
7. After using Otrivin, is your nasal congestion/cold making you less energetic than usual?
8. After using Otrivin, is your nasal congestion/cold making you less motivated than usual?
aSeverity scale:
An external file that holds a picture, illustration, etc.
Object name is 10.1177_17534666241228927-img3.jpg
Open in a separate window
QoL, quality of life; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

Every morning, participants’ QoL factors were assessed via completion of the WURSS-21 questionnaire and the additional QoL questions based on the effects of the study product used on the previous day. For example, the scores reported on day 1 show the results from day 0. As per leaflet instructions, xylometazoline hydrochloride 0.1% was used no more than three times a day for up to 7 days and participants had the option to stop treatment at their discretion (Supplemental Methods Section 6) based on their desire to treat nasal congestion. Opting out of the treatment before the completion of 7 days of treatment was possible if participants felt their symptoms did not warrant further treatment, or if their nasal congestion was resolved; both criteria were assessed daily. The last dose was the day of last treatment if before 7 days. On day 7, or on the day after the last dose was used, participants completed an exit survey. Participants who did not satisfy the criteria for participation and treatment compliance (Supplemental Methods Section 7) were considered dropouts.

Endpoints
The primary, secondary, exploratory, safety, and post hoc study objectives are summarized in Table 2.

Table 2.
Summary of the objectives of primary, secondary, exploratory, safety, and post hoc endpoints.

Objectives Endpoints
Primary
To evaluate the over-time effects of xylometazoline hydrochloride 0.1% on QoL factors and common cold symptoms among individuals experiencing nasal congestion associated with the common cold, following up to 7 days of treatment • WURSS-21 total score
• WURSS-21 total symptom domains
• WURSS-21 total QoL domains (Q12-think clearly, Q13-sleep well, Q14-breathe easily, Q15-walk, climb, exercise, Q16-accomplishing daily activities, Q17-work outside the home, Q18-work inside the home, Q19-interacting with others, Q20-living your personal life)
• Individual WURSS-21 symptom domains
(Q2-runny nose, Q3-plugged nose, Q4-sneezing, Q5-sore throat, Q6-scratchy throat, Q7-cough, Q8-hoarseness, Q9-head congestion, Q10-chest congestion, Q11-feeling tired)
Secondary
To evaluate, the over-time effects of xylometazoline hydrochloride 0.1% on additional measures of QoL factors among individuals experiencing nasal congestion associated with the common cold, following up to 7 days of treatment Snoring (Q1), alertness (slow in responses) (Q2), feeling self-conscious about how you sound (Q3), feeling self-conscious around people (Q4), smell (Q5) and taste (Q6), energy (Q7), and motivation (Q8)
Exploratory
To evaluate the median time to resolution of the eight additional QoL factors
Safety
To record AEs during the study period Number and percentage of patients reporting AEs or SAEs while on treatment related or not related to the product
Post hoc
• To evaluate the over-time effects of xylometazoline hydrochloride 0.1% on WURSS-21 individual QoL factors among individuals experiencing nasal congestion associated with the common cold, following up to 7 days of treatment
• To assess the median time to resolution of WURSS-21 individual QoL domains
• To determine the correlation between the WURSS-21 plugged nose symptom and the WURSS-21 individual QoL and the additional QoL factors
• To evaluate the over-time effects of xylometazoline hydrochloride 0.1% on five QoL categories (sleep quality, physical activities, sensation, vitality, and social) • Scores of each individual WURSS-21 QoL factor at baseline and after each day of xylometazoline hydrochloride 0.1% use, up to 7 days
• Median time to resolution of individual WURSS-21 QoL factors
• Correlation between plugged nose symptom and WURSS-21 questions 12–20 and the eight additional QoL questions
• Significance on improvement in five QoL categories that were created by grouping similar WURSS-21 factors and additional QoL factors, where applicable
Open in a separate window
AE, adverse event; Q, question; QoL, quality of life; SAE, serious AE; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

The summary of the individual QoL factors grouped to form the five QoL categories bundles are shown in Table 3.

Table 3.
Five additional QoL categories.

