Abstract
Background
Blocked or stuffy nose is a common and bothersome symptom of colds, particularly for young children who are unable to clear their noses on their own. Nasal saline solutions and nasal aspirators are designed to gently cleanse and remove blocking nasal secretions.
Objective
To assess the safety and performance of 2 monodose isotonic saline solutions (Narhinel 0.9% and Otrisal 0.74% sodium chloride; GSK Consumer Healthcare SARL, a Haleon company, Nyon, Switzerland) and 2 nasal aspirators with disposable hard- and soft-nozzle refills used as a standalone or combination treatment.
Methods
We conducted 2 observational, online questionnaire-based, postmarket clinical follow-up studies in Europeans who had used any of the devices ≥1 time in the past 6 months. Coprimary objectives were to confirm the safety and performance of the saline solutions (Narhinel and Otrisal, Study 1) and nasal aspirators (with hard- and soft-nozzle refills, Study 2). Safety was assessed via the proportion of patients reporting adverse events and/or device malfunctions while using the devices within the previous 6 months, and performance was assessed by satisfaction rated on a 5-point scale, with “satisfied” and “very satisfied” being the highest performance ratings.
Results
A total of 1136 (Study 1) and 1237 (Study 2) questionnaires were initiated by volunteer participants. Less than 2% of participants reported adverse events for any evaluated product in the previous 6 months. Most participants were “satisfied” or “very satisfied” with the devices for their intended use, with 78% to 91% of participants in the Narhinel arm, 73%–94% in the Otrisal arm, 71% to 95% in the soft-nozzle arm, and 71% to 80% in the hard-nozzle arm giving these ratings.
Conclusions
These data support the safety and performance of 2 monodose saline solutions (Narhinel and Otrisal) for nasal cleansing, nasal moisturization, and/or loosening nasal secretions, and of nasal aspirators (with hard- and soft-nozzle refills) for clearing a blocked nose and removing nasal secretions.
Key words: child, nasal blockage, nasal washing, rhinitis/therapy, sinusitis/therapy
Introduction
Blocked or stuffy nose is a common and bothersome symptom of colds, allergies, and exposure to environmental irritants in children and adults.1,2 For infants and young children who are unable to clear their noses on their own, a blocked nose may negatively influence eating and sleeping.2 Nasal saline solutions are intended to gently cleanse the nasal cavities when the nose is blocked (eg, during a cold or in allergic conditions), to moisturize the nasal mucosa when dry or irritated in case of minor nasal irritations or due to low humidity (eg, in heated/air-conditioned rooms, at high altitude, and when air traveling), and to thin and loosen nasal secretions to aid in their removal. In cases of excess mucus, nasal aspiration is designed to help clear a blocked nose by removing nasal secretions.3,4
Nasal irrigation has been recommended at national and international consensus conferences as adjuvant treatment for various sinonasal pathologies.5, 6, 7, 8 Nasal cleaning may play an important role in nasal bacterial carriage and related disease, and removal of nasal secretions may help prevent further complications such as ear infection (otitis), sinus infection (sinusitis), or cough.2,9 In children younger than age 2 years, daily lavage with saline solutions can improve symptoms of upper respiratory tract infection, which can lead to improved eating and sleeping, and in young children may help prevent future cold and flu episodes.2,9,10 In 1 study, use of nasal aspirators resulted in a statistically significant reduction in the frequency of cold episodes.2
Two observational, online questionnaire-based, postmarket clinical follow-up (PMCF) studies were conducted to assess the safety and performance of 2 monodose isotonic saline solutions (Narhinel and Otrisal; GSK Consumer Healthcare SARL, a Haleon company, Nyon, Switzerland) and 2 nasal aspirators with disposable hard- and soft-nozzle refills; the results of these studies are presented in this report.
