Mometasone furoate monohydrate nasal spray for the treatment of nasal congestion in allergic rhinitis

Allergic rhinitis (AR) affects an estimated 20–40 million Americans annually. It is a multifaceted condition comprising a range of symptoms, including nasal congestion, arguably the most bothersome symptom. Of the various types of medications available for the treatment of AR, intranasal corticosteroids are considered the most effective. Mometasone furoate nasal spray is an intranasal corticosteroid with anti-inflammatory properties. It is indicated for the treatment of the nasal symptoms of seasonal AR and perennial AR in adults and children, for the prophylaxis of nasal symptoms of seasonal AR and for the treatment of nasal polyps. Numerous clinical trials have demonstrated that mometasone furoate nasal spray effectively relieves nasal congestion in adults and children with AR, while providing excellent safety and tolerability.     

Olopatadine nasal spray for the treatment of allergic rhinitis

Olopatadine hydrochloride nasal spray (Patanase^® Nasal Spray, Alcon Laboratories, TX, USA) was approved by the US FDA in 2008, and is indicated for the relief of symptoms of seasonal allergic rhinitis (SAR), also referred to as allergic rhinosinusitis. Olopatadine is an antihistamine with selective H₁-receptor antagonist activity. Clinical trials of olopatadine nasal spray have demonstrated safety and efficacy in the treatment of SAR patients. With an onset of action of 30 min, olopatadine nasal spray has also been shown to improve quality of life, ability to perform work and the conduct of usual activities in SAR patients.     

Objective assessments of allergic and nonallergic rhinitis in young children

Background:  Allergic and nonallergic rhinitis are common childhood disorders.
Objective:  To study nasal eosinophilia and nasal airway patency in young children with allergic and nonallergic rhinitis to assess the pathology behind such diagnoses.
Methods:  We investigated 255 children at six years of age from the Copenhagen Prospective Study on Asthma in Childhood birth cohort assessing rhinitis history, specific immunoglobulin E relevant to rhinitis symptoms, nasal eosinophilia and nasal airway patency by acoustic rhinometry before and after decongestion. Associations were studied in a multivariate graphical model corrected for gender, height and nasal steroid usage.
Results:  Allergic rhinitis was significantly and directly associated with irreversible nasal airway obstruction (reduced decongested nasal airway patency) ( P  =   0.004), whereas nonallergic rhinitis was not. Both allergic rhinitis ( P  =   0.000) and nonallergic rhinitis ( P  =   0.014) were directly and significantly associated with nasal eosinophilia, but this association was stronger for allergic rhinitis.
Conclusion:  Allergic rhinitis and nonallergic rhinitis are of different pathologies as suggested from their different associations not only to allergy but importantly also to irreversible nasal airway obstruction and eosinophilic inflammation. Allergic rhinitis was significantly associated with nasal eosinophilia and irreversible nasal airway obstruction suggesting chronic inflammation and structural remodeling of the nasal mucosa in children at the age of 6 years. Nonallergic rhinitis exhibited no change in the nasal airway patency, but some nasal mucosal eosinophilia albeit less than children with allergic rhinitis.     

氮卓斯丁喷鼻剂治疗过敏性鼻炎的临床疗效观察

氮卓斯丁是一种新型抗组胺药,为考察氮卓斯丁喷鼻剂治疗过敏性鼻炎的疗效和安全性,进行了本项临床试验。采用多中心、随机、双盲、平行对照的方法,对照药为左卡巴斯丁喷鼻剂,受试者为中重度过敏性鼻炎患者,季节性过敏性鼻炎和常年性过敏性鼻炎分别连续给药14d和28d。共有136例完成了临床试验,氮卓斯丁组67例,左卡巴斯丁组69例。氮卓斯丁组总有效率82．1％,其中显效40．3％,左卡巴斯丁组则分别为76．8％和20．3％。两组均未发现严重不良反应。氮卓斯丁组与左卡巴斯丁组的不良反应发生率分别为22．1％和31．5％。氮卓斯丁组主要副作用为鼻干8．8％、口苦8．8％,左卡巴斯丁组主要副作用为鼻干16．4％、口干9．6％。氮卓斯丁喷鼻剂治疗过敏性鼻炎有较好的疗效和安全性。     

Long-term safety of fluticasone furoate nasal spray in adults and adolescents with perennial allergic rhinitis

