fluticasone and Sinusitis

Chronic rhinosinusitis (CRS) is a common sinonasal disorder which results in significant inflammation in the nasal cavity and paranasal sinuses. Topical nasal steroids play an important role in the treatment of CRS. Exhalation delivery system with fluticasone (EDS-FLU) utilizes a patient's forced exhalation to power the delivery of topical steroids to deeper areas of the nasal cavity and paranasal sinuses most affected by CRS. This review focuses on evidence surrounding the safety and efficacy of the EDS-FLU system.. Literature search was conducted of articles investigating the safety and efficacy of EDS-FLU. Relevant efficacy and safety data were examined and summarized from the studies.. The efficacy and safety of EDS-FLU in CRS, both with and without polyps, has been established in open-label and placebo-controlled phase 3 trials. There was significant improvement in the cardinal symptoms of CRS and subjective patient-reported outcomes scores. Additionally, there was objective improvement in sinonasal inflammation as measured by polyp grade. Recent studies have also established significant improvement in health status and general quality of life following treatment using EDS-FLU. Emerging data have also examined patients who have previously had endoscopic sinus surgery and on appropriate medical therapy and noted improvement in polyp burden and overall Lund-Kennedy scores after using EDS-FLU.. Exhalation delivery system with fluticasone demonstrates significant results in both patient-oriented outcomes and objective measures of sinonasal inflammation in patients with CRS with and without polyps. Further research is needed to investigate the long-term outcomes of EDS-FLU and to compare the effects of EDS-FLU with ESS. Exhalation delivery system with fluticasone provides an additional effective treatment modality for patients suffering from CRS.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Chronic Disease; Drug Delivery Systems; Exhalation; Fluticasone; Humans; Nasal Cavity; Paranasal Sinuses; Randomized Controlled Trials as Topic; Rhinitis; Sinusitis; Treatment Outcome

The aim of this article is to review the current literature regarding a novel method of topically delivering nasal steroids, namely exhalation delivery system-fluticasone (EDS-FLU), for the treatment of chronic rhinosinusitis (CRS).. Recent Food and Drug Administration approval of EDS-FLU and increasing evidence surrounding its efficacy and safety has led to an additional tool for the treatment of chronic rhinosinusitis. Compared with placebo, EDS-FLU has demonstrated significant improvements in patients' sinonasal symptoms and overall inflammatory control as well as quality of life measures. Additionally, using EDS-FLU can lead to polyp grade improvement and polyp elimination in patients with chronic rhinosinusitis with polyps. Furthermore, compared with controls, patients who received EDS-FLU were less likely to meet predefined surgical criteria at the conclusion of the study.. EDS-FLU has demonstrated significant improvement in managing symptoms and polyps in CRS. Receiving EDS-FLU was associated with a significant reduction in the proportion of patients meeting surgical criteria. Further studies are warranted to evaluate the long-term outcomes of EDS-FLU, especially as compared with steroid sprays and topical steroid irrigations, in management of CRS.

Topics: Administration, Intranasal; Chronic Disease; Drug Delivery Systems; Exhalation; Fluticasone; Glucocorticoids; Humans; Nasal Polyps; Rhinitis; Sinusitis

Advances in understanding the pathogenic mechanisms of both rhinitis and chronic rhinosinusitis have resulted in new treatment options, especially for chronic rhinosinusitis. A review of relevant medical and surgical clinical studies shows that intranasal corticosteroids, antihistamines, and allergen immunotherapy continue to be the best treatments for chronic rhinitis. Dupilumab is the first biologic approved for chronic rhinosinusitis with polyps. Omalizumab, mepolizumab, and benralizumab may have a future role in the treatment of chronic rhinosinusitis. Novel corticosteroid delivery devices such as an exhalation delivery system for fluticasone and bioabsorbable sinus implants provide enhanced and localized distribution of corticosteroids. Surgical management tailored to the underlying disease process improves clinical outcomes in chronic rhinosinusitis with or without nasal polyposis. Advances in the understanding of the heterogeneous nature of rhinitis and rhinosinusitis have resulted in more precise treatments. Improving the understanding of different endotypes should provide better knowledge to determine appropriate current and new therapies to treat these diseases.

Topics: Administration, Intranasal; Chronic Disease; Fluticasone; Humans; Nasal Polyps; Rhinitis; Sinusitis

Intranasal steroids have become part of the mainstay in the long-term management of chronic rhinosinusitis. A long-standing problem remains in efficient and easy-to-use delivery of topical corticosteroids to the nasal mucosa. Currently available means of intranasal steroid delivery include sprays, which are generally limited to treating the anterior nasal cavity, and rinses, which are not FDA-approved for this indication. The exhalation delivery system is a novel method of delivering fluticasone to the deeper areas within the nasal cavities, including the posterior nasal cavity and middle and superior meatuses.. Comprehensive literature review.. Recent large scale studies have suggested its efficacy and safety in the use of patients with both chronic sinusitis with polyposis and without polyps. Specifically, studies have demonstrated decreased Sinonasal Outcome Test scores of 20 points following treatment, as well as improvement of polyp grade by 1 or more point in more than 60% of patients. Furthermore, among patients with nasal polyps, there was approximately 60-70% decreased indication for surgery following EDS-FLU use.. EDS-FLU is an important adjunct therapy for sinonasal inflammatory disease.

Topics: Administration, Intranasal; Chronic Disease; Drug Delivery Systems; Exhalation; Fluticasone; Humans; Nasal Polyps; Rhinitis; Sinusitis; Treatment Outcome

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

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

Topics: Adrenal Cortex Hormones; Cataract; Chronic Disease; Clinical Trials as Topic; Double-Blind Method; Exhalation; Fluticasone; Humans; Nasal Polyps; Sinusitis

Chronic rhinosinusitis is common and sometimes complicated by nasal polyps (NPs). Corticosteroid nasal sprays are often unsatisfactory because they are ineffective at delivering medication to high/deep sites of inflammation.. We sought to assess whether an exhalation delivery system with fluticasone (EDS-FLU) capable of high/deep drug deposition improves outcomes.. Patients (n = 323) 18 years and older with moderate-to-severe congestion and NPs were randomized to twice-daily EDS-FLU (93, 186, or 372 μg) or exhalation delivery system (EDS)-placebo for 24 weeks (16 double-blind plus 8 open-label when all received 372 μg). Coprimary end points were change in nasal congestion/obstruction at 4 weeks and summed bilateral polyp grade at 16 weeks. Secondary end points included symptoms, polyp elimination, and functioning.. EDS-FLU was superior on both coprimary end points (P < .001 vs EDS-placebo, all doses). Mean polyp grade improved continuously through week 24 (P < .009, all comparisons), with polyps eliminated on at least 1 side in approximately 25% of patients at week 24 versus 8.7% with EDS-placebo (P ≤ .014, all comparisons). Sino-Nasal Outcomes Test scores also improved significantly versus those in patients receiving EDS-placebo (-21.1 to -21.4 vs -11.7 at week 16, P < .05 all doses). At the end of the double-blind period, EDS-FLU (all doses) significantly improved all 4 defining disease symptoms. In most patients (68%), those receiving EDS-FLU reported "much" or "very much" improvement. The number of patients eligible for surgery decreased by 62%-67%. The safety profile was similar to that reported in prior trials evaluating conventional corticosteroid nasal sprays in comparable populations.. EDS-FLU produces clinically and statistically significant improvement in all 4 diagnostically defining disease symptoms, polyp grade, and quality of life in patients with chronic rhinosinusitis with NPs.

Topics: Administration, Intranasal; Adult; Chronic Disease; Double-Blind Method; Female; Fluticasone; Humans; Male; Middle Aged; Nasal Polyps; Rhinitis; Sinusitis

Chronic rhinosinusitis (CRS) can be divided to CRS without nasal polyps (CRSsNP) and eosinophilic and non-eosinophilic CRS with nasal polyps (CRSwNP). There is little evidence on the efficacy of glucocorticoids and macrolides in different phenotypic patients. The aim of this study was to compare the benefit of glucocorticoids and macrolides following endoscopic sinus surgery (ESS) in different phenotypic CRS.. This study was a prospective single-blind comparative effectiveness trial. A total of 187 Chinese patients with CRS were stratified to CRSsNP and eosinophilic and non-eosinophilic CRSwNP group and then randomized to receive fluticasone propionate nasal spray at 200 microgram or clarithromycin tablet at 250 mg once daily for 3 months after ESS. Oral prednisone was given as a rescue therapy after the stop of study medication. Patients were assessed before ESS and 1, 3, 6 and 12 months after dosing. Symptom severity was scored by patients using visual analog scale method and endoscopic findings were scored by the senior physician blinded to treatment according to European Position Paper on Rhinosinusitis and Nasal polyps 2012.. The total and individual symptom scores, and total and individual endoscopic domain scores were reduced significantly after ESS in both medication groups, whereas no significant difference was observed for two medications at most follow-up visits in each subtype of CRS. No difference in the frequency of subjects with rescue therapy or refractory CRS was found between two medication groups either.. We could not show significant difference of effect between fluticasone propionate and clarithromycin in the post-operative treatment for CRSsNP and eosinophilic and non-eosinophilic CRSwNP patients.