QoL category QoL individual factors
Sleep quality • Sleep well (WURSS-21 Q13)
• Snoring (QoL Q1)
Vitality • Less energetic (QoL Q7)
• Less motivated (QoL Q8)
• Feel tired (WURSS-21 Q11)
• Alertness (slow in response, QoL Q2)
Physical activity • Breathe easily (WURSS-21 Q14)
• Walk, climb stairs, exercise (WURSS-21 Q15)
• Accomplish daily activities (WURSS-21 Q16)
Social activity • Interact with others (WURSS-21 Q19)
• Self-conscious around people (QoL Q6)
Sensation • Sense of smell (QoL Q4)
• Sense of taste (QoL Q5)
Open in a separate window
Q, question; QoL, quality of life; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

Statistical analysis
Sample size A non-parametric paired Wilcoxon test was performed to determine sample size, which was based on a significance level (α) of 0.05, 80% power (1 – β), and an estimated standardized effect size of 0.27. Using these parameters, a sample size of N = 125 eligible participants to retain 100 completed participants was obtained to be sufficient to observe improvement in QoL. The Full Analysis Set population and the modified intention-to-treat (mITT) population were considered the same in this instance as participants used the study product at least once and had data from at least one post-baseline QoL questionnaire to support at least one of the primary endpoint assessments.
Primary endpoint Primary analyses for QoL and data were summarized using the mITT population. The WURSS-21 questionnaire was completed at baseline, on each day of treatment and at the last dose used to determine the effect of xylometazoline hydrochloride 0.1% on QoL factors and cold symptoms. Daily WURSS-21 scores were calculated by adding each score of the 10 questions related to symptoms and the 9 questions related to QoL, 19 in total (Supplemental Methods Section 3). Two questions not related to specific symptoms or QoL factors, but overall performance, were not included in the total score. The severity scale range of the different WURSS-21 scores was calculated by multiplying the total number of individual symptom and/or QoL factors by the individual lowest (score = 0), very mild (score = 1), mild (score = 3), moderate (score = 5), and highest (score = 7) severity scores. Thus, the WURSS-21 total score severity ranged from 0 to 133, as the WURSS-21 total score included 19 symptoms and QoL factors. The WURSS-21 total symptom domain severity score ranged from 0 to 70, and the WURSS-21 total QoL domain severity score ranged from 0 to 63. The change from baseline in mean WURSS-21 scores were analyzed each day using a Student’s paired t-test, and p-values were assessed to a significance level of α = 0.05 and 95% confidence intervals (CIs).
Secondary endpoint Secondary analyses for QoL and data were summarized using the mITT population. Participants’ baseline scores were used to determine the effect of xylometazoline hydrochloride 0.1% on additional QoL factors. The changes from baseline in mean additional QoL scores were analyzed each day using a Student’s paired t-test, and p-values were assessed to a significance level of α = 0.05. Median post-treatment scores were presented for each day of treatment through day 7 or until data were no longer provided due to nasal symptom resolution, whichever came first.
Safety endpoint Adverse events (AEs) were summarized using the safety population, which included all participants who received at least one dose of the study product. All AEs were coded using the Medical Dictionary for Regulatory Activities (v25.1). The number of AEs and serious AEs (SAEs) and the number of participants with AEs/SAEs were tabulated by System Organ Class and Preferred Team. Causality assessment of the AEs was carried out by the virtual research organization prior to database lock.
Exploratory endpoint The times to resolution of QoL factors were evaluated using Kaplan–Meier curves. Analyses were summarized using the mITT population.
Post hoc analyses Post hoc analyses were evaluated using the mITT population. The changes from baseline in mean WURSS-21 individual QoL scores were analyzed each day using a Student’s paired t-test, and p-values were assessed to a significance level of α = 0.05. The median times to resolution of WURSS-21 individual QoL domains were analyzed using Kaplan–Meier curves. Correlations and significance between the WURSS-21 ‘plugged nose’ symptom, the WURSS-21 individual QoL domains (WURSS-21 questions 12–20), and the eight additional QoL factors were calculated using the Pearson correlation coefficient. The over-time effect of xylometazoline hydrochloride 0.1% was evaluated in five QoL categories (Table 3). The changes from baseline for the mean of each QoL category score were analyzed each day using a Student’s paired t-test, and p-values were assessed to a significance level of α = 0.05.
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Results
Study participants
A total of 172 adults were screened, of which 136 were enrolled in the study (Figure 2). Study documentation did not capture the reasons why 36 participants from the screening were not enrolled. Of the enrolled population, 129 participants reconfirmed eligibility upon study product receipt. Of these, 102 participants were included in the mITT population as they used the study product at least once and completed at least one post-baseline QoL questionnaire. Two participants from the mITT population discontinued the study due to ‘early termination’ for non-compliance reasons after using the study product (Supplemental Results Section 1). Data up to the time of discontinuation were included in the mITT analysis. Figure 2 also shows the number of participants remaining from day 1 through day 7 in the mITT population. A total of 100 participants completed the study, for which the scores of the last dose used were calculated.

