mometasone-furoate has been researched along with Nasal-Polyps* in 61 studies
8 review(s) available for mometasone-furoate and Nasal-Polyps
Article | Year |
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Efficacy of mometasone furoate for nasal polyps: A protocol for systematic review of randomized controlled trial.
This study aims to systematically explore the efficacy and safety of mometasone furoate (MTF) for patients with nasal polyps (NP).. We will search MEDLINE, Cochrane Library, PubMed, Springer, Web of Science, Ovid, Wangfang and Chinese Biomedical Literature Database from their inception to April 30, 2019 without language restrictions. All randomized controlled trials (RCTs) of MTF for the treatment of NP will be considered for inclusion. RevMan 5.3 software will be used for data synthesis, subgroup analysis, sensitivity analysis, as well as the meta-analysis.. Primary outcomes include change in symptom scores (as measured by any symptom scores), and polyp size (as assessed by any Polyp size scores or tools). Secondary outcomes consist of polyp recurrence, change in nasal air flow, quality of life outcomes (as measured by any quality of life scales, such as Short Form Health Survey is a 36-item), and adverse events.. This study will provide evidence for judging whether MTF is an effective and safe treatment for NP or not.. PROSPERO CRD42019134037. Topics: Administration, Intranasal; Anti-Inflammatory Agents; Humans; Mometasone Furoate; Nasal Polyps; Quality of Life; Randomized Controlled Trials as Topic; Recurrence; Research Design | 2019 |
A mometasone-eluting sinus implant (Sinuva) for nasal polyps.
Topics: Animals; Anti-Inflammatory Agents; Clinical Trials as Topic; Delayed-Action Preparations; Drug Implants; Humans; Mometasone Furoate; Nasal Polyps | 2018 |
Mometasone furoate sinus implant - a new targeted approach to treating recurrent nasal polyp disease.
Topics: Anti-Inflammatory Agents; Chronic Disease; Drug Implants; Endoscopy; Humans; Mometasone Furoate; Nasal Polyps; Paranasal Sinuses; Recurrence; Rhinitis; Sinusitis | 2018 |
Different types of intranasal steroids for chronic rhinosinusitis.
This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Topical (intranasal) corticosteroids are used with the aim of reducing inflammation in the sinonasal mucosa in order to improve patient symptoms.. To assess the effects of different types of intranasal steroids in people with chronic rhinosinusitis.. The Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 7); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 11 August 2015.. Randomised controlled trials (RCTs) with a follow-up period of at least three months comparing first-generation intranasal corticosteroids (e.g. beclomethasone dipropionate, triamcinolone acetonide, flunisolide, budesonide) with second-generation intranasal corticosteroids (e.g. ciclesonide, fluticasone furoate, fluticasone propionate, mometasone furoate, betamethasone sodium phosphate), or sprays versus drops, or low-dose versus high-dose intranasal corticosteroids.. We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - epistaxis (nosebleed). Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse event of local irritation. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.. We included nine RCTs (911 participants), including four different comparisons. None of the studies evaluated our first primary outcome measure, disease-specific HRQL. Fluticasone propionate versus beclomethasone dipropionate We identified two small studies (56 participants with polyps) that evaluated disease severity and looked at the primary adverse effect: epistaxis , but no other outcomes. We cannot report any numerical data but the study authors reported no difference between the two steroids. The evidence was of very low quality. Fluticasone propionate versus mometasone furoate We identified only one study (100 participants with polyps) that evaluated disease severity (nasal symptoms scores), which reported no difference (no numerical data available). The evidence was of very low quality. High-dose versus low-dose steroidsWe included five studies (663 participants with nasal polyps), three using mometasone furoate (400 µg versus 200 µg in adults and older children, 200 µg versus 100 µg in younger children) and two using fluticasone propionate drops (800 µg versus 400 µg). We found low quality evidence relating to disease severity and nasal polyps size, with results from the high-dose and low-dose groups being similar. Although all studies reported more improvement in polyp score in the high-dose group, the significance of this is unclear due to the small size of the improvements.The primary adverse effect, epistaxis , was more common when higher doses were used (risk ratio (RR) 2.06, 95% confidence interval (CI) 1.20 to 3.54, 637 participants, moderate quality evidence). Most of the studies that contributed data to this outcome used a broad definition of epistaxis, which ranged from frank bleeding to bloody nasal discharge to flecks of blood in the mucus. Aqueous nasal spray versus aerosol spray We identified only one poorly reported study (unclear number of participants for comparison of interest, 91 between three treatment arms), in which there were significant baseline differences between the participants in the two groups. We were unable to draw meaningful conclusions from the data.. We found insufficient evidence to suggest that one type of intranasal steroid is more effective than another in patients with chronic rhinosinusitis, nor that the effectiveness of a spray differs from an aerosol. We identified no studies that compared drops with spray.It is unclear if higher doses result in better symptom improvements (low quality evidence), but there was moderate quality evidence of an increased risk of epistaxis as an adverse effect of treatment when higher doses were used. This included all levels of severity of epistaxis and it is likely that the proportion of events that required patients to discontinue usage is low due to the low numbers of withdrawals attributed to it. If epistaxis is limited to streaks of blood in the mucus it may be tolerated by the patient and it may be safe to continue treatment. However, it may be a factor that affects compliance.There is insufficient evidence to suggest that the different types of corticosteroid molecule or spray versus aerosol have different effects. Lower doses have similar effectiveness but fewer side effects.Clearly more research in this area is needed, with specific attention given to trial design, disease-specific health-related quality of life outcomes and evaluation of longer-term outcomes and adverse effects. Topics: Administration, Intranasal; Adult; Beclomethasone; Child; Chronic Disease; Fluticasone; Humans; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Randomized Controlled Trials as Topic; Rhinitis; Sinusitis; Steroids | 2016 |
Intranasal steroids versus placebo or no intervention for chronic rhinosinusitis.
This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. The use of topical (intranasal) corticosteroids has been widely advocated for the treatment of chronic rhinosinusitis given the belief that inflammation is a major component of this condition.. To assess the effects of intranasal corticosteroids in people with chronic rhinosinusitis.. The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 8); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 11 August 2015.. Randomised controlled trials (RCTs) with a follow-up period of at least three months comparing intranasal corticosteroids (e.g. beclomethasone dipropionate, triamcinolone acetonide, flunisolide, budesonide) against placebo or no treatment in patients with chronic rhinosinusitis.. We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - epistaxis. Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse events of local irritation or other systemic adverse events. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.. We included 18 RCTs with a total of 2738 participants. Fourteen studies had participants with nasal polyps and four studies had participants without nasal polyps. Only one study was conducted in children. Intranasal corticosteroids versus placebo or no intervention Only one study (20 adult participants without polyps) measured our primary outcome disease-specific HRQL using the Rhinosinusitis Outcome Measures-31 (RSOM-31). They reported no significant difference (numerical data not available) (very low quality evidence).Our second primary outcome, disease severity , was measured using the Chronic Sinusitis Survey in a second study (134 participants without polyps), which found no important difference (mean difference (MD) 2.84, 95% confidence interval (CI) -5.02 to 10.70; scale 0 to 100). Another study (chronic rhinosinusitis with nasal polyps) reported an increased chance of improvement in the intranasal corticosteroids group (RR 2.78, 95% CI 1.76 to 4.40; 109 participants). The quality of the evidence was low.Six studies provided data on at least two of the individual symptoms used in the EPOS 2012 criteria to define chronic rhinosinusitis (nasal blockage, rhinorrhoea, loss of sense of smell and facial pain/pressure). When all four symptoms in the EPOS criteria were available on a scale of 0 to 3 (higher = more severe symptoms), the average MD in change from baseline was -0.26 (95% CI -0.37 to -0.15; 243 participants; two studies; low quality evidence). Although there were more studies and participants when only nasal blockage and rhinorrhoea were considered (MD -0.31, 95% CI -0.38 to -0.24; 1702 participants; six studies), the MD was almost identical to when loss of sense of smell was also considered (1345 participants, four studies; moderate quality evidence).When considering the results for the individual symptoms, benefit was shown in the intranasal corticosteroids group. The effect size was larger for nasal blockage (MD -0.40, 95% CI -0.52 to -0.29; 1702 participants; six studies) than for rhinorrhoea (MD -0.25, 95% CI -0.33 to -0.17; 1702 participants; six studies) or loss of sense of smell (MD -0.19, 95% CI -0.28 to -0.11; 1345 participants; four studies). There was heterogeneity in the analysis for facial pain/pressure (MD -0.27, 95% CI -0.56 to 0.02; 243 participants; two studies). The quality of the evidence was moderate for nasal blockage, rhinorrhoea and loss of sense of smell, but low for facial pain/pressure.There was an increased risk of. Most of the evidence available was from studies in patients with chronic rhinosinusitis with nasal polyps. There is little information about quality of life (very low quality evidence). For disease severity, there seems to be improvement for all symptoms (low quality evidence), a moderate-sized benefit for nasal blockage and a small benefit for rhinorrhoea (moderate quality evidence). The risk of epistaxis is increased (high quality evidence), but these data included all levels of severity; small streaks of blood may not be a major concern for patients. It is unclear whether there is a difference in the risk of local irritation (low quality evidence). Topics: Administration, Intranasal; Adolescent; Adrenal Cortex Hormones; Adult; Beclomethasone; Budesonide; Child; Chronic Disease; Fluticasone; Humans; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Placebos; Quality of Life; Randomized Controlled Trials as Topic; Rhinitis; Severity of Illness Index; Sinusitis; Steroids | 2016 |
[Polypous rhinosinusitis in the children].
We present an overview of the modern literature concerningpolypous rhinosinusitis (PRS) in the children. The information thus derived is compared with the available results of the clinical investigations involving the adults patients with this pathology. Allergic diseases and mucoviscidosis appear to be the pathological conditions most likely leading to the development of polyps in the nasal cavity. The patients suffering from rhinosinusitis associated with the disorders of arachidonic acid metabolismare very rarely encountered in the pediatric practice unlike those among the adult population. Intranasal glucocorticosteroids (INGCS), especially in the form of the mometasonefuroate nasal spray, are considered to be the most promising medications for the treatment of the children presenting with PRS. However, further clinical studies are needed to confirm the effectiveness and safety of this therapeutic modality.. Представлен обзор современной литературы по проблеме полипозного риносинусита (ПРС) у детей. Проведено сравнение с имеющимися данными клинических исследований у взрослых пациентов с ПРС. К заболеваниям, являющимся наиболее вероятной причиной роста назальных полипов у детей, относят аллергию и муковисцидоз. В отличие от взрослого населения, в педиатрической практике практически не встречаются пациенты с ПРС, ассоциированным с нарушением метаболизма арахидоновой кислоты. Наиболее перспективным в терапии ПРС у детей является использование современных ИнГКС, особенно назального спрея мометазона фуроата. Однако для подтверждения эффективности и безопасности данного лечения необходимы дальнейшие клинические исследования в данном направлении. Topics: Administration, Intranasal; Adult; Child; Cystic Fibrosis; Glucocorticoids; Humans; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Rhinitis; Sinusitis; Treatment Outcome | 2016 |
[Intranasal steroid therapy in inflammatory nasal-sinus pathology in pediatric age].
Nasal obstruction is the symptom par excellence signalling the onset of nasal-sinus inflammatory pathologies (allergic rhinitis, acute or intermittent rhinosinusitis without nasal polyps, persistent rhinosinusitis without nasal polyps, chronic or intermittent rhinosinusitis associated with nasal-sinus polyposis). This symptom is due, in particular, to the host's response to the etiological factor for which, where there is no accompanying infectious process, the therapy should be aimed at resolving the inflammatory response. The anti-inflammatory properties of steroid drugs have been used systemically with excellent results. Unfortunately, prolonged use can foster the onset of major side-effects. Hence, the need to create new pharmacological molecules with topical action, while maintaining the characteristics of systemically used steroids. Up to the present, many intranasal steroids have been examined with positive results in inflammatory nasal-sinus pathologies. It should be noted that systemic bioavailability after intranasal therapy with mometasone furoate (MF) is lowest with respect to other steroid molecules. In recent decades topical intranasal steroids have also been tested in adenoid hypertrophy, a typical infant condition, with encouraging results. For this reason, the authors have assessed the effectiveness of MF on the reduction of the adenoid mass and, consequently, on the improvement in obstructive nasal symptoms in the short term and after a long-term follow-up, obtaining positive results. To conclude, intranasal steroid drugs are certainly useful in the treatment of nasal-sinus inflammatory pathologies. Furthermore, our studies have shown that MF can improve the clinical picture of adenoid hypertrophy. Topics: Administration, Intranasal; Anti-Allergic Agents; Anti-Inflammatory Agents; Child; Controlled Clinical Trials as Topic; Drug Therapy, Combination; Glucocorticoids; Humans; Meta-Analysis as Topic; Mometasone Furoate; Nasal Obstruction; Nasal Polyps; Practice Guidelines as Topic; Pregnadienediols; Randomized Controlled Trials as Topic; Rhinitis; Sinusitis; Treatment Outcome | 2009 |
Topical glucocorticosteroids in rhinitis: clinical aspects.
