mometasone-furoate and Rhinitis--Allergic--Perennial

Data comparing the treatment effect of allergy immunotherapy and pharmacotherapy are lacking.. We sought to indirectly compare the treatment effect of sublingual immunotherapy (SLIT)-tablets with pharmacotherapy for seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).. Pooled data from randomized, double-blind, placebo-controlled trials for the clinical development programs of selected allergic rhinitis treatments were evaluated. Total nasal symptom scores (TNSSs) relative to placebo were compared. Subjects scored symptoms daily during entire pollen seasons in 6 timothy grass SLIT-tablet trials (n = 3094) and 2 ragweed SLIT-tablet trials (n = 658) and during the last 8 weeks of treatment in 2 house dust mite (HDM) SLIT-tablet trials (n = 1768). Subjects scored symptoms daily in 7 montelukast (10 mg, n = 6799), 9 desloratadine (5 mg, n = 4455), and 8 mometasone furoate nasal spray (MFNS; 200 μg daily, n = 2140) SAR or PAR trials. SLIT-tablet trials allowed rescue medication use, whereas most pharmacotherapy trials did not. A fixed-effect meta-analysis method estimated differences in on-treatment average TNSSs.. In grass and ragweed SLIT-tablet trials, overall improvement in TNSSs relative to placebo was 16.3% and 17.1%, respectively. In HDM SLIT-tablet trials, TNSS overall improvement relative to placebo was 16.1%. In the montelukast, desloratadine, and MFNS trials, TNSS overall improvement relative to placebo was 5.4%, 8.5%, and 22.2%, respectively, for SAR trials, and 3.7%, 4.8%, and 11.2%, respectively, for PAR trials.. Although comparisons were limited by study design heterogeneity and use of rescue medications in SLIT-tablet trials, effects on nasal symptoms with timothy grass and ragweed SLIT-tablets were nearly as great as with MFNS and numerically greater than with montelukast and desloratadine for SAR. HDM SLIT-tablet effects were numerically greater than all pharmacotherapies for PAR. SLIT-tablets offer the additional benefit of long-term efficacy.

Topics: Ambrosia; Anti-Allergic Agents; Humans; Loratadine; Mometasone Furoate; Phleum; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Sublingual Immunotherapy; Tablets; Treatment Outcome

During the last few years, fixed combinations of intranasal antihistamines and corticosteroids have been introduced for treatment of allergic rhinitis. The aim of this systematic review was to assess recent patents and clinical evidence for fixed combinations of intranasal antihistamines and intranasal corticosteroids in allergic rhinitis. Data base searches revealed that intranasal combinations of the antihistamine azelastine with the corticosteroids mometasone furoate, ciclesonide and fluticasone propionate, respectively, have been patented. Four randomized, double-blinded, parallel-group, placebo-controlled, multicenter trials sponsored by the manufacturer evaluated the fixed combination of intranasal azelastine 125 µg and fluticasone propionate 50 µg administered as one dose per nostril b.i.d. in patients with moderate-to-severe symptomatic allergic rhinitis ≥ 12 years of age. Three of the studies were published as a meta-analysis which found the fixed combination of azelastine and fluticasone propionate statistically significantly more efficacious in reducing baseline total nasal symptom score by 5.7 as compared to azelastine (4.4; P < 0.001), fluticasone propionate (5.1; P < 0.001) and placebo (3.0; P < 0.001). The findings were supported by secondary assessments of scores of specific nasal and ocular symptoms. Pharmacokinetic studies have revealed no drug-drug interactions but a discrete increase in bioavailability of fluticasone propionate which was considered clinically unimportant. Further efficacy and quality-of-life studies of combination products of nasal antihistamines and corticosteroids are needed, especially, in primary care settings and in children before fixed combination treatment can be considered first line therapy in allergic rhinitis. Fixed combination treatment of azelastine and fluticasone propionate may offer additional benefit to selected populations of adolescents and adults with moderate-to-severe symptoms.

Topics: Administration, Intranasal; Adolescent; Adrenal Cortex Hormones; Adult; Androstadienes; Animals; Drug Combinations; Evidence-Based Medicine; Fluticasone; Histamine Antagonists; Humans; Mometasone Furoate; Patents as Topic; Phthalazines; Pregnadienediols; Pregnenediones; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Treatment Outcome

Topics: Allergens; Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents; Bronchial Provocation Tests; Bronchodilator Agents; Environmental Exposure; Fluticasone; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic; Rhinitis, Allergic, Perennial

Intranasal corticosteroids (INSs) are a mainstay of treatment of allergic rhinitis (AR) nasal symptoms. The INS mometasone furoate nasal spray (MFNS) has well-documented efficacy and safety for the treatment and prophylaxis of nasal symptoms of seasonal AR (SAR) and for the treatment of nasal symptoms of perennial AR (PAR). Increasing interest has focused on whether INSs, including MFNS, may have beneficial effects on the ocular symptoms frequently associated with AR.. We performed a meta-analysis of 10 randomized, placebo-controlled trials of the efficacy of MFNS 200 mcg daily in relieving ocular allergy symptoms, including itching/burning, redness, and tearing/watering in both SAR and PAR. Four PAR studies and six SAR studies are included in the analysis. A fixed-effect inverse variance model was used to calculate weighted mean differences, 95% confidence intervals (CIs) for each comparison, and a combined overall treatment effect (Z) with P-value.. In both analyses of SAR and PAR studies, including 3132 patients, all individual ocular symptoms were reduced in patients treated with MFNS. Overall treatment effect was significant for all three individual ocular symptoms in the SAR studies (Z = 9.18 for tearing, Z = 10.15 for itching, and Z = 8.88 for redness; P < 0.00001 for all) and in the PAR studies (Z = 5.94, P < 0.00001 for tearing; Z = 2.43, P = 0.02 for itching; and Z = 2.42, P = 0.02 for redness).. Our findings add to the growing body of literature supporting the positive class effect of INSs, including MFNS, on ocular symptoms associated with SAR and PAR.

Topics: Adolescent; Adult; Aged; Anti-Allergic Agents; Child; Eye Diseases; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Sprays; Pregnadienediols; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Treatment Outcome; Young Adult

Mometasone furoate (Nasonex) is a high-potency intranasal corticosteroid available for the treatment and/or prophylaxis of the nasal symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). In the EU, it is approved for use in patients aged > or =6 years and, in the US, it is approved as a treatment in patients aged > or =2 years and as prophylaxis in those > or =12 years of age.Extensive experience in both clinical trials and the clinical practice setting has firmly established the efficacy and good tolerability profile of intranasal mometasone furoate in children and adults with PAR or SAR. Thus, intranasal mometasone furoate is a useful first-line option for the treatment and prophylactic management of these conditions, including in children as young as 2 years of age in some countries and 6 years of age in others.

Topics: Administration, Intranasal; Adult; Age Factors; Anti-Allergic Agents; Child; Child, Preschool; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Treatment Outcome

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.. 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.. 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; I(2) = 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).. 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.

Topics: Administration, Intranasal; Anti-Allergic Agents; Double-Blind Method; Humans; Mometasone Furoate; Placebos; Pregnadienediols; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Intranasal corticosteroids (INSs) are effective treatments for allergic rhinitis, rhinosinusitis, and nasal polyposis. In recent years, increased understanding of corticosteroid and glucocorticoid receptor pharmacology has enabled the development of molecules designed specifically to achieve potent, localized activity with minimal risk of systemic exposure. Pharmacologic potency studies using affinity and other assessments have produced similar rank orders of potency, with the most potent being mometasone furoate, fluticasone propionate, and its modification, fluticasone furoate. The furoate and propionate ester side chains render these agents highly lipophilic, which may facilitate their absorption through nasal mucosa and uptake across phospholipid cell membranes. These compounds demonstrate negligible systemic absorption. Systemic absorption rates are higher among the older corticosteroids (flunisolide, beclomethasone dipropionate, triamcinolone acetonide, and budesonide), which have bioavailabilities in the range of 34-49%. Studies, including 1-year studies with mometasone furoate, fluticasone propionate, and budesonide that evaluated potential systemic effects of INSs in children have generally found no adverse effects on hypothalamic-pituitary-adrenal axis function or growth. Clinical data suggest no significant differences in efficacy between the INSs. Theoretically, newer agents with lower systemic availability may be preferable, and may come closer to the pharmacokinetic/pharmacologic criteria for the ideal therapeutic choice.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Androstadienes; Animals; Anti-Allergic Agents; Fluticasone; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Mometasone furoate nasal spray (MFNS) is recommended as a first-line therapy for allergic rhinitis. The purpose of intranasal administration is to deliver maximally effective therapy to the affected nasal tissues while minimizing systemic exposure.. This article reviews the pharmacokinetic and pharmacodynamic properties of MFNS, highlighting the potential clinical relevance of data concerning its glucocorticoid receptor binding, bioavailability, and metabolism, and its role in activating and suppressing transcription of steroid-dependent genes.. A search of the MEDLINE and EMBASE databases (January 1995-July 2007) was undertaken to identify in vitro, preclinical, and clinical studies and review articles concerning MFNS. Searches were also conducted to identify articles on the pharmacokinetics, pharmacodynamics, and adverse effects of the intranasal corticosteroids discussed in this article. Pertinent abstracts from allergy society meetings and data from the author's research experience were also included.. The data reviewed indicate that MFNS has a number of qualities that are important in achieving nasal selectivity with minimal systemic adverse effects. For example, MFNS is stable in nasal tissues and is efficiently metabolized in the liver (AUC for a 400-microg dose: 127 fmol/mL x h). Its systemic bioavailability (0.46%) is one of the lowest among currently available intranasal corticosteroids. Bioactive glucocorticoid metabolites have not been observed in humans. The results of immunologic studies suggest that MFNS may reverse the exaggerated T-helper cell type 2 (Th2)-related cytokine response seen in allergic disease through preferential inhibition of Th2 over the T-helper cell type 1-related cytokine.. MFNS is an intranasal corticosteroid with a low potential for systemic adverse effects. The efficacy and safety profiles of MFNS seen in clinical use are consistent with its pharmacokinetic and pharmacodynamic properties.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Biological Availability; Histamine; Humans; Leukocytes; Molecular Structure; Mometasone Furoate; Nasal Mucosa; Pregnadienediols; Protein Binding; Receptors, Glucocorticoid; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Transcriptional Activation

The development of corticosteroids that are delivered directly to the nasal mucosa has alleviated much of the concern about the systemic adverse effects associated with oral corticosteroid therapy. However, given the high potency of these drugs and their widespread use in the treatment of allergic rhinitis, it is important to ensure that intranasal corticosteroids have a favourable benefit-risk ratio. One agent that typifies the systemic safety found in the majority of intranasal corticosteroids is mometasone furoate nasal spray, a potent and effective treatment for seasonal and perennial allergic rhinitis and nasal polyposis. Mometasone furoate does not reach high systemic concentrations or cause clinically significant adverse effects. Results from pharmacokinetic studies in adults and children suggest that systemic exposure to mometasone furoate after intranasal administration is negligible. This is probably because of the inherently low aqueous solubility of mometasone furoate, which allows only a small fraction of the drug to cross the nasal mucosa and enter the bloodstream, and because a large amount of the administered drug is swallowed and undergoes extensive first-pass metabolism. There is no clinical evidence that mometasone furoate nasal spray suppresses the function of the hypothalamus-pituitary-adrenal axis when the drug is administered at clinically relevant doses (100-200 microg/day); consequently, mometasone furoate nasal spray has not been associated with growth inhibition in children. The safety and tolerability of mometasone furoate nasal spray have been rigorously assessed in clinical trials involving approximately 4,500 patients, with epistaxis, headache and pharyngitis being the most common adverse effects associated with treatment in adolescents and adults. The clinical effectiveness of mometasone furoate nasal spray, coupled with its agreeable safety and tolerability profile, confirms its favourable benefit-risk ratio.

Topics: Administration, Intranasal; Anti-Allergic Agents; Humans; Mometasone Furoate; Nebulizers and Vaporizers; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Risk Assessment; Risk Factors; Treatment Outcome

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.

Topics: Anti-Allergic Agents; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Treatment Outcome

Mometasone furoate aqueous nasal spray (NS; Nasonex, Schering Corporation), is a synthetic corticosteroid approved for the prophylaxis and treatment of seasonal allergic rhinitis (SAR) and the treatment of perennial allergic rhinitis (PAR) in patients >or= 12 years of age, and for the treatment of SAR and PAR in children as young as 2 years of age. Studies demonstrate that mometasone furoate NS is a potent, clinically effective and well-tolerated intranasal corticosteroid with negligible systemic activity and which offers the convenience of once-daily dosing.

