Mometasone Furoate Nasal Spray Research Articles

Biofilms in chronic rhinosinusitis with polyps: is eradication possible?

The objective of the study was to reveal if mometasone furoate nasal spray as monotherapy or combined with long-term oral clarithromycin have influence on biofilms in chronic rhinosinusitis with polyps. The study is a randomized controlled trial in a tertiary referral hospital. Thirty-four patients with chronic rhinosinusitis completed the study. In the first group, 19 patients received mometasone furoate nasal spray 200 μg once daily for 8 weeks. In the second group, 15 patients received oral clarithromycin 500 mg twice daily for 2 weeks and continued once daily 250 mg tablet for subsequent 6 weeks, plus mometasone furoate. Scanning electron microscopy was the primary outcome measure. Secondary outcome measures included computerized tomography and sinonasal outcome test-20 items. Mucosal biofilms were detected in 23 of 34 (68%) patients on pretreatment polyp samples. After the treatment, biofilms disappeared in 1 of 11 patients in the first group, whereas the eradication of biofilms was evident in 6 of 12 (50%) patients in the second group. Tomography scores improved in eight patients of each group (42.1 and 53.4%, respectively). The comparison of improvements did not reveal significant difference between the groups. The overall symptom scores improved compared to the baseline levels. The mean changes of -8.8421 and -11.4000 in the first and second group, respectively, were not statistically different. Adding long-term low-dose oral macrolides to nasal steroids was effective in the eradication of biofilm. However, we were not able to demonstrate that combined therapy was superior in terms of the improvement in tomography and symptom scores.

Multicenter, Double-blind, Randomized, Placebo-controlled Study on Mometasone Furoate Nasal Spray in Japanese Pediatric Subjects with Perennial Allergic Rhinitis

Multicenter, Double-blind, Randomized, Placebo-controlled Study on Mometasone Furoate Nasal Spray in Japanese Pediatric Subjects with Perennial Allergic Rhinitis

Regional deposition of mometasone furoate nasal spray suspension in humans.

Nasal deposition studies can demonstrate whether nasal sprays treating allergic rhinitis and polyposis reach the ciliated posterior nasal cavity, where turbinate inflammation and other pathology occurs. However, quantifying nasal deposition is challenging, because in vitro tests do not correlate to human nasal deposition; gamma scintigraphy studies are thus used. For valid data, the radiolabel must distribute, as the drug, into different-sized droplets, remain associated with the drug in the formulation after administration, and not alter its deposition. Some nasal deposition studies have demonstrated this using homogenous solutions. However, most commercial nasal sprays are heterogeneous suspensions. Using mometasone furoate nasal suspension (MFS), we developed a technique to validate radiolabel deposition as a surrogate for nasal cavity drug deposition and characterized regional deposition and nasal clearance in humans. Mometasone furoate (MF) formulation was spiked with diethylene triamine pentacaetic acid. Both unlabeled and radiolabeled formulations (n = 3) were sprayed into a regionally divided nasal cast. Drug deposition was quantified by high pressure liquid chromatography within each region; radiolabel deposition was determined by gamma camera. Healthy subjects (n = 12) were dosed and imaged for six hours. Scintigraphic images were coregistered with magnetic resonance imaging scans to quantify anterior and posterior nasal cavity deposition and mucociliary clearance. The ratio of radiolabel to unlabeled drug was 1.05 in the nasal cast and regionally appeared to match, indicating that in vivo radiolabel deposition could represent drug deposition. In humans, MFS delivered 86% (9.2) of metered dose to the nasal cavity, approximately 60% (9.1) of metered dose to the posterior nasal cavity. After 15 minutes, mucociliary clearance removed 59% of the initial radiolabel in the nasal cavity, consistent with clearance rates from the ciliated posterior surface. MFS deposited significant drug into the posterior nasal cavity. Both nasal cast validation and mucociliary clearance confirm the radiolabel deposition distribution method accurately represented corticosteroid nasal deposition.

