Mometasone Furoate Nasal Spray Research Articles

The Efficacy of Elonide Nasal Corticosteroids in Managing Allergic Rhinitis: A Randomized, Double-Blinded Trial.

Background: Mometasone furoate nasal spray is efficacious in relieving allergic rhinitis symptoms. The objectives of this study were, firstly, to compare the efficacy of Elonide to Nasonex® and a placebo and secondly, to investigate the side effects of Elonide. Method: This was a prospective, single-centered, double blinded, randomized, placebo-controlled, non-inferiority trial. A total of 163 participants from the Otorhinolaryngology Clinic, Hospital Canselor Tuanku Muhriz (HCTM), were randomized into three treatment groups receiving Elonide (n = 56), Nasonex® (n = 54), and placebo (n = 53) nasal sprays using an online randomizer (Random.org). Treatment was administered for 4 weeks. The primary outcome measure was the Total Nasal Resistance (TNR), and the secondary outcomes were the Visual Analogue Score (VAS) and the Rhinoconjunctivitis Quality of Life Questionnaire (RQOLQ) score. Side effects were recorded. Results: There were significant improvements for all groups from baseline. The Elonide group had the greatest mean difference for all primary and secondary outcomes compared to Nasonex® and the placebo (0.77 ± 2.44 vs. 0.35 ± 1.16, p = 1.00 vs. 0.17 ± 0.82, p = 0.01). Elonide is non-inferior to Nasonex (p = 1.00) and superior to the placebo (p < 0.05). The highest side effects reported were for Nasonex (n = 14, 26%), followed by the placebo (n = 8, 16%) and Elonide (n = 6, 12%); headaches (n = 9, 17%) and sore throat (n = 9, 17%) were the most common. Conclusions: Elonide has similar efficacy to Nasonex® when compared to a placebo in the treatment of AR in adults. Elonide is safe and tolerable, with fewer side effects and no adverse side effects.

Efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, randomised, double-blind, phase 2 trial

There is no trial to assess the benefits of periodically using biologics during the pollen season in patients with uncontrolled seasonal allergic rhinitis (SAR), who have moderate-to-severe symptoms even after standard-of-care. This trial aimed to evaluate the efficacy and safety of the add-on administration of stapokibart, a humanised monoclonal antibody that targets interleukin-4 receptor alpha, in patients with uncontrolled SAR. In this investigator-initiated, randomised, double-blind, placebo-controlled trial, eligible patients received either stapokibart 600-300mg weekly (QW), every 2 weeks (Q2W), or placebo QW for 4 weeks. All patients were given mometasone furoate nasal spray and loratadine throughout the trial. The primary endpoint was the mean change from baseline in daily reflective total nasal symptom score (rTNSS) during 2-week treatment. Secondary efficacy outcomes included: the mean change from baseline in daily rTNSS during 4-week treatment; the mean changes and the mean percentage changes from baseline during 2-week and 4-week treatment in 1) daily rTNSS and reflective total ocular symptom score (rTOSS), 2) morning (AM)/evening (PM) rTNSS and rTOSS, 3) AM instantaneous total nasal symptom score (iTNSS) and instantaneous total ocular symptom score (iTOSS), 4) individual nasal and ocular symptoms; the change from baseline in Rhinoconjunctivitis Quality of-Life Questionnaire score during 4-week treatment. Exploratory endpoints included the change of prespecified markers related to type 2 inflammation pre- and post-treatment. Safety, immunogenicity, and pharmacokinetics were also evaluated. This study is registered with www.clinicaltrials.gov (NCT05470647). Between August 17, 2022, and December 28, 2022, 92 patients with uncontrolled SAR were enrolled from 4 centres in China and randomly assigned to receive stapokibart 600-300mg QW (n=31), stapokibart 600-300mg Q2W (n=30), or placebo QW (n=31), of whom 86 (93%) completed the study. Both stapokibart Q2W and QW did not significantly improve mean change from baseline in daily rTNSS compared with placebo in 2 weeks. The least-squares (LS) mean differences (97.5% confidence interval [CI]) compared with placebo were-1.0 (-2.3, 0.2) in stapokibart Q2W group (p=0.065) and-0.2 (-1.5, 1.0) in stapokibart QW group (p=0.67). For the secondary outcomes, compared with placebo, stapokibart Q2W presented significant improvements in the mean percentage change from baseline in daily rTNSS in 2 weeks (LS mean difference-12.9%, 95% CI-25.3%,-0.4%, p=0.043), as well as AM iTNSS over 2 weeks (LS mean difference-17.4%, 95% CI-31.0%,-3.8%, p=0.013) and 4 weeks (LS mean difference-15.4%, 95% CI-29.0%,-1.9%, p=0.026). Additionally, the nasal congestion score was significantly lower in stapokibart Q2W than placebo during 2-week (LS mean difference-0.4, 95% CI-0.7,-0.1, p=0.014) and 4-week (LS mean difference-0.4, 95% CI-0.7,-0.04, p=0.028) treatment. Treatment-emergent adverse events (TEAEs) occurred in 48% (15/31), 33% (10/30), and 61% (19/31) of patients receiving stapokibart QW, Q2W, and placebo, respectively. Most reported TEAEs were sinus bradycardia, hyperlipidaemia, and blood uric acid increased. In this phase 2 trial, both stapokibart regimens had an acceptable safety and tolerability profile but did not significantly improve daily rTNSS in patients with uncontrolled SAR. The efficacy of stapokibart in patients with uncontrolled SAR is being further investigated in ongoing phase 3 trials (clinicaltrials.gov, NCT05908032). Ministry of Science and Technology of the People's Republic of China; Ministry of Education of the People's Republic of China; National Natural Science Foundation of China; Chinese Academy of Medical Sciences.

