Highly sensitive liquid chromatography-mass spectrometry method for the quantitative analysis of mometasone furoate in human plasma: Method validation and application to clinical pharmacokinetic studies.

We report the development and the validation of a sensitive liquid chromatography-mass spectrometry (LC-MS/MS) method for mometasone furoate (MF) analysis in human plasma. Plasma samples were processed through liquid-liquid extraction and analyzed using LC-MS/MS operating in positive mode using multiple reaction monitoring of transitions m/z 520.9 â†’ 355.0 and m/z 525.8 â†’ 355.0 for MF and the internal standard (IS), respectively. Separation was achieved at 1.0 mL/min on a C18 column using a gradient elution of mobile phase of 0.05% ammonia in water (phase A) and acetonitrile (phase B). The assay range was 0.250-100 pg/mL and proved to be accurate and precise MF. Normalized recoveries were consistent and reproducible with a coefficient of variation (CV%) value of 6.0. The CV (%) of the IS normalized matrix factor was not observed in normal, lipemic, and hemolyzed plasmas. Dilutions of 1:10 were accurately quantified. A cycle of three freeze and thaw and stabilities at room temperature and on the autosampler were demonstrated. In addition, MF in the presence of indacaterol and glycopyrronium was proven to be stable at -70°C for at least 157 days. The present method was successfully applied to quantify MF in patients receiving MF, indacaterol, and glycopyrronium as a fixed-dose combination.

Long-lasting otic solution containing mometasone furoate can influence intradermal testing in dogs with healthy ears and otitis externa.

BACKGROUND: Topical therapy is preferred for otitis externa (OE) in dogs. Otic products commonly contain glucocorticoids that can be systemically absorbed and possibly interfere with diagnostic tests such as intradermal testing (IDT). HYPOTHESIS/OBJECTIVES: To determine the effect of a long-lasting otic solution containing mometasone furoate (MF) on IDT immediate reactions and to determine withdrawal time before IDT. ANIMALS: Seventeen dogs with healthy ears (Group 1) and 12 with OE (Group 2). MATERIALS AND METHODS: Intradermal injections of histamine, anticanine-immunoglobulin (Ig)E and saline were subjectively and objectively evaluated before treatment and weekly for 6 weeks, after a single application of a long-lasting otic solution containing MF. RESULTS: Statistically significant reductions in the mean subjective histamine scores after application of MF were observed at Weeks 1 (p = 0.012) and 2 (p = 0.028) in Group 1, and Weeks 1 (p = 0.00066), 2 (p = 0.02) and 4 (p = 0.034) in Group 2. Mean histamine objective scores were significantly reduced in Weeks 1 (p = 0.042), 2 (p = 0.0009), 3 (p = 0.001) and 5 (p = 0.018) in Group 1 only. The mean subjective anticanine-IgE scores were significantly reduced in Week 1 in both groups (p = 0.003, p = 0.0066), respectively. There were no significant changes in the mean anticanine-IgE objective score in either group. CONCLUSIONS AND CLINICAL RELEVANCE: Application of a long-lasting otic solution containing MF can interfere with IDT immediate reactions in healthy and OE dogs. Based on the subjective evaluation, IDT can be performed ≥2 weeks after application of the otic solution in healthy dogs, and ≥4 weeks in dogs with OE.

Efficacy and safety of self-made WenyangJianpi-qushi Decoction combined with mometasone furoate cream in the treatment of atopic dermatitis of spleen deficiency and dampness accumulation type.

Introduction: This work was to explore the efficacy and safety of self-made WenyangJianpi-qushi Decoction plus mometasone furoate cream in atopic dermatitis (AD) of spleen deficiency and dampness accumulation type. Material and method: 120 patients with this kind of atopic dermatitis were grouped: The Observation group (disease health education + basic treatment + mometasone furoate cream + self-made Decoction) and The Control group (disease health education + basic treatment + mometasone furoate cream), 60 cases in each group. The SCORAD score, serum IgE level, peripheral blood eosinophils, adverse events, recurrence rate, and total effective rate after treatment were observed.Result: Through treatment, SCORAD score of the observation group (29.96 ± 2.88) was lower as against controls (36.04 ± 3.12), p < 0.05. Through treatment, the peripheral blood eosinophil count in the observation group was (311.26 ± 50.19) 106/L, which was lower than (582.71 ± 54.75) 106/L in controls; the serum lgE of the observation group was (712.44 ± 93.32) IU/mL, which was lower than the controls (890.12 ± 81.25) IU/mL, p < 0.05. The Observation group (56/60, 93.33%) demonstrated superior total effective rate to the controls (34/60, 56.67%); The recurrence rate of the observation group was 4/60 (6.67%), which was lower than the controls 16/60 (26.67%), p < 0.05.Conclusion: Self-made WenyangJianpi-qushi Decoction plus mometasone furoate cream to treat atopic dermatitis of spleen deficiency and dampness accumulation type has significant efficacy and good safety.

