Efficacy of intranasal steroid spray (mometasone furoate) on treatment of patients with seasonal allergic rhinitis: Comparison with oral corticosteroids

Objective

Intranasal corticosteroids are effective for allergic rhinitis and broadly used in daily clinical practice. Systemic oral corticosteroids are also known to be effective for treatment of allergic rhinitis. These topical and systemic corticosteroids are both effective formulations for allergic rhinitis, and both drugs have some side effects. When treatment formulations for allergic rhinitis are selected based on side effects, topical corticosteroids are more commonly selected than systemic steroids. Systemic corticosteroids, on the other hand, have traditionally been believed to have higher and more instantaneous therapeutic effects than those of topical corticosteroids. However, there have been few reports of direct comparisons between topical corticosteroid and systemic corticosteroid efficacy. The purpose of this study was to evaluate the subjective outcomes of nasal symptom management using topical intranasal corticosteroid therapy or systemic oral corticosteroid therapy in patients with seasonal allergic rhinitis. We compared the efficacy of mometasone furoate nasal spray (MFNS) to betamethasone oral tablets (BOT) for the treatment of patients with seasonal allergic rhinitis.

Methods

In an open label study, patients with seasonal allergic rhinitis who had intermediate-to-severe symptoms and who visited the hospital without prior treatment were allocated to 1 of 3 treatment groups (noncorticosteroid group, topical corticosteroid group, and oral corticosteroid group). Evaluation was conducted using allergy diaries that consisted of patient questionnaires. The Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ) was used in this study.

Results

Compared to only loratazine nonsteroid therapy, both MFNS 200 μg once daily and BOT 0.25 mg twice daily significantly reduced the total and individual symptom scores for sneezing, nasal obstruction, watery nasal discharge, and nasal itching (P < 0.05). Scores for itching of the eyes were reduced slightly more in the MFNS group than in the noncorticosteriod treatment group, but the difference was not significant.

Conclusion

MFNS and BOT have virtually equivalent effects on nasal symptoms in patients with seasonal allergies. Our study was the first direct comparison between an intranasal corticosteroid spray and a systemic oral corticosteroid for seasonal allergic rhinitis. No significant differences were found in the therapeutic effects of the topical and systemic corticosteroids tested, suggesting that topical corticosteroids are expected to sufficiently improve nasal symptoms without administration of oral corticosteroids. Treatment with intranasal corticosteroid spray is more strongly recommended than treatment with systemic corticoid steroids, due to the side effects associated with each treatment.     

Effect of topical nasal steroid sprays on nasal mucosa and ciliary function

PURPOSE OF REVIEW: This review was conducted to examine current evidence focusing on the effect of nasal steroid sprays on nasal ciliary function. RECENT FINDINGS: Review of current literature suggests that long term effects of topical corticosteroid nasal sprays are safe and fail to cause damage to local nasal structure and function. SUMMARY: The use of corticosteroid nasal sprays for the treatment of allergic rhinitis is widely accepted. Popularity of this class of medications is based on a well-established combination of efficacy, tolerability, and safety. Although current literature suggests that the use of intranasal steroids is indeed safe, increasing indications for prolonged administration continue to fuel debate regarding the long-term effect on local nasal structure and function. The purpose of this article is to review current literature addressing the effects of the components of local intranasal steroid sprays on the structure and function of the nasal mucosa.     

Comparison of intranasal hypertonic dead sea saline spray and intranasal aqueous triamcinolone spray in seasonal allergic rhinitis

Intranasal corticosteroids are well known to be efficacious in the treatment of allergic rhinitis. Nasal irrigation with saline, including hypertonic saline, has long been recommended for the treatment of sinonasal disease, and it has been shown to have a positive effect on the physiology of the nasal mucosa. Until now, no study of the clinical efficacy of intranasal hypertonic Dead Sea saline as a monotherapy for seasonal allergic rhinitis has been reported. We conducted a prospective, randomized, single-blind, placebo-controlled comparison of intranasal hypertonic Dead Sea saline spray and intranasal aqueous triamcinolone spray in 15 patients with seasonal allergic rhinitis. Results were based on a 7-day regimen. Based on Rhinoconjunctivitis Quality of Life Questionnaire scores, clinically and statistically significant (p < 0.0001) improvements were seen in both active-treatment groups; as expected, the corticosteroid spray was the more effective of the two treatments. No significant improvement occurred in the control group. Our preliminary results not only confirm the efficacy of intranasal corticosteroid therapy in moderate-to-severe allergic rhinitis, they also suggest that the Dead Sea saline solution can be an effective alternative in mild-to-moderate allergic rhinitis, particularly with respect to nasal and eye symptoms. The hypertonicity of the Dead Sea solution may have a positive effect on the physiology of the nasal mucosa by improving mucociliary clearance. In addition, the dominant cation in the Dead Sea solution--magnesium--probably exerts anti-inflammatory effects on the nasal mucosa and on the systemic immune response.     