Эффективность и безопасность терапии мометазона фуроатом в сравнении с цетиризином у взрослых пациентов с сезонным аллергическим ринитом в условиях реальной клинической практики

Background: both H1-histamine blockers and intranasal corticosteroids are recommended as step 2 pharmacotherapy for allergic rhinitis (AR). Aim: to compare cetirizine and mometasone furoate (nasal spray) for AR treatment in patients requiring step 2 therapy in real-world clinical practice. Patients and Methods: this study enrolled 160 patients aged 18–75 years suffering from AR with pollen sensitization and requiring step 2 of therapy. The study was observational, open-label, comparative, and non-interventional. The patients were divided into two groups: main group (MG; n=80) who received over-the-counter medicine mometasone furoate (nasal spray) 200 μg/day regimen and comparison group (CG; n=80) who received cetirizine 10 mg/day orally for 1 month±2 days. Patients had three office visits. Each visit included a physical examination, anterior rhinoscopy, and self-assessment using the visual analog scale (VAS). Both patients and physicians completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Results: treatment efficacy was excellent (0-1 VAS score) in 52 (65%) patients in the CG and in 76 patients in the MG (95%, p&lt;0.05). Treatment efficacy was good (2-5 VAS scores) in 12 (15%) patients in the CG and in 4 (5%) patients in the MG. The study found that 5% of patients in the CG reported satisfactory results compared to 0% in the MG. Additionally, a significant difference (p&lt;0.001) in the reduction of the RQLQ score was reported among patients who experienced an improvement in quality of life by day 14 of treatment in the CG (-80.3±19.3) and MG (-113.3±34.7). The effectiveness of mometasone furoate (200 μg/day) as a monotherapy for 4 weeks was found to be superior to cetirizine treatment (10mg/day). Additionally, it was associated with a greater improvement in quality of life and better treatment tolerability due to fewer adverse events. Conclusions: mometasone furoate (nasal spray) can be recommended as a monotherapy for adults with mild to moderate AR. KEYWORDS: seasonal allergic rhinitis, mometasone furoate, cetirizine, intranasal corticosteroids, oral antihistamines. FOR CITATION: Churyukina E.V., Gamova I.V. Efficacy and safety of mometasone furoate therapy versus cetirizine in adults with seasonal allergic rhinitis in a real-world clinical setting. Russian Medical Inquiry. 2024;8(3):132–142 (in Russ.). DOI: 10.32364/2587- 6821-2024-8-3-3.

Is Topical Nasal Steroid Useful for Treatment of Otitis Media with Effusion in Children?

