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Journal of Personalized Medicine Jul 2022In order to evaluate the efficacy of intranasal mometasone furoate in patients with non-allergic rhinitis (NAR), a real-life, observational, prospective study is...
BACKGROUND
In order to evaluate the efficacy of intranasal mometasone furoate in patients with non-allergic rhinitis (NAR), a real-life, observational, prospective study is performed.
METHODS
Thirty-one patients (age 18-64 years) receive intranasal (mometasone furoate, 200 µg b.i.d. for 15 consecutive days per month for 6 consecutive months), plus isotonic nasal saline. The cytologic pattern of local inflammation, nasal airflow, through peak nasal inspiratory flow (PNIF), quality of life (QoL), through the rhinitis quality of life questionnaire (RQLQ), the sinonasal outcome test (SNOT-22), the short-form 36-item health survey (SF-36v2), and the combined symptom medication score (CSMS), and, finally, olfactory function, through Sniffin' sticks-16 identification test (SSIT-16), are evaluated at baseline and after treatment.
RESULTS
NARNE is the most frequent cytological pattern (48% of the total sample). The therapeutic response shows improvement in olfactory function and QoL.
CONCLUSIONS
The results of this study confirm that intranasal mometasone furoate is an effective treatment for patients with NAR.
PubMed: 35887676
DOI: 10.3390/jpm12071179 -
Pulmonary Therapy Sep 2023Suboptimal adherence to inhaled asthma therapy is associated with poor clinical outcomes. Digital companion paired inhaler devices record medication use and provide...
INTRODUCTION
Suboptimal adherence to inhaled asthma therapy is associated with poor clinical outcomes. Digital companion paired inhaler devices record medication use and provide reminders, thereby improving treatment adherence and asthma outcomes. This analysis assessed the impact of indacaterol/glycopyrronium/mometasone furoate (IND/GLY/MF) Breezhaler digital companion on medication adherence and symptom control in adults with asthma from Germany.
METHODS
This retrospective analysis included adults (≥ 18 years) with asthma and prescribed Breezhaler digital companion. Assessments included: mean medication adherence (number of puffs taken/prescribed × 100) and change in Asthma Control Test (ACT) scores [well controlled (≥ 20), not well controlled (15-20) and poorly controlled (≤ 15)] at 1 month after the first ACT (second ACT). The percent of patients with ≥ 80% medication adherence (days 16-30 and 76-90) and the change in ACT (baseline and ≥ 30 days) were analysed.
RESULTS
Of the 163 patients with 90 days data, ≥ 80% medication adherence was achieved in 82.8% and 72.4% of patients at months 1 and 3, respectively. Change in asthma control was examined in ~ 60% (n = 97) of patients who completed ≥ 2 ACTs through the application. At baseline, 33.0% of patients were well controlled and 53.6% were well controlled at second ACT. Furthermore, 43.3% patients reported very poor control at baseline which decreased to 22.7% at second ACT.
CONCLUSION
The use of IND/GLY/MF (Breezhaler) with a digital companion (sensor + application) may be associated with improved symptom control and high level of controller medication adherence in patients with asthma.
