mometasone-furoate and Rhinitis--Allergic--Seasonal

To review the pharmacology, efficacy, and safety of intranasal olopatadine hydrochloride-mometasone furoate (OM) combination in the treatment of seasonal allergic rhinitis (SAR).. The PubMed database and ClinicalTrials.gov were searched using the following terms: mometasone + olopatadine, GSP301, mometasone furoate, and olopatadine hydrochloride.. Articles published in English between January 1987 and August 2022 related to pharmacology, safety, and clinical trials were assessed.. In 2 phase II clinical trials, twice-daily (BID) and once-daily (QDay) intranasal OM demonstrated significant improvements in reflective total nasal symptom score (rTNSS) (BID. OM is indicated for treatment of SAR symptoms. Caution with use must be considered for certain high-risk patients, existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. Due to its quick and sustained onset of action, OM may be an ideal agent for initial treatment of moderate-severe SAR for patients 12 years and older.. OM significantly improves SAR symptoms and is a viable treatment option in short-term SAR.

Topics: Administration, Intranasal; Double-Blind Method; Humans; Mometasone Furoate; Nasal Sprays; Olopatadine Hydrochloride; Rhinitis, Allergic, Seasonal; Treatment Outcome

Allergic rhinitis (AR) is a common disease with an important impact on the quality of life and very high management costs. In many patients, the poor control of rhinitis symptoms often requires the use of different drugs, and polytherapy tends to reduce therapeutic adherence. According to the latest version of ARIA guidelines, the currently recommended drugs for the treatment of moderate-to-severe AR are second-generation antihistamines, intranasal corticosteroids, and their combination, even in a single nasal spray device. A single medication with a rapid onset of action, acting on breakthrough symptoms too, would be advantageous, also in terms of patient compliance.. GSP301 (olopatadine 600 µg - mometasone furoate 25 µg) is a novel intranasal formulation, combining the second-generation antihistamine olopatadine hydrochloride with mometasone furoate. Here, we review the evidence for GSP301, especially concerning the efficacy and safety profile of this intranasal combination in the treatment of AR.. The evidence provided in the current review clearly supports the use of GSP301 as a novel intranasal corticosteroid/antihistamine combination with a well-documented efficacy and safety profile in terms of rapid symptom relief and good tolerability.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Anti-Allergic Agents; Drug Combinations; Histamine Antagonists; Humans; Mometasone Furoate; Olopatadine Hydrochloride; Quality of Life; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Treatment Outcome

Intranasal corticosteroid (INCS) has a beneficial effect on ocular symptoms in allergic rhinitis (AR). To our knowledge, the cost-effectiveness of available INCS for AR with ocular symptoms is yet to be demonstrated.. To evaluate the cost-effectiveness of INCSs including Budesonide (BANS), Mometasone furoate (MFNS), Triamcinolone (TANS), and Fluticasone furoate (FFNS) on ocular symptoms associated with AR in the Thai context.. The percentage of effectiveness in improving total ocular symptoms score (TOSS) was derived from the result of a meta-analysis that estimated the SMD of each INCS treatment compared to placebo as clinical input parameters. A cost-effectiveness analysis based on a decision-tree model to assess one-year costs and outcomes from a Thai societal perspective. The outcomes were to compare incremental cost-effectiveness ratio (ICER). Probabilistic sensitivity analyses (PSA) were also conducted to capture parameter uncertainties.. 13 eligible RCTs with a total of 3,722 patients with SAR were included in the analysis. The percentage of effectiveness of FFNS, MFNS, TANS, and BANS was 59.89%, 45.60%, 24.89%, and 16.00%, respectively. The ICER of FFNS, MFNS, and TANS is THB-6,539.92, 4,593.83, and 1,401.24 compared to BANS. CECA result showed the probability of using FFNS is considered cost-effective in 87.50% of cases from zero value followed by MFNS (0.80%), TANS (5.40%), and BANS (6.30%). With a threshold greater than THB20,000, FFNS is considered a cost-effective strategy.. FFNS is a cost-effective option compared to alternative INCSs in Thailand for treating AR with ocular symptoms.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Anti-Allergic Agents; Cost-Effectiveness Analysis; Humans; Mometasone Furoate; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Treatment Outcome

GSP301 is a fixed-dose combination of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid). This meta-analysis aims to evaluate the efficacy and safety of GSP301 in the treatment of allergic rhinitis.. A systematic review and meta-analysis were conducted. The data were collected from PubMed, Cochrane Central Register of Controlled Trials and Embase databases till June 2021. In patients with AR, short-term (2/6 weeks) and long-term (52 weeks) effects of GSP301 were assessed. Average morning and evening 12-h reflective total nasal symptom score (rTNSS), instantaneous total nasal symptom score (iTNSS), reflective total ocular symptom score (rTOSS), instantaneous total ocular symptom score(iTOSS), Physician-assessed nasal symptom score (PNSS), rhinoconjunctivitis quality of life (RQLQ), rhinitis control assessment test (RCAT) and adverse events (AEs) were measured.. Five randomized controlled trials were included. GSP301 showed greatly improvement in rTNSS (MD = - 0.99; [95% CI - 1.19 to - 0.79]; P < 0.01; I. GSP301 is a safe and well-tolerated medication. It showed short-term benefits for seasonal and perennial AR, but may not help to improve patients' quality of life and rhinitis control in the long run.

Topics: Administration, Intranasal; Anti-Allergic Agents; Double-Blind Method; Humans; Mometasone Furoate; Nasal Sprays; Olopatadine Hydrochloride; Quality of Life; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Treatment Outcome

Allergic rhinitis (AR) is one the most common allergic diseases affecting from 10 to 40% of the population in different countries, including Russia. AR is a risk factor of bronchial asthma, other upper airway disease and may decrease patient quality of life, their productivity, increase probability of occupational traumatism, depression and anxiety. AR also presents a substantial economic burden. The rationale to use fixed dose combination of intranasal steroids and topical H1 antihistamines includes suboptimal control of symptoms by monotherapy, its complementary pharmacologic activity and the results of clinical trials. This review focused on fixed dose combination of intranasal mometasone furoate and olopataine. Double blind placebo-controlled and open clinical trials have confirmed that this combination decreased severity of nasal and ocular symptoms of seasonal and perennial AR, improved patient quality of life and had a good tolerability. Its efficacy was higher than those of monotherapy. Fast onset of action and sustainable effect on symptoms (during 1 yr) may improve adherence patients to the treatment and control of symptoms of AR.. Аллергический ринит (АР) является одним из наиболее распространенных заболеваний, поражающих от 10 до 40% населения в разных странах мира, в том числе и в России. Оно является значимым фактором риска развития бронхиальной астмы и болезней верхних дыхательных путей, существенно ухудшает качество жизни пациентов, оказывая отрицательное влияние на качество их сна, способность к обучению, производительность труда, может вызывать депрессию и тревогу, повышает риск производственного травматизма и из-за широкой распространенности имеет высокую стоимость лечения. Предпосылками создания для терапии АР фиксированных комбинаций, содержащих интраназальные глюкокортикостероиды и Н1-антигистаминные средства, явились потребность большинства пациентов в нескольких препаратах из-за тяжести его течения, недостаточный контроль заболевания при монотерапии, фармакологические свойства входящих в состав компонентов и результаты выполненных клинических исследований. В настоящем обзоре обсуждаются характеристики новой интраназальной комбинации, содержащей мометазона фуроат (МФ) и олопатадин (ОЛО). Результаты выполненных двойных слепых плацебо-контролируемых и открытых исследований свидетельствуют о том, что она уменьшает выраженность назальных и глазных симптомов сезонного и круглогодичного АР. Назальный спрей МФ/ОЛО улучшает качество жизни и характеризуется хорошей безопасностью. Эффективность комбинации МФ/ОЛО выше, чем у входящих в ее состав отдельных компонентов. Быстрота действия, выраженное и стойкое (в течение 12 мес) влияние на симптомы способны повысить приверженность пациентов проводимому лечению и улучшить контроль АР.

Topics: Anti-Allergic Agents; Histamine Antagonists; Humans; Mometasone Furoate; Quality of Life; Randomized Controlled Trials as Topic; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

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

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

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

Because most available treatments for managing seasonal allergic rhinitis show some side effects without reducing recurrence, natural anti-allergic products could represent an interesting treatment addition. This study aimed to analyse the efficacy and tolerance of quail egg as adjunctive therapy in seasonal allergic rhinitis.. In a Consolidated Standards of Reporting Trials compliant framework, patients with seasonal allergic rhinitis were prospectively randomised to receive mometasone nasal spray for four weeks or the same topical corticosteroid therapy plus commercially available oral quail egg and zinc tablets.. Forty patients were enrolled. The mometasone + quail egg and zinc tablets group showed a greater reduction in nasal itching, sneezing and total nasal symptom scores than the mometasone nasal spray only group. A higher proportion of participants in the mometasone + quail egg and zinc tablets group had good rhinitis control than in the mometasone nasal spray only group, with no need for rescue medications.. Despite the need for a further larger study, quail egg preliminarily appears to be an effective adjunct to topical steroid therapy in seasonal allergic rhinitis.

Topics: Administration, Intranasal; Anti-Allergic Agents; Double-Blind Method; Egg Hypersensitivity; Humans; Mometasone Furoate; Nasal Sprays; Pregnadienediols; Rhinitis, Allergic, Seasonal; Treatment Outcome; Zinc

Combination intranasal drugs with a corticosteroid and antihistamine are available in several countries with better effect than treatments with single agents. However, it remains unclear whether this effect is also seen in Japanese cedar pollinosis (JCP), the most prevalent seasonal allergic rhinitis in Japan. We investigated the effect of an add-on intranasal antihistamine with an intranasal corticosteroid in JCP during the pollen dispersal period. (UMIN000025508) METHODS: We performed a double-blinded, randomized, placebo-controlled trial from March 1 to 14, 2017. Patients (n = 20 per group) received either a mometasone furoate nasal spray (MFNS) plus a levocabastine nasal spray (levocabastine group) or MFNS plus a placebo nasal spray (placebo group). The primary endpoint was the difference in the total nasal symptom score (TNSS) after treatment between the two groups. Differences in the total ocular symptom score, total symptom score, total medication score, total symptom-medication score, and five individual symptoms as well as safety were the secondary endpoints.. The change in the TNSS from baseline was significantly greater in the levocabastine group than in the placebo group. A significant reduction in the TNSS was observed more than 6 days earlier in the levocabastine group than in the placebo group. Such add-on effects were also seen in the secondary endpoints. Both treatments were well-tolerated.. The intranasal antihistamine provided better control of not only nasal symptoms, but also of ocular symptoms, and decreased the need for rescue medications when added to intranasal corticosteroid treatment in JCP patients.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Anti-Allergic Agents; Cryptomeria; Drug Combinations; Histamine Antagonists; Humans; Mometasone Furoate; Nasal Sprays; Rhinitis, Allergic, Seasonal; Treatment Outcome

GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate.. To evaluate the efficacy, safety, and tolerability of GSP301 in pediatric patients (aged ≥6 to <12 years) with seasonal allergic rhinitis (SAR).. This double-blind, randomized, parallel-group study randomized 446 eligible patients 1:1 (GSP301 [olopatadine hydrochloride 665 μg and mometasone furoate 25 μg] or placebo) as 1 spray/each nostril twice daily for 14 days. The primary end point was change from baseline in average morning and evening subject-reported 12-hour reflective Total Nasal Symptom Score (rTNSS) over a 14-day treatment period analyzed using mixed-effect model repeated measures. Additional assessments included instantaneous Total Nasal Symptom Score, Pediatric Rhinoconjunctivitis Quality of Life Questionnaire, reflective Total Ocular Symptoms Score, instantaneous Total Ocular Symptoms Score, individual symptoms, Physician-assessed Nasal Symptom Score, and adverse events.. GSP301 showed clinically meaningful and statistically significant improvement in rTNSS vs placebo (-0.6; 95% confidence interval, -0.9 to -0.2; P = .001). Statistically significant improvements favoring GSP301 were shown for all individual rTNSS symptoms, instantaneous Total Nasal Symptom Score, and most of its individual symptoms, Physician-assessed Nasal Symptom Score (P = .01), and Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (P < .001). For ocular symptoms, numerical improvements favoring GSP301 were observed, with statistical significance achieved only for reflective "tearing/watering eyes" (P = .04). Treatment-emergent adverse events occurred in 12.0% and 10.4% of patients in the GSP301 and placebo groups, respectively. One subject (0.5%) (placebo group) experienced a serious adverse event (suspected viral meningitis) that was not related to the study treatment and was resolved.. GSP301 was well tolerated and efficacious for treating SAR symptoms in pediatric patients and showed a favorable safety profile.. ClinicalTrials.gov Identifier: NCT03463031.

Topics: Administration, Intranasal; Anti-Allergic Agents; Child; Double-Blind Method; Humans; Mometasone Furoate; Nasal Sprays; Olopatadine Hydrochloride; Quality of Life; Rhinitis, Allergic, Seasonal; Treatment Outcome

GSP301 is an investigational fixed-dose combination nasal spray of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid).. To evaluate efficacy and safety of GSP301 in patients with seasonal AR (SAR).. In this phase 2, double-blind, parallel-group study, patients (≥12 years of age) with SAR were equally randomized to twice-daily GSP301 (olopatadine 665 μg and mometasone 25 μg), once-daily GSP301 (olopatadine 665 μg and mometasone 50 μg), twice-daily or once-daily olopatadine monotherapy (665 μg), mometasone monotherapy (twice-daily 25 μg or once-daily 50 μg), or placebo for 14 days. The primary endpoint-mean change from baseline in morning and evening reflective Total Nasal Symptom Score (rTNSS)-was analyzed using analysis of covariance (ANCOVA; P < .05 = statistically significant). Average morning and evening 12-hour instantaneous TNSS (iTNSS), ocular symptoms, individual symptoms, onset of action, quality of life, and adverse events (AEs) were also assessed.. A total of 1111 patients were randomized. Twice-daily GSP301 provided statistically significant and clinically meaningful rTNSS improvements vs placebo (P < .001), twice-daily olopatadine (P = .049), and mometasone (P = .004). Similar significant improvements in iTNSS were observed with twice-daily GSP301 vs placebo (P < .001) and twice-daily mometasone (P = .007); improvements were not significant vs olopatadine (P = .058). Once-daily GSP301 provided significant rTNSS and iTNSS improvements vs placebo and once-daily olopatadine (P < .01, all) but improvements were not significant vs mometasone. Treatment-emergent AEs rates were 10.8%, 9.5%, and 8.2%, with twice-daily GSP301, once-daily GSP301, and placebo, respectively.. Twice-daily GSP301 treatment was efficacious and well tolerated, providing statistically significant and clinically meaningful improvements in rTNSS (primary endpoint) vs placebo and both monotherapies.. Clinicaltrials.gov Identifier NCT02318303.

Topics: Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Sprays; Olopatadine Hydrochloride; Rhinitis, Allergic, Seasonal; Treatment Outcome

GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate intended for seasonal allergic rhinitis (SAR) treatment.. To evaluate the efficacy and safety of once-daily or twice-daily GSP301 in a ragweed pollen environmental exposure chamber.. In this randomized, double-blind, double-dummy study, adults (18-65 years old) with SAR were equally randomized to 665 μg of olopatadine and 25 μg of mometasone (twice-daily GSP301), 665 μg of olopatadine and 50 μg of mometasone (once-daily GSP301), a US Food and Drug Administration-approved formulation of 137 μg of azelastine and 50 μg of fluticasone twice-daily (AzeFlu), a US Food and Drug Administration-approved formulation of 665 μg of olopatadine twice-daily, or placebo (twice-daily). During 2 visits (baseline and end of 14-day treatment), participants assessed SAR symptoms at specified time points. The primary end point-mean change from baseline in instantaneous total nasal symptom score (iTNSS) for twice-daily or once-daily GSP301 vs placebo-was analyzed by analysis of covariance. Onset of action, ocular symptoms, and adverse events were assessed.. A total of 180 participants were randomized. Treatment with twice-daily or once-daily GSP301 provided statistically significant improvements in iTNSS vs placebo (twice-daily GSP301: least squares mean difference, -3.60; 95% confidence interval [CI], -4.89 to -2.30; once-daily GSP301: least squares mean difference, -3.05; 95% CI, -4.35 to -1.76; P < .0001 for both). Significant improvements in iTNSS with twice-daily GSP301 occurred by 10 minutes after dosing (-1.26; 95% CI, -2.30 to -0.21; P = .02) and were maintained at all later time points except one (2.5 hours). Treatment-emergent adverse events occurred in 22.2%, 30.6%, 25.0%, 22.2%, and 16.7% of participants in the twice-daily GSP301, once-daily GSP301, AzeFlu, olopatadine, and placebo groups, respectively.. In an environmental exposure chamber model, twice-daily and once-daily GSP301 treatments were well tolerated and provided statistically significant and clinically meaningful SAR symptom improvement vs placebo.. ClinicalTrials.gov Identifier: NCT03444506.

Topics: Adult; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Environmental Exposure; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Sprays; Olopatadine Hydrochloride; Rhinitis, Allergic, Seasonal

GSP301 nasal spray is a fixed-dose combination of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid).. To evaluate the efficacy and safety of GSP301 in patients with seasonal allergic rhinitis (SAR).. In this double-blind study, eligible patients (≥12 years of age) with SAR were randomized 1:1:1:1 to twice-daily GSP301 (665 μg of olopatadine and 25 μg of mometasone), olopatadine (665 μg), mometasone (25 μg), or placebo for 14 days. The primary end point-mean change from baseline in average morning and evening 12-hour reflective Total Nasal Symptom Score (rTNSS)-was analyzed via a mixed-effect model repeated measures (P < .05 was considered to be statistically significant). Additional assessments included average morning and evening 12-hour instantaneous TNSS (iTNSS), ocular symptoms, individual symptoms, onset of action, quality of life, and adverse events (AEs).. A total of 1176 patients were randomized. GSP301 provided statistically significant and clinically meaningful rTNSS improvements vs placebo (least squares mean difference, -1.09; 95% CI, -1.49 to -0.69; P < .001) and vs olopatadine (P = .03) and mometasone (P = .02). Similar significant improvements in iTNSS were also observed with GSP301 (P < .05 for all). Furthermore, GSP301 significantly improved overall ocular symptoms, individual nasal and ocular symptoms, and quality of life vs placebo (P ≤ .001 for all). Onset of action for GSP301 was observed within 15 minutes and was maintained at all subsequent timepoints. Treatment-emergent AEs occurred in 15.6%, 12.6%, 9.6%, and 9.5% of patients in the GSP301, olopatadine, mometasone, and placebo groups, respectively.. GSP301 is efficacious and well tolerated vs placebo for treating SAR-associated nasal and ocular symptoms, with a rapid onset of action of 15 minutes in adult and adolescent patients 12 years and older.. ClinicalTrials.gov: NCT02870205.

Topics: Adolescent; Adrenal Cortex Hormones; Adult; Disease Progression; Double-Blind Method; Drug Combinations; Female; Histamine Antagonists; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Sprays; Olopatadine Hydrochloride; Quality of Life; Rhinitis, Allergic, Seasonal; Treatment Outcome; Young Adult

Topics: Adult; Anti-Allergic Agents; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Sprays; Olopatadine Hydrochloride; Placebos; Quality of Life; Rhinitis, Allergic, Seasonal; Treatment Outcome

GSP301 is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate developed as a single nasal spray.. To assess the relative bioavailability of olopatadine administered as GSP301 versus two olopatadine monotherapy nasal spray formulations.. In this single-dose, open-label, crossover study, healthy adults (18-65 years old) were equally randomized to one of six treatment sequences for three 48-hour treatment periods with GSP301 (olopatadine 665 μg-mometasone 50 μg), the olopatadine monotherapy component of GSP301 (OLO-sponsor; 665 μg) and U.S. Food and Drug Administration approved olopatadine (OLO; 665 μg); each treatment was administered as a single dose (two sprays in each nostril). To assess the relative bioavailability of olopatadine in the fixed-dose nasal spray versus two monotherapies, pharmacokinetic (PK) estimates, maximum plasma concentration (Cmax), area under the plasma concentration time curve (AUC) from time 0 to the last time point with measurable concentration (AUC0-t), and AUC from time 0 to time infinity (AUC0-∞) were compared by analysis of variance. Safety and tolerability were also evaluated.. A total of 30 healthy adults (mean age, 43.1 years) were randomized. The majority of the subjects were white men. The geometric mean ratios for natural log transformed Cmax, AUC0-t, and AUC0-∞ of olopatadine in GSP301 and OLO-sponsor were 86.63, 86.92, and 92.83, respectively. For GSP301 and OLO, geometric mean ratios for Cmax, AUC0-t, and AUC0-∞ were 84.68, 87.87, and 93.80, respectively. The percentage of subjects who reported treatment-emergent adverse events (AE) for GSP301, OLO-sponsor, and OLO were 13.8, 10.3, and 10.0%, respectively, with mild AEs reported. One subject withdrew from the study due to an AE (minor oropharyngeal pain) during OLO treatment, before receiving GSP301.. Olopatadine bioavailability with GSP301 was comparable with OLO-sponsor and OLO. The presence of mometasone in GSP301 did not considerably affect the PK of olopatadine. GSP301 was well tolerated, with only mild AEs reported.

