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1.
Sleep Med ; 116: 129-137, 2024 Apr.
Article En | MEDLINE | ID: mdl-38460418

IMPORTANCE: Pediatric obstructive sleep apnea (OSA) is a common disease that can have significant negative impacts on a child's health and development. A comprehensive evaluation of different pharmacologic interventions for the treatment of OSA in children is still lacking. OBJECTIVE: This study aims to conduct a comprehensive systematic review and network meta-analysis of pharmacological interventions for the management of obstructive sleep apnea in pediatric population. DATA SOURCES: PubMed, Web of Science, Embase, The Cochrane Library, and CNKI were searched from 1950 to November 2022 for pediatric OSA. STUDY SELECTION: Multiple reviewers included Randomized controlled trials (RCTs) concerning drugs on OSA in children. DATA EXTRACTION AND SYNTHESIS: Multiple observers followed the guidance of the PRISMA NMA statement for data extraction and evaluation. Bayesian network meta-analyses(fixed-effect model) were performed to compare the weighted mean difference (WMD), logarithmic odds ratios (log OR), and the surface under the cumulative ranking curves (SUCRA) of the included pharmacological interventions. Our protocol was registered in PROSPERO website (CRD42022377839). MAIN OUTCOME(S) AND MEASURE(S): The primary outcomes were improvements in the apnea/hypopnea index (AHI), while secondary outcomes included adverse events and the lowest arterial oxygen saturation (SaO2). RESULTS: 17 RCTs with a total of 1367 children with OSA aged 2-14 years that met the inclusion criteria were eventually included in our systematic review and network meta-analysis. Ten drugs were finally included in the study. The results revealed that Mometasone + Montelukast (WMD-4.74[95%CrIs -7.50 to -2.11], Budesonide (-3.45[-6.86 to -0.15], and Montelukast(-3.41[-5.45 to -1.39] exhibited significantly superior therapeutic effects compared to the placebo concerning apnea hypopnea index (AHI) value with 95%CrIs excluding no effect. Moreover, Mometasone + Montelukast achieved exceptionally high SUCRA values for both AHI (85.0 %) and SaO2 (91.0 %). CONCLUSIONS AND RELEVANCE: The combination of mometasone furoate nasal spray and oral montelukast sodium exhibits the highest probability of being the most effective intervention. Further research is needed to investigate the long-term efficacy and safety profiles of these interventions in pediatric patients with OSA.


Acetates , Cyclopropanes , Quinolines , Sleep Apnea, Obstructive , Sulfides , Child , Humans , Network Meta-Analysis , Acetates/therapeutic use , Sleep Apnea, Obstructive/drug therapy , Mometasone Furoate/therapeutic use
2.
Vet Rec ; 194(9): e3955, 2024 05 04.
Article En | MEDLINE | ID: mdl-38462781

BACKGROUND: A single-dose, in-clinic, veterinary professional-administered treatment for canine otitis externa was developed to improve compliance and canine welfare. METHODS: This multicentre, controlled, examiner-masked, randomised field trial was conducted in 316 dogs over 42 days. Dogs were treated once, on day 0, with the investigational product containing gentamicin, posaconazole and mometasone furoate (Mometamax Ultra [MU]) or twice (days 0 and 7) with a control product containing florfenicol, terbinafine and betamethasone acetate (CP). The primary endpoint was a composite otitis index score of 4 or less (of 12) on day 14 and 3 or less (of 12) on day 28. RESULTS: On day 28, treatment success was recorded in 128 of 143 MU-treated dogs (89.5%), significantly non-inferior to 116 of 133 (87.2%) CP-treated dogs (Farrington-Manning test, Z = 4.1351, p < 0.0001). For mixed cultures of Staphylococcus pseudintermedius and Malassezia pachydermatis, there was 100% treatment success in MU-treated dogs (n = 33), significantly non-inferior to 90.2% (37 of 41) in CP-treated dogs (Farrington-Manning test, Z = 3.1954, p = 0.0007). LIMITATIONS: Efficacy in chronic otitis externa cases was not investigated. Cytology was not used to aid in diagnosis or for identification of secondary pathogens. CONCLUSION: This unique combination, single-dose product is safe and effective in dogs with otitis externa. It offers enhanced compliance, canine welfare and quality of life by eliminating the owner burden of treating this painful condition.


