Comparison of the efficacy, safety, and onset of action of mizolastine, cetirizine, and placebo in the management of seasonal allergic rhinoconjunctivitis. MIZOCET Study Group.

BACKGROUND: Mizolastine is a potent and selective H1-receptor antagonist with additional anti-allergic properties. OBJECTIVE: The aim of this European multicenter, randomized, double-blind study was to compare the efficacy of mizolastine 10 mg (n = 122), cetirizine 10 mg (n = 125), and placebo (n = 128) once daily for 28 days in patients with seasonal allergic rhinoconjunctivitis (SAR), with focus on the onset of action. METHODS: Symptoms were evaluated by the investigator using a total symptom score (TS) and by the patient (first week). Responders (R) were patients with a TS decrease of at least 50%. Safety was assessed according to the spontaneous reporting of adverse events. RESULTS: Both mizolastine and cetirizine were effective in relieving the symptoms of SAR. After 7 days of treatment, the improvement in TS and responder's rate were significantly (P < .05) greater in patients treated with mizolastine (TS change versus baseline, mean +/- SD: -6.40 +/- 5.71; R: 55%) and cetirizine (TS change versus baseline: -6.24 +/- 5.24; R: 53%) than with placebo (TS change versus baseline: -4.11 +/- 5.91; R: 40%). Both drugs acted rapidly, within 2 hours of the first intake. During the first 3 days, mizolastine relieved symptoms more effectively than cetirizine, the difference being significant on the second (P = .027) and third (P = .050) day. Both mizolastine and cetirizine were well tolerated. CONCLUSION: Mizolastine 10 mg once daily is at least as effective as cetirizine in relieving symptoms of SAR, onset of action is rapid with clinical effect evident within 2 hours.     

Mizolastine therapy also has an effect on nasal blockade in perennial allergic rhinoconjunctivitis

Background Mizolastine is a new, nonsedating antihistamine with additional anti-inflammatory properties, providing relief in allergic rhinitis and urticaria. The aim of this study was to determine the efficacy and safety of 10 mg o.d. mizolastine given to patients with perennial allergic rhinoconjunctivitis.
Methods This double-blind, placebo-controlled study involved 257 patients suffering from the disease for more than 10 years. They were allocated, after a 1-week placebo run-in, to receive mizolastine (n = 133) or placebo (n = 124) for 4 weeks.
Results Mizolastine-treated patients showed significantly greater alleviation of nasal symptoms, with a mean decrease of 36% compared with pretreatment score, compared to a mean decrease of 10% in placebo patients (P<0.001). Nasal blockade responded favorably to mizolastine compared to placebo and was associated with a significant reduction in rhinoscopy findings (P=0.030). Likewise, the mean ocular symptom score decreased 40% in mizolastine-treated patients compared to 7% in the placebo group (P<0.003). The safety profile of mizolastine was satisfactory and similar to that of placebo.
Conclusions In patients suffering from perennial allergic rhinoconjunctivitis, mizolastine is a safe and potent treatment. Mizolastine's pronounced effect on nasal blockade could possibly be linked to its anti-inflammatory properties.     

Mizolastine provides effective symptom relief in patients suffering from perennial allergic rhinitis: a double-blind, placebo-controlled study versus loratadine.

BACKGROUND: Mizolastine is a nonsedating H1 histamine receptor antagonist with additional antiallergic properties currently marketed in Europe for the treatment of seasonal and perennial allergic rhinitis (PAR) and urticaria. OBJECTIVE: This multicenter, randomized, double-blind, parallel-group study was conducted to evaluate the efficacy and safety of mizolastine in PAR compared with loratadine and placebo. METHODS: After a 1-week placebo run-in period, 428 adult PAR patients received placebo (146 of 428), mizolastine 10 mg (141 of 428), or loratadine 10 mg (141 of 428) once daily for 28 days. Symptoms were evaluated by patients and physicians using a total nasal score, evaluating itching, rhinorrhea, nasal blockade, and sneezing severity. RESULTS: Mizolastine treatment resulted in a significantly greater decrease in patient-rated total nasal score than placebo after 2 weeks (D14; -42%, P < 0.001) and at the end of the treatment period (-46%, P = 0.01), and significantly greater than that observed with loratadine at D14 (P = 0.031). No significant difference in change in total nasal score was observed between loratadine and placebo at 2- and 4-week visits. The global safety was satisfactory and the incidence of adverse events was similar in the three treatment groups. CONCLUSIONS: Mizolastine provides effective symptom relief in PAR together with a satisfactory safety profile. Improvement with mizolastine was significantly greater than placebo throughout the study despite a large placebo effect. Also mizolastine's effects were greater those observed with loratadine after 2 weeks of treatment.     

