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A real-world study of quality of life following treatment with xylometazoline hydrochloride in individuals with common cold

Martina Hagen, Conceptualization, Formal analysis, Writing – review & editing, Kim Clark, Methodology, Writing – review & editing, Pranab Kalita, Conceptualization, Writing – review & editing, Gessica Serra, Methodology, Writing – review & editing, Edwin Sanchez, Formal analysis, Writing – review & editing, Gabor Varbiro, Formal analysis, Methodology, Writing – review & editing, and Mathieu M. Albasser, Formal analysis, Writing – review & editing

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Associated Data

Supplementary Materials

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Abstract

Background:

The common cold is a frequent, acute, and mild upper respiratory human disease. Nasal congestion has been considered the most bothersome symptom in the common cold, impacting quality of life (QoL). Topical decongestants containing steroids benefit QoL in allergic rhinitis, but no published research has assessed the impact of topical decongestants on QoL in the common cold.

Objective:

To evaluate the effects of xylometazoline hydrochloride 0.1% (Otrivin, GSK Consumer Healthcare SARL, Switzerland) for up to 7 days on QoL in participants with nasal congestion associated with the common cold.

Design:

This was a decentralized, longitudinal, open-label study.

Methods:

The study enrolled 136 participants (⩾18 years) with early symptoms of the common cold, of which 102 were included in the modified intention-to-treat (mITT) population. Within 24 h of study product receipt, participants confirmed a ‘plugged nose’ and ⩾1 other common cold symptom. Primary endpoints were Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) total score, total and individual symptom scores, and total QoL score. Secondary endpoints were additional QoL scores. Exploratory and post hoc analyses included median days to resolution for each QoL factor and analyses of five QoL categories.

Results:

Consistent improvements in symptoms and QoL were seen in the mITT population. From day 1, improvements were seen in the ‘plugged nose’ symptom (p = 0.0023), WURSS-21 total QoL score, and all individual QoL scores (p < 0.0001 for all). After the last dose needed, significant improvements were seen in sleep quality (73%), vitality (76%), physical activity (71%), social activity (80%), and sensation (81%). No serious or unexpected adverse events were reported.

Conclusion:

This study is the first to demonstrate in a real-life setting that treating nasal congestion in adults with xylometazoline hydrochloride 0.1% during the common cold positively impacts QoL factors relevant to daily living [Otrivin: Quality of Life (QoL) Impact in a Real-World Setting; https://clinicaltrials.gov/study/NCT05556148].

Keywords: decentralized, nasal congestion, real-world evidence, WURSS-21, xylometazoline nasal decongestant

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Infographic abstract

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Plain language summary

Impact of xylometazoline hydrochloride 0.1% on quality of life in people with blocked nose associated with the common cold

The common cold is a widespread, mild respiratory illness for which a hallmark symptom is a blocked or stuffy nose, which makes breathing and sleeping difficult. This study focused on how a nasal spray called Otrivin (containing xylometazoline hydrochloride 0.1%) impacts the quality of life (QoL) of people suffering from nasal congestion due to the common cold.

Participants answered a questionnaire called the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21), which helped understand how people experience respiratory symptoms and how different aspects of QoL were impacted. Participants also responded to eight additional QoL questions not covered in the WURSS-21.

The results showed that from the first day of using the nasal spray, participants experienced significant relief from the blocked nose symptom and reported an overall improvement in their QoL and well-being, such as in sleep quality, energy levels, senses, and physical and social activities.

In conclusion, this real-world study demonstrated that using xylometazoline hydrochloride 0.1% nasal spray during the common cold can significantly improve nasal congestion and various aspects of a person’s daily life. These findings provide valuable evidence for using this nasal spray to relieve symptoms and enhance the overall well-being of individuals with the common cold.

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Introduction

The common cold is an acute, mild upper respiratory disease and is considered the most frequent human disease.1,2 Most adults experience at least one episode of the common cold per year 3 with an average of four episodes yearly, 4 although frequency varies with age. 5 It is usually a self-limiting illness caused predominately by a rhinovirus. 1

The common cold is easily self-diagnosed, 6 and can last for 7–10 days. 1 Symptoms typically include nasal congestion, cough, sore throat, sneezing, runny nose, and headaches. 1 In addition, people with the common cold may also experience sleep disruption, 7 fatigue, 6 cognitive impairment,6,8 and reduced alertness. 8 Consequently, these symptoms impact individuals’ quality of life (QoL), such as the performance of daily activities, and individuals’ occupational functions.8,9