An external file that holds a picture, illustration, etc.
Object name is 10.1177_17534666241228927-fig2.jpg
Figure 2.
Disposition of participants.

aEnrolled population included all subjects who met the inclusion/exclusion criteria and have met the eligibility confirmation criteria (including a plugged nose score ⩾5 and another common cold symptom score ⩾3).

bSubjects who did not use the study product due to eligibility cessation, or participants who were unresponsive and discontinued the study.

cmITT population included all subjects who used the study product at least once and had at least one post-baseline QoL questionnaire. After receiving the study product, participants had to comply with a plugged nose score ⩾5 and another common cold symptom score ⩾3.

mITT, modified intention-to-treat; N, total number of subjects in the screened population and total number of participants who took concomitant medication; n, number of subjects in each subcategory; QoL, quality of life.

Demographics and other baseline characteristics

19. Interact with others

20. Live your personal life

Compared to yesterday, I feel that my cold is. . ..

21. Very much better – Somewhat better – A little better – The same – A little worse – Somewhat worse – Very much worse

Additional QoL questionnaire

Considering the past 24 h, please read each question and choose the answera that best reflects your experience with Otrivin use and your nasal congestion:

1. After using Otrivin, is your nasal congestion/cold making you snore during the night? (aFor those with sleeping partners only)

2. After using Otrivin, is your nasal congestion/cold making you slow in your responses?

3. After using Otrivin, is your nasal congestion/cold making you self-conscious about how you sound?

4. After using Otrivin, is your nasal congestion/cold affecting your sense of smell?

5. After using Otrivin, is your nasal congestion/cold affecting your sense of taste?

6. After using Otrivin, is your nasal congestion/cold making you self-conscious around people?

7. After using Otrivin, is your nasal congestion/cold making you less energetic than usual?

8. After using Otrivin, is your nasal congestion/cold making you less motivated than usual?

aSeverity scale:

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

Object name is 10.1177_17534666241228927-img3.jpg

Open in a separate window

QoL, quality of life; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

Every morning, participants’ QoL factors were assessed via completion of the WURSS-21 questionnaire and the additional QoL questions based on the effects of the study product used on the previous day. For example, the scores reported on day 1 show the results from day 0. As per leaflet instructions, xylometazoline hydrochloride 0.1% was used no more than three times a day for up to 7 days and participants had the option to stop treatment at their discretion (Supplemental Methods Section 6) based on their desire to treat nasal congestion. Opting out of the treatment before the completion of 7 days of treatment was possible if participants felt their symptoms did not warrant further treatment, or if their nasal congestion was resolved; both criteria were assessed daily. The last dose was the day of last treatment if before 7 days. On day 7, or on the day after the last dose was used, participants completed an exit survey. Participants who did not satisfy the criteria for participation and treatment compliance (Supplemental Methods Section 7) were considered dropouts.

Endpoints

The primary, secondary, exploratory, safety, and post hoc study objectives are summarized in Table 2.

Table 2.

Summary of the objectives of primary, secondary, exploratory, safety, and post hoc endpoints.