Can an antihistamine delay appearance of hay fever symptoms when given prior to pollen season?

Mizolastine is a new, nonsedating antihistamine providing satisfactory symptom relief in allergic conditions. The purpose of this study was to determine whether the onset of hay fever symptoms could be delayed in patients known to suffer seasonal allergic rhinoconjunctivitis symptoms if mizolastine was given before the pollen season. This double-blind study involved 342 patients, randomly allocated to once-daily 10 mg mizolastine ( n = 115), once-daily 120 mg terfenadine ( n = 116), or placebo ( n = 111) groups. All patients started treatment on 1 May, before the onset of the grass pollen season. The prophylactic effect of test drugs was assessed on their ability to delay the time to the first hay fever crisis of the season, which was defined by the occurrence of one of the following events: use of rescue medication, study withdrawal because of treatment failure, or total diary symptom score over 18. Active treatments prolonged the time to the first crisis by approximately 1 week (mizolastine 55 days, terfenadine 57 days) in comparison with placebo (50 days) (survival curve analysis: Logrank test, P = 0.01; Wilcoxon test, P = 0.03). Tolerability was satisfactory and comparable between groups. Thus, mizolastine can be safely used to delay and to treat symptoms of seasonal allergic rhinitis.     

Safety and efficacy of desloratadine 5 mg in asthma patients with seasonal allergic rhinitis and nasal congestion.

BACKGROUND: Antihistamines relieve most seasonal allergic rhinitis (SAR) symptoms, with the exception of nasal congestion, which is often the most troublesome symptom for patients. A nonsedating antihistamine that significantly decreases nasal congestion and improves symptoms of seasonal allergic asthma would be a significant advance in therapy. OBJECTIVES: To evaluate the safety and efficacy of desloratadine 5 mg in patients experiencing moderate SAR, nasal congestion, and symptoms of seasonal allergic asthma. METHODS: This 4-week, multicenter, parallel-group, double-blind study evaluated desloratadine treatment (5 mg once daily) versus placebo in 331 subjects with SAR and mild seasonal allergic asthma. Subjects evaluated SAR and asthma symptoms twice daily, recording 12-hour reflective and instantaneous severity evaluation scores. The primary efficacy parameter was the difference from baseline in AM/PM reflective total symptom scores. Changes in individual SAR and asthma symptoms were also analyzed. RESULTS: Compared with placebo, desloratadine significantly reduced mean AM/PM reflective total symptom scores for SAR, beginning with the first dose (P < 0.001) and continuing throughout days 1 to 15 (-4.90 vs -2.98; P < 0.001) and days 1 to 29 (-5.47 vs -3.73; P < 0.001). Desloratadine significantly decreased AM/PM reflective total asthma symptom scores for days 1 to 15 (P = 0.023) and AM/PM reflective nasal congestion scores over days 1 to 15 and days 1 to 29 (P = 0.006 and P = 0.014, respectively). Desloratadine was safe and well tolerated; adverse events were similar to placebo overall. CONCLUSIONS: Desloratadine provided significant relief from the signs and symptoms of SAR, including nasal congestion. In this patient population, symptoms of seasonal allergic asthma also improved.     