Topics: Administration, Intranasal; Anti-Allergic Agents; Anti-Inflammatory Agents; Clinical Trials as Topic; Drug Administration Schedule; Glucocorticoids; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Sinusitis

Topical administration of corticosteroids can reduce the total dose of corticosteroid required to treat the patient and minimize side effects. This logic has led to the development of intranasal corticosteroids (INCS) for allergic and perennial rhinitis. The second generation of these compounds includes beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate, mometasone furoate, and triamcinolone acetonide. There is evidence that the INCS are effective in rhinitis; however, there is concern about the potential for these compounds to cause growth suppression. In one study, beclomethasone dipropionate significantly reduced growth in children; however, treatment of children with mometasone furoate nasal spray for 1 year showed no signs of growth suppression. It is evident that the differences among INCS lie in their pharmacokinetics. Structural differences among the various INCS influence their metabolism. The goal of INCS therapy is to have a high ratio of topical to systemic activity. The drug delivery device, absorption of the drug, and drug distribution all contribute to effective topical activity of an INCS. In addition, individual drug metabolism and elimination (half-life and drug clearance) also contribute to the therapeutic index of a drug. Overall, the second-generation INCS cause minimal systemic effects at recommended doses.

Topics: Absorption; Administration, Intranasal; Adrenal Cortex Hormones; Adult; Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Child; Drug Delivery Systems; Fluocinolone Acetonide; Fluticasone; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Structure-Activity Relationship; Tissue Distribution; Triamcinolone Acetonide

Intranasal mometasone furoate (MF) has been extensively studied in adults and has been found to be safe and effective therapy for the treatment of allergic rhinitis. Several studies have now been conducted on pediatric patients. In all, 990 pediatric patients given mometasone furoate nasal spray (MFNS) have been studied in phase I, II, and III clinical trials. In a dose-ranging study, 5 doses of nasal spray (25, 100, and 200 microg MFNS daily and 168 microg beclomethasone dipropionate daily) were compared with placebo. The 100- and 200-microg daily doses of MFNS were found to be more effective than 168 microg beclomethasone dipropionate or 25 microg MFNS given daily. MFNS (100 microg once daily) was chosen as the appropriate dose. In clinical efficacy and safety trials, MFNS was given to 381 patients 3 to 11 years of age for 4 weeks (357 patients received 100 microg MFNS daily for 6 months) and was found to decrease symptom scores from baseline significantly better than placebo. The long-term safety of MFNS was also studied in 166 patients treated for one year; no significant changes in intraocular pressure were detected. Cosyntropin stimulation showed no decreases in cortisol. In adults, nasal mucosa showed improvement in appearance of epithelium and reduction of inflammatory infiltrates, and there were no signs of nasal atrophy.

Topics: Administration, Intranasal; Anti-Allergic Agents; Anti-Inflammatory Agents; Child; Child, Preschool; Clinical Trials as Topic; Cosyntropin; Dose-Response Relationship, Drug; Humans; Hydrocortisone; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Time Factors

Fluticasone propionate is an established corticosteroid administered intranasally for the treatment of rhinitis or by oral inhalation for the treatment of asthma. Mometasone furoate, a closely related corticosteroid currently available in an intranasal formulation, is being investigated in an oral inhalation formulation for the treatment of asthma.. This article reviews available data on the comparative structure-activity relationships, chemistry, pharmacology, pharmacokinetics, and systemic bioavailability of fluticasone propionate and mometasone furoate to assess whether claims of differences in the absolute systemic bioavailability of the 2 compounds are supported by the published literature.. Information for this review was identified through a MEDLINE search of the literature from 1966 to the present that contained the term mometasone or fluticasone. The resulting list was narrowed by excluding articles dealing with dermatologic applications. A systematic review was conducted of the identified literature pertaining to the molecular structure, topical potency, lipophilicity, pharmacokinetics, and bioavailability of the 2 agents. Additionally, the pharmacology of the 2 moieties was assessed by a review of the available literature on receptor binding affinity, transactivation and transrepression potency, and inhibition of inflammatory-cell cytokine expression.. Based on the available data, fluticasone propionate and mometasone furoate have similar physicochemical properties and structure-activity relationships. When administered intranasally, mometasone furoate is reported to have comparable relative systemic bioavailability to that of fluticasone propionate (mean plasma area under the curve, 123 pmol x h/L vs 112 pmol x h/L, respectively). When administered as a single dose by dry powder inhaler, orally inhaled fluticasone propionate is reported to have a total systemic bioavailability of approximately 17%, whereas that of mometasone furoate is reported to be < 1%. However, the mometasone furoate bioavailability study that reported the latter value used lower drug doses and a less sensitive assay than the fluticasone propionate bioavailability study. When multiple-dose data were used, mometasone furoate had an estimated 11% systemic bioavailability, similar to that of fluticasone propionate.. Inhaled fluticasone propionate and mometasone furoate appear to have comparable potential systemic absorption and, based on the total systemic bioavailabilities of the parent compounds, have a low potential for systemic side effects at the recommended clinical doses. However, in the case of mometasone furoate, the contribution of the active metabolites to systemic effects has not been adequately assessed.

Topics: Administration, Intranasal; Androstadienes; Biological Availability; Cytokines; Fluticasone; Humans; Mometasone Furoate; Pregnadienediols; Receptors, Glucocorticoid; Rhinitis, Allergic, Perennial; Time Factors

Intranasal steroids (INSs) are established as first-line treatment for allergic rhinitis. Extensive use of INSs with few reported adverse events supports the safety of these medications. Nevertheless, the prescription of more potent INSs for consistent and more prolonged use to younger and older patients, often in combination with inhaled corticosteroids, justifies the careful examination of their potential adverse systemic effects. Systemic bioavailability of INSs, by way of nasal and intestinal absorption, can be substantial; but current INSs vary significantly in their degree of first-pass hepatic inactivation and clearance from the body of the swallowed drug. For safety studies of INSs, distinguishing detectable physiologic perturbations from important adverse events is aided by an understanding of normal endocrine physiology and the methods used to test these systems. A review of available information indicates that (1) sensitive tests can measure the effects of INSs on biologic feedback systems, but they do not accurately predict clinically relevant adverse effects; (2) the primary factors that influence the relationship between therapeutic and adverse systemic effects of INSs are dosing frequency and efficiency of hepatic inactivation of swallowed drug; (3) INS treatment in recommended doses does not cause clinically significant hypothalamic-pituitary-adrenal axis suppression; (4) growth suppression can occur with twice-daily administration of certain INSs but does not appear to occur with once-daily dosing or with agents with more complete first-pass hepatic inactivation; (5) harmful effects of INSs on bone metabolism have not yet been adequately studied but would not be expected with the use of an INS dose and dosing frequency that do not suppress basal hypothalamic-pituitary-adrenal axis function or growth; and (6) these conclusions apply to INS treatment alone and in recommended doses-the risk of adverse effects in individual patients who are treated with INSs is increased by excessive dosing or concomitant inhaled corticosteroid or other topical corticosteroid therapy.

Topics: Administration, Intranasal; Androstadienes; Beclomethasone; Budesonide; Endocrinology; Fluocinolone Acetonide; Fluticasone; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Steroids; Triamcinolone Acetonide

The anti-inflammatory activity of corticosteroids has prompted the exploration of their use in the treatment of allergic rhinitis. The development of intranasal steroids has resulted in several agents with quick actions, localized effects, and great efficacy in the treatment of seasonal allergic rhinitis and the prophylactic management of perennial rhinitis. This article presents a concise review of the preclinical and clinical evidence with these new agents and provides data-based guidance for the selection of optimal agents. The survey reveals that mometasone furoate, a new inhaled steroid with topical activity, has the greatest binding affinity for the glucocorticoid receptor, followed by fluticasone propionate, budesonide, triamcinolone acetonide, and dexamethasone. Mometasone furoate also has strong anti-inflammatory activity, with IL-4 and IL-5 inhibition activities equivalent to those of fluticasone propionate. Clinically, both mometasone furoate and fluticasone propionate appear to be well tolerated, to have quick onsets of action, and to be equivalent in efficacy in the treatment of seasonal allergic and perennial rhinitis. Of the intranasal steroids currently available, mometasone furoate has been shown to have the least systemic availability and, consequently, is expected to have the fewest systemic side effects. Some suppression of overnight cortisol levels has been reported with fluticasone propionate (indicative of hypothalamic-pituitary-adrenal axis suppression).

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Androstadienes; Biological Availability; Clinical Trials as Topic; Fluticasone; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Mometasone furoate is a synthetic corticosteroid which has been evaluated for intranasal use in the treatment of adults and children with allergic rhinitis. In several large, well-controlled clinical trials, mometasone furoate 200 micrograms administered once daily as an aqueous intranasal spray was significantly more effective than placebo in controlling the symptoms associated with moderate to severe seasonal or perennial allergic rhinitis. Mometasone furoate was as effective as twice-daily beclomethasone dipropionate or once-daily fluticasone propionate in the treatment of perennial allergic rhinitis, and was as effective as twice-daily beclomethasone dipropionate and slightly more effective than once-daily oral loratadine in the treatment of seasonal allergic rhinitis. Mometasone furoate was also as effective as twice-daily beclomethasone dipropionate or once-daily budesonide, and significantly more effective than placebo in the prophylaxis of seasonal allergic rhinitis. The onset of action of mometasone furoate was approximately 7 hours in patients with seasonal allergic rhinitis. Mometasone furoate was as well tolerated as beclomethasone dipropionate, fluticasone propionate and budesonide in clinical trials, with an overall incidence of adverse events similar to placebo. Adverse events were generally mild to moderate and of limited duration. The most common adverse events associated with mometasone furoate therapy were nasal irritation and/or burning, headache, epistaxis and pharyngitis. Intranasal or oral mometasone furoate had no detectable effect on hypothalamic-pituitary-adrenal axis function in studies of < or = 1 year in duration.. Mometasone furoate is a well tolerated intranasal corticosteroid with minimal systemic activity and an onset of action of < or = 7 hours. It is effective in the prophylaxis and treatment of seasonal allergic rhinitis and the treatment of perennial allergic rhinitis in patients with moderate to severe symptoms.

Topics: Anti-Allergic Agents; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Topics: Adolescent; Adult; Child; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Sprays; Olopatadine Hydrochloride; Quality of Life; Rhinitis, Allergic, Perennial; Time Factors; Treatment Outcome

In the clinic, approximately 30% of children with adenoid hypertrophy (AH) concomitant with allergic rhinitis (AR) report poor responses to intranasal steroids. To determine whether the combination of mometasone furoate (MF) and oxymetazoline (OXY) is more effective than either agent alone, we performed a two-stage, parallel, randomized, double-blind, double-dummy, clinical trial with 240 AH children with concomitant perennial AR. During the first stage, all children were randomly assigned to the MF or control group for six weeks of treatment. During the second stage, the non-responders from stage one were randomly assigned to 4 groups for 8 weeks of treatment that involved receiving the following treatments: MF/OXY, MF/placebo, placebo/OXY, or placebo/placebo. During the first stage of treatment, 39% of the responders treated with MF achieved greater reductions in total and individual symptom scores than did those on placebo. During the second stage of treatment, the nasal congestion scores of the MF/OXY group significantly decreased. The adenoid/choana ratio of the MF/OXY-treated group decreased and the nasal volume increased significantly. Our results suggest that the combination of OXY and MF is effective and safe for the treatment of AH children with concomitant AR and has a rapid onset of action.

Topics: Adenoids; Case-Control Studies; Child; Demography; Female; Humans; Hypertrophy; Male; Mometasone Furoate; Nose; Oxymetazoline; Patient Compliance; Rhinitis, Allergic, Perennial

Various studies have investigated the efficacies of mometasone furoate monohydrate (MFM) and fluticasone propionate (FP) nasal sprays for adults. However, research on their effectiveness for children is limited. This study compares the efficacies of MFM and FP nasal sprays in pediatric patients with perennial-allergic rhinitis.. For this study, 94 perennial allergic rhinitis patients aged 6-12 years were randomly assigned to two treatment groups: an MFM group and an FP group. Treatment was provided for 4 weeks. The effects of the two agents were compared using the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire and total symptom scores (TSSs). Nasal-peak expiratory flow rates and eosinophil percentage in nasal smears were also compared between the two groups.. Patients in the MFM group exhibited significant improvement in their TSS (t = -2.65, p < 0.05). A detailed TSS analysis showed MFM to be more effective for relieving nasal symptoms, whereas FP was more effective for relieving non-nasal symptoms. Patient questionnaire scores suggested a significant reduction in symptoms for both the MFM (t = -7.23, p < 0.01) and FP (t = -5.43, p < 0.01) groups. The flow rate test results indicated significant improvements in the MFM group (t = 2.27, p < 0.05).. Following the 4-week therapy, MFM provided greater improvement compared to FP for symptoms of childhood perennial-allergic rhinitis. Based on their TSSs, the MFM group experienced more effective relief of nasal symptoms, whereas the FP group experienced more effective relief of non-nasal symptoms.