Otitis media with effusion is a common and important pediatric clinical problem; it is the leading cause of hearing impairment in children. Medical treatment remains controversial. To evaluate the usefulness of using topical nasal steroids in the treatment of otitis media with effusion. Between November 2019 and October 2022, a prospective controlled clinical study was carried out in the department of otolaryngology at Al-Jerrahat Teaching Hospital in Medical City, Baghdad, Iraq. This study comprised 40 patients with bilateral otitis media with effusion (23 males, 17 females). Two groups were created for the patients. Patients in group A (20 patients) were treated with mometasone furoate nasal spray; 1 puff (50 µg) in each nostril daily for 2 weeks, while the 20 patients in group B were treated with saline nasal spray; 1 puff in each nostril daily for 2 weeks. At the end of the first and second weeks of treatment, otoscopic examination was used to monitor the patients. At the end of the second post-treatment week, pure tone audiometry and tympanometry were performed again. Normal otoscopic results, a type A tympanogram, and enhanced pure tone hearing threshold average to be ≤20 dB HL within 0, 5, 1, and 4 KHz were used to characterize resolution of OME. The association between two means was determined using an independent sample t-test, while the association between categorical variables was determined using an X2-test. At the end of 2nd post-treatment week, there was no significant difference regarding improvement of otitis media with effusion regarding otoscopic, audiometric, and tympanometric results in both groups (P-value >0.05). Topical nasal steroid is unuseful for the treatment of otitis media with effusion in the short-term.

Assessing serum cytokine and immunoglobulin levels in patients with allergic rhinitis and allergic rhinoconjunctivitis before and after treatment supplemented with macromycetes

Background: In recent decades, the prevalence of allergic rhinitis (AR) has been increasing all over the world including Ukraine. Allergic rhinoconjunctivitis (ARC) is one of the most common clinical forms of AR. An imbalance between pro-inflammatory and anti-inflammatory cytokines is known to have a key role in allergic inflammation. Purpose: To compare cytokine and immunoglobulin levels among patients with AR and ARC treated with different therapeutic options. Material and Methods: Forty patients with AR and ARC (age range, 20 to 46 years) were included in the study. Disease duration ranged from 6 months to 2 years. Patients were divided into two subgroups of 20 patients each. Patients of subgroup 1 received the basic therapy (a 10-mg loratadin tablet daily and mometasone furoate nasal spray at a dosage of 200 μg once daily), whereas patients of subgroup 2, the basic therapy plus polypore macromycetes (Astmagan), one capsule twice daily. Treatment course duration was 90 days. The control group was composed of 25 healthy individuals. A comprehensive clinical immunological examination was conducted at baseline and on the completion of the treatment course. Enzyme-linked immunosorbent assay kits were used to determine serum levels of immunoglobulins A (IgA), IgM, IgG, and IgE, and cytokines (gamma interferon (IFN-γ) and IL4). Results: At baseline, serum levels of IgA, IgM and IgE were almost twice as high (р = 0.0008; 0.0005; and 0.0001, respectively); IgG, 1.2 times higher (р = 0.001); pro-inflammatory cytokine IL4, 3.5 times higher (р = 0.0001); and anti-inflammatory cytokine IFN-γ, 2.4 times lower (р = 0.0001) in patients with AR and ARC compared to controls, and these differences were significant. Astmagan, when used as an adjunct to the basic treatment of AR and ARC, contributed to 8%, 17%, 16.2%, 7.3% and 6.0% greater decreases in the serum levels of IgA, IgM, IgE, IgG and IL4, respectively, and a 16.6% greater increase in the serum level of IFN-γ compared to the basic treatment only, and these differences were significant, with an improvement in immune response to therapy.

The Efficacy of Double-Dose Mometasone Furoate Nasal Spray in Postoperative Management of Nasal Polyps: A Randomized Controlled Trial

