pulmicort and Rhinitis

Topical therapies play an important role in the management of chronic rhinosinusitis (CRS). A detailed literature review was undertaken to appraise recent evidence surrounding current topical therapies and novel treatments used in the setting of recalcitrant CRS.. Effective sinus surgery aids in the delivery of topical therapies. Budesonide nasal rinses delivered by saline irrigation offer clinical and symptomatic improvements pre and postoperatively with a well-proven safety profile. Topical steroids may additionally offer direct antibacterial effects as per in-vitro testing. Topical antibiotics are not recommended in routine practice; however, they may be of benefit for short-term eradication therapy. Novel treatments are under keen investigation and include bacteriophage, colloidal silver and manuka honey. The evidence base for these treatments is not robust enough to recommend their routine use at present.. Topical steroids delivered in conjunction with saline nasal irrigation offer the best combination of treatments in CRS and should be considered a standard of care. Wide surgical access and aggressive surgical debridement of polyposis facilitates the delivery of steroid irrigations to sinonasal mucosa and is associated with improved long-term outcomes following endoscopic sinus surgery. The use of novel treatments remains within the research setting alone.

Topics: Administration, Intranasal; Administration, Topical; Budesonide; Chronic Disease; Debridement; Glucocorticoids; Humans; Nasal Lavage; Nasal Polyps; Rhinitis; Saline Solution; Sinusitis

Topics: Administration, Topical; Budesonide; Chronic Disease; Glucocorticoids; Humans; Nasal Lavage; Prospective Studies; Retrospective Studies; Rhinitis; Sinusitis; Treatment Outcome

In the field of nasal drug delivery, among the preparations defined by the European Pharmacopoeia, nasal powders facilitate the formulation of poorly water-soluble active compounds. They often display a simple composition in excipients (if any), allow for the administration of larger drug doses and enhance drug diffusion and absorption across the mucosa, improving bioavailability compared to nasal liquids. Despite the positive features, however, nasal products in this form still struggle to enter the market: the few available on the market are Onzetra Xsail® (sumatriptan) for migraine relief and, for the treatment of rhinitis, Rhinocort® Turbuhaler® (budesonide), Teijin Rhinocort® (beclomethasone dipropionate) and Erizas® (dexamethasone cipecilate). Hence, this review tries to understand why nasal powder formulations are still less common than liquid ones by analyzing whether this depends on the lack of (i) real evidence of superior therapeutic benefit of powders, (ii) therapeutic and/or commercial interest, (iii) efficient manufacturing methods or (iv) availability of suitable and affordable delivery devices. To this purpose, the reader's attention will be guided through nasal powder formulation strategies and manufacturing techniques, eventually giving up-to-date evidences of therapeutic efficacy in vivo. Advancements in the technology of insufflation devices will also be provided as nasal drug products are typical drug-device combinations.

Topics: Administration, Intranasal; Animals; Beclomethasone; Biological Availability; Budesonide; Chemistry, Pharmaceutical; Dexamethasone; Drug Carriers; Drug Liberation; Equipment and Supplies; Excipients; Humans; Mucous Membrane; Nasal Absorption; Permeability; Powders; Rhinitis; Solubility; Water

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

There are many forms of rhinitis. Patients are diagnosed with non-allergic rhinitis when anatomic, infectious and allergic aetiologies have been excluded. The symptoms, including nasal congestion, blockage or obstruction, clear rhinorrhoea, sneezing and, less frequently, nasal itching, can range from mild to debilitating. It affects between 25% and 50% of patients with rhinitis. Several medications are widely used in the treatment of non-allergic rhinitis, including oral and topical nasal antihistamines, intranasal and (rarely) systemic corticosteroids, and anticholinergics. Capsaicin, the active component of chili peppers, delivered intranasally, is considered a treatment option for non-allergic rhinitis.. To assess the effectiveness of capsaicin in the management of non-allergic rhinitis compared with no therapy, placebo or other topical or systemic medications, or two or more of the above therapies in combination, or different capsaicin regimens.. We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 5); PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the search was 24 June 2015.. Randomised controlled trials in adult patients with non-allergic rhinitis comparing intranasal capsaicin with no therapy, placebo or other topical or systemic medications, or their combinations.. We used the standard methodological procedures expected by The Cochrane Collaboration.. We included four studies (five publications) involving 302 participants with idiopathic non-allergic rhinitis. All the included studies described patients with moderately severe, idiopathic non-allergic rhinitis who were between the ages of 16 and 65. Studies had follow-up periods ranging from four to 38 weeks. The overall risk of bias in the studies was either high or unclear (two studies had overall high risk of bias, while two others had low to unclear risk of bias). Using the GRADE system we assessed the evidence as being of low to moderate quality. A meta-analysis was not possible, given lack of similarity of the reported outcomes.Two studies compared capsaicin with placebo. One study reported that capsaicin resulted in an improvement of overall nasal symptoms (a primary outcome) measured on a visual analogue scale (VAS) of 0 to 10. There was a mean difference (MD) of -3.34 (95% confidence interval (CI) -5.24 to -1.44), MD -3.73 (95% CI -5.45 to -2.01) and MD -3.52 (95% CI -5.55 to -1.48) at two, 12 and 36 weeks post-treatment, respectively. Another study reported that, compared to placebo, capsaicin (at 4 µg/puff) was more likely to produce overall symptom resolution (reduction in nasal blockage, sneezing/itching/coughing and nasal secretion measured with a daily record chart) at four weeks post-treatment (a primary outcome). The risk ratio (RR) was 3.17 (95% CI 1.38 to 7.29).One study compared capsaicin to budesonide (an intranasal corticosteroid). This study found that patients treated with capsaicin had a better overall symptom score compared to those treated with budesonide (MD 2.50, 95% CI 1.06 to 3.94, VAS of 0 to 10). However, there were no differences in the individual symptom scores for headache, postnasal drip, rhinorrhoea, nasal blockage, sneezing and sore throat assessed during the last three days of a four-week treatment.One study compared two different regimens of capsaicin administration: five treatments in one day versus five treatments given every two to three days during two weeks. Using daily record charts, the study reported significant improvement of individual symptom scores for rhinorrhoea in patients treated five times per day, however numerical data were not presented. There were no improvements in the other outcomes: rhinorrhoea, nasal obstruction, sneezing and overall nasal symptoms, measured on a VAS.Finally, one of these studies also compared three doses of capsaicin (to placebo). Patients treated with a 1 µg versus 4 µg. Capsaicin may be an option in the treatment of idiopathic non-allergic rhinitis. It is given in the form of brief treatments, usually during the same day. It appears to have beneficial effects on overall nasal symptoms up to 36 weeks after treatment, based on a few, small studies (low-quality evidence). Well-conducted randomised controlled trials are required to further advance our understanding of the effectiveness of capsaicin in non-allergic rhinitis, especially in patients with non-allergic rhinitis of different types and severity, and using different methods of capsaicin application.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Capsaicin; Humans; Middle Aged; Randomized Controlled Trials as Topic; Rhinitis

To determine whether the use of topical nasal therapies with saline alone and in combination with antibiotics, antifungals, or corticosteroids is effective in the treatment of patients with chronic rhinosinusitis (CRS).. A systematic literature search was performed utilizing the MEDLINE database (1966 to May 2012), EMBASE database (1980 to May 2012), and the Cochrane Central Register of Controlled Trials.. Electronic databases were searched by three otolaryngologists. Studies on five major categories of topical nasal therapies searched included saline (hypotonic, isotonic and hypertonic); topical antibiotics, topical steroids, and topical antifungals were obtained. Randomized controlled trials and meta-analyses of randomized controlled trials were included.. Sixteen randomized controlled trials were identified examining topical saline (hypertonic or isotonic) in CRS patients. Two randomized controlled trials were found studying the effect of topical antibiotics in patients with CRS. Four randomized controlled trials were identified studying topical antifungal treatment for CRS. Twenty-five randomized controlled trials were found studying topical steroids in CRS patients.. A high aggregate quality of evidence supports the effectiveness of saline irrigations in treating CRS. There is insufficient evidence to support a clear benefit of topical antibiotics in patients with chronic rhinosinusitis. Topical antifungal therapies have not been shown to be significantly different in efficacy than saline controls on CRS outcomes. Topical steroids are beneficial in the treatment of CRS with nasal polyps, but have not been shown to be effective in CRS without nasal polyps.

Topics: Antifungal Agents; Budesonide; Chronic Disease; Glucocorticoids; Humans; Nasal Sprays; Rhinitis; Sinusitis

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

Evidence is accumulating that budesonide (BUD) forms intracellular esters in airways. which may affect both duration of action and therapeutic ratio of this drug. The aim of the present paper is to review the preclinical and human experimental evidence supporting the esterification of BUD, and to discuss the clinical implications this may have on asthma and rhinitis treatment.. After inhalation, intact BUD binds primarily to available steroid receptors, and mainly excess (unbound) BUD is esterified. Esterification of BUD is a rapid process: within 20 minutes of inhalation in the rat of radiolabeled BUD, approximately 80% of radioactivity within the trachea and main bronchi was associated with BUD esters, primarily BUD oleate. After 4 hours, the proportion of BUD esters/total cellular BUD was typically 40 to 50% for lung, 70 to 90% for trachea, and only 10 to 15% for peripheral muscle. Comparative in vitro and in vivo studies have shown that esterification prolongs BUD's anti-inflammatory activity longer than that of corticosteroids that can not form esters. Clinical studies have confirmed the prolonged presence of BUD esters, as well as intact BUD, in human airway tissues: 6 hours postdosing, nasal biopsy concentrations of intact BUD were >10-fold greater than those of fluticasone propionate and at 24 hours BUD was detectable in threefold more biopsies than fluticasone propionate. The impact of esterification on airway selectivity of BUD has also been demonstrated in vivo and using pharmacokinetic/pharmacodynamic models.. BUD is retained in airways as esters, a novel kinetic mechanism for synthetic glucocorticoids. In preclinical studies this esterification is correlated to a prolonged local tissue binding and efficacy, which is not found when the esterification is inhibited by an esterification blocker. Because less esters are formed in the systemic compartment than in airways/lung, the local benefit:systemic risk ratio may also be improved by this mechanism. BUD possesses favorable clinical properties, including its approved once-daily efficacy in asthma, which is probably in part attributable to esterification. However, a direct proof of the latter in patients requires effective and safe inhibitors of the esterification, which are not yet available. Therefore, evidence to support the therapeutic impact of esterification is still circumstantial.

Topics: Animals; Asthma; Bronchodilator Agents; Budesonide; Fatty Acids; Humans; Rhinitis

Inhaled budesonide is now well established in the management of adult and childhood asthma, and when nebulised, shows considerable promise in recurrent wheezing and in severe asthma in infants. Studies conducted since the drug was previously reviewed in the Journal in 1984 have confirmed the comparable efficacy of equal doses of budesonide and beclomethasone dipropionate, the ability of budesonide to reduce oral maintenance corticosteroid requirements, and demonstrated its potential as first-line treatment of mild to moderate asthma. Recent studies have established the usefulness and good tolerability of intranasal budesonide in the treatment of seasonal allergic and perennial rhinitis where the drug is more effective than disodium cromoglycate and at least as effective as beclomethasone dipropionate. After up to 10 years of treatment with inhaled budesonide there is no evidence that the drug damages the tracheobronchial lining or the nasal mucosa. Inhaled corticosteroids continue to play an important role in the treatment of asthma with an increasing focus on their role as first-line therapy, and widespread clinical experience has shown budesonide is an effective and well tolerated member of this class which should be considered where inhaled or intranasal administration of a corticosteroid is indicated.

