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.     

Effects of monotherapy with intra-nasal corticosteroid or combined oral histamine and leukotriene receptor antagonists in seasonal allergic rhinitis

BACKGROUND: The combination of a leukotriene receptor antagonist with an antihistamine may have beneficial effects in seasonal allergic rhinitis (SAR). OBJECTIVE: To determine how combined oral mediator blockade compares to monotherapy with intranasal corticosteroid in the treatment of SAR. METHODS: Twenty-two patients with seasonal allergic rhinitis were enrolled in a placebo controlled crossover study comparing 2 weeks therapy of either (a) 200 microg intranasal mometasone furoate (MF) once daily or (b) 10 mg oral montelukast plus 10 mg oral cetirizine once daily (MON/CZ), with a 7-10 day placebo period prior to each treatment period. Domiciliary measures of symptoms and nasal flow were recorded daily. Measurements of posterior rhinomanometry, acoustic rhinometry and nasal nitric oxide were made after all treatment and placebo periods. RESULTS: There were significant (P < 0.05) improvements in domiciliary peak nasal flow (l/min) with both MF (133 (3.8)) and MON/CZ (124 (3.8)) compared to pooled placebo (110 (4.0). Both treatments also showed significant improvement in terms of nasal blockage (units) (PL: 1.1(0.1), MF: 0.5 (0.1), MON/CZ 0.7 (0.1); and total nasal symptoms (units) (PL: 3.5 (0.3), MF 1.6 (0.3), MON/CZ 1.7 (0.3)), although there was no significant difference between the two active treatments. There were no significant differences between placebo and treatment for rhinomanometry, acoustic rhinometry or nitric oxide. CONCLUSIONS: Both intranasal mometasone furoate as monotherapy and oral cetirizine plus montelukast as cotherapy were equally effective for objective and subjective measures of treatment response in SAR. Domiciliary measurements of symptoms and peak flow were more sensitive than laboratory measurements of rhinomanometry, acoustic rhinometry and nasal nitric oxide.     

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.     

Nasal allergies and beyond: a clinical review of the pharmacology, efficacy, and safety of mometasone furoate

Mometasone furoate nasal spray (MFNS; Nasonex^®, Schering-Plough Corporation, Kenilworth, NJ, USA) is an effective and well-tolerated intranasal corticosteroid approved for the prophylactic treatment of seasonal allergic rhinitis, and the treatment of perennial allergic rhinitis. MFNS is a potent molecule with a rapid onset of action and excellent safety and efficacy profiles. Having recently received approval for the treatment of nasal polyposis, data indicate that MFNS may also be effective in rhinosinusitis.     

Once-daily mometasone furcate aqueous nasal spray (Nasonex™) in seasonal allergic rhinitis: an active- and placebo-controlled study

Mometasone furoate aqueous nasal spray (Nasonex™) was compared with beclomethasone dipropionate (BDP) aqueous nasal spray in a double-blind, randomized, placebo-controlled, double-dummy, parallel-group study of adults with moderate to severe seasonal allergic rhinitis. Patients allergic to at least one tree and/or grass aeroallergen received one of the following regimens for up to 4 weeks: mometasone furoate 100 μg once daily [OD] ( n = 126) or 200 μg OD ( n = 126), BDP 200 μg twice daily ( n = 126), or only placebo spray ( n = 123). Physician-rated nasal and total symptom scores, and global evaluation of overall condition and therapeutic response by physicians and patients, showed that the three active treatments were equally effective, and all three were significantly superior to placebo at most time points. Overall, mometasone furoate 200 μg OD demonstrated somewhat greater numerical, but not statistical, superiority to mometasone furoate 100 μg OD at the earliest evaluation time point. At the end of treatment, complete or marked relief was obtained in 77% of patients with mometasone furoate 100 μg/day, 79% with mometasone furoate 200 μg/day, and 74% with BDP, compared with 54% of placebo vehicle control patients. Mometasone furoate and BDP were equally well tolerated. It was concluded that mometasone furoate adequately controls symptoms of moderate to severe seasonal allergic rhinitis, offers the advantage of OD treatment, and is well tolerated.     