Materials and Methods
Study design
These were observational, online questionnaire-based, PMCF studies of 0.9% sodium chloride solution (Narhinel) and 0.74% sodium chloride solution (Otrisal) (Study 1); and 2 different nasal aspirators (both products of GSK Consumer Healthcare SARL, a Haleon company), 1 with disposable hard-nozzle refills and 1 with soft-nozzle refills (Study 2). Narhinel, Otrisal, and both aspirators are considered medical devices under European Union Medical Device Regulation 2017/745. Narhinel 0.9% sodium chloride monodose is commercialized under the following trademarks: Narhinel, Rhinomer, and ProRhinel; Otrisal 0.74% sodium chloride monodose is commercialized under the following trademarks: OTRISALIN, TIXYLIX, Otrivin, and Otribaby. Nasal aspirator and disposable nozzle refills (hard nozzle) are commercialized under the following trademarks: Otrivin, Rhinomer, Narhinel, and Otribebe; nasal aspirator and disposable nozzle refills (soft nozzle) are commercialized under the following trademarks: Otrivin, Rhinomer, Narhinel, Otribebe, Otribaby, Otri Baby, Otrisalin, and Prorhinel.
For Study 1, participants were recruited from Italy and Portugal (Narhinel) and the Netherlands, Sweden, and Greece (Otrisal). For Study 2, participants were recruited from Latvia, Estonia, Lithuania, and Russia (hard nozzle) and France, Italy, and Spain (soft nozzle). The recruitment period was from October 19, 2021, to November 25, 2021, for Study 1, and from November 8, 2021, to December 29, 2021, for Study 2. Study recruitment occurred until target enrollment was reached; specifically, at least 555 participants for each medical device. The slightly longer recruiting phase for Study 2 compared with Study 1 may be due to the different sales volume of the products, different levels of online survey engagement, and the holiday season. Hence, the actual duration of Study 1 was approximately 6 months and the duration of Study 2 was 7 months from participant recruitment to investigation report completion. Study participants were invited to participate in the study via digital advertisement and completed the questionnaire via a website.
Products and intended use
The monodose saline solutions in Study 1 were sterile, preservative-free isotonic saline solutions containing 0.9% sodium chloride (Narhinel) or 0.74% sodium chloride (Otrisal) in single-use, 5-mL vials. Their intended use is for nasal cleansing when the nose is blocked, nasal moisturization when the nasal mucosa is dry or irritated, and thinning and loosening nasal secretions and helping their removal. The nasal aspirators in Study 2 consisted of a reusable nasal aspirator body and a disposable nozzle to be changed with each use. The aspirators are available as 2 different products with either hard- or soft-nozzle refills, depending on the country. The intended use of the aspirators is for clearing a blocked nose and removing nasal secretions.
Participants
The target population for this study comprised individuals who had used any of the devices at least once within 6 months before the study start. Study participation was voluntary, and inclusion and exclusion criteria were the same for both studies.
Eligible participants were infants/babies (including those aged <2 weeks), children, or adults (older than age 18 years, including pregnant or breastfeeding women) who had used, supervised the use of, or been treated with the medical device during the previous 6 months. Participants (parent/guardian/caregiver of a minor) were included if they were reasonably able to operate an electronic resource (ie, had access to a computer, smartphone, or tablet, and had sufficient internet access to connect to the study platform) and complete the questionnaire in an electronic format.
Participants were excluded if they were unable to operate an electronic resource and complete the questionnaire in an electronic format, or had not used or supervised the use of Narhinel and/or Otrisal monodose solution (Study 1) or the nasal aspirators with disposable hard- or soft-nozzle refills (Study 2) in the previous 6 months.
No informed consent (or assent for minors) was required for study participation as no personally identifiable information and no Transmission Control Protocol/Internet Protocol/Universal Resource Locator addresses were collected. Consent was assumed at the time participants attested to completing the online questionnaire. The study protocols and participant questionnaires were reviewed and approved by an independent interdisciplinary clinical research ethics review committee where required. The studies were conducted in accordance with European Union Medical Device Regulation 2017/745, Medical Device Coordination Group 2020-7, European Nation International Organisation for Standardisation ISO 14155:2011, and International Organisation for Standardisation ISO 14155:2020 Good Clinical Practice, in addition to the Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments involving humans.
Assessments
The coprimary objectives of the studies were to evaluate the safety and performance of Narhinel and Otrisal monodose solutions for use by a person requiring (or by the caregiver of a person requiring) gentle cleansing and/or moisturizing of the nasal cavity and/or thinning and loosening nasal secretions to aid in their removal (Study 1) and 2 nasal aspirator devices with disposable hard- or soft-nozzle refills for use by a person requiring (or by the caregiver of a person requiring) clearing a blocked nose and removing nasal secretions (Study 2). In both studies, safety was assessed by the number of participants who reported an adverse event (AE) and/or device malfunction while using the device in the previous 6 months. Performance was assessed by the proportion of participants reporting satisfaction on a 5-point scale, with “satisfied” and “very satisfied” being the 2 highest performance ratings. The specific assessments in each category are detailed in the results, and corresponding sections of the study questionnaires are provided in the Supplemental Tables 1 and 2 in the online version at doi:10.1016/j.curtheres.2023.100725.