Dog Diseases , Gentamicins , Mometasone Furoate , Otitis Externa , Triazoles , Animals , Dogs , Dog Diseases/drug therapy , Otitis Externa/veterinary , Otitis Externa/drug therapy , Otitis Externa/microbiology , Mometasone Furoate/therapeutic use , Mometasone Furoate/administration & dosage , Treatment Outcome , Female , Male , Triazoles/therapeutic use , Triazoles/administration & dosage , Gentamicins/therapeutic use , Gentamicins/administration & dosage , Anti-Bacterial Agents/therapeutic use , Anti-Bacterial Agents/administration & dosage , Drug Therapy, Combination/veterinary , Antifungal Agents/therapeutic use , Antifungal Agents/administration & dosage , Suspensions
3.
JAMA ; 331(10): 866-877, 2024 03 12.
Article En | MEDLINE | ID: mdl-38470381

Importance: Allergic rhinitis affects an estimated 15% of the US population (approximately 50 million individuals) and is associated with the presence of asthma, eczema, chronic or recurrent sinusitis, cough, and both tension and migraine headaches. Observations: Allergic rhinitis occurs when disruption of the epithelial barrier allows allergens to penetrate the mucosal epithelium of nasal passages, inducing a T-helper type 2 inflammatory response and production of allergen-specific IgE. Allergic rhinitis typically presents with symptoms of nasal congestion, rhinorrhea, postnasal drainage, sneezing, and itching of the eyes, nose, and throat. In an international study, the most common symptoms of allergic rhinitis were rhinorrhea (90.38%) and nasal congestion (94.23%). Patients with nonallergic rhinitis present primarily with nasal congestion and postnasal drainage frequently associated with sinus pressure, ear plugging, muffled sounds and pain, and eustachian tube dysfunction that is less responsive to nasal corticosteroids. Patients with seasonal allergic rhinitis typically have physical examination findings of edematous and pale turbinates. Patients with perennial allergic rhinitis typically have erythematous and inflamed turbinates with serous secretions that appear similar to other forms of chronic rhinitis at physical examination. Patients with nonallergic rhinitis have negative test results for specific IgE aeroallergens. Intermittent allergic rhinitis is defined as symptoms occurring less than 4 consecutive days/week or less than 4 consecutive weeks/year. Persistent allergic rhinitis is defined as symptoms occurring more often than 4 consecutive days/week and for more than 4 consecutive weeks/year. Patients with allergic rhinitis should avoid inciting allergens. In addition, first-line treatment for mild intermittent or mild persistent allergic rhinitis may include a second-generation H1 antihistamine (eg, cetirizine, fexofenadine, desloratadine, loratadine) or an intranasal antihistamine (eg, azelastine, olopatadine), whereas patients with persistent moderate to severe allergic rhinitis should be treated initially with an intranasal corticosteroid (eg, fluticasone, triamcinolone, budesonide, mometasone) either alone or in combination with an intranasal antihistamine. In contrast, first-line therapy for patients with nonallergic rhinitis consists of an intranasal antihistamine as monotherapy or in combination with an intranasal corticosteroid. Conclusions and Relevance: Allergic rhinitis is associated with symptoms of nasal congestion, sneezing, and itching of the eyes, nose, and throat. Patients with allergic rhinitis should be instructed to avoid inciting allergens. Therapies include second-generation H1 antihistamines (eg, cetirizine, fexofenadine, desloratadine, loratadine), intranasal antihistamines (eg, azelastine, olopatadine), and intranasal corticosteroids (eg, fluticasone, triamcinolone, budesonide, mometasone) and should be selected based on the severity and frequency of symptoms and patient preference.


Glucocorticoids , Histamine Antagonists , Rhinitis, Allergic , Humans , Budesonide/administration & dosage , Budesonide/therapeutic use , Cetirizine/therapeutic use , Fluticasone/administration & dosage , Fluticasone/therapeutic use , Histamine H1 Antagonists/administration & dosage , Histamine H1 Antagonists/therapeutic use , Immunoglobulin E/immunology , Mometasone Furoate/administration & dosage , Mometasone Furoate/therapeutic use , Olopatadine Hydrochloride/administration & dosage , Olopatadine Hydrochloride/therapeutic use , Pruritus/etiology , Rhinitis, Allergic/complications , Rhinitis, Allergic/diagnosis , Rhinitis, Allergic/immunology , Rhinitis, Allergic/therapy , Rhinorrhea/etiology , Sneezing , Triamcinolone/administration & dosage , Triamcinolone/therapeutic use , Glucocorticoids/administration & dosage , Glucocorticoids/therapeutic use , Rhinitis/drug therapy , Histamine Antagonists/administration & dosage , Histamine Antagonists/therapeutic use , Administration, Intranasal
4.
Eur Arch Otorhinolaryngol ; 281(5): 2477-2487, 2024 May.
Article En | MEDLINE | ID: mdl-38291243