Sublingual immunotherapy with once-daily grass allergen tablets: a randomized controlled trial in seasonal allergic rhinoconjunctivitis

BACKGROUND: Specific immunotherapy is the only treatment modality that has the potential to alter the natural course of allergic diseases. Sublingual immunotherapy has been developed to facilitate access to this form of treatment and to minimize serious adverse events. OBJECTIVE: To investigate the efficacy and safety of sublingual grass allergen tablets in seasonal allergic rhinoconjunctivitis. METHODS: A multinational, multicenter, randomized, placebo-controlled trial conducted during 2002 and 2003. Fifty-five centers in 8 countries included 855 participants age 18 to 65 years who gave a history of grass pollen-induced allergic rhinoconjunctivitis and had a positive skin prick test and elevated serum allergen-specific IgE to Phleum pratense. Participants were randomized to 2500, 25,000, or 75,000 SQ-T grass allergen tablets (GRAZAX; ALK-Abelló, H?rsholm, Denmark) or placebo for sublingual administration once daily. Mean duration of treatment was 18 weeks. RESULTS: Average rhinoconjunctivitis scores during the season showed moderate reductions of symptoms (16%) and medication use (28%) for the grass allergen tablet 75,000 SQ-T (P = .0710; P = .0470) compared with placebo. Significantly better rhinoconjunctivitis quality of life scores (P = .006) and an increased number of well days (P = .041) were also observed. Efficacy was increased in the subgroup of patients who completed the recommended preseasonal treatment of at least 8 weeks before the grass pollen season (symptoms, 21%, P = .0020; and medication use, 29%, P = .0120). No safety concerns were observed. CONCLUSION: This study confirms dose-dependent efficacy of the grass allergen tablet. Although further studies are required, the greater tolerability of the tablet may permit immunotherapy to be available to a much broader group of patients with impaired quality of life caused by grass pollen allergy. CLINICAL IMPLICATIONS: For patients with grass pollen allergy, sublingual immunotherapy is well tolerated and can reduce symptoms and improve quality of life.     

Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis to mountain cedar.

BACKGROUND: A nasal spray containing the antiallergy agent olopatadine hydrochloride is being developed for the treatment of seasonal allergic rhinitis (SAR) to mountain cedar. OBJECTIVE: To evaluate the safety and efficacy of 2 concentrations of olopatadine nasal spray vs placebo nasal spray in patients with SAR to mountain cedar. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study. After a 3- to 21-day placebo run-in, 677 patients aged 12 to 81 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. RESULTS: Olopatadine spray (0.4% and 0.6%) was statistically significantly superior to placebo for percentage change from baseline in overall reflective and instantaneous TNSSs. Also, 0.6% olopatadine was statistically significantly superior to placebo for reducing the reflective and instantaneous assessments of sneezing, runny nose, itchy nose, stuffy nose, itchy eyes, and watery eyes. Olopatadine spray exhibited a safety profile comparable with that of placebo. CONCLUSIONS: Olopatadine nasal spray (0.4% and 0.6%) provided statistically significant improvements in allergic rhinitis symptoms compared with placebo regarding TNSSs and individual symptoms, including congestion, itchy and runny nose, sneezing, and itchy and watery eyes, in patients with SAR to mountain cedar. Olopatadine nasal spray administered twice daily was safe and well tolerated in adolescents and adults.     

Mizolastine

Mizolastine is a second generation antihistamine agent with high affinity and specificity for histamine H(1) receptors. Mizolastine has demonstrated antiallergic effects in animals and healthy volunteers and anti-inflammatory activity in animal models. Double-blind trials have shown mizolastine to be significantly more effective than placebo and as effective as other second generation antihistamine agents, such as loratadine or cetirizine, in the management of patients with perennial or seasonal allergic rhinitis and in patients with chronic idiopathic urticaria. Available data also suggest that prophylactic administration of mizolastine is significantly more effective than placebo and as effective as prophylactic terfenadine in delaying the onset of symptoms of seasonal allergic rhinitis. Mizolastine 10 mg/day is generally well tolerated, with the most common adverse events being drowsiness (7%), fatigue (2%), increased appetite (2%) and dry mouth (2%). In volunteers and patients the incidence of prolonged QT(c) interval was similar in mizolastine and placebo recipients, although mizolastine is contraindicated in those with cardiac disease or hepatic impairment or in those receiving erythromycin, ketoconazole or class I or III antiarrhythmic agents. Tests of psychomotor function in volunteers revealed no impairment after single doses of mizolastine 相似文献   

The efficacy and safety of fexofenadine HCl and pseudoephedrine, alone and in combination, in seasonal allergic rhinitis.