Exploratory objectives in Study 1 were to identify and evaluate the proportion of participants using the medical device with a noticeable decrease in the frequency of cold episodes for infants/babies and for uses other than those intended (eg, to clean the eyes, ears, or mouth). In Study 2, exploratory objectives were to identify and evaluate the proportion of participants using the medical device with a noticeable decrease in the frequency of cold episodes and for alleviation of infant/baby sleep disturbances and eating difficulties during a cold episode and to evaluate the levels of improvement and use of the medical device.
Statistical Analyses
Descriptive analyses were performed to understand the qualitative and quantitative nature of the data collected and the characteristics of the sample studied. Categorical variables were summarized as the number and proportion of the total number of study participants and by subgroups where appropriate. In each study, the safety analysis set (SAS) included all participants who completed the questionnaire, and the full analysis set (FAS) excluded 6 participants (3 in each study) who had data errors (instances of varying responses to the same question; some had the exact same answer appear in duplicate). Exact 1-sided upper 95% CIs were computed for the proportion of participants who reported AEs for each device based on the Clopper-Pearson method, for the study population and by device. No comparator group was included in either study.
Results
Study participants
In Study 1, 1136 questionnaires were initiated by volunteer participants who had used 1 of the monodose products in the previous 6 months; 97.4% (1107 out of 1136) of participants who fully completed a questionnaire for at least 1 monodose product were included in the FAS. All participants who completed a questionnaire were included in the SAS (97.7% [1110 out of 1136]) (Figure 1). Participants were equally distributed between study arms: 50.0% (553 out of 1107) were included in the Narhinel arm and 50.0% (554 out of 1107) in the Otrisal arm (Table 1). A total of 2.2% (24 out of 1107) were infants/babies younger than age 2 years, 0.7% (8 out of 1107) were pregnant women, and 1.4% (16 out of 1107) were breastfeeding women. Most participants in Study 1 were adults; 94.2% (521 out of 553) and 97.7% (541 out of 554) in the Narhinel and Otrisal arms, respectively, were older than age 18 years, whereas 5.8% (32 out of 553) and 2.3% (13 out of 554), respectively, were children (age 18 years or younger).
Figure 1.
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Table 1.
Participant demographics.*
| Study 1 | Study 2 | |||
|---|---|---|---|---|
| Narhinel† (n = 553) | Otrisal† solution (n = 554) | Soft nozzle (n = 554) | Hard nozzle (n = 553) | |
| Age, y | ||||
| ≤2 | 19 (3.5) | 5 (0.9) | 4 (0.7) | 137 (24.8) |
| >2–18 | 13 (2.4) | 8 (1.4) | 4 (0.7) | 7 (1.3) |
| >18 | 521 (94.2) | 541 (97.7) | 546 (98.6) | 409 (74.0) |
| Participant was pregnant while using the device‡ | ||||
| Yes | 6 (1.1) | 2 (0.4) | 2 (0.4) | 1 (0.2) |
| No | 245 (44.3) | 232 (41.9) | 241 (43.5) | 179 (32.4) |
| Not applicable | 170 (30.7) | 206 (37.2) | 229 (41.3) | 175 (31.6) |
| Participant was breastfeeding while using the device‡ | ||||
| Yes | 10 (1.8) | 6 (1.1) | 4 (0.7) | 11 (2.0) |
| No | 240 (43.4) | 228 (41.2) | 239 (43.1) | 170 (30.7) |
| Not applicable | 171 (30.9) | 206 (37.2) | 229 (41.3) | 174 (31.5) |
| Participant was pregnant and breastfeeding while using the device§ | 6 (1.1) | 2 (0.4) | 2 (0.4) | — |
| Who recommended the use of the device|| | ||||
| Doctor | 192 (34.7) | 190 (34.3) | 129 (47.6) | 145 (51.1) |
| Pharmacist | 250 (45.2) | 291 (52.5) | 112 (41.3) | 127 (44.7) |
| Midwife or health visitor | 15 (2.7) | 11 (2.0) | 3 (1.1) | 9 (3.2) |
| None of the above | 106 (19.2) | 82 (14.8) | 33 (12.2) | 19 (6.7) |
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⁎
Values are presented as n (%). Denominator for percentages is the total number of participants by device in the full analysis set.