Effect of topical corticosteroids on nasal patency after acute positive airway pressure exposure

IntroductionNasal congestion and obstruction are reported in the majority of continuous positive airway pressure users and are frequently cited as reasons for noncompliance. Baseline inflammation due to allergic rhinitis could increase or exacerbate the inflammatory effect of high airflow in the nasal cavity as the result of continuous positive airway pressure and lead to greater continuous positive airway pressure intolerance. In this setting, intranasal steroids would be expected to counteract the nasal inflammation caused by allergic rhinitis and/or continuous positive airway pressure.ObjectiveThe aim of the present study is to evaluate the effects of topical corticosteroid use on nasal patency after acute exposure to positive pressure.MethodsTen individuals with allergic rhinitis were exposed to 1 h of continuous airway pressure (15 cm H₂O) in the nasal cavity, delivered by a continuous positive airway pressure device. Visual analog scale, nasal obstruction symptom evaluation scale, acoustic rhinometry and peak nasal inspiratory flow were performed before and after the intervention. After 4 weeks topical nasal steroid (budesonide) application, positive pressure exposure was repeated as well as the first assessments.ResultsPatients reported a statistically significant improvement both on the visual analog (p = 0.013) and obstruction symptom evaluation scales (p < 0.01). Furthermore, objective measurements were improved as well, with increased nasal cavity volume on acoustic rhinometry (p = 0.02) and increased peak nasal inspiratory flow (p = 0.012), after corticosteroid treatment.ConclusionIn patients with allergic rhinitis, intranasal corticosteroid therapy improved objective and subjective parameters of nasal patency after acute exposure of the nasal cavity to positive pressure.     

Rhinitis medicamentosa

The diagnosis of rhinitis medicamentosa was made in 130 patients seen over a 10 year period from July 1967 to June 1977. There was an incidence of 1% in our otolaryngological practice. Patients had been taking the causal medication for an average of 21.4 months. There were 73 males and 57 females with the peak incidence in young and middle-age adults. The primary offending medications were decongestant nasal sprays in 85 patients, decongestant drops in 33, and a combination of these drugs in 12 patients. The major reasons for self-medication were 1. deviated nasal septum in 40 patients, 2. an acute upper respiratory infection in 33, 3. allergy in 18, 4. miscellaneous causes in 24 and 5. unknown in 15 patients. The initial management in addition to avoidance of the medication consisted of systemic antibiotics, decongestants, antihistamines, and sedatives depending on the severity of the rhinitis and the presence of secondary infection. Later treatment consisted of correction of the deviated septums, allergic management, and supportive care. Eight patients were considered to have complications of the disease by development of chronic ethmoiditis and nasal polyposis. The pharmacologic properties of the causal agents are thoroughly reviewed as they relate to the pathogenesis of this disease. It is felt that the ready commercial availability and limited clinical value of the topical nasal sprays and drops represents a certain risk to all patients using them.     

Acute candidiasis of the oro- and hypopharynx as the result of topical intranasal steroids administration

Topical nasal steroids have become increasingly popular for the treatment of allergic and other types of rhinitis. However, undesirable local effects of intranasal steroids, such as nasal irritation and burning, crusting and epistaxis are quite common. Candidiasis of the pharyngeal mucosa is a complication, which has not been described so far after treatment of rhinitis with intranasal topical corticosteroids. Between March 1997 and September 1998, we managed to treat successfully three patients with acute erythematous candidiasis of the pharynx, which was the result of the use of intranasal topical steroids. Mechanism, clinical features of acute pharyngeal candidiasis, differential diagnosis and treatment are discussed.     

Most patients overdose on topical nasal corticosteroid drops: an accurate delivery device is required

Otolaryngologists and general practitioners commonly prescribed intranasal corticosteroid drops for rhinitis. Compliance in real patients has not previously been studied, but is generally believed to be poor. Recent concerns over systemic adverse effects of topical corticosteroids have highlighted the risks of overdosing. Fifty patients, who were prescribed betamethasone, were prospectively studied for accuracy of compliance using a weighed dose study. Patients consistently administered inaccurate quantities of nasal corticosteroid drops, with a marked tendency to overdose up to four times the recommended daily dose (RDD) in some cases. The mean dose administered was 200 per cent of the RDD. Of the 50 patients, only seven (14 per cent) administered the correct dose. The introduction of metered-dose delivery systems should be considered to reduce the risk of inadvertent overdosing.     