Intranasal Olopatadine-Mometasone in the Treatment of Seasonal Allergic Rhinitis.

OBJECTIVE: To review the pharmacology, efficacy, and safety of intranasal olopatadine hydrochloride-mometasone furoate (OM) combination in the treatment of seasonal allergic rhinitis (SAR). DATA SOURCES: The PubMed database and ClinicalTrials.gov were searched using the following terms: mometasone + olopatadine, GSP301, mometasone furoate, and olopatadine hydrochloride. STUDY SELECTION AND DATA EXTRACTION: Articles published in English between January 1987 and August 2022 related to pharmacology, safety, and clinical trials were assessed. DATA SYNTHESIS: 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 P < 0.001 and QDay P < 0.001) and instantaneous total nasal symptom score (iTNSS) (BID P < 0.001 and P < 0.0001; QDay P < 0.001 and P < 0.0001). In 2 phase III clinical trials, BID OM showed significant improvements in rTNSS vs. placebo (P < 0.001), olopatadine monotherapy (P = 0.03 and P = 0.003), and mometasone monotherapy (P = 0.02 and P = 0.059). RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: 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. CONCLUSION: OM significantly improves SAR symptoms and is a viable treatment option in short-term SAR.

Multi-Gram Scale Synthesis and Characterization of Mometasone Furoate EP Impurity C.

Mometasone furoate is a synthetic corticosteroid used in the treatment of skin inflammatory conditions, hay fever and asthma. The industrial manufacturing routes to mometasone furoate are generally accompanied by the formation of numerous process impurities that need to be detected and quantified, as requested by regulatory authorities. The ready availability of such impurities in the required quantity and purity is therefore essential for toxicological studies, analytical method development and process validation. Herein, we report the multi-gram scale preparation of 21'-chloro-(16'α-methyl-3',11',20'-trioxo-pregna-1',4'-dien-17'-yl)-furan-2-carboxylate (mometasone furoate EP impurity C), one of the known impurities of mometasone furoate. This study also includes the systematic investigation of the final acylation step, as well as the characterization of the difuroate enol ether intermediate and its conversion to the target impurity C.

Comparative clinical pharmacology of mometasone furoate, fluticasone propionate and fluticasone furoate.