Out of all symptoms of the common cold, nasal congestion (also referred to as plugged nose or blocked nose) is a hallmark symptom of the disease that has been reported to be the most bothersome for the majority of people. 1 This symptom is not caused directly by the virus, but by the local inflammatory response to the viral infection. 10 Nasal congestion tends to peak on the second and third days of the illness,11,12 and contributes to sleep disruption 9 which results in daytime somnolence and mood changes. 13

Although there is no cure for the common cold, treatment can relieve the most bothersome symptoms. 1 Nasal congestion, for instance, can be relieved with topical decongestants, such as xylometazoline hydrochloride. 14 Xylometazoline hydrochloride is a nasal decongestant that constricts nasal blood vessels leading to reduction in mucosal swelling and increasing nasal airflow, allowing patients to breathe more easily during episodes of nasal congestion.6,14

Previous studies found that topical decongestants containing glucocorticoids benefit QoL in allergic rhinitis,15,16 but no known published research has assessed the impact of a topical decongestant on the QoL of individuals experiencing the common cold.

This study aimed to evaluate the over-time effects of using xylometazoline hydrochloride 0.1% (Otrivin) nasal spray on QoL among people experiencing nasal congestion associated with the common cold.

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Methods

This study was conducted in compliance with the protocol and in accordance with Good Clinical Practices, Medicines, and Healthcare Products Regulatory Agency regulations, and all applicable local and state regulations. The electronic informed consent (eIC) was made available to participants through the study app. Participants signed the eIC electronically and the date was added automatically. Signature of the eIC was required and obtained from all participants before any study-related activities. The eIC was reviewed by West Midlands, Edgbaston, Research Ethics Committee, Manchester, UK. IRAS project ID 1006069, REC:22/WM/0177. Approved by West Midlands – Edgbaston Research Ethics Committee 25 October 2022.

Study design and participants

This was a fully decentralized, longitudinal, open-label study to evaluate the effect on QoL factors in participants with the common cold using a nasal spray containing xylometazoline hydrochloride 0.1% in a real-world setting across the United Kingdom. No randomization was carried out in this study. The design of this study is not specific to any of the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network guidelines.

The study design ensured assessment of eligibility before and after the study product was provided to the participants. A summary of the study design and an overview of the schedule of activities can be found in Figure 1 and Supplemental Table 1, respectively. The first two steps of the study protocol were the pre-screening stage, and the screening stage. At the pre-screening stage, eligible participants were invited via email to download the study app and participants completed an eIC. Participants had an interview phone call with a medically qualified investigator to confirm personal details and medical history (Figure 1 and Supplemental Methods Sections 1 and 2). At the screening stage, participants who provided the eIC were asked to complete the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) 17 and the additional QoL questions as baseline assessments. Participants also confirmed their medical history, concomitant medication, and completed a product shipping form (Figure 1 and Supplemental Methods Sections 3–5). Participants completed the baseline questionnaires from the 7 November 2022; the last questionnaire was completed on the 20 December 2022.

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Figure 1.

Flowchart of the study design.

eIC, electronic informed consent; QoL, quality of life; WURSS-21, Wisconsin Upper Respiratory Symptom Survey-21.

Enrolled participants were supplied with xylometazoline hydrochloride 0.1% nasal spray (Otrivin) within 1 day of completing screening, and confirmed receipt and usability of the product via the study app. Upon product receipt, participants were required to re-confirm their eligibility by reporting nasal congestion (described as ‘plugged nose’ in the WURSS-21) of at least moderate intensity (score 5) and at least one other common cold symptom of at least mild intensity (score 3) as per the WURSS-21 questionnaire (Table 1). Participants started treatment on day 0 of the study protocol, which was expected to align with a very early stage of disease progression and peak symptom stage (Supplemental Table 1). This was considered a key period to start treatment of the common cold with xylometazoline hydrochloride 0.1% to relieve nasal congestion.

Table 1.

WURSS-21 QoL questionnaire and additional QoL questions answered by participants using a severity scale ranging from 0 to 7.

WURSS-21 questionnaire

Please fill in one circlea for each of the following items:

1. How sick do you feel today? Not sick (very mildly to severely as the score belowa)

Please rate the average severity of your cold symptoms over the last 24 h for each symptom:

2. Runny nose

3. Plugged nose

4. Sneezing

5. Sore throat

6. Scratchy throat

7. Cough

8. Hoarseness

9. Head congestion

10. Chest congestion

11. Feeling tired

Over the last 24 h, how much has your cold interfered with your ability to:

12. Think clearly

13. Sleep well

14. Breathe easily

15. Walk, climb stairs, exercise

16. Accomplish daily activities

17. Work outside the home

18. Work inside the home