The possibilities for the treatment of exudative otitis media in the children presenting with chronic adenoiditis

The objective of the present study was to improve the effectiveness of medicamental therapy of exudative otitis media in the children with recurrent and chronic adenoiditis. It was shown that the use of fluifort (carbocysteine lysine salt) for the treatment of exudative otitis media in the children presenting with chronic adenoiditis is a more effective approach in comparison with the expectant management. It is concluded that the application of carbocysteine lysine salt in combination with the mometasone furoate nasal spray ensures the rapid elimination of the symptoms of adenoiditis and significantly accelerates the resolution of exudative otitis media compared with the monotherapeutic treatment.

PRS11 - Clinical and Economic Analysis of Mometasone Furoate Nasal Spray in the Treatment of Rhinosinusitis in Mexico

PRS11 - Clinical and Economic Analysis of Mometasone Furoate Nasal Spray in the Treatment of Rhinosinusitis in Mexico

Effects of topical sprays on allergy-induced nasal obstruction in children

This study aims to evaluate the efficacy of mometasone furoate nasal spray, intranasal azelastine, and isotonic sea water nasal spray in the management of allergy-induced nasal obstruction. Between October 2007 and August 2008 60 patients (37 males, 23 females; mean age 9.8±2.6 years; range 7 to 16 years) with a history of allergic rhinitis were included in the study. Laboratory assays including the skin prick test, nasal smear, phadiatop, total immunoglobulin E (IgE), and complete blood count test were performed. The patients were classified into three groups including 20 in each, according to the topical treatment administered. Patients in group 1 received azelastine, group 2 received mometasone furoate nasal spray, and group 3 received isotonic sea water nasal spray. Nasal passage volume was calculated using an acoustic rhinometry device. Azelastine and mometasone furoate decreased nasal congestion and increased nasal cavity volume more effectively, compared to isotonic sea water nasal spray. Mometasone furoate and azelastine which decrease nasal congestion and increase nasal volume are effective in the management of allergic rhinitis in children.

The Effect of Medical Treatment on Voice Quality in Allergic Rhinitis

To evaluate the change in the voice quality of patients with allergic rhinitis (AR) after medical treatment. The study enrolled 69 subjects: 39 with high serum-specific IgE levels to inhalant allergens as the study group and 30 healthy individuals as controls. All patients were evaluated using the total nasal symptom score (TNSS) and voice handicap index-10 (VHI-10) and then underwent an acoustic voice analysis. After 1month of treatment with mometasone furoate nasal spray (two 50-μg puffs in each nostril once daily) and desloratadine (5-mg tablet once daily), the patients repeated the surveys and acoustic voice analysis. The results before and after treatment were compared. The TNSS and VHI-10 scores decreased significantly after treatment (p<0.01). After treatment, the acoustic analysis parameters improved significantly and were similar to the control group, and the maximum phonation time increased significantly (p<0.05). The voice quality of patients with AR is improved with medical treatment.

Mometasone Furoate Nasal Spray plus Oxymetazoline Nasal Spray: Short-term Efficacy and Safety in Seasonal Allergic Rhinitis

Allergic rhinitis (AR) and associated congestion adversely affect patients' lives. The intranasal corticosteroid mometasone furoate nasal spray (MFNS) is effective for AR symptoms including nasal congestion, and the intranasal decongestant oxymetazoline (OXY) is effective against nasal congestion, but the combination has not been fully studied. This study was designed to assess the efficacy of the combination of MFNS and OXY for the relief of seasonal allergic rhinitis (SAR) symptoms. This phase 2 controlled clinical trial randomized adolescent and adult subjects (≥12 years; 2-year SAR) to MFNS q.d. (200 μg) + 3 sprays/nostril of OXY 0.05% (MFNS + OXY3); MFNS q.d. + 1 spray/nostril of OXY (MFNS + OXY1); MFNS q.d.; OXY b.i.d.; or placebo for 15 days, with 1-week follow-up. Coprimary end points were change from baseline in morning/evening (A.M./P.M.) instantaneous (NOW) total nasal symptom score (TNSS) over days 1-15 and AUC (AUC[0-4 hr]) change from baseline in day 1 congestion. In 705 subjects, both combinations reduced A.M./P.M. NOW TNSS over days 1-15 significantly more than OXY b.i.d. or placebo (p ≤ 0.002). Mean standardized AUC(0-4 hr) day 1 congestion change from baseline was significantly greater in combination and OXY b.i.d. groups (MFNS + OXY3, -0.92; MFNS + OXY1, -0.80; OXY b.i.d., -1.06) versus placebo (-0.57) and MFNS q.d. (-0.63). Combinations and MFNS q.d. were significantly effective for A.M./P.M. NOW TNSS over each weekly period; OXY b.i.d. was superior to placebo in week 1. Adverse events (AEs) were few and similar across treatments; one MFNS q.d. and one placebo subject experienced a serious AE, with neither considered treatment related. Combining MFNS with OXY relieves SAR symptoms, including congestion, with faster onset of action than MFNS q.d. and better sustained efficacy than OXY b.i.d.

