Treatment Of Seasonal Allergic Rhinitis Research Articles

Efficacy and safety of azelastine nasal spray at a dose of 1 spray per nostril twice daily

Azelastine hydrochloride nasal spray is available worldwide for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis. One spray per nostril twice daily is the most commonly recommended dose. To determine the efficacy and safety of azelastine nasal spray, 1 spray per nostril twice daily, in patients with SAR. In 2 studies conducted in the United States we assessed 554 patients with moderate-to-severe SAR who were still symptomatic after a 1-week placebo lead-in period. Patients were randomized to 2 weeks of double-blind treatment with azelastine nasal spray, 1 spray per nostril twice daily, or placebo nasal spray. The primary efficacy variable was change from baseline in total nasal symptom score, consisting of sneezing, itchy nose, runny nose, and nasal congestion. Mean differences in total nasal symptom score between the azelastine and placebo groups were significant in both studies: 2.69 vs 1.31 (P = .01) in study 1 and 3.68 vs 2.50 (P = .02) in study 2. Bitter taste was reported by 8.3% of patients treated with 1 spray per nostril twice daily compared with the labeled incidence of 19.7% with 2 sprays per nostril twice daily. Somnolence was reported by 1 patient (0.4%) using the 1-spray regimen compared with the labeled incidence of 11.5% using the 2-spray regimen. Azelastine nasal spray at a dose of 1 spray per nostril twice daily is effective and has improved tolerability compared with 2 sprays per nostril twice daily in patients with SAR.

Meta‐Analysis of Azelastine Nasal Spray for the Treatment of Allergic Rhinitis

To systematically review the efficacy of azelastine nasal spray for the treatment of allergic rhinitis. Meta-analysis of published randomized controlled trials reported in English. Published literature from the PubMed-MEDLINE database. Patients aged at least 12 (United States) or 16 years (Europe) with allergic rhinitis or nonallergic vasomotor rhinitis. A global assessment of efficacy was used to estimate the number needed to treat for azelastine nasal spray compared with placebo or active comparators. The total symptom score was used to compare the effect size between azelastine and placebo. In five comparisons of azelastine and placebo, azelastine was most efficacious, with a summary number needed to treat of 5.0 (95% confidence interval [CI] 3.3-10.0). In reviewing 11 studies of azelastine versus active comparators, we found no significant difference between azelastine and active comparators (number needed to treat 66.7, 95% CI 14.3 to infinity to 25). Azelastine was more efficacious than placebo in terms of total symptom score (effect size of 0.36, 95% CI 0.26-0.46). Azelastine nasal spray was more efficacious than placebo in the treatment of allergic rhinitis. No significant differences were observed between azelastine and active comparators for the treatment of allergic rhinitis; however, when azelastine was compared with oral antihistamines as monotherapy, the trend favored azelastine. Because azelastine appears to be as efficacious as oral antihistamines, the choice of treatment for seasonal allergic rhinitis should depend on the patient's preference regarding the route of administration, adverse effects, and the cost of the drug.

Ocular Symptoms Benefit From Nasal Treatment of Seasonal Allergic Rhinitis

Ocular Symptoms Benefit From Nasal Treatment of Seasonal Allergic Rhinitis

Montelukast in the management of allergic rhinitis.

Allergic rhinitis is the most common atopic disorder seen in the outpatient clinic setting diagnosed by history, physical exam and objective testing. According to the Allergic Rhinitis and its Impact on Asthma (ARIA) document, it is classified by chronicity (intermittent or persistent), and severity which is based on symptoms and quality of life (mild, or moderate/severe). It has enormous socioeconomic costs and significant reduction in quality of life. Allergen avoidance should be implemented, particularly in children, to reduce level of exposure; unfortunately efforts are often inadequate. Montelukast, a novel medication, is an antagonist to the leukotriene receptor. It is nonsedating, dosed once daily, and has a safety profile similar in adults and children with approval down to 6 months of age. A review of the literature undoubtedly establishes montelukast as a viable alternative for the treatment of seasonal allergic rhinitis. Its benefits are equivalent to antihistamines, when used as monotherapy, but less than intranasal corticosteroids. The addition of an antihistamine to montelukast does appear to have added benefits and at times is reported to be equivalent to intranasal corticosteroids.