The introduction of nasal glucocorticosteroids, 30 years ago, has been the most important therapeutic progress in rhinitis management since the introduction of the first generation of antihistamines. Our knowledge of the mode of action of glucocorticosteroids in the nose has improved as the airway mucous membrane of the nose is easily accessible for investigation. However, the exact mechanism behind the marked clinical effect remains unclear. Topical glucocorticosteroids are highly effective in diseases characterized by eosinophil-dominated inflammation (allergic rhinitis, nasal polyposis), but not in diseases characterized by neutrophil-dominated inflammation (common cold, infectious rhinosinusitis). Experience for 30 years and a long series of controlled studies have shown that the treatment is highly effective and that the side effects are few and benign. Intranasal glucocorticosteroids can therefore be considered as first-line treatment for allergic and non-allergic, non-infectious rhinitis and nasal polyps. Topics: Administration, Topical; Androstadienes; Animals; Beclomethasone; Budesonide; Dexamethasone; Eosinophils; Fluocinolone Acetonide; Fluticasone; Glucocorticoids; Humans; Mometasone Furoate; Nasal Mucosa; Nasal Polyps; Pregnadienediols; Randomized Controlled Trials as Topic; Rhinitis; Treatment Outcome; Triamcinolone Acetonide | 2006 |
33 trial(s) available for mometasone-furoate and Nasal-Polyps
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Short-term postoperative efficacy of steroid-eluting stents for eosinophilic chronic rhinosinusitis with nasal polyps: A randomized clinical trial.
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.. 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.. 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.. 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. Topics: Chronic Disease; Drug-Eluting Stents; Humans; Mometasone Furoate; Nasal Polyps; Neoplasm Recurrence, Local; Prospective Studies; Rhinitis; Sinusitis; Treatment Outcome | 2023 |
Phase 3b randomized controlled trial of fevipiprant in patients with nasal polyposis with asthma (THUNDER).
Chronic rhinosinusitis with nasal polyps (CRSwNP) is associated with asthma, particularly of late onset. Current treatment options for CRSwNP have limitations, and there is an unmet need for other safe and effective therapies.. The aim of the THUNDER study was to determine the efficacy and safety of the prostaglandin D. THUNDER was a phase 3b, randomized, multicenter, double-blind, placebo-controlled, parallel-group, 16-week study of fevipiprant 150 mg or 450 mg once daily versus placebo. All patients received intranasal mometasone furoate 200 μg daily.. Ninety-eight patients were randomly assigned to fevipiprant 150 mg (n = 32), fevipiprant 450 mg (n = 34), or placebo (n = 32). Mean (SE) change from baseline in nasal polyp score at week 16 was 0.20 (0.224) for fevipiprant 150 mg, -0.10 (0.216) for fevipiprant 450 mg, and 0.14 (0.233) for placebo. Mean treatment difference was 0.05 (95% confidence interval, -0.59, 0.70; adjusted P = .979) for fevipiprant 150 mg versus placebo and -0.25 (95% confidence interval, -0.88, 0.39; adjusted P = .656) for fevipiprant 450 mg versus placebo. There was no meaningful difference in the secondary end points for fevipiprant versus placebo.. THUNDER provided no evidence of a role for fevipiprant in the treatment of patients with CRSwNP and asthma; future studies may establish a role for other DP Topics: Asthma; Chronic Disease; Double-Blind Method; Humans; Indoleacetic Acids; Mometasone Furoate; Nasal Polyps; Pyridines; Rhinitis; Sinusitis; Treatment Outcome | 2022 |
The Effect of Dupilumab on Intractable Chronic Rhinosinusitis with Nasal Polyps in Japan.
Dupilumab, which blocks the shared receptor component for interleukin-4 and interleukin-13, reduced polyp size, sinus opacification, and symptom severity, and was well tolerated in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the SINUS-52 study (NCT02898454). We assessed dupilumab in patients enrolled at Japanese centers.. Patients on a background of mometasone furoate nasal spray, received dupilumab 300 mg every 2 weeks (q2w) for 52 weeks (Arm A); dupilumab 300 mg q2w for 24 weeks, followed by every 4 weeks (q4w) for 28 weeks (Arm B); or placebo (Arm C). Co-primary endpoints were week 24 nasal polyp score (NPS), nasal congestion (NC) score, and sinus Lund-Mackay CT (LMK-CT) scores. Symptoms, sense of smell, health-related quality of life, and safety were assessed during the 52-week treatment period.. Of 49 patients enrolled in Japan, 45 completed the study. Week 24 least squares (LS) mean improvement versus placebo were as follows: NPS (Arm A: -3.1, P < .0001; Arm B: -2.1, P = .0011); NC score (Arm A: -1.2, P < .0001; Arm B: -0.9, P < .0001); and LMK-CT (Arm A: -5.1, P = .0005; Arm B: -2.8, P = .0425). The most common treatment-emergent adverse event in dupilumab and placebo-treated patients was nasopharyngitis.. Dupilumab provided rapid, significant, and clinically meaningful improvements for patients with CRSwNP in Japan. Dupilumab was well tolerated, and safety and efficacy were consistent with the overall study population.. 2 Laryngoscope, 131:E1770-E1777, 2021. Topics: Adult; Antibodies, Monoclonal, Humanized; Chronic Disease; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Japan; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Rhinitis; Severity of Illness Index; Sinusitis; Treatment Outcome | 2021 |
Dupilumab improves upper and lower airway disease control in chronic rhinosinusitis with nasal polyps and asthma.
Chronic rhinosinusitis with nasal polyps (CRSwNP) and type 2 asthma share the same inflammatory pathophysiology and are frequent comorbidities. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin 4 and interleukin 13, which are key and central drivers of type 2 inflammation.. We report the effect of dupilumab vs placebo on outcome measures of the upper and lower airways and health-related quality of life (HRQoL) in the pooled population of patients with CRSwNP and comorbid asthma from the phase 3 SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) studies.. In these randomized, double-blind, placebo-controlled trials, patients received subcutaneous dupilumab 300 mg (n = 438) or placebo (n = 286) every 2 weeks on a background of mometasone furoate nasal spray. Changes from baseline at week 24 in the upper and lower airway outcome measures are reported.. Of the 724 patients randomized, 428 (59.1%) had comorbid asthma. In patients with asthma at week 24, dupilumab vs placebo improved the nasal polyp score (-2.04), patient-reported nasal congestion score (-1.04), Lund-Mackay computed tomography scan score (-6.43), peak nasal inspiratory flow (46.15 L/min), and 22-item sinonasal outcome test score (-21.42; all P < .001). The forced expiratory volume in 1 second and 6-item asthma control questionnaire scores were also markedly improved with dupilumab vs placebo. The most common adverse events (nasopharyngitis, headache, injection-site erythema, worsening of nasal polyposis, and asthma) were more frequent with placebo than dupilumab.. Dupilumab improved upper and lower airway outcome measures and HRQoL in patients with severe CRSwNP and comorbid asthma and was well tolerated.. ClinicalTrials.gov Identifiers: NCT02912468 (SINUS-24) and NCT02898454 (SINUS-52). Topics: Adult; Antibodies, Monoclonal, Humanized; Asthma; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Interleukin-4 Receptor alpha Subunit; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Placebos; Quality of Life; Receptors, Interleukin-13; Rhinitis; Sinusitis; Surveys and Questionnaires; Young Adult | 2021 |
Omalizumab versus intranasal steroids in the post-operative management of patients with allergic fungal rhinosinusitis.
Allergic fungal rhinosinusitis (AFRS) is a common disorder with a high prevalence and a very high incidence of recurrence. Management includes surgery and medical treatment in the form of local and/or systemic steroids. However, some cases are resistant to the action of steroids and further treatment is warranted. Being an immune-mediated disorder, targeting IgE seems a logical step. Immunotherapy drugs acting on the IgE (e.g. omalizumab) can modify the clinical course of the disease. This study aimed at evaluating the effect of omalizumab on the clinical course of patients undergoing surgery for AFRS.. This is a two-arm prospective, randomized, single blind clinical trial among patients with AFRS. Twenty patients were included and randomly divided into two groups: Group A; 10 patients received a single subcutaneous injection of omalizumab (Xolair ' Novartis) (150 mg) 2 weeks postoperatively. Group B: 10 patients received local steroids nasal sprays (budesonide or mometasone furoate, 100 μg twice daily for 6 months, starting 2 weeks postoperatively. All patients underwent history, examination, CT scan and IgE level estimation and were submitted to endoscopic sinus surgery. They were evaluated at 4 weeks interval for 6 months.. In both groups there were highly significant differences between pre/post-operative SNOT-20 scores, TNSS scores, total IgE level and Philpott-Javer staging scores. Comparison between the two study groups at 24 weeks showed a highly significant difference (p = 0.001) between post-operative SNOT 20 and TNSS scores in favour of group A. There was no statistically significant difference between the two study groups as regarding postoperative total IgE or Philpott-Javer scores. There were two recurrences in both arms, but no significant side effects.. We compared a single post operative injection of omalizumab with twice daily intranasal steroid spray for 6 months. Both treatments were effective, but the omalizumab group showed a more significant clinical and endoscopic response. There were no significant side effects in both arms. This novel approach used a single low dose injection of omalizumab increased the compliance of the patients with minimal complications. Longer follow-up of the patients is ongoing to determine the optimal time for re-injection. The only downside was the higher cost of omalizumab compared to that of local steroids. Topics: Administration, Intranasal; Adolescent; Adult; Anti-Allergic Agents; Budesonide; Chronic Disease; Endoscopy; Female; Glucocorticoids; Health Status Indicators; Humans; Immunoglobulin E; Injections, Subcutaneous; Male; Mometasone Furoate; Mycoses; Nasal Polyps; Nasal Sprays; Omalizumab; Prospective Studies; Rhinitis, Allergic; Single-Blind Method; Sinusitis; Tomography, X-Ray Computed; Young Adult | 2020 |
Randomized clinical trial to evaluate mometasone lavage vs spray for patients with chronic rhinosinusitis without nasal polyps who have not undergone sinus surgery.
There is no consensus regarding the best route of intranasal delivery of corticosteroids in the treatment of chronic rhinosinusitis (CRS). The study objective of this work was to compare the impact of mometasone furoate nasal spray (MFNS) vs mometasone nasal irrigation in the management of CRS patients who have not undergone sinus surgery.. A double-blind, placebo-controlled, randomized clinical trial was conducted in adults with CRS. Individuals with nasal polyps and/or history of sinus surgery were excluded. Patients were randomized to receive 8 weeks of either MFNS or mometasone nasal irrigation. The primary outcome measure was change in the 22-item Sino-Nasal Outcome Test (SNOT-22) score between the 2 groups. Secondary outcome measures included patient global response to treatment and Lund-Kennedy endoscopy scores.. A total of 43 participants completed the study (n = 22, MFNS; n = 21,mometasone nasal irrigation). Fourteen (64%) participants in the MFNS group and 17 (81%) in the mometasone lavage group had a clinically meaningful improvement in SNOT-22 scores with a proportion difference of 17% (95% confidence interval [CI], -9% to 44%). The least-squares (LS) mean difference between the 2 groups for SNOT-22 was -8.6 (95% CI, -17.7 to 0.58; p = 0.07), whereas the LS mean difference between the 2 groups for Lund-Kennedy endoscopy scores was 0.16 (95% CI, -0.84 to 1.15; p = 0.75). No adverse events were associated with the study.. Both MFNS and mometasone nasal irrigations are beneficial in symptom management of CRS. Our study suggests that patients who perform mometasone lavage do better in a clinically meaningful way, but our results are not definitive and further studies are warranted. Topics: Adult; Humans; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Sinusitis; Therapeutic Irrigation | 2020 |
Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials.
Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by IgE hyperproduction and eosinophilic inflammation. The anti-IgE antibody, omalizumab, has demonstrated efficacy in patients with CRSwNP and comorbid asthma previously.. Our aim was to determine omalizumab safety and efficacy in CRSwNP in phase 3 trials (POLYP 1 and POLYP 2).. Adults with CRSwNP with inadequate response to intranasal corticosteroids were randomized (1:1) to omalizumab or placebo and intranasal mometasone for 24 weeks. Coprimary end points included change from baseline to week 24 in Nasal Polyp Score (NPS) and Nasal Congestion Score. Secondary end points included change from baseline to week 24 in Sino-Nasal Outcome Test-22 (SNOT-22) score, University of Pennsylvania Smell Identification Test, sense of smell, postnasal drip, runny nose, and adverse events.. Patients in POLYP 1 (n = 138) and POLYP 2 (n = 127) exhibited severe CRSwNP and substantial quality of life impairment evidenced by a mean NPS higher than 6 and SNOT-22 score of approximately 60. Both studies met both the coprimary end points. SNOT-22 score, University of Pennsylvania Smell Identification Test score, sense of smell, postnasal drip, and runny nose were also significantly improved for omalizumab versus placebo. In POLYP 1 and POLYP 2, the mean changes from baseline at week 24 for omalizumab versus placebo were as follows: NPS, -1.08 versus 0.06 (P < .0001) and -0.90 versus -0.31 (P = .0140); Nasal Congestion Score, -0.89 versus -0.35 (P = .0004) and -0.70 versus -0.20 (P = .0017); and SNOT-22 score, -24.7 versus -8.6 (P < .0001) and -21.6 versus -6.6 (P < .0001). Adverse events were similar between groups.. Omalizumab significantly improved endoscopic, clinical, and patient-reported outcomes in severe CRSwNP with inadequate response to intranasal corticosteroids, and it was well tolerated. Topics: Adrenal Cortex Hormones; Adult; Anti-Allergic Agents; Chronic Disease; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Omalizumab; Rhinitis; Sinusitis; Treatment Outcome | 2020 |
Dupilumab improves health-related quality of life in patients with chronic rhinosinusitis with nasal polyposis.
Chronic rhinosinusitis with nasal polyposis (CRSwNP) negatively affects health-related quality of life (HRQoL). In a previously reported randomized clinical trial (NCT01920893), addition of dupilumab to mometasone furoate in patients with CRSwNP refractory to intranasal corticosteroids (INCS) significantly improved endoscopic, radiographic, and clinical endpoints and patient-reported outcomes. The objective of this analysis was to examine the impact of dupilumab treatment on HRQoL and productivity using secondary outcome data from this trial.. Following a 4-week mometasone furoate nasal spray run-in, patients were randomized to commence subcutaneous dupilumab (600 mg loading dose, then 300 mg once weekly for 15 weeks [n = 30], or matched placebo [n = 30]). Outcomes included scores on the CRS disease severity visual analog scale (VAS), 22-item Sino-Nasal Outcome Test (SNOT-22), 5-dimension EuroQoL (EQ-5D) general health status VAS, and 36-item Short-Form Health Survey (SF-36) for HRQoL and nasal polyp-related healthcare resource use questionnaires.. Following 16 weeks of treatment, the proportion of patients with moderate-to-severe CRSwNP (VAS > 3-10) decreased from 86.2% to 21.4% with dupilumab and 88.0% to 84.2% with placebo. Dupilumab (vs placebo) resulted in significantly greater improvement in HRQoL, based on SNOT-22, SF-36, and EQ-5D VAS scores. The dupilumab group had a significantly lower adjusted annualized mean number of sick leave days (0.09, vs 4.18 with placebo, P = .015) and significantly greater improvement (vs placebo) in the SNOT-22 item "reduced productivity.". In adults with CRSwNP refractory to treatment with INCS alone, the addition of dupilumab reduced disease severity, significantly improved HRQoL, and improved productivity. Topics: Adult; Anti-Inflammatory Agents; Antibodies, Monoclonal, Humanized; Chronic Disease; Double-Blind Method; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Patient Reported Outcome Measures; Quality of Life; Rhinitis; Sinusitis; Treatment Outcome | 2020 |
Bioabsorbable steroid-releasing implants in the frontal sinus ostia: a pooled analysis.
Bioabsorbable steroid-releasing implants (mometasone furoate, 370 μg) are effective for improving postsurgical outcomes in the frontal sinus ostia (FSO). In this study we evaluated the effect of these implants on frontal outcomes in various patient subgroups with chronic rhinosinusitis (CRS) using pooled data from 2 randomized, controlled trials (RCTs).. A total of 160 subjects were enrolled in 2 RCTs. After surgery, subjects were randomized to receive an implant in 1 FSO with the contralateral side as control. Data through day 90 from the 2 studies were pooled and subgroup analyses were performed.. At day 30, relative to controls, steroid-releasing implants significantly reduced the need for postoperative interventions by 46.8% (95% confidence interval [CI], -60.7 to -27.9), for surgical interventions by 51.2% (95% CI, -68.2 to -25.2), and for oral steroid interventions by 37.2% (95% CI, -54.6 to -13.1) in the pooled data set. At day 90, statistically significant reductions (p < 0.05) in the need for postoperative interventions (relative reduction [RR], 30.2%), restenosis/occlusion rate (RR, 31.7%), and inflammation score (absolute difference, -6.0), and increase in estimated FSO diameter (absolute difference, 1 mm), favoring the treated side, were observed. Subgroup analyses of the pooled data showed statistically significant improvements (p < 0.05) at day 90 in restenosis/occlusion rate, and estimated FSO diameter, favoring the treated side across subgroups, with no statistically significant subgroup-by-treatment interactions.. Bioabsorbable steroid-releasing sinus implants improve outcomes of frontal sinus surgery through 90 days, irrespective of asthma status, previous endoscopic sinus surgery, extent of surgery, extent of polyps, or Lund-Mackay computed tomography stage in the FSO. Topics: Absorbable Implants; Adult; Aged; Chronic Disease; Drug Implants; Female; Frontal Sinus; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Rhinitis; Sinusitis; Treatment Outcome | 2019 |
A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps.
Topical intranasal corticosteroid sprays (INCSs) are standard treatment for nasal polyps (NPs), but their efficacy is reduced by poor patient compliance and impaired access of drug to the sinus mucosa. A corticosteroid-eluting sinus implant was designed to address these limitations in patients with recurrent polyposis after sinus surgery by delivering 1350 μg of mometasone furoate (MF) directly to the ethmoid sinus mucosa over approximately 90 days.. A randomized, sham-controlled, double-blind trial was undertaken in 300 adults with refractory chronic rhinosinusitis with NPs (CRSwNP), who were candidates for repeat surgery. Eligible patients were randomized (2:1) and underwent in-office bilateral placement of 2 implants or a sham procedure. All patients used the MF INCS 200 μg once daily. Co-primary efficacy endpoints were the change from baseline in nasal obstruction/congestion score and bilateral polyp grade, as determined by an independent panel based on centralized, blinded videoendoscopy review.. Patients treated with implants experienced significant reductions in both nasal obstruction/congestion score (p = 0.0074) and bilateral polyp grade (p = 0.0073) compared to controls. At day 90, implants were also associated with significant reductions in 4 of 5 prespecified secondary endpoints compared to control: proportion of patients still indicated for repeat sinus surgery (p = 0.0004), percent ethmoid sinus obstruction (p = 0.0007), nasal obstruction/congestion (p = 0.0248), and decreased sense of smell (p = 0.0470), but not facial pain/pressure (p = 0.9130). One patient experienced an implant-related serious adverse event (epistaxis).. Significant improvements over a range of subjective and objective endpoints, including a reduction in the need for sinus surgery by 61%, suggest that MF sinus implants may play an important role in management of recurrent NP. Topics: Adult; Chronic Disease; Double-Blind Method; Drug Implants; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Mucosa; Nasal Polyps; Paranasal Sinuses; Placebos; Recurrence; Sinusitis | 2018 |
Effects of mometasone furoate-impregnated biodegradable nasal dressing on endoscopic appearance in healing process following endoscopic sinus surgery: a randomized, double-blind, placebo-controlled study.
Postoperative care is an important factor affecting the outcome of endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS). The aim of this study was to test the effect of mometasone furoate (MF)-soaked biodegradable nasal dressings (BNDs) on endoscopic appearance in CRS patients with nasal polyps (CRSwNP) after ESS.. This study was a prospective, randomized, double-blinded, placebo-controlled study. A total of 64 CRSwNP patients with bilateral ESS were enrolled and randomly given 4 mL or 8 mL of MF-soaked BNDs (NasoPore) in 1 nasal cavity and the same amount of normal saline-soaked BNDs in the contralateral side. The BNDs were removed on the 7th or 14th postoperative day. Perioperative sinus endoscopy (POSE) and Lund-Kennedy scores were collected, on the 7th or 14th postoperative days and at 1, 2, and 3 postoperative months.. The POSE and Lund-Kennedy scores showed that in the 4-mL, 1-week group, no significant differences between the sides treated with MF-soaked BNDs and the normal saline-soaked control were observed at any postoperative visits. In the 4-mL, 2-week group, significant differences were found at the 2-week and 1-month postoperative visits but not at the 2-month and 3-month visits. In the 8-mL, 1-week group, significant differences were found at the 1-week, 1-month, and 2-month postoperative visits but not at the 3-month visit. In the 8-mL, 2-week group, significant differences were found at all postoperative visits.. This study reveals that MF-impregnated BNDs improve the endoscopic appearance in the healing process of CRSwNP after ESS. Topics: Administration, Intranasal; Adult; Aged; Anti-Inflammatory Agents; Bandages; Chronic Disease; Double-Blind Method; Endoscopy; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Nasal Surgical Procedures; Paranasal Sinuses; Rhinitis; Sinusitis; Wound Healing; Young Adult | 2018 |
Mometasone furoate nasal spray in the treatment of nasal polyposis in Chinese patients: a double-blind, randomized, placebo-controlled trial.
Although mometasone furoate nasal spray (MFNS) has demonstrated efficacy in nasal polyposis (NP) in Western populations, data in Asian populations is limited.. This randomized, double-blind study evaluated MFNS 200 μg twice per day (BID) vs placebo in Chinese adults with bilateral nasal polyps (graded as 1, 2, or 3 by the investigator). A 14-day placebo run-in period was followed by a 16-week treatment period with MFNS 200 μg BID vs placebo (1:1 ratio). The co-primary endpoints were change from baseline in nasal congestion/obstruction averaged over the first 4 weeks of treatment and change from baseline in the total polyp size score (sum of scores from the left and right nasal fossa) at week 16. Secondary endpoints included other sinonasal symptoms scores and safety outcomes such as monitoring laboratory measurements, vital signs, and adverse events (AEs).. There were 748 patients randomized, 375 received MFNS 200 μg BID and 373 received placebo. The between-treatment difference in least squares (LS) mean change from baseline in nasal congestion/obstruction over 4 weeks of treatment was -0.14 (95% confidence interval [CI], -0.22 to -0.06) for MFNS vs placebo (p = 0.0007). The between-treatment difference in LS mean change from baseline in total polyp size score at week 16 was -0.30 (95% CI, -0.45 to -0.15) for MFNS vs placebo (p < 0.0001). Serious AEs were rare (0.5% and 0.8% in MFNS and placebo groups, respectively) and considered not drug-related. There were significantly more AEs of epistaxis with MFNS vs placebo (p = 0.009).. This study demonstrated that MFNS was effective and well tolerated in this population of adult, Chinese patients with NP. Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Inflammatory Agents; China; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Treatment Outcome; Young Adult | 2016 |
Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial.