The role of mometasone furoate nasal spray in the treatment of adenoidal hypertrophy in the adolescents: a prospective, randomized, cross-over study

Aim of this work is to find out whether the symptoms attributable to adenoid hypertrophy in adolescents may be treated with intranasal mometasone furoate (MF) application. To learn if adenoid hypertrophy in adolescents may decrease in size with intranasal MF. A prospective, double blind, randomized, cross-over study was conducted in 28 subjects (12-18 years) with adenoidal hypertrophy. Subjects used intranasal MF or placebo for a duration of 6 weeks with a wash out period of 3 weeks. Subjective symptoms and adenoid size were evaluated. At the initiation of the study, there was no significant difference between the mean symptom scores for any of the sinonasal symptoms between the two treatment groups. There was significant improvement in total subjective symptoms (nasal blockage, rhinorrhea, cough, snoring and disruption of quality of life scores) with MF compared with placebo. Analysis of the symptoms separately showed a significant positive effect of MF on all symptoms except for rhinorrhea. Nasal endoscopic evaluation failed to demonstrate any difference in the reduction of the adenoid size between the two groups. MF has significant advantage over placebo for the symptoms attributable to adenoid hypertrophy in adolescents.

Safety of mometasone furoate nasal spray in the treatment of nasal polyps in children

Mometasone furoate nasal spray (MFNS) improves nasal symptoms and reduces polyp size in adults with nasal polyposis. This 4-month, multinational, randomized, double-blind study was conducted to assess the safety of MFNS in pediatric subjects aged 6-17yr. Subjects aged 6-11yr with bilateral nasal polyps received MFNS 100μg once or twice daily or placebo; those aged 12-17yr received MFNS 200μg once or twice daily or placebo. End-points included change in 24-h urinary free cortisol (primary), change in 24-h urinary free cortisol corrected for creatinine (key secondary), and adverse events. Efficacy parameters included polyp size, nasal symptoms, and investigator-evaluated therapeutic response, although the study was not powered for statistical analysis of efficacy. Least squares baseline mean urinary free cortisol level (nmol/24h) for both age groups combined (N=127) was 49.5 in the MFNS once-daily group, 39.6 in the MFNS twice-daily group, and 49.8 in the placebo group. Change in 24-h urinary free cortisol did not significantly differ among MFNS- and placebo-treated subjects. Least squares mean 24-h urinary free cortisol levels corrected for creatinine also showed no significant differences among MFNS- and placebo-treated subjects. No safety issues emerged. Results of this study confirm the safety profile of MFNS in pediatric patients with bilateral nasal polyps over 4months, even at double the recommended pediatric dosage for allergic rhinitis.

