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% Improvement 42.36 49.75 57.81 66.77 68.51 68.29 70.59 79.67 |
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Individual scores ranged from 0 (not at all) to 7 (severely). The ‘sensation category’ scores were calculated by adding the individual QoL factors grouped in this category. The ‘sensation 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. |
bLast dose includes all subjects’ last day of treatment regardless of study day. |
cPost hoc analysis: QoL category. |
dSecondary endpoint: additional QoL factors (Q4, Q5). |
CI, confidence interval; Q, question; QoL, quality of life; SE, standard error; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21. |
Other QoL factors |
The five remaining QoL factors were assessed individually; these were ‘think clearly’ (Q12), ‘work outside home’(Q17), ‘work inside the home’ (Q18), and ‘live your personal life’ (Q20) from the WURSS-21 questionnaire, and ‘being self-conscious about how you sound’ (Q3) from the additional QoL questionnaire. The mean (±SE) scores for each individual QoL factor at baseline are shown in Table 11. All ranged between 3.5 and 4.2, which could be considered mild (score = 3) to moderate (score = 5) in severity level. After treatment with xylometazoline hydrochloride 0.1%, significant improvements from day 1 were seen in ‘live your personal life’ and ‘being self-conscious about how you sound’ factors. ‘Work inside the home’ and ‘work outside the home’ showed a significant improvement from day 2 (Table 11). ‘Think clearly’ improved from day 3, a day later to the ‘head congestion’ symptom, which improved from day 2 (Supplemental Table 2). |
Table 11. |
Overview of changes observed in other WURSS-21 individual QoL and additional QoL factors. |
QoL 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 |
Self-conscious about how you sound c Mean ± SE 4.2 ± 0.19 2.2 ± 0.19 2.0 ± 0.20 1.6 ± 0.18 1.4 ± 0.19 1.1 ± 0.20 1.3 ± 0.27 0.9 ± 0.23 0.6 ± 0.12 |
95% CI (−2.39 to −1.57) (−2.66 to −1.81) (−3.14 to −2.32) (−3.40 to −2.43) (−3.68 to −2.66) (−4.02 to −2.54) (−4.24 to −2.70) (−4.05 to −3.25) |
p-Value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 |
% Improvement 46.97 52.42 63.38 68.29 73.62 71.91 78.79 85.48 |
n d 102 99 98 92 82 59 39 30 100 |
Think clearly e Mean ± SE 3.9 ± 0.17 4.2 ± 0.18 3.6 ± 0.19 2.7 ± 0.20 2.3 ± 0.21 2.0 ± 0.23 1.9 ± 0.31 1.5 ± 0.31 1.4 ± 0.18 |
95% CI (0.10–0.55) (−0.66 to 0.01) (−1.62 to −0.86) (−2.03 to −1.04) (−2.34 to −1.35) (−2.62 to −1.22) (−3.22 to −1.64) (−2.87 to −2.05) |
Difference 0.32 −0.33 −1.24 −1.54 −1.85 −1.92 −2.43 −2.46 |
p-Value 0.0051 0.0572 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 |
% Improvement NI 8.40 31.84 39.75 48.44 50.0 62.39 63.24 |
Work inside the home e Mean ± SE 3.5 ± 0.18 3.5 ± 0.19 2.7 ± 0.19 2.2 ± 0.20 1.8 ± 0.20 1.6 ± 0.23 1.6 ± 0.29 1.0 ± 0.28 1.0 ± 0.16 |
95% CI (−0.23 to 0.41) (−1.19 to −0.36) (−1.69 to −0.79) (−2.14 to −1.11) (−2.39 to −1.14) (−2.43 to −1.06) (−3.14 to −1.66) (−2.87 to −1.95) |
Difference 0.09 −0.78 −1.24 −1.62 −1.76 −1.74 −2.40 −2.41 |
p-Value 0.5711 0.0004 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 |
% Improvement NI 22.55 35.85 47.67 51.74 52.71 70.59 70.06 |
Work outside the home e Mean ± SE 4.0 ± 0.19 3.6 ± 0.20 2.8 ± 0.19 2.3 ± 0.21 1.8 ± 0.21 1.7 ± 0.22 1.5 ± 0.27 0.9 ± 0.27 1.1 ± 0.15 |
95% CI (−0.63 to 0.05) (−1.45 to −0.67) (−2.19 to −1.20) (−2.73 to −1.64) (−2.66 to −1.48) (−3.00 to −1.41) (−3.77 to −2.50) (−3.36 to −2.42) |
Difference −0.29 −1.06 −1.70 −2.18 −2.07 −2.21 −3.13 −2.89 |
p-Value 0.0892 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 |
% Improvement 7.47 27.15 42.51 55.08 54.46 59.31 77.05 73.35 |
Live your personal life e Mean ± SE 4.2 ± 0.16 3.8 ± 0.17 2.8 ± 0.18 2.3 ± 0.19 1.9 ± 0.20 1.9 ± 0.23 1.7 ± 0.28 1.0 ± 0.29 1.1 ± 0.17 |
95% CI (−0.80 to −0.17) (−1.77 to −0.99) (−2.36 to −1.46) (−2.87 to −1.86) (−2.67 to −1.53) (−2.95 to −1.56) (−3.90 to −2.37) (−3.61 to −2.69) |
Difference −0.48 −1.38 −1.91 −2.37 −2.10 −2.26 −3.13 −3.15 |
p-Value 0.0030 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 |
% Improvement 11.43 32.77 45.24 55.91 52.32 57.14 75.20 74.29 |
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Individual scores ranged from 0 (not at all) to 7 (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. |
cSecondary endpoint: additional QoL factor (Q3). |
dNumber of participants in this category who answered the WURSS-21 questionnaire. |
ePost hoc analysis: individual QoL factors (Q12, Q17–18, Q20). |
CI, confidence interval; NI, no improvement; Q, question; QoL, quality of life; SE, standard error; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21. |
By the last dose, the highest percentage of improvement was seen in ‘being self-conscious about how you sound’ by 85.5%; ‘live your personal life’ improved by 74.3%; ‘work inside the home’ and ‘work outside the home’ improved by 70.1% and 73.4%, respectively, and ‘think clearly’ improved by 63.2% (Table 11). |
Median time to resolution for ‘being conscious about how you sound’ was day 3; median time for resolution for ‘live your personal life’, ‘work inside the home’, and ‘work outside of the home’ was day 4; and mean time to resolution for ‘think clearly’ was day 5 (Figure 4). |