AIMS: To investigate the pharmacokinetics and effects on the hypothalamic-pituitary-adrenal (HPA) axis of mometasone furoate (MF), fluticasone propionate (FP) and fluticasone furoate (FF). METHODS: Study 1: Fourteen healthy participants received inhaled and intravenous MF (inhaled dose via Twisthaler) and FP (inhaled dose via Diskus), both given at 400 µg, using a randomised, single-dose, four-way crossover design. Study 2: Twenty-seven participants with mild to moderate asthma, who discontinued their corticosteroid medication for 5 days to obtain a baseline 24 h serum cortisol, received inhaled MF Twisthaler and FP Diskus, both given at 400 µg twice daily (BID), using a randomised, 14-day repeat dose, two-way crossover design. Study 3: Forty-four healthy participants were randomised to a double-blind, placebo-controlled, five-period crossover study where the following treatments were administered via the inhaled route for 7 days: FP Diskus (250, 500, 1000 µg BID), FF Diskus (100, 200, 400, 800, 1600 µg once daily [QD]) or placebo Diskus. In each study, 24-h serial blood samples were collected and assayed to assess concentrations of MF, 6ß-hydroxy mometasone, mometasone, FP, FF and cortisol. Pharmacokinetic and serum cortisol parameters were estimated as geometric means and 95% confidence intervals (CI). RESULTS: Study 1: For intravenous MF and FP, respectively: absolute bioavailability was 11.4% (95% CI: 7.5, 17.6) and 7.8% (6.3, 9.6); plasma clearance was 47 L/h (41, 52) and 60 L/h (52, 69); half-life was 7.4 h (6.9, 8.0) and 7.2 h (6.5, 8.0); and volume of distribution was 499 L (439, 567) and 623 L (557, 698). Inhalation of single dose MF or FP did not significantly affect serum cortisol (<10% reduction from baseline), whereas intravenous administration of MF or FP each changed serum cortisol by approximately -50% from baseline. Study 2: For MF and FP, respectively: area under the curve up to the last measurable concentration on Day 1 was 421 pg h/mL (270, 659) and 248 pg h/mL (154, 400), and on Day 14 was 1092 pg h/mL (939, 1269) and 591 pg h/mL (501, 696); absolute bioavailability was 12.8% (11.2, 14.2) and 8.9% (7.7, 10.2). On Day 14, 24-h serum cortisol change from baseline was -35% (-44%, -26%) and -18% (-28%, -5%) for MF and FP, respectively; the reduction was significantly greater for MF than FP (ratio for geometric adjusted mean serum cortisol concentration: 1.28 [1.04, 1.56]). Low plasma concentrations of 6ß-hydroxy mometasone were detected after intravenous dosing (Study 1) and after multiple inhaled dosing (Study 2); mometasone was not detected in any samples. Study 3: Inhaled FP and FF had similar systemic bioavailability estimates (12.0% [11.0, 13.2] and 15.0% [12.0, 17.3], respectively), but a differential effect on the HPA axis which was in agreement with the known 1.7-fold higher glucocorticoid receptor-binding affinity of FF versus FP. However, for FP 250 µg BID and FF 100, 200 and 400 µg QD, reduction in serum cortisol was not significantly different from placebo. For higher doses, FP 500 and 1000 µg BID, and FF 800 and 1600 µg QD, changes in serum cortisol concentration relative to placebo were -30%, -70%, -41% and -90%, respectively. Repeat inhaled dosing of FP 1000 µg/day (within the therapeutic dose range) resulted in comparable cortisol suppression to MF in the therapeutic range (30% reduction); whereas for FF this occurred at more than 3-fold above the therapeutic dose range (644 µg/day). CONCLUSIONS: Single inhaled and intravenous doses of MF and FP (400 µg) resulted in similar bioavailability and reductions in serum cortisol. Repeat dosing of inhaled MF and FP in the therapeutic range (800 µg/day) resulted in greater systemic exposure for MF, and a 35% reduction in serum cortisol that was 2-fold greater than for FP. The higher glucocorticoid receptor-binding affinity and bioavailability, lower clearance and the presence of active metabolites may contribute to the greater systemic exposure and effect on cortisol for MF. Repeat dosing of inhaled FP and FF resulted in similar systemic bioavailability but differed in terms of the dose required for comparable cortisol suppression to MF in the therapeutic range. Unlike FP and FF, MF has active metabolites that may contribute to its systemic effects, while device/formulation performance differences also exist between MF-containing products.

Mometasone furoate nasal spray in Italian children with seasonal allergic rhinitis: a comprehensive assessment.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Efficacy and safety of twice-daily olopatadine-mometasone combination nasal spray (GSP301) in the treatment of allergic rhinitis: a systematic review and meta-analysis.

PURPOSE: 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. METHODS: 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. RESULTS: 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; I2 = 0), iTNSS (MD = - 1.05; [95% CI - 1.44 to - 0.67]; P < 0.01; I2 > 50%), rTOSS (MD = - 0.50; [95% CI - 0.72 to - 0.29]; P < 0.01; I2 = 0), iTOSS (MD = - 0.64; [95% CI - 1.02 to - 0.26]; P < 0.01; I2 > 50%), PNSS (MD = - 1.01; [95% CI - 1.32 to - 0.69]; P < 0.01; I2 = 22.13%), RQLQ (MD = - 0.43; [95% CI - 0.57 to - 0.30]; P < 0.01; I2 = 0%) and RCAT (MD = 1.94; [95% CI 1.43-2.45]; P < 0.01; I2 = 0%) in the short term. No statistical difference was observed in the outcome of long-term PNSS, RQLQ and RCAT. CONCLUSION: 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.

The short-term effects of intranasal steroids on intraocular pressure in pediatric population.