BACKGROUND: Fluticasone furoate is a novel-enhanced affinity glucocorticoid and its long-term safety must be assessed. This study was designed to assess the safety and tolerability of 12-month intranasal administration of fluticasone furoate in adult and adolescent patients with perennial allergic rhinitis (PAR). METHODS: In this randomized, double-blind, placebo-controlled, parallel-group study, 806 patients with PAR were randomized to once daily (od) fluticasone furoate nasal spray 110 microg (n = 605) or vehicle placebo nasal spray (n = 201) for 12 months, following a 7- to 14-day screening period. Safety was assessed by monitoring adverse events (AEs), 24-h urinary cortisol excretion, nasal and ophthalmic examinations, electrocardiograms and clinical laboratory tests. Plasma concentrations of fluticasone furoate were determined from blood samples. RESULTS: Fluticasone furoate was well tolerated. The incidence of most AEs was similar to that observed with placebo, with the exception of epistaxis, which was more frequently reported on active treatment. There were no clinically meaningful differences between fluticasone furoate and placebo in terms of safety assessments, including mean changes in ophthalmic parameters and 24-h urine cortisol excretion. Plasma concentrations of fluticasone furoate were not quantifiable in the majority of patients following intranasal administration. CONCLUSIONS: Long-term (12-month) administration of fluticasone furoate 110 microg od revealed an AE profile typical of the intranasal corticosteroid class in both adult and adolescent patients with PAR, with no evidence of clinically relevant systemic corticosteroid exposure.     

Dose-ranging, placebo-controlled study of cetirizine nasal spray in adults with perennial allergic rhinitis

A total of 360 patients with perennial allergic rhinitis were randomized in a placebo-controlled, dose-finding study comparing three concentrations (0.06%, 0.125%, and 0.25%) of a cetirizine nasal spray, administered three times a day for 2 weeks. The primary criterion of efficacy was the percentage of days with no or only mild symptoms of rhinitis (PDMax1), as evaluated by the patients. The median PDMax1 were 16.7%, 30.8%, 42.9% and 26.7% for the placebo, 0.06%, 0.125%, and 0.25% groups, respectively. Although the global comparison among the four groups only approached statistical significance ( P = 0.076), the difference (26.2%) between the placebo and 0.125% groups was clinically and statistically significant ( P = 0.011). For the global evaluation by the investigator, the best results were seen in the 0.125% group ( P = 0.03). The occurrence of adverse events did not differ among the four treatment groups and consisted mainly of nasal events, occurring in 22.5%, 17.1%, 12.9%, and 24.4% of the patients for the placebo, 0.06%, 0.125%, and 0.25% groups, respectively ( P =0.184). These results indicate that the 0.125% concentration is significantly better than placebo and offers the best therapeutic ratio.     

Once daily fluticasone furoate nasal spray is effective in seasonal allergic rhinitis caused by grass pollen

BACKGROUND: Fluticasone furoate is a new enhanced-affinity glucocorticoid with a unique combination of pharmacodynamic and physicochemical properties suitable for topical activity. METHODS: In this multicentre, randomized, double-blind, placebo-controlled, parallel-group study, patients [adults and adolescents >or=12 years of age with seasonal allergic rhinitis (SAR)] received once-daily (od) treatment for 2 weeks with either fluticasone furoate nasal spray 110 microg (n = 141) or placebo nasal spray (n = 144) administered in a unique, side-actuated device. Efficacy measures included total nasal symptom score (TNSS) and total ocular symptom score (TOSS). Patients also reported their overall response to therapy and rated their quality of life using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). RESULTS: Fluticasone furoate significantly improved the mean change from baseline in daily reflective TNSS compared with placebo (treatment difference of -1.757; P < 0.001). Fluticasone furoate was also significantly more effective in improving the morning predose instantaneous TNSS (treatment difference of -1.898; P < 0.001) and daily reflective TOSS (treatment difference of -0.741; P = 0.001). A significant treatment effect was observed as early as day 1. Compared with placebo-treated patients, fluticasone furoate-treated patients showed significantly greater improvements in overall evaluation of response to therapy (P < 0.001), as well as in overall RQLQ score (P < 0.001). Fluticasone furoate was well tolerated. CONCLUSION: Fluticasone furoate nasal spray 110 mug od was effective in improving the nasal symptoms of SAR. It also produced significant improvements in ocular symptoms.     