A positive correlation was found between the plugged nose symptom and all QoL factors; one of the strongest correlations was with the ‘live your personal life’ factor (r = 0.6, p < 0.0001) (Table 12). |
Satisfaction |
At the exit survey, participants were asked to report their satisfaction with the treatment and if they would use the study product again based on their experience in this study. Most participants (n = 91) were satisfied [n = 35 (34.31%)] or very satisfied [n = 59 (57.84%)] with treatment, and 93% of participants reported that they would use xylometazoline hydrochloride 0.1% again. |
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Discussion |
The common cold can be caused by a plethora of different viruses.1,5 Due to the involvement of different pathologic mechanisms and the fact that the disease is acute and self-limited, there is no cure and it is usually managed through symptomatic treatment.5,18 Despite being a generally mild disease, the symptom severity of the common cold manifests widely among individuals9,19 and can impact QoL in terms of productivity9,20 and sleep quality, 9 among other factors. In particular, nasal congestion contributes significantly to sleep disturbances, absences from work, and general activity impairment.21,22 |
Assessment of QoL measures in similar non-life threatening conditions that rely on symptomatic management has been valuable in understanding the benefit–risk ratio of treatment options. 23 QoL analyses are now standard practice in clinical research in chronic conditions, such as allergic rhinitis, for which standard questionnaires have been developed to assess the effectiveness of symptom relief on the patient’s QoL.24–26 Similar to the common cold, nasal congestion is one of the most bothersome symptoms of allergic rhinitis.27–29 Although the common cold is not a chronic disease, the frequency of viral infections per adult and the associated symptoms can place a burden on the QoL of people experiencing a common cold.19,20 |
Xylometazoline hydrochloride has been established as a safe and efficacious nasal decongestant in the treatment of the common cold. 14 Combined with existing knowledge on the natural disease course, the present study was designed to gather insights on QoL data from a real-world setting, given that real-world data have the potential to supplement existing findings from randomized controlled trials. 30 |
To reflect how common cold sufferers experiencing a blocked nose use xylometazoline nasal spray in everyday life, a fully decentralized, longitudinal, real-world, open-label study design was chosen. The study was the first to demonstrate the effectiveness of a nasal decongestant on the common cold to improve QoL factors. WURSS-21 total score and total symptom score improved significantly from moderate to mild severity by day 2 of the study, whereas the WURSS-21 total QoL score significantly improved from day 1. These results suggest that although participants were still experiencing moderate symptoms, nasal decongestion may have helped them to resume their daily living at an earlier stage of the common cold compared with the natural course of the disease. |
Temporary or chronic impairment of sleep quality results in fatigue, irritability, slowed responses, and general daytime dysfunction. 31 In the common cold, nasal congestion and cough are the most commonly reported disruptive symptoms causing reduced sleep quality.32,33 Studies in allergic rhinitis have demonstrated that relief of nasal congestion improves sleep quality,34,35 and efficient symptom relief significantly improved the difficulty of falling asleep or waking up at night.28,36 In this study, participants who experienced nasal congestion due to the common cold reported improvements in sleep quality from day 1 after xylometazoline hydrochloride 0.1% usage, with similar findings for the associated QoL factors ‘sleep well’ and ‘snoring’. Analysis of individual symptom scores showed that nasal congestion (‘plugged nose’) positively correlates with the ‘sleep well’ factor (r = 0.60). These data suggest that alleviating nasal congestion during the early stages of the common cold is associated with improved sleep quality, thereby improving overall QoL. |
Sleep has also been shown to impact QoL factors related to vitality, such as ‘energy’, ‘motivation’, and ‘alertness’ (being slow in response).31,37 In this study, all QoL factors for vitality had improved from day 1, corroborating findings from the sleep quality category. A previous study showed that nasal decongestion with intranasal corticosteroids in allergic rhinitis was associated with improved sleep and reduced daytime fatigue. 28 In this study, the symptom of ‘plugged nose’ from the WURSS-21 questionnaire significantly improved from day 1, and the WURSS-21 individual symptom factor of ‘feeling tired’ showed a significant improvement from day 2, suggesting that xylometazoline hydrochloride 0.1% decongestion effect may also benefit patients experiencing the common cold. |