Objectives Endpoints

Primary

To evaluate the over-time effects of xylometazoline hydrochloride 0.1% on QoL factors and common cold symptoms among individuals experiencing nasal congestion associated with the common cold, following up to 7 days of treatment • WURSS-21 total score

• WURSS-21 total symptom domains

• WURSS-21 total QoL domains (Q12-think clearly, Q13-sleep well, Q14-breathe easily, Q15-walk, climb, exercise, Q16-accomplishing daily activities, Q17-work outside the home, Q18-work inside the home, Q19-interacting with others, Q20-living your personal life)

• Individual WURSS-21 symptom domains

(Q2-runny nose, Q3-plugged nose, Q4-sneezing, Q5-sore throat, Q6-scratchy throat, Q7-cough, Q8-hoarseness, Q9-head congestion, Q10-chest congestion, Q11-feeling tired)

Secondary

To evaluate, the over-time effects of xylometazoline hydrochloride 0.1% on additional measures of QoL factors among individuals experiencing nasal congestion associated with the common cold, following up to 7 days of treatment Snoring (Q1), alertness (slow in responses) (Q2), feeling self-conscious about how you sound (Q3), feeling self-conscious around people (Q4), smell (Q5) and taste (Q6), energy (Q7), and motivation (Q8)

Exploratory

To evaluate the median time to resolution of the eight additional QoL factors

Safety

To record AEs during the study period Number and percentage of patients reporting AEs or SAEs while on treatment related or not related to the product

Post hoc

• To evaluate the over-time effects of xylometazoline hydrochloride 0.1% on WURSS-21 individual QoL factors among individuals experiencing nasal congestion associated with the common cold, following up to 7 days of treatment

• To assess the median time to resolution of WURSS-21 individual QoL domains

• To determine the correlation between the WURSS-21 plugged nose symptom and the WURSS-21 individual QoL and the additional QoL factors

• To evaluate the over-time effects of xylometazoline hydrochloride 0.1% on five QoL categories (sleep quality, physical activities, sensation, vitality, and social) • Scores of each individual WURSS-21 QoL factor at baseline and after each day of xylometazoline hydrochloride 0.1% use, up to 7 days

• Median time to resolution of individual WURSS-21 QoL factors

• Correlation between plugged nose symptom and WURSS-21 questions 12–20 and the eight additional QoL questions

• Significance on improvement in five QoL categories that were created by grouping similar WURSS-21 factors and additional QoL factors, where applicable

Open in a separate window

AE, adverse event; Q, question; QoL, quality of life; SAE, serious AE; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

The summary of the individual QoL factors grouped to form the five QoL categories bundles are shown in Table 3.

Table 3.

Five additional QoL categories.

QoL category QoL individual factors

Sleep quality • Sleep well (WURSS-21 Q13)

• Snoring (QoL Q1)

Vitality • Less energetic (QoL Q7)

• Less motivated (QoL Q8)

• Feel tired (WURSS-21 Q11)

• Alertness (slow in response, QoL Q2)

Physical activity • Breathe easily (WURSS-21 Q14)

• Walk, climb stairs, exercise (WURSS-21 Q15)

• Accomplish daily activities (WURSS-21 Q16)

Social activity • Interact with others (WURSS-21 Q19)

• Self-conscious around people (QoL Q6)

Sensation • Sense of smell (QoL Q4)

• Sense of taste (QoL Q5)

Open in a separate window

Q, question; QoL, quality of life; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

Statistical analysis

Sample size A non-parametric paired Wilcoxon test was performed to determine sample size, which was based on a significance level (α) of 0.05, 80% power (1 – β), and an estimated standardized effect size of 0.27. Using these parameters, a sample size of N = 125 eligible participants to retain 100 completed participants was obtained to be sufficient to observe improvement in QoL. The Full Analysis Set population and the modified intention-to-treat (mITT) population were considered the same in this instance as participants used the study product at least once and had data from at least one post-baseline QoL questionnaire to support at least one of the primary endpoint assessments.

