fluticasone and Rhinitis

Nasal sprays with corticosteroids deliver medication to the restricted areas including anterior and inferior parts of the nasal cavity. The fluticasone exhalation delivery system (EDS-FLU) has recently been proved to improve care by increasing superior/posterior intranasal corticosteroid deposition.. This study aims to evaluate the efficacy of EDS-FLU in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).. A systematic literature review using Pubmed, Embase, Cochrane Library, and Web of Science was conducted to identify studies assessing the effect of EDS-FLU on outcomes in patients with CRSwNP.. Of the initial 108 abstracts reviewed, 4 full-text articles were included. The 22-item sinonasal outcome test scores were significantly decreased in patients with CRSwNP after receiving EDS-FLU twice a day (93, 186, or 372 μg) for 16 weeks when compared with exhalation delivery system (EDS)-placebo (all. This is the first systematic review of the clinical outcomes in patients with CRSwNP treated with EDS-FLU. EDS-FLU produced significant improvements regarding the quality of life, smell, and endoscopic assessment of polyp grade.

Topics: Chronic Disease; Exhalation; Fluticasone; Humans; Nasal Polyps; Quality of Life; Rhinitis

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

The review presents some information on known options for treatment of nonallergic rhinitis (NAR) with introduction to new therapies. The merits and limitations of recent advancements in pharmacotherapy of this common problem are briefly discussed as well.. Intranasal corticosteroids are first-line therapy for NAR. Fluticasone propionate and beclomethasone remain the only topical corticosteroids approved for NAR. The use of azelastine - another first-line option - has also been found to be effective even though NAR is a nonallergic entity by definition. Combination of fluticasone propionate and azelastine is a promising option in achieving better symptom reduction. Coadministration of intranasal corticosteroid and topical decongestants is an attractive topic that requires additional safety studies before recommending treatment. Although promising, no scientifically valid recommendation can be made for treatment of NAR with capsaicin. Surgical options in patients with refractory NAR are limited. New studies demonstrate a lack of correlation between objective outcome of radiofrequency ablation of the inferior turbinate and subjective patient symptoms.. The heterogeneity in clinical presentation makes NAR treatment a daily challenge for otolaryngologists. The diversity of clinical studies with use of unique outcome measures limit systematic reviews which may be instrumental in providing strong recommendations.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Beclomethasone; Capsaicin; Drug Therapy, Combination; Fluticasone; Humans; Nasal Decongestants; Phthalazines; Rhinitis; Sensory System Agents

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

The introduction of nasal glucocorticosteroids, 30 years ago, has been the most important therapeutic progress in rhinitis management since the introduction of the first generation of antihistamines. Our knowledge of the mode of action of glucocorticosteroids in the nose has improved as the airway mucous membrane of the nose is easily accessible for investigation. However, the exact mechanism behind the marked clinical effect remains unclear. Topical glucocorticosteroids are highly effective in diseases characterized by eosinophil-dominated inflammation (allergic rhinitis, nasal polyposis), but not in diseases characterized by neutrophil-dominated inflammation (common cold, infectious rhinosinusitis). Experience for 30 years and a long series of controlled studies have shown that the treatment is highly effective and that the side effects are few and benign. Intranasal glucocorticosteroids can therefore be considered as first-line treatment for allergic and non-allergic, non-infectious rhinitis and nasal polyps.

Topics: Administration, Topical; Androstadienes; Animals; Beclomethasone; Budesonide; Dexamethasone; Eosinophils; Fluocinolone Acetonide; Fluticasone; Glucocorticoids; Humans; Mometasone Furoate; Nasal Mucosa; Nasal Polyps; Pregnadienediols; Randomized Controlled Trials as Topic; Rhinitis; Treatment Outcome; Triamcinolone Acetonide

Inflammation is the pathogenetic basis of many airway diseases like asthma and rhinitis. This provides the rationale for a therapy with antiinflammatory drugs like inhaled corticosteroids (ICS), which are able to suppress the underlying pathologic processes, ensuring an effective control of the disease and improving patients's quality of life. Within ICS, fluticasone is endowed of a potent antiinflammatory activity, due to its high affinity for the the glucocorticoid receptor (allowing the use of 50% of the dose of other ICS) and of a negligible oral bioavailability (<1%), indicating a low potential for systemic exposure. Due to its high therapeutical index, fluticasone can be used in the management of severe asthma or other airway diseases at doses devoid of relevant unwanted systemic effects. Scientific literature has broadly demonstrated its efficacy and safety, even at high doses and in the long term use.

Topics: Adult; Androstadienes; Anti-Inflammatory Agents; Asthma; Child; Clinical Trials as Topic; Fluticasone; Humans; Rhinitis

The effectiveness of fluticasone propionate (FP) aqueous nasal spray in the treatment of rhinitis has been demonstrated in multiple controlled clinical studies. The onset of therapeutic effect of FP in these clinical trials appears to occur within 12 hours after administration of the initial dose.. This article presents an analysis from previous clinical trials that examined the efficacy of intranasal FP in patients with rhinitis to ascertain whether the time to onset of the therapeutic effect of this medication could be determined.. Completed randomized, double-blind, placebo-controlled studies with FP were evaluated to determine whether onset of effect could be evaluated based on the study designs. A study was deemed acceptable for evaluation of onset of effect if at least one evaluation of the intensity of nasal symptoms was completed within 12 hours after the initial dose of study medication and daily evaluations were made thereafter. Adult patients were included in the onset analysis if they received an initial FP dose of 200 microg. Pediatric patients who received an initial FP dose of 100 microg were also included. Onset of effect was evaluated by 1) examining the timepoints at which statistically significant differences were observed between FP and placebo in mean change from baseline for total nasal symptom score (TNSS); and by 2) using a binary probability model of success/failure to determine statistically significant differences from placebo.. Twenty-two studies met the criteria to evaluate onset of therapeutic effect; 3,605 patients with rhinitis received FP and 2,271 patients received placebo. This database represents the largest compilation of data ever assembled to determine the onset of therapeutic effect of a corticosteroid nasal spray. Two studies used a "park design" to examine onset of effect; statistically significant differences in TNSS favoring FP were achieved at hours 2 to 4 and at hour 12, respectively. Using a binary probability model of success/failure for analysis of TNSS in the remaining 20 studies not specifically designed to evaluate onset of effect, numerically greater improvements in TNSS for FP compared with placebo were found in 19 of the 20 studies within 12 hours of the administration of the first dose (P < .001). Pairwise comparisons showed statistically significant improvement for TNSS within 12 hours postdose in five of the studies for FP compared with placebo and in none for placebo compared with FP.. Onset of therapeutic effect occurs within 12 hours, and as early as 2 to 4 hours in some patients, after administration of the first dose of FP aqueous nasal spray.

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents; Double-Blind Method; Fluticasone; Humans; Models, Statistical; Randomized Controlled Trials as Topic; Rhinitis; Time Factors

The early inflammatory response during allergic rhinitis and asthma is associated with IgE-mediated mast cell activation and resultant release of primary inflammatory mediators. The late phase reaction is characterized by recruitment, activation and tissue infiltration of leucocyte populations, including T lymphocytes, eosinophils, basophils and neutrophils. T helper type 2 CD4+ cells, a T lymphocyte subset with a distinctive cytokine profile, are thought to regulate the recruitment and activation of other effector cells. This review discusses the results of studies conducted under experimental and natural conditions of allergen exposure, which confirm the presence of eosinophilia, changes in lymphocyte populations, and increased expression of a TH2-cytokine profile in the nasal mucosa following allergen-induced rhinitis, and the alleviation of both clinical symptoms and inflammatory responses by prior treatment with topical fluticasone propionate. Similar effects are demonstrated to occur in the lower airway following allergen challenge in asthma patients, and to be ameliorated by oral corticosteroid therapy. These studies add weight to the argument that asthma and rhinitis share a common pathophysiology characterized by similar inflammatory events, and should both benefit from early preventative treatment with topical corticosteroids.