BACKGROUND: Antihistamines effectively treat seasonal allergic rhinitis (SAR), although the ability of this drug class to reduce nasal congestion is limited. Nasal decongestants effectively treat nasal congestion but not the histamine-related components of SAR. Therefore antihistamine/nasal decongestant combinations are commonly used to maximize the treatment of SAR. Fexofenadine HCl is a nonsedating, long-acting H1 receptor antagonist that provides fast and effective relief from SAR. It is well tolerated, with no sedative or cardiotoxic effects. OBJECTIVE: We sought to compare the efficacy and safety of a fexofenadine HCl/pseudoephedrine HCl combination with that of each individual component in the treatment of ragweed allergy. METHODS: In this Canadian multicenter, double-blind, parallel-group study, 651 patients allergic to ragweed were randomized to receive 60 mg of fexofenadine HCl twice daily, 120 mg of sustained-release pseudoephedrine HCl twice daily, or a combination of the 2 drugs (60 mg of fexofenadine HCl/120 mg of sustained-release pseudoephedrine HCl) twice daily for 2 weeks. Efficacy analyses were based on symptom severity. In addition, a health economic assessment was performed. RESULTS: Combination therapy was significantly more effective than pseudoephedrine alone in improving primarily histamine-mediated symptoms (sneezing; rhinorrhea; itchy nose, palate, and/or throat; and itchy, watery, red eyes) and significantly more effective than fexofenadine alone in reducing nasal congestion. Combination therapy also produced greater improvements in daily activities and work productivity compared with the individual components. No serious adverse events were reported in any of the treatment groups. In addition, no clinically significant changes in 12-lead electrocardiogram parameters, vital signs, or clinical laboratory values were observed. CONCLUSION: Combination therapy is more effective than fexofenadine alone or pseudoephedrine alone in relieving the full spectrum of SAR symptoms (ie, both the primarily histamine-related symptoms and nasal congestion).     

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

BACKGROUND: A nasal spray containing the antiallergy agent olopatadine hydrochloride is being developed for the treatment of seasonal allergic rhinitis (SAR). OBJECTIVE: To evaluate the safety and efficacy of 2 concentrations of olopatadine nasal spray vs placebo in patients with SAR. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.     

Effects of adjuvant therapy with 0.1% olopatadine hydrochloride ophthalmic solution on quality of life in patients with allergic rhinitis using systemic or nasal therapy.

BACKGROUND: Allergic rhinoconjunctivitis patients are often treated with nasal or systemic allergy therapy, forgoing therapy for ocular symptoms. This treatment regimen leaves important aspects of the allergic reaction untreated and affects quality of life (QoL). The Rhinoconjunctivitis Quality of Life Questionnaire and the Allergic Conjunctivitis Quality of Life Questionnaire quantify separate aspects of QoL. OBJECTIVE: To determine the benefit gained in QoL, measured by these questionnaires, when antiallergy eyedrops (olopatadine) were added to patients' preexisting regimens of nasal or systemic allergic rhinitis treatment. METHODS: This was a 4-week prospective, multicenter, open-label, crossover, environmental QoL study. Visit 1 randomized patients to treatment group A or B and included baseline examinations and questionnaires. Group A instilled olopatadine twice daily and concomitantly with previously prescribed nasal or systemic antiallergy medication for 2 weeks. Group B received no ocular therapy and used only previously prescribed antiallergy medication for 2 weeks. Treatment group crossover occurred at visit 2. Patients again completed the questionnaires at visits 2 and 3. RESULTS: Two hundred patients completed the study, 97 in group A and 103 in group B. Groups A and B experienced ocular allergic symptoms for 3.88 and 3.96 days, respectively, during the week before baseline. At visits 2 and 3, questionnaire scores were significantly improved for each group when olopatadine was added compared with the nontreatment periods. By visit 2, olopatadine improved QoL by 49% compared with 5% in the nontreated group (P < .001). CONCLUSIONS: In this study, 90.5% of patients with allergic rhinitis treated nasally or systemically also had ocular allergic symptoms. Adding olopatadine to these patients' medication regimens significantly improved ocular allergic symptoms and overall QoL.     

Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis.

BACKGROUND: Symptoms of allergic rhinitis are mediated in part by cysteinyl leukotrienes. OBJECTIVE: To evaluate the clinical benefit of montelukast, a cysteinyl leukotriene receptor antagonist, administered once daily for treating seasonal allergic rhinitis. METHODS: This multicenter, randomized, double-blind, placebo- and active-controlled study enrolled 1,214 healthy, nonsmoking outpatients aged 15 to 85 years with spring allergic rhinitis, positive skin test to a spring allergen, and predefined daytime nasal symptoms. After a 3- to 5-day placebo run-in period, patients were randomly assigned to treatment with montelukast 10 mg (n = 522), loratadine 10 mg (n = 171), or placebo (n = 521) once daily at bedtime for 2 weeks. During the run-in and treatment periods, symptoms were evaluated in a daily diary using a 0 (best) to 3 (worst) scale. RESULTS: Baseline characteristics of randomized patients were clinically similar in the three treatment groups. Montelukast was significantly more effective than placebo (P = 0.003) in improving the daytime nasal symptoms score (difference in least square means, -0.09; 95% confidence interval, -0.16, -0.03) averaged over 2 weeks of therapy. The treatment effect of montelukast was significantly greater (P < 0.05), relative to placebo, for all secondary endpoints, including nighttime symptoms and daytime eye symptoms, patient and physician global evaluations of allergic rhinitis, and rhinoconjunctivitis quality of life. Loratadine, which served as a positive control, was significantly more effective than placebo for most endpoints, validating the study results. Both montelukast and loratadine were well tolerated. CONCLUSION: Therapy with montelukast significantly improves assessments of symptom severity as well as quality-of-life parameters for patients with seasonal allergic rhinitis.     

Olopatadine ophthalmic solution adjunctive to loratadine compared with loratadine alone in patients with active seasonal allergic conjunctivitis symptoms.

BACKGROUND: Olopatadine ophthalmic solution 0.1% (Patanol, Alcon Laboratories, Fort Woth, TX) is approved for the treatment of the signs and symptoms of allergic conjunctivitis. Loratadine 10 mg (Claritin, Schering-Plough, Madison, NJ) is a nonsedating oral antihistamine approved for the treatment of the signs and symptoms of allergic rhinitis. OBJECTIVE: To compare the efficacy of olopatadine used adjunctively with loratadine versus loratadine alone in patients with seasonal allergic conjunctivitis. METHODS: This three-center, observer-masked, treatment-controlled, randomized, parallel-group study involved patients aged 7 to 74 years with seasonal allergic conjunctivitis. Patients were treated for 7 days with either olopatadine twice daily adjunctive to loratadine once daily or only loratadine once daily. Efficacy variables (ocular itching and redness, physician's impression, patient's impression, patient diary ratings of ocular redness and itching), and safety parameters were evaluated during the screening visit and on days 0, 3, and 7. Patients completed the rhinoconjunctivitis quality of life questionnaire on days 0 and 7. RESULTS: Ninety-four patients received study drug. Patients receiving olopatadine twice daily in addition to loratadine once daily exhibited less ocular itching (P = 0.0436) and rated their ocular condition as more improved compared with those receiving loratadine alone (P < 0.0022). Twenty minutes after initial dosing, olopatadine plus loratadine relieved ocular itching and redness significantly better than loratadine alone (P = 0.001). Both treatment groups showed clinically meaningful improvements in overall quality of life in all but one of the rhinoconjunctivitis quality of life questionnaire domains. Overall, and in most domains, olopatadine plus loratadine also provided significantly better (P < 0.05) quality of life than loratadine alone at day 7. CONCLUSIONS: Compared with loratadine alone, olopatadine adjunctive to loratadine provides greater relief of ocular itching and redness, a better quality of life, and is well tolerated in patients with seasonal allergic conjunctivitis.     