PURPOSE: To evaluate the effect of intranasal mometasone furoate (INMF) on short-term intraocular pressure (IOP) alterations in children with allergic rhinitis (AR). METHODS: Children diagnosed with AR and to whom INMF nasal spray had been firstly prescribed were enrolled. Cases with any ocular diseases except for refractive errors were excluded. Complete ophthalmologic examinations including IOP measurements using Tonopen XL were performed before the treatment as well as at the first and sixth weeks of follow-up. Demographics and ophthalmologic findings were noted and statistically analyzed. RESULTS: Study population consisted of 62 right eyes of 62 children with a mean age of 8.55 ± 3.14 years. Of them, 29 were female (46.8%) and 33 were male (53.2%). Dilated fundoscopy revealed an enlarged Cup/Disc ratio in 12 eyes (19.4%). Family history of glaucoma was positive in 13 cases (21.0%). Mean best corrected visual acuity was found as 0.05 ± 0.08 logMAR. Initial IOP was 17.1 ± 2.3 mmHg; whereas it was measured as 18.2 ± 2.0 mmHg and 17.3 ± 2.1 mmHg at the first and sixth weeks of follow-up, respectively (p < 0.001). Both at the first and sixth weeks of follow-up, significant IOP rise was present in children with a positive family history of glaucoma (p < 0.001 and p = 0.003, respectively). Besides, increased IOP was found in participants with cupping revealed on fundoscopy at the first week of follow-up (p = 0.044). CONCLUSION: Since children have greater risk for steroid-induced ocular hypertensive response than adults, ophthalmologic evaluation must be recommended in children receiving intranasal steroids.

[Effective intranasal GCS application strategy of mono and combines forms in treating patients, suffering from allergic rhinitis. Evidence-based medicine to help a practitioner]. / Effektivnaya strategiya primeneniya mono- i kombinirovannykh form intranazal'nykh glyukokortikosteroidov v lechenii patsienta s allergicheskim rinitom. Dokazatel'naya meditsina v pomoshch' prakticheskomu vrachu.

OBJECTIVE: 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.

Dose bridging data for mometasone furoate in once-daily fixed-dose inhaled combinations of mometasone furoate/indacaterol and mometasone furoate/ indacaterol/glycopyrronium in patients with asthma.

Once-daily (o.d.) fixed-dose combinations of mometasone furoate/indacaterol acetate (MF/IND) and mometasone furoate/indacaterol acetate/glycopyrronium bromide (MF/IND/GLY), both delivered via the Breezhaler® device, are approved for the maintenance treatment of asthma. Across these fixed-dose combinations, while the doses of bronchodilators remain the same, the nominal doses of mometasone furoate in micrograms differ. This article presents the steps followed in bridging the mometasone furoate doses at the corresponding dose strengths in the mometasone furoate formulation delivered via the Twisthaler® and mometasone furoate/indacaterol acetate and mometasone furoate/indacaterol acetate/glycopyrronium bromide formulations delivered via the Breezhaler®. These were: (i) bridging the mometasone furoate doses in the Twisthaler® (previously approved) to mometasone furoate doses in the Breezhaler®; (ii) bridging the mometasone furoate doses in the Breezhaler® to mometasone furoate/indacaterol acetate and mometasone furoate/indacaterol acetate/glycopyrronium bromide formulation. Following this stepwise approach, it was determined that mometasone furoate 80 µg o.d. (medium-dose strength) and 160 µg o.d. (high-dose strength) in mometasone furoate/indacaterol acetate/glycopyrronium bromide formulation provided comparable inhaled corticosteroid efficacy to mometasone furoate 160 µg o.d. (medium-dose strength) and 320 µg o.d. (high-dose strength) in the mometasone furoate/indacaterol acetate formulation, respectively. These doses were used in the PLATINUM Phase III clinical program that investigated the efficacy and safety of mometasone furoate/indacaterol acetate and mometasone furoate/indacaterol acetate/glycopyrronium bromide combinations in patients with asthma.

Does longer duration of corticosteroid treatment improve clearance in vulvar lichen sclerosus? Results from a single centre, comparative, open label study.