Topics: Administration, Topical; Adrenal Cortex Hormones; Androstadienes; Anti-Inflammatory Agents; Asthma; Fluticasone; Glucocorticoids; Humans; Interferon-gamma; Interleukin-4; Interleukin-5; Leukocytes; Lung; Nasal Mucosa; Rhinitis

The intranasal corticosteroid fluticasone propionate is an effective agent for the treatment of rhinitis, demonstrating potent local anti-inflammatory activity and little, if any, systemic activity. Intranasal fluticasone propionate has shown clinical efficacy similar to that of other intranasal corticosteroids, including beclomethasone (administered at up to a 2-fold higher dosage than fluticasone), budesonide, flunisolide and triamcinolone acetonide, and provides greater relief from nasal symptoms (including nasal blockage) than antihistamine agents and intranasal sodium cromoglycate. Its efficacy in the treatment of seasonal allergic rhinitis and perennial allergic and nonallergic rhinitis has been demonstrated in large well-controlled studies in which the drug maintained adequate control of symptoms when administered in a once daily dose of 200 micrograms. In addition, fluticasone propionate has shown similar efficacy to that of beclomethasone in the treatment of nasal polyps; however, its use in the postoperative setting requires further investigation. Intranasal fluticasone propionate is well tolerated in the majority of patients, the incidence of adverse events being similar to that seen with placebo. Pharmacoeconomic analyses indicate that intranasal fluticasone propionate is significantly more cost-effective than the antihistamines terfenadine and loratadine. Overall quality of life was improved to a similar extent by fluticasone propionate and beclomethasone. In conclusion, recent clinical experience has confirmed that intranasal fluticasone propionate is a convenient, effective and well tolerated alternative to other intranasal corticosteroids and antihistamines for the treatment of rhinitis when administered once daily.

Topics: Administration, Intranasal; Androstadienes; Anti-Inflammatory Agents; Clinical Trials as Topic; Cost-Benefit Analysis; Fluticasone; Humans; Nasal Polyps; Quality of Life; Rhinitis

Fluticasone propionate (FP) is a novel androstane glucocorticoid with potent anti-inflammatory activity which has been effectively used, intranasally, as therapy for seasonal and allergic perennial rhinitis. When taken by the inhaled route, FP has shown significant therapeutic efficacy in the management of asthma. Fluticasone propionate is a highly lipophilic molecule with good uptake, binding and retention characteristics in human lung tissue. Fluticasone propionate has high glucocorticoid receptor selectivity and affinity, demonstrating rapid receptor association and slow receptor dissociation. In vitro, FP has been shown to potently inhibit T lymphocyte proliferation, cytokine generation, tumour necrosis factor alpha (TNF-alpha)-induced adhesion molecule expression, interleukin-5-induced eosinophilia, mucosal oedema and toluene 2,4-diisocyanate-induced mast cell proliferation, while promoting secretory leucocyte protease inhibitor production and eosinophil apoptosis. In human studies, FP has demonstrated marked vasoconstrictor potency in normal subjects and inhibited antigen-induced mucosal platelet activating factor/eicosanoid production, T lymphocytes and CD25+ cells in patients with rhinitis. Biopsy data from mild asthmatics demonstrate FP-associated reduction in CD3, CD4, CD8 and CD25 cells, with an accompanying reduction in eosinophil and mast cell markers. Clinical studies have evaluated lung function, bronchial reactivity, exacerbation rates and oral corticosteroid-sparing effect. Results show that FP has at least twice the clinical potency of beclomethasone dipropionate and budesonide. This appears to be achieved without an accompanying increase in systemic effects, suggesting a therapeutic index which may be higher than other currently available inhaled corticosteroids.

Topics: Androstadienes; Animals; Anti-Inflammatory Agents; Asthma; Clinical Trials as Topic; Dose-Response Relationship, Drug; Fluticasone; Humans; Lung; Rhinitis

Standard nasal steroid sprays are often first-line treatment for chronic rhinosinusitis (CRS), but many patients remain symptomatic despite their use. The exhalation delivery system with fluticasone (EDS-FLU) has been shown to be efficacious in mixed populations of symptomatic patients, but the question remains whether benefits would be similar in those already on traditional steroid sprays. The goal of this study was to compare EDS-FLU treatment outcomes in patients who have previously failed nasal steroids.. Using pooled data from the NAVIGATE I and II trials, EDS-FLU efficacy was compared in the subgroup treated with a conventional nasal steroid at trial entry (mean duration, ≈3 years) to efficacy in the overall study population. Sensitivity analyses were performed for more restrictive definitions of the subgroup changing from prior standard nasal steroids.. Of 482 total subjects, 218 (45.2%) reported using standard nasal steroid sprays at entry (mean duration, 1051 days). Across multiple outcome measures, improvements for "switchers" receiving EDS-FLU (least squares mean change from baseline vs EDS plus placebo) were comparable with improvements in the overall population. For EDS-FLU 372 μg, comparable improvements were observed in congestion (-0.73 vs -0.62), rhinorrhea (-0.71 vs -0.57), facial pain/pressure (-0.48 vs -0.41), and sense of smell (-0.35 vs -0.30) at week 4 and 22-item Sino-Nasal Outcome Test (-21.01 vs -20.52), Patient Global Impression of Change, and other outcomes at week 16. Results for EDS-FLU 186 μg were similar.. EDS-FLU comparably improves symptoms, irrespective of whether patients are symptomatic while using conventional nasal steroids before treatment.

Topics: Chronic Disease; Exhalation; Fluticasone; Humans; Nasal Polyps; Nasal Sprays; Rhinitis; Steroids

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

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

An important function of the healthy nose is the ability to adjust nasal patency in response to stimuli such as a change in posture between sitting and supine. We hypothesised that the regulation of nasal patency would be impaired in patients with asthma and mild rhinitis and that it could be improved by reducing nasal inflammation with a topical nasal steroid. This is a randomised, placebo-controlled, double-blind, cross-over study comprising 19 subjects with well-controlled asthma and a history of rhinitis without current treatment. The subjects were randomised to fluticasone propionate aqueous nasal spray (Beconase(®)), 200 μg daily, or placebo (FESS(®) saline nasal spray), for 6 weeks in a cross-over design with a 4-week wash-out between treatments. Nasal patency was measured with acoustic rhinometry, while sitting and supine and with peak nasal inspiratory flow (PNIF). Treatment response was also monitored with spirometry, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Short Form-36 (SF-36), and The Pittsburgh Sleep Quality Index. The minimal cross-sectional area remained unchanged between sitting and supine at baseline and after placebo but after fluticasone propionate there was a significant decrease. PNIF, RQLQ and SF-36 improved after fluticasone propionate, whereas sleep quality did not change. In well-controlled asthma and mild rhinitis, nasal steroid treatment normalised the neurovascular response to posture in the nasal mucosa and improved health-related quality of life. An impaired ability to regulate nasal patency could be a marker of upper airway inflammation in patients with asthma that can be measured non-invasively.