PURPOSE: This study aimed to examine the effectiveness of the combined maximal medical treatment for adenoid hypertrophy in preschool children. METHODS: Sixty-four children underwent one-year combined therapy with intranasal mometasone furoate, oral desloratadine, nasal saline irrigation, and bacteriotherapy. Additionally, decongestion drops were applied during scheduled breaks. RESULTS: Of the 64 treated children, 72% showed clinical improvement in adenoid symptoms while 28% did not improve and underwent surgery. These groups differed significantly in terms of the overall reduction in ailments after treatment (p < 0.001), infection rate (p < 0.001), catarrh severity (p < 0.001) and nasal patency (p < 0.001). Endoscopic examination confirmed that responders experienced, on average, a decrease of 8.4% in the adenoid/choana ratio and an improvement in mucosal coverage of the adenoid. These effects were not observed in the group of children whose parents opted for surgery after nine months of conservative treatment. CONCLUSIONS: The proposed new schema of long-term maximal medical treatment with the use of combined intermittent treatment of intranasal mometasone furoate and decongestion drops, oral desloratadine, nasal saline irrigation, and bacteriotherapy can be attempted in patients with adenoid hypertrophy symptoms, and responders may avoid the need for surgery. The applied treatment breaks resulted in a low number of therapeutic side effects.


Adenoids , Loratadine/analogs & derivatives , Humans , Child, Preschool , Prospective Studies , Mometasone Furoate/therapeutic use , Hypertrophy/drug therapy , Adenoidectomy
5.
Zhonghua Fu Chan Ke Za Zhi ; 59(1): 56-63, 2024 Jan 25.
Article Zh | MEDLINE | ID: mdl-38228516

Objective: To analyze and summarize the clinical and pathological characteristics, management, and efficacy of patients with vulvar lichen sclerosus (VLS) through a single center large sample study, and preliminarily to explore the frequency of maintenance treatment medication for VLS. Methods: The clinical data of VLS patients in Obstetrics and Gynecology Hospital of Fudan University from 2018 to 2021 were retrospectively collected. The clinicopathological characteristics (patients' age, course of disease, complicated disease history, family history, symptoms, signs and pathology), treatment and effects were retrospectively analyzed. The patients in the maintenance treatment stage were followed up regularly to explore the minimum frequency of individual medication to maintain the stability of the disease. Results: (1) General situation: a total of 345 patients with VLS were included in this study. The average age was (50.4±14.7) years (ranged from 8 to 84 years old), prevalence was highest in the 50-59 years group (30.1%, 104/345). Immune diseases occurred in 18.6% (33/177) of patients, 24.3% (43/177) of patients had allergic skin diseases, and 5.6% (10/177) of the patients' immediate family members had chronic vulvar pruritus or vulvar hypopigmentation. (2) Clinical features: the most common symptom was vulvar pruritus (96.1%, 196/204) among 204 patients with recorded symptoms. The most common sign was hypopigmentation of the vulva (96.3%, 206/214). The most common involved sites were labia minora (70.3%, 142/202), labia majora (67.8%, 137/202), and labial sulcus (59.4%, 120/202). The cumulative number of sites involved in 62 vulvar atrophy patients (2.7±1.1) was significantly higher than that in 152 non-atrophy patients (2.2±1.0; t=3.48, P=0.001). The course of vulvar atrophy was (9.3±8.5) years, which was significantly longer than that of non-atrophy patients [(6.6±5.6) years; t=2.04, P=0.046]. (3) Pathological features: among the 286 patients with electronic pathological sections, the most common pathological feature in the epidermis was epithelial nail process passivation (71.3%, 204/286). The common pathological features in the dermis were interstitial collagenization (84.6%, 242/286), and inflammatory cell infiltration (73.8%, 211/286). (4) Treatment: 177 patients received standardized treatment after diagnosis and were followed up regularly in our hospital. In the initial treatment stage, 26.0% (46/177) of the patients were treated with 0.05% clobetasol propionate cream, and 74.0% (131/177) of the patients were treated with 0.1% mometasone furoate ointment. The complete remission rates of the two methods were respectively 80.4% (37/46) and 74.0% (97/131), and there was no statistically significant difference (χ²=0.76, P=0.385). During maintenance treatment, 27.1% (48/177) of the patients took the medication twice a week, 35.0% (62/177) took the medication once a week, and 37.9% (67/177) took the medication once every 10 days. During follow-up after 6 months of maintenance treatment, there were no patients with recurrence of pruritus or progression of vulvar signs. Conclusions: The majority of VLS patients have itching, hypopigmentation, involvement of labia minora and labia majora, progressive atrophy, and inflammatory infiltration of dermis. Local treatments of mometasone furoate and clobetasol propionate have good initial therapeutic effects. The frequency exploration of individualized maintenance treatment could minimize the occurrence of adverse reactions when ensuring the stability of the patients' condition.