Topics: Aerosols; Asthma; Bronchodilator Agents; Budesonide; Glucocorticoids; Humans; Pregnenediones; Rhinitis

Owing to improvements made during the last 15 years in the pathophysiological and pharmacological research, many new corticosteroids have been successfully experimented. They have high activity on the target organ and they are suitable for long term therapies since they have not any systemic and/or local side effects. Nowadays the topical intranasal corticosteroid therapy is indispensable for allergic rhinitis treatment and it is very useful for many nasal and bronchopulmonary diseases (some chronic rhinitis, nasal polyposis, bronchial asthma, chronic obstructive bronchopulmonary diseases). The authors use their personal experience and carefully review the literature to describe the general aspects (pharmacology, pharmacokinetics, toxicology, side effects and contraindications) and to analyze the single drugs currently used in Italy and abroad. Finally, they compare the efficacy of each topical intranasal glucocorticoid among themselves and with other drugs.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Adult; Asthma; Beclomethasone; Budesonide; Child; Fluocinolone Acetonide; Humans; Hydrocortisone; Lung Diseases, Obstructive; Pregnenediones; Rhinitis

Topics: Budesonide; Chronic Disease; Drugs, Chinese Herbal; Endoscopy; Fumigation; Humans; Medicine, Chinese Traditional; Rhinitis; Sinusitis

Neutrophilic chronic rhinosinusitis with nasal polyps (CRSwNP) occur predominantly in Asian subjects. Appropriate treatments for this endotype have not been elucidated. This study aimed to evaluate the efficacy of budesonide nasal spray on neutrophilic CRSwNP.. Fifteen neutrophilic CRSwNP patients were included, and then they received budesonide nasal spray treatment for 3 months. Biopsies of nasal polyps (NPs) were obtained from these subjects. Their clinical indexes were scored using Visual Analog Scale (VAS), Sino-Nasal Outcome Test (SNOT)-22, and Endoscopic Appearances (EAs). Histological analyses were used to assess numbers of neutrophils, goblet cells, and submucosal gland cells in NPs. Percentages of CD8+ T cells and CD4+CD25+Foxp3+ regulatory T cells (Tregs) were evaluated using flow cytometry. Mucin 5AC (MUC5AC), MUC5B, myeloperoxidase (MPO), interferon (IFN)-γ, and interleukin (IL)-1β and their mRNAs were also examined. After that, we cultured NP tissues in vitro and evaluated the abovementioned inflammatory parameters before and after the administration of budesonide.. Budesonide nasal spray did not improve clinical evaluations including VAS, SNOT-22, and EA scores. Numbers of neutrophils and goblet cells, the score of submucosal gland cells, percentages of CD8+ T cells and Tregs, MUC5AC, MUC5B, MPO, IFN-γ, and IL-1β and their mRNAs were not decreased in NPs after the budesonide treatment. Furthermore, the administration of budesonide into NP cultures also did not reduce their levels in comparison with those before the treatment.. These findings demonstrate that budesonide treatment may not alleviate the inflammatory condition in neutrophilic CRSwNP.

Topics: Adult; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Female; Humans; Male; Middle Aged; Nasal Polyps; Nasal Sprays; Neutrophils; Pilot Projects; Rhinitis; Sinusitis

Oral and topical corticosteroids, and antibiotics form the mainstay medical treatment of chronic rhinosinusitis (CRS). Clinical outcomes vary depending on the chosen therapy, resident microbiome and disease phenotype. We conducted a double- blinded, placebo-controlled Randomised Controlled Trial (RCT) to investigate effects of medical therapy on clinical outcomes and associated microbiome shifts.. Fifty eligible patients (CRS with and without polyps) were treated for 3 weeks after randomisation into 3 arms: na- mely oral prednisolone, topical budesonide irrigations and oral doxycycline; each with appropriate placebo. Clinical scoring and microbiome swabs were performed on enrolment, at treatment completion and 3-weeks post treatment completion. Microbiome analysis was performed using the llumina-MiSeq next generation sequencing platform and QIME-2 pipeline.. Significant improvement in clinical scores was observed in prednisolone and budesonide arms at treatment completion but not with antibiotic. Sub-group analysis showed more pronounced effects in patients with polyposis. Corynebacterium and Staphylococcus species predominated, with variable bacterial relative abundance among different treatments at all time-points. The only significant microbiome finding was an increase in bacterial diversity in topical budesonide group immediately after treatment, which returned to baseline 3-weeks post treatment.. Clinical improvement was significant with oral and topical steroid but not empirical antibiotic. Although there were some associated microbiome changes with the various treatments, we could not ascertain the consistency of these and whether they do have a clinical significance at all.

Topics: Budesonide; Chronic Disease; Double-Blind Method; Doxycycline; Humans; Microbiota; Prednisolone; Rhinitis; Sinusitis

In China, clarithromycin is considered an effective treatment option for chronic rhinosinusitis (CRS) due to its unique immunopathologic characteristics. Our study's aim was to determine whether a topical steroid and clarithromycin combination is better than a single topical steroid for Chinese patients with CRS.. Patients with CRS with/without nasal polyps were included in this study and randomly assigned to a clarithromycin plus budesonide aqua nasal spray group (CLM + BUD, clarithromycin 0.25 g/d and budesonide 256 μg/d) or a budesonide-alone group (BUD, budesonide 256 μg/d). The treatment period was 3 months. The primary outcome was visual analog scale (VAS) score for 5 major symptoms and a general nasal symptom. Other assessments included the 22-item Sino-Nasal Outcome Test (SNOT-22), computed tomography scan (Lund-Mackay score), and rigid nasal endoscopy (Lund-Kennedy score). Nasal secretion evaluation was the secondary outcome.. Seventy-four patients were included and randomly assigned to the CLM + BUD group (n = 38) or the BUD group (n = 36). VAS scores for nasal obstruction, rhinorrhea, smell reduction, headache, nasal pain, and general nasal symptom were markedly improved in both treatment arms, but the differences between groups were not significant. Furthermore, SNOT-22, Lund-Mackay, and Lund-Kennedy scores improved significantly after treatment in both groups, and were slightly better in the CLM + BUD group. For the responders in the CLM + BUD group, interleukin (IL)-6 and IL-8 were markedly reduced.. The combination of CLM + BUD for the treatment of first-time-diagnosed CRS in this Chinese population cohort did not show a better effect compared with a single BUD regimen, but it may have a better effect in some patients with increased IL-6 or IL-8.

Topics: Administration, Topical; Adult; Anti-Bacterial Agents; Budesonide; China; Chronic Disease; Clarithromycin; Cytokines; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Nasal Polyps; Nasal Sprays; Rhinitis; Single-Blind Method; Sinusitis; Treatment Outcome; Young Adult

Recent studies suggest that budesonide added to saline nasal lavage can be an effective treatment for patients with chronic rhinosinusitis (CRS).. To evaluate the incremental effect of adding budesonide to large-volume, low-pressure saline sinus irrigation.. This double-blind, placebo-controlled, randomized clinical trial was conducted at a quaternary care academic medical center between January 1, 2016, and February 16, 2017. A total of 80 adult patients with CRS were enrolled; 74 completed baseline assessments; and 61 remained in the trial to complete all analyses. Data analysis was conducted from March 2017 to August 2017.. All study participants were provided with a sinus rinse kit including saline and identical-appearing capsules that contained either budesonide (treatment group) or lactose (control group). Patients were instructed to dissolve the capsules in the saline and use the resulting solution to irrigate both nasal cavities, using half the solution for each cavity, once daily for 30 days.. The primary outcome measure was the change in Sino-Nasal Outcome Test (SNOT-22) scores, pretreatment to posttreatment, in the budesonide group compared with the control group. Secondary outcome measures included patient-reported response to treatment, as measured with a modification of the Clinical Global Impressions scale, and endoscopic examination scored by the Lund-Kennedy grading system.. Of the 74 participants who completed baseline assessments (37 in each study arm), mean (SD) age, 51 (14.7) years, 50 (68%) were women. Of the 61 who remained in the trial to complete all analyses, 29 were randomized to budesonide treatment, and 32 to saline alone. The average change in SNOT-22 scores was 20.7 points for those in the budesonide group and 13.6 points for those in the control group, for a mean difference of 7 points in favor of the budesonide group (95% CI, -2 to 16). A total of 23 participants (79%) in the budesonide group experienced a clinically meaningful reduction in their SNOT-22 scores compared with 19 (59%) in the control group, for a difference of 20% (95% CI, -2.5% to 42.5%). The average change in endoscopic scores was 3.4 points for the budesonide group and 2.7 points for the control group. There were no related adverse events.. This study shows that budesonide in saline nasal lavage results in clinically meaningful benefits beyond the benefits of saline alone for patients with CRS. Given the imprecision in the treatment effect, further research is warranted to define the true effect of budesonide in saline nasal lavage.. ClinicalTrials.gov Identifier: NCT02696850.

Topics: Administration, Intranasal; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Patient Reported Outcome Measures; Quality of Life; Rhinitis; Saline Solution; Sinusitis; Therapeutic Irrigation; Treatment Outcome

The objective of the study is to investigate the impact of receiving daily WeChat services on one's cell phone on adherence to corticosteroid nasal spray treatment in chronic rhinosinusitis (CRS) patients after functional endoscopic sinus surgery (FESS). This study was a two-arm, randomized, follow-up investigation. Patients with chronic rhinosinusitis with/without nasal polyps following bilateral FESS were randomised to receive, or to not receive, daily WeChat service on their cell phone to take corticosteroid nasal spray treatment. A prescription of budesonide aqueous nasal spray 128 µg bid was given to all the subjects. Then they returned to the clinic after 30, 60, 90 days. The primary study outcome was adherence to nasal spray treatment, whereas secondary outcomes were change in endoscopic findings and SinoNasal Outcome Test-20 (SNOT-20). On the whole, there was a significant inter-group difference in the change of adherence rate (F = 90.88, p = 0.000). The WeChat group had much higher adherence rate than the control group during the follow-up. In terms of postoperative endoscopic scores and SNOT-20, except granulation score, no significant differences were observed between the two randomization groups. WeChat services are already after a short period of observation associated with improved adherence to corticosteroid nasal spray treatment in CRS patients after FESS.

Topics: Adult; Budesonide; China; Chronic Disease; Endoscopy; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Medication Adherence; Middle Aged; Mobile Applications; Nasal Sprays; Rhinitis; Sinusitis

Topics: Anti-Inflammatory Agents; Budesonide; Child; Female; Humans; Male; Nasal Lavage; Nose; Quality of Life; Rhinitis; Saline Solution, Hypertonic; Sinusitis; Sodium Chloride; Therapeutic Irrigation

Cysteinyl leukotriene (LT) has been proposed in the pathogenesis of chronic rhinosinusitis with nasal polyps (CRSwNP). This study sought to examine the expression of the LT receptor (LTR) in CRSwNP patients and evaluate the potential role of LTR antagonist (LTRA) in the management of eosinophilic CRSwNP (ECRS) patients.. Nasal polyps and uncinate process tissues were collected from 18 ECRS patients, 13 non-eosinophilic CRSwNP (non-ECRS) patients, and 16 control subjects. The messenger RNA (mRNA) and protein expression of LTR (cysteinyl leukotriene receptor 1 [CysLT1R] and cysteinyl leukotriene receptor 2 [CysLT2R]) was examined using quantitative reverse-transcription polymerase chain reaction (qRT-PCR), immunohistochemistry, and Western blot analysis. Moreover, the effects of LTRA and steroids on total nasal symptom scores (TNSS) of uncontrolled ECRS patients were evaluated.. The mRNA and protein expression of CysLT1R and CysLT2R was significantly increased in polyp tissues compared with healthy controls (p < 0.05). Compared with the non-ECRS subset, the ECRS subset showed significantly increased expression of CysLT1R and CysLT2R, as well as leukotriene C4 (LTC4) and leukotriene D4 (LTC4) levels (p < 0.05). Moreover, combined LTRA and steroids significantly decreased TNSS more than steroids alone in uncontrolled ECRS patients (p < 0.01).. Our findings indicate that LTR was differentially expressed between ECRS and non-ECRS patients, and that LTRA may be used as an additional therapy for ECRS patients.