Topics: Administration, Intranasal; Adolescent; Adrenal Cortex Hormones; Adult; Aged; Cross-Over Studies; Drug Combinations; Female; Healthy Volunteers; Histamine Antagonists; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Sprays; Olopatadine Hydrochloride; Rhinitis, Allergic, Seasonal; Young Adult

Topics: Administration, Intranasal; Anti-Allergic Agents; Butyrophenones; Double-Blind Method; Drug Therapy, Combination; Histamine H1 Antagonists; Humans; Mometasone Furoate; Piperidines; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Intranasal corticosteroid sprays (INCSs) are commonly used for therapy of allergic rhinitis (AR). Adherence to regular use of INCSs is influenced by patient perception and preferences of products. The study objective was to compare perceived sensory attributes of fluticasone furoate nasal spray (FFNS) and mometasone furoate nasal spray (MFNS) in AR patients.. In a multicenter, randomized, crossover, prospective study, 40 seasonal AR patients were administered both FFNS and MFNS for 2 weeks each in a crossover fashion, for a total of 4 weeks. Patients completed questionnaires for each product regarding perceived sensory attributes at the end of each two-week period of product administration.. FFNS was significantly preferred over MFNS. Significantly, fewer subjects perceived a bitter taste (p=0.01), medication running down their throat (p=0.033), and medication running out of their nose (p=0.002) with FFNS. MFNS was more frequently reported to induce nasal irritation (p=0.012), sneezing (p=0.017), and rhinorrhea (p=0.007) compared to FFNS. Interestingly, these findings were markedly observed in females. Medicine dripping out of the nose and nasal shooting were the most common problems reported for MFNS with a higher proportion of subjects who felt moderate-to-severe discomfort. Overall, 52.5% of patients expressed a preference for FFNS compared with 22.5% for MFNS.. Several perceived sensory attributes of FFNS were rated significantly superior to MFNS. FFNS may contribute to enhanced treatment outcomes in AR patients due to improved treatment adherence.

Topics: Administration, Intranasal; Adult; Aged; Androstadienes; Anti-Allergic Agents; Cross-Over Studies; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Sprays; Patient Preference; Rhinitis, Allergic, Seasonal; Sex Factors; Sneezing; Surveys and Questionnaires; Taste

Intranasal corticosteroids are effective for allergic rhinitis and broadly used in daily clinical practice. Systemic oral corticosteroids are also known to be effective for treatment of allergic rhinitis. These topical and systemic corticosteroids are both effective formulations for allergic rhinitis, and both drugs have some side effects. When treatment formulations for allergic rhinitis are selected based on side effects, topical corticosteroids are more commonly selected than systemic steroids. Systemic corticosteroids, on the other hand, have traditionally been believed to have higher and more instantaneous therapeutic effects than those of topical corticosteroids. However, there have been few reports of direct comparisons between topical corticosteroid and systemic corticosteroid efficacy. The purpose of this study was to evaluate the subjective outcomes of nasal symptom management using topical intranasal corticosteroid therapy or systemic oral corticosteroid therapy in patients with seasonal allergic rhinitis. We compared the efficacy of mometasone furoate nasal spray (MFNS) to betamethasone oral tablets (BOT) for the treatment of patients with seasonal allergic rhinitis.. In an open label study, patients with seasonal allergic rhinitis who had intermediate-to-severe symptoms and who visited the hospital without prior treatment were allocated to 1 of 3 treatment groups (noncorticosteroid group, topical corticosteroid group, and oral corticosteroid group). Evaluation was conducted using allergy diaries that consisted of patient questionnaires. The Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ) was used in this study.. Compared to only loratazine nonsteroid therapy, both MFNS 200μg once daily and BOT 0.25mg twice daily significantly reduced the total and individual symptom scores for sneezing, nasal obstruction, watery nasal discharge, and nasal itching (P<0.05). Scores for itching of the eyes were reduced slightly more in the MFNS group than in the noncorticosteriod treatment group, but the difference was not significant.. MFNS and BOT have virtually equivalent effects on nasal symptoms in patients with seasonal allergies. Our study was the first direct comparison between an intranasal corticosteroid spray and a systemic oral corticosteroid for seasonal allergic rhinitis. No significant differences were found in the therapeutic effects of the topical and systemic corticosteroids tested, suggesting that topical corticosteroids are expected to sufficiently improve nasal symptoms without administration of oral corticosteroids. Treatment with intranasal corticosteroid spray is more strongly recommended than treatment with systemic corticoid steroids, due to the side effects associated with each treatment.

Topics: Administration, Intranasal; Administration, Oral; Adult; Aged; Anti-Allergic Agents; Betamethasone; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Loratadine; Male; Middle Aged; Mometasone Furoate; Nasal Obstruction; Pregnadienediols; Rhinitis, Allergic, Seasonal; Young Adult

Little is known about the safety and effectiveness of early interventional treatment (EIT) with intranasal corticosteroids for seasonal allergic rhinitis. We designed a double-blinded, randomized, placebo-controlled 12-week trial of EIT with mometasone furoate nasal spray (MFNS) for Japanese cedar/cypress pollinosis (JCCP).. A total of 50 JCCP patients received MFNS (200μg once daily: n = 25) or placebo (n = 25) starting on February 1, 2010. Treatments continued until the end of April. The primary endpoint was the comparison of the total nasal symptom score (TNSS) between the MFNS and placebo groups. The secondary endpoints included comparisons of QOL, daytime sleepiness, nasal ECP levels, and safety.. Continuous dispersion of Japanese cedar pollen began on February 22. Although the placebo group showed a significant worsening of symptoms after the start of the continuous dispersion, no worsening occurred in the MFNS group. A significant difference in the TNSS between the two groups was seen starting at 4 weeks after the treatment. Similar results were seen for QOL and sleepiness. Nasal ECP levels in March were significantly lower in the MFNS group. A total of 56% of the MFNS group progressed to a persistent allergic rhinitis state in accordance with the ARIA classification, as opposed to 84% of the placebo group. MFNS was well tolerated, and the plasma cortisol concentrations were similar between the two groups.. EIT with MFNS for JCCP is both safe and effective. This treatment can potentially lessen symptoms and help pollinosis patients remain in the intermittent state.

Topics: Administration, Intranasal; Adult; Anti-Allergic Agents; Cryptomeria; Cupressus; Disease Progression; Disease-Free Survival; Female; Follow-Up Studies; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Obstruction; Pregnadienediols; Rhinitis, Allergic, Seasonal; Treatment Outcome; Young Adult

Intranasal steroids relieve nasal symptoms and ocular itch in allergic rhinitis. Itchy ear and palate are also common and bothersome symptoms but have received little attention in clinical trials of allergic rhinitis.. To ascertain the efficacy of mometasone furoate nasal spray in alleviating itchy ear and palate in seasonal allergic rhinitis.. Data were pooled from 4 randomized, double-blind, placebo-controlled trials of mometasone furoate nasal spray, 200 μg/d. Participants rated ear and palate itching from baseline through treatment day 15 as follows: 0, none; 1, mild; 2, moderate; and 3, severe.. A total of 962 study participants received mometasone furoate nasal spray or placebo. Baseline least squares mean itchy ear and palate score was 1.81 for participants receiving mometasone furoate nasal spray (n = 480) and 1.85 for participants receiving placebo (n = 482). Mometasone furoate nasal spray was associated with a greater decrease in itchy and ear palate score vs placebo during the 15-day study period (least squares mean change, -0.73 vs -0.45; P < .001). The difference reached significance on day 2 and persisted through day 15 (P ≤ .01 for each day). Results were similar in a subgroup of patients (n = 305) with moderate-to-severe symptoms at baseline. Adverse events with mometasone furoate nasal spray were similar to those observed in other studies of intranasal steroid therapy.. These preliminary findings suggest that mometasone furoate nasal spray effectively treats itchy ear and palate in individuals with seasonal allergic rhinitis. Itchy ear and palate is a relevant end point for future clinical trials of allergic rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Allergic Agents; Child; Double-Blind Method; Ear; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Sprays; Palate; Pregnadienediols; Pruritus; Rhinitis, Allergic, Seasonal; Treatment Outcome; Young Adult

Recent studies have examined the effects of intranasal corticosteroids (INSs) in relieving the ocular symptoms of seasonal allergic rhinoconjunctivitis (SAR) and perennial allergic rhinitis. However, because most of these studies were based on subjective assessments by patients, the associated factors and mechanism of action are unknown.. A single-center, randomized, double-blind, parallel-group study was carried out in which patients with SAR were randomly assigned to an INS mometasone furoate nasal spray (MFNS) group or to a placebo group and treated once daily for 4 weeks. Substance P concentrations in tears were measured, ocular and nasal symptoms were recorded by patients in an allergy diary, and findings were recorded by an ophthalmologist.. There was no significant difference between treatment groups in the mean change from baseline of substance P concentration in tears after 4 weeks of treatment, but the mean change tended to increase in the placebo group and tended to decrease in the MFNS group (P = 0.089). All ocular and nasal symptom scores, except eye tearing, were significantly lower in the MFNS group than in the placebo group. Furthermore, substance P concentrations were strongly correlated with ocular and nasal symptom scores.. In patients with SAR, INSs tend to decrease the substance P concentration in tears, which is correlated with the severity of ocular and nasal symptoms.

Topics: Administration, Intranasal; Adult; Anti-Allergic Agents; Conjunctivitis, Allergic; Demography; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Sprays; Placebos; Pregnadienediols; Rhinitis, Allergic, Seasonal; Substance P; Treatment Outcome

The usefulness of early interventional treatment (EIT) with intranasal corticosteroids (INSs) compared with postonset treatment (POT) has not been clarified.. To study the efficacy and safety of EIT with INSs compared with POT and placebo in Japanese cedar/cypress pollinosis.. We designed a 3-armed, double-blinded, randomized, placebo-controlled trial. Patients received mometasone furoate nasal spray (EIT group: n = 25), placebo (n = 25), or 4 weeks of placebo followed by 8 weeks of mometasone (POT group: n = 25) for a 12-week period starting on February 1, 2011. The primary end point was the comparison of the total nasal symptom score (TNSS) among the 3 groups. Total ocular symptom score (TOSS), total naso-ocular symptom score (TSS), Allergic Rhinitis and Its Impact (ARIA) on Asthma classification, and safety were the main secondary end points.. The placebo and POT groups, but not the EIT group, had a significant exacerbation of TNSS and TOSS soon after the start of pollen counts being high on consecutive days. The 12-week mean TSS in the EIT group (score, 2.3) was significantly lower than in the placebo (5.0; P < .01) and POT (3.9; P = .03) groups. All patients in the placebo and POT groups were classified as having persistent rhinitis, whereas 80% of the EIT group met the ARIA classification criteria (P = .03). The quality-of-life score and nasal eosinophil cationic protein levels were lower in the EIT and POT groups compared with the placebo group. Daytime sleepiness, smell disturbance, and the mean dose of loratadine taken as the rescue medication were similar. Treatment with mometasone was well tolerated.. EIT with INSs is superior to POT in controlling pollinosis.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Adult; Allergens; Anti-Allergic Agents; Cryptomeria; Cupressus; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Mometasone Furoate; Pollen; Pregnadienediols; Rhinitis, Allergic, Seasonal; Treatment Outcome; Young Adult