Optimal dose selection of fluticasone furoate nasal spray for the treatment of seasonal allergic rhinitis in adults and adolescents

Efficacy and safety of fluticasone furoate nasal spray, administered using a unique side-actuated device, were evaluated in patients > or =12 years of age with seasonal allergic rhinitis to determine the optimal dose. A randomized, double-blind, parallel-group, placebo-controlled, dose-ranging study was performed on 641 patients who received placebo (n=128) or fluticasone furoate, 55 microg (n=127), 110 microg (n=127), 220 microg (n=129), or 440 microg (n=130), once daily for 2 weeks. Fluticasone furoate was significantly more effective than placebo for mean changes from baseline over the 2-week treatment period in daily reflective total nasal symptom score (primary end point; p < 0.001 each dose vs. placebo), morning predose instantaneous total nasal symptom score (p < 0.001 each dose versus placebo), daily reflective total ocular symptom score (p < or = 0.013 each dose versus placebo), and morning predose instantaneous total ocular symptom score (p < or = 0.019 for three highest doses versus placebo). The onset of action for fluticasone furoate nasal spray versus placebo was observed 8 hours after the first. dose of study medication in the 110 and 440 microg treatment groups (p < or = 0.032). The incidence of adverse events, results of clinical laboratory tests, and changes in 24-hour urinary cortisol values were similar between active treatment groups and placebo. The preliminary profile of fluticasone furoate is that of a rapidly effective therapy that confers 24-hour efficacy for both nasal and ocular symptoms with once-daily dosing. The 110-microg dose was chosen for phase III development because it achieved statistically significant and clinically meaningful results for all efficacy end points and provided the optimal risk-benefit ratio.

Efficacy of pollen immunotherapy in seasonal allergic rhinitis

The efficacy of subcutaneous pollen immunotherapy has been documented in published double-blind, placebo-controlled studies related to treatment of seasonal allergic rhinitis. In the present study, subjective (symptom scores) and objective (nasal peak inspiratory flow, nasal smear, nasal biopsy) parameters were used to study the efficacy of pollen immunotherapy. Forty-eight patients (32 male), mean +/- SE age 13.6 +/- 2.8 years allergic to grass-pollen participated in the present study. Patients were divided into three groups: group I, 24 patients who did not receive pollen immunotherapy; group II, 12 patients who received the build-up phase of pollen immunotherapy; and group III, 12 patients who had just finished pollen immunotherapy. With regard to objective and subjective parameters these three groups were compared. When group I was compared to groups II and III, the patients who had not received any immunotherapy were found to have a high daytime nasal symptoms score (P < 0.01), high daytime eye symptoms score(P < 0.01) and high night-time symptoms score (P < 0.01). In objective parameters, it was found that group I had low nasal peak inspiratory flow (P < 0.05), and a high eosinophil count in nasal smears (P < 0.05) and peripheral blood (P < 0.05). It was also demonstrated that there was an increased eosinophil infiltration (P < 0.01) and mast cell infiltration (P < 0.05) in nasal biopsy in group I. There was no significant difference between group II and group III according to these results (P > 0.05). Immunotherapy leads to a better clinical and histopathological prognosis in children with seasonal allergic rhinitis.