Deposition pattern from a nasal pump spray

The initial distribution and subsequent clearance of aerosol from a hand-operated nasal pump spray has been assessed from gamma camera scans in ten normal subjects, following labelling of placebo sprays with 99Tcm labelled Teflon particles (mean diameter 2 micron). Aerosol was concentrated chiefly in the anterior part of the nose, but the area of deposition varied between subjects. No particles reached the lungs. A mean 56% of the dose was retained at the initial site of deposition 30 minutes after administration, while the remaining 44% of the dose had cleared to the nasopharynx. The initial partitioning of nasal pump sprays between ciliated and non-ciliated zones is relevant both for effective topical therapy of the nasal cavity, and for possible systemic drug delivery by the intranasal route.     

The add-on effect of an intranasal antihistamine with an intranasal corticosteroid in Japanese cedar pollinosis

ObjectiveCombination intranasal drugs with a corticosteroid and antihistamine are available in several countries with better effect than treatments with single agents. However, it remains unclear whether this effect is also seen in Japanese cedar pollinosis (JCP), the most prevalent seasonal allergic rhinitis in Japan. We investigated the effect of an add-on intranasal antihistamine with an intranasal corticosteroid in JCP during the pollen dispersal period. (UMIN000025508)MethodsWe performed a double-blinded, randomized, placebo-controlled trial from March 1 to 14, 2017. Patients (n = 20 per group) received either a mometasone furoate nasal spray (MFNS) plus a levocabastine nasal spray (levocabastine group) or MFNS plus a placebo nasal spray (placebo group). The primary endpoint was the difference in the total nasal symptom score (TNSS) after treatment between the two groups. Differences in the total ocular symptom score, total symptom score, total medication score, total symptom-medication score, and five individual symptoms as well as safety were the secondary endpoints.ResultsThe change in the TNSS from baseline was significantly greater in the levocabastine group than in the placebo group. A significant reduction in the TNSS was observed more than 6 days earlier in the levocabastine group than in the placebo group. Such add-on effects were also seen in the secondary endpoints. Both treatments were well-tolerated.ConclusionThe intranasal antihistamine provided better control of not only nasal symptoms, but also of ocular symptoms, and decreased the need for rescue medications when added to intranasal corticosteroid treatment in JCP patients.     

Assessment of sensory perceptions and patient preference for intranasal corticosteroid sprays in allergic rhinitis

BACKGROUND: Long-term intranasal corticosteroid sprays (INCSs), the mainstay of therapy in allergic rhinitis, differ little in efficacy and safety. Compliance to therapy is strongly influenced by patients' perceptions and preferences. We evaluated the acceptability, based on sensory perceptions, of beclomethasone, budesonide, fluticasone propionate (FP), and mometasone furoate (MF) nasal sprays. METHODS: A single-blind (patient), crossover study was performed; 114 patients with allergic rhinitis, categorized as "sneezers and runners" (group 1) and "blockers" (group 2) were assessed for their sensory perceptions (nasal spray evaluation questionnaire, 14 sensory attributes, and 100-point scale). RESULTS: Significantly more patients preferred MF because of its less irritation, liking of odor, more moistness, and less aftertaste. FP rated significantly higher odor strength and amount of irritation. Seventy-two (63%) patients were in group 1 and 42 (37%) patients were in group 2. MF was the most preferred drug in both group 1 (40 patients, 56%; p < 0.05) and group 2 (21 patients, 50%). Liking the odor was the strongest attribute that affected choice in group 1 (52 patients, 58%), and strength of aftertaste in group 2 (13 patients, 31%). Significantly more patients in group 1 (55 patients, 76%) could appreciate differences in attributes than in group 2 (27 patients, 64%). Ninety-one (80%) patients predicted a better compliance with their preferred drug. CONCLUSION: MF was the most preferred INCS in our patients. This was ascribed to less irritation, odor, and aftertaste along with superior moistness. "Sneezers and runners" appreciated significant differences in INCS. In patients with allergic rhinitis, assessment of sensory perceptions could play a crucial role in promoting compliance with therapy.     