Hypopigmentation , Vulvar Lichen Sclerosus , Female , Humans , Child , Adolescent , Young Adult , Adult , Middle Aged , Aged , Aged, 80 and over , Vulvar Lichen Sclerosus/drug therapy , Vulvar Lichen Sclerosus/complications , Vulvar Lichen Sclerosus/pathology , Clobetasol/adverse effects , Retrospective Studies , Mometasone Furoate/therapeutic use , Pruritus/chemically induced , Pruritus/complications , Pruritus/drug therapy , Atrophy/chemically induced , Atrophy/complications , Atrophy/drug therapy , Hypopigmentation/chemically induced , Hypopigmentation/complications , Hypopigmentation/drug therapy
6.
J Am Vet Med Assoc ; 262(3): 1-3, 2024 Mar 01.
Article En | MEDLINE | ID: mdl-38064895

OBJECTIVE: Albumins are protein molecules that account for 50% of total plasma protein. They are imperative in maintaining intravascular colloidal oncotic pressure, act as key scavenger molecules for oxygen free radicals, and perform a major role in transporting numerous substances and in wound healing. Hypoalbuminemia has been reported as the consequence of decreased intake, increased loss, decreased production, and redistribution. While anecdotal evidence of tyrosine kinase inhibitors causing hypoalbuminemia in canine patients exists, to the author's knowledge there is no formal report to this effect to date. This case report aims to bridge the gap between anecdotal evidence and literature. ANIMAL: 3-year-old neutered male hound-mix canine. CLINICAL PRESENTATION, PROGRESSION, AND PROCEDURES: The patient was presented for recurrent otitis externa refractory to treatments with orbifloxacin/mometasone/posaconazole otic suspension, miconazole/polymyxin B/prednisolone otic suspension, ketoconazole/TrizEDTA, and gentamicin/mometasone/clotrimazole, which prompted consideration of oral antifungals. Baseline blood work prior to initiation of fluconazole showed elevated alkaline phosphatase. Treatment was initiated with fluconazole, and blood work was rechecked and revealed hypoalbuminemia. Multiple diagnostic tests failed to reveal a cause of hypoalbuminemia. TREATMENT AND OUTCOME: Discontinuation of oclacitinib that the patient was being administered resulted in normalization of serum albumin. CLINICAL RELEVANCE: It is unclear whether hypoalbuminemia associated with oclacitinib administration is associated with worse outcomes for pathologies in canine patients; however, this seems to be the case in humans according to some reports. This report aims to take a step in the direction of this knowledge.


Dog Diseases , Hypoalbuminemia , Sulfonamides , Humans , Male , Dogs , Animals , Hypoalbuminemia/chemically induced , Hypoalbuminemia/drug therapy , Hypoalbuminemia/veterinary , Fluconazole/therapeutic use , Pyrimidines/adverse effects , Mometasone Furoate/therapeutic use , Dog Diseases/pathology
7.
Article Zh | WPRIM | ID: wpr-1012304

Objective: To analyze and summarize the clinical and pathological characteristics, management, and efficacy of patients with vulvar lichen sclerosus (VLS) through a single center large sample study, and preliminarily to explore the frequency of maintenance treatment medication for VLS. Methods: The clinical data of VLS patients in Obstetrics and Gynecology Hospital of Fudan University from 2018 to 2021 were retrospectively collected. The clinicopathological characteristics (patients' age, course of disease, complicated disease history, family history, symptoms, signs and pathology), treatment and effects were retrospectively analyzed. The patients in the maintenance treatment stage were followed up regularly to explore the minimum frequency of individual medication to maintain the stability of the disease. Results: (1) General situation: a total of 345 patients with VLS were included in this study. The average age was (50.4±14.7) years (ranged from 8 to 84 years old), prevalence was highest in the 50-59 years group (30.1%, 104/345). Immune diseases occurred in 18.6% (33/177) of patients, 24.3% (43/177) of patients had allergic skin diseases, and 5.6% (10/177) of the patients' immediate family members had chronic vulvar pruritus or vulvar hypopigmentation. (2) Clinical features: the most common symptom was vulvar pruritus (96.1%, 196/204) among 204 patients with recorded symptoms. The most common sign was hypopigmentation of the vulva (96.3%, 206/214). The most common involved sites were labia minora (70.3%, 142/202), labia majora (67.8%, 137/202), and labial sulcus (59.4%, 120/202). The cumulative number of sites involved in 62 vulvar atrophy patients (2.7±1.1) was significantly higher than that in 152 non-atrophy patients (2.2±1.0; t=3.48, P=0.001). The course of vulvar atrophy was (9.3±8.5) years, which was significantly longer than that of non-atrophy patients [(6.6±5.6) years; t=2.04, P=0.046]. (3) Pathological features: among the 286 patients with electronic pathological sections, the most common pathological feature in the epidermis was epithelial nail process passivation (71.3%, 204/286). The common pathological features in the dermis were interstitial collagenization (84.6%, 242/286), and inflammatory cell infiltration (73.8%, 211/286). (4) Treatment: 177 patients received standardized treatment after diagnosis and were followed up regularly in our hospital. In the initial treatment stage, 26.0% (46/177) of the patients were treated with 0.05% clobetasol propionate cream, and 74.0% (131/177) of the patients were treated with 0.1% mometasone furoate ointment. The complete remission rates of the two methods were respectively 80.4% (37/46) and 74.0% (97/131), and there was no statistically significant difference (χ²=0.76, P=0.385). During maintenance treatment, 27.1% (48/177) of the patients took the medication twice a week, 35.0% (62/177) took the medication once a week, and 37.9% (67/177) took the medication once every 10 days. During follow-up after 6 months of maintenance treatment, there were no patients with recurrence of pruritus or progression of vulvar signs. Conclusions: The majority of VLS patients have itching, hypopigmentation, involvement of labia minora and labia majora, progressive atrophy, and inflammatory infiltration of dermis. Local treatments of mometasone furoate and clobetasol propionate have good initial therapeutic effects. The frequency exploration of individualized maintenance treatment could minimize the occurrence of adverse reactions when ensuring the stability of the patients' condition.