Background: Nasal polyps are benign growths of nasal mucosa associated with inflammation and topical nasal corticosteroids are the medical treatment of choice. Surgical removal is indicated for patients not responding adequately to medical treatment. There is little evidence on the efficacy of double-dose mometasone furoate nasal spray and conventional dose to prevent the recurrence of nasal polyps and decrease nasal symptom score following endoscopic sinus surgery. Objective: To compare the efficacy of double-dose mometasone furoate and conventional dose to prevent the recurrence of postoperative nasal polyps. Materials and Methods: The present study was a randomized controlled trial. Thirty patients who met the inclusion criteria were randomly divided into two groups, 15 patients in each group. Group I patients were given mometasone furoate two sprays in each nostril twice a day (400 μg) and Group II received mometasone furoate two sprays in each nostril once a day (200 μg) as a conventional dose for six months. Grading of nasal polyps and nasal symptom score were recorded before and after treatment at the first, second, fourth, twelfth and twenty-four weeks. Results: After six months of the endoscopic sinus surgery, Meltzer clinical scoring system of nasal polyps showed an average score of 0.67±0.72 in the conventional dose, which was significantly reduced to 0.07±0.26 (p&lt;0.01) in the double dose of mometasone furoate. The average nasal symptom score in the conventional dose was 0.70±0.70, which was not significantly decreased to 0.30±0.50 (p=0.25) in the double dose. There were no side effects in both groups. Conclusion: Double-dose of mometasone furoate nasal spray might be recommended for preventing the recurrence of nasal polyps and decreasing nasal symptom score following surgery. Keywords: Nasal polyps; Intranasal corticosteroid; Endoscopic sinus surgery; Mometasone furoate; Recurrent nasal polyps; Nasal spray; Nasal symptom score; Randomized controlled trial; Postoperative management

Efficacy and safety of CM310 in severe eosinophilic chronic rhinosinusitis with nasal polyps (CROWNS-1): a multicentre, randomised, double-blind, placebo-controlled phase 2 clinical trial.

Severe eosinophilic chronic rhinosinusitis with nasal polyps (ECRSwNP) remains the most relapsed subtype of uncontrolled CRSwNP. CM310, a humanised anti-interleukin (IL)-4 receptor alpha monoclonal antibody, inhibits IL-4 and IL-13 signaling which underlying eosinophilic inflammation. This study aims to evaluate the efficacy and safety of CM310 in patients with severe ECRSwNP. A multicentre, randomised, double-blind, and placebo-controlled phase 2 clinical trial was conducted. 56 eligible adult patients with severe ECRSwNP were randomised 1:1 to receive subcutaneously either CM310 (300mg) or placebo every 2 weeks under the background therapy of mometasone furoate nasal spray (MFNS) for 16 weeks, with 8 weeks of follow-up. Coprimary endpoints included the changes from baseline in nasal polyp score (NPS) and nasal congestion score (NCS) at week 16. Key secondary endpoints included sinus Lund-Mackay CTscore, change in sinus volume occupied by disease, University of Pennsylvania Smell Identification Test score, 22-item Sino-nasal Outcome Test score, and total symptom score. Safety, pharmacodynamics, and changes in type 2 inflammation biomarkers were assessed. This study is registered with ClinicalTrials.gov, NCT04805398. Between April 6, 2021, and March 18, 2022, 27 patients respectively in both the CM310 and placebo groups completed the study. Findings suggested that CM310 improved the coprimary efficacy endpoints of decreasing nasal polyp size and alleviating nasal congestion compared with the placebo. Least squares (LS) mean differences (CM310 vs placebo) of change from baseline in NPS and NCS at week 16 were-2.1 (95% CI-2.9,-1.4; p<0.0001) and-0.9 (95%CI-1.4,-0.5; p<0.0001), respectively. Sinus CT scan revealed that Lund-Mackay CT score (LS mean difference [95%CI]-7.6, [-9.4,-5.8]; p<0.0001) and sinus volume occupied by disease (LS mean difference [95% CI]-37%, [-47%,-28%]; p<0.0001) were significantly improved with CM310 compared with placebo. In addition, CM310 significantly relieved the daily symptoms of patients with CRSwNP and improved their quality of life reflected by the improvements in the TSS (-2.6 [95% CI-3.5,-1.6]), UPSIT (10.4 [95% CI 6.8, 14.0]) and SNOT-22 score (-19.1 [95% CI-29.8,-8.5]). Compared with placebo, CM310 administration significantly reduced type 2-related biomarkers including the serum TARC and total IgE, and tissue eosinophils. The most common adverse events were upper respiratory tract infection, blood cholesterol increased, and tinnitus, but none were considered drug-related. These findings support CM310 as an effective additional treatment option to the standard of care in patients with severe ECRSwNP. KeyMed Biosciences (Chengdu) Limited.