Primary endpoint Primary analyses for QoL and data were summarized using the mITT population. The WURSS-21 questionnaire was completed at baseline, on each day of treatment and at the last dose used to determine the effect of xylometazoline hydrochloride 0.1% on QoL factors and cold symptoms. Daily WURSS-21 scores were calculated by adding each score of the 10 questions related to symptoms and the 9 questions related to QoL, 19 in total (Supplemental Methods Section 3). Two questions not related to specific symptoms or QoL factors, but overall performance, were not included in the total score. The severity scale range of the different WURSS-21 scores was calculated by multiplying the total number of individual symptom and/or QoL factors by the individual lowest (score = 0), very mild (score = 1), mild (score = 3), moderate (score = 5), and highest (score = 7) severity scores. Thus, the WURSS-21 total score severity ranged from 0 to 133, as the WURSS-21 total score included 19 symptoms and QoL factors. The WURSS-21 total symptom domain severity score ranged from 0 to 70, and the WURSS-21 total QoL domain severity score ranged from 0 to 63. The change from baseline in mean WURSS-21 scores were analyzed each day using a Student’s paired t-test, and p-values were assessed to a significance level of α = 0.05 and 95% confidence intervals (CIs).

Secondary endpoint Secondary analyses for QoL and data were summarized using the mITT population. Participants’ baseline scores were used to determine the effect of xylometazoline hydrochloride 0.1% on additional QoL factors. The changes from baseline in mean additional QoL scores were analyzed each day using a Student’s paired t-test, and p-values were assessed to a significance level of α = 0.05. Median post-treatment scores were presented for each day of treatment through day 7 or until data were no longer provided due to nasal symptom resolution, whichever came first.

Safety endpoint Adverse events (AEs) were summarized using the safety population, which included all participants who received at least one dose of the study product. All AEs were coded using the Medical Dictionary for Regulatory Activities (v25.1). The number of AEs and serious AEs (SAEs) and the number of participants with AEs/SAEs were tabulated by System Organ Class and Preferred Team. Causality assessment of the AEs was carried out by the virtual research organization prior to database lock.

Exploratory endpoint The times to resolution of QoL factors were evaluated using Kaplan–Meier curves. Analyses were summarized using the mITT population.

Post hoc analyses Post hoc analyses were evaluated using the mITT population. The changes from baseline in mean WURSS-21 individual QoL scores were analyzed each day using a Student’s paired t-test, and p-values were assessed to a significance level of α = 0.05. The median times to resolution of WURSS-21 individual QoL domains were analyzed using Kaplan–Meier curves. Correlations and significance between the WURSS-21 ‘plugged nose’ symptom, the WURSS-21 individual QoL domains (WURSS-21 questions 12–20), and the eight additional QoL factors were calculated using the Pearson correlation coefficient. The over-time effect of xylometazoline hydrochloride 0.1% was evaluated in five QoL categories (Table 3). The changes from baseline for the mean of each QoL category score were analyzed each day using a Student’s paired t-test, and p-values were assessed to a significance level of α = 0.05.

Go to:

Results

Study participants

A total of 172 adults were screened, of which 136 were enrolled in the study (Figure 2). Study documentation did not capture the reasons why 36 participants from the screening were not enrolled. Of the enrolled population, 129 participants reconfirmed eligibility upon study product receipt. Of these, 102 participants were included in the mITT population as they used the study product at least once and completed at least one post-baseline QoL questionnaire. Two participants from the mITT population discontinued the study due to ‘early termination’ for non-compliance reasons after using the study product (Supplemental Results Section 1). Data up to the time of discontinuation were included in the mITT analysis. Figure 2 also shows the number of participants remaining from day 1 through day 7 in the mITT population. A total of 100 participants completed the study, for which the scores of the last dose used were calculated.

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

Object name is 10.1177_17534666241228927-fig2.jpg

Figure 2.

Disposition of participants.

aEnrolled population included all subjects who met the inclusion/exclusion criteria and have met the eligibility confirmation criteria (including a plugged nose score ⩾5 and another common cold symptom score ⩾3).

bSubjects who did not use the study product due to eligibility cessation, or participants who were unresponsive and discontinued the study.

cmITT population included all subjects who used the study product at least once and had at least one post-baseline QoL questionnaire. After receiving the study product, participants had to comply with a plugged nose score ⩾5 and another common cold symptom score ⩾3.

mITT, modified intention-to-treat; N, total number of subjects in the screened population and total number of participants who took concomitant medication; n, number of subjects in each subcategory; QoL, quality of life.

Demographics and other baseline characteristics