Journal of Otology & RhinologyISSN: 2324-8785

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Research Article, J Otol Rhinol Vol: 3 Issue: 6

Preliminary Study of the Safety of Seasonal Allergic Rhinitis Treatment in Railway Personnel

Shinji Urata1*, Shinichi Ishimoto1, Shu Kikuta2, Haruko Ichinose1 and Satoshi Takeuchi1
1Department of Otolaryngology, JR Tokyo General Hospital, Tokyo, Japan
2Department of Otolaryngology, Faculty of Medicine, The University of Tokyo,Tokyo, Japan
*Corresponding author : Shinji Urata
MD, 2-1-3 Yoyogi, Shibuya, Tokyo, 151-8528, Japan
Tel: +81-03-3320-2200
E-mail: [email protected]
Received: March 25, 2014 Accepted: October 23, 2014 Published: December 04, 2014
Citation: Urata S, Ishimoto S, Kikuta S, Ichinose H, Takeuchi S (2014) Preliminary Study of the Safety of Seasonal Allergic Rhinitis Treatment in Railway Personnel. J Otol Rhinol 3:6. doi:10.4172/2324-8785.1000193

Abstract

Preliminary Study of the Safety of Seasonal Allergic Rhinitis Treatment in Railway Personnel

Objectives: The aim of the present survey was to develop guidelines for appropriate seasonal allergic rhinitis (SAR) treatment for railway personnel. The East Japan Railway Company (JR-EAST) carries the most passengers (6 billion per year) of any company worldwide. This was the first trial designed to assess the efficacy and safety of intranasal corticosteroids (INS) in JR-EAST drivers and conductors.

Methods: A prospective series of 55 JR-EAST employees diagnosed with SAR by otorhinolaryngologists was studied. INS alone were administered as soon as symptoms were noted, immediately after the start of cedar pollen dispersal. The treatment periods were 1 week and, 2, 3, 4 and 8 weeks. Efficacy as the primary endpoint was assessed using the Japanese Rhinoconjuctivitis Quality of life Questionnaire (JRQLQ). Safety as the second endpoint was assessed by monitoring adverse events.

Results: All 25 items of the JRQLQ improved significantly (p<0.01). The “overall evaluation” was aggravated in 2 patients (3.6%) and both had worsened ocular symptoms of “itchy eyes” and “watery eyes.” There was no sleep disturbance or daytime drowsiness affecting work. One patient reported “impaired sleep” but it did not affect work. Fifty-three (96.3%) were satisfied with INS treatment, and all 55 were able to continue treatment during the observation period and wanted to use INS in next cedar pollen season.

Conclusions: The present study showed that INS administration prevented deterioration of the quality of life and alleviated the sleep disturbance and daytime drowsiness from Japanese cedar pollinosis. INS was an effective, safe treatment for SAR among JR-EAST personnel. This study can become the basis for preliminary safety guidelines for SAR treatment railway employees.

Keywords: Allergic rhinitis; Seasonal allergic rhinitis; Cedar pollen; Intranasal corticosteroids; Oral antihistamines

Keywords

Allergic rhinitis; Seasonal allergic rhinitis; Cedar pollen; Intranasal corticosteroids; Oral antihistamines

Introduction

Allergic rhinitis (AR) is a common condition affecting over 400 million people worldwide. The prevalence of AR is markedly increasing to epidemic proportions as societies adopt Western lifestyles [1]. In Japan, epidemiological studies have demonstrated that the prevalence of seasonal AR (SAR) due to cedar pollen rose from 16% in 1998 to 26% in 2008 [2]. Cedar pollen AR is the most common form of the condition in Japan. AR is an IgE-mediated inflammation of the nasal mucosa induced after the membrane is exposed to an allergen and is characterized by the 3 symptoms of sneezing, nasal congestion and rhinorrhea. AR influences the quality of life (QOL) of patients by impairing the performance of daily activities. Moreover, AR is a social burden in terms of medical expenditure. In the USA, the mean total productivity loss per employee per year was US $593 for AR, which was the highest economic loss for any disease, in 2006 [3]. The Practical Guidelines for the Management of AR in Japan recommend that SAR patients should be treated early, as soon as symptoms are recognized, immediately after the start of the pollen dispersal season. Oral antihistamines (OAs) are the most frequently used drugs for the initial treatment of SAR in Japan, and intranasal corticosteroids (INS) are added to ameliorate the subsequent aggravation of nasal symptoms with increasing pollen dispersal [2,4-6]. The Allergic Rhinitis and its Impact on Asthma (ARIA) [1] and EU [7] guidelines recommend INS for patients with moderate-to-severe symptoms, and the American Academy of Allergy Asthma and Immunology (AAAAI) [8] recommends INS as first-line therapy when nasal congestion is major component.
There is still some degree of controversy concerning the most appropriate treatment of SAR among professional vehicle operator. The East Japan Railway Company (JR-EAST) carries 6 billion passengers per year, which is the most numerous global total. The safe transportation of passengers is the fundamental mission of railway personnel. There are about 15,000 railway drivers in Japan, of which 10,000 are engaged in our company. About 3,000 JR-EAST drivers have been developed SAR. OAs have side effects such as drowsiness, general fatigue and poor concentration, and therefore INS are recommended for the initial treatment of SAR in vehicle operators. However, there are no safety guidelines on the treatment of SAR among employees. This study aimed to evaluate the efficacy and safety of initial treatment with INS among JR-EAST personnel. To the best of our knowledge, this was the first clinical trial of initial SAR treatment using INS in railway employees.