Topics: Anti-Bacterial Agents; Chronic Disease; Clarithromycin; Fluticasone; Humans; Nasal Polyps; Prospective Studies; Rhinitis; Single-Blind Method; Sinusitis

Chronic rhinosinusitis is a common, high-morbidity chronic inflammatory disease, and patients often experience suboptimal outcomes with current medical treatment. The exhalation delivery system with fluticasone (EDS-FLU) may improve care by increasing superior/posterior intranasal corticosteroid deposition.. To evaluate the efficacy and safety of EDS-FLU versus EDS-placebo in patients with nasal polyps (NP). Coprimary end points were change in nasal congestion and polyp grade. Key secondary end points were Sino-Nasal Outcome Test-22 (SNOT-22) and Medical Outcomes Study Sleep Scale-Revised (MOS Sleep-R). Other prespecified end points included all 4 cardinal symptoms of NP, 36-Item Short Form Health Survey (SF-36), Patient Global Impression of Change (PGIC), Rhinosinusitis Disability Index (RSDI), and key indicators for surgical intervention.. Randomized, double-blind, EDS-placebo-controlled, multicenter study.. Three hundred twenty-three subjects with NP and moderate-severe congestion/obstruction, most with history of corticosteroid use (94.4%) and/or prior surgery (60.4%), were randomized to EDS-FLU 93 µg, 186 µg, or 372 µg or EDS-placebo twice daily (BID) for 24 weeks (16 double-blind + 8 single-arm extension with EDS-FLU 372 µg BID).. All EDS-FLU doses produced significant improvement in both coprimary end points ( P < .05) and in SNOT-22 total score ( P ≤ .005). EDS-FLU significantly improved all 4 cardinal symptoms of NP ( P < .05), including congestion/obstruction, facial pain/pressure, rhinorrhea/post-nasal drip, and hyposmia/anosmia. Approximately 80% of subjects reported improvement with EDS-FLU, with 65% reporting "much" or "very much" improvement by week 16. Adverse events were generally local in nature and similar to other intranasal steroids studied for similar durations in similar populations, with the most common being epistaxis.. In patients with chronic rhinosinusitis with NP (CRSwNP) who were symptomatic despite high rates of prior intranasal steroid use and/or surgery, EDS-FLU produced statistically significant and clinically meaningful improvements compared to EDS-placebo in multiple subjective and objective outcomes (symptoms, SNOT-22, RSDI, SF-36, PGIC, and NP grade), including all 4 cardinal symptoms of CRSwNP.

Topics: Adult; Chronic Disease; Double-Blind Method; Drug Delivery Systems; Exhalation; Female; Fluticasone; Humans; Male; Middle Aged; Nasal Obstruction; Nasal Polyps; Neoplasm Grading; Placebo Effect; Rhinitis; Sinusitis; Treatment Outcome

Topics: Adult; Aged; Chronic Disease; Dexamethasone; Double-Blind Method; Female; Fluticasone; Humans; Male; Middle Aged; Nasal Polyps; Nasal Sprays; Natural Orifice Endoscopic Surgery; Postoperative Care; Rhinitis; Secondary Prevention; Sinusitis; Treatment Outcome; Young Adult

We investigated the effect of topical steroids on clinical outcomes and related immune response of chronic rhinosinusitis with nasal polyp (CRSwNP) patients and in eradicating some polyps. We want to explore a new potential mechanism linked to Th-17 cells.. Prospective, double-blind, placebo-controlled studies with 24 allergic and nonallergic patients were randomized to either placebo or fluticasone furoate for 12 weeks. Assessment of clinical response, endoscopic score with biopsies of the inferior turbinate, and polyps before and after treatment were performed. Biopsies were stained for T-cells, eosinophils, neutrophils, and IL-17A/F.. Steroid treatment improved the mean symptoms scores from 7.12 to 4.02 (P < .01) and the polyp score from 5.13 to 3.31 (P < .05), but the comparison with placebo was not statistically significant in nonallergics due to insufficient study power. Steroid treatment decreased eosinophil counts on allergics but not neutrophils or T-cells. The IL-17A/F expression was higher in nonallergics with high neutrophil counts and was inclined by steroids. Compared to baselines, IL-17 cells were significantly less in allergic individuals and were not observed in allergics and with high neutrophil counts.. Topical steroids were more effective on certain nasal polyp phenotypes. Identification of polyp phenotype might be essential to ensure a better therapeutic response to intranasal corticosteroids.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Chronic Disease; Double-Blind Method; Female; Fluticasone; Humans; Immunoenzyme Techniques; Interleukin-17; Male; Middle Aged; Nasal Polyps; Prospective Studies; Rhinitis; Sinusitis

Nasal steroids are a critical part of the management of patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) after endoscopic sinus surgery (ESS). Increasingly, practitioners are using budesonide respules delivered to the sinonasal cavities, which is an off-label use, in lieu of traditional nasal steroids. There has been little research comparing budesonide with traditional nasal steroids and the most effective delivery method of budesonide.. A randomized controlled trial was performed on patients after ESS for CRSwNP in a tertiary care center. Patients were randomized into 1 of 3 groups: group A received fluticasone nasal spray twice daily; group B received budesonide respules via a mucosal atomization device (MAD) twice daily; and group C received budesonide respules instilled via the vertex-to-floor (VF) position twice daily. Primary endpoints were 22-item Sino-Nasal Outcome Test (SNOT-22) and Lund-Kennedy scores at 6 months.. Thirty-two patients were enrolled in the study, 23 of whom completed the 6-month trial. There were no significant differences among groups A, B, and C with respect to age, gender, asthma, aspirin sensitivity, or previous ESS. Group B had a statistically significant greater reduction in SNOT-22 and Lund-Kennedy scores at the primary endpoint of 6 months compared to groups A and C. Group C had the next greatest reduction, which was statistically significant, followed by group A.. Patients treated with budesonide after ESS for CRSwNP had greater improvement in SNOT-22 and Lund-Kennedy scores compared to fluticasone at 6 months. The data supports the use of budesonide respules, particularly with a MAD, over fluticasone for CRSwNP patients after ESS.

Topics: Adult; Budesonide; Chronic Disease; Endoscopy; Female; Fluticasone; Humans; Male; Middle Aged; Nasal Polyps; Nasal Sprays; Nebulizers and Vaporizers; Paranasal Sinuses; Rhinitis; Rhinoplasty; Sinusitis; Treatment Outcome

Post-irradiation rhinosinusitis is one of the most common untoward side effects in patients with nasopharyngeal carcinoma. This study aimed to evaluate the effect of fluticasone propionate aqueous nasal spray on post-irradiation rhinosinusitis.. Nasopharyngeal carcinoma patients who had undergone radiotherapy and subsequently developed chronic rhinosinusitis were randomised to receive either fluticasone propionate aqueous nasal spray 200 µg plus nasal irrigation or a single nasal irrigation, for six months. A questionnaire, nasal endoscopy and computed tomography were used to evaluate rhinosinusitis severity, at the beginning of treatment, and at three and six months after treatment.. The group who received fluticasone propionate aqueous nasal spray combined with irrigation had fewer nasal complaints (overall symptoms, blocked nose and headache were reduced), a better quality of life and less severe endoscopic findings than those who only received nasal irrigation at three and six months after treatment.. Nasal steroids are a safe and effective therapy for patients with post-irradiation rhinosinusitis.

Topics: Administration, Intranasal; Adult; Analysis of Variance; Anti-Inflammatory Agents; Carcinoma; Female; Fluticasone; Humans; Male; Nasal Lavage; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Radiotherapy; Rhinitis; Sinusitis; Treatment Outcome

Clara cell protein 16 (CC16) is an anti-inflammatory protein mainly expressed in the epithelial cells in the upper and lower airways. Eosinophil cationic protein (ECP) is an important marker of eosinophil activity in chronic inflammatory sinonasal diseases. The aim of this study was to evaluate mucosal production of CC16 and ECP in patients with perennial allergic rhinitis (PAR), nonallergic and allergic patients with chronic rhinosinusitis with nasal polyposis (CRSwNP), before and after nasal corticosteroid administration.. Twenty patients with PAR, 20 nonallergic CRSwNP patients, 20 allergic CRSwNP patients, and 20 healthy controls were included. Mucosal cytology samples were taken from all participants for quantification of eosinophils. CC16 and ECP levels were measured in the nasal secretion samples. The patients with chronic sinonasal inflammation were treated with fluticasone nasal spray for 14 days. Nasal symptoms assessment, cytological examination, and CC16 and ECP nasal fluid measurements were performed before and after the corticosteroid treatment.. Mean CC16 concentrations in nasal secretions were significantly lower in patients with PAR (p < 0.05) and allergic CRSwNP patients (p < 0.01) compared to controls. Mean ECP levels were significantly higher in patients with PAR, nonallergic CRSwNP patients, and allergic CRSwNP patients compared to the control group (p < 0.001, p < 0.01, p < 0.001, respectively). After nasal corticosteroid therapy, we found a highly significant increase of CC16 (p < 0.001) and reduction of ECP (p < 0.001) in nasal secretions in all 3 groups of patients.. CC16 and ECP measured in nasal secretions could be reliable markers for assessment of the recovery function of sinonasal mucosa during corticosteroid treatment.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Adult; Aged; Anti-Inflammatory Agents; Chronic Disease; Eosinophil Cationic Protein; Eosinophils; Female; Fluticasone; Humans; Leukocyte Count; Male; Middle Aged; Nasal Mucosa; Nasal Polyps; Rhinitis; Sinusitis; Uteroglobin

The present study investigated the effectiveness of a Pimpinella anisum-based herbal medicine for treating chronic rhinosinusitis (CRS) without polyps in comparison to fluticasone nasal spray, in a single-blinded randomized trial.. Patients with CRS without nasal polyps were randomly assigned into 2 treatment groups: individuals in the first group (n = 26) received 2 drops of a P. anisum-based herbal medicine (Sinupim) in each nostril every 12 hours, while those in the second group (n = 22) received 2 puffs of fluticasone nasal spray in each nostril every 12 hours. Both groups used their designated treatments for 4 weeks. Patients were evaluated by the 22-item Sino-Nasal Outcome Test (SNOT-22) at the start of the trial and after the completion of their treatment.. Although both treatments were effective in reducing patients' symptoms, there were significantly better results in the Sinupim group based on the SNOT-22 evaluation. Mean changes in computed tomography (CT) scan scoring in Sinupim and fluticasone groups before and after treatment were 2.22 ± 2.94 and 0.76 ± 1.39, respectively, which was significant within both groups (p < 0.05). Postnasal drip and nasal obstruction were more significantly improved in the Sinupim group.. A P. anisum-based herbal medicine may be an effective treatment for sinusitis without polyps. However, its wide acceptance needs further investigation.