Topics: Allergens; Androstadienes; Animals; Anti-Allergic Agents; Child; Dose-Response Relationship, Drug; Drug Administration Schedule; Dust; Female; Fluticasone; Follow-Up Studies; Humans; Male; Mites; Mometasone Furoate; Nasal Sprays; Patient Satisfaction; Pregnadienediols; Prospective Studies; Quality of Life; Rhinitis, Allergic, Perennial; Risk Assessment; Severity of Illness Index; Treatment Outcome

This study aimed at observing the efficacy of mometasone fuorate monohydrate nasal spray on obstructive adenoids in children and identifying the characteristics of responders using a pilot study including children aged 2-11 years, with evidence of more than 50 % obstruction. Allergic rhinitis and nasal obstruction were evaluated on baseline (V0), 6- (V1), and 12-week (V2) visits. Degree of obstruction was evaluated by nasopharyngoscopy at V0 and V2. Subjects received 100 μg mometasone fuorate daily. Results were compared with those of a matching control group. Nineteen children (8 females, 11 males; 2.25-8.50 years old, mean 4.24 years, median 4.00 years) completed treatment and follow-up adequately. There was 58 % reduction in a clinical score assessing the severity of adenoidal obstruction (P < 0.05), 56 % reduction in severity of obstructive symptom (P < 0.05), and 75 % reduction in allergic rhinitis score (P < 0.05) between V0 and V1. No further significant improvement was noticed between V1 and V2. The degree of obstruction dropped from 85 to 61 % as noted on endoscopy (P < 0.05). None in the control group showed spontaneous decrease or resolution of the symptoms. Age of patients, allergic rhinitis score, and severity of the clinical score had no impact on the response parameters. No side effects were observed. Mometasone furoate monohydrate nasal spray appears to be effective in treating children with obstructive adenoids. The effect seems to be independent of the presence of mild intermittent allergic rhinitis, the age of patient, or the severity of symptoms.

Topics: Adenoids; Anti-Inflammatory Agents; Child; Child, Preschool; Endoscopy; Female; Humans; Hypertrophy; Male; Mometasone Furoate; Nasal Obstruction; Pilot Projects; Pregnadienediols; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Treatment Outcome

Allergic rhinitis (AR) carries a high symptom burden and impact on quality of life. The ability of an AR treatment to achieve and sustain symptom suppression would be expected to enhance quality of life and improve long-term outcomes.. In this ad hoc analysis of data from 4 phase 3 clinical trials of mometasone furoate nasal spray (MFNS), subjects with perennial AR recorded the severity of nasal symptoms twice daily for 12 weeks on a 4-point scale to determine the total nasal symptom score.. In the pooled sample of 1,149 subjects, 580 received MFNS 200 μg per day and 569 received placebo. Significantly more subjects receiving MFNS achieved symptom suppression versus those receiving placebo: 63.3% (n = 367) versus 51.0% (n = 290; p < 0.001). Median time to suppression was significantly shorter with MFNS versus placebo (29 vs. 59 days; p < 0.001). Total suppression was achieved in a significantly greater percentage of patients receiving MFNS versus placebo (36.0 vs. 25.5%; p < 0.001).. A high level of symptom relief is attained faster and sustained longer with MFNS. This analysis validates the importance of treatment adherence to achieve optimal, sustained symptom relief.

Topics: Administration, Intranasal; Anti-Allergic Agents; Disease-Free Survival; Follow-Up Studies; Humans; Mometasone Furoate; Nasal Sprays; Pregnadienediols; Quality of Life; Rhinitis, Allergic, Perennial; Treatment Outcome

Allergic rhinitis, especially when persistent (PER) and associated with asthma heavily impairs patients' quality of life (QoL).. This study assessed the effect of mometasone furoate nasal spray (MFNS) on the QoL of patients with PER and asthma, using the Rhinasthma questionnaire (EUDRACT n. 2007-004683-45).. Patients with moderate/severe PER and intermittent asthma were randomized to MFNS (alcohol-free) 200 μg/day or placebo for 28 days. Rhinasthma was completed at baseline and at weeks 2 and 4. The total five symptom score (T5SS) for rhinitis, the asthma symptom score and the sum of the two [global symptoms score (GSS)] were recorded daily. The primary outcome was the change in the Rhinasthma global summary (GS) at the end of treatment. Secondary end-points were (a) the change from baseline to end of treatment of each Rhinasthma factor: upper airways (UAs), lower airways (LAs) and respiratory allergy impact; (b) the change from baseline to end of treatment of the T5SS and of the GSS and (c) the use of rescue medication.. Fifty-two adults were randomized. Compared with placebo, MFNS produced a significant change in the Rhinasthma GS (-10.4 vs. 0.4; P<0.01). MFNS also achieved a significant improvement of the UA (-16.6 vs. 0.1; P<0.001), LA (-10.8 vs. 1.1; P<0.001) and GSS (-6.7 vs. -3.1; P=0.019). The change of the T5SS was greater in the MFNS group but did not reach statistical significance.. In patients with PER rhinitis and intermittent asthma, MFNS improves the QoL and the burden of respiratory symptoms. Treating rhinitis may affect the asthma-related QoL.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Allergic Agents; Asthma; Double-Blind Method; Female; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Quality of Life; Rhinitis, Allergic, Perennial; Surveys and Questionnaires; Young Adult

Many patients with allergic rhinitis are reluctant to use daily intranasal steroids for prolonged periods. A self-adjusted regimen which delivers reasonable control of allergic rhinitis may be more acceptable to such patients.. To compare the efficacy of daily use of mometasone furoate nasal spray, versus a self-adjusted regimen, in patients with chronic allergic rhinitis, in terms of symptom control and nasal volume change.. Ambulatory visits in an office setting.. Sixty patients with chronic allergic rhinitis were randomised: 30 were prescribed mometasone furoate nasal spray once daily for six weeks, while 30 were prescribed the same spray daily for one week, every alternate day for one week and then on a self-adjusted regimen for four weeks. Patients kept a symptom diary documenting sneezing, rhinorrhoea, nasal blockage and nasal itching. Acoustic rhinometry was used to measure the total nasal cavity volume at the first visit and at the end of the treatment period.. The total nasal score on treatment days showed an improvement in both groups, compared with baseline measurements. There was no significant difference in total nasal scores between the two groups, except on days 10 (p = 0.043), 20 (p = 0.008), 23 (p = 0.19), 30 (p = 0.008) and 37 (p = 0.000), when the daily group's total nasal score was significantly lower than the self-adjusted group's total nasal score, and on day 8 (p = 0.004), when the self-adjusted group's total nasal score was significantly lower than the daily group's total nasal score. Total nasal cavity volume significantly increased in both groups (p = 0.0001), with no statistically significant difference between the groups.. Self-adjusted dosage of mometasone furoate nasal spray gives reasonable control of allergic rhinitis (albeit with some 'breakthrough' symptoms). Patients should learn how to control these symptoms with the least number of steroid doses.

Topics: Adult; Anti-Allergic Agents; Anti-Inflammatory Agents; Chronic Disease; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Cavity; Pregnadienediols; Rhinitis, Allergic, Perennial; Self Administration

Topics: Administration, Intranasal; Aged; Aged, 80 and over; Anti-Allergic Agents; Drug Administration Schedule; Epistaxis; Headache; Humans; Mometasone Furoate; Pharyngitis; Pregnadienediols; Rhinitis, Allergic, Perennial; Treatment Outcome; United States

Allergic rhinitis (AR) affects up to 40% of children by age 6 years. Perennial AR (PAR) causes sleep disturbance, diminishes concentration in school, impairs psychosocial functioning, and reduces quality of life. This study evaluated efficacy and long-term safety of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) in children with PAR.. This study comprised a double-blind, 4-week efficacy and safety period followed by a 6-month, open-label safety period. Primary efficacy variable during the double-blind period was mean change in physician-evaluated total nasal symptom score (TNSS) from baseline to day 15. Other efficacy variables during this phase included subject-evaluated TNSS, individual nasal symptoms, and total symptom score (TSS, nasal and non-nasal symptoms, summed). Physician-evaluated improvement in overall condition of PAR was assessed during the open-label period. Adverse events (AEs) were monitored throughout.. Subjects aged 3-11 years with PAR (n = 381) were randomized to MFNS 100 microg (n = 190) or placebo (n = 191) daily for 4 weeks; 357 subjects continued into the open-label period, receiving MFNS only. Between baseline and day 15, significantly greater mean changes were seen with MFNS-treated patients than placebo in physician-evaluated TNSS (-2.8, -39%, vs. -2.2, -32%; p = 0.02). Statistically significant improvements in MFNS versus placebo were reported for subject-evaluated TNSS, TSS, and individual nasal symptom scores (p < or = 0.03 for all). Improvement continued through the open-label period. Subjects treated with MFNS in both periods experienced a 45% further reduction in TSS in this study phase, while those who switched from placebo to MFNS saw a further 49% decrease. MFNS was well-tolerated in both periods. The most frequently reported treatment-related AEs during the double-blind period for MFNS and placebo, respectively, were epistaxis, seven (4%) and nine (5%); sneezing, five (3%) and seven (4%); headache, six (3%) and five (3%). During the open-label period, the AEs reported most often were epistaxis 37 (10%), headache nine (3%), and rhinitis 12 (3%).. Studies in children present unique challenges because subjects are too young to grasp subjective concepts such as symptom severity, especially as rated on a numbered scale. In addition, the 6-month extension of the placebo-controlled phase used a single agent. It is also possible that subjects' symptoms could have abated independent of mometasone furoate treatment.. MFNS 100 microg/day effectively reduces TNSS, TSS (including ocular symptoms), and individual symptoms associated with PAR and is well-tolerated for up to 6 months in children aged 3-11 years with a safety profile similar to placebo.

Topics: Administration, Intranasal; Anti-Allergic Agents; Child; Child, Preschool; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Mometasone Furoate; Nasal Sprays; Placebos; Pregnadienediols; Rhinitis, Allergic, Perennial; Time Factors; Treatment Outcome

Allergic rhinitis (AR) and related nasal congestion cause rhinitis-disturbed sleep (RDS). Intranasal corticosteroids reduce nasal congestion and improve sleep quality in AR but have not been extensively studied in RDS.. To evaluate the efficacy of mometasone furoate nasal spray (NS) on nasal symptoms, nasal patency, sleep variables, quality of life, and daytime functioning in perennial AR (PAR) and concomitant RDS.. In this double-blind 4-week study, 30 adults with PAR and moderate RDS were randomized 2:1 to receive mometasone furoate NS, 200 microg, or placebo each morning. The primary end point was the apnea-hypopnea index. Secondary outcome measures included changes in total nasal symptom score (TNSS), nighttime symptom score, daytime peak nasal inspiratory flow, nighttime flow limitation index, Rhinoconjunctivitis Quality of Life Questionnaire-Standardized (RQLQ-S) score, Epworth Sleepiness Scale score, and Work Productivity and Activities Impairment-Allergy Specific (WPAI-AS) questionnaire score. Analysis of covariance was used for all efficacy end points.. The apnea-hypopnea index at study end was not statistically significantly different between groups. However, mometasone furoate NS therapy significantly improved morning (P = .04) and evening (P = .01) TNSSs, morning (P = .049) and evening (P = .03) nasal obstruction/blockage/congestion, daily peak nasal inspiratory flow (P = .03), flow limitation index (P = .02), Epworth Sleepiness Scale score (P = .048), RQLQ-S score (P = .03), and 2 of 5 WPAI-AS domains. Among patients receiving mometasone furoate NS, TNSS improvements were significantly correlated with improved work- and non-work-related productivity.. In patients with PAR and RDS, mometasone furoate NS use improved nasal symptoms, sleepiness, and impairment in daily activities. Correlated reduced nasal symptoms and improved performance suggest that improving AR symptoms with mometasone furoate NS administration can benefit sleep and daytime functioning.