Female , Humans , Child , Adolescent , Young Adult , Adult , Middle Aged , Aged , Aged, 80 and over , Vulvar Lichen Sclerosus/pathology , Clobetasol/adverse effects , Retrospective Studies , Mometasone Furoate/therapeutic use , Pruritus/drug therapy , Atrophy/drug therapy , Hypopigmentation/drug therapy
8.
Asian Pac J Allergy Immunol ; 41(4): 263-272, 2023 Dec.
Article En | MEDLINE | ID: mdl-37874315

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


Anti-Allergic Agents , Rhinitis, Allergic, Seasonal , Rhinitis, Allergic , Humans , Cost-Effectiveness Analysis , Rhinitis, Allergic/drug therapy , Administration, Intranasal , Adrenal Cortex Hormones/therapeutic use , Mometasone Furoate/therapeutic use , Anti-Allergic Agents/therapeutic use , Treatment Outcome
9.
Int J Nanomedicine ; 18: 5685-5699, 2023.
Article En | MEDLINE | ID: mdl-37841023

Purpose: We designed a 0.05% mometasone furoate (MF) nanocrystal dispersion and investigated whether the application of MF nanocrystals in nasal formulations enhanced local absorption compared to traditional nasal MF formulations (CA-MF). Methods: MF nanocrystal dispersions (MF-NPs) were prepared by bead milling MF microcrystal dispersions (MF-MPs) consisting of MF, 2-hydroxypropyl-ß-cyclodextrin, methylcellulose, and purified water. Pluronic F-127 combined with methylcellulose, Pluronic F-68, or carbopol was used as a base for in situ gelation (thickener). MF concentrations were measured using high-performance liquid chromatography, and nasal absorption of MF was evaluated in 6 week-old male Institute of Cancer Research (ICR) mice. Results: The particle size range of MF prepared with the bead mill treatment was 80-200 nm, and the nanoparticles increased the local absorption of MF, which was higher than that of CA-MF and MF-MPs. In addition, unlike the results obtained in the small intestine and corneal tissue, the high absorption of nanocrystalline MF in the nasal mucosa was related to a pathway that was not derived from energy-dependent endocytosis. Moreover, the application of the in situ gelling system attenuated the local absorption of MF-NPs, owing to a decrease in drug diffusion in the dispersions. Conclusion: We found that nanoparticulation of MF enhances local intranasal absorption, and nasal bioavailability is higher than that of CA-MF. In addition, we demonstrate that viscosity regulation is an important factor in the design of nasal formulations based on MF nanocrystals. These findings provide insights for the design of novel nanomedicines with enhanced nasal bioavailability.


Nasal Absorption , Nasal Mucosa , Male , Animals , Mice , Mometasone Furoate/chemistry , Mometasone Furoate/therapeutic use , Nasal Mucosa/metabolism , Methylcellulose
10.
Expert Rev Clin Immunol ; 19(6): 575-584, 2023 06.
Article En | MEDLINE | ID: mdl-37038974

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


Anti-Allergic Agents , Rhinitis, Allergic, Seasonal , Rhinitis, Allergic , Humans , Olopatadine Hydrochloride/therapeutic use , Olopatadine Hydrochloride/adverse effects , Mometasone Furoate/therapeutic use , Mometasone Furoate/adverse effects , Quality of Life , Rhinitis, Allergic, Seasonal/diagnosis , Drug Combinations , Treatment Outcome , Histamine Antagonists/therapeutic use , Administration, Intranasal , Adrenal Cortex Hormones/therapeutic use , Rhinitis, Allergic/drug therapy , Anti-Allergic Agents/therapeutic use
12.
J Asthma ; 60(2): 403-411, 2023 02.
Article En | MEDLINE | ID: mdl-35348408