Topics: Adult; Chronic Disease; Female; Fluticasone; Humans; Iran; Male; Medicine, Traditional; Middle Aged; Paranasal Sinuses; Pimpinella; Plant Extracts; Plant Oils; Rhinitis; Seeds; Single-Blind Method; Sinusitis; Tomography, X-Ray Computed; Treatment Outcome; Young Adult

Intranasal corticosteroids (INS) have been proven effective in controlling postnasal drip, decreasing inflammatory response, reducing nasal swelling, and increasing aeration of the sinuses such that INS are recommended as treatment of sinusitis.. Fifty children with acute rhinosinusitis, 50 children with acute rhiniosinusitis and allergic rhinitis (AR), and 20 rhiniosinusitis children as control were selected for investigation. Each group had a single-blind treatment of three types: with coamoxiclav only, with coamoxiclav plus INS, and with matched placebo (without antibiotics and INS) for two weeks. Nasal symptoms were then evaluated. The outcome was measured by using major symptom score (MSS) after treatment for 14 days.. Therapeutic effectiveness was 92% in rhinosinusitis patients treated with co-amoxiclav and 84% in those treated with co-amoxiclav plus INS. Among patients with sinusitis combined with AR, therapeutic efficacy was 88% for those treated with co-amoxiclav and 96% for those treated with co-amoxiclav plus INS. Only 30% of the symptoms were reduced in the placebo group.. There are no statistical differences in the acute sinusitis group treated with co-amoxiclav with or without INS. In the sinusitis with AR group, the efficacy of co-amoxiclav with INS is higher than in children treated with co-amoxiclav alone.

Topics: Acute Disease; Administration, Intranasal; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Allergic Agents; Anti-Bacterial Agents; Drug Therapy, Combination; Female; Fluticasone; Humans; Male; Rhinitis; Rhinitis, Allergic; Single-Blind Method; Sinusitis; Treatment Outcome

Chronic rhinosinusitis is a common inflammatory condition in western countries. Nasal polyposis has different symptoms such as nasal obstruction, anterior or posterior nasal drip, reduced sense of smell, and facial pain. Medical and endoscopic treatments are the two main treatments for nasal polyposis. Our aim was to compare the efficacy of different methods on olfactory function. This is a non-randomized clinical trial study that was done on 60 patients who were divided into two groups (medical and surgical). Patients were matched based on age, history of smoking, and the severity of obstruction. The radiologist score of Lund-Mackay staging system was used to match patients in two arms of the trial based on the severity of nasal obstruction. Patients in surgery groups underwent functional endoscopic sinus surgery under general anesthesia and then received Fluticasone propionate nasal spray for 8 weeks (400 mcg bd). Patients in the medical group were only prescribed with Fluticasone propionate with the same duration and same dose as mentioned. As a result of treatment protocol, both medical and surgical group experienced improvement in olfactory function but statistical analyses revealed that surgery resulted in better resolution of symptoms. Our observation revealed that combined treatment had a better effect than medical treatment in restoring olfaction in patients with nasal polyposis.

Topics: Adolescent; Adult; Aged; Androstadienes; Anti-Inflammatory Agents; Chronic Disease; Combined Modality Therapy; Endoscopy; Female; Fluticasone; Humans; Male; Middle Aged; Nasal Obstruction; Nasal Polyps; Nasal Sprays; Olfaction Disorders; Paranasal Sinuses; Rhinitis; Sinusitis; Treatment Outcome; Young Adult

Fluticasone propionate and nasal saline irrigation have been used in the treatment of sinonasal diseases for a long time. Our study investigates the effect of the combination of large volume low pressure nasal saline irrigation and fluticasone propionate for the treatment of pediatric acute rhinosinusitis.. Ninety-one pediatric patients with acute rhinosinusitis were included in our study. The patients were randomized into two groups. The first group (n=45) was treated with standard therapy (antibiotherapy+nasal decongestant) for 2 weeks, the second group was treated with the large volume low pressure nasal saline+fluticasone propionate combination for 3 weeks. The clinical scores, radiologic evaluations (X-ray Waters view), peak nasal inspiratory flow (PNIF) measurements, total symptom scores and hematologic parameters (WBC, CRP, ESR) of the patients were evaluated and compared.. There were no significant differences in between the two groups regarding age, gender, height and weight. Even though the clinical scores of Group 2 improved more rapidly, there were no significant differences in between groups regarding clinical scores by the 21st day. There were no significant differences in post treatment radiologic evaluations (Waters graphy). Both groups had significant improvement of their post treatment PNIF values, yet the improvement was more marked in Group 2 than in Group 1. The rhinorrhea, nasal congestion, throat itching and cough symptoms improved more rapidly in Group 2 than in Group 1. Post-treatment nose itching and sneezing symptoms were significantly less in Group 2. The values of hematologic parameters were significantly reduced at the end of the 3rd week in both groups.. Our study is a first in investigating the combined use of large volume low pressure nasal saline and fluticasone propionate in acute pediatric rhinosinusitis, and the results reveal that the combination therapy was effective. Low pressure large volume nasal saline+fluticasone propionate combination can be employed as a new line of therapy for the treatment of pediatric acute rhinosinusitis, either by itself or combined with standard therapy.

Topics: Acute Disease; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Androstadienes; Anti-Inflammatory Agents; beta-Lactamase Inhibitors; Blood Sedimentation; C-Reactive Protein; Child; Combined Modality Therapy; Female; Fluticasone; Humans; Imidazoles; Inhalation; Male; Maxillary Sinus; Nasal Decongestants; Nasal Lavage; Prospective Studies; Radiography; Rhinitis; Sinusitis; Sodium Chloride

A combined therapy of fluticasone propionate nasal drops (FPND) and functional endoscopic sinus surgery (FESS) can improve quality of life (QoL). When compared with prior data, the results imply that a generic measure of psychological aspects of QoL may be better than measures of respiratory symptoms and clinical parameters to capture a patient's perception of the disease and its treatment.. To better understand effects of FPND and FESS on generic QoL.. Sixty nasal polyposis patients with concomitant asthma completed participation in a randomized, double-blind, placebo-controlled, 14-week study in which they responded to the General Well-Being Schedule (GWBS).. GWBS scores (i) increased significantly after administration of FPND, independent of FESS (from lower than normal to normal), (ii) increased after FESS independent of FPND (from lower than normal to normal), and (iii) increased additively after FPND and FESS.

Topics: Adult; Aged; Androstadienes; Anti-Allergic Agents; Asthma; Double-Blind Method; Endoscopy; Female; Fluticasone; Humans; Male; Middle Aged; Nasal Polyps; Prospective Studies; Quality of Life; Sinusitis

Intranasal corticosteroid irrigations, especially budesonide, are used increasingly in the management of chronic rhinosinusitis. In post-endoscopic sinus surgery patients, irrigations may offer improved delivery at higher doses to the paranasal sinuses than intranasal spray preparations. Fluticasone propionate may have higher potency and lower systemic bioavailability than budesonide, but there is little data on its effects as an intranasal irrigation on the hypothalamic-pituitary-adrenal axis or on ocular findings.. Adult patients who had previously undergone bilateral endoscopic sinus surgery and had not taken systemic corticosteroids in the last 6 months were prospectively enrolled. Subjects irrigated with 3 mg of fluticasone propionate in 240 mL saline solution twice daily. Salivary cortisol, intraocular pressure, and the presence of posterior subcapsular cataracts were measured before drug administration and after 6 weeks of continuous use.. Twenty-three subjects completed the study. No subjects had salivary cortisol levels below the normal range before or after therapy, and there was no statistical difference in mean salivary cortisol levels pretreatment and posttreatment (0.294 vs 0.392 μg/dL; p = 0.27). There was no clinical or statistical difference in mean intraocular pressure before or after therapy (13.3 vs 13.3 mmHg; p = 0.86). No subjects developed a posterior subcapsular cataract.. Fluticasone propionate irrigations did not suppress salivary cortisol levels or result in ocular changes. Irrigation with fluticasone propionate 3 mg in 240 mL saline twice daily may be a safe alternative to other intranasal or systemic corticosteroid treatments for chronic rhinosinusitis patients.

Topics: Adult; Aged; Androstadienes; Cataract; Chronic Disease; Female; Fluticasone; Humans; Hydrocortisone; Intraocular Pressure; Male; Middle Aged; Nasal Lavage; Pituitary-Adrenal System; Prospective Studies; Rhinitis; Saliva; Sinusitis; Treatment Outcome

Approximately 0.5-2% of upper respiratory tract infections in adults and 6-13% of viral upper respiratory tract infections in children are complicated by acute sinusitis. This study was aimed to evaluate the coadministration effect of fluticasone nasal spray (FNS) with amoxicillin for AS in children.. One hundred children 2 to 14 years of age with acute sinusitis referred to Shahid Mohammadi Pediatric Hospital in Bandar Abbas were randomly allocated into two equal intervention and control groups to receive amoxicillin with fluticasone nasal spray one puff twice daily for 14 days and amoxicillin 80 to 100 mg/kg/ day for 14 days respectively.. Twenty one (42%) of children in intervention group were cured completely and 2 (4%) children in control group had complete recovery (p < 0.001). Symptom severity score was 22.98 ± 2.95 before treatment that reduced to 13.26 ± 3.20 after treatment (p < 0.001).. Use of fluticasone can reduce the severity of symptoms of sinusitis in children.