Topics: Activities of Daily Living; Administration, Intranasal; Adolescent; Adult; Anti-Allergic Agents; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Obstruction; Pregnadienediols; Quality of Life; Rhinitis, Allergic, Perennial; Sleep Apnea Syndromes

Perennial allergic rhinitis (PAR) affects children at a young age. Current guidelines recommend intranasal corticosteroids as the first-line treatment in patients with moderate-to-severe or persistent disease or in those who have congestion. In this study, the long-term safety and efficacy of mometasone furoate nasal spray (MFNS) were assessed in children with PAR.. In this multicenter, active-controlled, evaluator-blind, 12-month study, 255 children aged 6-11 years with a >or=1-year history of PAR were randomized to receive once-daily MFNS 100 microg (n=166) or the active comparator beclomethasone dipropionate (BDP) 168 microg (n=85). Changes from baseline in overall PAR symptoms and response to treatment were rated at each visit. Cosyntropin stimulation testing, as well as tonometry and slit lamp procedures, were performed. Safety variables were assessed.. A total of 137 subjects in the MFNS group and 68 in the BDP group completed treatment. The mean reductions in physician- and subject-rated overall condition of PAR at week 52 were -42.1% and -39.7%, respectively, for MFNS, compared with -44.0% and -39.0%, respectively, for BDP. A total of 94% and 100% of MFNS and BDP subjects, respectively, reported adverse events (AEs), which were mostly mild or moderate. The most frequently reported treatment-related AEs in both groups were epistaxis, headache, and pharyngitis. Response to cosyntropin was normal and no posterior subcapsular cataracts were observed in either group. Although no significant changes in intraocular pressure were observed with MFNS, one subject receiving BDP demonstrated this effect.. Treatment with MFNS 100 microg once daily for 1 year was well tolerated in children 6-11 years old, with negligible systemic exposure and no evidence of suppression of the hypothalamic-pituitary-adrenal axis or ocular changes.

Topics: Aerosols; Anti-Allergic Agents; Anti-Inflammatory Agents; Beclomethasone; Cerebrospinal Fluid Rhinorrhea; Child; Cosyntropin; Demography; Double-Blind Method; Female; Humans; Hydrocortisone; Male; Mometasone Furoate; Nasal Obstruction; Pregnadienediols; Rhinitis, Allergic, Perennial

To evaluate the effects of nasal mometasone furoate on moderate to severe allergic rhinitis.. Patients with moderate to severe allergic rhinitis were enrolled and received mometasone furoate nasal spray 200 microg once daily for four weeks. Four hundreds and sixty-three patients completed the study. We weekly interviewed the patients to evaluate the symptoms, and the affection of disease on night sleep and daily life. Mini Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) and Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) were used to evaluate the quality of life.. The individual and total symptomatic scores of week 1, week 2 and week 4 decreased compared with baseline. The scores of Mini-RQLQ and NRQLQ of week 1, week 2 and week 4 decreased compared with baseline too. The scores of the next visit were significantly lower than those of the previous visit (P < 0.01).. A four-week administration of mometasone furoate nasal spray can effectively treat allergic rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Allergic Agents; Child; Female; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Quality of Life; Rhinitis, Allergic, Perennial; Surveys and Questionnaires; Young Adult

In order to assess the acceptability of a new scent-free formulation of mometasone furoate (Nasonex) among allergic rhinitis patients, who already have been treated by the scented formulation of Nasonex, a phone survey was performed with a sample of 216 patients recruited by Nasonex GP's prescribers and pharmacists. The aim of this survey is to assess the diagnosis modalities, the allergic rhinitis characteristics and associated symptoms in one hand and in the other hand, the main reasons which led them to prefer a new scent-free formulation, in comparison with the only commercialized scented mometasone furoate (Nasonex) at the time when this survey was conducted. The impact of unscented Nasonex on patient's compliance to treatment was also assessed. This survey confirms that the GP is the key actor who usually establish the allergy diagnosis and the interrogatory is the principle method used. The prick test was more often and significantly used in 35% of the perennial rhinitis instead of 19% in seasonal allergic rhinitis (p < or = 0.05). When the diagnosis of allergy was established by an allergologist, 89% of them used a prick test. In this survey, asthma was associated in 24% of the patients, particularly in who suffering from perennial allergic rhinitis. 85% of patients rate their smell as globally good. 75% of the treated patients were interested by the new unscented formulation of Nasonex, regardless of the type of their rhinitis, seasonal or perennial. About 60% of patients stated that the lack of odor will led them to be more compliant to their treatment.

Topics: Administration, Intranasal; Adult; Anti-Allergic Agents; Choice Behavior; Female; Humans; Male; Mometasone Furoate; Nebulizers and Vaporizers; Odorants; Patient Compliance; Patient Satisfaction; Pregnadienediols; Rhinitis, Allergic, Perennial; Surveys and Questionnaires; Taste

The efficacy of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) for treatment of nasal polyposis was demonstrated in 2 large clinical trials.. To evaluate the onset of MFNS symptomatic effect, data from the 2 trials were pooled and analyzed to determine the first day subjects experienced significant symptom relief.. Subjects with nasal polyposis randomized to MFNS 200 microg twice daily or placebo scored symptoms on a 3-point scale (0 = none; 3 = severe) and measured peak nasal inspiratory flow immediately before the morning dose. Onset of symptomatic effect was defined as the first day a statistically significant (P < .05) lasting response was observed for MFNS compared with placebo.. A total of 447 subjects with bilateral nasal polyps and clinically significant nasal congestion/obstruction were analyzed. Compared with placebo, MFNS 200 microg twice daily demonstrated statistically significant (P < .05) relief of anterior rhinorrhea by day 2 (-10.9% vs +5.7%), nasal congestion by day 3 (-15.1% vs -7.6%), postnasal drip by day 5 (+1.1% vs +4.6%), and sense of smell by day 13 (-9.6% vs -5.6%). Significant improvement in peak nasal inspiratory flow was seen by day 2 (increase of 6.22 L/min vs 1.48 L/min for placebo; P = .03).. Mometasone furoate nasal spray 200 microg twice daily rapidly improves the symptoms of nasal polyposis, leading to lasting relief of most major symptoms within 2 (24 hours after the first dose) to 5 days of initiating therapy.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Allergic Agents; Asthma; Double-Blind Method; Female; Humans; Inspiratory Capacity; Male; Middle Aged; Mometasone Furoate; Nasal Decongestants; Nasal Polyps; Pregnadienediols; Rhinitis, Allergic, Perennial; Smell

Rhinitis is common in asthmatic schoolchildren who are allergic to animal dander and constantly and indirectly exposed to these allergens in their everyday environment. As a patho-physiological linkage between nasal and bronchial inflammation has been proposed to exist, the primary objective of this study was to determine whether nasal administration of mometasone furoate (MSNF) can reduce bronchial inflammation, as reflected in the level of exhaled nitric oxide (F(E)NO) in asthmatic schoolchildren with dander allergy and mild-to-moderate rhinitis. Forty such children were assigned randomly to be treated for 4 wk with MSNF or placebo, employing a double-blind procedure. F(E)NO was the primary end-point measured and secondary end-points were nasal levels of NO, the concentration of eosinophilic cationic protein (ECP) in nasal lavage, the relative numbers of eosinophils in blood, forced expiratory volume in 1 s (FEV(1)), peak expiratory flow (PEF) and scoring of symptoms. There was no significant difference in the F(E)NO values of the treated and control groups at any time-point, whereas the nasal level of ECP was lower in the treated group compared with placebo (p = 0.05) on both days 7 and 28, and compared with baseline for the treated group (p = 0.06 on day 7, p = 0.02 on day 28). Furthermore, the mean blood eosinophil count decreased in the treated group, which also demonstrated lower scores for nasal symptoms compared with placebo, but neither of these differences were statistically significant. FEV(1), PEF and nasal levels of NO remained unchanged in both groups. Four weeks of nasal treatment with MSNF had no effect on bronchial inflammation, as reflected by exhaled NO, whereas signs of nasal and systemic eosinophil activation were reduced. Thus, nasal administration of a steroid as a strategy to reduce asthmatic inflammation remains questionable in mild-to-moderately severe cases of perennial rhinitis and asthma.

Topics: Adolescent; Anti-Allergic Agents; Anti-Inflammatory Agents; Asthma; Breath Tests; Double-Blind Method; Eosinophil Cationic Protein; Eosinophils; Exhalation; Female; Humans; Leukocyte Count; Male; Mometasone Furoate; Nitric Oxide; Pregnadienediols; Pulmonary Ventilation; Rhinitis, Allergic, Perennial

Response to a single dose nasal adenosine monophosphate challenge has been used as a surrogate inflammatory marker for allergic rhinitis. Attenuation of response following intranasal corticosteroid would further validate the challenge.. To assess the effect of 4 weeks of 200 mcg once daily mometasone furoate nasal spray on a simplified (single 160 mg dose) nasal adenosine monophosphate challenge.. Twenty participants with persistent allergic rhinitis completed a double blind placebo-controlled crossover study. Outcome measures were the peak nasal inspiratory flow and total nasal symptoms score responses to nasal adenosine monophosphate challenge, as well as domiciliary peak nasal inspiratory flow and patient symptom diary cards.. Mometasone significantly (P < 0.05) attenuated response time profiles vs. placebo for peak nasal inspiratory flow but not total nasal symptom scores. For the maximum percentage fall this amounted to a mean difference of 9.6% (95% confidence interval 1.3-17.9%). The coefficient of variation for repeatability was 48.7%. Improvements were seen in prechallenge and domiciliary measurements of peak nasal inspiratory flow (both P < 0.05) and total nasal symptom scores (both P < 0.01).. Mometasone attenuates the peak nasal inspiratory flow response to a single 160 mg nasal adenosine monophosphate challenge. Such challenges have been shown to be sensitive to the effects of antihistamines, antileukotrienes and now nasal steroids. This further supports their application as surrogate inflammatory markers for therapeutic trials in allergic rhinitis, potentially as 20 min challenges which can be conducted in a non-hospital setting.

Topics: Adenosine Monophosphate; Administration, Intranasal; Adolescent; Anti-Allergic Agents; Double-Blind Method; Female; Humans; Male; Mometasone Furoate; Nasal Provocation Tests; Pregnadienediols; Rhinitis, Allergic, Perennial; Treatment Outcome

Data on intranasal corticosteroids suggest that individual product attributes may influence patient preference for therapy in allergic rhinitis. The study objective was to compare product sensory attributes and their impact upon patient preference for scent-free mometasone furoate nasal spray (MFNS) versus fluticasone propionate nasal spray (FPNS) in patients with symptomatic allergic rhinitis.. In a double-blind, crossover study, 100 patients were randomized to MFNS microg followed by FPNS 200 microg, or vice versa. Patients rated the study drugs by completing an individual product sensory attributes questionnaire at the end of each period of drug administration. An overall sensory preference questionnaire was completed following crossover.. A significantly greater number of patients preferred MFNS to FPNS (p < 0.05). MFNS was superior for a number of individual sensory attributes based on mean patient ratings: significantly fewer patients perceived scent/odor (immediately and 2 minutes after drug administration; p < 0.001), taste (immediately after drug administration; p = 0.002), and after-taste (2 minutes after drug administration; p = 0.007) with MFNS compared with FPNS. Similarly, product sensory attribute preference data demonstrated that twice the number of patients preferred MFNS to FPNS for scent/odor (p = 0.0005), immediate taste (p = 0.005), and after-taste (p = 0.005). Fifty-four percent of patients said they would choose a prescription for MFNS compared with 33% for FPNS (p = 0.03). In addition, 47% of patients would be more likely to comply (use daily as directed) with MFNS compared with 25% with FPNS (p = 0.03).. Several individual sensory attributes of MFNS were rated significantly superior to FPNS. Overall, based on the tested sensory attributes, patients preferred MFNS to FPNS therapy for the treatment of allergic rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents; Double-Blind Method; Fluticasone; Humans; Middle Aged; Mometasone Furoate; Patient Satisfaction; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Thirty-six persistent allergic rhinitis (PAR) sufferers were studied, to both compare and correlate 15 minute response to nasal xylometazoline (XYLO) with 28 day response to nasal mometasone furoate (MF). 0.1% XYLO (1 spray each nostril) response was measured on two occasions, then a randomised double blind cross-over comparison of MF (200 mcg daily) to placebo conducted. Outcomes were peak nasal inspiratoly flow (PNIF), nasal forced inspiratory volume in one second (nFIV1) and nasal blockage score (NBS) improvements. Thirty-one participants completed per protocol. Within subject standard deviation for percentage improvement to XYLO was 26.0 for PNIF and 25.2 for nFIV1. Median % improvement (95%CI) in PNIF for XYLO vs. MF was 20.0 (11.4 to 31.0) vs. 9.6 (3.2 to 15.8) and in nFIV1 was 17.8 (10.0 to 28.1) vs. 3.3 (-4.3 to 19.1). XYLO effects were greater than MF (p<0.05) for PNIF, nFIV1 and NBS. There was no significant correlation of MF to XYLO improvements in PNIF, nFIV1 or NBS. In conclusion, acute reversibility to XYLO showed poor repeatability and XYLO reversibility is not predictive of decongestant response to nasal corticosteroid. XYLO was a stronger decongestant than MF but rhinitis medicamentosa still precludes any preference for long term XYLO therapy at this time.