PubMed: 37120785
DOI: 10.1007/s41030-023-00225-z -
Drug Design, Development and Therapy 2020In September 2019, published details of two large Phase III double-blind placebo-controlled studies (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52) confirming the... (Review)
Review
In September 2019, published details of two large Phase III double-blind placebo-controlled studies (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52) confirming the clinical efficacy of the biologic dupilumab in simultaneously blocking both IL-4/IL-13 signalling in chronic rhinosinusitis with nasal polyps (CRSwNP). The studies demonstrated that dupilumab (Dupixent, Sanofi and Regeneron) 300mg subcutaneously administered was clinically effective when added for patients with moderate to severe CRSwNP already maintained on the standard intranasal steroid mometasone furoate. Duration of treatment ranged from injections either 2 weekly for 24 weeks (SINUS-24) or every 2 weeks for 52 weeks or finally every 2 weeks for 24 weeks stepping down thereafter to every 4 weeks for a further 28 weeks (SINUS-52). Rapid improvements in all important parameters of disease burden were seen with such improvement maintained even where the frequency of injections was decreased. In patients with co-existent asthma, lung function and asthma control scores improved. This is consistent with the one airway hypothesis of shared T2 inflammatory programmes driving both disease syndromes. The studies formed the basis for FDA registration and clinical launch in the US, and EMA approval in Europe. Dupilumab presents a significant new treatment option in an area of urgent unmet therapeutic need in CRSwNP. Should dupilumab prove to be as effective in the real-life clinical environment as it has been in the studies, then a paradigm shift from sinonasal surgery to medical treatment of CRSwNP may need to occur in the ENT community. Questions in relation to best patient selection, combined upper and lower airway therapeutic pathways, long-term safety along with health economics and cost constraints ought now to be addressed.
Topics: Antibodies, Monoclonal, Humanized; Chronic Disease; Humans; Interleukin-13; Interleukin-4; Nasal Polyps; Rhinitis; Signal Transduction
PubMed: 32440101
DOI: 10.2147/DDDT.S243053 -
The Journal of Laryngology and Otology Apr 2023Because most available treatments for managing seasonal allergic rhinitis show some side effects without reducing recurrence, natural anti-allergic products could... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
Because most available treatments for managing seasonal allergic rhinitis show some side effects without reducing recurrence, natural anti-allergic products could represent an interesting treatment addition. This study aimed to analyse the efficacy and tolerance of quail egg as adjunctive therapy in seasonal allergic rhinitis.
METHOD
In a Consolidated Standards of Reporting Trials compliant framework, patients with seasonal allergic rhinitis were prospectively randomised to receive mometasone nasal spray for four weeks or the same topical corticosteroid therapy plus commercially available oral quail egg and zinc tablets.
RESULTS
Forty patients were enrolled. The mometasone + quail egg and zinc tablets group showed a greater reduction in nasal itching, sneezing and total nasal symptom scores than the mometasone nasal spray only group. A higher proportion of participants in the mometasone + quail egg and zinc tablets group had good rhinitis control than in the mometasone nasal spray only group, with no need for rescue medications.
CONCLUSION
Despite the need for a further larger study, quail egg preliminarily appears to be an effective adjunct to topical steroid therapy in seasonal allergic rhinitis.
Topics: Humans; Rhinitis, Allergic, Seasonal; Nasal Sprays; Zinc; Pregnadienediols; Egg Hypersensitivity; Mometasone Furoate; Anti-Allergic Agents; Administration, Intranasal; Treatment Outcome; Double-Blind Method
PubMed: 35582999
DOI: 10.1017/S0022215122001219 -
Clinical Drug Investigation Sep 2021In asthma, symptom control is a primary goal that is not consistently met with available treatment options. The first commercially available fixed-dose combination in a...
Cost-Utility Analysis of Fixed-Dose Combination of Indacaterol Acetate Glycopyrronium Bromide and Mometasone Furoate as a Maintenance Treatment in Adult Patients with Asthma Not Adequately Controlled with a Maintenance Combination of a Long-Acting Beta-Agonist and a High Dose of an Inhaled...
BACKGROUND AND OBJECTIVE
In asthma, symptom control is a primary goal that is not consistently met with available treatment options. The first commercially available fixed-dose combination in a single inhaler of a long-acting beta-agonist (indacaterol, IND), an inhaled corticosteroid (mometasone furoate, MF) and a long-acting muscarinic antagonist (glycopyrronium, GLY) has shown promising clinical results in phase III trials. The aim of the present study is to evaluate the cost-utility of IND/GLY/MF fixed-dose combination relative to a combination of salmeterol/fluticasone and tiotropium or salmeterol/fluticasone or IND/MF in adult patients with asthma, from the Italian Health Service (NHS) perspective.