Topics: Administration, Intranasal; Adult; Androstadienes; Anti-Allergic Agents; Asthma; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fluticasone; Follow-Up Studies; Humans; Male; Nasal Mucosa; Prospective Studies; Quality of Life; Rhinitis; Rhinometry, Acoustic; Severity of Illness Index; Treatment Outcome

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

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

Allergic rhinitis is a common airways hypersensitivity disease. Histamine and leukotrienes are involved in the pathogenesis of allergic rhinitis. Conventional treatments include topical steroids and antihistamines. Due to the adverse effects of these treatments, new drugs like leukotriene receptor antagonists are being investigated for the treatment of allergic rhinitis. A total of 90 patients suffering from allergic rhinitis were enrolled in this prospective, randomized, controlled study. Patients were divided randomly into three groups of 30 patients each. Group I was administered fluticasone nasal spray (200 μg in each nostril) once a day, Group II was administered fluticasone nasal spray (200 μg in each nostril) plus cetrizine (10 mg) orally once a day and Group III was administered fluticasone nasal spray (200 μg in each nostril) plus montelukast (10 mg) orally once a day. Efficacy was measured based on daytime and nighttime symptom scores. Safety was evaluated on the basis of psychomotor tests, laboratory investigations and subjective assessment. The present study showed that montelukast add-on therapy is as efficacious as conventional therapies in controlling total symptom score, but it is more efficacious in controlling nighttime symptoms. Furthermore, montelukast add-on therapy does not cause psychomotor impairment as observed with cetrizine.

Topics: Acetates; Administration, Intranasal; Administration, Oral; Adult; Androstadienes; Anti-Allergic Agents; Cetirizine; Cyclopropanes; Drug Therapy, Combination; Female; Fluticasone; Follow-Up Studies; Humans; Leukotriene Antagonists; Male; Nasal Sprays; Prospective Studies; Quinolines; Rhinitis; Sulfides

We assessed the efficacy of different forms of fluticasone propionate in the treatment of bilateral nasal polyposis in adult patients.. This double-blind, randomized, parallel group study included 34 patients, aged 16 years or over, with a diagnosis of bilateral nasal polyposis. The patients were randomized to three groups to receive fluticasone propionate in the form of aqueous nasal spray 100 microg twice daily, or nasal drop preparation 400 microg once or twice daily for 12 weeks. Once every four weeks, nasal volumes were measured by acoustic rhinometry and polyp size was assessed by a 4-mm rigid endoscope. Clinical symptom scores were assessed once a week.. The mean nasal polyp scores decreased significantly in all the groups (p<0.005). Total nasal volume did not improve significantly with the nasal spray. Although single daily nasal drop application increased total nasal volume significantly only at the end of treatment (p<0.05), increases with twice daily application were significant at 4, 8, and 12 weeks, compared to the baseline values and corresponding values of the other two groups (p<0.005). Nasal blockage and rhinitis symptom scores improved in all the groups (p<0.05), but the difference from the baseline was highest with twice daily nasal drop application. Smelling showed a significant improvement only with twice daily nasal drop application (p<0.05). In none of the groups did nasal discomfort scores differ significantly from the baseline at the end of treatment.. Nasal drop preparation of fluticasone propionate given twice daily showed the highest efficacy in increasing total nasal volume, decreasing nasal polyp size, and improving smelling and nasal blockage.

Topics: Administration, Intranasal; Adult; Aerosols; Aged; Androstadienes; Anti-Inflammatory Agents; Double-Blind Method; Endoscopy; Female; Fluticasone; Humans; Male; Middle Aged; Nasal Obstruction; Nasal Polyps; Nose; Prospective Studies; Rhinitis; Rhinometry, Acoustic; Smell; Treatment Outcome; Young Adult

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

Increased nasal airflow resistance (NAR) may contribute to the pathophysiology of obstructive sleep apnoea syndrome (OSAS) but studies investigating the effects of relieving nasal obstruction in OSAS have produced differing results. There are no reports of intranasal corticosteroid therapy in adult OSAS patients with reversible nasal obstruction.. We evaluated an intranasal corticosteroid, fluticasone propionate, in 24 consecutive snorers with associated rhinitis using a randomised, placebo controlled, crossover design. Patients underwent polysomnography, snoring noise, and NAR measurements at baseline and after each 4 week treatment period.. Twenty three patients completed the protocol and were divided into an apnoeic group (group A; 13 patients) and a non-apnoeic snoring group (group S; 10 patients) based on an apnoea-hypopnoea frequency (AHI) of > or =10/h or <10/h. AHI was significantly lower following treatment with fluticasone than with placebo in the total population (median (quartile range) 11.9 (22.6) v 20 (26.3); p<0.05) and in group A (23.3 (21.3) v 30.3 (31.9); p<0.05). Median (95% confidence interval) within subject differences for AHI were -3.2 (-17.7 to -0.2) in the total population and -6.5 (-29.5 to 1.8) in group A. NAR was also lower on fluticasone (2.74 (1.21) v 3.27 (1.38), p<0.01), within subject difference being -0.45 (95% CI -0.87 to -0.21). The changes in AHI and NAR in group A were significantly correlated (r=0.56; p<0.05). Snoring noise and sleep quality were unchanged but daily diary records indicated subjective improvements in nasal congestion and daytime alertness with fluticasone (p<0.02).. Intranasal fluticasone is of benefit to some patients with OSAS and rhinitis. The data suggest that this form of nasal obstruction may contribute to the pathophysiology of OSAS.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Adult; Aerosols; Airway Resistance; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Method; Female; Fluticasone; Humans; Male; Middle Aged; Polysomnography; Rhinitis; Sleep Apnea, Obstructive; Snoring

The purpose of this study was to evaluate whether the use of fluticasone propionate, mometasone furoate, or beclomethasone dipropionate for the treatment of rhinitis produced, as a side effect, an increase in the intraocular pressure; only one printed article proclaims that the increase of secondary intraocular pressure is due to the use of local nasal steroids.. We conducted a comparative, double-blind, experimental, prospective, longitudinal study in which 360 patients were divided at random into 4 groups; 90 of them were given a placebo (control group) and the other 270 were divided into 3 other groups of 90 patients each and given a different local nasal steroid for each group. Measurement parameters All patients had their intraocular pressure measured by Goldman's tonometry at 3 weeks, 6 weeks, 3 months, 6 months, and 1 year after using the placebo or local nasal steroid.. Variations were found in the intraocular pressure of patients who used local steroid, with discreet elevations in the beclomethasone dipropionate and mometasone furoate groups; however, variations were always within normal limits.. Fluticasone propionate, mometasone furoate, and beclomethasone dipropionate cause variations in the intraocular pressure, but the variations are within normal limits.

Topics: Adolescent; Adult; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Double-Blind Method; Fluticasone; Glucocorticoids; Humans; Intraocular Pressure; Middle Aged; Mometasone Furoate; Pregnadienediols; Prospective Studies; Rhinitis

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

Prostaglandins and leukotrienes are implicated in conditions of both the upper and lower airways. In the former they are deranged in nasal polyposis, intrinsic rhinitis and allergic rhinitis while in the latter they are involved in the pathogenesis of asthma. The aim of the present study was to measure mucosal eicosanoid levels in the three types of rhinitis and compare with controls. In addition, the effect of topical steroids on eicosanoid levels in rhinitis was examined. The levels of prostaglandins E(2) (PGE(2)) and D(2) (PGD(2)) and of leukotrienes E(4) (LTE(4)) and B(4) (LTB(4)) were measured in nasal biopsies from the inferior turbinates of patients suffering from perennial rhinitis and a control group. Rhinitis patients were classified into three categories: perennial allergic rhinitis (PAR), non-allergic rhinitis with eosinophilia (NARES) and noneosinophilic non-allergic rhinitis (NENAR) on the basis of symptoms, secretion eosinophilia, nasal resistance and allergy testing. Patients with rhinitis were randomized into two groups. One received fluticasone propionate nasal spray (FPANS) and the other a placebo (PNS) over a period of six weeks prior to the biopsies. One hundred and one patients with PAR, NARES or NENAR were recruited sequentially and the control group consisted of 21 patients with no evidence of rhinitis but with nasal obstruction due to septal deviation. Untreated rhinitics had significantly lower levels of PGE(2), PGD(2) and LTE(4) than non-rhinitic controls. Six-weeks' treatment with FPANS significantly increased the levels of those eicosanoids in patients with PAR and NARES but they were still significantly below normal. Levels of LTB(4) in all three rhinitis groups were not significantly different from controls and treatment with topical steroids had no effect. Their findings are contrary to current thinking that increased levels of eicosanoids, in particular cysteinyl-leukotrienes, play an important role in the pathogenesis of chronic, non-infective upper airway inflammation.