Montelukast in the Treatment of Allergic Rhinitis

Cysteinyl-leukotrienes (CysLTs) are endogenous mediators of inflammation and play an important role in allergic airway disease by stimulating bronchoconstriction, mucus production, mucosal oedema and inflammation, airway infiltration by eosinophils, and dendritic cell maturation that prepares for future allergic response. Montelukast inhibits these actions by blocking type 1 CysLT receptors found on immunocytes, smooth muscle and endothelium in the respiratory mucosa. Initially developed as a treatment for asthma, montelukast has more recently found use in the treatment of allergic rhinitis (AR). We conducted a systematic review of studies that have evaluated montelukast in the treatment of seasonal AR (SAR) and perennial AR (PAR), with and without concomitant asthma. Primary consideration was given to large, randomised, placebo-controlled, double-blind clinical trials in which AR endpoints were assessed and the use of concurrent treatments for AR was excluded. Eight such studies were found in the literature. The primary endpoint in these was daytime nasal symptom severity represented by a composite score derived from individual self-ratings of nasal congestion, rhinorrhoea, nasal pruritus and sneezing. Secondary endpoints have included these individual nasal symptom scores, additional scores for eye, ear and throat symptoms, the impact of rhinitis on quality of sleep, global evaluations of outcome by patients and physicians, and measures of the severity of concomitant asthma. A general outcome was that patients treated with montelukast had significantly greater improvements in their symptoms of SAR and PAR than did patients who were given a placebo. As monotherapy, montelukast exhibited efficacy similar to that of loratadine, but less than that of the intranasally administered corticosteroid fluticasone propionate. The use of montelukast in combination with antihistamines such as loratadine or cetirizine has generally resulted in greater efficacy than when these agents were used alone, and in some studies has produced results comparable with intranasally applied corticosteroids. In patients with AR comorbid with asthma, montelukast treatment has resulted in significant improvements in both, compared with placebo. Montelukast is well tolerated and has a favourable safety profile; adverse events have occurred at similar frequencies in patients taking either montelukast or placebo. Montelukast provides an effective and well tolerated oral treatment for allergic airway inflammation in patients with SAR or PAR without asthma, and in patients in whom AR is comorbid with asthma.

Once-daily Fluticasone Furoate∗ Nasal Spray (FFNS) is Effective for the Treatment of Seasonal Allergic Rhinitis (SAR) Caused by Ragweed ∗USAN-approved name

Once-daily Fluticasone Furoate∗ Nasal Spray (FFNS) is Effective for the Treatment of Seasonal Allergic Rhinitis (SAR) Caused by Ragweed ∗USAN-approved name

Effectiveness of ciclesonide nasal spray in the treatment of seasonal allergic rhinitis

Ciclesonide is an investigational corticosteroid under development for treatment of allergic rhinitis. Ciclesonide is converted to active metabolite, desisobutyryl-ciclesonide (des-CIC), by upper and lower airway esterases. In vitro studies in human nasal epithelial cells and bronchial epithelial cells have demonstrated a long duration of anti-inflammatory activity of des-CIC. To evaluate the dose-dependent efficacy and safety of a hypotonic intranasal formulation of ciclesonide in patients with seasonal allergic rhinitis (SAR). This was a phase 2, randomized, parallel-group, double-blind, placebo-controlled study. Adults (n = approximately 145 per treatment group) with a minimum 2-year history of SAR received placebo or ciclesonide (25, 50, 100, or 200 microg/d) for 14 days. The primary end point was change in the sum of morning and evening reflective total nasal symptom scores (TNSSs) over 2 weeks. Safety was monitored throughout the study. Ciclesonide, 100 microg/d (P = .04) and 200 microg/d (P = .003), significantly improved the sum of morning and evening reflective TNSS vs placebo at more than 2 weeks of treatment. Baseline values for morning and evening reflective TNSS ranged from 17.80 to 18.82 across treatment groups. The average change from baseline in reflective TNSS was -4.2 for placebo and -4.8, -4.8, -5.3, and -5.8 for ciclesonide, 25, 50, 100, and 200 microg/d, respectively. There were no dose-related differences in the incidence of adverse events among treatment groups. Results from this study indicate that 100-microg and 200-microg daily doses of ciclesonide are effective in the treatment of SAR. Ciclesonide, 200 microg/d, appears to be the optimal dose studied for reducing the symptoms of SAR while maintaining an acceptable safety profile.