Topics: Acetates; Adult; Anti-Inflammatory Agents; Biomarkers; Blotting, Western; Budesonide; Case-Control Studies; Chronic Disease; Cyclopropanes; Drug Therapy, Combination; Eosinophils; Female; Humans; Leukotriene Antagonists; Leukotrienes; Male; Middle Aged; Nasal Polyps; Prospective Studies; Quinolines; Receptors, Leukotriene; Reverse Transcriptase Polymerase Chain Reaction; Rhinitis; Sinusitis; Sulfides; Treatment Outcome

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

The recommended drug for moderate to severe chronic rhinitis is intranasal steroids (INS). However, nasal congestion could be refractory and need additional treatments.. We sought to explore the benefit of oxymetazoline (Oxymet) plus INS on nasal congestion without inducing rhinitis medicamentosa.. We performed a 60-week, randomised, double-blind clinical trial in 50 patients, 18 years of age or greater, with chronic rhinitis who had used INS and cetirizine and still had nasal congestion. Subjects were randomised to receive 2 sprays of 0.05% Oxymet in each nostril twice daily or placebo for 4 weeks. All patients received 2 sprays of budesonide (100 μg/spray) in each nostril twice daily and 10 mg cetirizine once daily from entry throughout the study. Nasal symptom scores, nasal peak inspiratory flow (NPIF) and Rhinoconjunctivitis Quality of Life (Rcq) scores were measured.. Oxymet significantly reduced nasal congestion in subjects with chronic rhinitis compared with placebo on the day of 15-28 and 29-42. In subjects with allergic rhinitis, nasal congestion scores in the Oxymet group were significantly reduced compared with those in the placebo group on days 4-7, days 8-14, days 15-28 and days 29-42. In the Oxymet group, post hoc analysis showed that subjects with allergic rhinitis significantly improved their nasal congestion scores compared to non-allergic individuals (N, allergic/non-allergic = 18/7, p < 0.05). The combination of INS and Oxymet was not associated with rhinitis medicamentosa.. The combination of INS and Oxymet provides additional benefit compared to INS monotherapy in relieving nasal congestion in subjects with chronic rhinitis and allergic rhinitis without developing rhinitis medicamentosa.

Topics: Administration, Intranasal; Adult; Budesonide; Chronic Disease; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Oxymetazoline; Rhinitis

To investigate the long term clinical effect of budesonide treatment in middle meatus for chronic rhinosinusitis(CRS) following endoscopic sinus surgery (ESS).. A total number of 53 patients with CRS received ESS were divided into two groups according to budesonide treatment: budesonide-treated group with 21 cases (39.6%) and control group with 32 cases (60.4%). Gelatin sponges soaked with 1 ml budesonide suspension were put in middle meatus in budesonide-treated group, while only gelatin sponges were put in middle meatus in control group. Visual analogy score (VAS), sino-nasal outcome test-22 (SNOT-22) and Lund-Kennedy endoscopic scale were carried out before ESS and two years after ESS.. In budesonide-treated group, there were a statistical difference before and after ESS in the VAS, SNOT-20 and Lund-Kennedy score (P<. 05). In control group, difference was also significant in VAS, SNOT-20 and Lund-Kennedy score before and after ESS (P < 0.05). The VAS gap of post-operative and pre-operative in two groups are significantly different (P<. 05). However, there was no significant difference in the SNOT-20 and Lund-Kennedy endoscopic scale gap before or after the operation between two groups.. It is safe, convenient and practicable to perform budesonide treatment in middle meatus following ESS, which can significantly ease the post-operative discomfort of nose.

Topics: Budesonide; Chronic Disease; Endoscopy; Humans; Nose; Paranasal Sinuses; Postoperative Period; Rhinitis; Sinusitis

There is little evidence on the efficacy of glucocorticoid transnasal nebulization therapy in patients with eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP).. We sought to evaluate the immunologic and remodeling effects of budesonide transnasal nebulization in patients with eosinophilic CRSwNP.. Sixty patients with eosinophilic CRSwNP were randomized to receive budesonide or placebo treatment for 14 days by means of transnasal nebulization in a double-blind manner. Endoscopic polyp size scores (maximum = 6 points, Kennedy score) and visual analog scale scores for nasal symptoms were assessed before and after treatment. Similarly, polyp samples were evaluated for inflammatory cytokines, matrix metalloproteinases (MMPs), and tissue inhibitors of metalloproteinases (TIMPs) by using an immunoassay; collagen by using histochemistry; eosinophils by using hematoxylin and eosin stain; and T-cell subsets by using flow cytometry.. Budesonide transnasal nebulization significantly reduced polyp size compared with placebo (mean difference between groups, -0.73 units; 95% CI, -1.15 to -0.32 units; P = .002) and improved symptoms. Polyp IL-5 and eotaxin expression decreased significantly, whereas TGF-β and IL-10 expression increased. Expression of IFN-γ and IL-17 was not altered. Budesonide transnasal nebulization consistently reduced eosinophil infiltration and TH2 cell frequency and increased natural regulatory T-cell and type 1 regulatory T-cell frequencies. Indices of remodeling, including albumin, MMP-2, MMP-7, MMP-8, and MMP-9, were significantly decreased, whereas collagen deposition and TIMP-1, TIMP-2, and TIMP-4 levels were significantly increased. Budesonide transnasal nebulization did not suppress the hypothalamic-pituitary-adrenal axis or cause any serious side effects.. Short-term budesonide transnasal nebulization is an effective and safe treatment option in patients with eosinophilic CRSwNP, achieving clinical improvement by regulating remodeling, cytokine expression, and T-cell subset distribution.

Topics: Adult; Aged; Bronchodilator Agents; Budesonide; Chronic Disease; Cytokines; Eosinophils; Female; Humans; Inflammation Mediators; Male; Middle Aged; Nasal Polyps; Nebulizers and Vaporizers; Rhinitis; Sinusitis; Treatment Outcome; Young Adult

To evaluate the efficacy and safety of a short course of nebulized budesonide via transnasal inhalation in chronic rhinosinusitis with nasal polyps.. Fifty patients with severe eosinophilic nasal polyps were randomized devided into study group (n = 25) and control group (n = 25). The study group received budesonide inhalation suspension (1 mg twice daily) via transnasal nebulization for one week and the control group received oral prednisone (24 mg QD). Visual analogue scales (VAS) of nasal symptoms, endoscopic polyp scores (kennedy scores) and morning serum cortisol concentrations were assessed in both groups pre- and post-treatment. Operation time and surgical field bleeding were evaluated.. Four subjects dropped out in control group. Budesonide transnasal nebulization caused a significant improvement in all nasal symptoms especially nasal obstruction (baseline: 8.25 ± 0.53; after treatment: 4.97 ± 0.97, P < 0.01) and reduced polyp size significantly (baseline: 4.64 ± 0.63; after treatment: 3.40 ± 0.76, P < 0.01) compared to pre-treatment. The patients treated with oral prednisone, however, showed more obvious improvement in nasal symptoms and polyp size, shorter operation time and better surgical field than budesonide group. Additionally, the morning serum cortisol concentration was mildly decreased after one week treatment in budesonide group [baseline (17.18 ± 2.83) μg/dl, after treatment (16.24 ± 2.93) μg/dl, P > 0.05], but all values were still located in normal range (normal range: 5-25 μg/dl). Conversely, the morning serum cortisol concentration in oral prednisone group was lower than normal limit [baseline (18.19 ± 2.81) μg/dl, after treatment (2.26 ± 0.70) μg/dl, P < 0.01].. Twice daily budesonide transnasal nebulization is an effective and safe treatment as evidenced by significant improvements in nasal symptoms and reduction in polyp size, coupled with an absence of hypothalamic-pituitary-adrenal axis suppression, which is safer than the systemic corticosteroids. Budesonide transnasal nebulization offers a viable treatment option for CRSwNP before operation.

Topics: Administration, Inhalation; Budesonide; Chronic Disease; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Nasal Obstruction; Nasal Polyps; Pituitary-Adrenal System; Prednisone; Rhinitis; Sinusitis; Suspensions

To compare normal saline (NS) vs. NS+budesonide irrigations in post- functional endoscopic sinus surgery (FESS) patients with chronic rhinosinusitis with polyposis (CRSwNP). Currently, no evidence exists for NS+budesonide irrigation over NS irrigation alone.. Prospective, single-blind, randomized controlled trial.. Subjects were prospectively enrolled to NS or NS+budesonide arms. Patients were evaluated at pre-operative and three post-operative visits (POV): POV1 (1-2 weeks post-op), POV2 (3-8 weeks post-op), and POV3 (3-6 months post-op). Patients were evaluated by three quality of life (QOL) questionnaires (SNOT-22, RSOM-31, and RSDI) and two olfaction scores (UPSIT and the PEA test).. Fifty patients were randomized, with 25 patients in the NS arm and 25 patients in the NS+budesonide arm. Two patients had unexpected pathology and were excluded from the study. By POV2 and POV3, patients experienced a significant improvement in all three QOL surveys, although the degree of improvement between arms was not significant up through POV3. Neither arm experienced significant olfactory improvement up through POV3.. While both NS and NS+budesonide treatments improve QOL for post-FESS patients, neither intervention significantly increases QOL as compared to the other. Olfaction was not significantly improved in either treatment group.

Topics: Adult; Budesonide; Chronic Disease; Female; Glucocorticoids; Humans; Male; Middle Aged; Nasal Polyps; Postoperative Care; Prospective Studies; Quality of Life; Recovery of Function; Rhinitis; Single-Blind Method; Sinusitis; Smell; Therapeutic Irrigation; Treatment Outcome

Budesonide is a potent corticosteroid commonly prescribed for management of inflammation in chronic rhinosinusitis (CRS). The standard for prescribing budesonide is via impregnated nasal saline irrigation (INSI), although recently the mucosal atomization device (MAD) has emerged as a theoretically superior method of distributing medication into the sinuses. The MAD atomizes medication into small droplets and this is thought to enhance absorption and improve bioavailability. However, no studies have shown whether enhanced absorption and improved bioavailability of budesonide via MAD causes adrenal suppression. The objective of this study is to determine whether budesonide via MAD affects the hypothalamic-pituitary-adrenal (HPA) axis.. Twenty CRS patients were recruited from a tertiary rhinology clinic and randomized to take budesonide (1 mg) via MAD or via INSI twice a day for 60 days. The adrenocorticotropic hormone (ACTH) stimulation test and 22-item Sinonasal Outcomes Test (SNOT-22) questionnaire were administered on days 1, 30, and 60 of the study. Plasma budesonide and cortisol levels were simultaneously quantified using a high-performance liquid chromatography-tandem mass spectrometry technique.. There was no indication of adrenal suppression in either group (n = 20) based on ACTH stimulation test results nor was there significant plasma budesonide levels detected in either group. Quality of life, as indicated by SNOT-22, did not differ between groups at 60 days (p = 0.404; 95% confidence interval [CI], -37.2 to 15.9), but SNOT-22 scores for patients using MAD did show statistically significant improvement at 60 days compared to baseline (p = 0.02).. The MAD is likely a safe and effective method of delivering budesonide to the sinuses in the short term.

Topics: Administration, Mucosal; Anti-Inflammatory Agents; Budesonide; Canada; Chronic Disease; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Nasal Polyps; Nebulizers and Vaporizers; Pituitary-Adrenal System; Prospective Studies; Quality of Life; Rhinitis; Sinusitis; Time Factors; Treatment Outcome

Evidence is lacking to guide the postoperative management of Samter's triad patients with chronic rhinosinusitis with polyposis (CRSwP) undergoing endoscopic sinus surgery (ESS). The purpose of this study was to compare three different standardized medication regimens prescribed to these patients after ESS.. Three-arm, randomized, double-blinded, controlled trial.. Patients with Samter's triad undergoing ESS were postoperatively randomized into three medication regimens, those being saline irrigation alone (control group A), saline irrigation plus separate budesonide nasal spray (group B), and saline irrigation mixed with budesonide nasal spray (group C). Outcome measures were Sino-Nasal Outcome Test scores, Lund-Mackay computed tomography scores, and Lund-Kennedy endoscopic scores taken at preoperative baseline, and then at 6 months and 1 year postoperatively. Side effect profiles were also measured (adrenocorticotropic hormone blood level ranges and intraocular pressure at the same interval points). Analysis of variance and χ(2) analyses were conducted using a Bonferroni correction method and routine descriptive statistics. Inter- and intragroup comparisons were made.. Sixty subjects were recruited. All groups were equivalent at baseline in all outcomes. All intragroup analyses showed statistically and clinically significant improvement in disease status as compared to baseline (P < .0167), with a sustained but lessened improvement at 1 year. However, no statistically or clinically significant differences were observed between groups at any time point (P > .05). There was no treatment effect noted.. In this study, nasal steroids did not confer any additional benefit over saline alone as post-ESS care for the Samter's triad CRSwP patient population.