METHODS
A two-state and 4-week cycle Markov model was used to estimate lifetime clinical outcomes and costs. Patients entered the model in stable disease and could experience a non-fatal exacerbation event. The exacerbation rate is dependent upon the therapy a patient is receiving, as per the IND/GLY/MF clinical trials. The impact of each type of exacerbation is accounted by applying a utility decrement, obtained from the literature, and a treatment cost. Utility values were obtained from the EQ-5D questionnaires in the IND/GLY/MF clinical trials. Lifetime costs considered in the analysis were drugs and exacerbation management. Probabilistic sensitivity analyses were carried out, with the aim of evaluating the impact of uncertainty on input parameters.
RESULTS
IND/GLY/MF is associated with a higher quality of life [+ 0.25 quality-adjusted life-year (QALY)] than salmeterol/fluticasone plus tiotropium, with an incremental cost of -€3213.90. The incremental cost-utility ratio indicates dominance. At a threshold of €5000 per QALY, IND/GLY/MF has nearly a 100% probability of being cost effective. IND/GLY/MF is associated with a higher quality of life (+ 0.21 QALY) than salmeterol/fluticasone, with an incremental cost of €2547.76. Incremental cost-utility ratio results in €11,897 per QALY. At a threshold of €20,000 per QALY, IND/GLY/MF has nearly a 100% probability of being cost effective. IND/GLY/MF is associated with a higher quality of life (+ 0.34 QALY) than IND/MF, with an incremental cost of €4745.91. Incremental cost-utility ratio results in €14,088 per QALY. At a threshold of €20,000 per QALY, IND/GLY/MF has nearly a 100% probability of being cost effective.
CONCLUSION
The results indicate that IND/GLY/MF is cost effective against the considered comparators in a cohort representative of adult patients with asthma in Italy.
Topics: Acetates; Adrenal Cortex Hormones; Adult; Asthma; Bronchodilator Agents; Cost-Benefit Analysis; Drug Combinations; Glycopyrrolate; Humans; Indans; Mometasone Furoate; Pulmonary Disease, Chronic Obstructive; Quality of Life; Quinolones; Treatment Outcome
PubMed: 34333742
DOI: 10.1007/s40261-021-01067-w -
Annals of Allergy, Asthma & Immunology... Feb 2019GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate intended for seasonal allergic... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate intended for seasonal allergic rhinitis (SAR) treatment.
OBJECTIVE
To evaluate the efficacy and safety of once-daily or twice-daily GSP301 in a ragweed pollen environmental exposure chamber.
METHODS
In this randomized, double-blind, double-dummy study, adults (18-65 years old) with SAR were equally randomized to 665 μg of olopatadine and 25 μg of mometasone (twice-daily GSP301), 665 μg of olopatadine and 50 μg of mometasone (once-daily GSP301), a US Food and Drug Administration-approved formulation of 137 μg of azelastine and 50 μg of fluticasone twice-daily (AzeFlu), a US Food and Drug Administration-approved formulation of 665 μg of olopatadine twice-daily, or placebo (twice-daily). During 2 visits (baseline and end of 14-day treatment), participants assessed SAR symptoms at specified time points. The primary end point-mean change from baseline in instantaneous total nasal symptom score (iTNSS) for twice-daily or once-daily GSP301 vs placebo-was analyzed by analysis of covariance. Onset of action, ocular symptoms, and adverse events were assessed.
RESULTS
A total of 180 participants were randomized. Treatment with twice-daily or once-daily GSP301 provided statistically significant improvements in iTNSS vs placebo (twice-daily GSP301: least squares mean difference, -3.60; 95% confidence interval [CI], -4.89 to -2.30; once-daily GSP301: least squares mean difference, -3.05; 95% CI, -4.35 to -1.76; P < .0001 for both). Significant improvements in iTNSS with twice-daily GSP301 occurred by 10 minutes after dosing (-1.26; 95% CI, -2.30 to -0.21; P = .02) and were maintained at all later time points except one (2.5 hours). Treatment-emergent adverse events occurred in 22.2%, 30.6%, 25.0%, 22.2%, and 16.7% of participants in the twice-daily GSP301, once-daily GSP301, AzeFlu, olopatadine, and placebo groups, respectively.