Dupilumab has demonstrated efficacy in patients with asthma and atopic dermatitis, which are both type 2 helper T-cell-mediated diseases.. To assess inhibition of interleukins 4 and 13 with dupilumab in patients with chronic sinusitis and nasal polyposis.. A randomized, double-blind, placebo-controlled parallel-group study conducted at 13 sites in the United States and Europe between August 2013 and August 2014 in 60 adults with chronic sinusitis and nasal polyposis refractory to intranasal corticosteroids with 16 weeks of follow-up.. Subcutaneous dupilumab (a 600 mg loading dose followed by 300 mg weekly; n = 30) or placebo (n = 30) plus mometasone furoate nasal spray for 16 weeks.. Change in endoscopic nasal polyp score (range, 0-8; higher scores indicate worse status) at 16 weeks (primary end point). Secondary end points included Lund-Mackay computed tomography (CT) score (range, 0-24; higher scores indicate worse status), 22-item SinoNasal Outcome Test score (range, 0-110; higher scores indicating worse quality of life; minimal clinically important difference ≥8.90), sense of smell assessed using the University of Pennsylvania Smell Identification Test (UPSIT) score (range, 0-40; higher scores indicate better status), symptoms, and safety.. Among the 60 patients who were randomized (mean [SD] age, 48.4 years [9.4 years]; 34 men [56.7%]; 35 with comorbid asthma), 51 completed the study. The least squares (LS) mean change in nasal polyp score was -0.3 (95% CI, -1.0 to 0.4) with placebo and -1.9 (95% CI, -2.5 to -1.2) with dupilumab (LS mean difference, -1.6 [95% CI, -2.4 to -0.7]; P < .001). The LS mean difference between the 2 groups for the Lund-Mackay CT total score was -8.8 (95% CI, -11.1 to -6.6; P < .001). Significant improvements with dupilumab were also observed for the 22-item SinoNasal Outcome Test (LS mean difference between groups, -18.1 [95% CI, -25.6 to -10.6]; P < .001) and sense of smell assessed by UPSIT (LS mean difference, 14.8 [95% CI, 10.9 to 18.7]; P < .001). The most common adverse events were nasopharyngitis (33% in the placebo group vs 47% in the dupilumab group), injection site reactions (7% vs 40%, respectively), and headache (17% vs 20%).. Among adults with symptomatic chronic sinusitis and nasal polyposis refractory to intranasal corticosteroids, the addition of subcutaneous dupilumab to mometasone furoate nasal spray compared with mometasone alone reduced endoscopic nasal polyp burden after 16 weeks. Further studies are needed to assess longer treatment duration, larger samples, and direct comparison with other medications.. clinicaltrials.gov Identifier: NCT01920893. Topics: Adult; Aged; Anti-Inflammatory Agents; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Chronic Disease; Double-Blind Method; Drug Administration Schedule; Female; Humans; Injections, Subcutaneous; Interleukin-13; Interleukin-4; Least-Squares Analysis; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Quality of Life; Sinusitis | 2016 |
RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study.
Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. Safety and efficacy were previously reported for a bioabsorbable sinus implant that elutes mometasone furoate for 3 months. Here we summarize longer-term outcomes.. A randomized, controlled, blinded study with 100 chronic rhinosinusitis with nasal polyps (CRSwNP) patients who failed medical treatment and were considered candidates for revision ESS. Treated patients (n = 57) underwent in-office implant placement. Control patients (n = 43) underwent a sham procedure. Endoscopic grading at 3 months by clinicians was corroborated by an independent review of randomized videoendoscopies by a panel of 3 sinus surgeons. Six-month follow-up included endoscopic grading and patient-reported outcomes.. At 6 months, treated patients experienced significant improvement in Nasal Obstruction Symptom Evaluation (NOSE) score (p = 0.021) and >2-fold improvement in mean nasal obstruction/congestion score (-1.06 ± 1.4 vs -0.44 ± 1.4; p = 0.124). Endoscopically, treated patients experienced significant reduction in ethmoid sinus obstruction (p < 0.001) and bilateral polyp grade (p = 0.018) compared to controls. Panel review confirmed a significant reduction in ethmoid sinus obstruction (p = 0.010) and 2-fold improvement in bilateral polyp grade (p = 0.099), which reached statistical significance (p = 0.049) in a subset of 67 patients with baseline polyp burden ≥2 bilaterally. At 6 months, control patients were at 3.6 times higher risk of remaining indicated for ESS than treated patients.. The symptomatic and endoscopic improvements observed confirm the efficacy of the steroid-eluting implant for in-office treatment of CRSwNP after ESS. These longer-term 6-month study results demonstrate that the steroid-eluting implant represents a durable, safe, and effective treatment strategy for this patient population. Topics: Absorbable Implants; Ambulatory Care; Anti-Inflammatory Agents; Chronic Disease; Endoscopy; Humans; Mometasone Furoate; Nasal Polyps; Paranasal Sinuses; Patient Reported Outcome Measures; Recurrence; Reoperation; Rhinitis; Sinusitis; Treatment Outcome | 2016 |
Does oxymetazoline increase the efficacy of nasal steroids in treating nasal polyposis?
Although nasal steroids are the mainstay treatments in nasal polyposis, up to one-half of patients do not respond and need surgical treatment. This study aimed to evaluate whether oxymetazoline administration produces any additive effect on nasal steroid therapy and whether rebound congestion develops after oxymetazoline treatment.. Sixty-eight patients with nasal polyposis were randomly assigned in a 1:1 ratio to receive either oxymetazoline plus mometasone furoate nasal spray (MFNS) or placebo plus MFNS, 2 sprays per nostril twice daily, with an interval of 5 minutes between each medication for 4 weeks. All the patients were then treated with MFNS, 2 sprays per nostril twice daily for 2 weeks. The nasal symptoms score, peak inspiratory flow index, nasal mucociliary clearance time (NMCCT), and total nasal polyps score were used to evaluate treatment outcomes. An intention-to-treat analysis was performed, and a worst case sensitivity analysis was applied to missing cases.. Thirty-four patients were allocated to the oxymetazoline-MFNS group, and 34 to the placebo-MFNS group. One patient in each group was lost to last-visit follow-up. At 4 weeks after beginning treatment, the oxymetazoline-MFNS group showed significantly greater improvement in blocked nose, hyposmia, peak flow, NMCCT, and total nasal polyps score than the placebo-MFNS group. During the nasal steroid phase, both groups showed continuing improvement in all outcome variables. However, the oxymetazoline-MFNS group still showed significantly greater improvement in blocked nose, hyposmia, NMCCT, and total nasal polyps score, but not peak flow, than the placebo-MFNS group at the end of the study.. The use of nasal steroids with oxymetazoline was more effective over 6 weeks than nasal steroids alone in improving blocked nose, hyposmia, nasal mucociliary clearance, and polyp size in treatment of nasal polyposis. There was no evidence of rebound congestion after 4 weeks of oxymetazoline treatment. Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Allergic Agents; Anti-Inflammatory Agents; Drug Synergism; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Oxymetazoline; Treatment Outcome; Young Adult | 2016 |
Efficacy of long-term low-dose macrolide therapy in preventing early recurrence of nasal polyps after endoscopic sinus surgery.
This study assessed efficacy of clarithromycin "long-term" macrolide therapy as an adjunct to maintenance therapy with nasal corticosteroids to prevent recurrence of nasal polyps (NP) after functional endoscopic sinus surgery (FESS).. A total of 66 patients with chronic rhinosinusitis and bilateral NP were randomized into 3 study arms, 22 patients in each arm. After FESS, patients in the first and second groups were treated with clarithromycin 250 mg/day for 12 and 24 weeks, respectively, whereas patients in the third group did not receive any clarithromycin. Patients in all 3 groups received maintenance therapy with mometasone furoate 400 μg/day. Patient assessment was conducted before the surgery and 6, 12, and 24 weeks after surgery, using a visual analogue scale (VAS), 20-item SinoNasal Outcome Test (SNOT-20), acoustic rhinometry, rhinomanometry, saccharin transit time, nasal endoscopy, computed tomography (CT) of paranasal sinuses, and measurement of the level of eosinophil cationic protein (ECP) in their nasal secretions.. The study confirmed efficacy of "long-term" macrolide therapy, resulting in significant improvement of all parameters except acoustic rhinometry and VAS in both clarithromycin groups as compared to the control. Concentration of ECP in the nasal secretions increased dramatically after surgery, then returned to baseline levels after 12 and 24 weeks of treatment with clarithromycin. In the control group, ECP level continued to increase and was significantly higher at the endpoint. Both groups with clarithromycin showed significantly better endoscopic and CT scores than the control group at the end point.. "Long-term" low-dose clarithromycin 250 mg/day is able to control eosinophilic inflammation and prevent early relapse of NP after FESS. Topics: Adrenal Cortex Hormones; Adult; Chemotherapy, Adjuvant; Chronic Disease; Clarithromycin; Endoscopy; Eosinophil Cationic Protein; Female; Follow-Up Studies; Humans; Male; Mometasone Furoate; Nasal Polyps; Paranasal Sinuses; Pregnadienediols; Recurrence; Rhinitis; Rhinomanometry; Sinusitis; Tomography, X-Ray Computed; Treatment Outcome | 2014 |
RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis.
Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. This study evaluated the safety and efficacy of a bioabsorbable steroid-eluting implant with 1350 μg of mometasone furoate for its ability to dilate obstructed ethmoid sinuses, reduce polyposis, and reestablish sinus patency.. This was a randomized, controlled, blinded study including 100 patients chronic rhinosinusitis with nasal polyposis (CRSwNP) refractory to medical therapy and considered candidates for revision ESS. Follow-up included endoscopic grading by investigators and patient-reported outcomes.. Treated patients (n = 53; age as mean ± standard deviation [SD] 47.8 ± 12.6 years; 55% male) underwent in-office bilateral placement. Control patients (n = 47; age 51.6 ± 13.1 years; 66% male) underwent a sham procedure. At 3 months, treated patients experienced a significant reduction in bilateral polyp grade (p = 0.0269) and ethmoid sinus obstruction (p = 0.0001) compared to controls. Treated patients also experienced a 2-fold improvement in the mean nasal obstruction/congestion score (-1.33 ± 1.47 vs -0.67 ± 1.45; p = 0.1365). This improvement reached statistical significance (p = 0.025) in patients with greater polyp burden (grade ≥2 bilaterally; n = 74). At 3 months, 53% of treated patients compared to only 23% of controls were no longer indicated for repeat ESS. There was no serious adverse event or clinically significant increases in intraocular pressure or cataract formation.. The symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in-office treatment of CRS patient with recurrent polyposis after ESS. The study results demonstrated that the steroid-eluting implant represents a safe and effective alternative to current management for this patient population. Topics: Absorbable Implants; Ambulatory Surgical Procedures; Anti-Inflammatory Agents; Chronic Disease; Drug Implants; Endoscopy; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Pregnadienediols; Prosthesis Design; Recurrence; Rhinitis; Sinusitis; Treatment Outcome | 2014 |
Efficacy and safety of erdosteine in the treatment of chronic rhinosinusitis with nasal polyposis - a pilot study.
Erdosteine was originally developed as a mucolytic agent. It is a multimechanism substance with anti-bacterial, anti-oxidant, and most importantly anti-inflammatory effects. Given similar mechanisms of action (suppression of cytokines, including tumor necrosis factor α), it could become a reasonable alternative to currently used treatments with macrolides or steroids.. To assess efficacy and safety of erdosteine in the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP).. A prospective non-interventional post-authorisation study comparing patients treated with erdosteine only or the combination of erdosteine and nasal corticosteroid spray for CRSwNP. The end-points were pre- and post-treatment changes in endoscopic score and subjective evaluation of CRSwNP related symptoms using a 22-item Sinonasal Outcome Test questionnaire. Patients underwent nasal endoscopy and filled the questionnaire before and after the treatment.. No patient experienced any adverse effect during the study. A comparison of pre- and post-treatment endoscopic findings and questionnaire values revealed significant reduction in both patient groups, with a significantly better response in the erdosteine only group.. Based on this pilot study, erdosteine seems effective in the treatment of CRSwNP and might become a reasonable alternative to currently used medication. The therapeutical role of erdosteine needs to be further assessed. Topics: Adult; Aged; Anti-Inflammatory Agents; Chronic Disease; Drug Therapy, Combination; Expectorants; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Pilot Projects; Pregnadienediols; Prospective Studies; Rhinitis; Sinusitis; Thioglycolates; Thiophenes; Treatment Outcome; Young Adult | 2013 |
Safety of mometasone furoate nasal spray in the treatment of nasal polyps in children.