Topics: Administration, Intranasal; Adult; Aged; Analysis of Variance; Budesonide; Double-Blind Method; Endoscopy; Female; Follow-Up Studies; Humans; Male; Middle Aged; Nasal Lavage; Paranasal Sinuses; Postoperative Care; Prospective Studies; Reference Values; Rhinitis; Risk Assessment; Sinusitis; Sodium Chloride; Treatment Outcome; Young Adult

To estimate the direct and indirect costs of severe asthma and the economic impact of its management to low-income families in Salvador, Brazil.. One hundred and ninety-seven patients with severe asthma and referred to a state-funded asthma center providing free treatment were evaluated. At registration, they were asked about family cost-events in the previous year and had a baseline assessment of lung function, symptoms and quality of life. During the subsequent year, they were reassessed prospectively.. One hundred-eighty patients concluded a 12-month follow-up. Eighty-four percent were female patients, and the median family income was US$ 2955/year. Forty-seven percent of family members had lost their jobs because of asthma. Total cost of asthma management took 29% of family income. After proper treatment, asthma control scores improved by 50% and quality of life by 74%. The income of the families increased by US$ 711/year, as their members went back to work. The total cost of asthma to the families was reduced by a median US$ 789/family/year. Consequently, an annual surplus of US$ 1500/family became available.. Family costs of severe asthma consumed over one-fourth of the family income of the underprivileged population in a middle-income country. Adequate management brings major economic benefit to individuals and families.

Topics: Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Brazil; Bronchodilator Agents; Budesonide; Cost of Illness; Ethanolamines; Family; Female; Fenoterol; Formoterol Fumarate; Humans; Male; Middle Aged; Poverty; Quality of Life; Rhinitis

To evaluate whether nasal administration of budesonide in adults with chronic rhinosinusitis for 30 days suppresses adrenal function and to assess its clinical efficacy.. An open-label prospective study.. Academic medical center.. We assessed adrenal function in 9 patients using the cosyntropin test before and after budesonide therapy.. Budesonide respule therapy.. Scores from the Sino-Nasal Outcome Test-20 (SNOT-20), a tool for assessing rhinosinusitis health and quality of life, were used to assess efficacy of budesonide treatment.. All of our patients showed adequate adrenal response to cosyntropin stimulation before and after the budesonide trial. The mean difference in SNOT-20 scores was -1 (95% confidence interval, -1.77 to -0.23; P = .02), indicating clinically significant improvement after therapy.. Our findings suggest that using budesonide nasal wash may be clinically effective in decreasing the symptoms of chronic rhinosinusitis and does so without suppression of the hypothalamic-pituitary-adrenal axis in patients with chronic rhinosinusitis.

Topics: Administration, Intranasal; Adolescent; Adrenal Cortex; Adult; Aged; Budesonide; Chronic Disease; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Glucocorticoids; Humans; Hydrocortisone; Immunoassay; Male; Middle Aged; Patient Satisfaction; Prospective Studies; Rhinitis; Sinusitis; Surveys and Questionnaires; Treatment Outcome; Young Adult

The objective of the present study was to evaluate the clinical response to topical budesonide in patients with nasal polyposis (NP) and to evaluate if there is any clinical event that may predict the response to treatment. Twenty patients with NP were assessed by a clinical questionnaire, nasal endoscopy and sinusal computed tomography. The patients were then medicated with budesonide, 256 microg/nostril/day, for a 2-month period and afterwards they were submitted to a new clinical questionnaire and a new endoscopy. Post-treatment endoscopy revealed a significant reduction of polyp size's score (4.25 vs. 2.90, p < 0.01), which was associated to improvement of nasal symptoms: posterior rhinorrhea, headache, hyposmia, anterior rhinorrhea, and sneezing (p < 0.05). There was also a significant improvement of the sum of scores (20.10 vs. 10.30, p < 0.0001). Cacosmia and nasal itching did not respond to medical treatment. Patients with a higher tomographic extension of the polyp presented a significantly worse clinical response (p < 0.05). We conclude that there was partial, but significant, improvement of nasal symptoms and polyp size after treatment with nasal budesonide and that this clinical improvement was inversely correlated to the tomographic extension of NP at diagnosis.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Endoscopy; Female; Glucocorticoids; Headache; Humans; Male; Middle Aged; Nasal Obstruction; Nasal Polyps; Olfaction Disorders; Paranasal Sinuses; Remission Induction; Rhinitis; Sneezing; Surveys and Questionnaires; Tomography, X-Ray Computed; Treatment Outcome

An open randomized comparative study was conducted in order to observe the efficacy and safety about intranasal Budesonide in the treatment of chronic nonallergic rhinitis.. Forty-two patients with chronic nonallergic rhinitis were treated with Budesonide aqueous nasal spray (256 microg once daily intranasally) for 8 weeks. All the patients were asked for return at week 1 and week 8. Efficacy was evaluated by measurement of nasal symptom scores and sign scores at week 0, week 1 and week 8.. All the parameters measured were improved after treatment. Specifically, from week 0 to week 1, the scores of nasal secretions, itchy feeling of the nose and headache showed a significant decrease than that before treatment. From week 0 to week 8, the scores of nasal obstruction, nasal secretions, itchy feeling of the nose, closed rhinolalia and headache were significantly less than the record at week 0. However, there were not significant influences on the smell disturbances, dryness of the throat. No serious adverse events were reported in the study.. Intranasal Budesonide is effective and safe in alleviating the symptoms of chronic nonallergic rhinitis.

Topics: Administration, Intranasal; Adult; Aged; Budesonide; Chronic Disease; Female; Glucocorticoids; Humans; Male; Middle Aged; Nose; Rhinitis; Treatment Outcome

To investigate the bacteriological character and pH value in nasal cavity and observe the efficacy following 8 week treatment with Budesonide aqueous nasal spray in chronic nonallergic rhinitis.. Forty-two patients with chronic nonallergic rhinitis were treated with Budesonide aqueous nasal spray (256 microg once daily intranasal) for 8 weeks. Bacteriological character was measured before and 8 weeks after treatment All the swab specimens were obtained from the inferior meatus, bacteriologic outcome was determined by general cultures. Nasal pH value was measured by using a probe sited under the inferior turbinate before and after treatment. Efficacy was evaluated by measurement of nasal symptom scores and sign scores before and 8 weeks after treatment.. The bacterial growth was present in 37 of 42 cases (88%) before the treatment (group 1), including 53 aerobic bacteria. The bacterial growth was present in 38 of 42 cases (90.47%) 8 weeks after treatment (group 2), including 46 aerobic bacteria. There was no significant difference in the bacterial distribution between group 1 and group 2 (chi2 = 0.416, P > 0.05). Budesonide aqueous nasal spray reduced pH value from 7.90 +/- 0.39 to 7.70 +/- 0.23 (t = 2.72, P < 0.05). All the parameters of symptoms were improved after treatment, including nasal obstruction, nasal secretions, itchy feeling of the nose, closed rhinolalia and headache.. Glucocorticoid aqueous nasal spray could be used safely for eight weeks and does not increase the risk of aerobes and fungi infection and reduce the pH in chronic nonallergic rhinitis. It is effective in relieving symptoms of patients with chronic nonallergic rhinitis.

Topics: Administration, Intranasal; Adult; Aged; Budesonide; Chronic Disease; Female; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Nasal Cavity; Rhinitis

This study evaluated the efficacy and tolerability of budesonide in an aqueous nasal spray (BANS) in patients with chronic rhinosinusitis. In this double-blind, placebo-controlled, multicentre, parallel-group study, patients (n = 167) with persistent rhinosinusitis symptoms despite 2-weeks' antibiotic treatment were randomised to receive BANS 128 micrograms b.i.d. or placebo for 20 weeks. Morning combined symptom scores (CSS) in patients receiving BANS decreased by a mean of -1.85 (95% CI -2.27, -1.43), versus -1.02 (-1.43, -0.61) in the placebo group (p = 0.005); corresponding values for evening CSS were -1.78 (-2.22, -1.35) and -1.02 (-1.45, -0.60), respectively (p = 0.012). BANS produced significant reductions in nasal congestion and discharge scores, and improved patients' sense of smell (morning only), versus placebo. Peak nasal inspiratory flow (PNIF) increased significantly during BANS treatment. In allergic patients, BANS significantly (p < 0.001) reduced both morning -1.40 (-2.18, -0.62) and evening -1.37 (-2.15, -0.58) CSS from baseline versus placebo, but changes in non-allergic patients (morning: -0.04 [-0.95, 0.87]; evening: 0.14 [-0.81, 1.09]) were not significant. PNIF was significantly (p < 0.01) increased in both allergic and non-allergic patients from baseline versus placebo. BANS is an effective and well-tolerated treatment for chronic rhinosinusitis.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Double-Blind Method; Female; Humans; Male; Middle Aged; Pharmaceutical Solutions; Rhinitis; Sinusitis

Both specific immunotherapy (SIT) and nasal steroid (NS) have been shown to effectively reduce symptoms of allergic rhinitis. Although a number of investigators have convincingly shown anti-inflammatory effects of both treatments in separate studies, few comparative studies have been performed.. The purpose of this study was to compare the effects of preseason SIT with a standardized allergen extract and NS in seasonal allergic disease (rhinoconjunctivitis and asthma).. We examined 41 patients allergic to birch pollen, 21 with rhinoconjunctivitis and 20 with both rhinoconjunctivitis and asthma; they were treated in a randomized, double-blinded comparative study with birch SIT and NS (budesonide 400 microg daily). Bronchial hyperresponsiveness was measured before and during the season. Changes in eosinophil number, eosinophil cationic protein, and eosinophil chemotactic activity (ECA) in peripheral blood were investigated.. Symptoms of rhinoconjunctivitis increased significantly less in the NS-treated patients than in the SIT-treated patients during the final 2 weeks of the season (P = .03 and P = .04, respectively). Seasonal peak expiratory flow values decreased significantly only in the NS-treated patients (P = .01). In the NS-treated patients, bronchial hyperresponsiveness increased significantly during the season (P = .0001); however, SIT treatment prevented seasonal PC(20) increase in the asthmatic patients. Measurement of blood eosinophils, eosinophil cationic protein, and eosinophil chemotactic activity demonstrated significant seasonal increase only in the NS-treated asthmatic patients.. Treatment with NS was more effective than short-course preseason SIT in reducing symptoms of rhinoconjunctivitis; however, the 2 therapies were equivalent in terms of the need for rescue medication. SIT prevented seasonal increase in bronchial hyperresponsiveness, eosinophil number, eosinophil cationic protein, and eosinophil chemotactic activity only in asthmatic patients. The mechanisms underlying bronchial hyperresponsiveness developing during allergen exposure in rhinitis might be different from those operating in asthma.

Topics: Administration, Intranasal; Adult; Allergens; Asthma; Blood Proteins; Bronchial Hyperreactivity; Budesonide; Conjunctivitis, Allergic; Double-Blind Method; Eosinophil Granule Proteins; Female; Humans; Immunotherapy; Male; Rhinitis; Ribonucleases

The aim of this prospective study was to evaluate the efficacy of a combined (local and systemic) steroid therapy on the extent of chronic polypoid rhinosinusitis and patient symptoms.. Subjects of this study were 20 patients with severe chronic polypoid rhinosinusitis with total or subtotal narrowing of the all sinuses. A nasal budesonide spray (2 x 0.1 mg/day) and an oral fluocortolone medication with a daily reduction during a 12-day period (total dose: 560 mg = group 1) and a 20-day period (total dose: 715 mg = group 2), respectively, were administered. Before and after the steroid treatment we evaluated the extent of the sinusitis with MRI and patient symptoms with symptom-related questionnaires.. A significant reduction (> 30%) of the chronic polypoid rhinosinusitis was observed in 50% of MRI findings. The steroid effect on polypoid masses was heterogeneous in different anatomic areas (maxillary sinus 40%, anterior ethmoid 19%, posterior ethmoid 33%, sphenoidal sinus 61%, frontal sinus 46%). Most sinusitis-related symptoms were distinctly diminished in most patients (80%). No major side effects were observed.. A combined short-term steroid therapy is highly effective in chronic polypoid rhinosinusitis, reducing the mucosal inflammation mainly in the large sinuses and reducing the incidence of symptoms significantly. However, this therapy was insufficient in the anterior ethmoid and cannot replace the current surgical treatment concept of the osteomeatal complex in CPR. The indication for such a short-term steroid therapy is the preoperative treatment. It facilitates functional endoscopic sinus surgery by reducing the extent of surgical procedures, the time, and thereby the risks of sinus surgery.