CONCLUSION
In an environmental exposure chamber model, twice-daily and once-daily GSP301 treatments were well tolerated and provided statistically significant and clinically meaningful SAR symptom improvement vs placebo.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03444506.
Topics: Adult; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Environmental Exposure; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Sprays; Olopatadine Hydrochloride; Rhinitis, Allergic, Seasonal
PubMed: 30321655
DOI: 10.1016/j.anai.2018.10.011 -
Journal of Pharmacy & Bioallied Sciences Apr 2024Dermoscopy particularly could be helpful in patients with steroid damaged face to assess and look for the damage caused by the steroid creams as also in cases where the...
BACKGROUND AND OBJECTIVES
Dermoscopy particularly could be helpful in patients with steroid damaged face to assess and look for the damage caused by the steroid creams as also in cases where the patient provides improper history.
MATERIALS AND METHODS
Patients attending to dermatology OPD with suspected/diagnosed TSDF between the ages of 18 and 60 years were enrolled and assessed on the basis of age, gender, residence, duration, potency, brand of application topical steroid creams, clinical and dermoscopic features.
RESULTS
Majority abusing the topical steroid creams were females (n-14) with mean age with SD of 34 ± 11 and were from rural areas (57.8%). Red raised lesions were the most common clinical presentation (n-15) with telangiectasias as the most common dermoscopic feature (n-26). Triple combination creams containing hydroquinone 2%, tretinoin 0.025%, and 0.1% mometasone were on the top of the list (n-20).
CONCLUSION
In this study, the importance of dermoscopy in assessing the features of topical steroid damaged face and preventing further damage is highlighted. Various factors causing topical steroid creams misuse and the easy availability of the creams is to be kept on check.
PubMed: 38882848
DOI: 10.4103/jpbs.jpbs_1191_23 -
Biomedicines Sep 2023Mometasone furoate (MF) is a kind of glucocorticoid with extensive pharmacological actions, including inhibiting tumor progression; however, the role of MF in head and...
Mometasone furoate (MF) is a kind of glucocorticoid with extensive pharmacological actions, including inhibiting tumor progression; however, the role of MF in head and neck squamous cell carcinoma (HNSCC) is still unclear. This study aimed to evaluate the inhibitory effect of MF against HNSCC and investigate its underlying mechanisms. Cell viability, colony formation, cell cycle and cell apoptosis were analyzed to explore the effect of MF on HNSCC cells. A xenograft study model was used to investigate the effect of MF on HNSCC in vivo. The core targets of MF for HNSCC were identified using network pharmacology analysis, TCGA database analysis and real-time PCR. Molecular docking was performed to determine the binding energy. Protein tyrosine phosphatase non-receptor type 11 (PTPN11)-overexpressing cells were constructed, and then, the cell viability and the expression levels of proliferation- and apoptosis-related proteins were detected after treatment with MF to explore the role of PTPN11 in the inhibitory effect of MF against HNSCC. After cells were treated with MF, cell viability and the number of colonies were decreased, the cell cycle was arrested and cell apoptosis was increased. The xenograft study results showed that MF could inhibit cell proliferation via promoting cell apoptosis in vivo. PTPN11 was shown to be the core target of MF against HNSCC via network pharmacology analysis, TCGA database analysis and real-time PCR. The molecular docking results revealed that PTPN11 exhibited the strongest ability to bind to MF. Finally, MF could attenuate the effects of increased cell viability and decreased cell apoptosis caused by PTPN11 overexpression, suggesting that MF can inhibit the progression of HNSCC by regulating PTPN11. MF targeted PTPN11, promoting cell cycle arrest and cell apoptosis, and consequently exerting effective anti-tumor activity.