Topics: Airway Resistance; Androstadienes; Anti-Inflammatory Agents; Chronic Disease; Dinoprostone; Double-Blind Method; Eosinophils; Fluticasone; Humans; Leukocyte Count; Leukotriene B4; Leukotriene E4; Leukotrienes; Nasal Mucosa; Nasal Polyps; Prostaglandin D2; Prostaglandins; Rhinitis; Rhinitis, Allergic, Perennial

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

Allergic rhinitis requires active intervention for symptom relief. A combination of antileukotriene and antihistamine drugs has been suggested to provide additive treatment benefits for patients with allergic rhinitis.. We evaluated how such a combination treatment would affect symptoms and local mucosal eosinophilia in comparison with a nasal glucocorticoid.. In a double-blind, randomized study 62 patients with grass pollen-induced allergic rhinitis received a nasal glucocorticoid (fluticasone propionate aqueous nasal spray [FPANS], 200 microg/d), an antileukotriene (montelukast, 10 mg/d), a combination of montelukast with an antihistamine (loratadine, 10 mg/d), or placebo throughout the season. Cromoglycate eyedrops and a limited amount of loratadine were allowed as rescue medication for severe symptoms. Patients recorded their symptoms for nasal blockage, itching, rhinorrhea, and sneezing. Before and during the season, nasal biopsy specimens were obtained from patients for evaluation of local eosinophilic inflammation.. During the peak season, both FPANS and combined montelukast-loratadine were significantly more effective than placebo and montelukast alone for daytime symptom prevention. For nighttime symptoms, FPANS was significantly more effective compared with all other treatments, whereas combined montelukast-loratadine and montelukast alone did not provide significant symptom prevention compared with placebo. The pollen-induced increase in the numbers of epithelial eosinophils was significantly lower for FPANS-treated patients compared with that seen in all other treatment groups.. In patients with seasonal allergic rhinitis, intranasal glucocorticoids are more effective than an antileukotriene drug or combined antileukotriene-antihistamine for the reduction of pollen-induced nasal eosinophilic inflammation and for control of nasal symptoms.

Topics: Acetates; Administration, Intranasal; Adult; Androstadienes; Circadian Rhythm; Cyclopropanes; Double-Blind Method; Eosinophils; Female; Fluticasone; Histamine H1 Antagonists; Humans; Loratadine; Male; Middle Aged; Nasal Mucosa; Pollen; Quinolines; Rhinitis; Rhinitis, Allergic, Seasonal; Sulfides

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

Many uncertainties remain in the diagnosis and treatment of preschool children with asthma symptoms.. We sought to determine the subgroups of preschool children (aged 12-47 months) with recurrent asthma symptoms most likely to respond to inhaled fluticasone propionate (200 microg/d).. Subgroups of pooled data from 2 similar 12-week multicenter studies were analyzed.. Children with frequent symptoms (symptoms on > or =3 days per week and a total of > or =75% days with symptoms during the 4-week run-in period; n = 169) showed a significantly greater increase in days without symptoms after fluticasone propionate treatment (0% to 45%) compared with after placebo treatment (0% to 25%, P =.005). Children with a family history of asthma (n = 213) also had a significantly greater increase in days without symptoms after fluticasone propionate (11% to 54%) compared with after placebo (7% to 35%, P =.002) and a significantly higher proportion of exacerbation-free patients (61% to 76%, P =.02). Children with less frequent symptoms, no family history of asthma, or both showed no significant treatment effect. There seemed to be no association between response to fluticasone propionate and history of rhinitis or eczema or the number of previous exacerbations.. Children with frequent symptoms, a family history of asthma, or both showed the greatest response to fluticasone propionate treatment. These findings may help to predict treatment outcome and guide the management of preschool children with recurrent asthma symptoms.

Topics: Administration, Inhalation; Age Factors; Androstadienes; Anti-Asthmatic Agents; Asthma; Child, Preschool; Double-Blind Method; Eczema; Family Characteristics; Female; Fluticasone; Humans; Infant; Male; Nebulizers and Vaporizers; Placebos; Respiratory Sounds; Rhinitis

Pregnancy rhinitis is a common condition with longstanding nasal congestion; troublesome for the mother, possibly also affecting the fetus. There is need for a safe, effective treatment. Nasal corticosteroids, indisputable in other types of rhinitis, have not been evaluated in pregnancy rhinitis. In this placebo-controlled, randomized, double-blind study with parallel groups, we evaluated the effect of 8 weeks of treatment with fluticasone propionate aqueous nasal spray in 53 women with pregnancy rhinitis. Daily symptom scores and nasal peak expiratory flow, as well as acoustic rhinometry before and after treatment, did not show any difference between the groups. Placebo resulted in 6/27 responders, compared with 5/26 for active treatment. There was no detectable influence on maternal cortisol as measured by morning S-cortisol and overnight 12-h-U-cortisol, or any difference in ultrasound measures of fetal growth or pregnancy outcome. Altogether, our study indicates no significant effects of the treatment described here.

Topics: Administration, Intranasal; Adolescent; Adult; Androstadienes; Anti-Inflammatory Agents; Double-Blind Method; Female; Fluticasone; Follow-Up Studies; Humans; Pregnancy; Pregnancy Complications; Probability; Reference Values; Rhinitis; Treatment Outcome

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

As both rhinitis and asthma are allergic conditions, they frequently occur together. The objective of this study was to assess the diurnal adrenocortical activity in asthmatics receiving inhaled (inh) and intranasal (n) formulations of two different corticosteroids, fluticasone propionate (FP) and triamcinolone acetonide (TAA), both given at clinically recommended doses.. Twelve stable moderately severe asthmatic subjects of mean age 23.9 years and mean forced expiratory volume in one second (FEV1) 84% predicted were recruited into a randomised placebo (PL) controlled two-way crossover study comparing nPL + inhPL, nPL + inhFP (880 micrograms bid), and nFP (200 micrograms once daily) + inhFP (880 micrograms bid) with nPL + inhPL, nPL + inhTAA (800 micrograms bid) and nTAA (220 micrograms once daily) + inhTAA (800 micrograms bid), each given for five days with a 10 day washout period. Twenty four hour integrated and fractionated (overnight, 08.00 hours, daytime) serum cortisol levels and urinary cortisol/creatinine excretion were measured.. For 24 hour and fractionated serum cortisol levels and corrected urinary cortisol/creatinine excretion there were significant (p < 0.05) differences between all active treatments and placebo. For 24 hour integrated serum cortisol levels the ratio between inhaled TAA and FP was 2.3 fold (95% CI 1.2 to 4.3), and for 24 hour urinary cortisol/creatinine excretion the ratio was two-fold (95% CI 1.2 to 3.4). For 24 hour urinary cortisol excretion, with all active treatments, individual abnormal low values of < 40 nmol (< 14.4 micrograms) occurred in 17/24 with FP compared with 4/24 with TAA (p < 0.0005). The 24 hour serum cortisol profile was flattened by FP but not with TAA. The addition of nasal corticosteroid did not produce further significant suppression of mean cortisol values, although with intranasal FP there were three more abnormal values for 24 hour urinary cortisol excretion than with inhaled FP alone.. Both inhaled FP and TAA caused significant suppression of adrenocortical activity which was twice as great with FP, the latter being associated with significantly more individual abnormal values and loss of the normal diurnal circadian rhythm. Fractionated serum cortisol levels and urinary cortisol/creatinine excretion were as sensitive as the respective integrated 24 hour measurements. Although the addition of intranasal formulations did not produce further significant suppression of mean values, there were more individual abnormal cortisol values associated with the addition of intranasal FP.