INTRODUCTION: The 52-week long-term safety of once-daily indacaterol acetate/glycopyrronium bromide/mometasone furoate (IND/GLY/MF) high-dose (150/50/160 µg) and IND/MF high-dose (150/320 µg) was evaluated in two studies enrolling Japanese patients with inadequately controlled asthma. METHODS: Study 1 (IND/GLY/MF) and Study 2 (IND/MF) were 52-week, phase III, open-label, single-arm, multicenter studies conducted in Japanese adult patients with inadequately controlled asthma. The primary endpoint was incidence and severity of treatment-emergent adverse events (AEs) over 52-weeks. RESULTS: In Study 1, 94 patients received IND/GLY/MF high-dose and 84 (89.4%) patients completed the 52-week study treatment; in Study 2, 51 patients received IND/MF high-dose and 48 (94.1%) patients completed the 52-week study treatment. In Study 1, 68.1% and 6.4% of 94 patients reported ≥1 AE and ≥1 serious AE (SAE) respectively. In Study 2, 78.4% of 51 patients reported ≥1 AE; no patients reported SAEs. The most commonly reported AEs were asthma (exacerbation; 30.9% and 54.9%) and nasopharyngitis (18.1% and 29.4%) in Study 1 and Study 2, respectively. Severe AEs including asthma (exacerbation) were reported in 13.8% and 13.7% of patients in Study 1 and Study 2, respectively. In Study 1, 10 patients (10.6%) reported treatment-related AEs, of which dysphonia (9 patients [9.6%]) was the most commonly reported; no treatment-related AEs were reported in Study 2. In Study 1, one death (not study drug-related) was reported after study discontinuation (92 days after last dose of study medication). CONCLUSIONS: Once-daily IND/GLY/MF and IND/MF high-dose were well-tolerated in Japanese patients with inadequately controlled asthma. No unexpected safety findings were observed.Supplemental data for this article is available online at.


Acetates , Asthma , Mometasone Furoate , Adult , Humans , Acetates/therapeutic use , Administration, Inhalation , Adrenergic beta-2 Receptor Agonists/therapeutic use , Asthma/drug therapy , Bronchodilator Agents/therapeutic use , Drug Combinations , East Asian People , Glycopyrrolate/therapeutic use , Mometasone Furoate/therapeutic use , Treatment Outcome
13.
Dermatology ; 239(1): 81-90, 2023.
Article En | MEDLINE | ID: mdl-36382657

BACKGROUND AND OBJECTIVES: Complete clearance of vulvar lichen sclerosus (VLS) occurs in a minority of treated patients. Disease persistence may impact patient well-being. The main objective of this study was to assess if achieving a complete clearance with a corticosteroid treatment leads to a benefit in terms of patient suffering and quality-of-life (QoL) impairment. METHODS: We performed an observational study on a cohort of VLS women, who applied mometasone furoate 0.1% ointment for 12 weeks. At treatment completion (T1), we compared the patients who achieved clearance in symptoms (Global Subjective Score [GSS] = 0) or in objective features (Global Objective Score [GOS] = 0) or in both with those who achieved a lower degree of improvement, on the basis of Pictorial Representation of Illness and Self-Measure (PRISM) and Dermatology Life Quality Index (DLQI) scores. RESULTS: In the whole sample (n = 101), GSS, GOS, PRISM, and DLQI scores significantly improved after treatment from baseline; 34 patients (35.8%) achieved GSS = 0, 26 (25.7%) achieved GOS = 0, and 11 (11.5%) clearance of GSS and GOS. PRISM scores at T1 were significantly higher in patients who achieved clearance of symptoms when compared with those who did not, including patients achieving 50-99% GSS improvement from baseline. DLQI scores were lower in patients who achieved clearance of symptoms, signs, or both when compared with the others. CONCLUSIONS: VLS clearance corresponded to a significant improvement in the QoL of VLS patients, also in comparison with those who achieved a substantial but incomplete decrease of symptom and sign scores, and should become an ideal therapeutic goal.


Dermatology , Vulvar Lichen Sclerosus , Humans , Female , Cohort Studies , Mometasone Furoate/therapeutic use , Treatment Outcome , Quality of Life , Vulvar Lichen Sclerosus/drug therapy , Adrenal Cortex Hormones/therapeutic use
14.
Int Forum Allergy Rhinol ; 13(5): 899-909, 2023 05.
Article En | MEDLINE | ID: mdl-36086876