A complete clearance of vulvar lichen sclerosus (VLS) is achieved in a minority of patients treated with a standard 12-week duration corticosteroid treatment. The aim of this pragmatic, retrospective, open label, comparative trial was to assess the effectiveness, in terms of complete clearance, of a 24-week treatment with mometasone furoate 0.1% ointment (MMF) and to compare it with a 12-week therapy. We included VLS patients treated with MMF administered for five consecutive days/week for 24 weeks (group A). The following were assessed: (a) clearance in Global Subjective Score (GSS), Global Objective Score (GOS) or both, (b) changes of these parameters and dyspareunia at treatment completion compared to baseline, (c) safety profile. All these assessments were compared with the same outcomes recorded among VLS patients who had previously undergone a 12-week MMF treatment (group B). Twenty-nine patients were included in group A and 32 in group B. The rates of patients who achieved the clearance of GSS, GOS or both parameters did not significantly differ between groups A and B. The groups did not differ in any of the effectiveness outcomes assessed. A 24-week duration corticosteroid treatment does not seem to provide significant therapeutic benefits in comparison with standard 12-week courses, especially considering the occurrence of complete clearance.

Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate administered as an inhaled fixed-dose combination in Japanese and Caucasian healthy subjects.

BACKGROUND: A once-daily (o.d.) fixed-dose combination of indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF) delivered via the Breezhaler® device (IND/GLY/MF) is being developed for treatment of asthma. This study compared steady-state pharmacokinetics of IND, GLY and MF between Japanese and Caucasian male subjects after multiple inhalations of IND/GLY/MF o.d. METHODS: This was a single-center, open-label, 2-treatment crossover study with a 21-day washout period. Japanese and Caucasian subjects received IND/GLY/MF 150/50/80 µg (inhaled corticosteroid [ICS] medium-dose) or 150/50/160 µg o.d. (ICS high-dose) for 14 days in each period. Pharmacokinetics were characterized up to 24 h post-dose on Days 1 and 14. RESULTS: In total, 16 Japanese (median age 31 years [range 20-40 years], mean weight 68.3 kg) and 17 Caucasian subjects (median age 27 years [range 21-43 years], mean weight 75.0 kg) were randomized. Geometric mean ratios (Japanese/Caucasian) [90% confidence interval (CI)] for Cmax for IND, GLY and MF at the high ICS dose on Day 14 were 1.31 [1.13, 1.51] 1.38 [1.13, 1.69] and 1.07 [0.969, 1.18], respectively. Geometric mean ratios (Japanese/Caucasian) [90% CI] for AUC0-24h on Day 14 for IND, GLY and MF at the high ICS dose were 1.17 [1.01, 1.35], 1.05 [0.920, 1.20] and 1.15 [1.05, 1.27] respectively. Similar trends were noted for all components for the medium ICS dose treatment. IND/GLY/MF was safe and well tolerated; no AEs suspected to be study drug-related were observed. CONCLUSION: Pharmacokinetics of IND, GLY and MF (high and medium dose) when delivered as a fixed-dose combination were comparable between Japanese and Caucasian subjects. The IND/GLY/MF combination at the administrated doses was safe and well tolerated in both ethnic groups. TRIAL REGISTRATION: Japan Registry of Clinical Trial: jRCT2031200227, retrospectively registered on 04, December, 2020.

Inhaled Budesonide vis-à-vis Inhaled Mometasone in Chinese Children with Mild Persistent Asthma: A Single-Center, Retrospective Study.

INTRODUCTION: A very limited option of inhaled corticosteroids (ICSs) is approved for pediatric use in China because in children the use of ICSs for long periods is associated with dose-dependent growth reduction. Due to the lack of consensus on which is the best ICS-based treatment option to manage mild persistent asthma in children, the present study was performed to evaluate the efficacy and safety of budesonide (BUD)-based therapy vis-à-vis mometasone-based therapy in children with mild persistent asthma. METHODS: A single-center, retrospective study was conducted in asthmatic children aged between 6 and 11 years. BUD and mometasone furoate (MF) were administered as per the approved dosing regimen using pressurized metered-dose inhalers via oral inhalation route for a period of 12 weeks. The study outcome was assessed in terms of the forced expiratory volume in 1 s (FEV1), symptom scores, and nonoccurrence of side effects. RESULTS: Among the 77 asthmatic children, 71 completed the study treatment and were used in carrying out the analysis. The improvement of spirometric parameters like FEV1, Tiffeneau-Pinelli index (FEV1/forced vital capacity [FVC]), and peak expiratory flow (PEF) values observed in the MF cohort was significantly greater than those of the BUD cohort (p < 0.05 for all). An increase of approximately 12%/child was observed for FEV1/FVC ratios for the BUD cohort and MF cohorts. After the 12-week study, the PEFm and PEFe values increased to about 50 L/min/child for the BUD cohort and about 98 L/min/child for the MF cohort. During the study, no asthma exacerbation event was observed in the MF cohort, whereas 1 child in the BUD cohort had asthma exacerbation in week 4. The use of rescue medication during the study was required for 16.2 and 6% of children, respectively, for BUD and MF cohorts. Owing to low dosing frequency, MF could provide a better treatment approach than BUD due to improved patient compliance. CONCLUSIONS: Although both drugs showed improvement in the quality of life of asthmatic children with manageable treatment-emergent adverse effects, the improvement was augmented in MF-treated children. LEVEL OF EVIDENCE: The level of evidence was III. Technical Efficacy Stage: The technical efficacy stage was 4.