Topics: Administration, Inhalation; Administration, Oral; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Drug Therapy, Combination; Female; Fluocortolone; Glucocorticoids; Humans; Image Processing, Computer-Assisted; Magnetic Resonance Imaging; Male; Middle Aged; Polyps; Prospective Studies; Rhinitis; Sinusitis

Intranasal budesonide and beclomethasone dipropionate (BDP), each administered as aqueous, aerosol formulations at dosages of 200 micrograms twice a day, morning and evening, were compared over a 3-week period in a randomized, parallel group study of 88 adults with seasonal allergic rhinitis. Budesonide treatment produced significantly lower mean symptom scores for the whole study compared with BDP for runny nose, itchy nose and sneezing (P < 0.05). The difference in nasal symptom scores produced by budesonide in comparison with BDP was particularly great towards the end of the treatment period. The budesonide-treated group also had lower scores for nasal blockage and two eye symptoms (runny and sore eyes), but the differences noted were not significant. Adverse events recorded by both groups were mild and transient. In conclusion, aqueously administered budesonide is likely to be of more clinical value than BDP for the control of seasonal allergic rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Endophthalmitis; Female; Glucocorticoids; Humans; Male; Medical Records; Middle Aged; Nasal Obstruction; Pregnenediones; Pruritus; Rhinitis; Rhinitis, Allergic, Seasonal; Single-Blind Method; Sneezing

The value of three objective tests of the nasal mucosa in 22 patients with perennial non-allergic rhinitis treated with a topical corticosteroid has been investigated. Placebo and three different dosages of a new steroid, budesonide, were administered intranasally using a double-blind, cross-over technique. Nasal airway resistance was not reduced by the steroid treatment as compared with the placebo treatment. Eosinophilia in nasal smears was reduced by budesonide. However, the value of this test was decreased by the fact that eosinophilia was found in less than 50% of the patients at the beginning of the trial. Metacholine-induced nasal secretion was significantly reduced by the budesonide treatment. Symptom scores for nasal obstruction, secretion and sneezing attacks were also significantly reduced by the steroid.

Topics: Administration, Intranasal; Adult; Aged; Airway Resistance; Budesonide; Clinical Trials as Topic; Double-Blind Method; Eosinophils; Female; Humans; Male; Methacholine Compounds; Middle Aged; Nasal Mucosa; Pregnenediones; Rhinitis; Sneezing

Chronic rhinosinusitis (CRS) is a chronic inflammatory condition affecting the nasal and paranasal sinuses of approximately 11.5% of the United States adult population. Oral corticosteroids are effective in controlling sinonasal inflammation in CRS, but the associated adverse effects limit their clinical use. Topical budesonide has demonstrated clinical efficacy in patients with CRS. Herein, we investigated the systemic delivery of liposomes tethered with poly(ethylene glycol) (PEG) and loaded with budesonide in a murine model of CRS. PEGylated liposomes encapsulated with budesonide phosphate (L-BudP) were administered via tail vein injection, and the feasibility of L-BudP to reduce sinonasal inflammation was compared to that of free budesonide phosphate (F-BudP) and topical budesonide phosphate (T-BudP) treatment over a 14-day study period. Compared to a single injection of F-BudP and repeat T-BudP administration, a single injection of L-BudP demonstrated increased and prolonged efficacy, resulting in the significant improvement of sinonasal tissue histopathological scores (p < 0.05) with decreased immune cell infiltration (p < 0.05). Toxicities associated with L-BudP and T-BudP treatment, assessed via body and organ weight, as well as peripheral blood liver enzyme and differential white blood cell analyses, were transient and comparable. These data suggest that systemic liposomal budesonide treatment results in improved efficacy over topical treatment.

Topics: Adult; Animals; Budesonide; Chronic Disease; Humans; Inflammation; Liposomes; Mice; Polyethylene Glycols; Rhinitis; Sinusitis

Pathophysiology-targeting treatments exist for aspirin-exacerbated respiratory disease (AERD) through aspirin desensitization and biologics, such as dupilumab. With increasing attention paid to these treatments, which may be associated with significant side effects and/or cost, there is little description of chronic rhinosinusitis with nasal polyps (CRSwNP) response to treatment with intranasal corticosteroids and saline irrigations in AERD.. To determine the effect of intranasal budesonide irrigations for the treatment of CRSwNP in AERD.. This is an observational study of 14 AERD patients presenting to a rhinology clinic for CRS who were treated with twice daily high volume, low pressure irrigations with 240 mL of saline to which a 0.5 mg/2 mL respule of budesonide was added. All participants completed a 22-item Sinonasal Outcome Test (SNOT-22) at enrollment and at follow up 1 to 6 months later. Polyp scores were also calculated at each time point.. SNOT-22 scores ranged from 26 to 98 (median: 40.5) at enrollment and 3 to 85 (median: 38.5) at follow-up. Polyp scores ranged from 2 to 6 (median: 4) at enrollment at 0 to 6 (median: 2) at follow-up. Over the treatment period, change in SNOT-22 score ranged from -38 to 16 (median: -18) and change in polyp score ranged from -2 to 0 (median: -0.5). Approximately 57% of participants experienced at least 1 minimal clinically important difference in SNOT-22 score and 21% of participants had a SNOT-22 score <20 at follow-up.. Medical management with intranasal corticosteroids and saline irrigations alone leads to significant improvement in sinonasal symptomatology in a subset of AERD.

Topics: Adrenal Cortex Hormones; Aspirin; Asthma, Aspirin-Induced; Budesonide; Chronic Disease; Humans; Nasal Polyps; Rhinitis; Sinusitis

CD8+CD25+Foxp3+ regulatory T cells (Tregs) play an important role in human's immune tolerance. The study was aimed to assess the influence of budesonide nasal spray on CD8+CD25+Foxp3+ Tregs and to evaluate their cellular functions in neutrophilic chronic rhinosinusitis with nasal polyps (CRSwNPs).. Fifteen patients with neutrophilic CRSwNPs were enrolled and received physiological saline or budesonide nasal spray treatment (Saline or Budesonide group) for 3 months. Nasal tissue samples were obtained from normal subjects or those patients and cultured in vitro. CD8+CD25+Foxp3+ Tregs were separated from normal or NP tissues and also cultured in vitro. Then interleukin (IL)-10 and its mRNA were evaluated in the above cell cultures. The cells were applied into NP cultures. Finally, myeloperoxidase (MPO), interferon (IFN)-γ, IL-1β, and tumor necrosis factor (TNF)-α were assessed in the tissue cultures.. CD8+CD25+Foxp3+ Tregs decreased in NP tissues. Budesonide administration did not enhance the percentage of these cells in polypoid tissues. IL-10 and its mRNA were increased in the above cell cultures from NPs. However, there were no statistical differences between the two treatments in the IL-10 expression. Additionally, levels of MPO, IFN-γ, IL-1β, and TNF-α were totally elevated in NP tissue cultures and reduced after the administration of CD8+CD25+Foxp3+ Tregs. However, there were no significant differences in concentrations of these mediators between these two groups of the CD8+CD25+Foxp3+ Tregs treatment in vitro.. The findings indicate that CD8+CD25+Foxp3+ Tregs might regulate the neutrophilic inflammation, and budesonide nasal spray therapy could not ameliorate the inflammation in neutrophilic CRSwNPs.

Topics: Adrenal Cortex Hormones; Budesonide; CD8-Positive T-Lymphocytes; Forkhead Transcription Factors; Humans; Inflammation; Interferons; Interleukin-10; Nasal Polyps; Nasal Sprays; Peroxidase; Rhinitis; RNA, Messenger; Sinusitis; T-Lymphocytes, Regulatory; Tumor Necrosis Factor-alpha

Among the most prevalent allergic conditions that affect children is anaphylactic rhinitis (AR). It is capable of leading to physical as well as mental health issues. Concomitant use of loratadine and budesonide may improve symptoms of AR more than treatment with either drug alone. To assess the efficacy and safety of combined loratadine and budesonide for patients experiencing AR is the aim of this study.. We will apply 2 independent authors in six databases, including EMBASE, Pub Med, Web of Science, China National Knowledge Infrastructure, WanFang Database, Chinese Scientific Journal Database (VIP database). Studies evaluating the efficacy and safety of combined loratadine and budesonide in patients with AR will include studies published between inception and Dec 2021. Accordingly, the data will have to be in English and Chinese. For the selection of data extraction, the studies and risk of bias assessment will be completed by 2 independent authors. Accordingly, data synthesis will be conducted through RevMan 5.3 software. The study will establish heterogeneity using the I2 test. Without correct data or information, there is a need for Publication bias, which is assessed by performing the Begg and Egger test and generating a funnel plot.. The study provides a trustable clinical foundation for loratadine and budesonide for AR treatment.OSF registration number: DOI 10.17605/OSF.IO/M2RFGEthics and dissemination: Because the present study is founded on existing studies, it does not require ethics approval.

Topics: Anaphylaxis; Budesonide; Child; Humans; Loratadine; Meta-Analysis as Topic; Research Design; Rhinitis; Systematic Reviews as Topic

This study discusses the effect of Biyanning Granules on local symptoms and systemic immune function of patients with chronic rhinosinusitis with nasal polyps(CRSwNP) within the 6 months of treatment by glucocorticoid nasal spray after surgical treatment. To be specific, a total of 237 CRSwNP patients, treated in Otorhinolaryngology Head and Neck Surgery in Shanxi Bethune Hospital, were enrolled. All patients were treated by nasal endoscopy and classified into hormone group(Budesonide Nasal Spray after surgery), Chinese medicine group(Biyanning Granules after surgery), and combination group(Budesonide Nasal Spray+Biyanning Granules after surgery) with random number table method, 79 cases in each group, and the treatment lasted 3 months. The follow-up was performed from the day of discharge to 12 months after the surgery. The clinical effect was observed. The visual analogue scale(VAS) scores and sino-nasal outcome test-20(SNOT-20) scale scores were used to assess patient's subjective symptoms and quality of life. Lund-Kennedy endoscopic score(LKES), Japanese T&T olfactometry, and standard olfactory test were used to evaluate the objective curative effect on patients. The levels of interleukin(IL)-21, CD4~+CD25~+Foxp3~+Treg, and CD4~+Th17 in peripheral blood were analyzed. The incidence of complications, recurrence rate, and adverse reactions during treatment were also recorded. The total effective rate after treatment in the combination group was higher than that in the hormone group and Chinese medicine group(P<0.05). VAS scores and SNOT-20 scale scores were lower in the three groups after treatment than before treatment and lower in the combination group than in the other two groups(P<0.05). The improvement in LKES and T&T standard olfactometry test was better in the combination group than in the other two groups(P<0.05). Serum levels of IL-21 and CD4~+Th17 in the three groups were lower than before treatment. The levels in the combination group were lower than those in the other two groups and lower in the hormone group than in the Chinese medicine group(P<0.05). Serum CD4~+CD25~+Foxp3~+Treg level was higher in the three groups after treatment than before, higher in the combination group than in the other two groups, and higher in the Chinese medicine group than in the hormone group(P<0.05). During the treatment, no serious adverse reactions were observed. After treatment, the combination group showed no significant difference in

Topics: Budesonide; Chronic Disease; Forkhead Transcription Factors; Glucocorticoids; Humans; Immunity; Medicine, Chinese Traditional; Nasal Sprays; Quality of Life; Rhinitis; Sinusitis

Intranasal corticosteroid drugs are widely used in chronic rhinosinusitis with nasal polyps (CRSwNP). In contrast to classical delivery with nasal pump sprays, pulsating aerosols can deliver significant doses into superior and posterior sinonasal spaces. A case-control study was designed to assess the efficacy of corticosteroid transnasal nebulization on short-term mucosal recovery and quality of life (QoL) following endoscopic sinus surgery in CRSwNP. Thirty patients were prospectively enrolled to receive either 1-month budesonide nasal pump spray or 1-month budesonide 100-Hz acoustic pulsating nebulization at the first postoperative visit (day 8). Patients were evaluated with Lund-Kennedy endoscopic score at day 8 (D8) and 1 month later (M1). CRS-related QoL questionnaires (SNOT22 and RhinoQOL) were fulfilled at M1. The Lund-Kennedy endoscopic scores compared between D8 and M1 were suggestively improved in the group treated with budesonide nebulization (mean difference between groups, - 18.28 units; 95%CI, - 31.29 to - 5.28 units, p = 0.014). QoL measurements were comparable at M1 between the groups of patients. No unexpected adverse event was described with both budesonide delivery protocols. In the early postoperative period, patients with CRswNP may benefit from pulsating nebulization. Large studies should be conducted to confirm the results. Safety profile related to systemic steroid absorption and bioavailability in chronic respiratory diseases also need to be addressed for further use.