BACKGROUND: Eosinophilic chronic rhinosinusitis with nasal polyps (ECRSwNP) is a refractory clinical phenotype with a high symptom burden and relapse rate. Steroid-eluting stents are safe and effective for reducing polyp size, symptom burden, and the need for revision sinus surgery. In this study we aimed to evaluate the efficacy and safety of steroid-eluting stent implantation on the surgical outcomes of patients with ECRSwNP. METHODS: This prospective, multicenter, randomized, intrapatient-controlled trial recruited patients 18 to 65 years of age with ECRSwNP who required surgery. Ninety-eight patients were enrolled and randomly implanted with absorbable steroid-eluting stents containing mometasone furoate in one sinus at the end of surgery. All patients received standard postoperative care and follow-up. The primary outcome was the Lund-Kennedy endoscopic score within 12 weeks postsurgery. Secondary outcomes included nasal symptoms scores, nasal resistance, acoustic rhinometry, nasal nitric oxide levels, 3-dimensional volumetric computed tomography scores, and eosinophil counts in the ethmoid mucosa. RESULTS: Ninety-five patients completed the trial. At postoperative weeks 4, 8, and 12, the Lund-Kennedy scores were significantly lower on the treatment side than on the control side (all p < 0.01). Compared with the treatment side, the control side exhibited higher tissue eosinophilia at week 4 and higher volumetric, nasal obstruction, and total nasal symptom scores at postoperative week 8 (p = 0.011, p = 0.011, p < 0.01, and p = 0.001, respectively). No adrenal cortical suppression or serious side effects were observed. CONCLUSION: Steroid-eluting stents reduce postoperative sinus mucosal edema, and eosinophilic inflammation, with persistent effects after stent disintegration, and are a good supplementary postsurgical treatment in patients with ECRSwNP.


Drug-Eluting Stents , Nasal Polyps , Rhinitis , Sinusitis , Humans , Nasal Polyps/drug therapy , Nasal Polyps/surgery , Prospective Studies , Rhinitis/drug therapy , Rhinitis/surgery , Treatment Outcome , Neoplasm Recurrence, Local , Sinusitis/drug therapy , Sinusitis/surgery , Mometasone Furoate/therapeutic use , Chronic Disease
15.
Ann Pharmacother ; 57(5): 570-578, 2023 05.
Article En | MEDLINE | ID: mdl-36123818

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.


Rhinitis, Allergic, Seasonal , Humans , Olopatadine Hydrochloride/adverse effects , Mometasone Furoate/therapeutic use , Mometasone Furoate/adverse effects , Rhinitis, Allergic, Seasonal/drug therapy , Rhinitis, Allergic, Seasonal/chemically induced , Nasal Sprays , Administration, Intranasal , Double-Blind Method , Treatment Outcome
16.
Otolaryngol Pol ; 77(6): 43-50, 2023 Dec 04.
Article En | MEDLINE | ID: mdl-38706259

A novel strategy for the treatment of allergic rhinitis results from the innovative combination of antihistamine and intranasal corticosteroid drugs. By combining two preparations with different mechanism of action, this novel approach facilitates quick and effective controls of all upper respiratory tract allergy symptoms. The article presents the results of a study of olopatadine hydrochloride and mometasone furoate fixed-dose combination (GSP301) administered intranasally from a spray formulation, with an attempt at positioning the treatment within the ARIA and EPOS guidelines.


Administration, Intranasal , Mometasone Furoate , Olopatadine Hydrochloride , Sinusitis , Humans , Mometasone Furoate/administration & dosage , Mometasone Furoate/therapeutic use , Olopatadine Hydrochloride/administration & dosage , Olopatadine Hydrochloride/therapeutic use , Sinusitis/drug therapy , Female , Male , Adult , Anti-Allergic Agents/administration & dosage , Anti-Allergic Agents/therapeutic use , Drug Combinations , Middle Aged , Treatment Outcome , Rhinitis, Allergic/drug therapy , Rhinitis/drug therapy , Rhinosinusitis
17.
Braz J Otorhinolaryngol ; 88 Suppl 5: S148-S155, 2022.
Article En | MEDLINE | ID: mdl-36243604

OBJECTIVES: Nigella sativa oil is known antiallergic and immunomodulatory effects. We aimed to compare this oil with mometasone furoate, a topical steroid, on a rat model in the prevention of allergic rhinitis symptoms. METHODS: A total of 28 two-to-four-month-old Wistar Hannover rats weighing 250-350 g were randomly divided into four groups of seven, which included control, allergic rhinitis, mometasone furoate, and Nigella sativa oil groups. Loss of cilia, an increase of goblet cells, vascular proliferation, inflammatory cell count, eosinophil infiltration, and the degree of hypertrophy in chondrocytes were assessed by light microscopy. RESULTS: The frequency of nasal scratching in the Nigella sativa oil group was found to be significantly lower compared with the allergic rhinitis group (p < 0.05). Typical inflammatory changes seen in allergic rhinitis were not detected in the Nigella sativa oil group. No inflammation was observed in 85.7% of both the healthy control group and the Nigella sativa oil group. In addition, no inflammation was observed in 71.4% of the mometasone furoate group, and this difference was found to be significant compared with the control group (p < 0.05). In addition, eosinophil infiltration, cilia loss, chondrocyte hypertrophy, vascular proliferation, and goblet cell increase were found to be significantly decreased in the mometazone furoate and Nigella sativa oil groups compared to the allergic rhinitis group (p < 0.05). CONCLUSION: According to the findings obtained from this study, we found anti-inflammatory and anti-allergic effects of Nigella sativa oil as equally effective as mometasone furoate in the treatment of experimentaly generated allergic rhinitis. LEVEL OF EVIDENCE: IV.