Pollinex® Quattro: a novel and well–tolerated, ultra short–course allergy vaccine

Pollinex® Quattro is a novel, ultra short-course vaccine for treatment of seasonal allergic rhinitis from grass, tree or ragweed pollen allergy. Its unique formulation combines chemically modified allergens adsorbed onto a L-tyrosine depot to enhance tolerability with the novel adjuvant, monophosphoryl lipid A, to improve efficacy. Controlled clinical studies indicate that four preseasonal injections with grass or tree formulations significantly reduce rhinoconjunctivitis symptoms and medication use, as well as elevate allergen-specific immunoglobulin G and blunt elevation of immunoglobulin E upon allergen exposure. Postmarketing surveillance studies indicate similar clinical outcomes. In all cases, the allergy vaccine was well tolerated with minimal local reactions, while systemic reactions were rare and mild. Results from recent investigational trials with grass and ragweed formulations are consistent with previous efficacy and safety outcomes, and will be used toward product registration in North America.

Efficacy and safety of ciclesonide nasal spray for the treatment of seasonal allergic rhinitis

Allergic rhinitis (AR), an inflammatory disease of the nasal mucosa, affects approximately 25% of adults and 40% of children in the United States. Ciclesonide nasal spray is a corticosteroid being developed as a hypotonic formulation for AR. We sought to evaluate the efficacy, safety, and tolerability of ciclesonide nasal spray in adult and adolescent patients with seasonal AR (SAR). In this double-blind study patients (age, >or=12 years) were randomized to receive 200 microg of intranasal ciclesonide (n = 164) or placebo (n = 163) once daily for 28 days. The primary measure was morning and evening patient-assessed reflective total nasal symptom score (TNSS). Additionally, instantaneous TNSSs, physician-assessed overall nasal signs and symptoms severity, and the results of the Rhinoconjunctivitis Quality of Life Questionnaire were evaluated. Adverse events were monitored throughout the study. Ciclesonide significantly improved average morning and evening reflective and instantaneous TNSSs compared with placebo over days 1 to 14 (P < .001). Improvements were also noted over days 1 to 28 (P < .001) and over days 15 to 28 (P = .011). Ciclesonide was well tolerated. Intranasal ciclesonide was superior to placebo in relieving nasal symptoms in adult and adolescent patients with SAR. These results confirm the dose range-finding study in patients with SAR and support the efficacy of ciclesonide in AR. In a clinical setting ciclesonide was shown to be safe and effective in the treatment of SAR in adolescent and adult patients.

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.

Advances in upper airway diseases and allergen immunotherapy

The purpose of this review is to highlight important articles on upper airway disease and immunotherapy that appeared in the Journal of Allergy and Clinical Immunology and elsewhere during 2005. In recent studies of tissue from patients with chronic hypertrophic eosinophilic sinusitis, increased leukotriene C4 synthase and 5-lipoxygenase activity and increased levels of cysteinyl leukotriene production were demonstrated that correlated with disease severity but not with whether the patient was aspirin sensitive. However, the cysteinyl leukotriene 1 receptor was increased in leukocytes in the sinus tissue only in those patients with aspirin sensitivity. Major basic protein, released by eosinophils into the mucus in the paranasal sinus lumen, was found to reach concentrations capable of damaging the sinus epithelium, predisposing to bacterial infections. Testing the hypothesis that chronic hypertrophic eosinophilic sinusitis represents a reaction to common fungi, a double-blind trial of intranasal instillation of amphotericin B was conducted. There were marginal but significant differences in favor of amphotericin B treatment for sinus mucosal thickening on the basis of computed tomography and the evidence of eosinophilic inflammation in the sinus mucus. The effectiveness of topical nasal corticosteroids for treatment of nasal polyps was confirmed in 2 large studies. Improvement in sleep quality and daytime drowsiness in patients with allergic rhinitis treated with nasal corticosteroids was reported to correlate with reduction in nasal obstruction. The statistical analysis behind studies that reported a decrease in asthma exacerbations with nasal corticosteroids or oral antihistamines has been questioned. It appears that the results of at least one of these studies are indeed too good to be true. Although caution is still indicated in administering immunotherapy to patients receiving beta-adrenergic blocking agents, the prohibition might not be absolute. A study in patients with Hymenoptera sensitivity given venom immunotherapy revealed no increase in serious adverse reactions to venom injections and no greater incidence of reactions to insect stings in those taking beta-blocking agents. Sublingual immunotherapy for 8 to 12 weeks in patients with hazelnut sensitivity significantly increased their tolerance to hazelnut in double-blind, placebo-controlled challenges while inducing increased IgG4 and IL-10 levels, indicating induction of regulatory T cells. There were a number of articles in the Journal of Allergy and Clinical Immunology in 2005 that addressed the entity of chronic hypertrophic eosinophilic sinusitis. In addition, an update of the "Practice parameters on sinusitis" was published. The major focus in allergen immunotherapy continues to be sublingual administration.