Topics: Administration, Intranasal; Anti-Allergic Agents; Chi-Square Distribution; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Imidazoles; Male; Mometasone Furoate; Nasal Decongestants; Pregnadienediols; Rhinitis, Allergic, Perennial; Spirometry; Statistics, Nonparametric; Treatment Outcome

This study evaluates the efficacy and systemic tolerability of licensed doses of mometasone furoate (Nasonex) and betamethasone sodium phosphate (Betnesol) in allergic chronic rhinosinusitis patients. It also assesses the diagnostic accuracy of morning salivary cortisol (MSC) concentrations to screen for adrenal suppression in these patients. Forty-eight patients were prospectively randomized to two treatment limbs. Symptom scores and adrenal function assessments were performed immediately prior to commencement and at the end of treatment. One (4 per cent) mometasone furoate and 14 (58 per cent) betamethasone sodium phosphate patients developed biochemical evidence of adrenal suppression. There were statistically significant (p < 0.005) reductions in symptom scores following treatment, but no significant difference (p > 0.05) between the drug groups regarding post-treatment symptom scores. As a screening tool for iatrogenic adrenal suppression, MSC had a sensitivity of 100 per cent and a specificity of 97 per cent. This study demonstrates the high risk of developing adrenal suppression secondary to betamethasone sodium phosphate therapy. The salivary cortisol assay is an accurate tool for monitoring adrenal function and is ideally suited to the out-patient setting.

Topics: Adolescent; Adrenal Insufficiency; Adult; Aged; Ambulatory Care; Anti-Allergic Agents; Anti-Inflammatory Agents; Betamethasone; Female; Humans; Hydrocortisone; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Prospective Studies; Rhinitis, Allergic, Perennial; Saliva; Sensitivity and Specificity; Sinusitis; Treatment Outcome

Evidence in vitro suggests that benzalkonium chloride, a preservative in many intranasal preparations, interferes with ciliary function and thus could potentially interfere with mucociliary transport, the mechanism for clearing secretions from the nasal cavity.. We performed a parallel randomized study with 10 subjects in each arm comparing Rhinocort AQUA (an intranasal steroid [budesonide] spray without benzalkonium chloride) and Nasonex (an intranasal steroid [mometasone furoate] spray with benzalkonium chloride). Before and after 2 weeks of treatment, subjects completed a Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and underwent a measurement of nasal clearance of a radioactive colloidal spray into the nose.. The groups were matched at entry for nasal clearance, even though there was variability among subjects. The amount of change after 2 weeks of treatment (Delta before versus after treatment) showed a significant difference in nasal clearance favoring budesonide. After 2 weeks of treatment, both budesonide and mometasone demonstrated overall improvement in quality of life as assessed by the RQLQ. Both treatments were well tolerated.. Our study extends the observation in vitro that demonstrates the adverse effect of benzalkonium chloride on cilia to a measurement in vivo of clearance. The effects after 2 weeks might not reflect changes after longer periods of treatment.. To determine the clinical significance of the small improvement in mucociliary transport will require large clinical trials.

Topics: Administration, Intranasal; Adult; Anti-Inflammatory Agents; Budesonide; Female; Humans; Male; Mometasone Furoate; Mucociliary Clearance; Nasal Obstruction; Pregnadienediols; Quality of Life; Rhinitis, Allergic, Perennial

To evaluate the systemic bioactivity of triamcinolone acetonide (TA) 220 micro g or mometasone furoate (MF) 200 micro g over 3 weeks in perennial allergic rhinitis.. Twenty-seven patients received TA 220 micro g or MF 200 micro g once daily for 3 weeks with a 2 week placebo washout period prior to each randomized treatment. Measurements were made at baseline after each washout and after each randomized treatment, comprising overnight 10-h urinary cortisol corrected for creatinine (OUCC), 08.00 h plasma cortisol and 08.00 h serum osteocalcin.. There were no significant differences between baseline values prior to TA or MF, and for any outcome measures comparing randomized treatments to respective baseline values or comparing TA with MF. For OUCC compared with baseline, the geometric mean fold suppression (95% CI) was 1.02 (0.78, 1.33) for TA (2% decrease), 1.07 (0.80, 1.42) for MF (7% decrease), and 1.05 (0.79, 1.39) for TA vs MF (5% decrease).. Standard doses of TA or MF over 3 weeks showed no differences in systemic bioactivity markers compared with respective baseline values after placebo washout, and there were no differences between TA vs MF.

Topics: Administration, Intranasal; Adult; Drug Evaluation; Female; Glucocorticoids; Humans; Male; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Triamcinolone

Nasal histamine challenge testing is a standard method of assessing upper airway hyperreactivity although there is still debate as to the best measure of response. The aim of the study was to evaluate peak nasal inspiratory flow rate (PIFR) as an endpoint during histamine challenge and compare this with rhinomanometry (Rhino) and acoustic rhinometry (AR). Twenty two patients with perennial allergic rhinitis (PAR) were enrolled into a 2-way randomised crossover study comparing placebo with intra-nasal mometasone furoate (MF) 200 mg once daily, with laboratory measurements of PIFR, AR and Rhino being made during histamine nasal challenge after each 10-14 day treatment period. Patients also recorded their domiciliary nasal symptoms and PIFR on a daily basis. With nasal challenge testing using PIFR PC30 there was a significant (p < 0.05) difference between MF and placebo but not with PC30 AR or PC175 Rhino. There was also significant (p < 0.05) improvement in terms of domiciliary total nasal symptom scores but not domiciliary PIFR. In conclusion PIFR after nasal challenge with histamine is a sensitive test of response to treatment with intra-nasal corticosteroids in PAR.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Cross-Over Studies; Female; Glucocorticoids; Humans; Male; Mometasone Furoate; Nasal Provocation Tests; Pregnadienediols; Pulmonary Ventilation; Rhinitis, Allergic, Perennial; Rhinomanometry; Rhinometry, Acoustic

To evaluate the role of AMP nasal challenge as a measure of short-term treatment response in patients receiving intranasal corticosteroids. Adenosine monophosphate (AMP) challenge has been shown to be a good inflammatory surrogate in the lower airways, but it has not been properly evaluated as a nasal challenge test.. Fourteen patients with perennial allergic rhinitis (PAR) were randomized to receive 2 weeks treatment with placebo (PL) or 200 microg intranasal mometasone furoate (MF) once daily in a randomized single-blind crossover study. AMP (25-800 mg ml-1) and histamine (0.25-8 mg ml-1) nasal challenge testing were performed after each treatment period with 30% decrease in minimal cross-sectional area (MCA). Domiciliary symptom data were collected.. There was a significant (P < 0.05) improvement in PC30 MCA and nasal volume with AMP but not with histamine comparing MF vs PL. This amounted to a 2.8 (95% CI 1.5, 4.0) and 0.7 (95% CI -0.5, 1.9) doubling-dose change for AMP and histamine challenges, respectively. There were significant (P < 0.05) improvements in nasal symptoms and quality of life.. AMP nasal challenge using acoustic rhinometry may be a useful test to assess short-term treatment response in patient with PAR.

Topics: Adenosine Monophosphate; Administration, Topical; Adult; Anti-Allergic Agents; Anti-Inflammatory Agents; Cross-Over Studies; Dose-Response Relationship, Drug; Female; Glucocorticoids; Histamine; Humans; Male; Mometasone Furoate; Nasal Provocation Tests; Pregnadienediols; Respiratory Function Tests; Rhinitis, Allergic, Perennial; Single-Blind Method

It is presumed that exposure to allergens in the environment occurs through both the eyes and the nose. Allergic rhinoconjunctivitis is typically treated with a nasal spray or systemic antihistamine, neither of which may provide adequate relief of the ocular component of the disease.. This study was designed to gain a better understanding of the physiologic interaction between the conjunctival and nasal mucosa and thus help establish a profile for the most effective ocular treatment in patients whose allergies have both an ocular and a nasal component.. This was a single-center, randomized, double-masked clinical study using the conjunctival allergen challenge (CAC) and nasal allergen challenge (NAC) models. It compared the clinical signs and symptoms induced by CAC and NAC, the effects of drugs administered by 3 different routes, and the movement of fluorescein after instillation into the eye and nose (Jones test), and assessed levels of of inflammatory mediators in tears and nasal secretions. At visit l, subjects previously identified as CAC responders underwent NAC to determine the dose of allergen necessary to elicit a sufficient positive reaction. At visit 2, which took place 1 week later, subjects with a positive reaction at visit 1 were randomized to group A (CAC) or group B (NAC), and underwent challenge to confirm the allergen dose necessary to produce a positive reaction. Subjects who qualified were randomized to receive 1 of 3 treatments: olopatadine 0.1% ophthalmic solution, placebo nasal spray, and placebo tablets; mometasone furoate monohydrate 50-microg nasal spray, placebo topical solution, and placebo tablets; or fexofenadine hydrochloride 180-mg tablets, placebo topical solution, and placebo nasal spray. All study medications were administered according to their approved labeling: drops were administered twice daily in the eyes, and the nasal sprays and tablets were administered once daily. At visit 3, which took place 1 week after visit 2, subjects received study medication and 15 minutes later underwent CAC or NAC as before. The primary efficacy variables were ocular itching, ocular redness, and overall nasal symptoms (sneezing, rhino rrhea/postnasal drip, nasal pruritus, palatal pruritus, and nasal congestion) rated on standard scales. Peak nasal inspiratory flow (PNIF) was measured at each visit, and the Jones test was performed at visits 1 and 3. At baseline and after challenge at visits 2 and 3, tear and nasal lavage samples were collected from a subset of randomly selected subjects for analysis of eosinophil cationic protein and tryptase.. Seventy-three subjects (42 women, 31 men; mean age, 45.26 years [range, 21-73 years]) were screened, and all were randomized to treatment. Two subjects did not complete the study. CAC induced clinically significant (>1 unit difference) ocular and nasal signs and symptoms, whereas NAC induced clinically significant nasal signs and symptoms only. In group A, there was a greater reduction in ocular itching with olopatadine compared with mometasone and fexofenadine at 3 minutes (P = 0.003 and P = 0.008, respectively) and 5 minutes (P = 0.007 and P = 0.013) after challenge. Although the difference was not statistically significant, overall relief of conjunctival redness (average of 3 vessel beds) was greatest in the olopatadine group, followed by fexofenadine. In group B, prevention of total nasal symptoms was significantly greater with mometasone compared with fexofenadine at 20 minutes (P = 0.006) and 30 minutes (P = 0.014) after challenge. There were no statistically significant differences between treatment groups in nasal symptom scores at any time point after CAC. There were also no significant differences in PNIF between treatment groups. Fluorescein was present in nasal secretions within 5 minutes of being instilled into the eye; no fluorescein was detected in the eye after instillation into the nose.. In this study, exposure of the nasal mucosa to allergen resulted in allergic rhinitis, and exposure of the ocular the ocular surface to allergen resulted in conjunctivitis with a secondary effect in the nose. These results suggest movement of allergens, their mediators, and antiallergy drugs from the ocular surfaces into the nasal cavity, with no meaningful movement from the nasal cavity to the ocular surface. In this controlled model, both the systemic agent and the nasal spray failed to control ocular symptoms. The topical ophthalmic solution provided the most effective management of allergic ocular signs and symptoms, and the nasal spray was most effective for nasal symptoms. Combined use of a nasal spray and topical ophthalmic solution may provide maximal relief in patients whose allergies have both ocular and nasal components.

Topics: Administration, Intranasal; Administration, Oral; Administration, Topical; Adult; Aged; Allergens; Anti-Allergic Agents; Conjunctiva; Conjunctivitis, Allergic; Dibenzoxepins; Double-Blind Method; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Mucosa; Olopatadine Hydrochloride; Ophthalmic Solutions; Pregnadienediols; Rhinitis, Allergic, Perennial; Tablets; Terfenadine; Time Factors

We investigated the effect of mometasone furoate on mucociliary clearance in patients with perennial allergic rhinitis.. The study included 25 patients (16 females, 9 males; mean age 30 years; range 18 to 50 years) with perennial allergic rhinitis. Mometasone furoate (nasal spray) was administered at a dose of 2 puffs (100 microgr) to each nostril daily for a month. Mucociliary clearance was evaluated by the saccharin test before and after treatment.. The mean mucociliary clearance time was 6.89 +/- 0.64 minutes before the treatment and 7.18 +/- 0.54 minutes after the treatment. No significant delay in the mucociliary clearance was detected (p > 0.05). The mean mucociliary clearance time did not differ significantly between male and female patients (p > 0.05).. The results suggest that mometasone furoate do not affect mucociliary clearance in patients with perennial allergic rhinitis.