Sense of smell in allergic and nonallergic rhinitis

Hyposmia is a fairly common complaint in patients with long-continuing aliergic or nonallergic rhinitis. Other factors such as aging, smoking, or nasal surgery may affect olfaction, but these have been little studied in rhinitisrelated hyposmia. The purpose of this study was to measure and compare olfactory thresholds in 105 rhinitis patients and 104 healthy controls and to analyze possible relationships between the sense of smell and rhinitis, age, sex, smoking, prick-test results, nasal resistance, and history of nasal or paranasal surgery. The olfactory threshold was assessed with a commercially available kit of squeeze-bottle pairs. The most important variables associated with the sense of smell were determined with stepwise multiple regression analysis, and intergroup differences were assessed with analysis of variance. The reference interval of olfactory thresholds by age was estimated with regression analysis. Nasal resistance was measured by active anterior rhinomanometry. Age and rhinitis were the only variables with significant effect on the olfactory threshold in the whole series. Both the proportion of hyposmic persons and the degree of the impairment of the sense of smell were significantly higher in the rhinitis group than in the control group. The nonallergic patients' sense of smell was poorer than that of seasonal or perennial allergic rhinitis patients. A history of operations for nasal polyposis was associated with hyposmia, but operations for chronic maxillary sinusitis were not. Neither smoking habits nor sex were related to olfactory thresholds. In conclusion, hyposmia in rhinitis patients is partly attributable to age-related changes, but our results indicate that the disease itself impairs the sense of smell.     

Differences between allergic and nonallergic rhinitis in a large sample of adolescents and adults

BACKGROUND: The aim of this study was to describe differences between allergic rhinitis (AR) and nonallergic rhinitis (NAR) in a large community-based sample of Danish adolescents and adults. METHODS: A total of 1,186 subjects, 14-44 years of age, who in a screening questionnaire had reported a history of airway symptoms suggestive of asthma and/or allergy, or who were taking any medication for these conditions were clinically examined. All participants were interviewed about respiratory symptoms and furthermore skin test reactivity, lung function and airway responsiveness were measured using standard techniques. RESULTS: A total of 77% of the subjects with rhinitis had AR, whereas 23% had NAR. Subjects with NAR were more likely to be females, OR = 2.05 (1.31-3.20), P = 0.002, to have persistent symptoms within the last 4 weeks, OR = 1.88 (1.23-2.89), P = 0.003, and to have recurring headaches, OR = 1.94, (1.12-3.37), P = 0.019. On the other hand, subjects with NAR were less likely to have airway hyperresponsiveness, OR = 0.40, (0.24-0.66), P < 0.001, food allergy, OR = 0.40, (0.19-0.36), P = 0.009 and to have been treated with antihistamines in the last 4 weeks, OR = 0.22, (0.13-0.38), P < 0.001 compared with subjects with AR. Subjects with AR were symptomatically worse within their season in terms of sneezing (P < 0.001) and itchy eyes (P < 0.001), compared to subjects with NAR, whereas nasal congestion and rhinorrhea were equally frequent in the two groups (P = 0.901 and P = 0.278, respectively). CONCLUSIONS: The proportion of subjects with NAR in an adolescent and adult population with rhinitis is around one-fourth. Women have NAR twice as often as men. In general, subjects with NAR have more persistent but equally severe symptoms compared to subjects with AR. However, subjects with AR have more sneezing and itchy eyes within their particular season of allergy compared to subjects with NAR.     

Onset of action of mometasone furoate nasal spray (NASONEX) in seasonal allergic rhinitis

BACKGROUND: Mometasone furoate nasal spray (MFNS, NASONEX ), is a new synthetic corticosteroid with considerable efficacy in the treatment of seasonal and perennial rhinitis and less than 0.1% systemic absorption. This study was designed to evaluate the time of onset of action of MFNS. The subjects were evaluated over the course of 2 weeks during the spring allergy season. METHODS: The effects of MFNS 200 microg given once daily for 2 weeks were evaluated in a randomized, multicenter, double-blind, placebo-controlled study in 201 patients with seasonal allergic rhinitis. Clinically significant onset of action was assessed prospectively by special patient diary cards kept during the first 3 days of treatment. RESULTS: By 12 h after initial dosage (the earliest evaluation), 28% of patients in the MFNS group experienced clinically significant relief, compared with 13% of those given placebo (P = 0.01). Median time to at least moderate symptom relief in patients who received MFNS was 35.9 h, compared with more than 72 h in patients given placebo (P<0.01). By 72 h, 64% of the patients receiving MFNS experienced at least moderate relief, compared with 40% of those treated with placebo (P<0.01). Both patient and physician ratings of symptom severity, response to treatment, and overall condition of rhinitis indicated significant (P<0.01) superiority of MFNS over placebo. MFNS was well tolerated, with adverse events comparable to placebo. CONCLUSIONS: MFNS provided rapid onset of clinically significant symptom relief in patients with seasonal allergic rhinitis.     