Relieving nasal congestion in children with seasonal and perennial allergic rhinitis: efficacy and safety studies of mometasone furoate nasal spray

Background In surveys of children with allergic rhinitis (AR), nasal congestion has been identified as the most frequently experienced and bothersome symptom. This analysis was conducted to investigate the effect of mometasone furoate nasal spray (MFNS) on congestion in children with AR.Methods Two multicenter, double-blind, placebo-controlled studies randomly assigned children to MFNS 100 μg or placebo, 1 spray/nostril QD for 4 weeks (Study 1: ages 6–11 years with seasonal AR [SAR] ≥1 year; Study 2: ages 3–11 years with perennial AR [PAR] ≥1 year). Least square (LS) means were obtained from an ANCOVA model with treatment and study center effects, with baseline score as a covariate. We conducted post hoc evaluation of changes from baseline in AM/PM PRIOR (average of reflective AM and PM scores) nasal congestion (0=none to 3=severe).Results Study 1: MFNS (n=134) reduced congestion significantly more than placebo (n=135) on day 2 (P=.004) and on 23/29 days (P≤.037). Change from baseline was −0.53 and −0.28 for MFNS and placebo (P<.001) over days 1–15 and −0.64 and −0.38 for MFNS and placebo (P<.001) over days 1–29. Study 2: MFNS (n=185) reduced congestion significantly more than placebo (n=189) on day 3 (P=.015) and on 22/29 days (P≤.047). Change from baseline was −0.56 and −0.36 for MFNS and placebo (P<.001) over days 1–15 and −0.64 and −0.45 for MFNS and placebo (P<.001) over days 1–29. MFNS was well tolerated, with no unusual or unexpected adverse events.Conclusion MFNS effectively relieved nasal congestion and was well tolerated in children with SAR or PAR.

Multicenter, Double-blind, Randomized, Placebo-controlled Study on Mometasone Furoate Nasal Spray in Japanese Pediatric Subjects with Perennial Allergic Rhinitis

Multicenter, Double-blind, Randomized, Placebo-controlled Study on Mometasone Furoate Nasal Spray in Japanese Pediatric Subjects with Perennial Allergic Rhinitis

Efficacy and safety of sublingual immunotherapy of allergic rhinitis in children between 4 and 5 years age group and 11 and 12 years age group

To evaluate the efficacy and safety of the sublingual immunotherapy with Dermatophagoides fannie drops on children with allergic rhinitis of different age groups (4 - 5 years old group and 11 - 12 years old group). Sixty-two children aged 4 - 5 years, and 71 children aged 11 - 12 years, who suffered from dust mite induced allergic rhinitis, was randomly divided into the sublingual immunotherapy (SLIT) + drug group and drug group. SLIT + drug group was treated with a standardized sublingual immunotherapy drops of Dermatophagoides fannie and combined with symptomatic therapy, drug group was treated with mometasone furoate nasal spray and desloratadine tablets as symptomatic treatment. These children were followed up for 2 years with one visit in every 3 months, then visited at the end of the study and 2-years after the treatment ended. Symptom scores and medication scores were recorded at each visit. Comprehensive evaluation of symptoms, medication, and patients' degree of satisfaction were used. Two years after SLIT finished, symptom scores (SLIT + drug group: 1.13 ± 1.05; drug group: 4.68 ± 3.09), medication scores (SLIT + drug group: 0.07 ± 0.04; drug group: 0.36 ± 0.25) of SLIT + drug group were significantly lower than those in drug group (t value were -8.43, -8.87, respectively, all P < 0.01). Also, the subjective assessment of patients' symptoms, medication, and treatment satisfaction in SLIT + drug group was significantly lower than those in drug group. Subjective assessment symptoms, medication, and treatment satisfaction in age group 4 - 5 was the same as in age group 11 - 12. After SLIT ended for 2 years, subjective assessment and treatment satisfaction in age 11 - 12 group was better than those in age 4-5 group in medication score. SLIT demonstrated clinical improvement in children of different ages during 2 years treatment. Two years after withdrawal, the symptom scores, medication score and subjective satisfaction in 11 years old group are better than those in 4-5 years old group.