Topics: Acute Disease; Administration, Intranasal; Adolescent; Amoxicillin; Androstadienes; Anti-Bacterial Agents; Anti-Inflammatory Agents; Child; Child, Preschool; Female; Fluticasone; Humans; Male; Single-Blind Method; Sinusitis

In the majority of CRS patients suffering from primary or recurrent CRS, topical glucocorticoids are highly effective. A subset of CRS patients, however, does not respond to (topical) glucocorticoids and requires surgical intervention. Although surgery is highly effective in those individuals, recurrence of disease is observed in some. In this study we describe our search for one or more predictors predicting the response to surgery in combination with peri-operative oral glucocorticoids in CRS patients.. Thirty-five inferior turbinate specimens were randomly selected from a larger group of CRS patients requiring FESS for persistent disease that either responded favorably or demonstrated recurrent disease. Tissue biopsies were taken at the time of surgery and compared for inflammatory markers, endothelial cell markers, and various leukocyte subsets using immunohistochemistry.. Compared to non-responders, the baseline level of lamina propria activated eosinophils is significantly increased in CRS patients responding to surgery in combination with peri-operative oral glucocorticoids treated or not treated post-operatively with topical glucocorticoids. No significant differences were observed for all other studied parameters. Post-operative treatment with FPANS 100 μg q.i.d. was significantly associated with response to treatment. A trend towards association was observed for increased numbers of eosinophils at baseline.. Our data suggest that CRS patients with higher levels of eosinophils are less likely to suffer from post-operative recurrent sinonasal disease when treated post-operatively with FPANS 100 μg q.i.d.

Topics: Adult; Aged; Androstadienes; Antibodies, Monoclonal; Chronic Disease; Combined Modality Therapy; Double-Blind Method; Endoscopy; Eosinophils; Female; Fluticasone; Glucocorticoids; Humans; Immunohistochemistry; Logistic Models; Male; Middle Aged; Mucous Membrane; Nasal Sprays; Recurrence; Rhinitis; Sinusitis; Treatment Outcome

Chronic rhinosinusitis associated with asthma is often difficult to treat effectively with intranasal corticosteroids alone. Thus, the aim of this study was to evaluate the effectiveness of combination treatment with an intranasal corticosteroid and a leukotriene-receptor antagonist (montelukast) in reducing the size of nasal polyps.. The subjects of this study were 20 patients with chronic rhinosinusitis associated with adult-onset asthma, which was being treated with inhaled corticosteroids. All patients were treated with intranasal fluticasone propionate, 200 microg/day, and montelukast, 10 mg/day, for 1 year. The size of nasal polyps and the score of sinus shadows were assessed with nasal endoscopy and computed tomography (CT), respectively, before and after treatment. The peripheral blood eosinophil counts were also evaluated before and after treatment.. Nasal polyps were significantly smaller after both 6 months (p<0.01) and 12 months of treatment (p<0.01) than before treatment. The decrease in the shadow score was statistically significant after both 6 months (p<0.01) and 12 months of treatment (p<0.01). Significant reductions in peripheral blood eosinophil counts were also seen after both 6 months (p<0.05) and 12 months of treatment (p<0.01). A significant correlation was found between the rate of change in the peripheral blood eosinophil count and that in the CT score after both 6 months (r=0.578, p=0.012) and 12 months (r=0.625, p=0.007).. Combined treatment with intranasal fluticasone propionate and montelukast, for at least 1 year, is effective for chronic rhinosinusitis associated with adult-onset asthma.

Topics: Acetates; Administration, Intranasal; Adrenal Cortex Hormones; Adult; Aged; Androstadienes; Anti-Allergic Agents; Asthma; Chronic Disease; Cyclopropanes; Drug Therapy, Combination; Eosinophils; Female; Fluticasone; Humans; Leukotriene Antagonists; Male; Middle Aged; Nasal Polyps; Quinolines; Rhinitis, Allergic, Perennial; Sinusitis; Sulfides; Tomography, X-Ray Computed; Treatment Outcome

To assess whether delivery of fluticasone propionate using a novel bi-directional delivery device (Opt-FP) offers therapeutic benefits in patients with chronic rhinosinusitis (CRS).. A prospective, single centre, randomized, double-blind, placebo (PBO)-controlled, parallel group study was conducted in adult subjects (n=20) with CRS without nasal polyps or only cobblestoned mucosa. Subjects received Opt-FP 400 µg or placebo twice daily for 12 weeks (n=10/group). Outcome measures included symptom scores, RSOM-31, CRS VAS, nasendoscopy, peak nasal inspiratory flow (PNIF) and magnetic resonance imaging (MRI).. Endoscopy score for oedema showed a highly significant and progressive improvement (12 weeks (median scores): Opt-FP -4.0, PBO -1.0, p=0.015). PNIF increased significantly during Opt-FP treatment compared to placebo (4 weeks: p=0.006; 8 weeks: p=0.03). After 12 weeks MRI scores in the Opt-FP group improved against baseline (p=0.039) and a non-significant trend was seen versus placebo. The nasal RSOM-31 subscale was significantly improved with Opt-FP treatment (4 weeks: p<0.009, 8 weeks: p<0.016, 12 weeks: NS). Sense of smell, nasal discomfort and combined score were all significantly improved (p<0.05). The Opt-FP was well tolerated.. The OptiNose breath-actuated bi-directional delivery device administering fluticasone propionate (400 µg b.i.d.) is an effective and well tolerated treatment for recalcitrant CRS.

Topics: Administration, Intranasal; Adult; Androstadienes; Anti-Inflammatory Agents; Chronic Disease; Double-Blind Method; Drug Delivery Systems; Equipment Design; Female; Fluticasone; Humans; Magnetic Resonance Imaging; Male; Middle Aged; Rhinitis; Sinusitis

The objective of this study was to determine the influence of individual anatomical differences on intranasal drug deposition. The data of a comparison of seven different administration techniques in ten healthy volunteers was used in this single-blind crossover pilot study. After intranasal administration of a dyed test formulation, endoscopic video imaging was done on seven non-sequential days. The deposition pattern per individual around the head of the middle turbinate was analyzed for each technique and correlated with the individual anatomy. Decreased deposition of dyed test formulation in the target area around the head of the middle turbinate was observed in the presence of minor septal deviations, narrow nasal valve areas, or inferior turbinate hypertrophy; a lateral head position helps to bypass a minor septal deviation. Although results are preliminary, we conclude that anatomy and head position are important factors in the deposition of topical nasal drugs and may be the key to improving individual local nasal (steroid) treatment.

Topics: Administration, Intranasal; Adult; Aerosols; Androstadienes; Anti-Inflammatory Agents; Cross-Over Studies; Endoscopy; Female; Fluticasone; Humans; Male; Nasal Polyps; Nose; Pilot Projects; Posture; Rhinitis; Single-Blind Method; Sinusitis; Treatment Outcome; Turbinates; Videotape Recording

One hundred nine patients with chronic rhinosinusitis underwent functional endoscopic sinus surgery. Seventy seven patients had polyposis. The population was studied prospectively for 5 years postoperatively. Seventy two patients attended the 5 year follow-up visit. At 1, 2, 3, 4 and 5 years of follow-up all outcome measures except olfactory detection thresholds (visual analogue scores, endoscopic findings, nasal mucociliary clearance times, total nasal volumes) were significantly improved compared to preoperative baseline values. Olfactory detection thresholds were significantly improved at 1 and 2 years postoperation. Patient symptom scores were improved in a greater percentage of patients than more objective outcome measures. Thirty eight patients required a total of 88 postoperative rescue medication courses with prednisolone and antibiotic. Twelve patients failed the study as they required at least 1 rescue medication course a month for 2 consecutive months. We demonstrated an 89% 5 year "survival" rate with regards to the risk of failure. The patients were also entered into a randomised, stratified, prospective, double-blind, placebo controlled study of fluticasone propionate aqueous nasal spray 200 mcg twice daily, commencing 6 weeks after FESS, with a 5 year follow-up. The change in overall visual analogue score was significantly better in the FPANS group at 5 years. The changes in endoscopic oedema and polyp scores and in total nasal volumes were significantly better in the FPANS group at 4 years but not 5 years. Last value carried forward analysis demonstrated that changes in endoscopic polyp score and in total nasal volume was significantly better in the FPANS group at 5 years. Significantly more prednisolone rescue medication courses were prescribed in the placebo group. Of the 12 patients who failed the study, 10 were in the placebo group. This difference nearly achieved significance.