Topics: Administration, Inhalation; Administration, Intranasal; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Cross-Over Studies; Female; Fluticasone; Forced Expiratory Volume; Humans; Male; Rhinitis; Single-Blind Method; Triamcinolone Acetonide

Topics: Administration, Topical; Adult; Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents; Double-Blind Method; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Nasal Decongestants; Nasal Mucosa; Rhinitis

Controversy still exists about the treatment of rhinitis medicamentosa and treatment has never been objectively evaluated.. To study the effect of fluticasone propionate aqueous nasal spray compared to placebo nasal spray in the treatment of rhinitis medicamentosa.. A parallel randomized, double-blind study was conducted to evaluate the treatment of rhinitis medicamentosa. Two groups containing 10 patients with rhinitis medicamentosa in each group stopped their overuse of nasal vasoconstrictor spray immediately and were treated with either fluticasone propionate nasal spray once daily 200 micrograms, or placebo nasal spray for 14 days. The nasal mucosal swelling was recorded with rhinostereometry, acoustic rhinometry and a peak inspiratory flow meter. Nasal stuffiness was estimated on a visual analogue scale in the morning and in the evening of each day.. The mucosal swelling decreased after 7 and 14 days of treatment with fluticasone propionate as well as placebo, but the reduction was significantly greater after treatment with fluticasone propionate. The symptom scores for nasal stuffiness showed a marked reduction during the treatment period in both groups, but there was a faster onset of symptom reduction after treatment with fluticasone propionate.. Fluticasone propionate is more effective and has a faster onset of action than placebo in the treatment of rhinitis medicamentosa. An adequate treatment of these patients consists of a combination of vasoconstrictor withdrawal and a topical corticosteroid to alleviate the withdrawal process.

Topics: Administration, Intranasal; Adult; Androstadienes; Anti-Inflammatory Agents; Double-Blind Method; Female; Fluticasone; Humans; Inspiratory Capacity; Male; Middle Aged; Nasal Mucosa; Rhinitis; Skin Tests

We performed a double-blind, crossover, placebo-controlled study on the effect of fluticasone propionate (FP) treatment on chronic eosinophilic rhinosinusitis in 15 patients with aspirin-induced asthma (AIA). There were 10 women and five men aged 32-60 years; average: 45 years. After a 10-day run-in period, patients underwent two 4-week treatment courses (FP vs placebo), separated by a 2-week washout interval. Clinical activity of FP was evaluated by daily measurement of peak nasal inspiratory flow (PNIF) and a scoring system of subjective symptoms. Nasal challenges with E-lysine aspirin, using active anterior rhinomanometry, were performed at the entry and on the last day of each treatment period. Weekly mean values of symptom scores were generally lower and PNIF measurements higher during treatment with FP than with placebo. This difference was statistically significant for most recorded parameters for the whole 4-week FP treatment. On average, the reactions evoked by aspirin nasal challenge were significantly shorter and milder after treatment with FP than with placebo. In 8/13 patients, FP completely prevented aspirin-precipitated nasal reaction, whereas protection after placebo was observed in only 2/12 subjects (P = 0.004). We conclude that intranasal FP is an effective therapy for chronic eosinophilic rhinitis in patients with AIA.

Topics: Administration, Intranasal; Adult; Androstadienes; Anti-Allergic Agents; Aspirin; Asthma; Chronic Disease; Cross-Over Studies; Double-Blind Method; Eosinophilia; Female; Fluticasone; Humans; Male; Middle Aged; Nasal Provocation Tests; Rhinitis

Topical corticosteroids are the therapy of choice for nonallergic, noninfectious perennial rhinitis (NANIPER). However, the efficacy of steroid therapy in NANIPER is controversial, as is its mode of action. To our surprise, of 300 patients initially diagnosed as having NANIPER, only 65 reached threshold nasal symptom scores. Patients were randomized into four different treatment regimens: placebo administered twice daily (BD) for 8 weeks, fluticasone propionate aqueous nasal spray (FPANS) (200 microg) once daily (OD) and placebo OD for 8 weeks, FPANS (200 microg) OD and placebo OD for 4 weeks followed by FPANS (200 microg) BD for 4 weeks, and FPANS (200 microg) BD for 8 weeks. A small decrease in nasal symptoms was found, which only reached significance for sneezing in the FPANS 200 microg BD group. A significant dose-dependent decrease in immunocompetent cells was found in nasal biopsy specimens obtained before, after 4 weeks, and after 8 weeks of treatment. We conclude that FPANS did not significantly reduce nasal symptoms in this group of selected NANIPER patients, even though a significant effect on cells in the nasal mucosa was seen.

Topics: Administration, Intranasal; Adolescent; Adult; Androstadienes; Anti-Inflammatory Agents; Biopsy; Cell Movement; Double-Blind Method; Female; Fluticasone; Glucocorticoids; Humans; Leukocyte Count; Male; Middle Aged; Nasal Mucosa; Rhinitis; Staining and Labeling

Fluticasone propionate is a new potent, topically active corticosteroid with negligable oral bioavailability. Data on its comparative efficacy in perennial allergic and non-allergic rhinitis are limited.. To compare the efficacy and safety of fluticasone propionate aqueous nasal spray (FPANS) 200 micrograms once or twice daily with beclomethasone dipropionate aqueous nasal spray (BPD) 200 micrograms twice daily and placebo in patients with allergic and non-allergic perennial rhinitis.. The 12-week study had a multicentre, double-blind, randomized, parallel group design. Efficacy was assessed from symptom scores recorded on daily diary cards.. FPANS 200 micrograms once or twice daily was significantly better than placebo but not better than BDP in relieving the nasal symptoms of rhinitis. FPANS at either dose was equally effective in the treatment of allergic and non-allergic perennial rhinitis. There were few adverse events and no treatment-related abnormalities in laboratory measurements in either FPANS-treated group. Comparison between treatment groups indicated that FPANS was as well tolerated as placebo and BDP at the doses studied.. In the majority of patients FPANS 200 micrograms once daily in as effective as BDP 200 micrograms twice daily in the relief of perennial allergic rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Aged, 80 and over; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Child; Double-Blind Method; Drug Administration Schedule; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Rhinitis; Rhinitis, Allergic, Perennial

The production of interleukin-5 and eosinophil cationic protein (ECP) in the nasal cavity was examined in 24 patients with rhinitis who were allergic to the house dust mite. During a double-blind placebo-controlled cross-over study, fluticasone propionate aqueous nasal spray (200 micrograms) was administered twice daily for 2 weeks. After four basal nasal lavages provocation with house dust mite extract was performed and nasal lavages were collected every hour for 9.5 h. Interleukin-5 was present in detectable amounts in nasal lavages from patients allergic to house dust mite. Nasal challenge with house dust mite extract caused immediate nasal symptoms and increased levels of interleukin-5. Between 3.5 and 8.5 h after the challenge symptoms recurred and interleukin-5 levels increased, reflecting a late phase reaction. Eosinophil cationic protein, a marker of activated eosinophils, was released between 6.5 and 9.5 h after challenge. Treatment with fluticasone propionate (as an aqueous nasal spray) significantly decreased the evoked interleukin-5 and ECP levels in the late phase reaction. This response was correlated with an improved symptom score. This could indicate that the number and activity of eosinophils are increased during the late phase allergic reaction, a response that is inhibited by corticosteroids.