The effectiveness of intranasal corticosteroids in combined allergic rhinitis and asthma syndrome

Background Allergic rhinitis (AR) and asthma often coexist and may represent two manifestations of the same disease recently named combined AR and asthma syndrome (CARAS). Aim To review the common pathophysiology of combined AR and asthma and to investigate the efficacy of intranasal corticosteroids (INCS). Methods Medline was used to identify articles relevant to mechanisms. A Cochrane systematic review was performed to assess the efficacy of INCS in CARAS. Results There is cross‐talk, evidence of a common inflammatory response in both sites, linked by a systemic component. The efficacy of anti‐inflammatory INCS on asthma outcomes was assessed in a systematic review of 12 randomized controlled trials involving 425 subjects. After INCS there were non‐significant trends for improvement in asthma symptom score (standardized mean difference (SMD) of 0.61; P=0.07), forced expiratory volume in 1 s (SMD of 0.31; P=0.08), and morning peak expiratory flow (weighted mean difference of 36.51; P=0.06). There was no impact on methacholine airways responsiveness (SMD of ?0.20; P=0.4). The review identified two promising new treatment options in united airway disease such as INCS as monotherapy in rhinitis and mild asthma, and a combined intranasal and intrabronchial corticosteroid (IBCS) deposition technique. Conclusion Common mucosal inflammatory responses occur in CARAS. This systematic review shows trends for a benefit of INCS in CARAS, but recognizes that more research is needed. At this stage, the current best practice is to treat asthma conventionally with IBCS with or without β₂‐agonist and to add INCS to improve specific rhinitis symptoms.     

Obtaining concomitant control of allergic rhinitis and asthma with a nasally inhaled corticosteroid

Allergic rhinitis (AR) and asthma coexist frequently and a dual treatment is recommended by prescribing topical nasal plus oral inhaled corticosteroids. The purpose of this study was to assess the efficacy of a nasally inhaled corticosteroid aiming at concomitant control of AR and asthma. A controlled trial was conducted among 60 patients with AR and asthma, aged 6-18 years, who were randomized into two groups. During 8 weeks, the experimental group (30 patients) received exclusively fluticasone propionate hydrofluoroalkane (FP-HFA) inhaled through the nose (mouth closed) using a large volume spacer attached to a face mask. The comparison group (30 patients) received a nasal spray of isotonic saline plus oral inhalation of FP-HFA through a mouthpiece attached to the same spacer. Clinical scores for AR and asthma, nasal inspiratory peak flow (NIPF), and spirometry were assessed by blinded observers. There was a significant improvement in AR scores and NIPF in the experimental group (P or= 0.20). Prebronchodilator FEV(1) (% predicted value) improved by 10% in both groups, comparing values at inclusion with those obtained at the end of follow up. Our results suggest that nasally inhaled FP-HFA through a spacer may control AR and asthma in children and adolescents. This approach is likely to result in higher compliance, lower costs, and fewer side effects.     

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.     

Characteristics of patients with seasonal allergic rhinitis and concomitant asthma

BACKGROUND: Allergic rhinitis and asthma often co-exist and appear to produce a continuum of airway disease, but whether the clinical characteristics of asthma in patients with seasonal rhinitis differ from those of persistent asthma has not been examined. OBJECTIVE: The aim of this retrospective study was to characterize the clinical features of patients with seasonal allergic rhinitis with concomitant asthma and to compare them with those in patients with persistent asthma. METHODS: The patient populations for this study were derived from nine prospective, placebo-controlled planned clinical trials of similar design. Six studies (958 patients) enrolled patients with seasonal allergic rhinitis and concomitant asthma; three (607 patients) involved patients with persistent asthma. In all studies, patients were excluded from oral corticosteroid therapy in the preceding 3 months, and from inhaled corticosteroids in the preceding month. RESULTS: Patients with seasonal rhinitis and asthma had a significantly (P<0.001) higher total asthma symptom score than those with persistent asthma. In particular, cough was three times more severe. The need for beta(2)-agonist as a rescue medication and the ratio of forced expiratory volume in 1 s/forced vital capacity (FVC) were similar in the two groups whereas forced expiratory fraction 25-75%/FVC was significantly (P<0.02) reduced in the persistent asthmatics. Asthma and nasal symptom severity scores were correlated in patients with seasonal rhinitis and asthma (P<0.0001). CONCLUSIONS: Patients with seasonal allergic rhinitis and concomitant asthma appear to differ from those with persistent asthma. A prospective study should be designed to discover whether patients with seasonal rhinitis and asthma may represent a distinct nosological entity, 'allergic airway disease'.     