Anti-Allergic Agents , Eosinophilia , Pregnadienediols , Rhinitis, Allergic , Rats , Animals , Pregnadienediols/therapeutic use , Rats, Wistar , Mometasone Furoate/therapeutic use , Rhinitis, Allergic/drug therapy , Anti-Allergic Agents/pharmacology , Anti-Allergic Agents/therapeutic use , Hypertrophy , Administration, Intranasal
18.
Medicine (Baltimore) ; 101(35): e30237, 2022 Sep 02.
Article En | MEDLINE | ID: mdl-36107506

This retrospective study investigated the effectiveness of calamine lotion (CL) as an adjunctive therapy to mometasone furoate ointment (MFO) in the treatment of infant eczema (IE). This retrospective study analyzed the electronic medical records of 50 IE infants. They were allocated to a treatment group or a control group, with 25 subjects in each group. All infants in both groups received MFO. In addition, infants in the treatment group underwent CL. The outcomes were effectiveness based on the eczema area and severity index, lesion area, and pruritus severity. We analyzed the outcomes before and after treatment. The results of this study showed that infants in the treatment group had more effective in effectiveness based on eczema area and severity index (P < .01), lesion area (P < .01), and pruritus severity (P = .01) than those in the control group. However, no medical records reported any adverse events in either group. The results of this study showed that CL added to MFO was more effective than MFO alone in the treatment of infants with IE.


Dermatitis, Atopic , Eczema , Eczema/drug therapy , Humans , Mometasone Furoate/therapeutic use , Ointments , Pruritus/drug therapy , Pruritus/etiology , Retrospective Studies
19.
J Integr Complement Med ; 28(11): 895-903, 2022 Nov.
Article En | MEDLINE | ID: mdl-36103288

Objectives: Radiotherapy is one of the treatments used for different types of cancer. Acute radiodermatitis is one of its most common complications. Despite the high prevalence of radiodermatitis, few studies investigated how to prevent or treat this complication. Hence, a standard treatment has not been introduced so far. We sought to evaluate the efficacy of Dermolina-Henna cream, a new polyherbal formulation, compared to Mometasone cream for alleviating acute radiodermatitis among breast cancer patients. Design: Randomized active-control double-blind clinical trial. Setting/Location: The oncology clinic of Shohaday-e Tajrish Hospital (Tehran, Iran). Subjects: Women older than 18 years with breast cancer undergoing radiotherapy. Interventions: Patients were instructed to apply a thin layer of Dermolina-Henna or Mometasone cream once daily on their lesions at least 3 h after radiotherapy for 4 weeks, and if grade I or II radiodermatitis developed, also afterward. Patients were visited weekly until end of study at after 4 weeks. Radiation Therapy Oncology Group standard questionnaires were evaluated and recorded every week as the primary outcome. Outcome measures: Primary outcome was defined as evaluating the efficacy of Dermolina-Henna cream to change the radiodermatitis grade, while the level of patients' satisfaction and the rate of adverse events recorded by patients were secondary outcomes. Results: The trends on decrease in number of lesions, erythema, radiodermatitis grade, burning sensation, pain, and itchiness were statistically significant for each treatment, separately (p < 0.001), except for radiodermatitis grade in Mometasone group (p = 0.4). Dermolina-Henna was significantly better than Mometasone in alleviating burning sensation (p < 0.001) and itchiness (p = 0.041). Approximately 3.7% of patients showed adverse events and 3.7% declared dissatisfaction in both groups. Conclusions: In summary, we showed that Dermolina-Henna cream and Mometasone cream were significantly effective in decreasing severity of radiodermatitis symptoms among patients with breast cancer. Dermolina-Henna cream was significantly superior to Mometasone cream in alleviating burning and itchiness. Clinical Trial Registration Number: IRCT20200115046144N1.


Breast Neoplasms , Lawsonia Plant , Radiodermatitis , Humans , Female , Radiodermatitis/drug therapy , Mometasone Furoate/therapeutic use , Breast Neoplasms/complications , Double-Blind Method , Iran/epidemiology , Emollients/therapeutic use
20.
Allergol Immunopathol (Madr) ; 50(5): 61-67, 2022.
Article En | MEDLINE | ID: mdl-36086965

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.


Nasal Obstruction , Pregnadienediols , Rhinitis, Allergic, Seasonal , Child , Double-Blind Method , Humans , Inflammation/drug therapy , Mometasone Furoate/therapeutic use , Nasal Sprays , Pregnadienediols/therapeutic use , Quality of Life , Rhinitis, Allergic, Seasonal/drug therapy
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