Links between allergic rhinitis and asthma

航线的过敏疾病，包括季节的鼻炎，长期的长期的鼻炎和气喘，作为航线 mucosa 的煽动性的混乱被认出，但是在煽动性的反应的地点和疾病的临床的表明不同。气喘和过敏鼻炎经常在一样的病人共存并且被认为分享普通预先安排与环境影响交往的基因因素。两疾病特别地在西洋化的国家在最近的十年在流行增加了。这增加过时的人或物大部分归因于象暴露那样的环境因素到天线污染物质，和早年生活事件，包括到可能影响 IgEproduction 的传染代理人的暴露的度，自从在基因水池的一个重要变化有不够的时间。

알레그라정(염산펙소페나딘 180 mg)에 대한 한미염산펙소페나딘정의 생물학적 동등성

Fexofenadine, one of selective histamine receptor antagonists, has been used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The bioequivalence of two fexofenadine hydrochloride preparations, containing 180 mg fexofenadine hydrochloride, was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Hanmi Fexofenadine Hydrochloride made by Hanmi Pharm. Co. and the reference product was Allegra made by Handok Parmaceuticals Co.. Twenty healthy male subjects were randomly divided into two groups and a cross-over study was employed. After one tablet was orally administered, blood was taken at predetermined time intervals and the concentration of fexofenadine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, and , were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of and were and , respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Fexofenadine Hydrochloride Tablet is bioequivalent to Allegra Tablet.

INHIBITION OF OAT3-MEDIATED RENAL UPTAKE AS A MECHANISM FOR DRUG-DRUG INTERACTION BETWEEN FEXOFENADINE AND PROBENECID

Fexofenadine, a nonsedating antihistamine drug, is effective for the treatment of seasonal allergic rhinitis and chronic urticaria. Simultaneous administration of probenecid increases the plasma concentration of fexofenadine due to an inhibition of its renal elimination in healthy volunteers (Clin Pharmacol Ther 77:17-23, 2005). The purpose of the present study is to investigate the possibility that the drug-drug interaction between fexofenadine and probenecid involves the renal basolateral uptake process. The uptake of fexofenadine was determined in HEK293 cells expressing human organic anion transporter 1 (OAT1/SLC22A6), OAT2 (SLC22A7), OAT3 (SLC22A8), and organic cation transporter 2 (OCT2/SLC22A2). Only hOAT3-HEK showed a significantly greater accumulation of fexofenadine than that in vector-HEK, which was saturable with K(m) and V(max) values of 70.2 microM and 120 pmol/min/mg protein, respectively. Inhibition potency of probenecid for the uptake of fexofenadine was compared between hOAT3 and organic anion-transporting peptide 1B3 (hOATP1B3), a transporter responsible for the hepatic uptake of fexofenadine (Drug Metab Dispos 33:1477-1481, 2005). The K(i) values were determined to be 1.30 and 130 microM for hOAT3 and hOATP1B3, respectively, with Hill coefficients of 0.76 and 0.64, respectively. The K(i) value of probenecid for hOAT3, but not for hOATP1B3, was significantly lower than the maximum unbound plasma concentration of probenecid at clinical dosages. These results suggest that the renal drug-drug interaction between fexofenadine and probenecid is probably explained by an inhibition of the renal uptake of fexofenadine via hOAT3, at least in part.