Efficacy of Mometasone Furoate and Fluticasone Furoate on Persistent Allergic Rhinoconjunctivitis

Allergic rhinoconjunctivitis denotes both nasal and ocular manifestation of allergy, which may be solely treated with intranasal steroid. This study compares the efficacy of mometasone furoate nasal spray (NS) and fluticasone furoate NS in treatment of allergic rhinoconjunctivitis. The secondary objective is to study the severity of baseline ocular symptoms in allergic rhinoconjunctivitis. Seventy-eight patients with allergic rhinoconjunctivitis were assessed subjectively and objectively using twice-daily symptom scores for nasal (reflective total nasal symptom score [rTNSS] and instantaneous TNSS [iTNSS]) and ocular (reflective total ocular symptom score [rTOSS] and instantaneous TOSS [iTOSS]) symptoms, rhinoconjunctivitis quality-of-life questionnaires (RQOLQs), and acoustic rhinometry. All measurements were taken at baseline and at 4 and 8 weeks of treatment. Sixty-three patients who were randomized into the mometasone furoate group (n = 36) and the fluticasone furoate group (n = 27) completed the study. Seventy-six percent of patients had mild ocular symptoms, 20.5% had moderate symptoms, and only 2.6% had severe symptoms at baseline based on the iTOSS; 65.1% had mild nasal symptoms and 3% had severe nasal symptoms. There was significant reduction in the symptom scores after 1 week (p < 0.05). Both groups had significant improvement in RQOLQ scores after 1 month, which further improved at 2 months (p < 0.05). The nasal dimensions also improved in both groups (p < 0.05) but there was no statistically significant difference between groups. Both mometasone furoate and fluticasone furoate are effective as single-modality treatment of allergic rhinoconjunctivitis. The majority of patients manifest mild ocular symptoms that may be solely treated with intranasal steroids.

Efficacy of intranasal steroid spray (mometasone furoate) on treatment of patients with seasonal allergic rhinitis: Comparison with oral corticosteroids

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.

Does Oral Prednisolone Increase the Efficacy of Subsequent Nasal Steroids in Treating Nasal Polyposis?

Although combined oral and nasal steroid therapy is widely used in nasal polyposis, a subset of patients show an unfavorable therapeutic outcome. This study aimed to evaluate whether oral prednisolone produces any additive effects on subsequent nasal steroid therapy and to evaluate if any clinical variables can predict therapeutic outcome. Using a 3:2 randomization ratio, 67 patients with nasal polyposis received 50 mg of prednisolone and 47 patients received placebo daily for 2 weeks, followed by mometasone furoate nasal spray (MFNS) at 200 micrograms twice daily for 10 weeks. Clinical response was evaluated by nasal symptom score (NSS), peak expiratory flow index (PEFI), and total nasal polyps score (TNPS). Potential predictor variables were assessed by clinical history, nasal endoscopy, allergy skin test, and sinus radiography. At the end of the 2-week oral steroid phase, the prednisolone group showed significantly greater improvements in all nasal symptoms, nasal airflow, and polyp size than the placebo group. In the nasal steroid phase, while the MFNS maintained the outcome improvements in the prednisolone group, all outcome variables in the placebo group showed continuing improvements. At the end of the nasal steroid phase, there were no significant differences of most outcome improvements between the two groups, except in hyposmia, PEFI, and TNPS (p = 0.049, p = 0.029, and p = 0.005, respectively). In the prednisolone group, patients with polyps grade 3 and endoscopic signs of meatal discharge showed significantly less improvement in total NSS, PEFI, and TNPS than patients with grade 1-2 size and negative metal discharge. In the 12-week treatment evaluation of nasal polyposis, pretreatment with oral steroids had no significant advantage for most nasal symptoms other than earlier relief; however, combined oral and nasal steroid therapy more effectively improved hyposmia, polyps size, and nasal airflow. Polyps size grade 3 and/or endoscopic signs of meatal discharge predisposed to a poorer treatment outcome.

Early interventional treatment with intranasal corticosteroids compared with postonset treatment in pollinosis

BackgroundThe usefulness of early interventional treatment (EIT) with intranasal corticosteroids (INSs) compared with postonset treatment (POT) has not been clarified. ObjectivesTo study the efficacy and safety of EIT with INSs compared with POT and placebo in Japanese cedar/cypress pollinosis. MethodsWe 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. ResultsThe 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. ConclusionEIT with INSs is superior to POT in controlling pollinosis.