†
GSK Consumer Healthcare SARL, a Haleon company, Nyon, Switzerland.
‡
Collected only for participants in age categories “>6 to 18 years” and “>18 to 65 years.”
§
A participant may be both pregnant and breastfeeding while using the device. These participants were considered in both subpopulations.
||
For Study 2, “n (%)” represents who recommended the standalone use of the device (rather than combination use of a nasal saline solution and the device).
In Study 2, 1237 questionnaires were initiated by volunteer participants who had used 1 of the devices in the previous 6 months; 89.5% (1107 out of 1237) of participants who fully completed a questionnaire for an aspirator product were included in the FAS (Figure 1). The SAS included 89.7% (1110 out of 1237) of participants who submitted a completed questionnaire. Participants were equally distributed between the soft- and hard-nozzle arms: 50.0% (554 out of 1107) were included in the soft-nozzle arm and 50.0% (553 out of 1107) in the hard-nozzle arm (Table 1). Overall, 86.3% (955 out of 1107) of the study participants were adults, 12.7% (141 out of 1107) were infants/babies younger than age 2 years, 1.4% (15 out of 1107) were breastfeeding women, and 0.3% (3 out of 1107) were pregnant women. Most participants in the soft- and hard-nozzle arms were adults (older than age 18 years: 98.6% [546 out of 554] and 74.0% [409 out of 553], respectively), whereas 1.4% and 26.0%, respectively, were children (age 18 years or older). Approximately half of participants (49.9% [552 out of 1107]) used the device with nasal saline irrigation (ie, combination use).
Although the products are primarily designed for infants/babies and children, most of the participants were listed as adults in both studies. This discrepancy is likely due to caregivers responding to survey questions on behalf of the infants/babies and children they care for and entering their own age information instead of the age of the infants/babies or children on whom the products were used.
Safety
Safety event information is presented in Table 2. In Study 1 overall, 15 participants (1.4% [95% CI, 0.0%–2.1%]) reported AEs and/or device malfunctions during the previous 6 months: 8 in the Narhinel arm (1.4% [95% CI, 0.0%–2.6%]) and 7 in the Otrisal arm (1.3% [95% CI, 0.0%–2.4%]). In Study 2, 16 participants (1.4% [95% CI, 0.0%–2.2%]) reported AEs and/or device malfunctions during the previous 6 months: 7 in the soft-nozzle arm (1.3% [95% CI, 0.0%–2.4%]) and 9 in the hard-nozzle arm (1.6% [95% CI, 0.0%–2.8%]). Across both studies, no AEs or device malfunctions were reported for infants younger than age 2 weeks and in pregnant women; 1 breastfeeding woman reported a device malfunction in Study 2. The proportion of participants who reported AEs and/or device malfunctions with standalone (without nasal saline irrigation) or combined (with nasal saline irrigation) use was similar (8 participants each, 1.4%).
Table 2.
Safety events.
| Event | No. of participants | Proportion of participants (95% CI)* |
|---|---|---|
| Study 1 | ||
| Participants who reported AEs or DMs | 15 | 1.4 (0–2.1) |
| Device† | ||
| Narhinel | 8 | 1.4 (0–2.6) |
| Otrisal | 7 | 1.3 (0–2.4) |
| Subpopulation | ||
| Infants/babies aged <2 wk | 0 | 0 |
| Pregnant women | 0 | 0 |
| Breastfeeding women | 0 | 0 |
| Study 2 | ||
| Participants who reported AEs or DMs‡ | 16 | 1.4 (0–2.2) |
| Device | ||
| Hard nozzle | 9 | 1.6 (0–2.8) |
| Soft nozzle | 7 | 1.3 (0–2.4) |
| Subpopulation | ||
| Infants/babies aged <2 wk | 0 | 0 |
| Adults | 9 | 0.9 |
| Pregnant women | 0 | 0 |
| Breastfeeding women§ | 1 | 6.7 |
| Type of use | ||
| Standalone | 8 | 1.4 |
| Combination | 8 | 1.4 |
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AE = adverse event; DM = device malfunction.