A comparison of topical budesonide and oral montelukast in seasonal allergic rhinitis and asthma

BACKGROUND: Allergic rhinitis and asthma commonly coexist and are both mediated by similar inflammatory mechanisms. Leukotriene antagonists may therefore be an alternative to corticosteroid therapy. OBJECTIVE: To compare oral montelukast with inhaled plus intranasal budesonide in patients with seasonal allergic rhinitis and asthma. PATIENTS AND METHODS: A single-blind double-dummy placebo-controlled crossover study was performed comparing once daily 10 mg oral montelukast with 400 microg inhaled plus 200 microg intranasal budesonide in 12 patients with allergic rhinitis and asthma: mean (S.E.) age 34.0 years (2.7), forced expiratory volume in 1 s (FEV1) 91.2 (3.8)% predicted. Each treatment was for 2 weeks with a 1-week placebo run-in and washout. Measurements were made after each active treatment and placebo for: adenosine monophosphate bronchial challenge, exhaled and nasal nitric oxide. Patients also recorded their domiciliary peak expiratory flow, nasal peak inspiratory flow, asthma and seasonal allergic rhinitis symptoms. RESULTS: There were no significant differences between the placebos for any measurement. For adenosine monophosphate PC20, geometric mean fold differences (95% confidence interval (CI) for difference) were 6.4 (2.2-18.6) for placebo vs. budesonide, 2.9 (1.0-8.4) for placebo vs. montelukast, and 2.1 (1.1-4.5) for budesonide vs. montelukast. For exhaled nitric oxide (p.p.b.) there was significant (P < 0.05) suppression with both montelukast (10.9) and budesonide (10.1) compared with placebo (18.8). For nasal nitric oxide and nasal peak flow there were only significant differences with budesonide compared with placebo. Both treatments reduced total seasonal allergic rhinitis symptoms but only budesonide had a significant effect on nasal symptoms. CONCLUSION: Once-daily inhaled plus intranasal budesonide and once daily montelukast showed comparable efficacy on lower airway, but only the budesonide had significant efficacy on upper airway inflammatory markers. Both treatments significantly reduced allergic rhinitis symptoms.     

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.     

Combination of omalizumab and specific immunotherapy is superior to immunotherapy in patients with seasonal allergic rhinoconjunctivitis and co-morbid seasonal allergic asthma

Background The treatment of allergic asthma by specific immunotherapy (SIT) is hampered by potential side-effects.
Objective The aim of this study was to study the effect of omalizumab, a monoclonal anti-IgE antibody, in combination with SIT in patients with seasonal allergic rhinoconjunctivitis (SAR) and co-morbid seasonal allergic asthma (SAA) incompletely controlled by conventional pharmacotherapy.
Methods A randomized, double-blind, placebo-controlled, multi-centre trial was performed to assess the efficacy and safety of omalizumab (Xolair^®) vs. placebo in combination with depigmented SIT (Depigoid^®) during the grass pollen season. Omalizumab or placebo was started 2 weeks before SIT; the whole treatment lasted 18 weeks. Primary endpoint was daily 'symptom load', the sum of daily scores for symptom severity and rescue medication use.
Results A total of 140 patients (age 11–46 years) were randomized; and a total of 130 finished the study. Combination therapy reduced the symptom load by 39% ( P =0.0464, Wilcoxon test) over SIT monotherapy. This difference was mainly due to reduced symptom severity ( P =0.0044), while rescue medication use did not change significantly. Combination therapy also improved asthma control (Asthma Control Questionnaire, P =0.0295) and quality of life in the case of asthma (Asthma Quality of Life Questionnaire, P =0.0293) and rhinoconjunctivitis (Rhinoconjunctivitis Quality of Life Questionnaire, P =0.0537). Numbers of patients with 'excellent or good' treatment efficacy according to ratings of investigators (75.0% vs. 36.9%) or patients (78.5% vs. 46.1%) were markedly higher in the combination group than under SIT alone.
Conclusion Combination of omalizumab with SIT for treatment of patients with SAR and co-morbid SAA was safe and reduced the symptom load in a statistically significant and clinically meaningful manner.     