Mometasone furoate nasal spray (MFNS) improves nasal symptoms and reduces polyp size in adults with nasal polyposis. This 4-month, multinational, randomized, double-blind study was conducted to assess the safety of MFNS in pediatric subjects aged 6-17 yr.. Subjects aged 6-11 yr with bilateral nasal polyps received MFNS 100 μg once or twice daily or placebo; those aged 12-17 yr received MFNS 200 μg once or twice daily or placebo. End-points included change in 24-h urinary free cortisol (primary), change in 24-h urinary free cortisol corrected for creatinine (key secondary), and adverse events. Efficacy parameters included polyp size, nasal symptoms, and investigator-evaluated therapeutic response, although the study was not powered for statistical analysis of efficacy.. Least squares baseline mean urinary free cortisol level (nmol/24 h) for both age groups combined (N = 127) was 49.5 in the MFNS once-daily group, 39.6 in the MFNS twice-daily group, and 49.8 in the placebo group. Change in 24-h urinary free cortisol did not significantly differ among MFNS- and placebo-treated subjects. Least squares mean 24-h urinary free cortisol levels corrected for creatinine also showed no significant differences among MFNS- and placebo-treated subjects. No safety issues emerged.. Results of this study confirm the safety profile of MFNS in pediatric patients with bilateral nasal polyps over 4 months, even at double the recommended pediatric dosage for allergic rhinitis. Topics: Administration, Intranasal; Adolescent; Anti-Inflammatory Agents; Child; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Pregnadienediols; Treatment Outcome | 2013 |
Multimodality topical therapy for refractory chronic rhinosinusitis: our experience in thirteen patients with and twelve patients without nasal polyps.
Topics: Administration, Topical; Adult; Anti-Bacterial Agents; Anti-Inflammatory Agents; Chronic Disease; Cohort Studies; Combined Modality Therapy; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Nebulizers and Vaporizers; Pregnadienediols; Rhinitis; Sinusitis | 2013 |
Comparison of montelukast and mometasone furoate in the prevention of recurrent nasal polyps.
The aim of our study was to compare the effects of montelukast and mometasone furoate nasal spray on the postoperative course of patients with nasal polyposis.. Fifty patients diagnosed with nasal polyposis between March 2006 and August 2007 were included in the study. All patients underwent bilateral endoscopic sphenoethmoidectomy and were randomized postoperatively into two groups. Group A (n = 25) received 10 mg montelukast per day and group B (n = 25) received 400 µg mometasone furoate nasal spray twice daily. All patients were followed up for 6 months. Sino-Nasal Outcome Test (SNOT)-22 scores, polyp grades, computerized tomography (CT) scores (Lund-Mackay), eosinophils in peripheral blood and polyp tissue were evaluated before and after surgery.. There was a significant reduction in SNOT-22 scores in both groups throughout the study period. There was a significant difference in the recurrence rate between both groups with a marginal advantage of mometasone furoate nasal spray. Eosinophils in peripheral blood were found to be effective on the recurrence rate (p < 0.05).. In conclusion, both drugs seem to have a complementary action and further studies are needed to determine which patients should receive which treatment. Topics: Acetates; Administration, Intranasal; Adult; Aged; Anti-Inflammatory Agents; Cyclopropanes; Endoscopy; Eosinophils; Ethmoid Sinus; Female; Follow-Up Studies; Humans; Leukotriene Antagonists; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Pregnadienediols; Prospective Studies; Quinolines; Secondary Prevention; Sphenoid Sinus; Sulfides; Tomography, X-Ray Computed; Treatment Outcome | 2012 |
Topical gel therapy for sinonasal polyposis in Samter's triad: preliminary report.
Rhinosinusitis and polyposis are difficult to treat in patients with Samter's triad; they commonly recur despite sinus surgery, antibiotics, and/or nasal steroids. The present study assesses the efficacy of a multimodal regimen that includes topical corticosteroids and antibiotics delivered through a hydroxyethyl cellulose gel and by nebulization.. Eleven patients with Samter's triad who had polyposis and rhinosinusitis that recurred despite endoscopic sinus surgery were treated with a 6-week course of multimodal topical therapy consisting of a hydroxyethyl cellulose gel that releases corticosteroids and antibiotics, topical nebulization of corticosteroids and antibiotics, saline solution rinses, and sinus debridement. Clinical outcomes were evaluated by Lund-Kennedy endoscopic and symptom scores. Histologic assessment was evaluated by hematoxylin and eosin staining before and after treatment.. Both Lund-Kennedy symptom and endoscopic scores showed.a progressive and statistically significant decline throughout the course of treatment, reaching at 6 weeks 42% of the pretreatment values (p = 0.005) for the Lund-Kennedy symptom score and 34% (p = 0.002) for the endoscopic score, respectively; however, the significance of the improvement was lost with time.. Topical gel therapy improves clinical symptoms, endoscopic findings, and sinus membrane histologic features in patients with refractory Samter's triad, but the improvement is transient, suggesting that a longer therapeutic period might be needed. Topics: Administration, Topical; Adult; Aged; Anti-Bacterial Agents; Anti-Inflammatory Agents; Aspirin; Asthma; Debridement; Drug Hypersensitivity; Endoscopy; Female; Gels; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Pregnadienediols; Rhinitis; Sinusitis; Syndrome; Treatment Outcome | 2012 |
Effect of antioxidants on the clinical outcome of patients with nasal polyposis.
To investigate the therapeutic effects of antioxidants on the clinical and biochemical outcome of patients with nasal polyposis.. Thirty-four patients with nasal polyposis were divided into two groups receiving either intranasal steroid or intranasal steroid plus per-oral vitamins A, C and E and selenium. Paranasal sinus computed tomography, endoscopy, and polyp tissue and serum sampling were conducted pre- and post-therapy. Serum levels of malondialdehyde, superoxide dismutase, nitrite and myeloperoxidase and tissue levels of malondialdehyde and superoxide dismutase were measured. Group results were compared using the Mann-Whitney U test and Wilcoxon signed-rank test.. Both groups had significantly lower tissue parameters, computed tomography scores and serum malondialdehyde levels, comparing pre- versus post-treatment results. Post-treatment, the steroid plus antioxidant group had significantly lower tissue malondialdehyde levels and a greater fall in tissue and serum malondialdehyde, compared with the steroid group.. Serum and tissue levels of malondialdehyde (an oxidative marker) were significantly decreased by adding antioxidants to standard therapy. This is the first report of the positive effects of adding antioxidants to steroid therapy for nasal polyposis. Topics: Adult; Aged; Anti-Inflammatory Agents; Antioxidants; Ascorbic Acid; Female; Free Radical Scavengers; Free Radicals; Humans; Male; Malondialdehyde; Middle Aged; Mometasone Furoate; Nasal Polyps; Nitrites; Oxidative Stress; Peroxidase; Pregnadienediols; Selenium; Superoxide Dismutase; Treatment Outcome; Vitamin A; Vitamin E; Young Adult | 2011 |
ADVANCE: a multisite trial of bioabsorbable steroid-eluting sinus implants.
Disease recurrence and adverse wound healing in the form of inflammation, polyposis, adhesions, and middle turbinate lateralization may induce suboptimal outcomes following sinus surgery. The study objective was to assess the safety and effectiveness of a bioabsorbable, steroid-eluting implant used following functional endoscopic sinus surgery in patients with chronic rhinosinusitis (CRS).. Prospective, multicenter, single-cohort trial enrolling 50 patients.. The study allowed bilateral or unilateral steroid-eluting implant placement. Oral and topical steroids were withheld for 60 days postoperatively. Endoscopic follow-up was performed to 60 days. Patient-reported outcomes (Sino-Nasal Outcome Test-22 Questionnaire, Rhinosinusitis Disability Index) were collected to 6 months. Efficacy was assessed by grading inflammation, polyp formation, adhesions, and middle turbinate position. Safety assessment included ocular exams at baseline and 30 days.. Implants were successfully placed in all 90 sinuses. Mean inflammation scores were minimal at all time points. At 1 month, the prevalence of polypoid edema was 10.0%, significant adhesions 1.1%, and middle turbinate lateralization 4.4%. Changes from baseline in patient-reported outcomes were statistically significant (P < .0001). No clinically significant changes from baseline in intraocular pressure occurred.. This consecutive case series provides clinical evidence of the safety, effectiveness, and clinical utility of a bioabsorbable steroid-eluting implant for use in CRS patients. The implant was associated with favorable rates of sinus patency. At 1 month, minimal degrees of inflammation and adhesions were observed, suggesting a positive clinical impact of local steroid delivery without evidence of ocular risk. Topics: Adult; Aged; Anti-Inflammatory Agents; Chronic Disease; Drug-Eluting Stents; Endoscopy; Ethmoid Sinusitis; Feasibility Studies; Female; Follow-Up Studies; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Patient Satisfaction; Postoperative Care; Postoperative Complications; Pregnadienediols; Rhinitis; Secondary Prevention; Sinusitis; Wound Healing; Young Adult | 2011 |
Preoperative treatment with topical corticoids and bleeding during primary endoscopic sinus surgery.
To find out whether the constant preoperative use of a topical corticoid (mometasone furoate [MF]) could really improve the operative field quality and decrease bleeding during endoscopic sinus surgery (ESS).. Double-blind, randomized controlled trial.. Tertiary referral center.. Seventy patients with chronic rhinosinusitis (CRS) with and without polyps underwent ESS under standardized general anesthesia with equal randomization into two groups. During four weeks within the preoperative period, 35 cases were treated with MF, while the other half received placebo matching sprays. Total blood loss, operation time, and surgical field quality were recorded.. Intraoperative blood loss in the MF-treated group was 142.8 mL, less than in the control group (170.6 mL). The difference between the groups is 27.7 mL (95% confidence interval [CI] 3.5-51.92), statistically significant: P = 0.025. Time of surgery was 59 minutes in the MF group and 70 minutes in the control group. The difference was 11.2 minutes (95% CI 2.82-19.51), which is statistically significant: P = 0.009. The quality of the endoscopic surgical field was significantly better for patients treated with MF. Treatment with topical corticoid enables significantly reduced bleeding, decreased operation time, and improved endoscopic vision during ESS for CRS.. The use of topical corticoid (MF) in the preoperative period can improve endoscopic vision, reduce bleeding, and decrease operation time in CRS patients with and without polyps undergoing ESS, but our sample size cannot exclude small, and possibly trivial, group differences. Topics: Administration, Intranasal; Administration, Rectal; Adult; Anti-Inflammatory Agents; Blood Loss, Surgical; Chronic Disease; Double-Blind Method; Endoscopy; Female; Glucocorticoids; Humans; Male; Mometasone Furoate; Nasal Polyps; Paranasal Sinuses; Pregnadienediols; Preoperative Care; Rhinitis; Sinusitis | 2010 |
Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery.
To evaluate the effect of mometasone furoate on prevention or reduction of nasal polyp relapse and worsening of symptoms after functional endoscopic sinus surgery (FESS).. Randomized, double-blind, placebo-controlled, multicenter study.. Ten ear, nose, and throat clinics in Sweden.. Adult subjects with bilateral nasal polyps fulfilling the criteria for surgery who underwent FESS.. Two weeks after FESS, subjects were randomized to receive mometasone furoate nasal spray, 200 microg once daily, or placebo.. Time to relapse, defined as an increase of 1 point or more on a 0- to 6-point endoscopic polyp scale.. In the per-protocol population (n = 104), median time to relapse was 173 and 61 days for the mometasone and placebo groups, respectively (P = .007; hazard ratio [95% confidence interval], 0.72 [0.55-0.93]). In the intent-to-treat population (n = 159), median time to relapse was greater than 175 days in the mometasone group and 125 days in the placebo group (P = .049; hazard ratio, 0.79 [0.62-0.99]). The most common adverse event was epistaxis, with 6 cases reported in the mometasone group and 3 in the placebo group.. Postoperative use of mometasone furoate, 200 microg once daily, provided a statistically significant longer time to relapse of nasal polyps than did placebo in subjects with bilateral nasal polyposis who had undergone FESS. The ability of mometasone to prevent or prolong the time to relapse among subjects undergoing FESS is important because this may prolong the time to subsequent surgery.. clinicaltrials.gov Identifier: NCT00731185. Topics: Administration, Intranasal; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Dose-Response Relationship, Drug; Double-Blind Method; Endoscopy; Female; Follow-Up Studies; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Paranasal Sinus Diseases; Postoperative Complications; Pregnadienediols; Secondary Prevention; Treatment Outcome; Young Adult | 2009 |
Effect of corticosteroids on wound healing after endoscopic sinus surgery.