⁎
Exact 1-sided upper 95% CI for safety based on the Clopper-Pearson method.
†
GSK Consumer Healthcare SARL, a Haleon company, Nyon, Switzerland.
‡
The response to the question, “Have you reported any experienced side effects or medical device malfunctions to GSK (Consumer Healthcare SARL, a Haleon company)” was binary and did not require participants to provide details about the specific AE.
§
The 1 breastfeeding woman was included in the 9 adults who reported an AE/side effect or DM.
Performance
Study 1.
Most of the participants reported being “satisfied” or “very satisfied” when using the Narhinel or Otrisal solutions for their intended use, with 78% to 91% of participants giving these ratings for Narhinel and 73% to 94% for Otrisal, depending on the symptom (Figure 2A). The highest device performance for the monodose saline solutions was noted for nasal cleansing (90.7% [95% CI, 88.2%–100%] and 93.9% [95% CI, 91.8%–100%] for the Narhinel and Otrisal arms, respectively), followed by nasal moisturization (79.8% [95% CI, 76.3%–100%] and 78.3% [95% CI, 74.7%–100%]) and loosening nasal secretions (77.6% [95% CI, 72.8%–100%] and 72.9% [95% CI, 68.0%–100%]), respectively.
Figure 2.
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Study 2
Most participants reported being “satisfied” or “very satisfied” when using an aspirator for its intended use, with 70.8% to 95.2% of participants giving these ratings in the soft-nozzle arm and 70.5% to 80.1% in the hard-nozzle arm, depending on the symptom (Figure 2B). The device performance was given the highest ratings of satisfaction for relief of blocked nose (95.2% [95% CI, 93.2%–100%] and 80.1% [95% CI, 76.3%–100%] for the soft and hard nozzles, respectively), followed by relief of ear infections (75.2% [95% CI, 70.7%–100%] and 76.0% [95% CI, 71.6%–100%]), relief of sinus infections (74.4% [95% CI, 70.7%–100%] and 74.1% [95% CI, 69.8%–100%]), and relief of cough (70.8% [95% CI, 64.0%–100%] and 70.5% [95% CI, 63.7%–100%]), respectively.
When an aspirator was combined with nasal saline irrigation, a similar performance level was reported for both devices: 77.7% (220 out of 283) in the soft-nozzle arm and 79.6% (214 out of 269) in the hard-nozzle arm, regardless of symptoms that prompted the device utilization.
Exploratory end points
Study 1.
Exploratory analyses are shown in Figure 3. In Study 1, more than half of the participants reported a decrease in the frequency of cold episodes when using Narhinel or Otrisal solutions in the previous 6 months (53.7% [297 out of 553] and 58.1% [322 out of 554], respectively). Among infants younger than age 2 years, a noticeable decrease in the frequency of cold episodes was reported for 31.6% (6 out of 19) of participants in the Narhinel arm and 20.0% (1 out of 5) of participants in the Otrisal arm.
Figure 3.
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Participant satisfaction was reported for both solutions when used for indications other than those intended: cleaning the eyes (65% [65 out of 553] and 65% [63 out of 554] for Narhinel and Otrisal, respectively), the ears (74.6% [44 out of 553] and 71.4% [45 out of 554]), and the mouth (69.7% [46 out of 553] and 74.6% [50 out of 554]). When treating symptoms other than those intended, participants generally saw a decrease in the frequency of cold episodes. In particular, when the solutions were used to clean the eyes, 46.0% (46 out of 100) and 55.7% (54 out of 97) of participants in the Narhinel and Otrisal arms, respectively, reported a noticeable decrease in the frequency of cold episodes. Similar noticeable decreases in the frequency of cold episodes were observed when the solutions were used to clean the ears (52.5% [31 out of 59] of Narhinel users and 54.0% [34 out of 63] of Otrisal users). When the solutions were used to clean the mouth, fewer Narhinel users noticed a decrease in the frequency of cold episodes (33.3% [22 out of 66]) vs Otrisal users (53.7% [36 out of 67]).
Study 2
Exploratory analyses are presented in Figure 4. Overall, decreases in the frequency of cold episodes were reported for more than half (61.2% [339 out of 554]) of participants after using the soft-nozzle aspirator and 36.2% (200 out of 553) after using the hard-nozzle aspirator (Figure 4A). For infants/babies younger than age 2 years, decreases in the frequency of cold episodes were reported for 25.0% (1 out of 4) and 24.8% (34 out of 137) of participants after using the soft- and hard-nozzle aspirators, respectively (Figure 4A).