Topics: Administration, Intranasal; Adult; Aerosols; Androstadienes; Anti-Inflammatory Agents; Double-Blind Method; Endoscopy; Female; Fluticasone; Follow-Up Studies; Humans; Male; Postoperative Care; Prospective Studies; Rhinitis; Sinusitis; Solutions; Time Factors

Steroid treatment is the mainstay of therapy for nasal polyps and rhinosinusitis. Oral steroids have considerable systemic side effects, and nasal sprays do not sufficiently reach the middle meatus, where polyps originate. Nasal drops might be a more useful formula to deliver steroids into the middle meatus.. We sought to investigate whether treatment with fluticasone propionate nasal drops (FPNDs) can reduce the need for surgery, as measured by signs and symptoms of nasal polyposis and chronic rhinosinusitis, in patients who are on the waiting list for functional endoscopic sinus surgery (FESS).. Fifty-four patients (28 male) with severe nasal polyposis, chronic rhinosinusitis, or both indicated for FESS were included in a 12-week, double-blind, placebo-controlled study. Use of intranasal steroid spray was stopped at least 4 weeks before randomization. Signs and symptoms were recorded before, during, and at the end of the study period. At the end of the study, a computed tomographic scan was performed, and the need for operation was reassessed by using a standardized scoring method.. FESS was no longer required in 13 of 27 patients treated with FPNDs versus 6 of 27 in the placebo group (P < .05). Six patients from the placebo group dropped out versus 1 from the FPND group. Symptoms of nasal obstruction, rhinorrhea, postnasal drip, and loss of smell were reduced in the FPND group (P < .05). Peak nasal inspiratory flow scores increased significantly (P < .01). Polyp volume decreased in the FPND group (P < .05), and computed tomographic scores improved in both groups (P < .05).. Treatment with FPNDs in patients indicated for FESS can reduce the need for surgery.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Androstadienes; Chronic Disease; Double-Blind Method; Fluticasone; Humans; Male; Middle Aged; Nasal Polyps; Rhinitis; Sinusitis; Solutions

Topical nasal steroids such as beclomethasone dipropionate and fluticasone propionate have been widely used in the treatment of rhinitis and polyposis. An increase in infection has occurred with the use of fluticasone propionate after endoscopic polypectomy.. The purpose of this study was to determine the prevalence of nasal and paranasal infections with the use of topic nasal steroids after endoscopic polypectomy and to compare the recurrence rates of the polyposis.. We conducted a prospective, comparative, open, experimental, longitudinal study at an academic tertiary referral medical center.. One hundred sixty-two patients in whom endoscopic polypectomy had been indicated were randomly divided into 3 groups of 54 patients each. The patients from the first group were treated with saline lavage only. Patients from the second group also received fluticasone propionate 400 microg/day in nasal spray after lavage. Patients from the third group received beclomethasone dipropionate 600 microg/day after lavage. The prevalence of infections and recurrence of polyposis was compared in the 3 groups.. Three patients, 2 in the placebo group and 1 in the beclomethasone group, developed infections during the first 3 months after surgical procedure. The recurrence of polyps in the group without steroids was 44%. In contrast, 15% from the patients treated with fluticasone showed recurrence of polyposis; furthermore, 26% of the patients treated with beclomethasone showed recurrence of polypsosis, with a minimum follow-up of 12 months.. The use of nasal steroids does not seem to increase the prevalence of infections after endoscopic polypectomy.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Endoscopy; Female; Fluticasone; Humans; Male; Middle Aged; Nasal Polyps; Otorhinolaryngologic Surgical Procedures; Prevalence; Prospective Studies; Recurrence; Sinusitis

To conduct the first prospective, randomized, controlled trial evaluating and comparing the medical and surgical treatment of polypoid and nonpolypoid chronic rhinosinusitis (CRS).. Ninety patients with CRS were equally randomized either to medical or surgical therapy. All patients underwent pre- and posttreatment assessments of visual analogue score (VAS), the Sinonasal Outcome Test-20 (SNOT-20), the Short Form 36 Health Survey (SF-36), nitric oxide (NO), acoustic rhinometry, saccharine clearance time (SCT), and nasal endoscopy. Each patient had three assessments: before starting the treatment, after 6 months, and, finally, after 1 year.. Both the medical and surgical treatment of CRS significantly improved almost all the subjective and objective parameters of CRS (P <.01), with no significant difference being found between the medical and surgical groups (P >.05), except for the total nasal volume in CRS (P <.01) and CRS without polyposis (P <.01) groups, in which the surgical treatment demonstrated greater changes.. CRS should be initially targeted with maximal medical therapy (e.g., a 3 month course of a macrolide antibiotic, douche, and topical steroid), with surgical treatment being reserved for cases refractory to medical therapy. The presence of nasal polyps is not a poor prognostic factor for the efficacy of CRS therapy, either surgical or medical.

Topics: Adult; Androstadienes; Anti-Inflammatory Agents; Endoscopy; Female; Fluticasone; Follow-Up Studies; Humans; Male; Middle Aged; Nitric Oxide; Prospective Studies; Quality of Life; Rhinitis; Rhinometry, Acoustic; Sinusitis

Local corticosteroids are widely used in the treatment of nasal polyps and chronic rhinosinusitis both before and after nasal surgery. Their efficacy after functional endoscopic sinus surgery (FESS) has not been fully established by placebo-controlled trials.. This double-blind placebo-controlled randomized study was performed in order to investigate whether fluticasone propionate aqueous nasal spray (FPANS) reduces the recurrence rate of nasal polyps and chronic rhinosinusitis during the first year after FESS.. The trial looked at 162 patients aged 18 years and older requiring FESS for chronic rhinosinusitis or nasal polyps. After FESS combined with peri-operative systemic corticosteroids, patients were randomized and given FPANS 400 microg b.i.d., FPANS 800 microg b.i.d. or placebo b.i.d. for the duration of 1 year. Patients were withdrawn from the trial (but still included in the study for statistical purposes) if there were recurrent or persistent diseases, defined as progressive regrowth of nasal polyps, recurrent signs and symptoms of chronic sinusitis combined with abnormalities on computed tomography scan and persistent complaints for at least 2 months after FESS.. A significant reduction of symptoms was seen after FESS. After 1 year, 46 patients had been withdrawn from the trial because of recurrent diseases and 32 patients because of persistent symptoms. No differences in the number of patients withdrawn because of recurrent or persistent diseases were found between the patients treated with FPANS and patients treated with placebo. We were also unable to find a positive effect of FPANS compared with placebo in several subgroups such as patients with nasal polyps, high score at FESS or no previous sinus surgery.. This placebo-controlled study does not show that treatment with FPANS up to 1 year after FESS had a positive effect compared with placebo.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents; Chronic Disease; Double-Blind Method; Endoscopy; Female; Fluticasone; Humans; Male; Middle Aged; Nasal Polyps; Paranasal Sinuses; Secondary Prevention; Sinusitis; Treatment Outcome

Chronic rhinosinusitis is frequently associated with asthma. A Th2 cytokine pattern has been recently reported in chronic rhinosinusitis in asthmatic children.. To evaluate the effects of treating concomitant chronic rhinosinusitis on respiratory symptoms and function and immunopathological parameters in asthmatic children.. Eighteen children with moderate asthma (age range, 5 to 12 years) poorly controlled by high doses of inhaled corticosteroids and chronic rhinosinusitis were evaluated for symptoms, spirometry, and inflammation at baseline, after treatment, and 1 month after suspension of treatment. All of the children were treated with a combination of amoxicillin and clavulanate (20 mg/kg twice daily) and fluticasone propionate aqueous nasal spray (100 microg/d) for 14 days. A short course of oral corticosteroids was also prescribed (deflazacort, 1 mg/kg daily for 2 days, 0.5 mg/kg daily for 4 days, and 0.25 mg/kg daily for 4 days). Rhinosinusal lavage for cytokine measurements and a nasal scraping for cytologic analysis were performed in all patients before and after medical treatment.. A negative endoscopy result was demonstrated in 15 children after treatment. Symptoms and respiratory function significantly improved after treatment and 1 month later; 8 children had intermittent asthma and 10 had mild asthma. A significant reduction of inflammatory cell numbers was detected in all asthmatic children. Interleukin 4 levels significantly decreased (P < 0.001), whereas interferon-y levels increased (P < 0.001).. Treatment of chronic rhinosinusitis is able to improve symptoms and respiratory function in asthmatic children, reducing inflammatory cells and reversing the cytokine pattern from a Th2 toward a Th1 profile.

Topics: Amoxicillin-Potassium Clavulanate Combination; Androstadienes; Anti-Inflammatory Agents; Asthma; Child; Child, Preschool; Drug Therapy, Combination; Endoscopy; Female; Fluticasone; Forced Expiratory Volume; Humans; Interferon-gamma; Interleukin-4; Male; Neutrophils; Pregnenediones; Rhinitis, Allergic, Perennial; Sinusitis

The aims of the study were to determine: 1) how mucociliary activity in acute bacterial rhinosinusitis is affected; 2) how this activity is changed by therapy; 3) the effects of topical agents on mucociliary clearance, and 4) the most appropriate topical agent(s) to be used in the therapy of sinusitis.. Five groups of patients with acute bacterial rhinosinusitis were studied prospectively.. All patients had 500 mg oral amoxicillin and 125 mg oral clavulanic acid preparations given three times daily for 3 weeks. According to the topical agent applications, these groups included: group I (n = 12), no topical treatment was given; group II (n = 14), two puffs for each nostril once daily of 50 microg/100 mL fluticasone propionate was given; group III (n = 9), one puff for each nostril three times daily of 0.05% oxymetazoline was given; group IV (n =12), 3% sodium chloride (NaCl) (buffered to pH 6.5-7 at room temperature) was given; and group V (n =13), 10-mL solutions of 0.9% NaCl (buffered to pH 6.5--7 at room temperature) were given for nasal irrigations three times daily. All patients had medication for 3 weeks and were controlled each week. The saccharin method was used to measure nasal mucociliary clearance. To investigate the early effects of the topical agents for groups II to V, an additional test was repeated 20 minutes after the basal mucociliary clearance recordings. The test was repeated in the first, second, and third weeks of the treatment.. The mucociliary clearance was significantly slower in the acute bacterial rhinosinusitis group than in the control group. There was no significant difference between the basal mucociliary clearance and the 20th minute mucociliary clearance of the fluticasone propionate and 0.9% NaCl solution groups. The mean values of the basal and the 20 minute's mucociliary clearance of the oxymetazoline group were 24.72 +/- 6.16 and 15.5 +/- 7.45 minutes, respectively, which were statistically significant. The mean values of the basal and the 20th minute mucociliary clearance of the 3% NaCl solution groups were 19.45 +/- 9.35 and 15.45 +/- 8.20 minutes, respectively, which were also statistically significant. In the first group (without topical treatment), the basal mucociliary clearance became significantly shorter after the second week of treatment. In the first and second weeks of the treatment of the oxymetazoline group, the mucociliary clearance did not change significantly, but after the third week the mucociliary clearance was significantly shorter. In the 3% NaCl solution group, significant improvement began from the first week and continued through the third week. Comparing the basal and the third weeks' mucociliary clearance values among the groups, the oxymetazoline and 3% NaCl solution groups revealed more significant improvement than the other groups, but this improvement was not different from the improvement of group I. There was still a statistically significant difference in the mucociliary clearance of the post-treatment sinusitis groups from the control group.. The oxymetazoline and 3% NaCl solution groups seemed to be more effective in mucociliary clearance, but there was no significant difference in improvement among the groups. The improvement of acute bacterial rhinosinusitis takes more than 3 weeks, according to the mucociliary clearance values of the groups.