In terms of physical activity, these results suggest that once participants were able to breathe easily, they were able to increase their daily activities and even perform mild exercise after 2 days of treatment. The ‘walk, climb stairs, exercise’ factor and ‘accomplish daily activities’ both had a severity level of mild-to-moderate at baseline. After treatment with xylometazoline hydrochloride 0.1%, a significant improvement was observed from day 2, correlating with the symptom of ‘feeling tired’ from the vitality category. Furthermore, the QoL factor ‘breathe easily’ showed significant improvement on day 1 and demonstrated the strongest positive correlation with nasal congestion (‘plugged nose’ symptom) (r = 0.72). |
It was observed that ‘being conscious around people’ and ‘interacting with others’ were mildly affected at baseline and significantly improved from day 1 and day 2, respectively. It may be expected that the fatigue or irritability experienced during a common cold episode drive social withdrawal. However, early intervention to relieve nasal congestion with xylometazoline hydrochloride 0.1% may help people to carry out daily activities requiring social exposure sooner. |
This study also showed that xylometazoline hydrochloride 0.1% significantly improved the senses of ‘smell’ and ‘taste’ from day 1. As the olfactory and gustatory systems are central to the process of food consumption, 38 these results suggest that xylometazoline hydrochloride 0.1% usage may have made it easier for participants to enjoy food and ensure necessary nutritional uptake during the early stages of the common cold. |
Other QoL parameters, such as ‘being self-conscious around people’ and ‘being self-conscious about how you sound’, may be related to negative feelings (embarrassment or negative self-judgments) that could be a cause of anxiety. 39 In this study, nasal congestion relief improved the self-consciousness QoL factors assessed from day 1, suggesting that during the early stages of the common cold, the disease burden may have reduced when using xylometazoline hydrochloride 0.1%. |
Some QoL factors assessed in this study were not expected to be affected by the alleviation of nasal congestion. Instead, these factors were likely resolved on their own through the natural disease course, such as the ‘think clearly’ factor, which we found to significantly improve from day 3. The effect of the common cold on ‘thinking clearly’ is not well understood. However, the combined effects of sleep disruption, 40 and the underlying mechanism of inflammation may impact neurotransmitter function, 10 may cause irritability and mild cognitive impairment during a common cold episode.8,41 |
This study showed a significant improvement in all symptoms and QoL factors evaluated. More than 90% of participants in this study reported product satisfaction and would use xylometazoline hydrochloride 0.1% again. As participants were recruited at an early stage of the common cold and started treatment by the peak symptom stage, changes in symptom severity during this study may be attributed to xylometazoline hydrochloride 0.1% treatment. Given the well-known natural history of the common cold, 12 and that xylometazoline hydrochloride 0.1% efficiently reduces nasal congestion, 14 these data suggest that nasal congestion relief may positively impact participants’ QoL. |
Nevertheless, a limitation of this study is the single-arm and open-label design, which does not include a direct comparison with a control group. Furthermore, as the study design focused on real-world evidence, the use of concomitant medications was permitted, apart from other types of decongestants. Therefore, some of the observed symptomatic improvements may not be solely due to treatment with the study drug. Additionally, as the common cold is a self-limiting disease, it is also important to delineate which symptomatic improvements can be attributed to the effectiveness of xylometazoline hydrochloride 0.1% treatment, compared with symptomatic resolution during the natural course of disease. |
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Conclusion |
This study is the first to demonstrate that treating nasal congestion with xylometazoline hydrochloride 0.1% during the common cold positively impacts QoL factors relevant to daily living in a real-life setting. Findings from this study suggest that xylometazoline hydrochloride 0.1% usage during the common cold helps improve breathing, may have positive implications on sleep quality, general performance, and enable individuals to feel better during an episode of the common cold. The results presented in this real-world study provide a broader perspective on symptom relief during the common cold and the positive impact this has on QoL, which may inform healthcare decision making for patients and providers alike. |
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Supplemental Material |
sj-docx-1-tar-10.1177_17534666241228927 – Supplemental material for A real-world study of quality of life following treatment with xylometazoline hydrochloride in individuals with common cold: |
Click here to view.(65K, docx) |
Supplemental material, sj-docx-1-tar-10.1177_17534666241228927 for A real-world study of quality of life following treatment with xylometazoline hydrochloride in individuals with common cold by Martina Hagen, Kim Clark, Pranab Kalita, Gessica Serra, Edwin Sanchez, Gabor Varbiro and Mathieu M. Albasser in Therapeutic Advances in Respiratory Disease |