A quantitative analysis of the intranasal delivery of topical nasal drugs to the middle meatus: spray versus drop administration

The delivery of nasal drugs specifically to the middle meatus is of critical importance in the medical treatment of rhinosinusitis. In this respect, topical nasal drug administration by drops has generally been perceived to be superior to nasal sprays, although there is a lack of evidence to support this notion. This study aims to compare the intranasal delivery of nasal sprays and drops to the middle meatus in vivo, using a novel quantitative method. A surgical patty was placed in the middle meatus. Radio-labelled topical nasal drops and aqueous sprays were administered in a standardized fashion in normal volunteers (10 nasal cavities). The subsequent absorption of administered radio-labelled saline on the patty was measured using a gamma counter. A randomized prospective crossover design was used for the study. The mean percentage (range) of absorbed administered saline on the swab was 8.7 (0.3-39.5) and 9.7 (0.03-20.4) for the spray and drop administration techniques respectively (p = 0.8). Thus, there is wide variation in the delivery of topical nasal drugs and the perceived superiority of nasal drop administration, in terms of delivery to the middle meatus, may be incorrect.     

Ten days' use of oxymetazoline nasal spray with or without benzalkonium chloride in patients with vasomotor rhinitis.

CONTEXT: In most countries, the use of topical nasal decongestants is limited to a maximum of 10 days because of the risk of developing rebound mucosal swelling and rhinitis medicamentosa. OBJECTIVE: To determine whether topical nasal decongestants can be safely used for 10 days in patients with chronic inflammation of the nasal mucosa. DESIGN: Double-blind, randomized, controlled, parallel study. PATIENTS: Thirty-five patients with vasomotor rhinitis selected from our outpatient department. INTERVENTION: Eighteen patients received oxymetazoline hydrochloride (0.5 mg/mL) nasal spray containing the preservative benzalkonium chloride (0.1 mg/mL), and the other 17 were treated with oxymetazoline nasal spray without benzalkonium chloride. Before and after the treatment, recordings of the nasal mucosa and minimal cross-sectional area were made with rhinostereometry and acoustic rhinometry, followed by histamine hydrochloride challenge tests. Symptoms of nasal stuffiness were estimated on visual analog scales (0-100) in the morning and the evening, just before the nasal spray was used. RESULTS: No rebound swelling was found after the 10-day treatment in the 2 groups with either of the methods or as estimated by symptom scores. In the group receiving oxymetazoline containing benzalkonium chloride, but not in the other group, the histamine sensitivity was significantly reduced after treatment (P<.001). CONCLUSIONS: It is safe to use topical nasal oxymetazoline with or without benzalkonium chloride for 10 days in patients with vasomotor rhinitis. However, this study indicates that benzalkonium chloride in nasal decongestant sprays affects the nasal mucosa also after short-term use.     

The management of rhinitis in patients with functional epiphora: a randomized controlled crossover trial

BACKGROUND: Nasolacrimal duct obstruction, secondary to inflammation of the nasal mucosa, can result in epiphora. This can be treated successfully with topical corticosteroids, avoiding the need for surgery. This study tests the hypothesis that treating clinically significant rhinitis improves the symptoms of epiphora. METHODS: A randomized controlled crossover trial (pilot study) was performed at the Cumberland Infirmary, Carlisle. Patients were assessed in an epiphora clinic by a consultant ophthalmologist and were included in the trial if they had bilateral functional epiphora, i.e., the nasolacrimal duct was patent on syringing. Twenty-three patients were then referred to a consultant otolaryngologist, where the severity of rhinitis and epiphora were assessed using visual analogue scales, subjective scoring, and clinical assessment. The 11 patients suitable for the study were randomized into two groups. The treatment group received nasal corticosteroids and the control group received no treatment, both groups changing treatment arms at a specified point. Subjective and objective scores were assessed at the beginning, midpoint, and end of each treatment period. RESULTS: Seven of 11 patients showed an improvement in epiphora scores with topical therapy. Six patients documented a symptomatic improvement. Eight patients showed an improvement in symptoms and signs of rhinitis, with two patients continuing on nasal corticosteroids for nasal symptoms only. There was a statistically significant improvement in both epiphora symptom scores and clinical findings of rhinitis in patients treated with nasal steroids (p = 0.021 and 0.019, respectively). CONCLUSION: Epiphora secondary to rhinitis can be treated successfully with intranasal steroids. Patients with epiphora should be asked about symptoms of rhinitis and should always have their nose examined for evidence of intranasal pathology.     