Beclomethasone dipropionate hydrofluoroalkane for the treatment of allergic rhinitis

Allergic rhinitis (AR) is a common respiratory disease, and its prevalence is increasing all over the world, both in adults and in children. Patients experience symptoms that may negatively impact on physical, social and psychological well-being. Hence, if left untreated, allergic rhinitis may significantly affect quality of life. Under current guidelines, intranasal corticosteroids are considered the most effective drugs and they are recommended as first-line therapy. Among the several corticosteroid intranasal sprays available, beclomethasone dipropionate is one of the most prescribed. Recently, new intranasal hydrofluoroalkane-propelled formulations with little or no impact on the ozone layer have been developed for the treatment of AR. The use of these devices might improve patients’ adherence to treatment, avoiding some of the most common side effects associated with aqueous formulations. This review provides the most recent evidence for the efficacy and safety of beclomethasone dipropionate hydrofluoroalkane nasal aerosol in the treatment of allergic rhinitis.     

Nasal biopsy is superior to nasal smear for finding eosinophils in nonallergic rhinitis

The presence of eosinophils was compared in nasal biopsy and smear. Thirty-two nonallergic rhinitis patients, of whom six had nasal polyps, were included in the study. The specimens were studied light-microscopically after staining with hematoxylin-eosin. The association between the presence of polyps and the finding of eosinophils in the biopsy specimens proved to be significant. Ten normal subjects served as controls. It was far more simple to detect eosinophils in the biopsy samples than in the nasal smears. When we considered biopsies with at least four eosinophils in four fields as hypereosinophilic, our group of patients contained 25% nonallergic rhinitis with eosinophilia syndrome (NARES) patients.     

Once daily fluticasone propionate aqueous nasal spray controls symptoms of most patients with seasonal allergic rhinitis

This multicentre, randomized, double-blind, parallel-group study was designed to compare the efficacy and tolerability of fluticasone propionate aqueous nasal spray 200 μg once daily (FPANS 200 μg od) with FPANS 200 μg twice daily (bd) in patients whose seasonal rhinitis symptoms were not completely controlled with FPANS 200 μg od. A total of 549 patients initially received FPANS 200 μg od during the open-treatment phase of the study. After 2 weeks, 65% of patients had their symptoms well controlled by FPANS 200 μg od and continued with this treatment for a further 2 weeks. The remainder received either FPANS 200 μg od or FPANS 200 μg bd for a further 2 weeks. Efficacy was evaluated by the analysis of symptom-free days. In the uncontrolled group, there was a significant increase in the percentage of symptom-free days in the FPANS 200 μg bd group over the FPANS 200 μg od group for nasal blockage on waking (P<0.05) and nasal blockage during the day (P<0.05). Similar trends were observed for sneezing, rhinorrhoea, nasal itching, and eye symptoms. There was a significant increase in the percentage of days with a symptom score of less than 2 in the FPANS 200 μg bd group for nasal blockage during the day (P < 0.05). Adverse events were similar in nature and frequency in each treatment group. It is concluded that in the majority of patients symptoms of seasonal rhinitis are well controlled by FPANS 200 μg od. In the minority of patients whose symptoms are not adequately controlled by a once daily dose, FPANS 200 μg bd provides additional relief, particularly from nasal blockage.     

Management of rhinitis: allergic and non-allergic

RHINITIS IS A GLOBAL PROBLEM AND IS DEFINED AS THE PRESENCE OF AT LEAST ONE OF THE FOLLOWING: congestion, rhinorrhea, sneezing, nasal itching, and nasal obstruction. The two major classifications are allergic and nonallergic rhinitis (NAR). Allergic rhinitis occurs when an allergen is the trigger for the nasal symptoms. NAR is when obstruction and rhinorrhea occurs in relation to nonallergic, noninfectious triggers such as change in the weather, exposure to caustic odors or cigarette smoke, barometric pressure differences, etc. There is a lack of concomitant allergic disease, determined by negative skin prick test for relevant allergens and/or negative allergen-specific antibody tests. Both are highly prevalent diseases that have a significant economic burden on society and negative impact on patient quality of life. Treatment of allergic rhinitis includes allergen avoidance, antihistamines (oral and intranasal), intranasal corticosteroids, intranasal cromones, leukotriene receptor antagonists, and immunotherapy. Occasional systemic corticosteroids and decongestants (oral and topical) are also used. NAR has 8 major subtypes which includes nonallergic rhinopathy (previously known as vasomotor rhinitis), nonallergic rhinitis with eosinophilia, atrophic rhinitis, senile rhinitis, gustatory rhinitis, drug-induced rhinitis, hormonal-induced rhinitis, and cerebral spinal fluid leak. The mainstay of treatment for NAR are intranasal corticosteroids. Topical antihistamines have also been found to be efficacious. Topical anticholinergics such as ipratropium bromide (0.03%) nasal spray are effective in treating rhinorrhea symptoms. Adjunct therapy includes decongestants and nasal saline. Investigational therapies in the treatment of NAR discussed include capsaicin, silver nitrate, and acupuncture.     