Approximately 20% patients with chronic rhinosinusitis undergoing Functional Endoscopic Sinus Surgery (FESS) experience impaired wound healing, leading to recurrences of sinusitis and polyps.. We investigated the efficacy of oral+ local steroids in wound healing, following FESS in subjects with a chronic rhinosinusitis with/without nasal polyps. Ninety-nine subjects were randomised to receive 6 months' treatment with mometasone furoate nasal spray (MFNS) 200 microg bid or placebo in double-blind manner approximately 2 weeks after FESS. Postoperative mean total score for several endoscopic parameters scores assessed at 6 months was calculated as the primary efficacy end-point. An endoscopic combination score (for inflammation, oedema, and polyps), a total symptoms score, and percent subjects requiring rescue medication, were assessed as secondary end-points.. MFNS led to greater, although not significant, reductions in total endoscopic scores in all subjects, compared with placebo. The combination scores, however, indicated significantly improved healing with MFNS than with placebo for all subjects (median scores: 0.0 vs 2.0, p = 0.02), and particularly for subjects with nasal polyps (median scores: 2.0 vs 4.0, p = 0.03). The total symptom scores and percent subjects requiring rescue medication were similar in the two groups. MFNS was well tolerated.. These results suggest that treatment with MFNS following sinus surgery may improve wound healing, particularly in subjects with nasal polyps. Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Chronic Disease; Double-Blind Method; Endoscopy; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Pilot Projects; Pregnadienediols; Prospective Studies; Rhinitis; Sinusitis; Wound Healing; Young Adult | 2009 |
Onset of symptomatic effect of mometasone furoate nasal spray in the treatment of nasal polyposis.
The efficacy of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) for treatment of nasal polyposis was demonstrated in 2 large clinical trials.. To evaluate the onset of MFNS symptomatic effect, data from the 2 trials were pooled and analyzed to determine the first day subjects experienced significant symptom relief.. Subjects with nasal polyposis randomized to MFNS 200 microg twice daily or placebo scored symptoms on a 3-point scale (0 = none; 3 = severe) and measured peak nasal inspiratory flow immediately before the morning dose. Onset of symptomatic effect was defined as the first day a statistically significant (P < .05) lasting response was observed for MFNS compared with placebo.. A total of 447 subjects with bilateral nasal polyps and clinically significant nasal congestion/obstruction were analyzed. Compared with placebo, MFNS 200 microg twice daily demonstrated statistically significant (P < .05) relief of anterior rhinorrhea by day 2 (-10.9% vs +5.7%), nasal congestion by day 3 (-15.1% vs -7.6%), postnasal drip by day 5 (+1.1% vs +4.6%), and sense of smell by day 13 (-9.6% vs -5.6%). Significant improvement in peak nasal inspiratory flow was seen by day 2 (increase of 6.22 L/min vs 1.48 L/min for placebo; P = .03).. Mometasone furoate nasal spray 200 microg twice daily rapidly improves the symptoms of nasal polyposis, leading to lasting relief of most major symptoms within 2 (24 hours after the first dose) to 5 days of initiating therapy. Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Allergic Agents; Asthma; Double-Blind Method; Female; Humans; Inspiratory Capacity; Male; Middle Aged; Mometasone Furoate; Nasal Decongestants; Nasal Polyps; Pregnadienediols; Rhinitis, Allergic, Perennial; Smell | 2008 |
A randomized controlled trial of mometasone furoate nasal spray for the treatment of nasal polyposis.
To evaluate the efficacy and safety of mometasone furoate nasal spray (NS) for the treatment of nasal polyposis.. Randomized, double-blind, placebo-controlled, parallel-group, multicenter study.. A total of 24 centers in 17 countries.. A total of 310 subjects 18 years or older with bilateral nasal polyps.. (1) A 200-microg dose of mometasone furoate NS in the morning and matching placebo in the evening; (2) 200-microg doses of mometasone furoate NS in the morning and evening; or (3) matching placebo in the morning and evening. All 3 regimens were administered as a nasal spray for 4 months.. Primary end points were change from baseline to last assessment in physician-assessed bilateral polyp grade and change from baseline in subject-assessed congestion and/or obstruction score averaged over the first month of treatment. Analysis of variance was used for all efficacy end points except for change in bilateral polyp grade, for which baseline polyp grade was added as a covariate to the analysis of variance model to account for any between-group baseline differences in this variable.. Mometasone furoate NS doses of 200 microg administered once or twice daily produced greater reductions in bilateral polyp grade at the end point than placebo, with differences reaching statistical significance with twice-daily dosing (P = .04). Over 1 month, both mometasone furoate NS regimens produced statistically superior improvements from baseline in congestion and/or obstruction score vs placebo (P = .01 for once-daily dosing; P<.001 for twice-daily dosing). The drug was well tolerated.. Mometasone furoate NS is an effective and well-tolerated treatment for bilateral nasal polyposis in adults, reducing nasal polyp size and symptoms of nasal congestion and/or obstruction. Topics: Administration, Intranasal; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Pregnadienediols; Retrospective Studies; Treatment Outcome | 2006 |
The efficacy and safety of once-daily mometasone furoate nasal spray in nasal polyposis: a randomized, double-blind, placebo-controlled study.
In subjects with mild-to-moderate nasal polyposis, treatment with mometasone furoate nasal spray (MFNS) 200 microg once daily (QD) significantly decreases nasal congestion, reduces polyp size, and improves quality of life.. To evaluate the efficacy and safety of MFNS, administered QD in the morning, in subjects with mild-to-moderate nasal polyposis.. This randomized, double-blind, double-dummy, placebo-controlled clinical trial enrolled subjects with mild-to-moderate nasal polyposis at 12 centers in Denmark, Finland, Norway, and Sweden. Inclusion criteria were: age > or = 18 years, a diagnosis of bilateral nasal polyps, and clinically significant nasal congestion. Following a 2-4-week run-in period, subjects were randomized to receive MFNS 200 microg QD or matching placebo for 16 weeks.. A total of 298 subjects were randomized to treatment. Of those subjects included in the intent-to-treat efficacy analysis (n = 291), a statistically greater proportion of the MFNS group than the placebo group had improvements in investigator-assessed nasal congestion score between baseline and end point (the primary outcome) (74.3% vs 46.8%; p < 0.001). Significant benefits of MFNS were also seen for secondary end points, including polyp size, sense of smell, peak nasal inspiratory flow, therapeutic improvement, and quality-of-life measures. MFNS was well tolerated, with no unusual or unexpected adverse events. Topics: Administration, Intranasal; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Obstruction; Nasal Polyps; Pregnadienediols; Quality of Life; Treatment Outcome | 2006 |
Efficacy and safety of mometasone furoate nasal spray in nasal polyposis.
Studies have suggested that topical corticosteroids are effective in the treatment of nasal polyps; however, this has yet to be confirmed in a large, robust clinical trial.. To evaluate the efficacy and safety of mometasone furoate nasal spray (MFNS) for nasal polyposis.. A total of 354 subjects with bilateral nasal polyps and clinically significant congestion/obstruction participated in this multinational, randomized, double-blind, placebo-controlled study. Subjects received MFNS 200 microg once or twice daily or placebo for 4 months. Coprimary endpoints were (1) change from baseline to last assessment in physician-evaluated bilateral polyp grade score and (2) change from baseline averaged over month 1 in subject-assessed nasal congestion/obstruction. ANOVA was used for all efficacy endpoints, except for change in bilateral polyp grade score, for which baseline polyp grade was added as a covariate.. Compared with placebo, MFNS 200 microg administered once or twice daily produced significantly greater reductions in bilateral polyp grade score (P < .001, P = .010, respectively) and congestion/obstruction (P = .001, P < .001), as well as improvement in loss of smell (P < .001, P = .036), anterior rhinorrhea (P < .001 for both), and postnasal drip (P < .001, P = .001) over month 1. MFNS 200 microg twice daily was superior to MFNS 200 microg once daily in reducing congestion/obstruction (P = .039), and there were more improvers in the MFNS 200 microg twice daily group (P = .035). MFNS was well tolerated in both groups.. MFNS 200 mug, once or twice daily, was safe and significantly superior to placebo in reducing polyp grade (size and extent) and improving congestion/obstruction and return of sense of smell. MFNS is an effective medical treatment for nasal polyposis and may reduce or delay the need for surgery. Topics: Administration, Intranasal; Adolescent; Adult; Aged; Aged, 80 and over; Double-Blind Method; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Pregnadienediols | 2005 |
Treatment of recurrent chronic hyperplastic sinusitis with nasal polyposis.
To demonstrate the long-term efficacy of intranasal furosemide, an inhibitor of the sodium chloride cotransporter channel at the basolateral surface of the respiratory epithelial cell, vs no therapeutic intervention vs intranasal mometasone furoate, a corticosteroid, in preventing relapses of chronic hyperplastic sinusitis with nasal polyposis.. Randomized prospective controlled study. Patients were examined every 6 months during follow-up (range, 1-9 years).. One hundred seventy patients with bilateral obstructive or minimally obstructive chronic hyperplastic sinusitis with nasal polyposis.. All patients were surgically treated in the ENT Department, University of Siena Medical School. One month after surgery, group 1 patients (n = 97) started treatment with intranasal furosemide, group 2 (n = 40) received no therapeutic treatment, and group 3 (n = 33) were treated with mometasone.. Clinical and instrumental evaluation of postoperative outcomes.. Seventeen (17.5%) of 97 patients in group 1, 12 (30.0%) of 40 patients in group 2, and 8 (24.2%) of 33 patients in group 3 experienced nasal polyposis relapses. We noted a prevalence of early-stage relapse in patients treated with furosemide or mometasone, whereas patients who did not receive any treatment experienced more severe grades of chronic hyperplastic sinusitis with nasal polyposis (P<.005).. Use of intranasal furosemide represents a valid therapeutic treatment in the prevention of chronic hyperplastic sinusitis with nasal polyposis. Topics: Administration, Intranasal; Adult; Anti-Inflammatory Agents; Chronic Disease; Diuretics; Female; Furosemide; Humans; Hyperplasia; Male; Middle Aged; Mometasone Furoate; Nasal Obstruction; Nasal Polyps; Paranasal Sinuses; Pregnadienediols; Prospective Studies; Secondary Prevention; Sinusitis; Sodium Chloride Symporters; Symporters; Treatment Outcome | 2003 |
[Nasonex effectiveness in allergic rhinitis and chronic polypous rhinosinusitis].
Topics: Adolescent; Adult; Anti-Inflammatory Agents; Child; Child, Preschool; Chronic Disease; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Treatment Outcome | 2000 |
20 other study(ies) available for mometasone-furoate and Nasal-Polyps
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Murine model for chronic rhinosinusitis: an interventional study.
Chronic rhinosinusitis (CRS) is a complex inflammatory disease of the sinonasal tract. To understand this disease entity and develop targeted treatments, a reproducible animal model is paramount.. To optimize a murine model of eosinophilic CRS by establishing benchmark histological markers and validate its fidelity in evaluating intranasal treatments.. Forty-five Balb/c mice were included in the 7-week protocol. Experimental animals (n = 20) were induced a CRS disease state upon receiving intraperitoneal sensitization with ovalbumin (OVA), followed by intranasal OVA with Aspergillus oryzae protease. Analysis of complete blood count with differential, peripheral blood smear, and histological markers from the nasal cavity mucosa were performed. CRS mice were additionally treated with intranasal saline (n = 5) or mometasone (n = 10) and compared with control groups of untreated CRS (n = 5) and healthy (n = 5) mice after week 7.. Histological analysis of experimental animal nasal mucosa revealed significantly higher levels of eosinophilic tissue infiltration/degranulation, hyaline droplets, Charcot-Leyden crystals, and respiratory epithelial thickness compared to healthy controls. Treatment with mometasone significantly reversed the histopathological changes observed in CRS mice.. This murine model induced substantial local eosinophilic inflammation within sinonasal mucosa, that was reversible with mometasone. This model may be used to evaluate the efficacy of therapeutics designed to target CRS. Topics: Animals; Chronic Disease; Disease Models, Animal; Eosinophilia; Mice; Mometasone Furoate; Nasal Mucosa; Nasal Polyps; Rhinitis; Sinusitis | 2023 |
Use of intraoperative frontal sinus mometasone-eluting stents decreased interleukin 5 and interleukin 13 in patients with chronic rhinosinusitis with nasal polyps.