Mometasone furoate nasal spray (MFNS), a potent intranasal corticosteroid with proved efficacy in relieving nasal allergic rhinitis symptoms, has demonstrated effectiveness in improving ocular symptoms associated with seasonal allergic rhinitis (SAR) in retrospective analyses.. We sought to evaluate prospectively the efficacy of MFNS in reducing total ocular symptom scores (TOSSs) and individual ocular symptoms in subjects with SAR.. Subjects 12 years or older (n = 429) with moderate-to-severe baseline symptoms were randomized to MFNS, 200 microg once daily, or placebo in this 15-day, double-blind, parallel-group study. Subjects evaluated morning instantaneous TOSSs and daily reflective TOSSs, total nasal symptom scores (TNSSs; both instantaneous TNSSs and reflective TNSSs, respectively), and individual ocular and nasal symptoms. Mean changes from baseline averaged over days 2 to 15 (instantaneous) and days 1 to 15 (reflective) were calculated. Quality of life was assessed by using the Rhinoconjunctivitis Quality of Life Questionnaire.. MFNS treatment yielded significant reductions from baseline versus placebo in instantaneous TOSSs (-0.34, P = .026, coprimary end point), instantaneous TNSSs (-0.88, P < .001, coprimary end point), reflective TOSSs (-0.44, P = .005), and reflective TNSSs (-1.06, P < .001). Significant decreases in all individual reflective ocular symptoms and instantaneous eye itching/burning and eye watering/tearing were observed for MFNS versus placebo (P < .05). Numeric improvements in instantaneous eye redness were seen but did not reach statistical significance. Improvements in Rhinoconjunctivitis Quality of Life Questionnaire total scores and individual symptom domains were achieved with MFNS treatment versus placebo (P < .001). MFNS was well tolerated.. This prospective study demonstrates that MFNS significantly reduces ocular symptoms in subjects with SAR.

Topics: Administration, Intranasal; Adult; Aerosols; Anti-Allergic Agents; Double-Blind Method; Female; Headache; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Obstruction; Pregnadienediols; Pruritus; Quality of Life; Retrospective Studies; Rhinitis, Allergic, Seasonal; Tears

Mometasone furoate nasal spray (MFNS) can reduce the symptoms and improve quality of life in Chinese patients with moderate to severe allergic rhinitis (AR).. To evaluate the effects of MF on symptoms and quality of life in Chinese patients with moderate to severe AR.. In a multicenter and open-label study, 500 patients with moderate to severe AR were enrolled and received MFNS 200 microg once daily. We visited the patients four times (at baseline, and week 1, 2, and 4) to record symptom scores and the influence of AR on daytime activities and quality of sleep. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) and the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) were used in this study.. Compared with the baseline, MFNS significantly reduced the total and individual symptom scores and nocturnal sleep and daytime activities scores at week 1, 2, and 4 according to the Mini-RQLQ and NRQLQ.

Topics: Adolescent; Adult; Aged; Anti-Allergic Agents; Asian People; Child; China; Female; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Quality of Life; Rhinitis, Allergic, Seasonal; Sleep; Young Adult

Burdensome symptoms of allergic rhinitis (AR) include nasal and ocular symptoms such as itching, tearing and redness. Intranasal corticosteroids are efficacious in the treatment of nasal symptoms of AR.. It was the aim of this study to determine the efficacy of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) in relieving ocular symptoms associated with seasonal AR (SAR).. Ocular symptom data were analyzed for subjects >or=12 years of age, randomized to MFNS 200 mug q.d. (n = 176) or placebo (n = 177) in a placebo-controlled, double-blind clinical trial. Post hoc efficacy analysis assessed the mean change from baseline in subject-reported total ocular symptom scores (TOSS) averaged over the treatment period.. Mean baseline TOSS was 4.91 for the MFNS group and comparable (5.05) for the placebo group - combined average for individual symptoms such as itching, tearing and redness ranged from 0 (no symptoms) to 9 (all symptoms, severe). Mean change from baseline in TOSS averaged over days 1-15 was -1.42 for the MFNS group and -0.94 for the placebo group (p = 0.02), for an observed treatment difference of 0.49 (statistical data rounded to 2 decimal positions). Improvement in individual symptoms (eye itching, tearing and redness) contributed to this treatment effect; the greatest improvement occurred with tearing, which decreased -0.52 from the baseline score 1.59 in the MFNS group and -0.31 from 1.67 in those receiving placebo (p < 0.01), for an observed treatment difference of 0.21. Treatment with MFNS was safe and well tolerated.. MFNS is effective in reducing ocular symptoms of SAR, in addition to its established efficacy in reducing nasal symptoms of SAR.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Androstadienes; Anti-Allergic Agents; Budesonide; Child; Double-Blind Method; Eye Diseases; Female; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Seasonal

Intranasal corticosteroids and nonsedating antihistamines are the drug classes most often prescribed to treat allergic rhinitis (AR). Treatment guidelines recommend a combination of these agents for moderate-to-severe AR. However, clinical studies have found that combining an antihistamine with an intranasal corticosteroid provides few or no advantages over monotherapy with an intranasal corticosteroid.. To compare the efficacy of mometasone furoate nasal spray (NS) plus loratadine with that of monotherapy with the individual agents in patients 12 years and older with at least a 2-year history of seasonal AR.. In a multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study, 702 patients were randomized to receive mometasone furoate NS, 200 microg, plus loratadine, 10 mg (n = 169); mometasone furoate NS, 200 microg (n = 176); loratadine, 10 mg (n = 181); or placebo (n = 176) once daily for 15 days. Primary efficacy variables were total nasal symptom score (TNSS) and total symptom score (TSS) as recorded on diary cards.. No statistically significant differences were observed between mometasone furoate NS plus loratadine and mometasone furoate NS monotherapy for the primary efficacy variables. For TNSS and TSS, all 3 active drug therapies were more effective than placebo (P < or = .02). Both mometasone furoate NS treatment regimens were more effective than loratadine or placebo for TNSS (P < .01 for both) and TSS (P < or = .03 for both), whereas loratadine was more effective than placebo for TNSS only (P = .02).. Combination therapy with mometasone furoate NS and loratadine provided benefits similar to monotherapy with mometasone furoate NS for the symptoms of seasonal AR. Therefore, mometasone furoate NS monotherapy was shown to be an effective treatment for seasonal AR.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Allergic Agents; Child; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Loratadine; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Seasonal; Treatment Outcome

Allergic rhinitis (AR) is more appropriately termed allergic rhinoconjunctivitis owing to the equally bothersome nasal and ocular symptoms. Extensive evidence supports the ability of intranasal corticosteroids to reduce nasal symptoms of AR, although less evidence is available to define clearly their impact on allergic conjunctivitis.. To determine the effect of the intranasal corticosteroid mometasone furoate nasal spray (NS) on the ocular symptoms of seasonal AR.. This retrospective pooled analysis of 4 placebo-controlled clinical studies randomized patients 12 years and older with symptomatic seasonal AR to receive mometasone furoate NS, 200 microg once daily (n = 491), or placebo (n = 492). Ocular symptom (eye tearing [epiphora], itching [pruritus], and redness [erythema]) severity was rated by patients twice daily on a 4-point scale (0 = none to 3 = severe) in the morning and evening, with scores averaged to obtain a daily mean score. Efficacy variables were the pooled mean change from baseline in the averaged morning and evening total ocular symptom score (TOSS) and the individual ocular symptom scores.. The change in mean TOSS from baseline to days 1 to 15 was -1.33 (-19.8%) with mometasone furoate NS and -0.93 (-5.6%) with placebo (P < .001). Improvements in individual symptoms were significantly better with mometasone furoate NS than with placebo on days 2 (tearing) and 4 (itching and redness). A slightly greater reduction in TOSS was seen with mometasone furoate NS treatment in the evening than in the morning.. This detailed analysis of an intranasal corticosteroid on individual ocular symptoms supports the positive impact of mometasone furoate NS on ocular symptoms.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Allergic Agents; Child; Conjunctivitis, Allergic; Eye; Female; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Retrospective Studies; Rhinitis, Allergic, Seasonal

The preventive use of medications has been proposed to be effective in the treatment of seasonal rhinitis.. To evaluate the efficacy and safety of mometasone furoate and nedocromil sodium nasal sprays as prophylactic treatment for moderate to severe seasonal allergic rhinitis (SAR).. Sixty-one patients were recruited from 3 referral allergy centers. Inclusion criteria were history of SAR for 2 years or longer, sensitization to relevant local pollen (grasses, Parietaria, and olive), and age older than 12 years.. An open-label, randomized, parallel-group, "real-life" study design was used. Patients received mometasone furoate nasal spray once daily or nedocromil sodium nasal spray 3 times daily starting 2 to 4 weeks before the pollen season and continuing for up to 4 months. Instructions regarding the use of additional medications were given. Diary cards recording symptoms, use of medication, and adverse events were kept by the patients.. All 61 patients completed the study. The prophylactic use of mometasone furoate vs nedocromil sodium led to significantly more days without symptoms (75.1% vs 54.5%; P < .001). The mometasone furoate group also had lower nasal symptom scores (mean, 1.4 vs 2.9; median, 0 vs 2; P < .001) and was more satisfied (93.1% vs 43.5%; P < .001). No serious adverse event was recorded, and there was no difference between the treatments in any adverse event.. Prophylactic administration of mometasone furoate before the pollen season is safe and may lead to improved control of SAR compared with the use of nedocromil sodium.

Topics: Administration, Intranasal; Adolescent; Adult; Anti-Allergic Agents; Child; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nedocromil; Pregnadienediols; Rhinitis, Allergic, Seasonal

Drug treatment and specific immunotherapy (SIT) are both effective in seasonal rhinoconjunctivitis, but the former acts only on allergic symptoms while the latter modifies the natural history of the disease. Only a few studies compared the clinical efficacy of the two treatments with contrasting results. We planned a study to compare the efficacy of SIT (15 patients) and drug treatment (15 patients) in moderate to severe seasonal rhinoconjunctivitis caused by sensitization to grass pollen. SIT was performed by a 5-grass extract standardized in IR and absorbed onto calcium phosphate (Phostal, Stallergénes, Antony, France) using the conventional build-up phase in 12 weeks and a maintenance treatment with monthly injection for three years. Drug treatment was done with cetirizine as antihistamine, mometasone furoate as nasal topical steroid, and levocabastine eyedrops. All patients registered during the pollen season their symptoms and drug consumption. After one year 12 of 15 patients treated with SIT had less symptoms and drug consumption in respect to baseline compared to none in drug treated group (p = 0.021) and after three years 15 of 15 were improved in group A compared to one of 15 in group B (p = 0.008). These findings indicate an higher efficacy of SIT in patients with seasonal rhinitis not only in the long term but also in the first year of treatment.