Methods

Study design
This study was initiated in January 2013. JR-EAST drivers and conductors who had been diagnosed with Japanese cedar pollinosis were enrolled. Both patients who had new-onset cedar pollinosis and those who had previously been diagnosed with cedar pollinosis were included. The patients received INS alone from 1 week before the start of the Japanese cedar pollen dispersal season until subjective symptoms were noted. Fluticasone furoate (FF) or mometasone furoate (MF) was then administered by spraying 27.5 μg ×2 pushes (daily total 110 μg) and 50 μg ×2 pushes (daily total 200 μg) in each nostril once daily, respectively. Cedar pollen-specific IgE was confirmed to be class 2 or greater in serum specimens.
The study inclusion criteria were JR-EAST drivers and conductors (on conventional lines and Shinkansen bullet trains). The exclusion criteria were: patients who had received oral antihistamines (OAs) and/or INS at the first medical examination; those in whom corticosteroids were contraindicated; those in whom complications such as nasal polyps, acute/chronic rhinitis or sinusitis were present; those receiving current immunotherapy; women who were or planned to become pregnant or were lactating; a history of gastric ulcers or diabetes; and patients judged by a physician to be inappropriate for study participation from an efficacy and safety perspective. The study was conducted in Japan Railway General Hospital in accordance with the Helsinki Declaration (2000) and ethical guidelines for clinical trials after the protocol had been approval by the JR General Hospital Ethics Committee.
Evaluation of QOL
We assessed the 55 patients using the Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ) (Figure 1). The JRQLQ was modified based on the RQLQ to take into account Japanese culture after translation into Japanese [5]. The JRQLQ consists of 3 parts:
Figure 1: Japanese Allergic rhinitis Standard Quality of Life Questionnaire (JRQLQ No. 1). Adapted from Reference 5.
• 6 questions on nasal/ocular symptoms
• 17 questions on QOL
• An overall evaluation (face picture scale).
For the evaluation of symptoms, each item was evaluated on a 5- point scale (0–4). A score that was at least 1 point higher than the score at the start of the study (baseline) was taken to indicate aggravation. Differences were evaluated using the paired t-test and considered significant at a p value of less than 0.01.
Safety
All unfavorable signs and symptoms observed during the period of drug administration were classified as adverse events. The safety items evaluated included analysis of data obtained during the study period and symptoms experienced during the study period.

Results

Fifty-five JR-EAST drivers and conductors, comprising 48 men and 7 women aged 21–63 (mean 35) years, completed the study. Thirtyeight patients received FF and the other 17 MF. The treatment periods were 1 week (FF = 3), 2 weeks (FF = 17, MF = 1), 3 weeks (FF = 9, MF = 4), 4 weeks (FF = 9, MF = 9) and 8 weeks (MF = 3). 35 patients had previously been diagnosed with cedar pollinosis, and 20 patients were new-onset.
QOL
All items in the JRQLQ improved significantly (p<0.01) after drug administration (Table 1). The average improvement rate was 1.28 ± 0.32 (range 0.80 ± 1.06 to 2.03 ± 1.18) (Figure 2). The most improvement was reported for “runny nose”, and the least was for “reluctant to meet friends or relatives.” The post-treatment scores for “itchy eyes” and “overall evaluation” were still higher than 1.0, although the scores for the other 23 items were less than 1.0. Worsening of “itchy eyes” was reported by 3 patients (5.4%) and of “watery eyes” by 2 patients (3.6%). One patient (1.8%) reported “reduced function at work/home” and “impaired sleeping,” while 2 (3.6%) stated that their “overall evaluation” had decreased. Both of the latter 2 patients experienced worsening of the ocular symptoms of “itchy eyes.” Fifty-three patients (96.3%) were “very satisfied” with the treatment, and all 55 (100%) hoped to use INS during next pollen season.
Table 1: JRQLQ scores at baseline and posttreatment and magnitude of change with p-values (paired t-test).
Figure 2: Bar chart of improvement rate and mean change from baseline. All showed significantly improvement (p<0.01).
Safety
INS were well tolerated in all patients, and no systemic side effects were observed during the study period.