Topics: Adult; Androstadienes; Animals; Blood Proteins; Cross-Over Studies; Double-Blind Method; Eosinophil Granule Proteins; Female; Fluticasone; Humans; Interleukin-5; Male; Middle Aged; Mites; Nasal Cavity; Rhinitis; Ribonucleases

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

Different treatments exist for allergic rhinitis (AR), including pharmacotherapy and allergen immunotherapy (AIT), but they have not been compared using direct patient data (i.e., "real-world data"). We aimed to compare AR pharmacological treatments on (i) daily symptoms, (ii) frequency of use in co-medication, (iii) visual analogue scales (VASs) on allergy symptom control considering the minimal important difference (MID) and (iv) the effect of AIT.. We assessed the MASK-air® app data (May 2015-December 2020) by users self-reporting AR (16-90 years). We compared eight AR medication schemes on reported VAS of allergy symptoms, clustering data by the patient and controlling for confounding factors. We compared (i) allergy symptoms between patients with and without AIT and (ii) different drug classes used in co-medication.. We analysed 269,837 days from 10,860 users. Most days (52.7%) involved medication use. Median VAS levels were significantly higher in co-medication than in monotherapy (including the fixed combination azelastine-fluticasone) schemes. In adjusted models, azelastine-fluticasone was associated with lower average VAS global allergy symptoms than all other medication schemes, while the contrary was observed for oral corticosteroids. AIT was associated with a decrease in allergy symptoms in some medication schemes. A difference larger than the MID compared to no treatment was observed for oral steroids. Azelastine-fluticasone was the drug class with the lowest chance of being used in co-medication (adjusted OR = 0.75; 95% CI = 0.71-0.80).. Median VAS levels were higher in co-medication than in monotherapy. Patients with more severe symptoms report a higher treatment, which is currently not reflected in guidelines.

Topics: Adrenal Cortex Hormones; Desensitization, Immunologic; Fluticasone; Humans; Rhinitis; Rhinitis, Allergic

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

Rhinitis and asthma are linked, but substantial knowledge gaps in this relationship exist.. We sought to determine the prevalence of rhinitis and its phenotypes in children and adolescents with asthma, assess symptom severity and medication requirements for rhinitis control, and investigate associations between rhinitis and asthma.. Seven hundred forty-nine children with asthma participating in the Asthma Phenotypes in the Inner-City study received baseline evaluations and were managed for 1 year with algorithm-based treatments for rhinitis and asthma. Rhinitis was diagnosed by using a questionnaire focusing on individual symptoms, and predefined phenotypes were determined by combining symptom patterns with skin tests and measurement of serum specific IgE levels.. Analyses were done on 619 children with asthma who completed at least 4 of 6 visits. Rhinitis was present in 93.5%, and phenotypes identified at baseline were confirmed during the observation/management year. Perennial allergic rhinitis with seasonal exacerbations was most common (34.2%) and severe. Nonallergic rhinitis was least common (11.3%) and least severe. The majority of children remained symptomatic despite use of nasal corticosteroids with or without oral antihistamines. Rhinitis was worse in patients with difficult-to-control versus easy-to-control asthma, and its seasonal patterns partially corresponded to those of difficult-to-control asthma.. Rhinitis is almost ubiquitous in urban children with asthma, and its activity tracks that of lower airway disease. Perennial allergic rhinitis with seasonal exacerbations is the most severe phenotype and most likely to be associated with difficult-to-control asthma. This study offers strong support to the concept that rhinitis and asthma represent the manifestations of 1 disease in 2 parts of the airways.

Topics: Adolescent; Adrenergic beta-2 Receptor Agonists; Anti-Allergic Agents; Asthma; Bronchodilator Agents; Child; Female; Fluticasone; Humans; Male; Phenotype; Prevalence; Rhinitis; Salmeterol Xinafoate; Severity of Illness Index

Topics: Adrenal Cortex Hormones; Double-Blind Method; Exhalation; Fluticasone; Humans; Nasal Polyps; Rhinitis

Intranasal steroid sprays are fundamental in the medical management of inflammatory rhinological conditions. Side effects are common, but these may be related to the method of application rather than the medication itself.. A survey was distributed to patients using intranasal steroid sprays at the ENT out-patient clinic at Aberdeen Royal Infirmary over three months. This evaluated the spray technique used, side effects and compliance.. Of 103 patients, 22 patients (21.4 per cent) reported side effects, including nasal irritation and epistaxis. Of the 20 patients with epistaxis, 80 per cent used an ipsilateral hand technique (p = 0.01). Thirty patients demonstrated poor compliance because of lack of symptom improvement or side effects. Seventy-seven per cent of this group used the ipsilateral hand technique.. Patients who used their ipsilateral hand to apply the intranasal steroid spray were more likely to develop epistaxis and have poor compliance than those who used other techniques. Patients who struggle with compliance because of side effects should avoid this method of intranasal steroid application.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Beclomethasone; Epistaxis; Female; Fluticasone; Humans; Male; Medication Adherence; Middle Aged; Mometasone Furoate; Nasal Sprays; Rhinitis; Surveys and Questionnaires; Young Adult

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 glucocorticoids are the treatment of choice in the therapy of rhinitis. The differences in efficiency of particular medications proven by therapeutic index may result from differences in composition of particular formulations as well as from diverse deposition in nasal cavities. Intranasal formulations of glucocorticoids differ in volume of a single dose in addition to variety in density, viscosity and dispenser nozzle structure. The aim of this report was to analyze the deposition of most often used intranasal glucocorticoids in the nasal cavity and assessment of the usefulness of a nose model from a 3D printer reflecting anatomical features of a concrete patient.. Three newest and most often used in Poland intranasal glucocorticoids were chosen to analysis; mometasone furoate (MF), fluticasone propionate (FP) and fluticasone furoate (FF). Droplet size distribution obtained from the tested formulations was determined by use of a laser aerosol spectrometer Spraytec (Malvern Instruments, UK). The model of the nasal cavity was obtained using a 3D printer. The printout was based upon a tridimensional reconstruction of nasal cavity created on the basis of digital processing of computed tomography of paranasal sinuses. The deposition of examined medications was established by a method of visualization combined with image analysis using commercial substance which colored itself intensively under the influence of water being the dominant ingredient of all tested preparations. On the basis of obtained results regions of dominating deposition of droplets of intranasal medication on the wall and septum of the nasal cavity were compared.. Droplet size of aerosol of tested intranasal medications typically lies within the range of 25-150 µm. All tested medications deposited mainly on the anterior part of inferior turbinate. FP preparation deposited also on the anterior part of the middle nasal turbinate, marginally embracing a fragment of the central part of this turbinate as well together with deposition in the middle and superior nasal meatus reaching the region of nasal ceiling and olfactory field. MF preparation deposited on the anterior part of the inferior turbinate and central part of this turbinate alike. The area of mucous membrane of lateral wall of nasal cavity on which MF deposited was similar to the area achieved after the application of FP preparation but much greater than in the case of FF preparation. FF drug deposition concentrates only on the anterior part of the inferior turbinate. Despite directing the drug to the lateral wall of the nasal cavity a great proportion of examined preparations deposit also on the nasal septum.. The practical application of tridimensional representation (3D printout) of actual geometry of nasal cavity to establish the deposition of inGKS was proven. Droplet size and the geometry of the aerosol cloud introduced into the nostril determine the significant deposition of medication droplets in the anterior part of the nasal cavity. Both physical properties of the drug as well as spraying system applied influence spatial distribution of the drug. The interaction of the air flow with the layer of deposited fluid plays a major role in the deposition of the drug in the nasal cavity, therefore it is so important that the drug does not drain by gravity but remains at the site of deposition which may be reinforced by thixotropic properties of the preparation.