Figure 4.
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Aspirator effects on sleeping and eating during cold episodes (blocked nose, sinus infection, and ear infection) were collected for infants/babies younger than age 2 years (Figure 4B). In the hard-nozzle arm (n = 137), 17 infants/babies younger than age 2 years “could not get to sleep within 30 minutes”; moderate and strong improvements were reported for 35.3% (6 out of 17) and 41.2% (7 out of 17), respectively. Forty-six infants/babies in this arm were reported to be “waking up in the middle of the night or early morning”; moderate and strong improvements were reported for 39.1% (18 out of 46) and 43.5% (20 out of 46), respectively. It was reported that 108 infants/babies “could not breathe comfortably during sleep”; moderate and strong improvements were reported for 40.7% (44 out of 108) and 46.3% (50 out of 108), respectively. In addition, 46 infants/babies were “coughing or snoring loudly during sleep”; moderate and strong improvements were reported for 37.0% (17 out of 46) each. Finally, 66 infants/babies had “eating difficulties during a cold episode”; moderate and strong improvements were reported for 34.8% (23 out of 66) and 53.0% (35 out of 66), respectively.
In the soft-nozzle arm (n = 4), 2 participants reported using the device to treat blocked nose that caused “waking up in the middle of the night or early morning,” with strong improvement noted by both. One participant reported using the device because the person with blocked nose “could not breathe comfortably during sleep,” and noted moderate improvement. No participants reported using the soft-nozzle aspirator for improvement of eating difficulty during cold episodes.
Discussion
These 2 studies were observational, online questionnaire-based, PMCF studies to further evaluate the safety and performance of Narhinel and Otrisal monodose solutions and 2 nasal aspirators with hard- and soft-nozzle refills in participants who used the devices within the previous 6 months. Together, the results of both studies reaffirmed the safety of the saline solutions and aspirators, given that <2% of participants reported AEs or device malfunctions for any evaluated product in the previous 6 months. In addition, participants reported high levels of satisfaction with the performance of each of the devices for their intended use.
The data collected from these studies are supported by other findings regarding the utility of nasal saline washing and nasal aspirators for cleansing, moisturizing, and unblocking nasal passages.4,11 In 1 randomized trial, adults with frequent sinusitis reported high levels of satisfaction and compliance with daily nasal irrigation, with 95% (42 out of 44) who answered questions about satisfaction and side effects stating they would continue to use the approach.12 Another study found similar results among children with allergic rhinitis, with significant improvements reported in quality of life and user satisfaction.13 The data from these 2 studies align with our findings of high satisfaction with nasal saline from all types of users, not just those with nasal or sinus issues.4,11
Published data describing the performance of nasal aspirators are limited.3 In 1 analysis of survey results, parents of young children reported high levels of satisfaction with Narhinel in combination with an aspirator and stated it was more effective compared with other similar devices, as well as easy to use.9 Although our study did not investigate ease of use, we reported similar high levels of satisfaction. In another study, more parents using Narhinel with the aspirator reported high satisfaction compared with those using saline alone.2 Similarly, our data indicated high levels of satisfaction with combination use of either hard- or soft-nozzle aspirators with saline solutions.2
Exploratory end points indicated that some participants experienced a decrease in the frequency of cold episodes when using the saline solutions and aspirators. Clinical studies and a clinical guideline from the American Academy of Otolaryngology–Head and Neck Surgery consistently support the use of saline irrigation as an effective means to combat a blocked nose due to the common cold.5,14, 15, 16, 17 Exploratory analyses of aspirator use also showed improvements in sleeping and eating for infants and babies during a cold episode with device use. Findings from clinical studies indicated that regular nasal saline irrigation and nasal aspiration are effective options for managing cold symptoms, including in infants and young children.10,16 Saline irrigation appears to be helpful in treating rhinologic symptoms due to acute upper respiratory tract infection and allergic rhinitis in children and infants.10,17, 18, 19, 20, 21 Together with existing literature, data from the current study further confirm the utility of Narhinel and Otrisal monodose saline solutions and nasal aspirators as treatment of symptoms of the common cold in children and adults.