Topics: Adrenal Cortex Hormones; Budesonide; Case-Control Studies; Chronic Disease; Humans; Nasal Polyps; Nasal Sprays; Quality of Life; Rhinitis; Sinusitis; Steroids

Evaluate the impact of perennial allergic rhinitis (PAR) on the health-related quality of life (HRQL) and measure performance issues that are of major concerns for PAR patients, as well as determining the effect of intra-nasal steroids (INS) on PAR and associated congestion, sleep complaints, and daytime sleepiness.. This study was a cross-sectional study. A total of 78 PAR patients underwent otorhinolaryngological examination and skin test. All participants filled in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ), the Stanford Sleepiness Scale (SSS), and the Epworth Sleepiness Scale (ESS). Participants were asked to undergo treatment with Budesonide (BUD) topical aqueous nasal spray for eight weeks. After the treatment period, all participants were again asked to answer the three questionnaires.. The results of this study found statistically significant improvements in the overall NRQLQ score (p < 0.001) and individual NRQLQ domain scores (p < 0.05) after INS treatment. A statistically significant reduction in symptom severity in the four NRQLQ domains before and after treatment was found (p < 0.05), except for restlessness, post-nasal drip, and avoiding symptom triggers (p = 0.575, 0.172, and 0.705, respectively). There was a statistically significant difference in ESS and SSS scores before and after treatment (p < 0.001).. PAR has a significant impact on sleep quality and, as a result, a lower QOL. This study demonstrates that INS is an effective modality in the treatment of PAR and positively impacts patients' QOL by improving nasal symptoms, daytime fatigue, and somnolence, and sleep quality.

Topics: Administration, Intranasal; Budesonide; Cross-Sectional Studies; Humans; Quality of Life; Rhinitis; Rhinitis, Allergic, Perennial; Sleep Quality

Eosinophilic chronic rhinosinusitis (eCRS), contemporarily classified as diffuse type 2 dominant chronic rhinosinusitis (CRS), is characterized by eosinophil-dominant mucosal inflammation. Contemporary management of eCRS as an inflammatory airway condition is multimodal with corticosteroid irrigations after the surgical creation of a neosinus cavity.. To assess long-term treatment outcomes in patients with primary diffuse type 2 CRS or eCRS receiving multimodal treatment.. A prospective cohort study of patients seen in a tertiary rhinology practice recruited from May 2010 to November 2018 was conducted. Follow-up duration was 12 months or more following endoscopic sinus surgery (ESS) with a neosinus cavity formed. Data analysis was performed from August to November 2020. Consecutive adult (≥18 years) patients diagnosed with primary diffuse type 2 dominant CRS or eCRS based on the European Position Paper on Rhinosinusitis and Nasal Polyps 2020 criteria were included. Type 2 inflammation was defined as more than 10 eosinophils per high-power field obtained from sinus mucosal biopsy and managed with neosinus cavity ESS and ongoing corticosteroid irrigations. Exclusion criteria were less than 12 months of follow-up and secondary CRS.. Endoscopic sinus surgery with complete removal of intersinus bony partitions to create a neosinus cavity. Nasal irrigation (240 mL) with betamethasone, 1 mg, or budesonide, 1 mg, daily for 3 to 6 months after ESS and tapered to an as-needed basis (minimum, 2-3 per week).. Poor control was defined as polyp recurrence (polyp growth in >1 sinus area on a single side), use of long-term systemic therapy (biologic therapy or ≥3 consecutive months of oral corticosteroids), and revision surgery involving polypectomy. The disease in patients with no poor control criteria was defined as well controlled, and the disease in those with 1 or more criteria was considered poorly controlled. Maintenance medical therapy use and patient-reported outcomes based on the 22-item Sinonasal Outcomes Test for preoperative and last follow-up were collected.. Of the 222 participants recruited with primary diffuse type 2 dominant CRS or eCRS and minimum of year of follow-up, 126 were men (56.8%). Mean (SD) age was 54.8 (13.6) years, and median (SD) follow-up was 2.2 (2.2) years. Of the 222 patients, 195 (87.8%) had well-controlled disease, 16 (7.2%) had polyp recurrence, 7 (3.2%) continued to receive long-term oral corticosteroid therapy, 5 (2.3%) received biologic therapy, and 8 (3.6%) underwent a revision polypectomy. Clinically meaningful change on the 22-item Sinonasal Outcomes Test and the nasal subdomain score was maintained at the last follow-up in 134 patients (67.0%). Poor disease control was not associated with poor adherence to irrigation use.. The findings of this cohort study suggest that long-term disease control and reduction in symptom burden in patients with primary diffuse type 2 CRS or eCRS might be achieved when managed as an inflammatory disorder. Maintenance corticosteroid irrigations in the population examined appeared to be successfully self-tapered to disease activity.

Topics: Betamethasone; Budesonide; Chronic Disease; Cohort Studies; Endoscopy; Eosinophilia; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Middle Aged; Nasal Lavage; Nasal Mucosa; Nasal Polyps; Paranasal Sinuses; Postoperative Complications; Rhinitis; Sinusitis

Chronic rhinosinusitis and nasal polyps (CRNP) is a common public health concern for general population, and is thought to negatively impact their quality of life. Although previous studies have reported that nasal nebulization inhalation of budesonide (NNIB) can benefit patients with such condition, its conclusions are still inconsistent. Thus, this study will assess the efficacy and safety of NNIB for the treatment of CRNP.. To identify any associated studies, we will comprehensively and systematically search Cochrane Library, PubMed, EMBASE, Web of Science, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. We will search all electronic databases from inception to the present with no limitations of language and publication status. Two independent reviewers will undertake selection of study, data collection, and study quality evaluation, respectively. Another reviewer will help to settle down any different opinions between both of them. Study quality will be checked using Cochrane risk of bias tool, and statistical analysis will be performed using RevMan 5.3 software.. This study will assess the efficacy and safety of NNIB for the treatment of CRNP through assessing primary outcomes of nasal symptoms and polyp sizes, and secondary outcomes of serum cortisol levels, health-related quality of life, and any expected and unexpected adverse events.. The results of this study will summarize the up-to-date evidence on assessing the efficacy and safety of NNIB for the treatment of CRNP.. INPLASY202040108.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Humans; Meta-Analysis as Topic; Nasal Polyps; Nebulizers and Vaporizers; Rhinitis; Sinusitis; Systematic Review as Topic

Topics: Adult; Aged; Anti-Inflammatory Agents; Betacoronavirus; Budesonide; Chronic Disease; Coronavirus Infections; COVID-19; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Lavage; Pandemics; Pilot Projects; Pneumonia, Viral; Pregnanes; Retrospective Studies; Rhinitis; SARS-CoV-2; Sinusitis; Treatment Outcome

Topics: Budesonide; CD8-Positive T-Lymphocytes; Chronic Disease; Forkhead Transcription Factors; Humans; Nasal Mucosa; Nasal Polyps; Rhinitis; T-Lymphocytes, Regulatory

A short-course oral corticosteroid taper and topical intranasal corticosteroids may be used to maximize the success of medical management for chronic rhinosinusitis with nasal polyps (CRSwNP). In this study, we sought to identify characteristics that would be predictive of efficacy for this combination regimen.. Sixty-four patients with CRS, bilateral polyps, a polyp score of at least 3, and a 22-item Sino-Nasal Outcome Test (SNOT-22) score ≥20 were prospectively enrolled and uniformly treated with a 15-day prednisone taper and twice daily dilute budesonide irrigations. Participants were assessed at enrollment and at follow up, 2 to 5 months later. Clinical and demographic characteristics were assessed at enrollment. At both time points, CRS symptoms were assessed with SNOT-22, and polyp score (range, 0 to 6) was assessed endoscopically. Associations were determined with regression.. Pretreatment SNOT-22 score (adjusted β = -0.83; 95% CI, -1.08 to -0.58; p < 0.001) and comorbid asthma (adjusted β = 15.75; 95% CI, 4.74 to 26.75; p = 0.007) were associated with a change in SNOT-22 experienced over the study period. Achieving a greater-than-1 minimal clinically important difference (MCID) improvement in SNOT-22 score was also associated with pretreatment SNOT-22 score (adjusted OR = 1.09; 95% CI, 1.04 to 1.14; p < 0.001) and comorbid asthma (adjusted OR = 0.13; 95% CI, 0.03 to 0.72; p = 0.019). SNOT-22 score ≥47 had 81.5% sensitivity and 78.4% specificity to detect patients experiencing 1 MCID improvement. Pretreatment polyp score was not associated with any outcome metric.. In treatment of CRSwNP with prednisone and budesonide irrigations, pretreatment endoscopy was not informative of treatment response. Pretreatment SNOT-22 and comorbid asthma may be more predictive.

Topics: Administration, Intranasal; Administration, Oral; Adrenal Cortex Hormones; Adult; Aged; Budesonide; Chronic Disease; Female; Humans; Male; Middle Aged; Nasal Polyps; Prednisone; Rhinitis; Sino-Nasal Outcome Test; Sinusitis; Treatment Outcome

Topical corticosteroids are currently employed to reduce established airway inflammation; their prophylactic use might help limit cellular damage against harmful stimuli.. To determine the effects of a prophylactic topical application of budesonide (BD) on an in vivo nasal epithelium injury model induced by trichloroacetic acid (TCA).. C57Bl/6 mice were exposed to intranasal TCA topical application. Three groups received topical intranasal BD, saline solution, or no intervention prior to a single topical exposure to TCA. Controls were not exposed to TCA. Whole nasal cavity coronal sections were analyzed at 1, 3, and 6 days postinjury at tissue and cellular levels using histopathological analysis, immunofluorescent staining, and fresh tissue RNA microarray analysis.. Prophylactic topical corticosteroid exposure protected the nasal epithelium from acute damage, maintaining epithelial thickness and cell survival. Six days following TCA exposure, epithelial and cellular changes were less pronounced on the BD-treated group compared to all exposure groups. The microarray analysis was used to evaluate the gene transcripts in all treatment groups. Ciliary tip protein, Sentan, and submucosal protein S100b were identified as potential factors in epithelial airway protection; immunofluorescent staining corroborated their presence and location within the respiratory epithelium.. Topical corticosteroid treatment to the nasal epithelium can mitigate several of the early deleterious effects of acute epithelial damage in experimental airway injuries caused by TCA. These findings suggest a novel, direct cytoprotective effect of corticosteroids on the nasal epithelium, and the potential of expanding the use of prophylactic periprocedural topical corticosteroids for respiratory epithelial tissues.

Topics: Administration, Topical; Adrenal Cortex Hormones; Animals; Budesonide; Disease Models, Animal; Female; Gene Expression Profiling; Gene Expression Regulation; Glucocorticoids; Mice, Inbred C57BL; Microtubule-Associated Proteins; Nasal Mucosa; Rhinitis; S100 Calcium Binding Protein beta Subunit; Trichloroacetic Acid

Budesonide improves the prognosis of chronic rhinosinusitis (CRS). However, few reports have examined whether its use for nasal irrigation, compared to normal saline, improves the prognosis of patients after endoscopic sinus surgery (ESS). We compared the effects of nasal irrigation with budesonide and normal saline in CRS patients after ESS.. Sixty CRS patients who had undergone ESS were randomly divided into an experimental group (30 patients), which used budesonide nasal irrigation, and a control group (30 patients), which used normal saline nasal irrigation. All patients received regular follow-up evaluations and were assessed via questionnaires, including the Lund-Kennedy endoscopic score (LKES), the symptom visual analog scale (VAS), the 22-item Sino-Nasal Outcome Test (SNOT-22), the Short-Form 36-Item Questionnaire (SF-36), the Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS) and a side effects scale.. Scores of polyposis, mucosal edema, secretions and total score of LKES; VAS scores of nasal blockage, hyposmia and rhinorrhea; and SNOT-22 results in both groups were significantly improved 3 months after ESS. Scores of polyposis, mucosal edema, secretions and scarring and total score of LKES in experimental group were significantly better than in control group 3 months after ESS. No significant differences were observed in SF-36, SAS or SDS before or 3 months after ESS within or between the two groups. The side effects of the two groups were not significantly different.. Nasal irrigation improved the prognosis of CRS patients after ESS. Budesonide nasal irrigation had a better effect than normal saline nasal irrigation.