Topics: Administration, Intranasal; Adolescent; Adult; Allergens; Anti-Allergic Agents; Anti-Inflammatory Agents; Cetirizine; Conjunctivitis, Allergic; Desensitization, Immunologic; Drug Therapy, Combination; Female; Histamine H1 Antagonists, Non-Sedating; Humans; Male; Mometasone Furoate; Ophthalmic Solutions; Piperidines; Poaceae; Pollen; Pregnadienediols; Rhinitis, Allergic, Seasonal; 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

Current guidelines recommend intranasal glucocorticosteroids as first-line therapy for seasonal allergic rhinitis.. To compare the efficacy, cost-effectiveness, and tolerability of the topical glucocorticosteroid mometasone furoate, the topical antihistamine levocabastine hydrochloride, and the cromone disodium cromoglycate in seasonal allergic rhinitis.. This study was performed during the 2003 grass pollen season as an open, randomized, parallel-group, single-center study of 123 patients assigned to receive mometasone furoate (200 microg once daily), levocabastine hydrochloride (200 microg twice daily), or disodium cromoglycate (5.6 mg 4 times daily). Symptom scores and nasal inspiratory peak flow measurements were recorded in a patient diary. The global efficacy of the study medication was evaluated by patients after treatment. Eosinophil cationic protein concentrations were measured in nasal secretions before and after treatment. Cost-effectiveness was evaluated as medication cost per treatment success.. Mometasone furoate therapy was significantly superior to the use of levocabastine or disodium cromoglycate with respect to all nasal symptoms, the global evaluation of efficacy, and eosinophil cationic protein concentration. Furthermore, mometasone furoate therapy was significantly superior to disodium cromoglycate therapy with respect to nasal inspiratory peak flow. Medication cost per treatment success was lowest with mometasone furoate use and highest with levocabastine use.. This is the first study to compare mometasone furoate nasal spray with nonsteroidal topical treatments for seasonal allergic rhinitis. Mometasone furoate nasal spray was confirmed as a first-choice topical treatment option for seasonal allergic rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Anti-Allergic Agents; Cromolyn Sodium; Eosinophil Cationic Protein; Female; Humans; Male; Middle Aged; Mometasone Furoate; Piperidines; Pregnadienediols; Respiratory Function Tests; Rhinitis, Allergic, Seasonal; Treatment Outcome

A recent survey estimated that 85% of patients with allergic rhinitis experience nasal congestion. This symptom considerably impacts quality of life.. To evaluate the effectiveness of mometasone furoate nasal spray (MFNS) in subjects with seasonal allergic rhinitis (SAR) experiencing moderate-to-severe nasal congestion.. Data were obtained from 4 randomized, double-blind, placebo-controlled studies of MFNS 200 microg once daily in patients with SAR. Subject-evaluated nasal congestion score data (score range 0-3) from subjects receiving MFNS or placebo were analyzed as a pool and grouped according to baseline score (all pts. with scores >2.5, >2.75, or 3.0). The 2-week average change in score from baseline was analyzed.. Significant improvements in mean nasal congestion score were seen with MFNS (n = 490) versus placebo (n = 492; p < 0.001). Overall, there was a 27% improvement in this score in patients receiving MFNS versus 13% with placebo. MFNS produced significant reductions in the nasal congestion score compared with placebo, even in patients with the most severe baseline congestion (0.98 vs 0.52; p < 0.001). Improvements in scores from baseline of 32%, 33%, and 34% were seen with MFNS versus 22%, 21%, and 18% with placebo (for baseline scores of >2.5, >2.75, or 3.0, respectively), confirming the effectiveness of MFNS regardless of congestion severity. This represents an improvement approximating a decrease from severe to moderate congestion or from moderate-to-severe to mild-to-moderate congestion. MFNS was well tolerated.. MFNS 200 microg once daily produces statistically significant improvements in nasal congestion score compared with placebo, alleviating severe congestion in patients with moderate-to-severe SAR.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Child; Double-Blind Method; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Obstruction; Pregnadienediols; Rhinitis, Allergic, Seasonal; Structure-Activity Relationship

Cough commonly occurs as a symptom of seasonal allergic rhinitis (SAR), an inflammatory condition of the nasal mucous membranes that results in rhinorrhea, nasal stuffiness/congestion, nasal itching, and sneezing. Mometasone furoate nasal spray (MFNS, Nasonex, Schering, Kenilworth, NJ), an anti-inflammatory nasal corticosteroid, has been shown to be safe and effective in reducing the nasal inflammation of SAR.. To examine the effectiveness of MFNS in relieving SAR-associated cough, in addition to nasal symptoms.. This was a multicenter, randomized, double-blind study. Patients 12 years of age or older with > or = 1-year history of SAR symptoms, positive skin test to a prevailing seasonal allergen, moderate nasal symptoms, and moderate cough were treated for 14 days with MFNS 200 microg daily (n = 122) or placebo (n = 123).. The group treated with MFNS showed significant improvement in the daytime cough severity score at endpoint compared with placebo (P = 0.049). Improvement in the nighttime cough severity score showed a trend in favor of MFNS treatment. Treatment with MFNS significantly improved total nasal symptoms in both the daytime and nighttime compared with placebo at endpoint (P < or = 0.017). Overall daytime symptom scores (cough + total nasal) improved significantly compared with placebo at endpoint (P = 0.005). Overall nighttime symptom scores improved significantly compared with placebo at endpoint (P = 0.028). Treatments were well tolerated, with no significant differences in the incidence of adverse events.. MFNS is effective and well tolerated in the treatment of daytime cough associated with SAR.

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Aged; Anti-Allergic Agents; Anti-Inflammatory Agents; Child; Cough; Double-Blind Method; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Decongestants; Nasal Obstruction; Pregnadienediols; Pruritus; Rhinitis, Allergic, Seasonal; Safety; Sneezing; Treatment Outcome

Drug selection for optimal treatment of allergic rhinitis may be difficult and involve many diverse factors.. To evaluate montelukast, in the treatment of patients with seasonal allergic rhinitis, as an adjuvant to mainstay therapies, i.e., antihistamines and corticosteroids.. The study was a prospective, three-phased (per lasted 2 weeks) clinical trial. In phase I, patients were separated into two groups, based on the predominating symptoms: (1) runners (patients with moderate to severe sneezing/itchy, watery nose/itchy, watery eyes), and (2) blockers (patients with moderate to severe nasal congestion). The runners received antihistamine loratidine 10 mg daily, and the blockers received intranasal corticosteroid mometasone furoate 200 microg. In phase II, if patients were dissatisfied with the initial treatment, they were assigned to receive another study drug additionally. In phase III, for the patients unsatisfied with the treatment of loratidine plus mometasone furoate, montelukast 10 mg once daily was added.. Of the 169 patients who entered phase I, 150 could be evaluated for treatment efficacy and safety. There were 108 runners and 42 blockers. Physicians' and patients' assessments indicated that in phase I 58 runners (60.0% of 50 runners) and 36 blockers (33.3% of six blockers) were satisfied with their therapy. In phase II, 30 runners (27.7%) and two blockers (4.7%) were satisfied with the addition of other study drug. Totally 62.6% of patients were satisfied at the end of phase I, and 84.0% at the end of phase II. Sixteen patients (66.6% of 24 patients) were satisfied with the addition of montelukast to the previous two drugs (in total, 10.6% of patients). Fourteen patients (12.2%) treated with loratadine, and three patients (0.3%) treated with mometasone, reported side-effect.. The results of this trial indicate that 10% of patients with seasonal allergic rhinitis may be treated with the supplement of montelukast to mainstay therapy.

Topics: Acetates; Adjuvants, Immunologic; Adolescent; Adrenergic beta-Antagonists; Adult; Aged; Cyclopropanes; Drug Therapy, Combination; Female; Histamine H1 Antagonists; Humans; Leukotriene Antagonists; Loratadine; Male; Middle Aged; Mometasone Furoate; Patient Satisfaction; Pregnadienediols; Prospective Studies; Quinolines; Rhinitis, Allergic, Seasonal; Sulfides

Topics: Adult; Anti-Allergic Agents; Double-Blind Method; Humans; Mometasone Furoate; Pregnadienediols; Prospective Studies; Rhinitis, Allergic, Seasonal; Sensory Thresholds; Smell

Symptoms of seasonal allergic rhinitis may vary greatly. Hence, for research purposes, there is a need for disease-like models of allergic rhinitis. In a preliminary study, involving 7 days' challenge with allergen, promising symptom consistency was obtained and dose-response to a glucocorticosteroid could, in part, be demonstrated.. To establish this model of seasonal allergic rhinitis and test the hypothesis that mometasone furoate is more potent than budesonide as an antirhinitis drug.. Thirty-eight patients with seasonal allergic rhinitis received treatment with spray-formulations of placebo, budesonide 64 microg, budesonide 256 microg, and mometasone furoate 200 microg in a double-blind, crossover design. After 3 days' treatment, individualized nasal allergen-challenges were administered daily for 7 days while the treatment continued. Nasal symptoms and peak inspiratory flow (PIF) were recorded.. During the last 3 days of allergen challenge without active treatment, consistent around-the-clock symptoms were recorded and recordings during these days were used in the analysis. With few exceptions the active treatments reduced nasal symptoms and improved nasal PIF (P values <0.001 to 0.05). Budesonide caused dose-dependent improvements in evening symptoms, morning nasal PIF, and nasal PIF recorded 10 minutes after allergen-challenge (P values <0.05). Budesonide 256 microg produced greater improvement than mometasone furoate 200 microg for nasal PIF 10 minutes after allergen-challenge (P < 0.05).. The present allergen challenge method, producing consistent symptoms and nasal PIF data, emerges as a model of seasonal allergic rhinitis well suited for exploring potency and efficacy of drug intervention. The present data do not support the view that mometasone furoate is a more potent antirhinitis drug than budesonide.

Topics: Administration, Topical; Adult; Anti-Allergic Agents; Anti-Inflammatory Agents; Budesonide; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Models, Immunological; Mometasone Furoate; Nasal Provocation Tests; Pregnadienediols; Rhinitis, Allergic, Seasonal

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

Allergic rhinitis is an inflammatory disease often associated with bronchial asthma. Intranasal corticosteroids and oral antihistamines are the first-choice drugs. Patient training is relevant to asthma management, but little is known about its impact on rhinitis. We evaluated the role of patient training in the treatment of allergic rhinitis and its effects on nasal and bronchial symptoms.. One hundred and one patients (M/F = 62/39, age range 12-62 years) with pollen-induced rhinitis (32 with concomitant mild asthma) were enrolled. They were randomized into three groups: A (n = 30) with drug therapy alone, B (n = 35) with drug therapy plus training on the use of nasal spray, and C (n = 36) the same as B plus a lesson on rhinitis and asthma. All patients received mometasone furoate nasal spray for 8 weeks as regular therapy, plus rescue medications on demand. Symptoms and drug consumption were evaluated during the pollen season.. The rate of noncompliance/dropout was highest in the untrained patients (P = 0.001). No difference in nasal symptoms was seen among the three groups. On the other hand, group C had significantly fewer asthma symptoms (P = 0.02) and less albuterol use (P = 0.005) than group A. Moreover, the trained group globally used less rescue medication than the other groups (P = 0.02).. Detailed training of patients seems to improve compliance with treatment, reduce concomitant asthma symptoms, and reduce the use of symptomatic drugs.