Efficacy of topical steroid treatment in children with severe phimosis in China: A long-term single centre prospective study.

AIM: To evaluate the efficacy of topical steroid (0.1% mometasone furoate) therapy and factors affecting long-term outcome of paediatric severe phimosis in China. METHODS: A total of 1550 patients with severe phimosis classified by Kikiros system were prospectively enrolled in the study from January 2016 to February 2020. They were prescribed with 0.1% mometasone furoate twice a day for 4 weeks. Patients were re-evaluated at the end of weeks 2, 4, 8 and 6 months follow-up. RESULTS: A total of 1499 patients completed the treatment, 71.1% responded at the end of week 4. The long-term success rate was 66.0% over a mean follow-up of 26.9 months. The success rate of grade 4 phimosis was significantly higher than that of grade 5 at 4, 8 weeks and 6 months (P = 0.005, P < 0.001 and P < 0.001, respectively). Patients with balanoposthitis had a poorer outcome compared with patients without symptoms and patients symptoms by prepuce ballooning or urinary tract infections (P < 0.001). Initial grade of 5 phimosis and symptom with balanoposthitis were independent risk factors for recurrence. All patients had no systemic side effects, 23 cases developed local erythema or burning sensation. CONCLUSION: Topical steroid (0.1% mometasone furoate) is an effective treatment for severe phimosis in children. The recurrence was related to the grade or symptoms of severe phimosis.

Corticosteroid nasal spray for recovery of smell sensation in COVID-19 patients: A randomized controlled trial.

OBJECTIVES: To evaluate the role of the topical corticosteroid, mometasone furoate, nasal spray in the treatment of post COVID-19 anosmia. METHODS: A prospective, randomized, controlled trial was conducted among patients with post COVID-19 anosmia. One hundred patients were randomly assigned to two groups; group I included 50 patients received mometasone furoate nasal spray in an appropriate dose of 2 puff (100 µg) once daily in each nostril for 3 weeks with olfactory training, group II included 50 patients were advised to keep on olfactory training only. The assessment of smell was done using (Visual Analog Scale from 0 to 10). All patients were initially evaluated after their recovery from COVID-19 and followed up for 3 weeks. The smell scores were recorded weekly and the duration of smell loss was recorded from the onset of anosmia till the full recovery. RESULTS: In both groups, the smell scores significantly improved by the end of the third week (P < 0.001). By comparing smell scores between both groups after 1 week, 2 weeks, and 3 weeks of treatment, there were no statistically significant differences between both groups. In group I, (62%) of patients completely recovered their sense of smell after 3 weeks of treatment, compared to (52%) of patients in group II (P = 0.31). CONCLUSION: The results suggested that using mometasone furoate nasal spray as a topical corticosteroid in the treatment of post COVID-19 anosmia offers no superiority benefits over the olfactory training, regarding smell scores, duration of anosmia, and recovery rates. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04484493.

Topical corticosteroids for phimosis in children: a network meta-analysis of randomized clinical trials.