Topics: Administration, Inhalation; Adolescent; Adult; Anti-Allergic Agents; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Mometasone Furoate; Mucociliary Clearance; Nasal Mucosa; Pregnadienediols; Rhinitis, Allergic, Perennial; Treatment Outcome

Although they have comparable safety and efficacy profiles, different intranasal corticosteroids possess different sensory/chemical properties that can be easily differentiated by patients, and which may influence their preference and compliance.. We sought to compare patient assessments of sensory attributes of three intranasal corticosteroid sprays: triamcinolone acetonide aqueous (TAA), fluticasone propionate (FP), and mometasone furoate (MF).. In a multicenter, randomized, double-blind, crossover study, 95 patients with allergic rhinitis rated 14 sensory items (100-point scales), product preference, and likelihood of compliance with treatment.. Immediately after administration, compared with MF, TAA was rated as having significantly better comfort during administration, less irritation, less odor strength, preferred odor, more moistness of nose/throat, milder taste (all P < or = 0.001), and preferred taste (P < or = 0.01). Compared with FP, TAA was rated as having significantly less odor strength, preferred odor (both P < or = 0.001), more moistness of nose/throat (P < or = 0.01), and milder taste (P < or = 0.05). Two minutes after application, TAA was rated as having less aftertaste than FP (P < or = 0.01) or MF (P < or = 0.001), and produced significantly less irritation (FP P < or = 0.05; MF P < or = 0.01). Of patients, 54.7% said they would prefer a prescription of TAA over one for MF (24.2%; P = 0.001) or FP (21.1%; P = 0.001). More patients indicated that they would be more compliant with treatment if given the TAA prescription (67.4%) than if given a prescription with FP (54.7%) or MF (49.5%).. Several of the TAA sensory attributes were preferred over those of MF and FP. Patient preference may play a role in enhancing treatment compliance. Such findings indicate that TAA nasal spray may be a better choice than MF or FP in the treatment of seasonal and perennial allergic rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Aged; Androstadienes; Anti-Allergic Agents; Cross-Over Studies; Double-Blind Method; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Mometasone Furoate; Patient Satisfaction; Perception; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Triamcinolone Acetonide

Using conventional methods, it has been difficult to show differences in efficacy between intranasal corticosteroids in perennial rhinitis.. To compare the effects of budesonide and mometasone on nasal symptoms and nasal airflow in perennial allergic rhinitis.. Four hundred thirty-eight patients (age > 18 years old) were randomized to budesonide, 256 microg or 128 microg, mometasone furoate 200 microg, or placebo, once daily for 4 weeks. Efficacy was evaluated by nasal index score (NIS; the sum of scores for blocked nose, runny nose, and itchy nose/sneezing) and peak nasal inspiratory flow (PNIF).. All three active treatments significantly reduced the NIS compared with placebo. There was no significant difference between the treatments, although the effect of budesonide, 256 microg, tended to be greater than that of the other regimens. PNIF was significantly improved with all three active treatments: the effect of budesonide 256 microg on morning and evening PNIF was significantly greater than that of mometasone furoate and 128 microg budesonide. Budesonide had a rapid onset of action, showing a significantly greater effect on evening PNIF than mometasone furoate during the first 10 days. For all active treatments, significant improvements in NIS were seen within 4 hours of the first dose. All three treatments were well tolerated.. The objective parameter PNIF was capable of demonstrating greater efficacy of budesonide 256 microg compared with budesonide 128 microg and mometasone furoate 200 microg, whereas the combined nasal symptom score could only distinguish active treatment from placebo.

Topics: Administration, Intranasal; Adult; Aged; Budesonide; Female; Humans; Hungary; Inspiratory Capacity; Male; Middle Aged; Mometasone Furoate; Nose; Portugal; Pregnadienediols; Rhinitis, Allergic, Perennial; Spain; Sweden

Intranasal corticosteroids are used widely for the treatment of allergic rhinitis because they are effective and well tolerated. However, their potential to suppress growth of pediatric subjects with allergic rhinitis continues to be a concern, particularly in light of reports of growth suppression after treatment with intranasal beclomethasone dipropionate or intranasal budesonide (see the article by Skoner et al in this month's issue). A 1-year study of prepubertal patients between 3 and 9 years of age with perennial allergic rhinitis was conducted to assess the effects on growth of mometasone furoate aqueous nasal spray (MFNS), a new once-daily (QD) intranasal corticosteroid with negligible bioavailability.. This was a randomized, placebo-controlled, double-blind, multicenter study. Ninety-eight subjects were randomized to treatment with either MFNS 100 microg QD or placebo for 1 year. Each subject's height was required to be between the 5th and 95th percentile at baseline, and skeletal age at screening was required to be within 2 years of chronological age, as determined by left wrist x-rays. Washout periods for medications that affect either childhood growth or allergic rhinitis symptoms were established based on estimated period of effect, and these medications were prohibited during the study. However, short courses of either oral prednisone lasting no longer than 7 days or low-potency topical dermatologic corticosteroids lasting no longer than 10 days were permitted if necessary. Height was measured with a calibrated stadiometer at baseline and at 4, 8, 12, 26, 39, and 52 weeks, and the primary safety variable was the change in standing height. The rate of growth was also calculated for each subject as the slope (linear regression) of the change in height from baseline using data from all visits of subjects who had at least 2 visits. Hypothalamic-pituitary-adrenocortical- (HPA)-axis function was assessed via cosyntropin stimulation testing at baseline and at 26 and 52 weeks. All analyses were based on all randomized subjects (intent-to-treat principle). The change from baseline in standing height was analyzed by a 2-way analysis of variance that extracted sources of variation attributable to treatment, center, and treatment-by-center interaction.. Demographic characteristics were similar at baseline. Eighty-two subjects completed the study (42 in the MFNS group and 40 in the placebo group), and 93% of subjects achieved at least 80% compliance with therapy. After 1 year of treatment, no suppression of growth was seen in subjects treated with MFNS, and mean standing heights were similar for both treatment groups at all time points. For the primary safety variable (change in height from baseline), both treatment groups were similar at all time points except for weeks 8 and 52. Subjects treated with MFNS had a slightly greater mean increase in height than subjects treated with placebo at these time points: the change in height was 6.95 cm versus 6.35 cm at the 1-year time point. However, the rate of growth (.018 cm/day) averaged for all time points over the course of the study was similar for both treatment groups. Additional analyses found that MFNS did not retard growth in any sex or age subgroup of subjects. The use of exogenous corticosteroids other than the study drug was also similar among the 2 treatment groups. Results from cosyntropin stimulation testing confirmed the absence of systemic effects of MFNS. The change from baseline in the difference between prestimulation and poststimulation levels was similar for both treatment groups after 1 year of treatment, with no evidence of HPA-axis suppression in MFNS-treated subjects at any time point. Incidences of treatment-related adverse events were similar for both treatment groups, with 16% of MFNS-treated subjects reporting adverse events, compared with 22% of placebo-treated subjects.. (ABSTRACT TRUNCATED)

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Child; Double-Blind Method; Female; Glucocorticoids; Growth; Growth Disorders; Humans; Male; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial

Topics: Adolescent; Adult; Anti-Inflammatory Agents; Child; Child, Preschool; Chronic Disease; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Treatment Outcome

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Beclomethasone; Body Height; Child; Child, Preschool; Double-Blind Method; Female; Glucocorticoids; Humans; Long-Term Care; Male; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial

Mometasone furoate (MF) aqueous nasal spray is a potent intranasal glucocorticoid with low systemic bioavailability. Knemometry has been shown to be a sensitive method of detecting systemic effects of exogenous steroids in children.. We sought to assess whether MF (100 or 200 microg) or budesonide intranasal aqueous spray (400 microg) influences the short-term lower leg growth rate in children with seasonal or perennial allergic rhinitis.. MF, budesonide, and placebo were administered once daily for 2 weeks to 22 children aged 7 to 12 years (mean, 10 years) in a randomized, double-blind, crossover study. Lower leg measurements were done before and after each 2-week treatment period. Two-week washout intervals separated each treatment period.. There were no significant differences in lower leg growth rates among the MF 200 microg (0.95 +/- 0.79 mm; mean +/- SD), budesonide 400 microg (0.73 +/- 0.61 mm), or placebo (0.69 +/- 0.70 mm) groups. The growth rate of the group receiving a 100-microg dose of MF (1.16 +/- 0.67 mm) was greater than that for the group receiving placebo (P =.024) or budesonide (P =.033). No statistically significant sequence effect (P =.11), carry-over effect (P =.24), overall treatment effect (P =.086), or period effect (P =.065) was detected.. No short-term adverse effects on linear lower leg growth rates were detected after once daily MF or budesonide at clinically relevant doses.

Topics: Administration, Intranasal; Anti-Allergic Agents; Anti-Inflammatory Agents; Budesonide; Child; Cross-Over Studies; Double-Blind Method; Female; Glucocorticoids; Growth; Humans; Leg; Male; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Time Factors; Treatment Outcome

Allergic rhinitis is associated with specific histopathologic changes in the nasal mucosa including squamous metaplasia and local eosinophilia. Previous studies have shown that mometasone furoate aqueous nasal spray is effective and well tolerated in reducing perennial rhinitis and seasonal allergic rhinitis symptoms. We undertook a multicenter, open-label study to evaluate, by nasal biopsy, the tissue changes associated with mometasone furoate use (200 microg/day) during a 12-month treatment period in patients with perennial rhinitis. Of the 69 patients enrolled in the study, 52 completed all 12 months of treatment. Nasal biopsy specimens obtained from patients at baseline and after treatment were evaluated in a blinded fashion by computerized image analysis, qualitative histologic examination, and immunocytochemistry. Morphologic examination of nasal biopsy specimens showed a decrease in focal metaplasia, no change in epithelial thickness, and no sign of atrophy after treatment with mometasone furoate. Immunocytochemical analyses of nasal biopsy specimens obtained before and after treatment revealed a significant decrease in major basic protein-positive eosinophils and tryptase-positive mast cells in the epithelium and lamina propria after treatment. Mometasone furoate appeared to attenuate the inflammatory process by reducing the extent of inflammatory cell infiltration, particularly of eosinophils. This study demonstrated that long-term administration of mometasone furoate is not associated with adverse tissue changes in the nasal mucosa of patients with perennial rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Angiogenesis Inducing Agents; Anti-Inflammatory Agents; Atrophy; Biopsy; Blood Proteins; Chymases; Eosinophil Granule Proteins; Eosinophilia; Eosinophils; Epithelium; Female; Follow-Up Studies; Glucocorticoids; Humans; Image Processing, Computer-Assisted; Immunohistochemistry; Inflammation Mediators; Male; Mast Cells; Metaplasia; Middle Aged; Mometasone Furoate; Nasal Mucosa; Pregnadienediols; Rhinitis, Allergic, Perennial; Ribonucleases; Serine Endopeptidases; Single-Blind Method; Tryptases

Intranasal corticosteroids are regarded as the first-line treatment for allergic rhinitis, but few studies have directly compared their systemic effects.. The purpose of this study was to compare the systemic bioactivity of aqueous formulations of intranasal budesonide, mometasone furoate (MF), and triamcinolone acetonide (TAA) in terms of adrenal, bone, and white blood cell markers.. Twenty patients with allergic rhinitis, mean age (SE) 35.7 (3.5) years were studied in a single-blind, randomized, 4-way crossover design, with treatments separated by 7-day washout periods, comparing placebo with budesonide 200 micro(g) once daily, MF 200 micro(g) once daily, and TAA 220 micro(g) once daily. After 5 days of treatment at steady-state, serial blood and urine samples were taken for 24 hours. Collective and fractionated measurements (daytime, overnight, and 8 AM) were done on plasma cortisol and urine cortisol/creatinine excretion. Plasma osteocalcin and blood eosinophil counts were measured at 8 AM.. There was no significant difference between placebo and the active treatments with any of the markers of adrenal suppression. Mean values (SE) for 24-hour area under the curve plasma cortisol (nmol/L.hr) were placebo, 6312.9 (564.4); budesonide, 5908.8 (496.8); MF, 6374.1 (509.9); and TAA, 6239.2 (552.0). Twenty-four hour urinary cortisol/creatinine ratio (nanomoles per millimoles) showed placebo, 9.2 (0.5); budesonide, 8.5 (0.5); MF, 8.6 (0.4); and TAA, 8.6 (0.4). The diurnal circadian rhythm was unaffected, and there were only occasional patients with abnormally low cortisol values. There was also no suppression in terms of osteocalcin (placebo, 1.27 nmolL; budesonide, 1.22 nmol/L; MF, 1.33 nmol/L; and TAA, 1.24 nmol/L) and blood eosinophil count (placebo, 0.29 x 10(9)/L; budesonide, 0.27 x 10(9)/L; MF, 0.25 x 10(9)/L; and TAA, 0.24 x 10(9)/L).. Neither budesonide, MF, nor TAA produced significant systemic suppression of adrenal, bone, or white blood cell markers at the doses studied. This reflects the good safety profile of these aqueous intranasal formulations when taken at clinically recommended doses.