Airway function and nasal inflammation in seasonal allergic rhinitis and asthma

BACKGROUND: Allergic rhinitis (AR) and asthma are frequently associated and characterized by a Th2-dependent inflammation. Nasal and bronchial obstruction may be objectively measured. OBJECTIVE: The aim of this study was to evaluate the relationships among upper and lower airway function and nasal inflammation in subjects with seasonal allergic rhinitis (SAR) and asthma. METHODS: Twenty out-patients (12 males and eight females, mean age: 23.4+3.6 years) with SAR and asthma were evaluated during the pollen season. All of them showed a moderate-severe grade of nasal obstruction. Total symptom score, rhinomanometry, spirometry, nasal lavage, and nasal scraping were obtained in all subjects. Eosinophils were counted by conventional staining; IL-4 and IFN-gamma were measured by immunoassay on fluids recovered from nasal lavage. RESULTS: Functional parameters, i.e. nasal airflow and forced expiratory volume in 1 s (FEV(1)), were correlated with nasal eosinophils (R(2)>0.83, P<0.001). Inflammatory parameters, i.e. eosinophils were correlated with immunological parameters, i.e. IL-4 and IFN-gamma levels (R(2)=0.93, P<0.001). Nasal symptoms were correlated with nasal airflow (rho=-0.71, P< or =0.01) and eosinophils (rho=0.72, P<0.01). Nasal airflow was correlated with FEV(1) (r=0.89, P<0.0001). CONCLUSIONS: This study demonstrates the close connection between Th2 cytokines and eosinophil infiltration in the nose. There is also clear evidence concerning the relationships between eosinophils infiltration and cytokines levels. Nasal eosinophils can be regarded as the most important predictors of upper and lower airway functions. These findings constitute first evidence of a relationship among nasal Th2-related inflammation and nasal and bronchial airflow in patients with SAR and asthma.     

Impact of intranasal corticosteroids on asthma outcomes in allergic rhinitis: a meta‐analysis

Given the relationship between allergic rhinitis (AR) and asthma, it can be hypothesized that reducing inflammation in the upper airway with intranasal corticosteroid (INCS) medications may improve asthma outcomes. The goal of this study was to perform a systematic review with meta‐analysis of the efficacy of INCS medications on asthma outcomes in patients with AR and asthma. Asthma‐specific outcomes from randomized, controlled studies evaluating INCS medications in patients with AR were evaluated, including studies that compared INCS sprays to placebo, INCS sprays plus orally inhaled corticosteroids to orally inhaled corticosteroids alone, and nasally inhaled corticosteroids to placebo. Sufficient data for meta‐analysis were retrieved for 18 trials with a total of 2162 patients. Asthma outcomes included pulmonary function, bronchial reactivity, asthma symptom scores, asthma‐specific quality of life, and rescue medication use. The subgroup of studies comparing INCS spray to placebo had significant improvements in FEV1 (SMD = 0.31; 95% CI, 0.04–0.58), bronchial challenge (SMD = 0.46; 95% CI, 0.12–0.79), asthma symptom scores (SMD = −0.42; 95% CI, −0.53 to −0.30), and rescue medication use (SMD = −0.29; 95% CI, −0.58 to −0.01). Nasal inhalation of corticosteroids significantly improved morning and evening peak expiratory flow. There were no significant changes in asthma outcomes with the addition of INCS spray to orally inhaled corticosteroids. Thus, the results of this meta‐analysis demonstrated that intranasal corticosteroid medications significantly improve some asthma‐specific outcome measures in patients suffering from both AR and asthma. This effect was most pronounced with INCS sprays when patients were not on orally inhaled corticosteroids, or when corticosteroid medications were inhaled through the nose into the lungs. Overall, intranasal corticosteroid medications improve some asthma‐specific outcome measures in patients with both AR and asthma. Further research is needed to clarify the role of INCS sprays as asthma‐specific therapy, as well as the role of the nasal inhalation technique as a monotherapy in patients suffering from both asthma and AR.

     

Allergic rhinitis and asthma comorbidity: ARIA classification of rhinitis does not correlate with the prevalence of asthma