BACKGROUND: Corticosteroids and hyaluronidase are trialed for treating phimosis in children. We carried out the present network meta-analysis to compare the therapeutic effect of these drugs. METHODS: Electronic databases were searched for appropriate randomized clinical trials. Odds ratio (OR) with 95% confidence intervals (95% CI) was used as the effect estimate. A random-effects model was used for generating the pooled estimates. Rankogram plot was used for ranking the drugs. MAIN OUTCOME MEASURES: Proportions of patients with remission (partial/complete) and with complete remission. RESULTS: Mometasone (OR 6.53, 95% CI 2.85, 14.96), betamethasone/hyaluronidase (OR 12.1, 95% CI 4.27, 34.49), triamcinolone (OR 19.15, 95% CI 4.47, 81.96), dexamethasone (OR 21.38, 95% CI 5.71, 79.98), betamethasone (OR 23.02, 95% CI 6.92, 79.54), hydrocortisone (OR 23.2, 95% CI 5.91, 91.02) and methylprednisolone (OR 50.47, 95% CI 4.45, 572.72) were observed with significantly higher proportions of patients with remission (partial/complete) compared to placebo. Dexamethasone, triamcinolone, betamethasone, betamethasone/hyaluronidase, clobetasol, mometasone, and hydrocortisone were observed with significantly higher proportions of patients with complete remission compared to placebo. Beclomethasone was not observed to be superior to either placebo or other drugs. Rankogram plot revealed methylprednisolone followed by hydrocortisone had the maximum statistical probability of being 'the best' in the pool for remission and betamethasone followed by hydrocortisone for complete remission. CONCLUSION: Topical methylprednisolone, hydrocortisone, and betamethasone were observed with better clinical resolution of phimosis compared to other corticosteroids. Very high potent corticosteroids like beclomethasone and clobetasol were not observed with superior benefits compared to other corticosteroids. Considering low-potency, hydrocortisone shall be preferred until further evidence emerges.

[Combine therapy as a modern approach to treatment of allergic rhinitis].

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.

The efficacy of mometasone furoate for children with asthma: a meta-analysis of randomized controlled trials.

INTRODUCTION: The influence of mometasone furoate for paediatric asthma remains controversial. AIM: We conducted a systematic review and meta-analysis to explore the efficacy and safety of mometasone furoate for paediatric asthma. MATERIAL AND METHODS: We have searched PubMed, Embase, Web of science, EBSCO, and Cochrane library databases through October 2019 for randomized controlled trials assessing the effect of mometasone furoate versus placebo for paediatric asthma. This meta-analysis was performed using the random-effects model. RESULTS: Four RCTs were included in the meta-analysis. Overall, as compared to placebo for paediatric asthma, mometasone furoate is associated with substantially increased predicted forced expiratory volume in 1 s (FEV1) (mean difference (MD) = 7.53; 95% CI: 7.02-8.04; p < 0.00001), FEV1 (MD = 0.11; 95% CI: 0.10-0.12; p < 0.00001), and morning peak expiratory flow (AM PEF) (MD = 17.70; 95% CI: 9.91-25.49; p < 0.00001), but demonstrates no obvious effect on pharyngitis (RR = 0.96; 95% CI: 0.59-1.58; p = 0.89), upper respiratory tract infections (RR = 0.73; 95% CI: 0.50-1.05; p = 0.09), or adverse events (RR = 1.05; 95% CI: 0.84-1.31; p = 0.69). CONCLUSIONS: Mometasone furoate may be effective and safe for paediatric asthma.

Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study.

Indacaterol (IND; 150 µg), glycopyrronium (GLY; 50 µg) and mometasone furoate (MF; 160 µg [high-dose ICS] and 80 µg [medium-dose ICS]) have been formulated as a once-daily (o.d.) fixed-dose combination treatment delivered via the Breezhaler® device for the treatment of patients with asthma. In this randomized (n = 116), double-blind, double-dummy, active comparator-controlled, three-period cross-over study we evaluated the benefit of o.d. IND/GLY/MF versus twice daily (b.i.d.) salmeterol/fluticasone propionate combination (SFC; 50/500 µg; high-dose ICS) treatment (NCT03063086). Overall, 107 patients completed the study. The study met its primary objective by demonstrating superiority of o.d. IND/GLY/MF at medium and high-dose ICS over b.i.d. SFC (high-dose ICS) in peak FEV1 after 21 days of treatment (+ 172 mL with high-dose and + 159 mL with medium-dose IND/GLY/MF versus SFC, p < 0.0001 for each comparison). We also observed that a higher percentage of patients did not need rescue medicine with IND/GLY/MF (high-dose ICS, 58%; medium-dose ICS, 52%) compared with SFC (45%) during the last week of each treatment period. Study treatments were well-tolerated with no relevant differences in tolerability between both IND/GLY/MF doses and SFC. In conclusion, both doses of IND/GLY/MF provided superior lung function benefits compared with twice-daily, standard-of-care SFC at the highest approved dose. TRIAL REGISTRATION: ClinicalTrials.gov, (Identifier: NCT03063086), EudraCT start date: May 11, 2017; First patient first visit / study initiation date: May 31, 2017.