Topics: Acute Disease; Administration, Topical; Adolescent; Adult; Aged; Analysis of Variance; Androstadienes; Bacterial Infections; Child; Female; Fluticasone; Follow-Up Studies; Humans; Male; Middle Aged; Mucociliary Clearance; Nasal Mucosa; Oxymetazoline; Probability; Prospective Studies; Reference Values; Rhinitis; Sinusitis; Sodium Chloride; Treatment Outcome

Chronic rhinosinusitis (CRS) is a recalcitrant inflammatory process which has a marked detrimental impact on quality of life. At the present there is no cure for this condition, measures are taken to stop progression, and provide symptomatic relief. Topical corticosteroids are commonly prescribed in the management of CRS, but few trials show effectiveness in clinical settings. We set up a randomized, double-blind, placebo-controlled trial to study the effectiveness of a topical corticosteroid agent--fluticasone propionate aqueous nasal spray (FPANS) in patients with CRS. We measured symptoms, diary card, and rigid endoscopy scores, acoustic rhinometry, middle meatal swabs, blood tests--CRP, ESR, WBC, and eosinophil count. Measurements were done at the start of the trial, at 8 weeks, and 16 weeks where possible. Twenty-two patients completed the trial, 9 received FPANS, and 13 had placebo. There was no difference between the 2 groups on all counts. When patients were considered as one group, there was an improvement in the diary card scores (p = 0.054), comparing baseline to 8 or 16 weeks. There was no evidence that the regular use of topical corticosteroid increased the risk of developing an infection. An important observation was that the topical corticosteroid did not precipitate acute sinusitis. There is compelling evidence that topical corticosteroids down-regulate cytokine expression, and it is likely that a larger, and longer multi-centre trial may prove their efficacy in CRS.

Topics: Administration, Intranasal; Adult; Androstadienes; Anti-Inflammatory Agents; Chronic Disease; Double-Blind Method; Female; Fluticasone; Glucocorticoids; Humans; Male; Placebos; Rhinitis; Sinusitis; Statistics, Nonparametric

It is not known whether intranasal corticosteroids are beneficial to treat acute rhinosinusitis in patients with a history of chronic or recurrent sinus symptoms.. To assess whether the addition of an intranasal corticosteroid to antibiotic therapy affects the speed and rate of recovery of such patients with acute rhinosinusitis.. A double-blind, randomized, placebo-controlled multicenter trial of 95 patients (median age, 39 years) with a history of recurrent sinusitis or chronic rhinitis and evidence of acute infection by sinus radiograph or nasal endoscopy, which was conducted from October 1998 through April 2000 at 22 sites (12 primary care and 10 otolaryngology).. Two puffs (total dose, 200 microgram) of fluticasone propionate (n = 47) or placebo nasal spray (n = 48) in each nostril once daily for 21 days; all received 2 puffs of xylometazoline hydrochloride in each nostril twice daily for 3 days and 250 mg of cefuroxime axetil twice daily for 10 days.. Time to clinical success (patient reported cured or much improved) during telephone follow-up at 10, 21, and 56 days.. A total of 88 patients (93%) completed follow-up. Patients recorded their symptoms, work assessment, and compliance during the 3-week treatment phase. Patients receiving fluticasone achieved a significantly higher rate of clinical success than patients receiving placebo (93.5% vs 73.9%; P =.009). Patients treated with fluticasone improved significantly more rapidly (median of 6.0 days to clinical success) vs patients in the placebo group (median of 9.5 days; P =.01).. The addition of fluticasone to xylometazoline and antimicrobial therapy with cefuroxime improves clinical success rates and accelerates recovery of patients with a history of chronic rhinitis or recurrent sinusitis who present for treatment of acute rhinosinusitis.

Topics: Acute Disease; Administration, Intranasal; Adult; Androstadienes; Anti-Inflammatory Agents; Cefuroxime; Cephalosporins; Chronic Disease; Cost of Illness; Double-Blind Method; Drug Therapy, Combination; Female; Fluticasone; Glucocorticoids; Humans; Imidazoles; Male; Middle Aged; Nasal Decongestants; Proportional Hazards Models; Quality of Life; Rhinitis; Sinusitis

To assess the cellular and humoral effects of unilateral topical steroid application on the nasal mucosa of chronic sinusitis patients.. Cohort study with randomized grouping.. Chronic sinusitis patients awaiting endonasal sinus surgery were randomly divided into a study group and a control group. All patients underwent allergy studies and categorized as allergic or nonallergic. Patients in the study group were exposed unilaterally to fluticasone propionate nasal spray, 100 microg/day for 4 to 6 weeks before the planned surgery. The control group was not exposed to steroids. At the time of surgery, anterior ethmoid mucosa specimens were obtained. The samples were immunostained for CD3, MBP, CD68, elastase, and tryptase. In situ hybridization was used for the detection of interleukin (IL)-4, IL-5, and interferon gamma (IFN-gamma) mRNA. The results were compared between the treated and untreated sides of exposed patients, as well as with nontreated controls.. Twenty-one patients consented to participate in the study. The number of CD3-, MBP-, and tryptase-positive cells was significantly less in the treated and untreated sides of exposed patients, compared with unexposed controls. IL-4 and IL-5 mRNA were significantly downregulated in the treated side of allergic patients, as compared with nontreated patients. This effect could not be shown for IL-4 in nonallergic patients.. Topical steroid therapy had an anti-inflammatory effect on both allergic and nonallergic chronic sinusitis patients. The unilateral application of the steroid spray affected the contralateral side as well.

Topics: Administration, Intranasal; Adult; Androstadienes; Anti-Inflammatory Agents; Cytokines; Female; Fluticasone; Humans; Immunohistochemistry; In Situ Hybridization; Interferon-gamma; Interleukin-4; Interleukin-5; Male; Respiratory Hypersensitivity; RNA, Messenger; Sinusitis; Treatment Outcome

To test whether the use of fluticasone dipropionate nasal spray after endoscopic ethmoidectomy for multiple polyps is associated with a high incidence of infection. DESIGN. Randomized control study comparing the incidence of infection with the use of beclomethasone dipropionate or fluticasone propionate nasal spray after functional endoscopic sphenoethmoidectomy. Patients were followed up for 6 to 12 months.. Sixty patients with recurrent bilateral nasal polyps underwent functional endoscopic sphenoethmoidectomy and were then randomly allocated into 2 groups of 30 patients each. One group received beclomethasone dipropionate spray (100 micrograms in each nostril every 12 hours), and the other group received fluticasone propionate spray (100 micrograms/d in each nostril).. In the fluticasone propionate group, 6 patients (20%) developed acute gram-positive pansinusitis requiring hospitalization and discontinuation of treatment.. The use of fluticasone dipropionate aqueous nasal spray for the postoperative control of recurrent nasal polyps seems to be associated with a high incidence of acute pansinusitis.

Topics: Acute Disease; Adult; Aerosols; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Combined Modality Therapy; Endoscopy; Female; Fluticasone; Humans; Incidence; Male; Middle Aged; Nasal Polyps; Postoperative Care; Postoperative Complications; Sinusitis

Sinus surgery removes inflamed tissue, restores airflow, and improves delivery of medication into surgically opened spaces. The exhalation delivery system with fluticasone (EDS-FLU; XHANCE. We aimed to compare EDS-FLU treatment responses in patients with recurrent symptoms after endoscopic sinus surgery (ESS) and patients who have never had sinus surgery.. Data were pooled from two large, controlled trials (NAVIGATE I and II) for exploratory analyses. Chronic rhinosinusitis symptoms, polyp grade, and quality-of-life measures were compared between patients with prior ESS and those without prior ESS.. Patients with prior ESS (exhalation delivery system-placebo [n = 53], EDS-FLU 186 μg [n = 52], and EDS-FLU 372 μg [n = 49]) and unoperated patients (exhalation delivery system-placebo [n = 108], EDS-FLU 186 μg [n = 108], and EDS-FLU 372 μg [n = 111]) treated with EDS-FLU reported similar and substantial benefits as measured by multiple symptom and quality-of-life/functioning outcomes (congestion score, 22-Item Sinonasal Outcomes Test [SNOT-22], Rhinosinusitis Disability Index [RSDI], Patient Global Impression of Change) and by nasal polyp grade. In previously operated patients, unlike surgery-naive patients, multiple outcomes (SNOT-22, RSDI, polyp grade) consistently showed numerically but not statistically greater responses to the higher dose.. Patients with recurrent symptoms after sinus surgery who were treated with EDS-FLU demonstrated significant symptom and quality-of-life improvement. Unlike unoperated patients, patients with prior ESS had a numerically but not statistically greater response to the higher dose of EDS-FLU (two sprays per nostril twice a day).