Topics: Administration, Intranasal; Androstadienes; Anti-Allergic Agents; Fluticasone; Glucocorticoids; Humans; Mometasone Furoate; Nasal Cavity; Poland; Rhinitis

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

Long-term use of decongestant nasal spray (alpha adrenergic agonist) causes nasal congestion by rhinitis medicamentosa.. We clinically reviewed the cases of 33 patients of rhinitis medicamentosa (23 men, 10 women; mean age, 44.4±15.6 years) treated with nasal steroid sprays instead of decongestant nasal sprays in our clinic from October, 2011 to December, 2012.. Periods of drug use were generally long. Only 7 cases had a duration of use less than 1 year, and about half (48.5%) had a duration of use longer than 2 years. Causes of use included acute inflammation (n=6), chronic rhinosinusitis (n=2), and allergic rhinitis (n=20) and unknown cause (n=5). About two-third of the patients failed to answer questions concerning their use of decongestant nasal spray in a questionnaire prior to examination; therefore, careful observation was necessary. Among the 33 cases, 31 were followed up, all of whom showed improvement and stopped using decongestant nasal spays within 4 weeks. Periods for recovery were as follows: 3 days in 19 cases (61.3%) and 1 week in 25 cases (80.6%). Duration of drug use did not correlate with the period required for recovery; therefore, these results suggest that patients with long-term drug use are able to improve quickly.. Rhinitis medicamentosa with nasal congestion appears readily reversible with suitable treatment.

Topics: Adolescent; Adrenergic alpha-Agonists; Adult; Aged; Androstadienes; Drug Substitution; Female; Fluticasone; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Decongestants; Nasal Obstruction; Nasal Sprays; Pregnadienediols; Retrospective Studies; Rhinitis; Time Factors; Treatment Outcome; Young Adult

Topics: Androstadienes; Anti-Allergic Agents; Drugs, Generic; Fluticasone; Humans; Nasal Sprays; Rhinitis

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

Patients with allergic rhinitis (AR) show increased production of the Th2-related cytokines. Almost always, intranasal corticosteroid (INC) and antihistamine are used as routine therapy of AR. This study was performed to determine the in vitro secretion of cytokines profiles of PBMCs in patients with AR sensitive to Chenopodium album (Ch.a) pollens before and after treatment with INC (Fluticasone propionate) and oral antihistamine (Loratadine). PBMCs of 20 patients with AR, were tested in vitro for cytokine production. These cells were stimulated with natural or recombinant Ch.a. The levels of IL-4, IL-13 and IFN-, were measured in supernatants of cultured cell 96h after stimulation using ELISA. The PBMCs of 20 normal individuals were also similarly treared for comparison of results. The production of IL-4 by the patients' cells stimulated with either Ch.a or rCh.a was significantly higher than normal levels before therapy (p=0.04 and p=0.02, respectively). After therapy, a significant decrease in production of IL-4 and a significant increase in production of IL-10 were found in PBMCs stimulated with natural Ch.a, in comparison to the results before stimulation (p=0.03 for IL-4; p=0.04 for IL-10). Similarly, these results were seen in the production of IL-4 and IL-10 stimulated with rCh.a allergen after therapy in comparison to the results before stimulation (p=0.01 for IL-4; p=0.03 for IL-10). This study suggests INC (Fluticasone propionate) and oral antihistamine (Loratadine) have the capacity to inhibit the production of IL-4 and shift Th2/Th1 responses, probably due to increase the level of immunoregulatory IL-10. Therefore, it could be concluded that therapy with INC and antihistamine has pharmacologic and immunologic therapeutic effects on AR patients.

Topics: Adult; Allergens; Androstadienes; Anti-Allergic Agents; Case-Control Studies; Chenopodium album; Cytokines; Female; Fluticasone; Humans; Interferon-gamma; Interleukin-10; Interleukin-13; Interleukin-4; Leukocytes, Mononuclear; Loratadine; Male; Pollen; Rhinitis; Th1 Cells; Th2 Cells; Young Adult

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

Since allergic rhinitis in asthma patients is associated with worse asthma control, the treatment of the comorbid condition may improve outcomes.. A 1-year retrospective study using the UK Mediplus database (2001-2004) included asthmatic patients aged 15-55 with allergic rhinitis. Patients starting therapy based on the Global Initiative for Asthma guidelines, defined as an increase in inhaled corticosteroids (high-dose inhaled corticosteroids, hdICS), or the addition of montelukast (ICS+MON) or long-acting beta-agonists (ICS+LABA) to ICS, were studied. Univariable and multiple logistic regressions evaluated asthma-related outcomes.. Among 2,596 asthma and allergic rhinitis patients, 83.2% initiated ICS+LABA, 12.1% hdICS and 4.7% ICS+MON. The mean age was 34 years and 60% were female. ICS+MON patients had more moderate-severe asthma (p = 0.04). Approximately 84% of the ICS+LABA patients experienced an asthma control failure compared to 50% in the other groups (p < 0.0001). The proportions of patients requiring treatment change were 73.8, 22 and 27.3% in the ICS+LABA, hdICS and ICS+MON groups, respectively (p = 0.001). Asthma-related resource use was similar among all groups. The ICS+MON group received fewer mean prescriptions for oral corticosteroids (p = 0.024) than the other groups (p = 0.026).. In asthma and allergic rhinitis, treatment with ICS+MON or hdICS was associated with lower rates of asthma control failure and fewer treatment changes than the ICS+LABA group. MON users also required fewer oral corticosteroids.

Topics: Acetates; Adolescent; Adrenergic beta-Agonists; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Cohort Studies; Comorbidity; Cyclopropanes; Drug Therapy, Combination; Female; Fluticasone; Humans; Male; Middle Aged; Quinolines; Rhinitis; Sulfides; Treatment Outcome; United Kingdom

Due to common features of asthma and allergic rhinitis, a single therapeutic approach to treating both of these conditions has been proposed.. To compare and contrast the use of rhinitis medications in a group of children initiating various controller therapies for asthma.. A retrospective, observational study using an integrated managed care database of children aged 4-17 years with an initial medical claim for asthma and an initial pharmacy claim for fluticasone propionate (FP) and salmeterol in a single inhaler (FSC), FP alone, montelukast (MON), or combination FP + MON. Outcomes included the percentage of children initiating controller asthma therapy with prescriptions for non-sedating antihistamine (NSA) and intranasal corticosteroids (INCS) and the mean number of prescriptions for NSA and INCS.. A total of 5247 children were included. The percentage of children who filled prescriptions for NSA or INCS and the mean number of prescriptions dispensed was similar among children treated with FSC, FP, MON, and FP + MON. There were no significant differences in the relative risk of dispensing either a NSA or INCS across cohorts. Observational studies are limited by their use of administrative data and lack of access to patient records.. Children started on common asthma controller therapy are frequent users of rhinitis medications. The quantity and frequency of these medications is not different between dispensed asthma regimens.