Prevalence and severity of asthma and allergies in schoolchildren in Lhasa, Tibet

BACKGROUND: The International Study of Asthma and Allergies in Childhood (ISAAC) demonstrated that large variations existed in the prevalence of symptoms of asthma, allergic rhinoconjunctivitis and eczema throughout the world and that environmental factors and lifestyle customs are major determinants of the prevalence and severity of these diseases. However, the relevant data about children living at high-altitude locations were considered to be underreported. OBJECTIVE: The ISAAC Phase III programme was carried out in Lhasa, the Tibetan Autonomous Region in China, at an elevation of 3658 m above sea level to examine the occurrence of asthma, allergic rhinoconjunctivitis and eczema in schoolchildren aged 13-14 years. METHODS: All 3196 schoolchildren in eight public junior high schools in urban Lhasa who were confirmed to be 13-14 years old were invited and participated in both written and video questionnaire investigations, among which 3190 pieces of data (49.8% of boys and 50.2% of girls) were validated and analysed. RESULTS: Among the overall observations, the prevalence of 'having ever experienced wheezing', 'current wheezing' and 'diagnosed to have asthma' was 1.4%, 0.8% and 1.1%, respectively. The prevalence of current exercise-induced asthma and current nocturnal cough was 7.1% and 4.6%, respectively. The current prevalence of allergic rhinoconjunctivitis and eczema was 5.2% and 0.4%, respectively. In addition, the prevalence of rhinoconjunctivitis symptoms during the past 12 months showed no discernable differences throughout the year. CONCLUSION: The prevalence of asthma, allergic rhinoconjunctivitis and eczema over the past 12 months was the lowest among the centres, that performed ISAAC worldwide.     

Specific immunotherapy with SQ standardized grass allergen tablets in asthmatics with rhinoconjunctivitis

BACKGROUND: The best way to prevent allergy symptoms is to treat the allergic condition. Specific immunotherapy with grass allergen tablets 75,000 SQ-T (Grazax, Phleum pratense, ALK-Abelló) is safe and efficacious in rhinoconjunctivitis patients. As rhinoconjunctivitis often co-exists with asthma, we aimed to confirm safety and efficacy in grass allergic subjects with asthma and rhinoconjunctivitis. METHODS: A randomized, double-blind, placebo-controlled, multicentre trial was performed 10-14 weeks prior to and during the grass pollen season 2004. About 114 subjects were randomized 2 : 1 to grass allergen tablets or placebo. The primary end points were average asthma medication and symptom scores during the grass pollen season, and secondary variables were average rhinoconjunctivitis symptom and medication scores during the grass pollen season. Additionally, number of well days was defined post hoc. RESULTS: Differences in asthma medication and symptom scores between the treatment groups were negligible. The mean difference in asthma medication score was below 0.1 and 0.3 for asthma symptom score [a single inhalation of salbutamol (200 microg) was scored 2]. No serious adverse events were reported. A reduction in rhinoconjunctivitis symptom score of 37% (P = 0.004) and a 41% (P = 0.036) reduction in medication score was found in the grass pollen season for subjects treated with the grass allergen tablet compared with placebo. Well days increased by 54% (P = 0.002). CONCLUSIONS: Self-administration of the grass allergen tablet was safe. The treatment did not impair asthma control and confirmed considerable symptom prevention and reduced medication use. It addresses the allergic condition and represents a baseline treatment for grass pollen allergy.     