Topics: Chronic Disease; Endoscopy; Exhalation; Fluticasone; Humans; Nasal Polyps; Randomized Controlled Trials as Topic; Rhinitis; Sinusitis; Treatment Outcome

Topics: Chronic Disease; Fluticasone; Humans; Nasal Polyps; Rhinitis; Sinusitis

Topics: Fluticasone; Humans; Nasal Polyps; Sinusitis

Although subsequent anti-inflammatory treatments are indispensable for patients with chronic rhinosinusitis (CRS) undergoing sinus surgery, few studies have explored the factors influencing the efficacy of postoperative anti-inflammatory treatment.. We aimed to develop prediction models for the response to glucocorticoid- and macrolide-based postoperative therapy in CRS patients.. We performed a post-hoc analysis of our previous study comparing the efficacy of fluticasone propionate and clarithromycin in the postoperative treatment of CRS patients. Clinical characteristics and treatment outcome information were collected. In addition, diseased sinonasal mucosal tissues obtained during surgery were processed for Bio-Plex analysis of protein levels of 34 biomarkers. Classification trees were built to predict refractory CRS based on clinical characteristics and biological markers for patients treated with fluticasone propionate or clarithromycin. A random forest algorithm was used to confirm the discriminating factors that formed the classification trees.. One year after surgery, 22.7% of the patients (17/75) treated with fluticasone propionate, and 24.3% of those (18/74) treated with clarithromycin were diagnosed with refractory CRS. Nasal tissue IL-8 and IgG3 levels and headache VAS scores in the fluticasone propionate group, and nasal tissue IgG4 levels and overall burden of symptoms VAS scores in the clarithromycin group, were identified as discriminating factors forming the classification tree to predict refractory CRS. The overall predictive accuracy of the model was 89.3% and 87.8% for fluticasone propionate- and clarithromycin-based postsurgical treatment, respectively.. Classification trees built using clinical and biological parameters could be helpful in identifying patients with poor response to fluticasone propionate- and clarithromycin-based postoperative treatment.

Topics: Androstadienes; Biomarkers; Chronic Disease; Double-Blind Method; Fluticasone; Glucocorticoids; Humans; Macrolides; Rhinitis; Sinusitis

Inhaled nasal corticosteroid sprays (INS) are often inadequate to treat chronic rhinosinusitis (CRS). The exhalation delivery system with fluticasone (EDS-FLU; XHANCE®) may improve outcomes in CRS by increasing medication delivery to target superior/posterior anatomic sites. This study assessed safety and efficacy of EDS-FLU in a large population with moderate-to-severe CRS with or without nasal polyps (CRSwNP, CRSsNP).. Prospective, multicenter, 12-week, single-arm study of EDS-FLU 372 Â#181;g twice daily (BID) at 38 U.S. sites. Safety was assessed by adverse-event evaluations, nasal endoscopy, and ocular examinations. Efficacy was serially assessed by outcomes including nasal endoscopy (Lund-Kennedy Score, polyp grade), patient- and physician-reported outcomes (22-item Sinonasal Outcome Test [SNOT-22]), study-defined surgical indicator assessment, and Patient Global Impression of Change (PGIC).. 705 comparatively refractory subjects were enrolled, 603 CRSsNP and 102 CRSwNP [moderate-to-severely symptomatic; baseline SNOT-22 ~43, high rates of prior INS use (92.3%) and/or prior surgery (27.5%)]. More than 90% reported improvement on treatment by PGIC. SNOT-22 scores improved substantially and similarly in patients with NP (-23.7) and without NP (-24.4). Among patients with baseline Lund-Kennedy edema scores >0, 33.3% (CRSwNP) and 54.8% (CRSsNP) had complete resolution of edema. In CRSwNP patients, 48% had polyp elimination in ?1 nostril, 63% had ?1-point improvement in polyp grade, mean bilateral polyp grade decreased from 2.9 to 1.6, and study-defined surgical eligibility decreased. EDS-FLU was generally well tolerated, with a safety profile similar to conventional INS sprays when used to treat CRS CONCLUSION: EDS-FLU 372 #181;g BID in the treatment of CRS with or without polyps was safe, well-tolerated, and produced substantial improvement across a broad range of both objective and subjective measures.

Topics: Chronic Disease; Endoscopy; Exhalation; Fluticasone; Humans; Nasal Polyps; Prospective Studies; Rhinitis; Sinusitis

A novel, bioabsorbable, fibrinogen-based implant has been developed as a mucosal dressing after endoscopic sinus surgery (ESS). This implant can be formulated with fluticasone propionate (FP) for local elution of corticosteroid to reduce postoperative inflammation and promote mucosal healing.. This study investigated the biocompatibility and pharmacokinetics of the implant in a rabbit model.. Implants with and without FP were placed on both intact and demucosalized maxillary sinuses of 33 New Zealand White rabbits. Sinuses with either intact or denuded bone without implants acted as controls. Histopathologic assessments were carried out at 5, 15, and 28 days. Concentrations of FP in the maxillary sinus mucosa, nasal cavity mucosa, and plasma were measured for up to 44 days.. Implants placed on intact mucosa or denuded bone were grossly integrated within 15 days. Minimal foreign body reaction was seen with negligible differences for inflammation, fibrosis, or bone remodeling among controls, sinuses with the implant, or sinuses with the implant plus FP, at all time points. All samples also showed complete or near-complete percentage reepithelialization at 28 days, although the denuded bone controls demonstrated greater percentage reepithelialization at 5 days compared with denuded bone with the implant or implant plus FP (p < 0.0001). The maxillary sinus mucosa demonstrated levels of FP of >140 ng/g up to 44 days. Plasma concentrations of FP were generally very low and were undetectable after day 7.. The implant and the implant plus FP seemed to be biocompatible in rabbits. The implant plus FP effectively eluted steroid locally over at least 44 days, with negligible plasma concentrations. Further studies are warranted regarding potential therapeutic applications in patients undergoing ESS for chronic rhinosinusitis.

Topics: Absorbable Implants; Animals; Drug Delivery Systems; Fluticasone; Materials Testing; Paranasal Sinuses; Rabbits; Rhinitis; Sinusitis

Endoscopic sinus surgery (ESS) improves symptoms for many chronic rhinosinusitis (CRS) patients by enlarging the size of sinus ostia, improving mucociliary clearance, and facilitating access for topical therapies. However, the effect of surgery on the sinonasal microbiota remains poorly understood. This study examined changes in bacterial communities in CRS patients before and after surgery.. Swab samples were taken from the middle meatus of 23 patients undergoing ESS. Follow-up swabs were taken in clinic (mean 120 days postsurgery). Symptom scores and antibiotic use were recorded. Bacterial communities were characterized using 16s ribosomal RNA (rRNA) gene-targeted amplicon sequencing and bacterial abundance was measured using quantitative polymerase chain reaction (PCR). Coexisting asthma, aspirin sensitivity, antibiotic use, and presence of polyps were controlled for.. Unpredictable shifts in bacterial community composition were seen postoperatively. ESS was associated with increased bacterial richness. Many taxa had changes in average relative abundance and prevalence. Staphylococcus was the only dominant taxa to increase significantly in relative abundance (p = 0.002). Changes in bacterial communities were driven more by intersubject variability (p = 0.007) than other study factors. Finegoldia, a minority taxon, was associated with a reduction in abundance following ESS, increases in patients with higher symptoms scores, and reductions in patients with reduced total bacterial burden.. This study documented changes in bacterial composition and abundance in the middle meatus following ESS. The complexity of these changes reflects the variability between patients. Modern molecular techniques highlight the currently limited knowledge of the impact of therapies on the microbiology of CRS.

Topics: Adult; Aged; Bacteria; Chronic Disease; Endoscopy; Female; Fluticasone; Humans; Male; Microbiota; Middle Aged; Paranasal Sinuses; Rhinitis; RNA, Bacterial; RNA, Ribosomal, 16S; Sinusitis

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

Intranasal steroids are the first line of treatment for chronic rhinosinusitis. Although contamination of adjunctive devices (e.g. irrigation bottles) has been much investigated, little is known about nasal contamination of the metered-dose spray bottles used to deliver intranasal steroids, and the potential influence on disease chronicity.. Twenty-five prospectively recruited patients with stable chronic rhinosinusitis underwent microbiological analysis of their nasal vestibule and middle meatus and also of their steroid bottle tip and contents. Additionally, bottle tips were inoculated in vitro with Staphylococcus aureus and various sterilisation techniques tested.. For 18 of the 25 (72 per cent) patients, both nasal and bottle tip swabs grew either Staphylococcus aureus or coagulase-negative staphylococci. Staphylococcus aureus was cultured from 7 of the 25 (28 per cent) patients, and 5 of these 7 had concomitant bacterial growth from both nose and steroid bottle. Thus, the cross-contamination rate was 71 per cent for Staphylococcus aureus infected patients and 20 per cent overall. Sterilisation was effective with boiling water, ethanol wipes and microwaving, but not with cold water or dishwashing liquid.. Nasal steroid spray bottle tips can become contaminated with sinonasal cavity bacteria. Simple sterilisation methods can eliminate this contamination. Patient education on this matter should be emphasised.

Topics: Administration, Intranasal; Aged; Androstadienes; Anti-Inflammatory Agents; Chronic Disease; Equipment Contamination; Female; Fluticasone; Fomites; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Cavity; Nasal Sprays; Patient Education as Topic; Pregnadienediols; Prospective Studies; Rhinitis; Sinusitis; Staphylococcus aureus; Sterilization

Chronic rhinosinusitis and asthma are expressions of airway inflammatory diseases that frequently coexist, especially in the case of adult-onset asthma. Both conditions have similar pathological features, while one affects the upper airways and the other the lower airways. Whether the treatment of bronchial inflammation affects the severity of sinus disease remains an unanswered question. We report a case of refractory chronic rhinosinusitis with co-morbid adult-onset asthma that effectively improved upon treatment with a daily dose of 200 μg (100 μg b.i.d.) of inhaled fluticasone propionate (FP).

Topics: Administration, Inhalation; Androstadienes; Asthma; Bronchodilator Agents; Chronic Disease; Female; Fluticasone; Humans; Middle Aged; Rhinitis; Sinusitis; Treatment Outcome

Topics: Androstadienes; Chronic Disease; Cone-Beam Computed Tomography; Cyclooxygenase 2; Dithiothreitol; Fluticasone; Head; Humans; Imaging, Three-Dimensional; Nasal Lavage; Nose Diseases; Nose Neoplasms; Papilloma, Inverted; Rhinitis; Sinusitis

NF-ĸB is an essential transcription factor strongly associated to inflammatory response in chronic rhinosinusitis with nasal polyps (CRSwNP). DHMEQ is a NF-ĸB inhibitor that has been previously described with a greatpotential indecreasing inflammation in diseases other than CRSwNP. The aim of study isto evaluate the ability of DHMEQ to reducethe inflammatory recruiters on CRSwNP and to compare its anti-inflammatory profile as a single-agent or in association with fluticasone propionate (FP).. nasal polyp fibroblasts were cultured in TNF-α enriched media. Cells were submitted to three different concentrations (1, 10 and 100nM) of either FP, DHMEQ or both. Inflammatory response was accessed by VCAM-1, ICAM-1 and RANTES expression (by RTQ-PCR) and protein levels by ELISA. Nuclear translocation of NF-ĸB was also evaluated.. both FP and DHMEQ inhibited inflammatory recruiters' production and NF-ĸB nuclear translocation. Interestingly, the anti-inflammatory effect from the association steroids plus DHMEQ was more intense than of each drug in separate.. DHMEQ seems efficient in modulating the inflammatory process in CRSwNP. The synergic anti-inflammatory effect of DHMEQ and steroids may be a promising strategy to be explored, particularly in the setting of steroid-resistant NP.

Topics: Active Transport, Cell Nucleus; Androstadienes; Anti-Inflammatory Agents; Benzamides; Cell Survival; Cells, Cultured; Chemokine CCL5; Cyclohexanones; Cytokines; Fibroblasts; Fluticasone; Gene Expression; Humans; Inflammation Mediators; Intercellular Adhesion Molecule-1; Nasal Polyps; NF-kappa B; Rhinitis; Sinusitis; Tumor Necrosis Factor-alpha; Vascular Cell Adhesion Molecule-1

The postnasal drip (PND) syndrome is often linked as a cause of chronic cough although this is disputed.. We examined the effect of specific topical treatment of rhinosinusitis on cough in patients presenting with a chronic cough associated with a postnasal drip or 'nasal catarrh'.. Patients presenting with a chronic cough and who complained of PND were enrolled and symptoms of PND and cough were assessed by questionnaire and by a capsaicin cough response. Rhinosinusitis was assessed by questionnaires, direct examination of the nose and by high-resolution computed tomography. In an open study, they were treated with fluticasone nasules, ipratropium bromide and azelastine nasal sprays for 28 days, after which they were re-assessed.. Eighteen out of 21 patients completed the study. All patients reported having the presence of mucus in the throat. Mean cough score improved post-treatment (p<0.05), but there was no significant change in capsaicin cough sensitivity or nasal catarrh questionnaire score. There was improvement in anterior nasal discharge symptom scores (p=0.005) and in endoscopic nasal scores post-treatment (p<0.01), with a tendency to improved PND scores.. In a pilot open 'real-life' study treatment targeted towards rhinosinusitis accompanying PND syndrome and chronic cough led to an improvement in cough. A randomised controlled study is now needed to confirm or refute these findings.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Androstadienes; Anti-Inflammatory Agents, Non-Steroidal; Chronic Disease; Cough; Female; Fluticasone; Humans; Male; Middle Aged; Nasal Mucosa; Phthalazines; Quality of Life; Rhinitis; Sinusitis; Surveys and Questionnaires; Syndrome; Tomography, X-Ray Computed; Treatment Outcome; Young Adult

Chronic sinusitis with eosinophils easily recurs after endoscopic sinus surgery. The condition is usually complicated by asthma, and many eosinophils are present in the sinus mucosa. One conservative treatment method is the administration of glucocorticoids locally or systematically. To evaluate the efficacy and tolerability of intranasal fluticasone propionate for the treatment of chronic sinusitis with eosinophils, seven patients with chronic sinusitis with eosinophils were treated over a 12-week period using a fluticasone propionate aqueous nasal spray (800 microg per day in each nostrilz). The Symptons of 7 patients, especially nasal discharge and nasal obstructions, improved and an expanded air space was observed on paranasal CT images. The percent of drug systemically available after intranasal administration varied by less than 1% for intranasal fluticasone propionate. Therefore, even if intranasal fluticasone propionate is administerved at double the usual dose, it is unlikely to cause systemic side effects. Fluticasone propionate aqueous nasal spray at double the usual dose is effective for the treatment of chronic sinusitis with eosinophils.

Topics: Administration, Intranasal; Adult; Androstadienes; Anti-Inflammatory Agents; Chronic Disease; Eosinophilia; Female; Fluticasone; Humans; Male; Middle Aged; Sinusitis; Treatment Outcome

A Th2 cytokine pattern has recently been reported both in allergic and nonallergic chronic rhinosinusitis in asthmatic children. The aim of the study was to evaluate the cytokine pattern in chronic rhinosinusitis in allergic and nonallergic asthmatic children before and after medical treatment. Thirty asthmatic children were evaluated, 18 males and 12 females (mean age 9.1 years). Sixteen were allergic and 14 were nonallergic. All children were asthmatic and suffered from chronic rhinosinusitis, whose diagnosis was confirmed by endoscopy. All of them were treated with amoxicilline-clavulanate (20 mg/kg b.i.d.) and fluticasone propionate aqueous nasal spray (100 microg daily) for 14 days; a short course of oral corticosteroid was also prescribed (deflazacort 1 mg/kg daily for 2 days, 0.5 mg/kg daily for 4 days and 0.25 mg/kg daily for 4 days). Rhinosinusal lavage and nasal cytology were performed in all subjects before and after medical treatment. IL4 and IFNgamma were measured by immunoassay and inflammatory cells were counted by conventional staining. Thirteen allergic children and 12 nonallergic children showed a negative endoscopy after the treatment. Allergic subjects showed a significant decrease of IL4 (p = 0.0002) and a significant increase of IFNgamma (p = 0.03) after the treatment. Nonallergic children showed a significant decrease of IL4 (p = 0.0007) and a nonsignificant increase of IFNgamma. A significant reduction of the inflammatory infiltrate was detected in all asthmatic children (p < 0.05). This study confirms a Th2 polarization in chronic rhinosinusitis both in allergic and nonallergic asthmatic children. Moreover, the medical treatment of chronic rhinosinusitis reversed the cytokine pattern from a Th2 towards a Th1 profile both in allergic and nonallergic children.

Topics: Amoxicillin-Potassium Clavulanate Combination; Androstadienes; Anti-Allergic Agents; Anti-Bacterial Agents; Asthma; Child; Child, Preschool; Chronic Disease; Endoscopy; Female; Fluticasone; Humans; Interferon-gamma; Interleukin-4; Male; Sinusitis; Th2 Cells; Treatment Outcome

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

Topics: Acute Disease; Administration, Intranasal; Adult; Androstadienes; Anti-Inflammatory Agents; Cefuroxime; Cephalosporins; Drug Therapy, Combination; Evidence-Based Medicine; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Randomized Controlled Trials as Topic; Sinusitis

Acute community-acquired sinusitis is considered a bacterial complication of the common cold. Radiologic abnormalities in sinuses occur, however, in most patients with upper respiratory virus infections.. Assessment of the occurrence, clinical profile, laboratory findings, and outcome of radiologically confirmed sinusitis was carried out as part of a common cold study in young adults.. Clinical examinations and radiography of the paranasal sinuses were carried out on days 1, 7, and 21 in 197 patients with the common cold. The symptoms were recorded on diary cards on days 1 to 20. Ten viruses and 5 bacteria were studied as etiologic agents of common cold as reported earlier. Serum C reactive protein concentrations, erythrocyte sedimentation rates, and total white blood cell counts with differentials were determined in 40 randomized subjects on day 7. The effect of 6 days of intranasal fluticasone propionate treatment of the common cold in the prevention of sinusitis was analyzed.. On day 7, 39% of patients with the common cold in the placebo group (n = 98) had sinusitis, which we would prefer to call viral sinusitis. The symptoms of patients with sinusitis and those without it were not clinically distinguishable. Viral infection was detected in 81.6% of patients with sinusitis. No significantly increased levels of antibodies to bacteria were detected. Serum C reactive protein concentrations, erythrocyte sedimentation rates, and white blood cell counts were low in patients with sinusitis. All patients made a clinical recovery within 21 days without antibiotic treatment. Fluticasone propionate treatment tended to prevent paranasal sinusitis, especially in rhinovirus-positive subjects.. Viral sinusitis frequently occurs in the early days of the common cold, but it is a self-limited illness. The sinuses should not be imaged in patients with the common cold if the signs and symptoms of illness gradually become less severe and no specific signs suggestive of bacterial sinusitis occur.

Topics: Adult; Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents; Blood Sedimentation; C-Reactive Protein; Common Cold; Community-Acquired Infections; Female; Fluticasone; Humans; Leukocyte Count; Male; Paranasal Sinuses; Radiography; Sinusitis; Treatment Outcome

Topics: Androstadienes; Anti-Inflammatory Agents; Fluticasone; Humans; Research Design; Sinusitis