Mometasone-eluting stents (MES) have demonstrated improvement in short-term endoscopic outcomes and reduce short- to medium-term rescue interventions. Their effect on the local inflammatory environment, longer-term patient-reported outcomes, and radiographic severity have not been studied.. Middle meatal mucus and validated measures of disease severity were collected before and 6 to 12 months after endoscopic surgery in 52 patients with chronic rhinosinusitis with nasal polyps (CRSwNPs). Operative findings, type 2 mediator concentrations, intraoperative variables, and disease severity measures were compared between those who did and those who did not receive intraoperative frontal MES.. A total of 52 patients with CRSwNPs were studied; 33 received frontal MES and were compared with 19 who did not. Pre-endoscopic sinus surgery (ESS) middle meatus (MM) interleukin (IL) 13 and eosinophil cationic protein (ECP) were higher in the stented group (p < 0.05), but pre-ESS clinical measures of disease severity were similar as were surgical extent and post-ESS medical management. Intraoperative eosinophilic mucin was more frequent in the stented group (58% vs 11%, p = 0.001). IL-5 (p < 0.05) and IL-13 (p < 0.001) decreased post-ESS in the stented group, but this was not observed in the nonstented group. Post-ESS IL-4 and IL-13 were higher in the nonstented vs stented group (p < 0.05 for both).. Although patients who received intraoperative frontal MES had significantly higher pre-ESS MM IL-13 and ECP, patients who received frontal MES had lower concentrations of IL-4 and IL-13 than those who did not at a median of 8 months post-ESS. However, these changes did not correspond to significantly different measures of symptomatic or radiographic disease severity. Topics: Chronic Disease; Drug-Eluting Stents; Endoscopy; Frontal Sinus; Humans; Interleukin-13; Interleukin-4; Interleukin-5; Mometasone Furoate; Nasal Polyps; Rhinitis; Sinusitis | 2022 |
P-glycoprotein inhibition with verapamil overcomes mometasone resistance in Chronic Sinusitis with Nasal Polyps.
P-glycoprotein (P-gp) is a membrane efflux pump which is overexpressed in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and promotes Type 2 inflammation. Glucocorticoids (GC) are substrates of P-gp suggesting that overexpression may additionally contribute to GC resistance in CRSwNP. This study aims to determine whether P-gp inhibition using verapamil enhances mometasone retention and efficacy in nasal polyp explants.. IRB approved study in which organotypic polyp explants were exposed to mometasone (4.15 μg/mL) and verapa- mil (125 μg/mL) as mono and combination therapy. The effect of verapamil on mometasone tissue retention over time was deter- mined using HPLC. The effect of verapamil on mometasone anti-inflammatory function was determined using ELISA for secreted IL-5. Groups were compared using Kruskal-Wallis test.. P-gp expression strongly and significantly inversely correlated with mometasone retention 1hr after exposure, with a ne- arly 6-fold reduction in tissue retention between the lowest and highest P-gp expressing polyp explants. P-gp inhibition reversed this effect and significantly improved mometasone retention at 1hr relative to mometasone alone. The combination of mome- tasone and verapamil significantly reduced IL-5 secretion relative to vehicle control and outperformed either treatment alone.. Our study confirms that P-gp contributes to mometasone resistance. This P-gp mediated resistance was successfully reversed by addition of the P-gp inhibitor verapamil. Verapamil further significantly enhanced the anti-inflammatory effect of mometasone when given as a combination therapy. Topics: ATP Binding Cassette Transporter, Subfamily B; ATP Binding Cassette Transporter, Subfamily B, Member 1; Chronic Disease; Humans; Mometasone Furoate; Nasal Polyps; Rhinitis; Sinusitis; Verapamil | 2021 |
In-office Placement of Mometasone Furoate Sinus Implants for Recurrent Nasal Polyps: A Pooled Analysis.
Topics: Absorbable Implants; Adult; Ambulatory Surgical Procedures; Anti-Inflammatory Agents; Chronic Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Paranasal Sinuses; Prosthesis Implantation; Randomized Controlled Trials as Topic; Recurrence; Rhinitis; Sinusitis; Treatment Outcome | 2019 |
Antibiofilm effects of topical corticosteroids and intranasal saline in patients with chronic rhinosinusitis with nasal polyps depend on bacterial species and their biofilm-forming capacity.
Microbial biofilms have been implicated in the pathogenesis of chronic rhinosinusitis with nasal polyposis (CRSwNP). Intranasal application of corticosteroids and saline is a reliable option for their management. The aim of our study was to evaluate in vitro antibiofilm effects of corticosteroids and isotonic and hypertonic nasal saline in CRSwNP patients. The sinus mucosal specimens were harvested from the ethmoid cavity of 48 patients with CRSwNP and further subjected to hematoxylin-eosin staining and microbiology analysis. The biofilm-forming capacity of isolated bacterial strains was detected by microtiter-plate method and the effects of therapeutic doses of mometasone, fluticasone, isotonic and hypertonic saline on biofilm production were investigated. Bacterial strains were isolated in 42 (87.5%) patients: one organism in 34 (80.9%) and two organisms in 8 (19.1%). Staphylococcus epidermidis (34%) and Staphylococcus aureus (28%) were the most prevalent bacteria in biofilms of CRSwNP patients. Corticosteroids and saline solutions significantly reduced biofilm formation (p < 0.01 and p < 0.05, respectively) with better efficacy of fluticasone and isotonic nasal saline. Treatment with fluticasone, mometasone, isotonic and hypertonic nasal saline completely prevented biofilm production in 66, 50, 84 and 38% of bacterial strains, respectively. The most significant density reduction was observed in biofilm formed by Staphylococcus aureus, Pseudomonas aeruginosa and Streptococcus pneumoniae compared to other bacterial species (p < 0.01, p < 0.05, p < 0.05, respectively). The antibiofilm effects of corticosteroids and saline solutions also greatly depended on bacterial biomass (p < 0.05), with the most significant effect on high compared to small amount of formed biofilm. The topical steroids and nasal saline are shown to be potent antibiofilm agents in patients with CRSwNP. The effects of tested compounds depend on bacterial species and volume of formed biofilm. Topics: Administration, Intranasal; Adrenal Cortex Hormones; Adult; Aged; Biofilms; Chronic Disease; Drug Therapy, Combination; Female; Fluticasone; Humans; In Vitro Techniques; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Prospective Studies; Pseudomonas aeruginosa; Rhinitis; Sinusitis; Sodium Chloride; Staphylococcus aureus; Staphylococcus epidermidis; Streptococcus pneumoniae | 2017 |
Subcutaneous Dupilumab and Mometasone Furoate Nasal Spray for Chronic Rhinosinusitis With Polyps.
Topics: Anti-Inflammatory Agents; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Chronic Disease; Humans; Injections, Subcutaneous; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Rhinitis; Sinusitis | 2016 |
Effect of sodium hyaluronate added to topical corticosteroids in chronic rhinosinusitis with nasal polyposis.
Available medical treatments for chronic rhinosinusitis (CRS) with nasal polyposis (CRSwNP) comprise systemic and topical therapies. Although topical corticosteroids are effective in the treatment of CRS, they are not completely devoid of adverse effects. Thus, care has to be taken when long-term treatments are prescribed. There is recent evidence that sodium hyaluronate (SH), the major component of many extracellular matrices, promotes tissue healing, including activation and moderation of the inflammatory responses, cell proliferation, migration, and angiogenesis.. The aim of the study was to evaluate clinical outcomes and quality of life in two groups of patients with CRSwNP treated with topical corticosteroids alone or in combination with 9 mg of high-molecular-weight SH.. The impact of treatments was determined by using nasal endoscopy and validated quality of life questionnaires (Short Form-36, 22-item Sino-Nasal Outcome Test, visual analog scale [VAS]). Eighty subjects who had CRS with grade IV nasal polyposis: 40 diagnosed with allergic rhinitis (AR) and 40 with non-allergic-eosinophilic rhinitis (NARES) based on skin-prick test and nasal cytology results, were divided in two groups. Group I comprised 40 subjects (20 AR and 20 NARES), who received mometasone furoate plus SH; group II comprised 40 subjects (20 AR and 20 NARES), who received mometasone furoate plus saline solution alone. All the patients were followed up for 3 months.. At baseline, no statistically significant differences were observed between the groups and the VAS score showed a moderate-to-severe degree of disease. After treatments, Lund and Kennedy, Short Form-36, 22-item Sino-Nasal Outcome Test, and VAS scores were statistically significant in both groups but slightly in favor of the group I and in the subjects with allergic CRSwNP.. Analysis of our data indicated that an SH supplement to standard corticosteroid seems to play an important role in improving the severity of symptoms, the endoscopic appearance, and discomfort associated with CRSwNP. This effect seems to be strongest in patients with allergic CRSwNP. Topics: Administration, Topical; Adrenal Cortex Hormones; Adult; Chronic Disease; Endoscopy; Female; Humans; Hyaluronic Acid; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Quality of Life; Rhinitis; Sinusitis; Surveys and Questionnaires; Visual Analog Scale; Wound Healing | 2016 |
Effects of intranasal steroid treatment on the presence of biofilms in non-allergic patients with chronic rhinosinusitis with nasal polyposis.
Microbial biofilms have been implicated in the pathogenesis of chronic rhinosinusitis with nasal polyposis (CRSwNP). Intranasal application of corticosteroids (INCS) is a reliable option in the management of CRSwNP. INCS medication has been suspected to influence the presence and thickness of microbial biofilms and inflammatory cell patterns in CRSwNP. Two series of identical nasal polyps obtained from non-allergic patients with CRSwNP (n = 56), who underwent endoscopic sinus surgery (ESS), were processed to hematoxylin-eosin (H.E.) and Gram staining, respectively. Patients were recruited into three groups. Group A (n = 21) consisted of patients with continuous preoperative INCS treatment. In group B (n = 17), patients were never treated by INCS, while in group C (n = 18) INCS medication was stopped at least 6 months before ESS. Biofilm positivity varied from 76.4 to 88.8% in different subject groups. These values and average thickness of biofilms did not reach statistically significant levels (Mann-Whitney's U probe, p > 0.05) in different patient groups. In contrast, microscopic pattern and numbers of predominant inflammatory cell populations displayed obvious differences according to INCS treatment (Mann-Whitney's U probe, p < 0.001). According to these observations, INCS treatment does not affect the presence and thickness of microbial biofilms in CRSwNP. In contrast, it has significant effects on the pattern of inflammatory cells infiltrating the subepithelial layer, which might result in beneficially altered extracellular matrix production and cytokine release. Topics: Administration, Intranasal; Adrenal Cortex Hormones; Adult; Aged; Biofilms; Case-Control Studies; Chronic Disease; Cytokines; Endoscopy; Eosinophils; Extracellular Matrix; Female; Gram-Positive Cocci; Humans; Image Interpretation, Computer-Assisted; Leukocyte Count; Male; Middle Aged; Mometasone Furoate; Nasal Mucosa; Nasal Polyps; Neutrophils; Pregnadienediols; Rhinitis; Sinusitis; Tomography, X-Ray Computed | 2014 |
Steroid-eluting sinus implant for in-office treatment of recurrent polyposis: a pharmacokinetic study.
Long-term use of systemic glucocorticoid therapy has been associated with hypothalamic-pituitary-adrenal axis suppression and other systemic adverse events. This pharmacokinetic study evaluated the systemic safety and performance of a bioabsorbable sinus implant that gradually releases 1350 μg of mometasone furoate directly to the sinus mucosa.. A prospective, single-center study treating 5 adult patients with recurrent polyposis after bilateral total ethmoidectomy. Each patient received 2 steroid-releasing implants in-office under local/topical anesthesia. Plasma concentrations of mometasone furoate and cortisol were determined before placement and through 30-day follow-up, which also included endoscopic grading and patient-reported outcomes.. Five patients (mean age 46.2 ± 9.2 standard deviation [SD] years; 60% male) underwent successful placement in all 10 ethmoid sinuses. There were no serious adverse events. The plasma concentrations of mometasone furoate were generally below the lower limit of quantification (LLOQ) of the assay (30 pg/mL). Cortisol concentrations at follow-up ranged from 3.9 to 5.7 mg/dL compared to 4.7 mg/dL at baseline. At 1 month, there was a significant improvement in bilateral polyp grade (p = 0.037), nasal obstruction score (p = 0.002), and 22-item Sino-Nasal Outcome Test (SNOT-22) (p = 0.010) compared to baseline.. The reported 100% placement success, negligible systemic exposure to mometasone furoate released over time, lack of adrenal suppression, and the absence of serious adverse events suggest that the implant provides a valid and safe option for the in-office treatment of recurrent polyposis. Randomized, controlled, blinded clinical studies are underway to provide further evidence of safety and efficacy. Topics: Absorbable Implants; Adult; Anti-Inflammatory Agents; Biological Availability; Chromatography, High Pressure Liquid; Drug Implants; Enzyme-Linked Immunosorbent Assay; Female; Humans; Hydrocortisone; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Paranasal Sinuses; Pregnadienediols; Prospective Studies; Tandem Mass Spectrometry; Treatment Outcome | 2014 |
Down-regulation of EMP1 is associated with epithelial hyperplasia and metaplasia in nasal polyps.