Topics: Adult; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Endoscopy; Female; Humans; Male; Middle Aged; Nasal Lavage; Nasal Obstruction; Paranasal Sinuses; Postoperative Complications; Prognosis; Rhinitis; Sinusitis; Treatment Outcome

A high percentage of patients with COPD report chronic nasal symptoms. The study aims to evaluate the clinical impact of a 2-month treatment with inhaled nasal budesonide (100 µg per nostril twice daily) in patients affected by COPD with chronic rhinitis comorbidity.. Fifty-three stable COPD patients in therapy according to the Global initiative for chronic Obstructive Lung Disease recommendations were enrolled; 49 completed the study. At enrollment (visit 0), patients underwent skin prick test and rhinoscopy. At visit 0 and after 1 month (visit 1) and 2 months (visit 2) of therapy with nasal budesonide, patients underwent spirometry, and COPD assessment test (CAT), Sinonasal Outcome Test (SNOT 22), and modified Medical Research Council dyspnea scale were administered. Differences in continuous variables, after 2 months of treatment with nasal budesonide, were evaluated using a paired. Two months of treatment with nasal budesonide showed a significant statistical improvement in the total scores of CAT, SNOT 22, and modified Medical Research Council (. The results of the present study indicate the importance of careful evaluation of the presence of chronic nasal symptoms in all COPD patients and suggest beneficial clinical effect from treatment with nasal budesonide in terms of COPD symptoms and quality of life.

Topics: Administration, Intranasal; Aged; Anti-Inflammatory Agents; Budesonide; Female; Humans; Italy; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Quality of Life; Rhinitis

Budesonide (BUD)/formoterol (FM) dry powder inhaler has a feature that the fine particle fraction output is dependent on users' inspiratory flow rate. The aim of this study was to assess the amount of nasally exhaled BUD/FM inhaled in the different inspiratory flow rate. We also examined the effect of nasal exhalation of BUD/FM dry powder inhaled on radiographic evidence of sinonasal inflammation in asthmatic patients with eosinophilic chronic rhinosinusitis (ECRS).. The quantitative amount of nasally exhaled BUD/FM was analyzed by high-performance liquid chromatography in 3 healthy subjects. We retrospectively evaluated the effect of nasal exhalation of BUD/FM dry powder inhaled at > 60 L/min on radiographic evidence of sinonasal inflammation, which was assessed according to the Lund-Mackay staging (LMS) system, in 7 consecutive patients with asthma and ECRS.. The amount of nasally exhaled BUD in the setting of inhaling BUD/FM dry powder inhaler at 60 L/min (subject 1: 25.8 ng/mL; subject 2: 37.3 ng/mL; subject 3: 30.0 ng/mL) was high compared to at 30 L/min (subject 1: 9.3 ng/mL; subject 2: 4.1 ng/mL; subject 3: 9.2 ng/mL) in each healthy subject. Nasal exhalation of BUD/FM dry powder significantly reduced total (p = 0.018) and ethmoid LMS scores (p = 0.0077).. Nasal exhalation technique of BUD/FM dry powder inhaled at "fast" inspiratory flow has a potential of simultaneously treating asthma and ECRS.
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Topics: Administration, Inhalation; Adult; Aged; Asthma; Bronchodilator Agents; Budesonide; Drug Combinations; Dry Powder Inhalers; Eosinophils; Female; Forced Expiratory Flow Rates; Formoterol Fumarate; Humans; Male; Middle Aged; Retrospective Studies; Rhinitis; Sinusitis; Tomography, X-Ray Computed

Several topical treatments are used in the management of Chronic Rhinosinusitis (CRS), some of which the safety and efficacy has yet to be determined. The purpose of this study was to investigate the effect of commonly used topical treatments on the sinonasal epithelial barrier.. Normal saline (0.9% Sodium Chloride), hypertonic saline (3% Sodium Chloride), FESS Sinu-Cleanse Hypertonic, FLO Sinus Care and Budesonide 1 mg/ 2 ml were applied to the apical side of air-liquid interface (ALI) cultures of primary human nasal epithelial cells (HNECs) from CRS patients (n=3) and non-CRS controls (n=3) for 24 hours. Epithelial barrier structure and function was assessed using trans-epithelial electrical resistance (TEER), measuring the passage of Fluorescein Isothiocyanate labelled Dextrans (FITC-Dextrans) and assessing the expression of the tight junction protein Zona Occludens-1 (ZO-1) using immunofluorescence. Toxicity was assessed using a Lactate Dehydrogenase (LDH) assay. Data was analysed using ANOVA, followed by Tukey HSD post hoc test.. Hypertonic solution and budesonide significantly increased TEER values in CRS derived HNECs. In contrast, FESS Sinu-Cleanse Hypertonic significantly reduced TEER 5 minutes after application of the solution followed by an increase in paracellular permeability of FITC-Dextrans (30 minutes) and increased LDH levels 6 hours after application of the solution.. Our findings confirm that isotonic and hypertonic saline solutions do not compromise epithelial barrier function in vitro but underscore the importance of examining safety and efficacy of over-the-counter wash solutions.

Topics: Administration, Intranasal; Administration, Topical; Budesonide; Cells, Cultured; Chronic Disease; Epithelial Cells; Glucocorticoids; Humans; Isotonic Solutions; Microscopy, Fluorescence; Rhinitis; Saline Solution, Hypertonic; Sinusitis; Sodium Chloride; Tight Junctions

Although short-term use (≤2 months) of atomized topical nasal steroids has been shown to be safe and effective, the long-term safety has yet to be demonstrated. The aim of this study was to determine the impact of long-term topical budesonide treatment via the mucosal atomization device (MAD) on the hypothalamic-pituitary-adrenal axis (HPAA) and intraocular pressure (IOP).. A cross-sectional study of patients with chronic rhinosinusitis (CRS), with or without nasal polyposis, managed with daily nasal budesonide via MAD was conducted at a tertiary rhinology center. Patients using systemic steroids within 3 months of assessment were excluded. HPAA impact was assessed using the cosyntropin stimulation test for adrenal function and a survey of relevant symptomatology. Patients also underwent tonometry to assess for elevated IOP potentially related to corticosteroid use.. A total of 100 CRS patients were recruited with a mean budesonide treatment duration of 23.5 months (range, 6-37 months). Stimulated cortisol response was diminished in 3 patients (3%). No patients with adrenal suppression had relevant symptomatology. IOP was elevated in 6 patients (6%).. These findings suggest that there is a risk of adrenal suppression and raised IOP associated with the long-term use of topical nasal budesonide via MAD. Otolaryngologists should consider periodic surveillance for these adverse events in this patient cohort.

Topics: Administration, Intranasal; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Female; Glucocorticoids; Humans; Hypothalamo-Hypophyseal System; Intraocular Pressure; Male; Middle Aged; Nasal Polyps; Nebulizers and Vaporizers; Pituitary-Adrenal System; Rhinitis; Sinusitis

Off-label high-volume sinonasal budesonide irrigations are commonly used during the management of chronic rhinosinusitis (CRS). Although short-term use (4 to 8 weeks) has been demonstrated to be safe, the long-term effects on the hypothalamic-pituitary-adrenal (HPA) axis remain unclear. The objective of this study is to determine whether CRS patients using long-term (minimum greater than 12 months) budesonide sinonasal irrigations have evidence of HPA axis suppression.. Patients with CRS being managed with high-volume sinonasal budesonide irrigations were recruited from 2 tertiary level rhinology clinics between March 2014 and July 2015. Inclusion criteria were as follows: (1) adult (age greater than 18 years); (2) guideline-based diagnosis of CRS; (3) previous endoscopic sinus surgery; (4) minimum of twice daily high-volume sinonasal budesonide irrigation (concentration of 1 mg per irrigation; total daily dose of 2 mg); and (5) a minimum of 12-month duration. Exclusion criteria included systemic corticosteroid use within 3 months of HPA axis testing. The primary outcomes were morning (am) serum cortisol levels and, when indicated, cosyntropin stimulation levels.. A total of 35 patients fulfilled eligibility criteria and underwent HPA axis testing. Mean duration of budesonide sinonasal irrigation therapy use was 38.2 months (2.9 years). The mean ± standard deviation (SD) am serum cortisol was 431.2 ± 146.9 nmol/L (normal, 200 to 650 nmol/L). Subsequent cosyntropin stimulation tests, in indicated patients (n = 19), demonstrated no evidence of HPA axis suppression.. Outcomes from this study suggest that daily high-volume sinonasal budesonide irrigations fail to produce evidence of HPA axis suppression with prolonged courses lasting longer than 2 years.

Topics: Adult; Aged; Budesonide; Chronic Disease; Cohort Studies; Cross-Sectional Studies; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Nasal Lavage; Off-Label Use; Pituitary-Adrenal System; Rhinitis; Sinusitis; Time Factors; Treatment Outcome; Young Adult

Although the safety of topical nasal steroids is well established for nasal spray forms, data regarding the safety of steroid irrigations is limited. We studied the effect of long-term budesonide nasal irrigations (>6 months) on hypothalamic-pituitary-adrenal axis (HPAA) function and intraocular pressure (IOP) in patients post-endoscopic sinus surgery.. This was retrospective case series. Adrenal function was assessed by using the high-dose cosyntropin stimulation test.. A total of 48 patients were assessed, with a mean duration of budesonide irrigations of 22 months. Stimulated cortisol levels were abnormally low in 11 patients (23%). None reported to have symptoms of adrenal suppression. Three of 4 patients who repeated the study being off budesonide for at least 1 month returned to near normal levels. Logistic regression analysis revealed that concomitant use of both nasal steroid sprays and pulmonary steroid inhalers was significantly associated with HPAA suppression (p = 0.024). Patients with low stimulated cortisol levels were able to continue budesonide irrigations under the supervision of an endocrinologist without frank clinical manifestations of adrenal insufficiency. IOP was within normal limits in all patients.. Long-term use of budesonide nasal irrigations is generally safe, but asymptomatic HPAA suppression may occur in selected patients. Concomitant use of both nasal steroid sprays and pulmonary steroid inhalers while using daily budesonide nasal irrigations is associated with an increased risk. Rhinologists should be alerted to the potential risks of long-term use of budesonide nasal irrigations, and monitoring for HPAA suppression may be warranted in patients receiving long-term budesonide irrigation therapy.

Topics: Adult; Aged; Budesonide; Chronic Disease; Cosyntropin; Female; Glucocorticoids; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Intraocular Pressure; Male; Middle Aged; Nasal Lavage; Pituitary-Adrenal System; Rhinitis; Serum Albumin; Sinusitis

Topics: Budesonide; Chronic Disease; Endoscopy; Humans; Olfaction Disorders; Postoperative Complications; Rhinitis; Rhinoplasty; Sinusitis; Surveys and Questionnaires

A patient with a well-healed, functional cochlear implant (CI) experienced a CI and mastoid infection shortly after initiating large-volume nasal irrigations after sinus surgery. The goal of this report is to bring attention to a rare complication and to question if large-volume nasal irrigation is safe in CI recipients.. Single patient at a tertiary care hospital.. A CI recipient began using large-volume nasal irrigations with saline and budesonide after undergoing sinus surgery.. CI infection and mastoiditis.. Two weeks after starting nasal irrigations, the patient presented with mastoiditis and CI infection. Mastoid and intranasal middle meatal cultures both grew Group A streptococcus.. Large-volume nasal irrigations may be related to our patient's CI infection, ultimately leading to explantation. Though a causal relationship cannot be definitively proven, awareness of this potential safety issue should be disseminated.