Efficacy and Safety of Ciclesonide Nasal Spray for the Treatment of Seasonal Allergic Rhinitis

RATIONALE: Intranasal corticosteroids are considered the most effective treatment for the management of allergic rhinitis (AR) symptoms. The objective of this study was to evaluate the efficacy and safety of a new corticosteroid in development for the treatment of asthma and AR, ciclesonide (CIC), in patients with seasonal AR (SAR).METHODS: In this phase III, double-blind, placebo-controlled trial, patients with SAR (age ≥ 12 years) were randomized to receive intranasal CIC 200 μg (n = 164) or placebo (n = 163) once daily for 28 days. Patient-assessed total nasal symptom score (TNSS), physician-assessed overall nasal signs and symptoms severity (PANS), and Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) were evaluated. Adverse events (AEs) were monitored throughout the study.RESULTS: Ciclesonide significantly improved the average of am and pm reflective TNSS and instantaneous TNSS versus placebo from Days 1 through 14 (primary endpoint) and over the 28-day treatment period (p <0.001). Furthermore, CIC showed similar improvements in both am and pm placebo-adjusted reflective TNSS, suggesting a 24-hour effect. At Day 15, CIC improved RQLQ by -1.17 ± 0.10 compared with improvement of -0.72 ± 0.10 with placebo (p = 0.002). The frequency of treatment-related AEs was low and comparable between treatment groups, and the placebo-adjusted epistaxis rate for CIC was 1.8%.CONCLUSIONS: Ciclesonide administered intranasally was superior to placebo in relieving nasal symptoms in adult and adolescent patients with SAR. Ciclesonide was well tolerated, with a safety profile comparable with placebo and a low epistaxis rate. These data support the continued clinical development of CIC nasal spray. RATIONALE: Intranasal corticosteroids are considered the most effective treatment for the management of allergic rhinitis (AR) symptoms. The objective of this study was to evaluate the efficacy and safety of a new corticosteroid in development for the treatment of asthma and AR, ciclesonide (CIC), in patients with seasonal AR (SAR). METHODS: In this phase III, double-blind, placebo-controlled trial, patients with SAR (age ≥ 12 years) were randomized to receive intranasal CIC 200 μg (n = 164) or placebo (n = 163) once daily for 28 days. Patient-assessed total nasal symptom score (TNSS), physician-assessed overall nasal signs and symptoms severity (PANS), and Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) were evaluated. Adverse events (AEs) were monitored throughout the study. RESULTS: Ciclesonide significantly improved the average of am and pm reflective TNSS and instantaneous TNSS versus placebo from Days 1 through 14 (primary endpoint) and over the 28-day treatment period (p <0.001). Furthermore, CIC showed similar improvements in both am and pm placebo-adjusted reflective TNSS, suggesting a 24-hour effect. At Day 15, CIC improved RQLQ by -1.17 ± 0.10 compared with improvement of -0.72 ± 0.10 with placebo (p = 0.002). The frequency of treatment-related AEs was low and comparable between treatment groups, and the placebo-adjusted epistaxis rate for CIC was 1.8%. CONCLUSIONS: Ciclesonide administered intranasally was superior to placebo in relieving nasal symptoms in adult and adolescent patients with SAR. Ciclesonide was well tolerated, with a safety profile comparable with placebo and a low epistaxis rate. These data support the continued clinical development of CIC nasal spray.