Vasomotor rhinitis update

PURPOSE OF REVIEW: This review was conducted to examine new data on vasomotor rhinitis, a common clinical problem. RECENT FINDINGS: Recent publications highlight advances in the study of the pathophysiology of vasomotor rhinitis. Electron microscopic and ultracytochemical evaluation of the nasal mucosa in vasomotor rhinitis demonstrates an emerging role of neuropeptides and nitric oxide in the pathogenesis of vasomotor rhinitis. Ozone, cigarette smoke, and other environmental factors may trigger neurogenic mechanisms that lead to vasomotor rhinitis. Objective tests have documented the presence of hypoactive sympathetic autonomic dysfunction. Such assessments also suggest autonomic dysfunction as a possible link between vasomotor rhinitis and gastroesophageal reflux disease. Recent publications propose nasal secretory protein analysis as a possible diagnostic tool. Evidence-based review of treatment outcomes shows topical sprays of azelastine, budesonide, and ipratropium to be of benefit in vasomotor rhinitis. SUMMARY: A better understanding of the role of nitric oxide and neuropeptides in the pathogenesis of vasomotor rhinitis has opened new avenues in research, diagnosis, and management. Clinical diagnosis may be aided by the analysis of nasal secretory proteins. Effective treatments include antihistamine, anticholinergics, and steroid nasal sprays.     

An endoscopic photographic comparison of nasal drug delivery by aqueous spray

There is general agreement that the delivery of topical nasal medication by sprays is suboptimal. This study examines the distribution of spray to the anterior end of the middle turbinate as a guide to the distribution to the middle meatus by means of an endoscopic photographic comparison using dyed aqueous nasal spray. The technique was found to be reproducible. The effect of vigorously inhaling whilst spraying was studied by means of a randomized crossover trial and was found to have no significant effect. This technique could be used in conjunction with other means of assessing intranasal distribution when assessing improved topical nasal drug delivery systems.     

The delivery of topical nasal sprays and drops to the middle meatus: a semiquantitative analysis

The distribution of nasal drugs specifically to the middle meatus is of vital importance in the treatment of rhinosinusitis and nasal polyposis. It is widely assumed that the intranasal distribution is superior with nasal drops rather than spray delivery. However, a comparison of nasal spray and drop delivery specifically to this area has not been studied before. This study aims to compare semiquantitatively the intranasal distribution of nasal sprays and drops to the middle meatus in vivo. A novel method was used whereby a neurosurgical patty was placed in the middle meatus. Topical nasal drops and aqueous sprays dyed with methylene blue (0.1% v/v) were administered in a standardized fashion in normal volunteers. The subsequent absorption of administered dye was classified on a four-point scale. A randomized prospective cross-over design was used for the study. We found that there was no difference in the delivery of nasal drug to the middle meatus between either method of drug administration (P > 0.2). The perceived superiority of nasal drops may therefore be as a result of the acknowledged systemic effect of betamethasone drops.     

A study of intranasal distribution of azelastine hydrochloride aqueous nasal spray with different spray techniques

Topical aqueous nasal sprays are widely used in treating patients with a variety of nasal diseases. Previous studies have suggested that drug delivery to the ciliated mucosa is generally suboptimal. Little is known about the effects of nasal spray delivery technique on intranasal distribution and efficacy of topical nasal drugs. We assessed the intranasal distribution of a nasal spray with two commonly used techniques using azelastine hydrochloride labelled with fluorescein. After spraying, the nasal cavity was photographed endoscopically in two standardized positions, one showing the anterior portion in the region of the nasal valve and one the area of the middle meatus. The photographs were computer analysed to identify the proportion of coverage of fluorescein in each image field. The majority of drug was distributed anteriorly with poor coverage posterior to the nasal valve area. This was the case with both of the positions tested.     

Acoustic rhinometric assessment of nasal obstruction after treatment with fluticasone propionate in patients with perennial rhinitis

Objective: To investigate the effect of fluticasone propionate (FP) on the symptom of nasal obstruction and to assess the correlation between the subjective visual analogue score (VAS) and the objective acoustic rhinometry (AR) measurements. Methods: A prospective study of 45 consecutive patients, 30 males and 15 females with a mean age of 27 years (range: 16–59 years), with moderate/severe symptoms of perennial rhinitis who were treated by FP nasal spray for 4 weeks. AR and VAS were used to evaluate, compare and correlate the efficacy of FP nasal sprays. Results: There was a significant improvement in the VAS post-treatment (3.9) compared with pre-treatment (6.3). There was also a significant increase in the nasal volume (V) and minimum cross-sectional area (MCA) after intranasal FP. Good correlation between the total MCA and total V was noted. Subjective improvements in symptoms did not correlate well with objective measurements as the correlation between VAS and AR was poor. Conclusion: Our study provides subjective and objective evidence on the efficacy of intranasal FP in improving nasal obstruction in perennial rhinitis. AR also proved to be a useful instrument in monitoring the effectiveness of medical therapy for perennial rhinitis.