This study also explored the benefits of combination use of monodose solutions with nasal aspirators. Previous studies have shown that combining saline lavage with nasal aspiration leads to more effective nasal cleansing compared with no nasal washing and no use of an aspiration device.16 Approximately half of the participants in Study 2 paired the aspirator with nasal saline irrigation, and participants’ experiences with the device were similar to when the aspirator was used as a standalone treatment; almost 80% of participants were either “satisfied” (49%) or “very satisfied” (30%) when the aspirator was combined with nasal saline irrigation. These data suggest that the aspirator exhibits satisfactory and safe performance with or without concomitant saline irrigation.
This study has limitations. Because of the nature of the study design, it cannot be confirmed whether the same participant submitted unique questionnaires for each family member who used the evaluated products in the previous 6 months because no personally identifiable information and no transmission control protocol/internet protocol/universal resource locator addresses were collected. Also, in responses to demographic questions, it is likely that caregivers responding to survey questions on behalf of small children entered their own age information and not the age of the children, which is why most of the study population is listed as adults when the products are clearly designed for babies. The low numbers of participants in the subpopulations of interest limit the ability to draw definitive conclusions on safety and performance from these data. In addition, sex identification was not included in the questionnaire and therefore no sex-based analyses were performed. Per the instructions for use, medical advice should be sought before use of these devices in these groups.
Conclusions
Overall, this PMCF study generated clinical evidence that supports the safety and performance of Narhinel and Otrisal monodose saline solutions for their intended use of loosening nasal secretions, nasal cleaning, and nasal moisturization, and of the 2 nasal aspirators with disposable hard- and soft-nozzle refills for their intended use of clearing a blocked nose and removing nasal secretions. Additional analyses measured good satisfaction with the solutions and aspirators across a range of exploratory end points, including use of the devices to decrease the frequency of cold episodes (Studies 1 and 2), use of the device for other indications (Study 1), and use of the device for alleviation of infant/baby sleep disturbances following cold symptoms (Study 2). Data from these studies also support safety and performance when the aspirator is used as a standalone treatment or in combination with nasal saline irrigation. These findings indicate that nasal saline cleaning and nasal aspiration are useful approaches to treating the bothersome effects of a blocked nose for users of all ages.
CRediT authorship contribution statement
Mathieu M. Albasser: Conceptualization, Formal analysis, Funding acquisition, Methodology, Supervision, Writing – original draft, Writing – review & editing. Edwin Sanchez: Formal analysis, Methodology, Writing – original draft, Writing – review & editing. Mariane B． Fernandes: Writing – original draft, Writing – review & editing. Nisha Patel: Writing – original draft, Writing – review & editing. Petr Novak: Conceptualization, Formal analysis, Methodology, Writing – original draft, Writing – review & editing. Martina Hagen: Formal analysis, Supervision, Validation, Writing – original draft, Writing – review & editing.
Declaration of Competing Interest
Funding for this study was provided by Haleon (formerly GSK Consumer Healthcare).
M. Albasser, E. Sanchez, M. Fernandes, P. Novak, and M. Hagen are employees of Haleon. N. Patel is an employee of GSK. The authors have indicated that they have no other conflicts of interest regarding the content of this article.
Acknowledgments
The authors thank all participants and everyone involved in the conduct and analysis of the study. Medical writing assistance was provided by Eric Berlin at Peloton Advantage, LLC, an OPEN Health company, Parsippany, New Jersey, and was funded by Haleon.
Conceptualization was undertaken by P. Novak and M. Albasser. Formal analysis was undertaken by P. Novak, E. Sanchez, M. Albasser, and M. Hagen. Funding acquisition was undertaken by M. Albasser. Methodology was undertaken by P. Novak, E. Sanchez, and M. Albasser. Supervision was performed by M. Hagen and M. Albasser. Validation was undertaken by M. Hagen. Writing of the original draft, design, review, and approval was undertaken by M. Hagen, M. Fernandes, P. Novak, E. Sanchez, M. Albasser, and N. Patel. All listed authors meet the criteria for authorship set forth by the International Committee of Medical Journal Editors (ICMJE).
Footnotes
Supplementary material associated with this article can be found, in the online version, at doi:10.1016/j.curtheres.2023.100725.
Appendix. Supplementary materials
mmc1.docx (51.1KB, docx)
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