Topics: Administration, Intranasal; Adrenal Cortex Function Tests; Adult; Anti-Inflammatory Agents; Biomarkers; Budesonide; Circadian Rhythm; Cross-Over Studies; Female; Humans; Hydrocortisone; Leukocyte Count; Male; Mometasone Furoate; Osteocalcin; Osteogenesis; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Single-Blind Method; Triamcinolone Acetonide

Mometasone furoate (Nasonex), in a new once-daily aqueous nasal spray formulation, has been shown to be as effective and well-tolerated as twice-daily beclomethasone dipropionate aqueous nasal spray in treating symptoms of seasonal allergic rhinitis and perennial rhinitis.. To compare the effectiveness and tolerability of mometasone furoate to placebo and to fluticasone propionate aqueous nasal spray, all treatments administered once-daily, in patients with perennial rhinitis.. This was a 3-month, randomized, double-blind, double dummy, parallel group study in 550 patients, aged 12 to 77 years, at 25 centers in Canada, Latin America, and Europe. Patients allergic to at least one perennial allergen, with confirmed allergy history, skin test positivity, and moderate to severe symptomatology, were eligible to receive one of the following treatments, once daily in the morning: mometasone furoate 200 micrograms, fluticasone propionate 200 micrograms, or placebo. The primary efficacy variable was the change from baseline in total AM plus PM diary nasal symptom score over the first 15 days of treatment.. Four hundred fifty-nine patients were valid for efficacy. For the primary efficacy variable, mometasone furoate was significantly (P < .01) more effective than placebo and was not statistically different from fluticasone propionate (percent reductions from baseline were 37, 39, and 22 for mometasone furoate, fluticasone propionate, and placebo, respectively). Generally, similar trends were seen for physician-evaluated total nasal symptoms, and patient-rated and physician-rated overall condition and response to therapy. Overall, mometasone furoate was at least as effective as fluticasone propionate at equivalent doses. There was no evidence of tachyphylaxis. All treatments were well tolerated.. Mometasone furoate and fluticasone propionate adequately controlled symptoms of perennial rhinitis and were well tolerated.

Topics: Administration, Inhalation; Adolescent; Adult; Aged; Androstadienes; Anti-Inflammatory Agents, Non-Steroidal; Child; Double-Blind Method; Drug Administration Schedule; Female; Fluticasone; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial

Mometasone furoate (Nasonex), in a new once-daily aqueous nasal spray formulation, has been shown to be as effective and well-tolerated as twice-daily beclomethasone dipropionate aqueous nasal spray in treating symptoms of seasonal allergic rhinitis and perennial rhinitis.. To compare the effectiveness and tolerability of mometasone furoate to placebo and of fluticasone propionate aqueous nasal spray, all treatments administered once-daily, in patients with perennial rhinitis.. This was a 3-month, randomized, double-blind, double dummy, parallel group study in 550 patients, aged 12 to 77 years, at 25 centers in Canada, Latin America, and Europe. Patients allergic to at least one perennial allergen, with confirmed allergy history, skin test positivity, and moderate to severe symptomatology, were eligible to receive one of the following treatments, once daily in the morning: mometasone furoate 200 micrograms, fluticasone propionate 200 micrograms, or placebo. The primary efficacy variable was the change from baseline in total AM plus PM diary nasal symptom score over the first 15 days of treatment.. Four hundred fifty-nine patients were valid for efficacy. For the primary efficacy variable, mometasone furoate was significantly (P < .01) more effective than placebo and was not statistically different from fluticasone propionate (percent reductions from baseline were 37, 39, and 22 for mometasone furoate, fluticasone propionate, and placebo, respectively). Generally, similar trends were seen for physician-evaluated total nasal symptoms, and patient-rated and physician-rated overall condition and response to therapy. Overall, mometasone furoate was at least as effective as fluticasone propionate at equivalent doses. There was no evidence of tachyphylaxis. All treatments were well tolerated.. Mometasone furoate and fluticasone propionate adequately controlled symptoms of perennial rhinitis and were well tolerated.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents; Double-Blind Method; Drug Administration Schedule; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Mometasone Furoate; Placebos; Pregnadienediols; Rhinitis, Allergic, Perennial; Skin Tests; Treatment Failure

Perennial allergic rhinitis is chronic and persistent, may lead to a constellation of secondary complaints including sinusitis, mouth-breathing, and some symptoms resembling a permanent cold, and often requires constant medical intervention. Well-tolerated nasal corticosteroids, alone or in combination with antihistamines, have been found to be very effective in treating this condition.. To compare the effectiveness and tolerability of mometasone furoate aqueous suspension, a new once daily nasal spray, to placebo vehicle and to beclomethasone dipropionate, administered twice daily, in patients with perennial allergic rhinitis.. This was a randomized, double-blind, placebo-controlled, double-dummy, parallel group study, in 427 patients age 12 years and older at 24 centers in Canada and Europe. Patients allergic to at least one perennial allergen, confirmed by medical history, skin testing, and adequate symptomatology were eligible to receive one of the following regimens for 3 months: mometasone furoate, 200 micrograms only daily; beclomethasone dipropionate, 200 micrograms twice daily (400 micrograms total dose); or placebo vehicle control. The primary efficacy variable was the change from baseline in total AM plus PM diary nasal symptom score over the first 15 days of treatment.. Three hundred eighty-seven patients were valid for efficacy. For the primary efficacy variable, mometasone furoate was significantly (P < or = .01) more effective than placebo and was indistinguishable from beclomethasone dipropionate. Similar trends were seen among individual symptoms, physician symptom evaluations, and therapeutic response. There was no evidence of tachyphylaxis. All treatments were well tolerated.. Mometasone furoate nasal spray adequately controls symptoms of perennial allergic rhinitis, offers the advantage of once daily treatment, and is well tolerated.

Topics: Administration, Intranasal; Adolescent; Adult; Anti-Inflammatory Agents; Beclomethasone; Child; Circadian Rhythm; Double-Blind Method; Drug Administration Schedule; Female; Humans; Loratadine; Male; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial

To assess the efficacy of nasal expiratory sound analysis in determining the degree of nasal obstruction.. We have analyzed and recorded the expiratory nasal sounds in 18 healthy controls and in 30 patients with inferior turbinate hypertrophy before and after the administration of nasal corticosteroid treatment. Analysis consisted of the time-expanded waveform, spectral analysis with time-averaged fast Fourier transform and waveform analysis of nasal sound.. Before treatment, an increase in sound intensity at high frequency was observed in the sound analyses of the patients, whereas after treatment, a decrease in sound intensity at high frequency was noted in the sound analyses of the patients. The differences between the patients and the control group were statistically significant. Data obtained with the Odiosoft-Rhino method were correlated with symptom scores and endoscopic examination.. Expiratory nasal sound is a practical and objective tool, which can be reliably used not only for the assessment of the degree of nasal blockage but also for the comparison of different treatment alternatives.

Topics: Administration, Intranasal; Adult; Animals; Anti-Allergic Agents; Case-Control Studies; Female; Humans; Immunoglobulin E; Male; Mometasone Furoate; Nasal Obstruction; Pregnadienediols; Pyroglyphidae; Reproducibility of Results; Rhinitis, Allergic, Perennial; Rhinometry, Acoustic; Signal Processing, Computer-Assisted; Skin Tests

Glucocorticoids (GCs) are well known for their anti-inflammatory effects, which are elicited through a transcriptional mechanism via a cytosolic glucocorticoid receptor (cGR)-mediated genomic effect. However, recent in vitro studies report that GCs can act as a membrane glucocorticoid receptor (mGR). This study aimed to examine whether mometasone furoate (MF) influences the nasal symptoms induced by histamine, substance P, ATP. Furthermore, the influences of various compounds on MF action were studied in vivo. The mice were intranasally administered with nasal symptom-inciting agents, and the occurrences of sneezing and nasal rubbing were counted. MF repressed the nasal symptoms caused when it was administered 10, 30 and 60min before the induction of nasal symptoms. The repressive effect observed 10min after the administration of MF was inhibited by RU486, a GR antagonist, but not by actinomycin D, a transcriptional inhibitor. In contrast, the repressive effect observed 60min after the administration of MF was inhibited by RU486 and actinomycin D. Therefore, the effects observed 10 and 60min after the MF administration were classified as non-genomic and genomic effects, respectively. The non-genomic effect suppressed the nasal symptoms induced by m-3M3FBS, a phospholipase C (PLC) activator, and was inhibited by U-73122, a PLC inhibitor. The genomic effect was inhibited by N-(p-amylcinnamoyl) anthranilic acid, a phospholipase A2 (PLA2) inhibitor. These results indicate that MF has a non-genomic effect through repression of the activation of PLC via the mGR, and MF has also a genomic effect that was influenced by the inhibition of PLA2 through transcriptional regulation via cGR.

Topics: Adenosine Triphosphate; Animals; Behavior, Animal; Cinnamates; Disease Models, Animal; Estrenes; Female; Genomics; Glucocorticoids; Histamine; Hormone Antagonists; Mice; Mice, Inbred ICR; Mifepristone; Mometasone Furoate; ortho-Aminobenzoates; Phospholipase A2 Inhibitors; Pregnadienediols; Pyrrolidinones; Receptors, Glucocorticoid; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Sneezing; Substance P; Type C Phospholipases

We present two patients with allergic rhinitis who developed perioral dermatitis (PD) after initiating intranasal steroid spray. Both patients had been previously misdiagnosed as having contact or seborrheic dermatitis, and therefore inappropriately and unsuccessfully treated with topical steroids. Physicians should be aware of this potential side effect of intranasal steroids to avoid incorrect therapeutic measures. In the setting of nasal steroids use, PD probably is an under-reported and commonly misdiagnosed condition that should be thought when a patient treated with nasal steroids present with small erythematous papules, papulovesicles, and papulopustules occurring against a background of redness, beginning in the nasolabial areas and spreading rapidly to the perioral zone.

Topics: Administration, Intranasal; Adolescent; Androstadienes; Anti-Allergic Agents; Child; Dermatitis, Perioral; Female; Fluticasone; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial

Intranasal corticosteroids (INS) are the first line treatment for allergic rhinitis (AR). To guide clinical decision-making, we created a therapeutic index (TIX) for INS reflecting efficacy and safety.. A Medline search (1966 to June 2009) was carried out to identify all placebo-controlled randomized trials, and observational reports for safety issues, with Dexamethasone, Budesonide (BUD), Fluticasone propionate (FP), Fluticasone furoate (FF), Flunisolide, Mometasone furoate (MF), Triamcinolone (TRIAM), and Beclomethasone dipropionate (BDP) as treatment for AR. Data on three efficacy (nasal symptoms, ocular symptoms, global assessment) and three safety outcomes (epistaxis, growth, systemic ocular effects) were extracted. Meta analyses were performed for each INS and outcome and results were categorised into scores by quartiles. Scores of the three efficacy and safety outcomes were summed up to create summation scores for efficacy (ES) and side effects (AES), respectively with a maximum of 9 points. The TIX was then defined as the ratio of ES and AES.. Data of 84 studies were extracted. Based on availability of data, a TIX was calculated for 6 substances. BUD showed the highest efficacy score followed by MF and TRIAM. The lowest scores for side effects were achieved by MF and TRIAM followed by FP. These findings resulted in TIX scores of 7 and 5 for MF and TRIAM, respectively, indicating a high efficacy and low potential of adverse events. Medium scores were reached by BUD and FP and lower scores by BDP and FF.. Although safety and efficacy is proven for all available INS by multiple studies, the systematic aggregation and analysis of data allows for a differentiated summary on clinically important features.