Topics: Administration, Intranasal; Adolescent; Adult; Anti-Allergic Agents; Anti-Inflammatory Agents; Asthma; Child; Disease Management; Female; Humans; Male; Middle Aged; Mometasone Furoate; Patient Compliance; Patient Dropouts; Patient Education as Topic; Pregnadienediols; Rhinitis, Allergic, Seasonal

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

Topics: Acetates; Administration, Intranasal; Anti-Inflammatory Agents; Cetirizine; Cross-Over Studies; Cyclopropanes; Drug Therapy, Combination; Histamine H1 Antagonists; Humans; Leukotriene Antagonists; Mometasone Furoate; Pregnadienediols; Quinolines; Rhinitis, Allergic, Seasonal; Single-Blind Method; Sulfides; Treatment Outcome

Allergen specific nasal challenge (ASNC) is an optimal model to study the pathophysiologic mechanisms sustaining allergic inflammation, particularly the adhesion molecules promoting cellular infiltration of nasal mucosa. Topical corticosteroids have been accepted as a highly effective anti-inflammatory therapy for allergic rhinitis.. The aim of this double-blind, randomized, placebo-controlled study was the evaluation of inflammatory events, during the late-phase, after a 2-week treatment with nasal mometasone furoate (MF), 200 microg daily, or placebo, using the model of ASNC.. A total of 42 patients with allergic rhinitis underwent nasal challenge before and after treatment. The following parameters were evaluated at baseline, and 6 hours (late-phase) after ASNC: 1) nasal symptoms (rhinorrhea, itching, sneezing, obstruction); 2) inflammatory cells (eosinophils and neutrophils); 3) eosinophil cationic protein (ECP) and tumor necrosis factor-alpha (TNF-alpha) in nasal lavage; and 4) intercellular adhesion molecule-1 expression on nasal epithelial cells.. MF nasal spray was associated with late-phase reductions of: 1) clinical symptoms (P < 0.03); 2) eosinophil (P < 0.004) and neutrophil (P < 0.003) infiltration; 3) ECP (P < 0.001) and TNF-alpha (P < 0.05); and 4) intercellular adhesion molecule-1 expression on nasal epithelial cells (P < 0.001).. The present results demonstrate that MF has a significant effect on late-phase events, reducing the cellular influx and activation.

Topics: Administration, Intranasal; Adolescent; Adult; Allergens; Anti-Allergic Agents; Anti-Inflammatory Agents; Blood Proteins; Double-Blind Method; Eosinophil Granule Proteins; Eosinophilia; Eosinophils; Female; Humans; Intercellular Adhesion Molecule-1; Leukocyte Count; Male; Middle Aged; Mometasone Furoate; Nasal Lavage Fluid; Nasal Mucosa; Nasal Provocation Tests; Neutrophils; Pregnadienediols; Rhinitis, Allergic, Seasonal; Ribonucleases; Tumor Necrosis Factor-alpha

Measurement of domiciliary nasal peak inspiratory flow rate (PIFR) may have a role in the objective assessment of treatment response in seasonal allergic rhinitis (SAR).. We wished to evaluate the relationship between domiciliary measurement of nasal PIFR and a variety of symptoms associated with rhinitis.. Thirty-eight nonasthmatic patients, mean age (SEM) 30 years (1.4), with symptomatic SAR were evaluated in a placebo-controlled, single-blind, double-dummy, three way parallel group study. Patients received oral cetirizine 10 mg once daily and were randomized to receive, in addition, either: (i) intranasal mometasone furoate 200 microgram (n = 14); (ii) oral montelukast 10 mg (n = 11); or (iii) placebo (n = 13). All treatments were given once daily for 4 weeks and were preceded by a 1 week placebo period. Domiciliary diary cards were used to record morning (am) and evening (pm) domiciliary nasal PIFR and symptom (nasal, eye, throat) scores and impact on daily activity. A total daily symptom score was then calculated from the sum of these separate symptom scores.. Baseline values for symptom scores and PIFR after placebo run-in were not significantly different when comparing the three groups. After 4 weeks of active treatment, there were significant (P < 0.05) improvements in nasal symptoms, total daily symptoms and PIFR with all treatments, with there being no significant confounding effect of pollen count, when analysed as a covariate. There were significant (P < 0.01) correlations for nasal symptom scores vs PIFRam (r = - 0.51) and PIFRpm (r = - 0.56), and similarly for daily activity vs PIFRam (r = - 0.42) and PIFRpm (r = - 0.48).. These results suggest that domiciliary measurements of nasal peak flow correlate significantly with symptoms of seasonal allergic rhinitis and may therefore be a potentially useful objective short-term marker of treatment response.

Topics: Acetates; Adolescent; Adult; Aged; Anti-Allergic Agents; Cetirizine; Cyclopropanes; Drug Therapy, Combination; Histamine H1 Antagonists; Humans; Inspiratory Capacity; Leukotriene Antagonists; Middle Aged; Mometasone Furoate; Pollen; Pregnadienediols; Quinolines; Rhinitis, Allergic, Seasonal; Self Administration; Single-Blind Method; Sulfides; Treatment Outcome

The clinical effect and tolerance of momethasone furoate (MF) glucocorticoid nasal spray (MFNS) were studied in 14-70 year-old patients suffering from seasonal allergic rhinitis. The patients administered daily one (morning) dose, 100 micrograms each, of MF into both nostrils, for a period of 14 days. They did not use other medicines affecting nasal symptoms. Nasal symptoms (nasal discharge, nasal obstruction, nasal itching, sneezing) and non-nasal symptoms (lacrimation, eye itching/burning sensation, palatal itching, ear itching, general itching), scored 0 to 3, and serving as a basis for evaluating the effect, were registered before treatment (day 1) and at visits on 3, 7 and 14th day. Of the 196 patients involved in the open multicentric study, 188 completed the study. The total average nasal symptom scores decreased, already after 3 days of treatment, from 8.7 to 4.1 and to 1.6 by the 14th day. Decrease of non-nasal symptoms was also conspicuous, however, lacrimation persisted in 57 of 188 cases, while eye itching--mainly in moderate and mild form--in 90 cases. The general condition of rhinitis before the treatment was evaluated by the examiners as severe or very severe in 155 cases (82%), as symptom-free (99 cases) on day 14 in, and mild (71 cases), in 170 cases (90%). The therapeutic effect was considered by both, patients and physician, as excellent, in 106 (56%) and 115 (61%) cases, resp. and as good in 63 (34%) and 56 cases (30%). Side-effects were mostly mild and transitory. Treatment was not discontinued due to side-effect in any of the cases. Based on the results, MFNS, administered in a single daily dose of 200 micrograms, has proved to be an effective and safe glucocorticoid preparation, also easy to use locally, in the treatment of allergic rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Allergic Agents; Anti-Inflammatory Agents; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Seasonal; Severity of Illness Index; Treatment Outcome

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

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

Topics: Administration, Intranasal; Adolescent; Adult; Anti-Allergic Agents; Child; Double-Blind Method; Female; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Seasonal; Self Care; Time Factors

The efficacy and safety of mometasone furoate aqueous nasal spray (MFNS; Nasonex) 200 microg once daily for the treatment and prophylaxis of seasonal allergic rhinitis (SAR) and treatment of perennial rhinitis have been demonstrated in adults. However, the dose response of MFNS in pediatric patients has not yet been characterized.. This study was conducted to determine the dose-response relationship of 3 different doses of MFNS in a pediatric population.. This was a multicenter, double-blind, active- and placebo-controlled study of 679 children 6 to 11 years of age with histories of SAR and documented positive skin test responses. Patients were randomized to one of the following treatment groups for 4 weeks: MFNS 25 microgram once daily, MFNS 100 microgram once daily, MFNS 200 microgram once daily, beclomethasone dipropionate 84 microgram twice daily (168 microgram/day), or placebo. Physician evaluations were performed at days 4, 8, 15, and 29, and patient evaluations were analyzed for days 1 to 15 and 16 to 29.. The mean reduction from baseline in physician-evaluated total nasal symptom scores at day 8 (the primary efficacy variable) was significantly greater in the MFNS and beclomethasone dipropionate groups than in the placebo group (P

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Child; Child, Preschool; Dose-Response Relationship, Drug; Double-Blind Method; Drug Tolerance; Female; Glucocorticoids; Humans; Male; Mometasone Furoate; Placebos; Pregnadienediols; Rhinitis, Allergic, Seasonal; Therapeutic Equivalency

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

The aim of this open study was to evaluate the efficacy and safety of new topical corticosteroid Nasonex (mometasone furoate) in allergic, seasonal rhinitis. The investigations were carried out on 30 patients with proven grass pollen allergy. Nasonex was administered intranasally during the pollen season, in a single dose 200 micrograms. During the 3 subsequent visits nasal and nonnasal symptom (total and individual) scores and patient reaction to the treatment were evaluated. Rhinomanometry and number of eosinophils in nasal smear were calculated before and after the treatment. Complete or marked relief of symptoms was observed in 24 patients, moderate improvement in 4 patients and no positive reaction in 2 cases. Nasonex markedly inhibited eosinophil influx to the nasal mucosa. No adverse reaction was observed during 2-week Nasonex treatment. We conclude that Nasonex aerosol is a very effective and well tolerated drug in the treatment of seasonal allergic rhinitis.

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

Efficacy of topical nasal steroid therapy for allergic rhinitis is usually evaluated by patient and clinician assessments of subjective symptom changes in diaries and at clinical interviews.. We sought to complement the subjective measures with objective measures of nasal cytology, biochemistry, and function.. In this double-blind, randomized study patients with seasonal allergic rhinitis (SAR) 12 years of age or older received 200 microg mometasone furoate nasal spray (n = 80) or placebo spray (n = 41) once daily for 2 weeks. Subjective assessments by clinician and patient comprised symptom/sign scores and overall therapeutic response evaluations. Objective measures included nasal cytology, nasal biochemistry, nasal airway resistance (NAR), mucociliary clearance, and olfactory functions.. Mometasone furoate produced a significantly greater decrease than placebo in subjective measures of SAR for total symptom score (-46% vs -30%, p < 0.05), total nasal score (-47% vs -30%, p < 0.024), individual nasal symptom scores, and overall therapeutic response. The objective measures of eosinophil, basophil, and neutrophil counts and mucociliary clearance were significantly better in mometasone furoate- than in placebo-treated patients. Similarly, within-treatment statistically significant improvements were produced by mometasone furoate but not by placebo sprays for levels of eosinophilic cationic protein, tryptase and albumin, NAR, and odor identification. Significant positive correlations were found between NAR and nasal stuffiness and between eosinophils, basophils, and neutrophils and both eosinophilic cationic protein and albumin.. Subjective measures of SAR were significantly improved in the mometasone furoate group by comparison with placebo-treated patients. Objective assessments supported the subjective findings because within-treatment measures were frequently significantly improved after mometasone furoate treatment but not after placebo treatment.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Albumins; Anti-Allergic Agents; Anti-Inflammatory Agents; Child; Double-Blind Method; Glucocorticoids; Humans; Interviews as Topic; Middle Aged; Mometasone Furoate; Mucociliary Clearance; Nasal Mucosa; Nasal Obstruction; Outcome Assessment, Health Care; Pregnadienediols; Rhinitis, Allergic, Seasonal; Smell; Treatment Outcome