Comparison of nasal steroid with antihistamine in prophylactic treatment against pollinosis using an environmental challenge chamber

Environmental challenge chambers (ECC) have been used to expose people to pollen allergens within a stable atmosphere and to examine the efficacy of treatment. Although pollinosis is one of the typical IgE-mediated type I allergic diseases, allergic inflammation is thought to contribute to the fundamental pathogenesis and prophylactic treatment may reduce exacerbations of pollinosis. The purpose of this study was to compare the efficacy of prophylactic treatment with nasal steroid (mometasone furoate nasal spray) or an antihistamine (fexofenadine) in the control of cedar pollinosis using the ECC. In a randomized, double-blind two-way crossover study, 48 patients received nasal steroid or antihistamine for 7 consecutive days (days 1-7). On day 8, patients were exposed to cedar pollen (8000 grains/m(3)) in the ECC for 3 hours. Nasal symptoms induced by pollen exposure were assessed. Total nasal symptom scores (TNSSs) during the exposure in the ECC were not significantly different between the antihistamine and the nasal steroid groups. Nasal symptoms induced by pollen exposure using the ECC persisted for up to 3 days. TNSSs after pollen exposure on days 8-11 were significantly lower in the nasal steroid group compared with the antihistamine group. Prophylactic treatment with nasal steroid is more effective than antihistamine against pollinosis, particularly in the late phase. Clinical trial registration JAPIC CTI 101182 (www.clinicaltrials.jp/user/ctiMain_e.jsp).

A Retrospective Comparison of Acute Rhinosinusitis Outcomes in Patients Prescribed Antibiotics, Mometasone Furoate Nasal Spray, or Both

Antibiotics are frequently used to treat acute rhinosinusitis (ARS; acute sinusitis), although many episodes are viral. Because of community resistance concerns, current evidence provides limited support for the use of antibiotics in ARS. We conducted a retrospective comparative effectiveness outcomes assessment of the nasal steroid mometasone furoate nasal spray (MFNS) versus antibiotics among ARS patients in clinical practice. Using the General Practice Research Database (United Kingdom), the earliest ARS event between January 1, 2005 and December 31, 2008 (index event) for patients aged 12-75 years and an antibiotic or MFNS prescription ±2 days was identified. Treatment cohorts were MFNS monotherapy (MM), MFNS + antibiotic (MAT), and antibiotic monotherapy (AM). Logistic regression adjusted for potential confounders and compared odds of rhinosinusitis-related medical encounters and related prescriptions in the 3- to 30-day postindex period. There were 12,679 eligible patients (651 MM; 2285 MAT; 9743 AM). Compared with the reference cohort AM, during the 3- to 30-day postindex period, lower adjusted odds (p < 0.001) of having one or more rhinosinusitis-related medical encounters was observed for MM (odds ratio [OR] = 0.39; 95% CI, 0.26-0.58) and MAT (OR = 0.51; 95% CI, 0.42-0.62); having one or more rhinosinusitis-related prescriptions for MM (OR = 0.51; 95% CI, 0.42-0.63) and MAT (OR = 0.58; 95% CI, 0.52-0.65); having one or more antibiotic, nasal steroid, or oral steroid prescriptions for MM (OR = 0.36; 95% CI, 0.28-0.46) and MAT (OR = 0.51; 95% CI, 0.46-0.58); and having one or more antibiotic prescriptions for MM (OR = 0.43; 95% CI, 0.33-0.58) and MAT (OR = 0.63; 95% CI, (0.55-0.72). Compared with AM, using MFNS for initial ARS treatment, alone or with an antibiotic, is associated with a decreased likelihood of both subsequent rhinosinusitis-related medical encounters and use of related prescriptions.

Effects of intranasal mometasone furoate on itchy ear and palate in patients with seasonal allergic rhinitis

BackgroundIntranasal 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. ObjectiveTo ascertain the efficacy of mometasone furoate nasal spray in alleviating itchy ear and palate in seasonal allergic rhinitis. MethodsData 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. ResultsA 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. ConclusionThese 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.