Topics: Acetates; Administration, Intranasal; Adolescent; Adrenal Cortex Hormones; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Child; Child, Preschool; Cyclopropanes; Drug Combinations; Drug Prescriptions; Fluticasone; Fluticasone-Salmeterol Drug Combination; Histamine H1 Antagonists, Non-Sedating; Humans; Hypersensitivity; Leukotriene Antagonists; Quinolines; Retrospective Studies; Rhinitis; Sulfides

The efficacy of fluticasone propionate aqueous nasal spray (0.05% w/w) in the treatment of rhinitis medicamentosa has been studied in an animal model (guinea pig). Rhinitis medicamentosa was induced through the instillation of 0.05% naphthazoline nitrate (Privine) for 8 weeks. Fluticasone propionate nasal spray was then administered to the animals for 2 weeks. The spray successfully cleared the interstitial edema which is the pathologic hallmark of rhinitis medicamentosa. The study suggests that fluticasone propionate nasal spray can be beneficial in the treatment of patients with rhinitis medicamentosa.

Topics: Administration, Intranasal; Androstadienes; Animals; Disease Models, Animal; Drug Hypersensitivity; Fluticasone; Guinea Pigs; Microscopy, Electron; Naphazoline; Nasal Decongestants; Nasal Mucosa; Rhinitis; Treatment Outcome

The effects of mometasone furoate on experimental allergic rhinitis in rats were studied in comparison with that of fluticasone propionate. Topical application of both drugs inhibited dose-dependently the increase of nasal symptoms (sneezing and nasal rubbing) after antigen challenge to the nasal cavity of actively sensitized rats. Mometasone furoate and fluticasone propionate at concentrations of 0.01 or 0.1% significantly inhibited both nasal rubbing and sneezing 1 h after topical application of both drugs. The relative potencies of mometasone furoate in nasal rubbing and sneezing compared to fluticasone propionate were 5.01 and 6.87, respectively. Mometasone furoate (0.02%) and fluticasone propionate (0.1%) significantly inhibited the increase of antigen-induced nasal rubbing even 6 h after topical application, indicating that both drugs have a long-lasting effect.

Topics: Administration, Topical; Androstadienes; Animals; Anti-Allergic Agents; Disease Models, Animal; Fluticasone; Male; Mometasone Furoate; Outcome Assessment, Health Care; Pregnadienediols; Rats; Rats, Wistar; Rhinitis

Topics: Administration, Intranasal; Androstadienes; Anti-Allergic Agents; Benzalkonium Compounds; Controlled Clinical Trials as Topic; Fluticasone; Humans; Nasal Mucosa; Rhinitis; Sodium Chloride

Ozone (O3) is the principal oxidant pollutant in photochemical smog. Repeated exposures to O3 induces inflammation and mucous cell metaplasia in the nasal airways of laboratory animals. Our study was designed to determine the efficacy of a topical anti-inflammatory corticosteroid in preventing O3-induced rhinitis and mucous cell metaplasia in rat nasal epithelium. Male F344 rats were exposed to filtered air (0 ppm O3; air-controls) or 0.5 ppm O3, 8 h/day, for 3 or 5 days. Immediately before and after each exposure, rats received an intranasal instillation (50 microl/nasal passage) of a topical corticosteroid, fluticasone propionate (FP; 25 microg/nasal passage) or its vehicle only (0.01% ethanol in saline). Rats were killed 2 h after the third exposure (3-day exposure) or 3 days after the fifth exposure (5-day exposure) and nasal tissues were processed for light microscopy. Numeric densities of epithelial cells and neutrophils, and the amount of intraepithelial mucosubstances (IM) in the epithelium lining the maxilloturbinates were morphometrically determined. There were no significant differences in any measured parameter in air-exposed rats instilled with FP compared with air-exposed rats instilled with vehicle. Vehicle-treated rats exposed to ozone had neutrophilic rhinitis with 3.3- and 1.6-fold more intraepithelial neutrophils (3-day and 5-day exposure, respectively) and marked mucous cell metaplasia (5-day exposure only) with numerous mucous cells and approximately 60 times more IM in the nasal transitional epithelium compared with vehicle-treated air-controls. FP-treated rats exposed to ozone had minimal nasal inflammation (1.3-fold more intraepithelial neutrophils only after 3-day exposure) and minimal mucous cell metaplasia (5-fold more IM only after 5-day exposure) compared with vehicle-instilled, air-exposed rats. Results of this study indicate that FP-treatment is effective in attenuating not only O3-induced rhinitis (30-60% reduction) but also O3-induced mucous cell metaplasia (85% reduction) in rat nasal transitional epithelium. The cellular and molecular mechanisms involved in FP-induced attenuation of O3-induced nasal lesions remain to be determined.

Topics: Administration, Topical; Androstadienes; Animals; Anti-Inflammatory Agents; Cell Count; DNA; Epithelial Cells; Fluticasone; Glucocorticoids; Male; Metaplasia; Nasal Mucosa; Neutrophils; Ozone; Rats; Rats, Inbred F344; Rhinitis

The purpose of the study is to investigate the relationship between inhaled or intranasal adrenergic agonists and corticosteroids and the development of central serous chorioretinopathy (CSC).. The medical records of three patients with CSC who were found to use inhaled adrenergic agents or corticosteroids or both were identified prospectively. A survey of members of the Retina, Macula, and Vitreous societies and the National Registry of Drug-Induced Ocular Side Effects identified three additional cases.. Six patients with CSC were found to be chronic users of corticosteroid (four patients) or both beta adrenergic agonist and corticosteroid (two patients) metered dose inhalers or nasal sprays. In three cases, there was a close temporal correlation between the use of a corticosteroid nasal spray and the development of CSC.. These findings suggest that, in patients who are susceptible, the periocular or systemic absorption of inhaled corticosteroids may be sufficient to produce CSC in humans, supporting previous hypotheses regarding the pathogenesis of the disorder. Further studies are needed to confirm this association and to determine whether inhaled adrenergic agents also contribute to the development of this disorder. Patients in whom CSC develops while using corticosteroid inhalers or nasal sprays should be alerted to the possible relationship between CSC and these agents.

Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Albuterol; Androstadienes; Asthma; Beclomethasone; Bronchitis; Choroid Diseases; Exudates and Transudates; Female; Fluorescein Angiography; Fluticasone; Fundus Oculi; Glucocorticoids; Humans; Male; Middle Aged; Pigment Epithelium of Eye; Prospective Studies; Retinal Detachment; Retinal Diseases; Rhinitis; Risk Factors; Triamcinolone Acetonide; Visual Acuity

The usual nasal response to head submersion in aquatic mammals is an increase in resistance to airflow, the so-called "diving reflex". Although less well-developed in humans, it is nevertheless present. It is likely to occur due to a relative increase of parasympathetic over sympathetic control of the nasal vasculature. Non-eosinophilic non-allergic rhinitis is thought to be due to a similar imbalance and we have attempted to establish whether the diving reflex is abnormal in this condition and whether intranasal fluticasone propionate for 6 weeks has any effect in modifying the nasal response.

Topics: Administration, Intranasal; Airway Resistance; Androstadienes; Anti-Allergic Agents; Case-Control Studies; Cold Temperature; Diving; Female; Fluticasone; Humans; Male; Reflex; Rhinitis; Time Factors