PubMed: 37892971
DOI: 10.3390/biomedicines11102597 -
Annals of Family Medicine 2012Acute sinusitis is a common condition in ambulatory care, where it is frequently treated with antibiotics, despite little evidence of their benefit. Intranasal... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Acute sinusitis is a common condition in ambulatory care, where it is frequently treated with antibiotics, despite little evidence of their benefit. Intranasal corticosteroids might relieve symptoms; however, evidence for this benefit is currently unclear. We performed a systematic review and meta-analysis of the effects of intranasal corticosteroids on the symptoms of acute sinusitis.
METHODS
We searched MEDLINE, EMBASE, the Cochrane Central register of Controlled Trials (CENTRAL), and Centre for Reviews and Dissemination databases until February 2011 for studies comparing intranasal corticosteroids with placebo in children or adults having clinical symptoms and signs of acute sinusitis or rhinosinusitis in ambulatory settings. We excluded chronic/allergic sinusitis. Two authors independently extracted data and assessed the studies' methodologic quality.
RESULTS
We included 6 studies having a total of 2,495 patients. In 5 studies, antibiotics were prescribed in addition to corticosteroids or placebo. Intranasal corticosteroids resulted in a significant, small increase in resolution of or improvement in symptoms at days 14 to 21 (risk difference [RD] = 0.08; 95% CI, 0.03-0.13). Analysis of individual symptom scores revealed most consistently significant benefits for facial pain and congestion. Subgroup analysis by time of reported outcomes showed a significant beneficial effect at 21 days (RD = 0.11; 95% CI, 0.06-0.17), but not at 14 to 15 days (RD = 0.05; 95% CI, -0.01 to 0.11). Meta-regression analysis of trials using different doses of mometasone furoate showed a significant dose-response relationship (P=.02).
CONCLUSIONS
Intranasal corticosteroids offer a small therapeutic benefit in acute sinusitis, which may be greater with high doses and with courses of 21 days' duration. Further trials are needed in antibiotic-naïve patients.
Topics: Acute Disease; Administration, Intranasal; Adrenal Cortex Hormones; Adult; Anti-Bacterial Agents; Child; Dose-Response Relationship, Drug; Humans; Regression Analysis; Sinusitis
PubMed: 22585889
DOI: 10.1370/afm.1338 -
European Review For Medical and... Feb 2024Endoscopic evaluation becomes difficult when excessive secretion/hypersalivation occurs in the upper airway. Intranasal corticosteroids and antihistamines reduce...
OBJECTIVE
Endoscopic evaluation becomes difficult when excessive secretion/hypersalivation occurs in the upper airway. Intranasal corticosteroids and antihistamines reduce symptoms of rhinorrhea and nasal congestion. For this reason, in our study, we aimed to examine the effects of mometasone furoate and azelastine on both the amount of secretion and upper airway obstruction in terms of possible benefits during drug-induced sleep endoscopy (DISE).
PATIENTS AND METHODS
A total of 92 patients participated in the study [69 (75%) were males and 23 (25%) were females]. Three groups in Group 1 used intranasal mometasone furoate for 30 days, Group 2 used intranasal azelastine for 30 days, and Group 3 did not use any nasal spray for 30 days. Then, DISE was performed on all patients on the 30th day. Upper airway obstructions detected in DISE were interpreted according to the VOTE classification. Furthermore, the amount of secretion and patients' tolerance levels observed during DISE were also assessed.
RESULTS
Multilevel obstruction was detected in 94.5% of all patients participating in the study. Tolerance was poor in 18 (19.5%) of the patients participating in the study. Better DISE tolerance was determined in the female gender. DISE tolerance was also better in underweight and normal-weight patients (BMI < 25).
CONCLUSIONS
This study first investigated nasal mometasone furoate and azelastine on DISE. This study showed that prior use of nasal mometasone furoate or azelastine before DISE did not affect the amount of secretion, tolerance level, severity, and configuration of obstruction.
Topics: Male; Humans; Female; Mometasone Furoate; Nose; Endoscopy; Sleep; Phthalazines
PubMed: 38436176
DOI: 10.26355/eurrev_202402_35464