Ultra-Short-Course Seasonal Allergy Vaccine (Pollinex?? Quattro)

This novel ultra-short-course seasonal allergy vaccine, containing glutaraldehyde-modified allergens and the adjuvants 3-deacylated monophosphoryl lipid A (MPL) and L-tyrosine, requires a preseasonal course of only four injections to be effective in the treatment of seasonal allergic rhinitis. In patients with seasonal allergic rhinitis and/or allergic asthma, a four-injection vaccination course with either the grass pollen or tree pollen allergy vaccine significantly reduced skin prick sensitivity reactions, significantly elevated allergen-specific IgG levels and significantly reduced the seasonally induced boost of IgE. Preseasonal vaccination of adult patients with either grass pollen or tree pollen allergy vaccine significantly reduced the median combined symptom/medication score compared with placebo. Similarly, preseasonal vaccination of children and adolescents with allergies to grass pollen or tree pollen significantly reduced the global symptom and medication use scores compared with the previous pollen season. Postmarketing surveillance indicated that after a course of vaccination, 82% of patients experienced reduced symptoms and 62% reduced their rescue medication use compared with the previous season. The allergy vaccine was generally well tolerated. Local reactions, mainly injection-site redness and swelling, were more common than systemic reactions. There were no serious adverse events.

Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis

A nasal spray containing the antiallergy agent olopatadine hydrochloride is being developed for the treatment of seasonal allergic rhinitis (SAR). To evaluate the safety and efficacy of 2 concentrations of olopatadine nasal spray vs placebo in patients with SAR. This was a multicenter, randomized, double-blind, placebo-controlled study. After a 3- to 21-day placebo run-in, 565 patients aged 12 to 80 years were randomized to receive 0.4% or 0.6% olopatadine or placebo, 2 sprays per nostril twice daily for 2 weeks. Patients evaluated morning and evening reflective and instantaneous nasal symptoms (sneezing, stuffy nose, runny nose, and itchy nose, which compose the total nasal symptom score [TNSS]) and ocular symptoms and completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Olopatadine spray (0.4% and 0.6%) was significantly superior to placebo for percentage change from baseline in overall reflective (P = .004 and P < .001, respectively) and instantaneous (P = .02 and P = .003, respectively) TNSSs. Also, 0.6% olopatadine was significantly superior to placebo for reducing the reflective and instantaneous assessments of sneezing, runny and itchy nose, and itchy eyes; the instantaneous assessments of watery eyes; and the overall and all 7 domain scores of the RQLQ (P < .05). Olopatadine spray exhibited a safety profile comparable with that of placebo. Olopatadine nasal spray (0.4% and 0.6%) provided statistically significant improvements in allergic rhinitis symptoms compared with placebo regarding TNSSs (reflective and instantaneous) and in quality-of-life variables in patients with SAR. Olopatadine nasal spray administered twice daily was safe and well tolerated in adolescents and adults.

Azelastine nasal spray and desloratadine tablets in pollen-induced seasonal allergic rhinitis: a pharmacodynamic study of onset of action and efficacy

ABSTRACTObjective: To assess the efficacy and onset of action of azelastine nasal spray and desloratadine tablets in patients with allergen-induced seasonal allergic rhinitis (SAR).Research design and methods: 46 adult patients with a history of SAR were exposed to a controlled grass pollen concentration for 6 h in the Vienna Challenge Chamber (VCC) in each treatment period according to a randomised, double-blind (double-dummy), three-period, three-sequence crossover design (wash-out period of 12 days). Single doses of study medication (one puff nasal spray into each nostril of azelastine, 0.28 mg, or placebo before swallowing one encapsulated tablet of desloratadine, 5 mg) were administered 2 h after the start of the allergen challenge. Results of subjective and objective assessments were recorded throughout the challenge.Results: Efficacy of azelastine nasal spray was significantly superior compared to desloratadine tablets ( p = 0.005) and placebo ( p < 0.001). Desloratadine was significantly better than placebo ( p < 0.001). Decrease both in Major Nasal Symptom Score (MNSS) and in Total Nasal Symptom Score (TNSS) was fastest after azelastine treatment. Improvement of nasal symptom severity was most pronounced after azelastine treatment for all nasal symptoms including nasal congestion. Onset of action was 15 min for azelastine compared to 150 min for desloratadine. Both active preparations were safe and well tolerated.Conclusions: This study confirms the usefulness of azelastine nasal spray for the symptomatic treatment of seasonal allergic rhinitis. Concerning onset of action in particular, the results favour the topical treatment over systemic therapy.