The aim of this study was to assess protein and mRNA expression of epithelial membrane protein 1 (EMP1) in the nasal mucosa of patients with nasal polyps (NP), and to determine what changes occur in response to glucocorticosteroid (GC) treatment.. NP tissue was obtained from 55 patients, 18 of whom were treated with nasal GCs (i.e. these 18 patients had NP biopsies taken before and after treatment). Biopsies of inferior turbinate mucosa from 30 healthy subjects were used as controls. Quantitative PCR and immunohistochemistry were performed to determine the expression levels of EMP1. EMP1 mRNA expression was significantly lower (2.77-fold) in tissues from NP patients before GC treatment when compared to controls, but was increased in these patients after GC treatment. EMP1 staining in nasal epithelium co-localized with both basal (p63(+)) and differentiated (CK18(+)) epithelial cells. Their immunoreactivity was significantly greater in controls than NP patients. EMP1 mRNA levels were lower in the epithelium with severe hyperplasia (1.79-fold) or with metaplasia (1.85-fold) as compared to those with mild to moderate hyperplasia or non-metaplastic epithelium, respectively. Positive correlations between EMP1 and other epithelial cell-related gene (e.g. JUN, PTGS2, AREG etc.) mRNAs were observed.. EMP1 could be a biomarker for aberrant epithelial remodelling and metaplasia in chronic inflammatory upper airway mucosa (e.g. NP). Topics: Adult; Anti-Inflammatory Agents; Down-Regulation; Epithelium; Female; Humans; Hyperplasia; Male; Metaplasia; Middle Aged; Mometasone Furoate; Nasal Mucosa; Nasal Polyps; Neoplasm Proteins; Pregnadienediols; Receptors, Cell Surface | 2013 |
Mometasone and desloratadine additive effect on eosinophil survival and cytokine secretion from epithelial cells.
Although antihistamines and topical corticosteroids are used in combination to treat allergic rhinitis, their additive effect has not been yet demonstrated. The aim was investigate the antiinflammatory additive effect of mometasone and desloratadine on cytokine and sICAM-1 secretion by epithelial cells, and on eosinophil survival stimulated by human epithelial cells secretions from nasal mucosa and polyps.. Epithelial cells obtained from nasal mucosa or polyps were stimulated with 10% fetal bovine serum in presence of mometasone (10(-11) M-10(-5) M) with/without desloratadine (10(-5) M). Cytokine and sICAM-1 concentrations in supernatants were measured by ELISA. Peripheral blood eosinophils were incubated during 4 days with epithelial cell secretions with (10(-11) M-10(-5) M) and/or desloratadine (10(-5) M) and survival assessed by Trypan blue. Results are expressed as percentage (mean ± SEM) compared to control.. Fetal bovine serum stimulated IL-6, IL-8, GM-CSF and sICAM-1 secretion. In mucosa and polyp epithelial cells, mometasone inhibited this induced secretion while desloratadine inhibited IL-6 and IL-8. The combination of 10(-5) M desloratadine and 10(-9) M mometasone reduced IL-6 secretion (48 ± 11%, p < 0.05) greater extent than mometasone alone (68 ± 10%) compared to control (100%). Epithelial cell secretions induced eosinophil survival from day 1 to 4, this effect being inhibited by mometasone. At day 4, the combination of mometasone (10(-11) M) and desloratadine (10(-5) M) provoked an increased inhibition of eosinophil survival induced by cell secretions (27 ± 5%, p < 0.01) than mometasone (44 ± 7%) or desloratadine (46 ± 7%) alone.. These results suggest that the combination of desloratadine and mometasone furoate have a greater antinflammatory effect in an in vitro model of eosinophil inflammation than those drugs administered alone. Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Cell Survival; Cells, Cultured; Cytokines; Dose-Response Relationship, Drug; Eosinophils; Epithelial Cells; Female; Granulocyte-Macrophage Colony-Stimulating Factor; Humans; Intercellular Adhesion Molecule-1; Interleukin-6; Interleukin-8; Loratadine; Male; Middle Aged; Mometasone Furoate; Nasal Mucosa; Nasal Polyps; Paracrine Communication; Pregnadienediols; Time Factors | 2011 |
Foxp3+ T regulatory cells (Tregs) are increased in nasal polyps (NP) after treatment with intranasal steroid.
The pathogenesis of chronic rhinosinusitis (CRS) with nasal polyps(NP) is still poorly understood. To evaluate the role of Foxp3+ T regulatory cells (Tregs) in the pathogenesis and management of NP, we investigated the location and expression of Foxp3 in NP before and after treatment with intranasal steroid. NP specimens were obtained from 14 patients with NP before and after intranasal administration of mometasone (50 microg/day for 4 weeks). Foxp3 was detected by double immunofluorescence stain, quantitative reverse transcriptase polymerase chain reaction (RT-PCR), flow cytometry and western blot. The concentration of interleukin(IL)-10 in supernatants of homogenized tissue was measured by enzyme-linked immunosorbent assay (ELISA). We found that Foxp3 and IL-10 were downregulated in NP compared to the control mucosa (P<0.05). Foxp3 and IL-10 expression were increased significantly after intranasal steroid treatment (P<0.05). And Foxp3 was tightly correlated with IL-10 in NP (P<0.05) after treatment. These data suggest that Foxp3 is downregulated in NP and intranasal steroid attenuates the chronic inflammatory response by enhancing the expression and function of Foxp3 in NP. Topics: Administration, Intranasal; Adult; Blotting, Western; Enzyme-Linked Immunosorbent Assay; Female; Flow Cytometry; Fluorescent Antibody Technique, Direct; Forkhead Transcription Factors; Glucocorticoids; Humans; Interleukin-10; Male; Middle Aged; Mometasone Furoate; Nasal Mucosa; Nasal Polyps; Pregnadienediols; Reverse Transcriptase Polymerase Chain Reaction; RNA, Messenger; T-Lymphocytes, Regulatory; Young Adult | 2008 |
Nitric oxide evaluation in upper and lower respiratory tracts in nasal polyposis.
A decrease in nasal nitric oxide (NO) and an increase in exhaled NO have been demonstrated in patients with nasal polyposis (NP).. The aims were to evaluate the flux of NO from the three compartments of the respiratory tract, namely, upper nasal, lower conducting and distal airways, and to search for relationships between NO parameters and indexes of upper and lower disease activity (bronchial reactivity and obstruction). The effect of medical treatment of polyposis was also evaluated.. Seventy patients with polyposis were recruited. At baseline, pulmonary function tests (spirometry, plethysmography, bronchomotor response to deep inspiration using forced oscillation measurement of resistance of respiratory system, methacholine challenge, multiple flow rates of exhaled NO and nasal NO measurements) were performed together with an assessment of polyposis [clinical, endoscopic and computed tomography (CT) scores].. Statistical relationships were demonstrated between nasal NO flux and severity scores (clinical: rho=-0.31, P=0.015; endoscopic: rho=-0.57, P<0.0001; CT: rho=-0.46, P=0.0005), and between alveolar NO concentration and distal airflow limitation (FEF(25-75), rho=-0.32, P=0.011). Thirty-six patients were assessed after 11 [7-13] (median [interquartile]) months of medical treatment, demonstrating an improvement in clinical and endoscopic scores, an increase in nasal NO flux, a decrease in NO flux from conducting airways, an improvement in the mild airflow limitation (forced expiratory volume in 1 s, FEF(25-75), even in non-asthmatic patients) and a decrease in the bronchoconstrictor effect of deep inspiration.. The medical treatment of NP improves both airway reactivity and obstruction, whatever the presence of asthma, suggesting a functional link between upper and lower airway functions. Topics: Adult; Airway Obstruction; Anti-Allergic Agents; Anti-Inflammatory Agents; Asthma; Breath Tests; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Nitric Oxide; Prednisolone; Pregnadienediols; Respiratory System; Spirometry | 2008 |
For a few years now I've had nasal stuffiness, decreased sense of smell, and headaches. I recently found out nasal polyps are probably responsible for my symptoms. What are my treatment options?
Topics: Adrenal Cortex Hormones; Headache; Humans; Mometasone Furoate; Nasal Polyps; Olfaction Disorders; Pregnadienediols | 2005 |
Comment on EP3OS treatment recommendations.
Topics: Anti-Inflammatory Agents; Humans; Mometasone Furoate; Nasal Polyps; Practice Guidelines as Topic; Pregnadienediols | 2005 |
Expanding the evidence base for the medical treatment of nasal polyposis.
Topics: Administration, Intranasal; Humans; Mometasone Furoate; Nasal Polyps; Pregnadienediols | 2005 |
State and trait anxiety in patients affected by nasal polyposis before and after medical treatment.
The present study aimed to establish whether anxiety and depression in nasal polyposis play a role in genesis of the disease, or are a consequence of symptoms. Anxiety levels were evaluated in state and trait forms, and depression, in 30 consecutive patients presenting nasal polyposis before and after effective 7 months' medical treatment with nasal mometasone, loratadine and montelukast. Before and at the end of treatment, patients were asked to fill in the State and Trait Anxiety Inventory and the Zung self-rating depression scale. In 63.15% of patients with high levels of state anxiety before therapy, these were reduced (p < 0.004) after treatment. In 61.9% of patients with high levels of trait anxiety before treatment, these were reduced (p < 0.002) after treatment. There were no significant differences in depression. Anxiety in nasal polyposis is present both as a state and as a trait, and is significantly reduced after effective medical treatment, showing that anxiety is a reversible consequence of nasal polyposis in most cases. Topics: Acetates; Administration, Intranasal; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Anxiety; Cyclopropanes; Depression; Female; Histamine H1 Antagonists, Non-Sedating; Humans; Leukotriene Antagonists; Loratadine; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Pregnadienediols; Quinolines; Severity of Illness Index; Sulfides; Surveys and Questionnaires; Time Factors | 2004 |
[Influence of rhinologic usual and unusual drugs on fibroblasts from nasal polyps in cell culture].
Nasal polyposis is treated by surgery and/or by medication but in parts without permanent remission. Fibroblasts and their proliferation are involved in the complex mechanism of polyp genesis. Therefore we have analysed the influence of 12 medications on fibroblasts from nasal polyps growing in vitro.. Nasal polyps, obtained during usual surgical procedure, are enzymatically digested and cultured in serum containing media. The growing cells are identified as fibroblasts using flow cytometry with a AS02-FITC antibody (Dianova). The analysis is achieved with 5 - 6 different fibroblast cultures in each medicament tested, mostly using concentrations of the active substance from 0.006 to 1.333 mg/ml. The fibroblasts are cultured 4 days in the presence of active substances or as controls. Finally the cells are trypsinated and counted.. Mometason, Beclomethason, Fluticason, Verapamil and Timolol are the group with the strongest reduction of fibroblasts. Mometason shows a reduction to 6 % of controls at a concentration of 30 micro g/ml whereas the reduction at this concentration amounts to 30 - 60 % in the other members of this group. Mesazalin, Methylprednisolone and Pentoxifylline demonstrate the smallest influence; Prednisolon-21-hydrogen-succinate, Pilocarpin, Piroxicam and Diclofenac show an effect on a middle level.. A strong reduction of fibroblasts from nasal polyps in vitro is possible with usual rhinological medicaments but also with unusual substances in this field. Topics: Administration, Topical; Adrenergic beta-Antagonists; Androstadienes; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Antirheumatic Agents; Beclomethasone; Calcium Channel Blockers; Cells, Cultured; Culture Media; Diclofenac; Fibroblasts; Fluticasone; Glucocorticoids; Hematologic Agents; Humans; In Vitro Techniques; Mesalamine; Methylprednisolone; Mometasone Furoate; Muscarinic Agonists; Nasal Polyps; Pentoxifylline; Pilocarpine; Piroxicam; Prednisolone; Pregnadienediols; Time Factors; Timolol; Verapamil | 2003 |
Practical issues relating to intranasal steroid therapy.
Topics: Administration, Intranasal; Adult; Aerosols; Androstadienes; Anti-Inflammatory Agents; Budesonide; Child; Female; Fluticasone; Humans; Male; Mometasone Furoate; Nasal Polyps; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Singapore; Sinusitis; Triamcinolone Acetonide | 2002 |
[Chronic sinusitis, polyps, snoring. Topical glucocorticosteroid can relieve symptoms].
Topics: Administration, Topical; Anti-Inflammatory Agents; Chronic Disease; Glucocorticoids; Humans; Mometasone Furoate; Nasal Polyps; Nose Neoplasms; Pregnadienediols; Sinusitis; Snoring | 2001 |