Effectiveness of Kinetic Oscillation Stimulation Treatment in Persistent Moderate-severe Allergic Rhinitis Compared to Medical Therapy

Introduction: KOS represent an innovative non-surgical solution developed at the Karolinska University Hospital in Stockholm (Sweden) which consists of a intranasal stimulation via an air inflated catheter indicated to treat non allergic rhinitis and migraine. The KOS method for rhinitis has proved to be so effective as it simultaneously stimulates the nasal mucosa and the local autonomic nervous system, which represents the predisposing ultrastructural factor and is able to maintain the neurogenic inflammation responsible for the nasal symptoms of chronic rhinitis, very disabling for the quality of life of rhinitic patients. We wanted to verify whether the positive results obtained in the treatment of non-allergic rhinitis that we observed in our previous study could also be obtained in patients with allergic rhinitis, who similarly share many of the nasal symptoms. Materials and Methods: A total of 110 patients (63 males), aged &gt;18 years, consecutively enrolled, all undergoing complete ENT evaluation with physical clinical examination, endoscopy, nasal symptoms VAS and SNOT-22 questionnaire, affected by allergic rhinitis (AR) persistent moderate-to-severe grade. All patients were alternately assigned to 2 homogeneous groups (Group A: Control Subjects, Group B: KOS Treated Patients), each group included 55 individuals. Simple randomization was achieved with a sequence of random numbers from a computer-generated sequence. During the study, both groups received standard medications (Ebastine tablet 10 mg and Mometasone furoate nasal spray 50 mcg/actuation per nostril per day) for 90 days. At the beginning of medical treatment, group B patients underwent first KOS treatment (repeated after 20 days). Both groups were asked to report any side effects during the study. Results: The treated patients already benefited immediately after the extraction of the balloon reporting a sensation of a more patent nose and reduction of nasal secretions which progressively improves in the following days. For the subjective complaints (nasal obstruction, sneezing, rhinorrhea, and itching), the improvement was significant within each group, with the most significant improvements in treatment group B. When the KOS treatment group was compared with medical treatment alone (Group A), greater efficacy was observed in Group B with regards to the reduction of nasal symptoms and nasal endoscopic findings. Regarding the objective results (rhinomanometric assessments), similar trends, such as subjective ones, were observed within each group. The improvements within each treatment group were significant without side effects. Comparison between Groups A and B, before and after treatment, with the SNOT-22 questionnaire relating to the 5 most important questions (5 most important items) showed an improvement in both study groups but with better results, however regards efficacy, in Group B. Discussion: Our results reveal a greater efficacy achieved using a combined approach, with the association between medical treatment and KOS, compared to medical treatment alone, in the control of the sympotms of AR associated with hypertrophy of the inferior turbinates. The symptoms evaluated by VAS showed greater efficacy in their control in those patients in treatment group B, in particular those patients who had undergone treatment with KOS presented objective parameters (AAR, endoscopic score) and SNOT-22 better than the group receives only medical care. Conclusion: KOS treatment, in combination with medical therapy, improves nasal flow more effectively than medical treatment alone in persistent moderate to severe AR. In particular, the local nasal symptoms were significantly reduced. Patients undergoing the KOS treatment report improvement in their nasal rhinitis symptoms within a few days, which improve further, also in our experience, after a second boost application.

Visualization of nasal powder distribution using biomimetic human nasal cavity model

Nasal drug delivery efficiency is highly dependent on the position in which the drug is deposited in the nasal cavity. However, no reliable method is currently available to assess its impact on delivery performance. In this study, a biomimetic nasal model based on three-dimensional (3D) reconstruction and three-dimensional printing (3DP) technology was developed for visualizing the deposition of drug powders in the nasal cavity. The results showed significant differences in cavity area and volume and powder distribution in the anterior part of the biomimetic nasal model of Chinese males and females. The nasal cavity model was modified with dimethicone and validated to be suitable for the deposition test. The experimental device produced the most satisfactory results with five spray times. Furthermore, particle sizes and spray angles were found to significantly affect the experimental device's performance and alter drug distribution, respectively. Additionally, mometasone furoate (MF) nasal spray (NS) distribution patterns were investigated in a goat nasal cavity model and three male goat noses, confirming the in vitro and in vivo correlation. In conclusion, the developed human nasal structure biomimetic device has the potential to be a valuable tool for assessing nasal drug delivery system deposition and distribution.

The Effect of Mometasone Furoate Nasal Spray on Blood Oxygenation in Allergic Rhinitis Patients

Allergic rhinitis (AR) is a disease that presents with symptoms like nasal discharge, blockage, and itchiness, which impair the quality of life of most patients depending on its severity. The most common symptom in AR patients is a persistent bilateral nasal blockage, which may indirectly and potentially affect the airflow into the lung. However, the symptoms can be controlled using intranasal steroid spray (INS). This study investigated the role of nasal obstruction in lowering blood oxygenation and how INS improved blood oxygenation. This study included 33 patients with AR. Subjects with moderate-to-severe nasal obstruction were recruited based on the Visual Analogue Scale (VAS), and mometasone furoate nasal spray (MFNS) – two puffs twice a day for two weeks was given. Pre- and post-medication parameters compared included nasal obstruction VAS, partial oxygen arterial pressure (PaO2), partial arterial carbon dioxide pressure (PaCO2), and oxygen saturation (O2 saturation). All parameters were substantially different between pre- and post-medication. VAS, PaO2, PaCO2, and O2 saturation were significantly different before and after medicine (p&lt;0.01). A comprehensive treatment of nasal obstruction using MFNS helps improve blood oxygenation and nasal obstruction in AR patients.

Efficacy of mometasone furoate nasal spray in the treatment of acute rhinosinusitis

BackgroundAcute rhinosinusitis (ARS) refers to a group of disorders characterized by inflammation of the respiratory epithelium of the nose and paranasal sinuses lasting from 7 to 28 days. In the treatment of ARS in addition to an antibiotic, intranasal corticosteroids hasten the clearance of bacteria, decrease the frequency and severity of disease recurrence, and reduce the duration of infection. The purpose is to compare the efficacy of the combination of mometasone furoate nasal spray (MFNS) with amoxicillin and amoxicillin alone in the treatment of acute rhinosinusitis. A total of 120 patients (≥ 12 years) were randomized into 2 groups: group A (N: 60) receiving amoxicillin 500 mg thrice daily alone and group B (N: 60) receiving amoxicillin 500 mg thrice daily and MFNS 200 μg twice daily for 7 days. Patients were followed up after 7 days. The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire was taken before and after. The total score of SNOT-22 was compared between the groups.ResultsThere was a reduction in the mean total SNOT score in both groups from 21.32 ± 11.29 to 9.37 ± 6.55 in group A and from 26.68 ± 11.97 to 3.07 ± 3.46 in group B which were statistically significant (p < 0.001) in both groups. The posttreatment mean score with the amoxicillin group was 9.31 ± 6.55 and that of the amoxicillin and mometasone furoate group was 3.07 ± 3.46, and their mean difference was 6.3 ± 0.95. In comparison, MFNS with amoxicillin was significantly (p < 0.001) superior than amoxicillin alone.Conclusion Patients receiving amoxicillin alone or amoxillin with MFNS, both  showed improvement of symptoms in ARS. However, amoxicillin with MFNS showed significantly higher improvement and relief of symptoms in ARS than amoxicillin alone.

Is Mometasone Effective in Treating Otitis Media with Effusion?

Otitis media with effusion (OME) is the long-term deposition of mucus in the middle ear cleft. It is the leading cause of childhood hearing loss and a common childhood infection. It can impair communication and life quality. OME's direct and indirect costs are also crucial. Improving OME care is crucial. This study examines intranasal mometasone's efficacy in treating otitis media with effusion. A clinical trial study was conducted during a period from January 2021 to June 2022. It included 80 patients suffering from otitis media with effusion bilaterally (160 ears) who had an intact tympanic membrane and tympanometry type B. These patients were included only if they had a hearing change or loss noted by the parents or by the patient if he or she could complain for three months or more. These patients were split into two groups. Group A had 80 ears (40 patients) who got one puff of mometasone furoate nasal spray in each nostril every day for three months, and Group B had 80 ears (40 patients) who got one puff of seawater nasal spray in each nostril every day for the same period. On the first visit, otoscopic findings were recorded, and all patients had pure-tone audiometry and tympanometry performed. All of the above-mentioned measures were repeated and compared to the records from the first visit at the end of the three months of treatment. After treatment, 75% of ears in Group A changed from type B to type A tympanometry. This was significantly higher than in Group B, where only 15% of ears changed from type B to type A tympanometry. Regarding retraction, 75% of ears in Group A showed no retraction after treatment with mometasone furoate, while in Group B, it was 40%. The average pure-tone audiometry score in Group A improved after therapy. Corticosteroids are effective in the treatment of otitis media with effusion and safer when used as topical intranasal steroids than systemic preparations.

A comparative study of fluticasone propionate, mometasone furoate, and saline nasal spray in the treatment of children with adenoid hypertrophy}

A comparative study of fluticasone propionate, mometasone furoate, and saline nasal spray in the treatment of children with adenoid hypertrophy}

Efficacy and safety of a new mometasone furoate nasal spray formulation in patients with acute rhinosinusitis: a randomized clinical trial

Common inflammatory airway disorders, such as seasonal and perennial allergic rhinitis, acute sinusitis, and nasal polyposis, can have a significant impact on patient health and quality of life. Intranasal corticosteroids are recommended as part of treatment plans for each of these illnesses because they reduce inflammation and thus symptoms. In order to compare the efficacy and safety of a new nano formulation of mometasone furoate nano-nasal spray (MF-NNS) with a commercially available nasal spray called mometasone furoate nasal spray (MFNS) for the treatment of allergic rhinitis, 20 rhinitis patients were enrolled in this randomized controlled trial (10 to 50 years). Patients were given 50 mcg MF-NNS doses in the morning and evening. This regimen was administered as a nasal spray for a 3-week efficacy and safety phase. The primary endpoints changed from baseline in the subjects’ congestion as determined by the physicians’ assessment of allergic rhinitis. Analysis of variance was used to evaluate all efficacy end points. More clinical trials have shown that MF-NNS reduces both objective and subjective markers of inflammation in adults, adolescents, and children.

First Approval of Generic Mometasone Furoate Nasal Suspension Spray in Japan: Similarities and Differences Between Japan and the USA.

The Ministry of Health, Labour and Welfare (MHLW) in Japan approved the first generic version of Nasonex in February 2018. The Pharmaceuticals and Medical Devices Agency requires in vitro, pharmacokinetic, and pharmacodynamic or clinical endpoint data to approve generic nasal spray drug products. However, the MHLW has not published basic principle for approving nasal generic drug products. Therefore, this article summarizes the data used for the approval of the first generic Nasonex based on publicly available data. Additionally, we compare the bioequivalence evaluations regarding the human studies based on the generic version of Nasonex between Japan and the USA.

Efficacy of Mometasone Furoate Nasal Spray with Oral Montelukast in the treatment of Otitis Media with Effusion with or without Adenoid Hypertrophy and Atopic diseases

Bacground:Otitis media with effusion [OME] is a common chronic but silent disease of middle ear in children and is the commonest cause of hearing impairment, delayedlanguage development and altered quality of life.Though surgical management is the treatment of choice but now alternative medical treatment with steroid nasal spray is well accepted. Aim of this study: In this prospective, randomized placebo control study we want to observe the efficacy of Mometasone furoate nasal spray in conjunction with oral Leukotriene receptor blocker [Montelukast] in comparison to Mometasone furoate nasal spray only and normal saline spray as placebo for 3 months. Materials and Methods: Total sixty children aged 2-12 years old diagnosed with bilateral OME for at least 3 months with or without enlarged adenoid &amp; atopic diseases, were randomly allocated into three equal groups. The first group A received Mometasonefouroate nasal spray plus Tab Montelukast for 12 weeks and second group B received only mometasonefouroate nasal spray &amp;third group C received normal saline spray for the same duration. Result: Otoscopic clinical exam, Pure Tone audiometry &amp; tympanometry were done at the end of treatment [3 months duration]. In otoscopic examination normal tympanic membrane finding show significant improvement in group A than group B &amp; group C and tympanometric result in group A , show 80% improvement in middle ear status &amp; had larger chi-square value then group B [60% improvement] and group C [10% improvement] and pure tone audiometry result show highest hearing threshold improved in group A and were more significant than group B and control group C. Conclusion: Mometasone furoate nasal spray is a much more effective medical treatment option in resulution of OME when it is combined with oral Leukotriene receptor blocker Montelukastas it helps to normalize the Eustachian tube function and middle ear status by decreasing enlarged adenoid size, atopic disorders and improving hearing power &amp; quality of life. Bangladesh Journal of Medical Science Vol. 21 No. 04 October’22 Page : 836-841

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

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.

Intranasal Corticosteroid Treatment on Recovery of Long-Term Olfactory Dysfunction Due to COVID-19.

Background and AimsOlfactory dysfunction is a recognized manifestation in patients infected with Coronavirus Disease 2019 (COVID‐19). This investigation aimed to assess the effect of mometasone furoate intranasal spray on the improvement of smell dysfunction in post‐COVID‐19 patients.Materials and MethodsThis randomized placebo‐controlled trial included 80 non‐hospitalized adult patients who had persistent anosmia or severe microsmia for more than 4 weeks due to COVID‐19 infection. The participants were randomly allocated to the intervention or placebo group to receive mometasone furoate nasal spray or sodium chloride intranasal spray during 4 weeks of follow‐up, respectively. The patients' olfactory dysfunction was assessed in terms of visual analog scale (VAS), and smell test score according to the modified version of the University of Pennsylvania smell identification test for the Iranian population.ResultsA total of 70 participants completed the follow‐up period and were analyzed in this study. By comparing the olfactory scores including smell test and VAS scores, no significant differences were found between case and control groups at baseline, 2, and 4 weeks intervals. However, the change of both olfactory scores at pre to post‐treatment intervals and 2–4 weeks was significantly higher in the mometasone group relative to the placebo group. At post‐treatment, the frequency of anosmia was 22.9% reduced in the case group compared to the control group.ConclusionOverall, there was no significant difference in olfactory dysfunction between the two groups during follow‐up. However, based on the significant between‐group difference in terms of olfactory scores changes, it seems that the nasal corticosteroids may be a positive effect on the recovery process of patients who received more than 2 weeks.Level of EvidenceII Laryngoscope, 2022

Effect of Loratadine Tablets in Combination with Other Drugs on Nasal Physiological Function and T Lymphocyte Subsets in Patients with Allergic Rhinitis.

Objective To investigate the effects of loratadine tablets in combination with other drugs on nasal physiological function and T lymphocyte subsets in patients with allergic rhinitis (AR). Methods A total of 120 AR patients treated in our hospital from February 2018 to February 2021 were randomly divided into control group and research group. The control group was given mometasone furoate nasal spray combined with loratadine tablets, while the research group was given budesonide combined with loratadine. The efficacy, duration of clinical symptom remission, immune function indicators, T lymphocyte subset, nasal physiological function, and incidence of adverse reactions were compared between the two groups. Results The efficacy results of the two groups showed that the effective rate of the research group was 96.67%, while the effective rate of the control group was 83.33%. The effective rate in the research group was higher compared to the control group (χ2: 5.925 P < 0.05). The results of clinical symptom relief time showed that the clinical symptom relief time of nasal congestion, itching, runny nose, and sneezing in the research group was lower than that in the control group, and the difference was statistically significant (P < 0.05). The results of the comparison of immune function indicators showed that the IL-6, IL-8, and IgE of the research group were lower than those of the control group, while the Th1/Th2 of the research group were higher than those of the control group. There were no statistically significant differences in T lymphocyte subsets before nursing, but after treatment, the T lymphocyte subsets of the two groups decreased, and the level of CD3+, CD4+, CD8+, CD4+, and CD4+/CD8+ lymphocytes in the research group was lower than that of the control group, and the difference was statistically significant (P < 0.05). Before treatment, there exhibited no significant difference in nasal physiological function, but after treatment, the nasal physiological function of the two groups was enhanced, and the MTT, NR, and MCR of the research group were lower than those of the control group, and the difference was statistically significant (P < 0.05). Finally, the incidence of adverse reactions in the research group was lower compared to the control group, and the difference was statistically significant (P < 0.05). Conclusion Budesonide and loratadine are effective in improving patient efficacy, T lymphocyte subsets, and nasal physiological function, and are safer.

Method Development, Validation and Estimation of Relative Response Factor for the Quantitation of Known Impurities in Mometasone Furoate Nasal Spray Dosage form by RP-HPLC with UV/PDA Detector

Method Development, Validation and Estimation of Relative Response Factor for the Quantitation of Known Impurities in Mometasone Furoate Nasal Spray Dosage form by RP-HPLC with UV/PDA Detector