Topics: Administration, Intranasal; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Fluocinolone Acetonide; Fluticasone; Glucocorticoids; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Treatment Outcome; Triamcinolone

To evaluate the effects of nasal mometasone furoate on oral and nasal nitric oxide (NO) production in patients with allergic rhinitis.. Twenty-seven patients with moderate to severe symptoms of persistent allergic rhinitis were treated with mometasone furoate nasal spray (200 microg/d. qd) for 2 weeks. Nasal and oral exhaled nitric oxide concentrations, symptoms of rhinitis and quality of life were investigated before and after the treatment.. There was a significant improvement in nasal exhaled nitric oxide concentrations, symptoms of rhinitis and quality of life, but not in oral exhaled nitric oxide concentrations. Subjective improvements in symptoms and quality of life did not correlate significantly with objective measurements.. Our study provides subjective and objective evidence on the efficacy of intranasal mometasone furoate in improving nasal symptoms and quality of life, as well as reducing nasal inflammation.

Topics: Administration, Intranasal; Adolescent; Adult; Anti-Allergic Agents; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nitric Oxide; Pregnadienediols; Quality of Life; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Young Adult

Intranasal corticosteroids (INCSs) seem to be the best medication available to control and eliminate symptoms of allergic rhinitis. However, the amounts of nasal steroids prescribed and used were not directly proportional to the number of allergic rhinitis cases in Turkey. Herein, we aimed to clarify the unexpectedly low prescription and use of INCSs in Turkey by checking the outlook of patients' and physicians' perspectives. The patients' perspective on oral and nasal steroids was evaluated with a custom-designed questionnaire drawn up specifically for this preliminary study. The physicians' perspective on prescribing nasal steroids was evaluated with the data obtained from the IMS Health Turkey reports. The findings we obtained in this survey by analyzing data from the self-administered questionnaires showed that among these young people, oral and nasal steroids were on the whole well-known drugs. Hence, even though steroids in general are well-known drugs, the young people we surveyed mainly remained uninformed about their safety. The incidence of using nasal steroids if prescribed is higher than the one with oral steroids; that may be due to the lack of knowledge about nasal steroids. The analysis of the IMS Health Turkey data for nasal steroid prescriptions between 2005 and 2008 shows that the market share has increased steadily. The role of INCSs in the treatment of allergic rhinitis is increasingly being recognized as an appropriate and effective treatment option. However, patients' and parents' concerns over the safety of INCS therapy have frequently resulted in their being positioned as a second-line treatment choice. Physicians need to be aware that patients may have a significant information gap. Instructing the family and caregivers about the correct use of INCS therapy is an important part of treatment.

Topics: Administration, Intranasal; Adult; Androstadienes; Anti-Inflammatory Agents; Attitude of Health Personnel; Budesonide; Drug Prescriptions; Female; Fluticasone; Health Knowledge, Attitudes, Practice; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Surveys and Questionnaires; Triamcinolone; Young Adult

We undertook comparative analysis of ciliotoxic effect of glucocorticosteroids frequently used for catheterization of the eustachian tube in patients presenting with exudative otitis media and concomitant allergic rhinitis. It was shown that the recovery of transport function of ciliary epithelium and appreciable clinical effect of the treatment were achieved by the application of mometasone furoate. Dexamethasone was next to mometasone in terms of efficiency whereas hydrocortisone produced much lower beneficial effect. It is concluded that, taking into account high bioavailability of dexametasone and hydrocortisone (> 80%) and contraindications to their intranasal administration, the preference should be given to medications with lower bioavailability.

Topics: Adolescent; Adult; Catheterization; Cilia; Dexamethasone; Epithelium; Eustachian Tube; Female; Glucocorticoids; Humans; Hydrocortisone; Male; Middle Aged; Mometasone Furoate; Otitis Media with Effusion; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Treatment Outcome; Young Adult

Exhaled nitric oxide (NO) measurement at multiple exhalation flow rates allows calculation of flow-independent NO parameters: alveolar NO concentration, bronchial NO flux, bronchial diffusing capacity of NO and bronchial wall NO concentration.. In the present study, we measured the flow-independent NO parameters and inflammatory markers in exhaled breath condensate (EBC) and in serum in 14 patients with seasonal allergic rhinitis (AR) without asthma, and in 14 age- and sex-matched healthy volunteers.. At symptomatic stage before the treatment, patients with AR had higher bronchial wall diffusing capacity of NO than healthy volunteers (p = 0.024), but there were no differences in bronchial wall NO concentration or alveolar NO concentration. Patients with AR had also increased 8-isoprostane levels in the EBC (p = 0.040), and increased serum levels of IgE (p = 0.002) and eosinophil cationic protein (ECP; p = 0.027). Two-week treatment with nasal glucocorticoid mometasone decreased symptom scores and serum ECP levels but had no effect on NO parameters or 8-isoprostane levels in EBC.. Noninvasive markers of airway inflammation showed subclinical lower airway inflammation in patients with AR without asthma, but short-term treatment with nasal glucocorticoids did not affect most of the markers of lower airway inflammation.

Topics: Adult; Biomarkers; Breath Tests; Bronchi; Dinoprost; Eosinophil Cationic Protein; Female; Glucocorticoids; Humans; Inflammation; Male; Mometasone Furoate; Nitric Oxide; Pregnadienediols; Respiratory Function Tests; Rhinitis, Allergic, Perennial; Young Adult

The main purpose of this study was to prepare a novel in situ gel system for nasal delivery of MF and study its efficacy on allergic rhinitis model. An ion-activated in situ gel was developed and characterized with gellan gum as a carrier. The system was stable kept at 40+/-2 degrees C for 6 months, and the micrographic results showed that in situ gel was safety without mucosa irritation when given at 20 microg once daily for 1 month to rats with allergic rhinitis. MF in gellan gum produced obviously effect on allergic rhinitis at the doses of 20 microg/body following intranasal administration, and the efficacy was significantly superior to that of the common suspension (P<0.01). The in situ gel system is a promising approach for the intranasal delivery of MF for the therapeutic effects improvement.

Topics: Administration, Intranasal; Animals; Anti-Allergic Agents; Anura; Disease Models, Animal; Drug Carriers; Drug Stability; Drug Storage; Female; Gels; Male; Mometasone Furoate; Nasal Mucosa; Polysaccharides, Bacterial; Pregnadienediols; Rats; Rats, Wistar; Rhinitis, Allergic, Perennial; Toxicity Tests

To determine whether the chloride channel protein CLC-3 is upregulated in patients with allergic rhinitis (AR) and whether topical corticosteroid treatment decreases the expression of CLC-3.. Histologic study.. Academic research.. Eighteen patients with AR were included in the study.. Expression of CLC-3 was detected by immunohistochemistry and by reverse transcription-polymerase chain reaction before and at 4 weeks after treatment with the topical corticosteroid mometasone furoate.. Strong CLC-3 expression was detected in epithelium and in submucosal glands. An increased presence of CLC-3 was demonstrated in nasal mucosa compared with that in normal nasal tissue. A statistically significant difference in CLC-3 gene expression level was found in nasal tissues before vs at 4 weeks after treatment with mometasone.. CLC-3 may have a role in modulating the pathogenesis of AR. Decreased expression of CLC-3 may be the mechanism of action of corticosteroid treatment in controlling AR.

Topics: Administration, Topical; Adult; Anti-Allergic Agents; Chloride Channels; Female; Humans; Immunoenzyme Techniques; Male; Middle Aged; Mometasone Furoate; Nasal Mucosa; Pregnadienediols; Reverse Transcriptase Polymerase Chain Reaction; Rhinitis, Allergic, Perennial; Statistics, Nonparametric; Up-Regulation

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Allergic Agents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Mucosa; Pregnadienediols; Rhinitis, Allergic, Perennial; Smell

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Androstadienes; Anti-Allergic Agents; Budesonide; Drug Administration Schedule; Fluticasone; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Triamcinolone Acetonide

To compare product attributes, preferences, and expected compliance associated with triamcinolone acetonide aqueous (TAA-AQ), fluticasone propionate (FP), and mometasone furoate (MF) nasal sprays in patients with allergic rhinitis.. Data from 2 randomized, double-blind crossover studies with identical design were pooled (N = 215). Patients completed a 14-item sensory attributes questionnaire immediately after each product, and stated their preference and expected compliance with a prescription after receiving all products.. Compared with FP and MF, TAA-AQ was associated with significantly less odor and greater liking of odor ( P < 0.001); and less taste, less dryness of nose/throat, less aftertaste, and greater overall liking ( P < 0.05). Significantly more patients preferred most a prescription of TAA-AQ (50.0%) versus FP (25.0%; P < 0.001) and MF (25.0%; P < 0.001), and would "definitely comply" with TAA-AQ (62.5%) versus FP (49.0%; P < 0.01) and MF (51.0%; P < 0.01).. TAA-AQ was associated with significantly more positive sensory attributes, higher preference, and better expected compliance than FP and MF.. Patients' preferences for the sensory attributes of an intranasal corticosteroid may affect adherence to treatment.

Topics: Administration, Intranasal; Adult; Androstadienes; Anti-Allergic Agents; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Mometasone Furoate; Nebulizers and Vaporizers; Patient Compliance; Patient Satisfaction; Pregnadienediols; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Surveys and Questionnaires; Triamcinolone Acetonide

We undertook a prospective study of the efficacy of a new intranasal steroid, mometasone furoate nasal spray (Nasonex; Schering-Plough Corp, Kenilworth, NJ).. Chinese patients with allergic rhinitis were recruited. The patients were assessed by a questionnaire that included demographic data and a Rhinitis Symptoms Score. Objective assessments of the nasal passages were performed with a 2.7-mm 30-degree rigid nasoendoscope and scored according to the modified Lund and Kennedy sinusitis staging and scoring for endoscopic appearances of the nasal cavity in rhinosinusitis. Patients were assessed before treatment, and then 200 microg/d MFNS was prescribed. Patients were reevaluated after 8 and 16 weeks of commencement of MFNS. A total of 51 patients completed the 16-week study.. There were significant reductions in mean Rhinitis Symptoms Score from 6.19 to 3.8 (P < 0.001) and mean Endoscopic Appearance Score from 4.6 to 3.58 (P = 0.046). Analysis showed that there were reductions in the severity of all 3 aspects of rhinitis symptoms: rhinorrhea, sneezing, and nasal obstruction.. Mometasone furoate nasal spray was effective in controlling allergic rhinitis and was well tolerated by patients.

Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Aged; Anti-Allergic Agents; China; Female; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Prospective Studies; Rhinitis, Allergic, Perennial; Solutions

Topics: Administration, Intranasal; Adult; Aerosols; Androstadienes; Anti-Inflammatory Agents; Budesonide; Child; Female; Fluticasone; Humans; Male; Mometasone Furoate; Nasal Polyps; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Singapore; Sinusitis; Triamcinolone Acetonide

The goal of treatment in pediatric allergic rhinitis is to provide effective prevention of or relief from allergic rhinitis symptoms as safely and effectively as possible. Removing or avoiding allergens is always advised; however, pharmacotherapy is often necessity. Pharmacologic options include systemic decongestants, which are associated with irritability and insomnia, particularly in children. Antihistamines are widely used; however, first-generation antihistamines are known to cause dry mouth and sedation. Oral corticosteroids are very effective but can have unwanted systemic effects. Over the past decade, intranasal corticosteroids have been shown to be the most effective form of pharmacologic treatment for allergic rhinitis. Data support the use of intranasal corticosteroids as first-line therapy over oral antihistamines; nonetheless, some clinicians have been reluctant to prescribe these agents, particularly for children, because of concerns for systemic effects. Overall, the newer corticosteroids, including mometasone furoate (MF), beclomethasone dipropionate, and budesonide have an improved risk-benefit ratio compared with older cortico-steroids and are now considered the drug of choice for pediatric allergic rhinitis. A good deal of evidence exists that confirms the lack of systemic effects from intranasal cortico-steroids. However, reports of decreased bone growth in children receiving intranasal budesonide short-term and beclomethasone dipropionate long-term have heightened concerns that some of these drugs may have systemic effects. A new intranasal corticosteroid, MF nasal spray, has been studied in children 3 to 12 years of age and has been shown to be effective. Intranasal MF is available with once-daily dosing, which has the potential to decrease systemic side effects.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Anti-Allergic Agents; Anti-Inflammatory Agents; Child; Child, Preschool; Clinical Trials as Topic; Growth Disorders; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Topics: Administration, Topical; Anti-Inflammatory Agents; Glucocorticoids; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial