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Pharmaceutics Jan 2023Mometasone furoate (MF) is a medium-potency synthetic glucocorticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. However, its role in the...
Mometasone furoate (MF) is a medium-potency synthetic glucocorticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. However, its role in the treatment of ocular inflammation has not yet been explored. This work investigated the anti-inflammatory activity of MF in ocular tissues. First, the in vivo safety of the intravitreal (IVT) injection of MF (80, 160, and 240 µg) was evaluated via clinical examination (including the assessment of intraocular pressure), electroretinography (ERG), and histopathology. Second, MF was tested in an experimental model of bacillus Calmette-Guérin (BCG)-induced uveitis in Wistar rats. Intraocular inflammation was then evaluated via a slit-lamp and fundus examination, ERG, histopathology, and the quantification of pro-inflammatory markers. Intravitreal MF showed no toxicity in all the investigated doses, with 160 µg leading to attenuated disease progression and improvement in clinical, morphological, and functional parameters. There was a significant reduction in the levels of inflammatory markers (myeloperoxidase, interleukins 6 and 1β, CXCL-1, and tumor necrosis factor-alpha) when compared to the levels in untreated animals. Therefore, MF should be further investigated as a promising drug for the treatment of ocular inflammation.
PubMed: 36678822
DOI: 10.3390/pharmaceutics15010193 -
JAMA Pediatrics Mar 2023Obstructive sleep-disordered breathing (SDB) in children is characterized by snoring and difficulty breathing during sleep. SDB affects at least 12% of otherwise healthy... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Obstructive sleep-disordered breathing (SDB) in children is characterized by snoring and difficulty breathing during sleep. SDB affects at least 12% of otherwise healthy children and is associated with significant morbidity. Evidence from small clinical trials suggests that intranasal corticosteroids improve SDB as measured by polysomnography; however, the effect on symptoms and quality of life is unclear.
OBJECTIVE
To determine whether intranasal mometasone furoate is more effective than intranasal saline for improving symptoms and quality of life in children with SDB.
DESIGN, SETTING, AND PARTICIPANTS
The MIST trial was a multicenter, randomized, double-blind, placebo-controlled trial, recruiting participants from June 8, 2018, to February 13, 2020. Children aged 3 to 12 years who were referred to a specialist for significant SDB symptoms were included; exclusions were previous adenotonsillectomy, body mass index greater than the 97th percentile, and severe SDB. Randomization was stratified by site, and data were analyzed on an intention-to-treat basis from October 28, 2020, to September 25, 2022.
INTERVENTIONS
Participants were randomly assigned to receive mometasone furoate, 50 μg, or sodium chloride (saline), 0.9%, 1 spray per nostril daily, dispensed in identical bottles.
MAIN OUTCOMES AND MEASURES
The primary outcome was resolution of significant SDB symptoms (ie, reduction to a level no longer requiring referral to a specialist as per the American Academy of Pediatrics guidelines) at 6 weeks, measured by parental report of symptoms using the SDB Score.
RESULTS
A total of 276 participants (mean [SD] age, 6.1 [2.3] years; 146 male individuals [53%]) were recruited, 138 in each treatment arm. Resolution of significant SDB symptoms occurred in 56 of 127 participants (44%) in the mometasone group and 50 of 123 participants (41%) in the saline group (risk difference, 4%; 95% CI, -8% to 16%; P = .51) with 26 participants lost to follow-up and missing values managed by multiple imputation. The main adverse effects were epistaxis, affecting 12 of 124 participants (9.7%) in the mometasone group and 18 of 120 participants (15%) in the saline group, and nasal itch/irritation, affecting 12 of 124 participants (9.7%) in the mometasone group and 22 of 120 participants (18%) in the saline group.
CONCLUSIONS AND RELEVANCE
Results of this randomized clinical trial suggest that there was no difference in treatment effect between intranasal mometasone and saline for the management of SDB symptoms. The results suggest that almost one-half of children with SDB could be initially managed in the primary care setting and may not require referral to specialist services, as is currently recommended.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry: ANZCTRN12618000448246.
Topics: Male; Humans; Child; Mometasone Furoate; Quality of Life; Nasal Sprays; Australia; Administration, Intranasal; Pruritus; Saline Solution; Sleep Apnea Syndromes; Treatment Outcome
PubMed: 36648937
DOI: 10.1001/jamapediatrics.2022.5258 -
Iranian Journal of Basic Medical... Jan 2023A new binary mixture containing mometasone furoate (MF) and calcipotriol (CP) is suggested to manage psoriasis; since the combined stability profile of these drugs is...
Simultaneous determination of mometasone furoate and calcipotriol in a binary mixture by validated HPLC and chemometric-assisted UV spectrophotometric methods and identification of degradation products by LC-MS.
OBJECTIVES
A new binary mixture containing mometasone furoate (MF) and calcipotriol (CP) is suggested to manage psoriasis; since the combined stability profile of these drugs is poorly understood.
MATERIALS AND METHODS
Herein MF, CP, and their mixtures were subjected to various stress conditions. Also, stability-indicating HPLC was developed and validated according to ICH guidelines with Box-Behnken design. The degradation products (DPs) were predicted and identified using LC-MS. The bioactivity and toxicity of DPs were studied using molecular docking and alamarBlue assay, respectively. Spectroscopic techniques of the first derivative, first-derivative ratio, and the mean-centering of ratio spectra were also used to determine MF and CP in the mixture because of spectra overlapping.
RESULTS
The major degradants for MF in alkaline conditions were DP1, DP2, and DP3, while in thermal and UV conditions, only DP1 was generated. CP gave one degradant in all conditions. No new impurity was observed in the MF and CP mixtures. The results of spectrophotometry showed good linearity in the range of 4-50 and 2-20 µg/ml, while linearity for HPLC was in the range of 4-50 and 0.5-2.5 µg/ml for MF and CP, respectively. Recovery was 99.61-100.38% for UV and 100.4% for HPLC methods of MF and 100.6-101.4% for UV and 99.5% for HPLC methods of CP.
CONCLUSION
The developed methods can be used as simple, accurate, precise, and rapid techniques for routine quality control of MF and CP mixtures.
PubMed: 36594065
DOI: 10.22038/IJBMS.2022.65436.14396 -
Pharmaceutics Nov 2022A pre-formulation study was carried out to obtain liposomal formulations of mometasone furoate as an alternative system to marketed forms of corticosteroid for the...
A pre-formulation study was carried out to obtain liposomal formulations of mometasone furoate as an alternative system to marketed forms of corticosteroid for the treatment of inflammatory skin lesions. Mometasone furoate was loaded in glycerosomes and glyceroethosomes, which were also modified with hyaluronic acid (glyceroethohyalurosomes). Vesicles were designed, elaborated, and characterized, and their biocompatibility, efficacy against oxidative stress and skin lesions were assessed in vitro, in human epidermal cells, and in vivo, in a mouse skin epidermal hyperplasia model. All formulations tested showed great encapsulation efficiency, nanometric size, formed monodispersed systems and a highly negative Z potential. Similar values were obtained over nine months storage at 4 °C, which indicates the great stability of the three types of nanoliposomes at least during the time tested. Among them, 0.1% mometasone furoate glyceroethohyalurosomes were the best formulation to protect cells against oxidative stress and their anti-inflammatory efficacy was confirmed in vivo, being even more effective than the marketed form (Elocom), as the reduction in the inflammation was even ~15% higher than that achieved with the commercial cream. Selected formulations could be potential candidates as new vehiculation systems for mometasone furoate. The presence of hyaluronic acid in glyceroethohyalurosomes makes them the best candidates in preventing/treating skin inflammatory lesions.
PubMed: 36559053
DOI: 10.3390/pharmaceutics14122558 -
Medicine Dec 2022Allergic rhinitis (AR) is considered to be 1 of the most difficult diseases to treat globally. It has a serious impact on the quality of life and social economy of...
Observation on the efficacy of sublingual immunotherapy with dust mite allergen for perennial allergic rhinitis and the mechanism of action on ILCs with ILC1s and ILC2s and ILC3s.
BACKGROUND
Allergic rhinitis (AR) is considered to be 1 of the most difficult diseases to treat globally. It has a serious impact on the quality of life and social economy of patients and has become an important global health problem. Several drugs have been recommended to treat AR, but their effectiveness and mechanism of action in these patients remain unclear. The purpose of this study will be to compare the efficacy and mechanism of action of 2 drugs for the treatment of AR (moderate to severe): a Dermatophagoides Farinae Drops Sublingual Immunotherapy and a Momethasone Furoate nasal spray as an adjunct to the treatment of subjects with AR.
METHODS
A randomized, prospective, double-blind (patient and evaluator) clinical trial. The participants (n = 60) will be randomly distributed into 2 groups. The experimental group will receive a sublingual Immunotherapy for 3 months. The control group will receive the mometasone furoate nasal spray for 3 months. Before treatment, 1 month and 3 months after treatment, total nasal symptom score scale, Visual analogue Scale and Quality of Life questionnaire of rhinoconjunctivitis will be measured and Changes of the serums of IgE, interferon-γ, IL-4, IL-17, tumor necrosis factor-α, IL-5, IL-9, IL-13, IL-25, IL-33, vascular endothelial growth factor, TSLP and IL-22 in both groups. The measurements will be performed by the same researcher who was unaware of the participants' subgroup.
DISCUSSION
We believe that the treatment of perennial AR with sublingual Immunotherapy and nasal hormones will be more effective in these patients. Furthermore, the sublingual Immunotherapy mainly acts mostly on the cellular immunity, while nasal hormones mainly act on local inflammatory responses. We expect to clarify which treatments are more effective and how they work in improving perennial AR.
Topics: Humans; Allergens; Immunity, Innate; Lymphocytes; Nasal Sprays; Prospective Studies; Quality of Life; Rhinitis, Allergic; Vascular Endothelial Growth Factor A; Sublingual Immunotherapy; Antigens, Dermatophagoides; Randomized Controlled Trials as Topic
PubMed: 36482599
DOI: 10.1097/MD.0000000000032019 -
Indian Journal of Otolaryngology and... Oct 2022To compare the effectiveness between topical mometasone furoate nasal spray versus topical fluticasone furoate nasal spray in the treatment of chronic rhinosinusitis....
Comparison Between Effectiveness of Topical Mometasone Furoate Nasal Spray Versus Topical Fluticasone Furoate Nasal Spray in the Treatment of Chronic Rhinosinusitis: A One Year Hospital Based Study.
To compare the effectiveness between topical mometasone furoate nasal spray versus topical fluticasone furoate nasal spray in the treatment of chronic rhinosinusitis. Randomized control trial was conducted involving 70 patients. One group received topical mometasone furoate nasal spray and the other group received fluticasone furoate nasal spray for 3 weeks. All patients were prescribed oral ciprofloxacin for 3 weeks and were subjectively evaluated using the Lund and Mackay staging system and objectively using nasal endoscopy by the Lund and Kennedy scoring system. There was no inter group significance but all patients improved significantly after the administration of either of the steroid sprays. Following administration of steroid nasal sprays, there was clinically significant improvement in the symptoms and signs of chronic rhinosinusitis, but there was no statistical significance between the two study groups. Thus, steroid nasal sprays significantly improve the symptoms and resolution of signs of chronic rhinosinusitis. The choice of drug still remains uncertain to the clinician. However, long term studies with more sample size is needed to arrive at sound conclusions.
PubMed: 36452763
DOI: 10.1007/s12070-020-01872-3 -
American Journal of Translational... 2022To compare the effects of mometasone furoate in combination with loratadine and montelukast sodium on inflammatory factors and pulmonary function in children with...
OBJECTIVE
To compare the effects of mometasone furoate in combination with loratadine and montelukast sodium on inflammatory factors and pulmonary function in children with allergic rhinitis (AR).
METHODS
In this retrospective study, a total of 89 children with AR admitted to our hospital from March 2020 to October 2021 were enrolled. Among them, 47 children who received mometasone furoate combined with loratadine were designated group A, while the other 42 with mometasone furoate combined with montelukast sodium were group B. The clinical efficacy of both groups was compared, and the levels of inflammatory factors IL-6 and TNF-α as well as the changes of pulmonary function levels were tested during the treatment. Adverse reactions during treatment were recorded. Finally, children were followed up for 3 months to record rhinitis recurrence after discontinuation of the treatment.
RESULTS
There was no statistical difference in clinical treatment efficacy between both groups (P>0.05), while the levels of IL-6, TNF-α, and IgE were lower in children in group A than in group B at 2 weeks of treatment. Group A's lung function indexes, including forced expiratory volume in one second (FEV1%), forced expiratory volume in one second/forced vital capacity (FEV1/FVC) and peak expiratory flow (PEF), were higher than in group B (all P<0.05). The total incidence of adverse reactions was dramatically lower in group A than group B (P<0.05). Follow-up demonstrated no difference in the recurrence rate of rhinitis between both groups of children (P>0.05). Higher TNF-α after treatment, history of allergy, family history of rhinitis, combined asthma, and parental history of smoking were independent risk factors for relapse after discontinuation of the drug in children.
CONCLUSION
Both mometasone furoate combined with either loratadine or montelukast sodium had good effects in AR, while the first option had a faster inhibitory effect on inflammatory factors and a better protection of lung function in children.
PubMed: 36398245
DOI: No ID Found -
Frontiers in Pediatrics 2022Twice daily 0.1% mometasone furoate is an effective treatment for phimosis in children. However, mometasone furoate has an important therapeutic advantage because it is...
BACKGROUND
Twice daily 0.1% mometasone furoate is an effective treatment for phimosis in children. However, mometasone furoate has an important therapeutic advantage because it is effective in once-daily applications. This study was to compare the efficacy of two different topical 0.1% mometasone furoate regimens for the treatment of symptomatic severe phimosis in pediatric patients.