BACKGROUND: Allergic rhinitis and asthma comorbidity is supported by both the similar underlying pathogenesis and immunologic mechanisms. The aim of this study was to verify whether the characteristics of rhinitis classified according to the new Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines correlate with the prevalence of asthma. METHODS: From 1 March to 30 June 2002, a multi-centre cross-sectional study was conducted by 154 allergists chosen from throughout Italy. Duration, severity of rhinitis (according to the ARIA classification) and the type of allergic sensitizations were compared with the prevalence of asthma. RESULTS: One thousand three hundred and twenty-one consecutive rhinitis-allergic patients aged 18 years or older were enrolled for the study. The majority of patients, 1060 (80.24%), were on medication at the time of their specialist visit. Mild intermittent rhinitis was diagnosed in 7.7% of patients, moderate/severe intermittent in 17.1%, mild persistent in 11.6%, and moderate/severe persistent in 63.6%. The prevalence of asthma was 48% in patients with mild intermittent rhinitis, 49.6% in moderate-severe intermittent rhinitis, 36.6% in mild persistent rhinitis and 47.5% in moderate severe persistent patients. No correlation between the ARIA categories of rhinitis and the prevalence of asthma was found. A multivariate analysis, after adjustment for age, sex, type of sensitization, level of severity and duration of rhinitis classified according to the ARIA guidelines, demonstrated that age, over 41 years [risk ratio (RR) 1.260, 95% confidence interval (CI) 1.072-1.482] and especially over 51 years (RR 1.460, 95% CI 1.237-1.723), sensitization to indoor allergens (mite and cat), (RR 1.203, 95% CI 1.060-1.366), and polysensitization (RR 1.178, 95% CI 1.004-1.383) are significant risk factors for asthma. CONCLUSION: In allergic rhinitis (AR) patients referred to a specialist, the features of AR as defined by the ARIA classification are not able to predict the presence of asthma, therefore all such patients should be assessed for asthma.     

Therapeutic points of intervention and clinical implications: role of desloratadine

Desloratadine, a potent, once-daily, orally active, nonsedating, histamine H₁-receptor antagonist, inhibits the release of histamine and other inflammatory mediators. Once-daily desloratadine therapy rapidly reduces the symptoms of perennial allergic rhinitis and seasonal allergic rhinitis (SAR), reduces the use of inhaled albuterol by patients with SAR and concomitant asthma, and improves symptoms and quality of life in patients with chronic idiopathic urticaria. An open-label, observational study in SAR patients revealed that desloratadine therapy significantly reduced nasal, ocular, dermal, asthma, and total symptoms, and enabled half of the patients with concomitant asthma to reduce their use of asthma medications. Globally, more than 91% of patients and physicians judged desloratadine to have excellent or good efficacy, and more than 98% judged it to have excellent or good tolerability. Furthermore, desloratadine therapy improved quality of life, decreasing by more than 10-fold the percentage of patients whose daily activities and/or sleep were moderately or severely affected by SAR. Allergic rhinitis, a major chronic airway disease that is a risk factor for asthma, warrants extended diagnostic procedures and well-tolerated therapy that encompasses the entire airway, addresses multiple steps in the allergic inflammatory cascade, and is effective on nasal, ocular, dermal, asthma, and total symptoms.     

Efficacy of mometasone furoate nasal spray in the treatment of allergic rhinitis. Meta-analysis of randomized, double-blind, placebo-controlled, clinical trials

Rationale: Several randomized, double‐blind, placebo‐controlled clinical trials have demonstrated the efficacy of mometasone furoate nasal spray (MFNS) in the treatment of allergic rhinitis (AR) thus allowing for a meta‐analysis to determine the overall treatment effect. Methods: A comprehensive search of the MEDLINE, LILACS, SCOPUS, and the Cochrane Library databases up to 31 October, 2007 was carried out. Randomized, double‐blind, placebo‐controlled, clinical trials evaluating the efficacy of MFNS in patients with AR compared to placebo were included. Total nasal symptom scores (TNSS), individual nasal symptoms, total non‐nasal symptom scores (TNNSS) and nasal airflow were analysed as the standardized mean difference (SMD). Meta‐analysis was performed with the random or the fixed effect models depending on heterogeneity, by using revman 5 software. Data synthesis: Sixteen of the 113 identified articles met the inclusion criteria. For MFNS efficacy on TNSS, 2998 participants were analysed: 1534 received MFNS and 1464 placebo. Mometasone furoate nasal spray was associated with a significant reduction in TNSS (SMD ?0.49, 95% CI: ?0.60 to ?0.38; P < 0.00001; I² = 50.1%). A significant effect on SMD for nasal stuffiness/congestion (?0.41; 95% CI: ?0.56 to ?0.27), rhinorrhoea (?0.44; 95% CI: ?0.66 to ?0.21), sneezing (?0.40; 95% CI: ?0.57 to ?0.23) and nasal itching (?0.39; 95% CI: ?0.53 to ?0.25) was also demonstrated. Mometasone furoate nasal spray treated subjects also showed a significant reduction in TNNSS (?0.30; 95% CI: ?0.43 to ?0.18). The proportion of patients with adverse events was similar for MFNS and placebo (0.99; 95% CI: 0.81–1.20; P = 0.91). Conclusions: This meta‐analysis provides a level Ia evidence for the efficacy of MFSN in the treatment of AR vs placebo. Adverse events frequency was similar in both groups.