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 is a potent glucocorticoid that can markedly inhibit proinflammatory Th2 cytokines in vitro. An aqueous nasal spray formulation has been shown to be clinically active in reducing the symptoms of perennial and seasonal allergic rhinitis.. To determine whether pretreatment with mometasone furoate 200 microg once daily decreases specific indices of early and late phase nasal inflammation compared with placebo.. A randomized, double-blind, placebo-controlled crossover study was conducted using nasal provocation with ragweed antigen in 21 patients with ragweed-induced allergic rhinitis out of the ragweed season; the treatment period was 2 weeks. Symptom scores, rhinoprobe cytology, and nasal lavage fluid were collected during early and late phase periods for nasal cytokines (interleukin, 1, 4, 5, 6, and 8) and leukotriene B4 determinations using ELISA and RIA.. Mean nasal symptom scores and sneezing frequency were consistently lower with mometasone furoate compared with placebo. Treatment was associated with a statistically significant early phase (30-minute time point) reduction in nasal lavage histamine levels compared with placebo (14.3 versus 20.2 ng/mL, P = .02). Within-treatment comparisons suggested that mometasone furoate reduced the antigen-induced late-phase response for IL-6, IL-8, and eosinophils compared with pretreatment. There were similar, but smaller, changes seen in the placebo group for these measurements. There were no statistically significant changes following antigen challenge in IL-1, IL-4, IL-5, LTB4, or in other nasal cytology parameters.. These results suggest that the clinical activity of mometasone furoate nasal spray in seasonal allergic rhinitis is likely due, in part, to a reduction in the levels of histamine in nasal secretions related to the early phase response, and reductions in IL-6, IL-8, and eosinophils during the late phase response.

Topics: Adult; Anti-Allergic Agents; Anti-Inflammatory Agents; Cross-Over Studies; Double-Blind Method; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Mucosa; Nasal Provocation Tests; Pregnadienediols; Rhinitis, Allergic, Seasonal; Sneezing; Time Factors

Topical nasal corticosteroids are rapidly gaining acceptance as first-line therapy for seasonal allergic rhinitis, but there is a desire for effective corticosteroids with an improved safety profile over existing products.. A multicenter, double-blind dose ranging study was conducted to compare the activity and tolerance of four doses of mometasone furoate nasal spray (tradename Nasonex) and placebo in adult patients with seasonal allergic rhinitis.. Four hundred eighty patients with seasonal allergic rhinitis were enrolled and randomized to receive mometasone furoate nasal spray 50 micrograms (n = 96), 100 micrograms (n = 95), 200 micrograms (n = 98) or 800 micrograms (n = 95), or placebo vehicle (n = 95) once daily for 28 days.. All of the doses of mometasone furoate nasal spray showed activity in reducing the severity of rhinitis. The 200-microgram dose reduced total nasal symptom scores and total symptom scores throughout the study (P < .05 versus placebo vehicle). The 50-microgram dose and the 100-microgram dose showed less consistent activity at early timepoints (days 3 and 7), while the 800 microgram dose did not provide significant additional benefits over the 200-microgram dose. All dose levels were well tolerated. The results of this trial indicate that 200 micrograms once daily is the optimum dose of mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Dose-Response Relationship, Drug; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Seasonal

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

Topics: Administration, Inhalation; Administration, Topical; Adolescent; Adult; Aged; Anti-Allergic Agents; Anti-Inflammatory Agents; Beclomethasone; Double-Blind Method; Female; Glucocorticoids; Humans; Loratadine; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Seasonal

Topical nasal corticosteroids have become a mainstay of treatment for the symptoms of seasonal allergic rhinitis (SAR). It is likely that topical corticosteroids, by blocking an initial influx of inflammatory cells in the nasal mucosa induced by aeroallergens, may have a preventive effect on nasal allergy symptoms when administered before the pollen season.. This study was designed to assess the efficacy and safety of an 8-week course of mometasone furoate nasal spray (MFNS), 200 micrograms once daily, in the treatment of SAR compared with beclomethasone dipropionate aqueous nasal spray (BDP), 168 micrograms twice daily, and placebo vehicle, when treatment is initiated before the anticipated onset of the ragweed season.. Three hundred forty-nine patients with SAR to ragweed pollen from nine centers in the Northeast and Midwest of the United States were randomized to one of the three intranasal study medications (MFNS, 200 micrograms once daily, BDP, 168 micrograms twice daily, or placebo vehicle), starting 4 weeks before the estimated start of the ragweed season.. The proportion of "minimal symptom" days (total nasal symptom score < or = 2) was statistically significantly higher in both the MFNS and BDP groups when compared with the placebo vehicle group (p < 0.01). The two active treatment groups were not statistically significantly different from each other. MFNS and BDP displayed a similar safety profile that did not differ from placebo.. This suggests that MFNS, 200 micrograms (once daily), is a useful therapy in the prophylactic treatment of SAR.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Beclomethasone; Double-Blind Method; Glucocorticoids; Humans; Immunosuppressive Agents; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Seasonal

To summarize effective intranasal glucocorticosteroids (GCS) application strategies in treatment of patients, suffering from allergic rhinitis (depending on disease type), based on actual research results. Current study determines the place of fixed intranasal GCS and topic antihistamine medication combination, specifically azelastine and mometasone furoate, as a first line of choice therapy in treatment of patients, suffering from allergic rhinitis. Effective application of stage therapy allows us establish control over allergic inflammation and significantly decrease pharmaceutical load in cases of patients, suffering from allergic rhinitis.. На основании результатов современных исследований обобщить эффективные стратегии использования интраназальных глюкокортикостероидов в лечении пациентов с аллергическим ринитом в зависимости от фенотипа заболевания. Обсуждается место фиксированной комбинации интраназальных глюкокортикостероидов и топических антигистаминных препаратов, в частности азеластина гидрохлорида и мометазона фуроата, в качестве терапии первого выбора в курсовом лечении пациентов с аллергическим ринитом. Эффективное использование алгоритма ступенчатой терапии позволит достичь контроля аллергического воспаления и существенно уменьшить фармаконагрузку на пациента с аллергическим ринитом.

Topics: Administration, Intranasal; Evidence-Based Medicine; Humans; Mometasone Furoate; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Seasonal allergic rhinitis (SAR) is a common disease of childhood and is characterized by type 2 inflammation, bothersome symptoms, and impaired quality of life (QoL). Intranasal corticosteroids are effective medications in managing SAR. In addition, mometasone furoate nasal spray (MFNS) is a well-known therapeutic option. However, the literature provided no data about the effects of MFNS in European children with SAR. Thus, this study addressed this unmet requirement.. MFNS was compared to isotonic saline. Both treatments were prescribed: one drop of spray per nostril, twice a day, for 3 weeks. Nasal cytology, total symptom score (TSS), visual analogic scale concerning the parental perception of severity of symptoms, and the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) were assessed at baseline, after 7 and 21 days, and 1 month after discontinuation.. MFNS significantly reduced eosinophil and mast cell counts, improved QoL, and relieved symptoms, as assessed by doctors and perceived by parents. These effects persisted over time, even after discontinuation. Both treatments were safe and well-tolerated.. The present study documented that a 3-week MFNS treatment was able to significantly dampen type 2 inflammation, improve QoL, and reduce severity of symptoms in Italian children with SAR, and was safe.

Topics: Child; Double-Blind Method; Humans; Inflammation; Mometasone Furoate; Nasal Obstruction; Nasal Sprays; Pregnadienediols; Quality of Life; Rhinitis, Allergic, Seasonal

Birch pollen is a prevalent aeroallergen during the springtime allergy season. In field studies, variable allergen exposure and environmental factors can affect data quality while environmental exposure units (EEUs) deliver controlled, standardized, and reproducible allergen exposures.. To inform study design for EEU trials evaluating antiallergic therapies.. In this prospective study, 76 participants with birch allergy experienced 3 exposures to birch pollen: (1) an out-of-season EEU challenge (two 3-hour sessions on consecutive days); (2) a natural seasonal exposure; and (3) an in-season EEU challenge (3-hour exposure for 2 weeks after birch pollen season initiation).. The total nasal symptom score, total ocular symptom score, and total symptom score (TSS = total nasal symptom score plus total ocular symptom score) were assessed every 30 minutes and daily during EEU and natural exposures. A high association between TSSs and day 2 of the out-of-season and in-season EEU challenges was noted, with a good association between the maximum TSS during the natural and in-season EEU challenges, and natural season and day 2 of the out-of-season EEU challenge (P < .001 for all). Participants had higher maximum change from the baseline TSS during day 2 of the out-of-season EEU challenge (12.4) vs the following: (1) first day (9.8); (2) in-season EEU challenge (8.4); and (3) natural seasonal exposure (7.6) (P < .001 for all).. A strong association was seen between the presence of allergy symptoms and exposure to birch pollen in the EEU (maximum change in symptom scores during day 2) and in the field. A hybrid trial design may be useful to demonstrate the clinical efficacy of novel antiallergic therapies requiring fewer participants and shorter timelines and expediting treatment availability.

Topics: Adult; Allergens; Anti-Allergic Agents; Betula; Cetirizine; Environmental Exposure; Female; Humans; Male; Mometasone Furoate; Olopatadine Hydrochloride; Pollen; Prospective Studies; Rhinitis, Allergic, Seasonal; Seasons; Severity of Illness Index

Pharmacotherapy for allergic rhinitis is based on different categories of drugs used either in monotherapy or in combination regimens. The current clinical guidelines suggest a stepwise approach to pharmacotherapy for allergic rhinitis. The use of intranasal corticosteroids is considered as the preferred second-stage pharmacotherapy. Inadequate control of AR symptoms in first-line therapy is a common problem. Integrated care pathways (ICP), developed taking into account the data obtained about patients using a mobile application, suggest the use of intranasal corticosteroids as the first line of therapy, including in patients with intermittent rhinitis who have not previously received treatment when assessing the condition according to the VAS for more than 5 points, in patients who received earlier treatment when assessing the condition according to the VAS less than 5 points. According to the data in the medical decision support system and continuing medical education UpToDate, inhaled corticosteroids are considered as the first-line drugs for the pharmacotherapy of allergic rhinitis. In terms of pharmacodynamic efficacy, intranasal corticosteroids are comparable to each other. The selection criteria can be considered: the value of systemic absorption; lipophilicity; the start time of the action; frequency of introduction, organoleptic properties; the possibility of influencing non-nasal symptoms. The use of sprays containing both a glucocorticoid and an antihistamine (mometasone furoate/azelastine hydrochloride) opens up additional pharmacotherapeutic possibilities in the treatment of allergic rhinitis.. Фармакотерапия аллергического ринита основана на различных категориях препаратов, используемых либо в монотерапии, либо в комбинированных схемах. Действующие клинические рекомендации предполагают ступенчатый подход к проведению фармакотерапии при аллергическом рините. Применение интраназальных глюкокортикостероидов (ГКС) рассматривается в качестве предпочтительной фармакотерапии на второй ступени. Недостаточный контроль симптомов аллергического ринита при назначении терапии первой линии является частой проблемой. Интегрированные схемы лечения (ICP), разработанные с учетом данных, полученных от пациентов с использованием мобильного приложения, предполагают в качестве первой линии терапии применение интраназальных ГКС, в том числе у пациентов с интермиттирующим ринитом, не получавших ранее лечения, при оценке состояния по визуально-аналоговой шкале (ВАШ) более 5 баллов, а также у пациентов, получавших ранее лечение, при оценке состояния по ВАШ менее 5 баллов. Согласно данным системы поддержки принятия медицинских решений и непрерывного медицинского образования UpToDate, ингаляционные ГКС рассматриваются в качестве препаратов первой линии фармакотерапии аллергического ринита. По фармакодинамической эффективности интраназальные ГКС сопоставимы между собой. В качестве критериев выбора можно рассматривать: величину системной абсорбции; липофильность; время начала действия; кратность введения; органолептические свойства; возможность влияния на неназальные симптомы. Применение спреев, содержащих как ГКС, так и антигистаминный препарат (мометазона фуроат / азеластина гидрохлорид), открывает дополнительные фармакотерапевтические возможности в лечении аллергического ринита.