Discussion

This is the first study specifically assessing efficacy and safety of INS for railway personnel affected by SAR. AR is not a life-threatening condition, although it has a substantial effect on QOL and creates a social burden through decreased productivity [1]. Sleep disturbance is commonly observed in SAR, which can lead to daytime drowsiness [9,10]. In the present study, total nasal symptom scores (TNSS) and the Japanese edition of the Epworth Sleepiness Scale (JESS) were correlated significantly (p=0.019) and positively (p=0.332 by Spearman’s correlation coefficient by rank test). In recent systematic reviews, it was clearly demonstrated that INS improved not only nasal symptoms but also ocular symptoms, sleep disturbance, and daytime drowsiness without any side effects [11-20]. Meltzer et al. [15] confirmed that MF improved drowsiness using the Work Productivity and Activities Impairment-Allergy Specific (WPAI-AS) questionnaire. The geometric means of the absolute bioavailability of FF and MF are 0.50% and 0.46%, respectively, providing strong evidence for fewer systemic side effects of INS [21,22]. The long-term clinical benefits of INS (FF and MF) for SAR were demonstrated in a 12-month study [11-13].
Until last cedar pollen season, fexofenadine HCl was administered to JR-EAST drivers and conductors because sleep disturbance and/or daytime drowsiness do not tend to occur with this medication. 35 drivers had an use experience of fexofenadine HCl. However, 21 of 35 (60.0%) who received an OA complained about the treatment, for the following reasons: 14 (40%) did not respond sufficiently; 13 (37%) complained of an adverse event associated with sleep; and 7 (20%) could not take an OA at the same time each day due to conflicts with work schedules. On the other hand, 53 patients (96.3%) were very satisfied with the INS treatment, and all 55 (100%) continue INS use and wanted to use it in the next cedar pollen allergy season. As in previous studies [20], the symptoms “itchy eyes” and “watery eyes” improved 53 patients (94.5%).
OAs including fexofenadine HCl are appropriate for treatment of SAR. However, they do not appear appropriate as first-line treatment in railway personnel for 3 main reasons. First, many drivers are not able to comply with the treatment regimen of taking an OA at the same time each day due to their varying schedules. Second, there is a possibility of sleep disturbance and/or daytime drowsiness associated with OA administration, although not with INS treatment. Finally, sleep disturbance and/or daytime drowsiness can potentially occur when pollen dispersal increases if an OA is insufficiently effective as the initial treatment. INS, which are easy-to-use (do not require drinking water, involve once-daily administration, and are packaged in conveniently sized containers), effective, and have few side effects, are recommended for use as soon as early cedar pollinosis symptoms are noted. INS may also improve sleep disturbance and daytime drowsiness [14,18,19]. INS are not only associated with a lower potential need for additional treatment compared with OAs but also have a higher treatment compliance rate. As we instructed patients to use INS shortly after brushing their teeth in the morning, all 55 (100%) were able to continue using INS once daily.
Further studies should investigate the JRQLQ in addition to the TNSS, JESS, and WPAI-AS. In addition, the Uchida-Kraepelin test, which is a version of a vocational aptitude test, should be examined during the next cedar pollen season. The accumulation of more cases is necessary to verify the results of the present study, which will enable the development of SAR treatment protocol guidelines for JR-EAST personnel.

Conclusion

FF and MF significantly reduced the symptoms of SAR including ocular symptoms, sleep disturbance, and daytime drowsiness without any adverse events. INS are also expected to improve treatment compliance. The results of this study indicated that INS are suitable as initial treatment for SAR in railway drivers and conductors.

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