METHODS
A total of 1,689 patients with symptomatic severe phimosis classified by the Kikiros system were prospectively enrolled in the study from March 2018 to February 2021. A total of 855 patients received 0.1% mometasone furoate twice-daily (BID group) and 834 patients received 0.1% mometasone furoate once-daily (QD group) for 4 weeks.
RESULTS
A total of 1,595 boys completed the treatment (798 and 797 in the BID and QD groups, respectively). The success rate of the BID group was higher than that of the QD group at the end of week 2 (44.8% vs. 33.3%, < 0.05), while there was no difference in the success rate at 4 weeks and 3 months between the two groups (70.7% vs. 69.7%, and 66.8% vs. 64.9%, respectively) ( > 0.05). In both treatment groups, the success rate of grade 5 phimosis was lower than that of grade 4 at 2 weeks, 4 weeks, and 3 months. A total of 83 patients experienced recurrence of phimosis. Only fifteen patients had local mild adverse drug reactions.
CONCLUSION
Topical application of 0.1% mometasone furoate once-daily or twice-daily for 4 weeks had comparable efficacy in children with symptomatic severe phimosis. A once a day regimen may be more suitable for children. Topical steroid application is more effective in children with low-grade phimosis than those with high-grade phimosis.
PubMed: 36389352
DOI: 10.3389/fped.2022.1025899 -
Journal of the American Veterinary... Nov 2022To characterize the clinical course and long-term prognosis of a suspected novel cause of neurogenic keratoconjunctivitis sicca (nKCS) secondary to florfenicol,...
OBJECTIVE
To characterize the clinical course and long-term prognosis of a suspected novel cause of neurogenic keratoconjunctivitis sicca (nKCS) secondary to florfenicol, terbinafine hydrochloride, mometasone furoate (Claro and Neptra) or florfenicol, terbinafine, betamethasone acetate (Osurnia).
ANIMALS
29 client-owned dogs.
PROCEDURES
Online survey and word-of-mouth recruitment were conducted to identify dogs that developed clinical signs of nKCS after application of otitis externa medication containing terbinafine and florfenicol. A retrospective analysis of medical records of dogs meeting inclusion criteria was then conducted. Included dogs had onset of clinical signs of nKCS within 1 day after application of otitis externa medications containing terbinafine and florfenicol and had documentation of low Schirmer tear test value (< 15 mm/min) of affected eyes.
RESULTS
29 dogs with medical records available for review met the inclusion criteria. Documented return of clinically normal tear production was identified in 24 of 29 dogs, with a median time from application of ear medication to documented return of clinically normal tear production of 86 days (range, 19 to 482 days). A corneal ulcer was diagnosed in 68% (20/29). Multivariable Cox regression analysis showed being referred to an ophthalmologist (P = .03) and having a deep ulcer (P = .02) were associated with a longer time to documentation of Schirmer tear test ≥ 15 mm/min.
CLINICAL RELEVANCE
Dogs that developed nKCS within 1 day after application of otitis externa medications containing terbinafine and florfenicol had a good prognosis for return of normal tear production within 1 year.
Topics: Dogs; Animals; Terbinafine; Keratoconjunctivitis Sicca; Otitis Externa; Retrospective Studies; Dog Diseases; Tears
PubMed: 36350754
DOI: 10.2460/javma.22.07.0301 -
Life (Basel, Switzerland) Sep 2022Persistent olfactory dysfunction is a major concern post-COVID-19, affecting up to 5% of all patients. Different therapeutic options, including mometasone nasal spray,...
Persistent olfactory dysfunction is a major concern post-COVID-19, affecting up to 5% of all patients. Different therapeutic options, including mometasone nasal spray, have been recommended, only some of which have been validated for post-COVID-19 olfactory dysfunction. In this study we psychophysically assessed the effect of intranasally applied mometasone furoate on the recovery of olfaction. The spray was applied with a long applicator so that the olfactory cleft could be reached effectively. After olfactory dysfunction had been confirmed psychophysically using Sniffin' Sticks, patients were randomly assigned to two different treatment arms: the study group ( = 40) underwent olfactory training and intranasal administration of mometasone furoate twice daily, whereas the control group ( = 46) performed olfactory training only. After a study duration of three months, psychophysical testing of olfaction was repeated using Sniffin' Sticks. We found no benefit of an additional topical administration of mometasone furoate compared to olfactory training alone. These results psychophysically confirm two previous studies which were based on patients' subjective self-ratings. Our findings are in contrast to current recommendations for the management of olfactory dysfunction post-COVID-19, which might have to be adapted accordingly.
PubMed: 36294918
DOI: 10.3390/life12101483