Topics: Administration, Intranasal; Anti-Allergic Agents; Humans; Mometasone Furoate; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Treatment Outcome

Topics: Anti-Allergic Agents; Dose-Response Relationship, Drug; Female; Humans; Male; Mometasone Furoate; Nasal Sprays; Phenotype; Rhinitis, Allergic, Seasonal; Severity of Illness Index; Treatment Outcome

To analyze the clinical feature and treatment methods of Artemisia pollinosis.. Skin prick test results of 14 426 cases from Beijing Tongren hospital and pollen concentration of Beijing observatory from 2007 to 2011 were analyzed to identify the clinical feature of Artemisia pollinosis patients and its correlation with the pollen concentration. Patients were given leukotriene receptor antagonists (Montelukast) for 2 weeks, followed by 4 weeks of mometasone furoate nasal spray (EIT group: n = 21), or only 4 weeks of mometasone furoate nasal spray (POT group: n = 16). The nasal symptom score was compared between 2 groups.SPSS 16.0 software was used to analyze the data.. Artemisia pollinosis accounted for 30.8% (4 442/14 426) of all SPT positive allergic rhinitis patients, and most Artemisia SPT positive results were strong positive(3 793/4 442, 85.4%); onset age peak of Artemisia pollinosis patients was at the age of 19 to 30, onset time concentrated in August to September, was consistent with the peak period of Artemisia pollen concentration; EIT treatment using leukotriene receptor antagonists two weeks before pollen season significantly improved sneeze, sniveling and rhinocnesmus symptoms (t value was 3.28, 3.92, 3.09, respectively, all P < 0.01) compared with post-onset treatment (POT). But nasal obstruction and cough symptoms had no significant difference between two groups (t value was 0.85, 1.52, respectively, all P > 0.05).. Artemisia pollen is the main pollen allergen in Beijing, EIT treatment was effective to pollinosis.

Topics: Acetates; Adolescent; Adult; Age of Onset; Allergens; Artemisia; Child; China; Cyclopropanes; Female; Humans; Male; Middle Aged; Mometasone Furoate; Pollen; Pregnadienediols; Quinolines; Rhinitis, Allergic, Seasonal; Seasons; Sulfides; Treatment Outcome; Young Adult

To evaluate symptom scores and nasal smear cytology findings in seasonal allergic rhinitis patients, before and after treatment.. Twenty-nine consecutive adult patients with seasonal allergic rhinitis were evaluated prospectively. They received mometasone furoate nasal spray and cetirizine for 21 days. Nasal and ocular symptom scores were recorded before and after treatment. Nasal cytology was also assessed as a means of determining treatment.. The combined use of an intranasal corticosteroid and an oral antihistamine caused a significant improvement in nasal and ocular symptom scores. Cytological evaluation revealed significant reduction in nasal eosinophil, neutrophil and goblet cell counts after three weeks' treatment.. Symptom scoring systems are widely used for the evaluation of drug efficacy in allergic rhinitis treatment. When investigating the disease and evaluating treatment efficacy, objective as well as subjective methods are needed. Nasal cytological assessment is a simple, objective method which provides valuable information about the nasal mucosa.

Topics: Administration, Intranasal; Adult; Aged; Anti-Allergic Agents; Cetirizine; Drug Therapy, Combination; Female; Granulocytes; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Mucosa; Nasal Obstruction; Pregnadienediols; Prospective Studies; Rhinitis, Allergic, Seasonal; Treatment Outcome; Young Adult

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

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

Topical corticosteroids are recommended as initial therapy in allergic rhinitis (AR) patients. We investigated clinical efficacy of monotherapy with topical steroid and combined therapy in AR patients.. Ninety-five AR patients sensitive to grass pollens according to skin prick test results were enrolled in this placebo-controlled and open study. Patients were divided to four groups. Group-1 received only intranasal mometasone furoate (MF) 200microg (n=25), group-2 received intranasal MF and oral desloratadine (DLR) 5mg (n=25), group-3 received intranasal MF and oral montelukast (MSK) 10mg (n=25), group-4 received only placebo (n=20). Efficacy was assessed on the basis of total nasal symptom scores, rhinoconjunctivitis quality of life questionnaire scores and nasal inspiratory peak flow rates.. All groups that received treatment had better results when compared to the placebo group. Significant improvement in total nasal symptom scores was first evident at the end of the 2nd week in group-2. Group-3 had better results than those of the other groups at the end of the 1st month (p<0.05). Quality of life scores were significantly better in group-2 and -3 when compared to those in group-1 (p<0.05).. Although corticosteroids are the mainstay of treatment in allergic rhinitis, montelukast may be considered as an additional agent especially in treatment of patients with impaired quality of life and it may be used to reduce nasal symptom scores.

Topics: Acetates; Administration, Intranasal; Administration, Oral; Adolescent; Adult; Anti-Allergic Agents; Cyclopropanes; Drug Therapy, Combination; Female; Histamine H1 Antagonists, Non-Sedating; Humans; Intradermal Tests; Leukotriene Antagonists; Loratadine; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Pulmonary Ventilation; Quality of Life; Quinolines; Rhinitis, Allergic, Seasonal; Sulfides

Topics: Administration, Intranasal; Androstadienes; Anti-Allergic Agents; Conjunctivitis, Allergic; Fluticasone; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Seasonal

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

A 60-year-old man developed a bullous contact dermatitis after topical corticosteroid treatment of dermatitis on his lower leg. Subsequent patch testing showed cross-reactions to numerous group B and group D corticosteroids as well as cross-reactions to group C desoximetasone and group D1 mometasone furoate. His patch-test result was negative for the group A corticosteroids hydrocortisone and tixocortol pivalate. We discuss the uncommon finding of cross-reactions to desoximetasone and mometasone furoate.

Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Asthma; Cross Reactions; Dermatitis, Allergic Contact; Desoximetasone; Diagnosis, Differential; Humans; Leg; Male; Middle Aged; Mometasone Furoate; Patch Tests; Pregnadienediols; Rhinitis, Allergic, Seasonal

The present study was undertaken to clarify the effects of mometasone on nasal symptoms induced by repeated intranasal application of antigen in sensitized rats in comparison with that of chlorpheniramine. Rats received mometasone intranasally or chlorpheniramine orally 1 h before a topical antigen challenge for 7 days. Mometasone caused a decrease in the instances of nasal rubbing and an inhibition of this response was observed during the treatment period. Almost identical findings were observed with chlorpheniramine. This response was inhibited, even after the interruption of mometasone treatment, while such an effect was not observed with chlorpheniramine. On day 36, the changes in sensitivity to histamine were investigated. Unlike chlorpheniramine, hypersensitivity to histamine was significantly reduced in the mometasone-treated group. The passive cutaneous anaphylaxis titers were elevated and reached a maximum 8 days after the start of the topical antigen challenge. The passive cutaneous anaphylaxis titer in the mometasone-treated group was significantly lower than that in the control group. The results indicated that mometasone is effective in allergic rhinitis, not only during the period of application, but also after the interruption of application.

Topics: Administration, Intranasal; Animals; Anti-Allergic Agents; Antigens; Behavior, Animal; Chlorpheniramine; Disease Models, Animal; Histamine; Male; Mometasone Furoate; Pregnadienediols; Rats; Rats, Wistar; Rhinitis, Allergic, Seasonal; Time Factors

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

Topics: Anti-Allergic Agents; Asthma; Child; Drug Therapy, Combination; Glucocorticoids; Histamine H1 Antagonists; Humans; Loratadine; Mometasone Furoate; Pregnadienediols; Quality of Life; Rhinitis, Allergic, Seasonal

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents, Non-Steroidal; Fluticasone; Humans; Mometasone Furoate; Patient Satisfaction; Pregnadienediols; Rhinitis, Allergic, Seasonal; Triamcinolone Acetonide

The authors appraised the clinical efficacy of mometasone furoate in patients with seasonal allergic rhinitis and rhinoconjunctivitis.. An open, two-week trial was conducted in 89 patients between 1 July and 15 September 2001. A baseline oto-rhinolaryngological examination was performed. Nasal obstruction, rhinorrhea, sneezing, and itching as well as ocular, throat and ear clinical signs and general symptoms including cough and dyspnea were characterized using a symptom score. Mometasone furoate was administered intranasally in 100 micrograms doses into both nostrils. Depending on the severity of symptoms, antiallergic eye drops and systemic antihistamines were also allowed. After two weeks of treatment, a follow-up physical examination was performed and the symptom score was re-evaluated. Potential adverse events that had occurred during the treatment period were recorded.. Mometasone furoate nasal spray alleviated all four nasal symptoms promptly and effectively. In particular, treatment resulted in a 93 percent decrease of overall symptom score. None of the participants discontinued treatment due to the occurrence of adverse effects.. These results demonstrate that mometasone furoate nasal spray is a safe and effective intranasal corticosteroid for the therapy of SAR/SARC seasonal allergic rhinitis and rhinoconjunctivitis.

Topics: Administration, Inhalation; Administration, Topical; Adult; Anti-Allergic Agents; Anti-Inflammatory Agents; Conjunctivitis; Female; Glucocorticoids; Humans; Hungary; Male; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Seasonal; Severity of Illness Index; Treatment Outcome

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

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

Topics: Administration, Intranasal; Aerosols; Anti-Allergic Agents; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Seasonal

Topics: Anti-Inflammatory Agents; Humans; Mometasone Furoate; Patient Compliance; Pregnadienediols; Rhinitis, Allergic, Seasonal