Desloratadine for allergic rhinitis

Seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) affect up to 40% of the population (depending on geographical area), and are associated with significant morbidity, socioeconomic costs and reductions in quality of life. Antihistamines are a first-line therapy, with newer nonsedating agents having superseded sedating first-generation drugs. Desloratadine is a nonsedating, nonimpairing antihistamine that is effective in relieving nasal and non-nasal symptoms of SAR and PAR, including nasal congestion. Desloratadine has a 24-h duration of action, enabling once-daily dosing and providing relief of morning symptoms. Clinical trials have demonstrated that it has no performance impairment, cardiovascular effects or clinically relevant interactions with other tested medications. This article reviews the use of desloratadine in the treatment of SAR and PAR.     

Combining desloratadine and pseudoephedrine in the treatment of seasonal allergic rhinitis

Nonsedating antihistamines are a first-line therapy in the management of allergic rhinitis. They relieve the majority of the histamine-mediated symptoms of the condition, including rhinorrhea, sneezing, and pruritus. The nonsedating antihistamine desloratadine is effective in alleviating the symptoms of both seasonal and perennial allergic rhinitis. It may also have some decongestant properties, and thus help to alleviate nasal congestion. Administering desloratadine in combination with the decongestant pseudoephedrine may offer allergic rhinitis patients with moderate-to-severe nasal congestion the benefits of desloratadine’s effectiveness for alleviating histamine-mediated symptoms plus pseudoephedrine’s relief from nasal congestion. This drug profile reviews a combination therapy containing desloratadine and pseudoephedrine, approved in the USA for the relief of the symptoms of seasonal allergic rhinitis, including nasal congestion.     

Effects of fexofenadine and desloratadine on subjective and objective measures of nasal congestion in seasonal allergic rhinitis

BACKGROUND: In vitro studies have shown much higher H1-receptor antagonist potency with desloratadine (DL) compared to fexofenadine (FEX), although it is unclear whether this has any clinical relevance on disease control parameters in seasonal allergic rhinitis (SAR), especially for nasal congestion. OBJECTIVE: To compare the relative efficacy between presently recommended doses of DL and FEX on daily measurements of peak nasal inspiratory flow (PNIF) and nasal symptoms in SAR. METHODS: Forty-nine patients with SAR were randomized into a double-blind, placebo-controlled cross-over study during the grass pollen season, comparing 2 weeks of once daily treatment with (a) 180 mg FEX or (b) 5 mg DL, taken in the morning. There was a 7-10 day placebo run-in and washout prior to each randomized treatment. Measurements were made in the morning (AM) and in the evening (PM) for PNIF (the primary outcome variable), nasal and eye symptoms. The average of AM/PM values were used for analysis. RESULTS: There were significant (P < 0.05) improvements, compared to placebo, with FEX and DL, for PNIF, nasal blockage, nasal irritation, and total nasal symptoms, but not nasal discharge or eye symptoms. There were no significant differences between active treatments. Values for PNIF (L/min) for mean placebo baseline, mean difference from baseline (95% CI for difference) were 126, 10 (4-16) for FEX; and 122, 11 (4-17) for DL. The mean difference (95% CI) between FEX vs. DL was 1 L/min (-7-8). Values for total nasal symptoms (out of 12) were: 3.2, 0.7 (0.2-1.2) for FEX; and 3.4, 0.9 (0.3-1.5) for DL, and for nasal blockage (out of 3) were: 1.1, 0.2 (0.1-0.4) for FEX; and 1.2, 0.3 (0.1-0.5) for DL. The mean difference (95% CI) in total nasal symptoms and nasal blockage between FEX vs. DL was 0.1 (-0.6-0.8) and 0.1 (-0.2-0.3), respectively. CONCLUSIONS: Recommended once daily doses of fexofenadine and desloratadine were equally effective in improving nasal peak flow and nasal symptoms in SAR.