Fluticasone furoate nasal spray: a single treatment option for the symptoms of seasonal allergic rhinitis

BACKGROUND: Fluticasone furoate (USAN-approved name) is a novel, enhanced-affinity glucocorticoid administered in a unique side-actuated device for the management of seasonal allergic rhinitis (SAR). OBJECTIVE: We sought to evaluate the efficacy and safety of once-daily fluticasone furoate nasal spray, 110 microg, in patients aged 12 years or older with fall SAR. METHODS: Patients (n = 299) received fluticasone furoate or placebo for 2 weeks in this double-blind, parallel-group randomized study. Patients evaluated nasal and ocular symptoms using a 4-point categoric scale. Efficacy was assessed on the basis of the mean change from baseline in reflective and instantaneous total nasal symptom scores and reflective total ocular symptom scores. RESULTS: Fluticasone furoate produced significantly greater improvements than placebo in daily reflective total nasal symptom score (-1.473, P < .001; primary end point), morning predose instantaneous total nasal symptom score (-1.375, P < .001), daily reflective total ocular symptom score (-0.600, P = .004), and patient-rated overall response to therapy (P < .001). The onset of therapeutic effect occurred at 8 hours after initial administration. Fluticasone furoate was well tolerated. CONCLUSION: Fluticasone furoate, 110 microg once daily, was effective and well tolerated for the treatment of nasal symptoms of SAR in patients aged 12 years and older. Treatment also produced significant improvements in ocular symptoms. Fluticasone furoate was fast acting, as indicated by an 8-hour onset of action, and provided 24-hour symptom control. CLINICAL IMPLICATIONS: New treatments for the bothersome symptoms of SAR are needed. One such treatment, fluticasone furoate nasal spray, provides effective relief of the symptom profile of SAR.     

The effect of natural pollen exposure on eosinophil apoptosis and its relationship to bronchial hyperresponsiveness in patients with seasonal allergic rhinitis.

BACKGROUND: Limited data suggest that there is increased eosinophilic inflammation in the airways of patients with seasonal allergic rhinitis (SAR) during pollen season even if they do not have asthma. OBJECTIVE: To investigate the effect of natural pollen exposure on inflammatory cells and apoptosis of eosinophils and its association with bronchial hyperresponsiveness (BHR) during and out of pollen season in SAR patients sensitized to only grass pollens. METHODS: Forty SAR patients and 10 patients with nonallergic rhinitis (NAR) from Ankara, Turkey, were recruited to participate in the study. Two induced sputum samples were taken from SAR patients during pollen season (May-June) and out of pollen season (November-January), but only 1 induced sputum sample was taken from NAR patients. Slides of induced sputum were evaluated by 2 cytologists with the use of light microscopy after cytocentrifuged and dyed with May-Grünwald-Giemsa stain. Induced sputum samples were sufficient for differential cell counts in 14 SAR and 7 NAR patients. RESULTS: Eosinophil counts in SAR patients were statistically higher in pollen season (19.4% +/- 16.2%) compared with out of season (4.6% +/- 6.9%, P = .003) and with NAR patients (4.7% +/- 9.5%, P = .01). The apoptotic eosinophil counts in SAR patients were statistically higher out of pollen season (3.0% +/- 4.5%) than in pollen season (0.38% +/- 0.80%, P = .02) and higher than those of NAR patients (0.14% +/- 0.26%, P = .005). The apoptotic ratio was statistically higher after pollen season compared with pollen season (0.720% +/- 0.394% vs 0.044% +/- 0.116%, P = .002). Blood eosinophil counts of SAR patients were increased during the pollen season (364 +/- 187/mm3) compared with out of season (278 +/- 219/mm3, P = .04) and with NAR patients (85 +/- 54/mm3, P = .001). The number of SAR patients who had BHR during the pollen season (7/14) was higher than the number who had BHR out of season (2/14, chi2 = 4.2, P = .04). CONCLUSION: Our data indicate that changes in eosinophil counts and eosinophil apoptosis may be related to the changes of natural pollen exposure and seasonal changes of BHR in SAR patients.     

Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients

Background: Bilastine is a novel, nonsedating H₁‐antihistamine developed for symptomatic treatment of Allergic Rhinitis and Chronic Idiopathic Urticaria. The objective of this study was to compare the efficacy and safety of bilastine 20 mg vs placebo and desloratadine 5 mg in subjects with seasonal allergic rhinitis (SAR). Methods: This randomized, double blind, placebo‐controlled, parallel‐group multicentre study evaluated the effect of 2 weeks’ treatment with bilastine 20 mg, desloratadine 5 mg or matched placebo once daily, in 12–70 years old symptomatic SAR patients. All subjects assessed the severity of nasal (obstruction, rhinorrhoea, itching, and sneezing) and nonnasal (ocular itching, tearing, ocular redness, itching of ears and/or palate) symptoms on a predetermined scale to provide a total symptom score (TSS), composed of nasal and nonnasal symptom scores (NSS and NNSS, respectively). The primary efficacy measure was the area under the curve (AUC) for the TSS over the entire treatment period. Results: Bilastine 20 mg significantly reduced the AUC of TSS to a greater degree from baseline compared to placebo (98.4 with bilastine vs 118.4 with placebo; P < 0.001), but not compared to desloratadine 5 mg (100.5). Bilastine 20 mg was not different from desloratadine 5 mg but significantly more effective than placebo in improving the NSS, NNSS, and rhinitis‐associated discomfort scores (P < 0.05), and rhinoconjunctivitis quality of life questionnaire total (P < 0.005) and four out of seven individual domain (P < 0.05) scores. The incidence of treatment emergent adverse events was similar for bilastine (20.6%), desloratadine (19.8%), and placebo (18.8%). Conclusion: Bilastine 20 mg once daily was efficacious, safe and not different from desloratadine 5 mg once daily in the treatment of SAR symptoms.     

Prevalence and risk factors for allergic rhinitis and atopic eczema among schoolchildren in Israel: results from a national study.

BACKGROUND: There is growing evidence that the prevalence rates of asthma and allergic diseases are increasing, especially among children. Several risk factors are under investigation. OBJECTIVE: To evaluate the prevalence and risk factors for allergic diseases, including allergic rhinitis (AR) and atopic eczema (AE), among 13- to 14-year-old schoolchildren in Israel. METHODS: A modified version of the International Study of Asthma and Allergies in Childhood written questionnaire was administered to a national sample of schoolchildren 13 to 14 years old in Israel. The questionnaire was completed by the schoolchildren themselves. RESULTS: There were 10,057 complete questionnaires available for analysis. The prevalence of AR symptoms ever and current AR were 41.6% and 9.4%, respectively. Allergic rhinoconjunctivitis symptoms ever were reported by 15.8% of the children. The prevalence rates of 6 months of itchy rash ever and AE were 5.9% and 7.8%, respectively. After adjustment for demographic and environmental factors, current asthma, parental history of asthma, and population group were the most significant risk factors for current AR (odds ratio [OR], 4.47; 95% confidence interval [CI], 3.70-5.40; OR, 1.30; 95% CI, 1.02-1.66; and OR, 1.75; 95% CI 1.45-2.13; respectively) and AE (OR, 2.30; 95% CI, 1.80-2.90; OR, 1.80; 95% CI, 1.40-2.30; and OR, 1.70; 95% CI, 1.40-2.00; respectively). CONCLUSIONS: Israeli children have a low prevalence rate of current AR and a midrange rate of AE. Arabs have lower prevalence rates of allergic diseases than Jews, and the prominent risk factors for those diseases are current asthma and parental history of asthma.     

Efficacy of cetirizine in the treatment of seasonal allergic rhinoconjunctivitis

The efficacy of cetirizine, 10 mg once daily, in the treatment of seasonal allergic rhinoconjunctivitis was evaluated in a double-blind placebo-controlled trial. Sixteen patients monosensitized to olive pollen were treated simultaneously for 6 weeks, including one pollen season. Severity of symptoms and rescue drug consumption were significantly lower in the cetirizine group.