Topics: Administration, Intranasal; Aged; Anti-Inflammatory Agents; Budesonide; Cochlear Implantation; Cochlear Implants; Female; Humans; Male; Mastoiditis; Nasal Lavage; Paranasal Sinuses; Rhinitis; Sinusitis; Sodium Chloride

To investigate the effect of oral plus intranasal corticosteroid (CS) treatment on nasal polyp (NP) mucosa remodeling from patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP).. Case series, retrospective study.. Patients (n = 18) with severe CRSwNP were treated with oral prednisone for 2 weeks and intranasal budesonide for 12 weeks. NP biopsies were obtained from patients biopsies before (w0) and after 2 weeks (w2) and 12 weeks (w12) of CS treatment. Matrix metalloprotease 1 (MMP-1), MMP-2, MMP-7, MMP-9, and tissue inhibitor of metalloprotease type 1 (TIMP-1) expression was evaluated by immunohistochemistry in cell and tissue structures. Epithelial damage, eosinophil infiltration, and collagen content were also examined in NP tissues before and after CS treatment.. Compared to w0: 1) oral plus intranasal CS significantly (P < .01) increased presence of submucosal glands at w2, decreased epithelial cell hyperplasia at w12, and decreased tissue eosinophilia at w2 and w12; 2) CS treatment significantly (P < .05) increased immunoreactivity for MMP-1 and MMP-2 in the epithelium at w2, but decreased immunoreactivity for MMP-9 in the epithelium at w2 and w12; 3) at w12, CS significantly (P < .05) reduced MMP-9 immunoreactive positivity and intensity in the extracellular matrix, while increasing total collagen amount in the extracellular matrix; and 4) CS treatment significantly (P < .01) reduced the number of eosinophils and their MMP and TIMP-1 immunoreactive expression.. CS treatment modulates NP mucosa remodeling, particularly by promoting epithelial repair, regulating tissue remodeling markers, increasing total collagen content, and reducing tissue eosinophil infiltration.. 4

Topics: Administration, Intranasal; Administration, Oral; Biopsy; Budesonide; Chronic Disease; Collagenases; Drug Therapy, Combination; Eosinophils; Female; Glucocorticoids; Humans; Immunohistochemistry; Male; Middle Aged; Nasal Mucosa; Nasal Polyps; Prednisone; Retrospective Studies; Rhinitis; Sinusitis; Tissue Inhibitor of Metalloproteinases

Intranasal and oral corticosteroids are widely used in the management of chronic rhinosinusitis with nasal polyps (CRSwNP). Higher-dose topical nasal steroids (HDTNS) such as budesonide irrigations are increasingly used for long-term maintenance in these patients. Oral steroids have the potential to cause increased intraocular pressure (IOP) and glaucoma. It is unclear whether HDTNS have the same potential. The objective of this study was to determine the effect of intranasal budesonide irrigations on IOP.. Two groups of patients with CRSwNP treated with budesonide irrigations were prospectively enrolled. Patients with history of elevated IOP or glaucoma were excluded. Patients in group 1 had been using budesonide for at least 1 month and had IOP measured once at the time of enrollment. Group 2 consisted of patients who were placed on budesonide at the time of enrollment and had IOP measured both before and after at least 4 weeks of therapy.. Ten patients in group 1 and 8 patients in group 2 completed the study. In group 1, the average duration of therapy at enrollment was 6.3 months (1-22 months). Only 1 patient had a single eye pressure above 21 mmHg. None of the patients in group 2 had a significant change in IOP or IOP over 21 mmHg.. Intranasal budesonide irrigations given for a period of at least 1 month do not appear to increase IOP.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Female; Follow-Up Studies; Glaucoma; Humans; Male; Middle Aged; Nasal Polyps; Ocular Hypertension; Prospective Studies; Rhinitis; Sinusitis; Therapeutic Irrigation; Young Adult

Nasal steroids play an important role in the postoperative management of patients with chronic rhinosinusitis (CRS). However, commercially available nasal steroid sprays may not deliver adequate amounts of medication to the entire postoperative sinus cavity. The off-label use of budesonide nasal irrigation (BNI) theoretically solves this problem by delivering concentrated steroid solution through a high-pressure, high-volume system. Several studies have attested to the safety of BNI, but there are very few reports of its efficacy.. This is a retrospective review of prospectively-collected data. We identified 60 patients who were prescribed BNI postoperatively, but had a lapse in therapy for 1 month or longer. The 20-item Sinonasal Outcomes Test (SNOT-20) and Lund-Kennedy endoscopy scores while the patients were using BNI were compared with scores from the same patients while they were not using BNI. Student paired t test was used for statistical analysis.. Thirty patients had eosinophilic chronic rhinosinusitis (eCRS) with polyps (eCRSwNP), 13 had allergic fungal sinusitis (AFS), 13 had Samter's triad (ST), and 4 had eosinophilic chronic rhinosinusitis without polyps (eCRSsNP). Mean follow-up time was 25 months (range, 2-89 months). Overall, SNOT-20 scores were significantly lower with BNI (p < 0.05). On subgroup analysis, SNOT-20 scores were significantly improved with BNI for patients with eCRS and Samter's triad (p = 0.04, 0.03). Endoscopy scores were significantly improved only in the eCRS group (p = 0.02).. The addition of BNI is beneficial in the postoperative management of patients with CRS.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Drug Dosage Calculations; Endoscopy; Female; Follow-Up Studies; Humans; Male; Middle Aged; Postoperative Care; Prospective Studies; Rhinitis; Sinusitis; Therapeutic Irrigation; Young Adult

Eosinophils appear to be central inflammatory cells in the pathogenesis of rhinosinusitis with nasal polyps (NP). One of the most predominantly recognized eosinophil chemoattractants is RANTES. The aim of this study was to assess the influence of vitamin D (VD) derivates on RANTES expression in the culture of nasal polyp fibroblasts.. NP fibroblast cell cultures derived from 16 patients with NP were first stimulated with bacterial LPS and than incubated in increasing concentrations (from 10(-7)M to 10(-4)M) of calcitriol, tacalcitol or budesonide and in combination with one of VD derivate with budesonide in 1:1, 1:3 and 3:1 ratios. Quantitative analysis of RANTES level was conducted in culture supernatants using an ELISA method.. The highest calcitriol concentration (10(-4)M) as well as tacalcitol at 10(-5)M and 10(-4)M reduced RANTES production significantly compared to the control (201.1pg/ml, 338.7pg/ml, 211.3pg/ml v 571.78pg/ml; p<0.05). Budesonide and calcitriol administered in 1:3 ratio and budesonide and tacalcitol in 1:1 and 1:3 reduced RANTES concentration significantly better than each of the drug used in monotherapy (p<0.05). Budesonide and tacalcitol in 1:1 and 1:3 ratios suppressed RANTES production to the lowest level (171.8±97.6pg/ml and 178.7±105.22pg/ml, respectively).. Active VD compounds via downregulation of RANTES production exert a potential role as a complementary element in the therapy of chronic rhinosinusitis with NP. Compounds consisting of budesonide and VD derivate have an advantage over both drugs used in monotherapy.

Topics: Anti-Inflammatory Agents; Budesonide; Calcitriol; Cells, Cultured; Chemokine CCL5; Dihydroxycholecalciferols; Drug Synergism; Fibroblasts; Glucocorticoids; Humans; Nasal Polyps; Rhinitis; Sinusitis; Vitamin D

Studies of the genetics of chronic rhinosinusitis offer potential insights into the pathophysiology of this poorly understood condition. However, genetic studies are both expensive and time consuming-hence the importance of establishing beforehand the proper population and target genes. We wished to identify patient factors associated with a proposed definition of severe chronic rhinosinusitis to minimize heterogeneity and maximize the impact of genetic contributions. We therefore wanted to determine if the response to a standardized therapy following endoscopic sinus surgery could be used as a viable phenotypic criterion for subsequent genetic studies.. Retrospective chart review.. Tertiary sinus centre.. Seventy-one cases of chronic rhinosinusitis refractory to medical and surgical treatment were studied. They formed two groups according to their response to a standardized treatment protocol. We collected information concerning patients' characteristics and bacteriology on endoscopic culture.. 60.5% patients were managed successfully with budesonide irrigations. Atopy was present in 33.8%, asthma in 69.0%, and aspirin sensitivity in 33.3%. The rate of asthma was higher in nonresponders. Bacterial colonization rates showed the presence of Staphylococcus aureus (36.4%), gram-negative rods (29.1%), and Pseudomonas aeruginosa (32.7%).. Patients with refractory chronic rhinosinusitis represent a severely diseased, more homogeneous population in which the genetic contribution(s) to disease may be maximal. Strong associations with asthma, aspirin intolerance, and atopy suggest links between these disorders. Irrigation with budesonide solution appears to be effective in management. Studies of the genetics of chronic rhinosinusitis will include genes known to be involved with both asthma and innate immunity.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Bacterial Infections; Budesonide; Chronic Disease; Dermatitis, Atopic; Female; Genetic Techniques; Humans; Male; Middle Aged; Phenotype; Retrospective Studies; Rhinitis; Sinusitis; Therapeutic Irrigation

In this evidence-based case report we studied the clinical question: Does intranasal corticosteroid (INCS) monotherapy reduce time to recovery in adults with acute noncomplicated rhinosinusitis? The search yielded 490 papers, of which only two were relevant and had a high validity regarding our clinical question.

Topics: Acute Disease; Administration, Intranasal; Adult; Amoxicillin; Budesonide; Evidence-Based Medicine; Female; Glucocorticoids; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis; Sinusitis; Treatment Outcome

Vitamin D (VD) and its different analogues, besides their classic role as regulators of calcium and phosphor homeostasis, have emerged as a large family of antiproliferative agents. Such properties suggested VD potential as a therapy for chronic inflammatory diseases, including nasal polyposis (NP). NP growth involves both an inflammatory process and the proliferation of fibroblast as an important factor inducing aberrations in the phenotype of the epithelium. The aim of this study was to investigate the possible influence of 1alpha,25-dihydroxyvitamin D(3) (calcitriol) and 1alpha,24(R)-dihydroxyvitamin D(3) (tacalcitol) in monotherapy and in combination with budesonid R (BR) on NP fibroblast proliferation.. The study involved 26 samples of NP. NP cells were cultured on 96-well plates beginning with a concentration of 5 x 10(3) cells per well with RPMI 1640 medium supplemented with antibiotics and 10% foetal bovine serum. After the fourth to sixth passage the medium was replaced with a nutrient medium with calcitriol or tacalcitol in a defined concentration (from 10(-9) M to 10(-3) M) alone or in combination with BR in 1:1, 1:3 or 3:1 ratios, each at concentrations from 10(-5) M to 10(-3) M.. Growth inhibition of nasal fibroblasts exposed to calcitriol or tacalcitol was noted. Significant antiproliferating activity was observed at calcitriol concentrations of 10(-4) M and 10(-3) M after 48 h, and at a concentration of 10(-3) M after 72 h with the percentage of proliferating cells reduced to 30% compared to the control samples (P < 0.05). In cells treated with tacalcitol the maximal effect was seen at 10(-4) M after 48 h and at 10(-3)M after 72 h with a 60% inhibition with respect to the control (P < 0.05). The inhibition of fibroblast proliferation reached the maximal level when they were exposed to calcitriol: BR (1 : 1) or tacalcitol: BR (1 : 1), each at a concentration of 10(-4) M, after 72 h (82% and 69%, respectively).. The antiproliferative activity of calcitriol and tacalcitol in NP cultures was confirmed. Because of its lower toxicity and higher activity tacalcitol seems to be the more promising agent in NP therapy, both as a single medication and in treatment protocols with BR.

Topics: Apoptosis; Budesonide; Calcitriol; Cell Proliferation; Cells, Cultured; Cholecalciferol; Dihydroxycholecalciferols; Dose-Response Relationship, Drug; Fibroblasts; Humans; Nasal Mucosa; Nasal Polyps; Rhinitis; Sinusitis

To evaluate the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression by budesonide nasal irrigations in the treatment of refractory chronic rhinosinusitis with polyposis (CRSwP).. Retrospective, descriptive review of patient charts.. Tertiary care rhinology practice in an academic teaching hospital.. Eighteen adult subjects with CRSwP refractory to conservative medical therapy.. The charts of consecutive patients identified as being treated with topical budesonide in saline for nasal irrigation from January to October 2006 were reviewed. In all cases, pre- and posttreatment morning cortisol levels had been measured following at least 8 weeks of uninterrupted therapy. In addition, a subset of patients who continued therapy longer than 8 weeks had undergone the more sensitive adrenocorticotropic hormone (ACTH) stimulation test.. All pre- and posttreatment morning cortisol levels were within the normal range. For an 8-week treatment period, there was no evidence of HPA axis suppression (p=.4171). For patients who continued treatment beyond 8 weeks, ACTH stimulation did not detect HPA axis suppression. Furthermore, there were no issues with compliance or acceptability, nor were any adverse side effects reported.. Budesonide in saline sinonasal irrigation for the treatment of refractory CRSwP does not cause HPA axis suppression. The efficacy of this higher dose of steroid delivered locally would benefit from further study.

Topics: Adult; Budesonide; Chronic Disease; Cohort Studies; Glucocorticoids; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Nasal Lavage; Nasal Polyps; Pituitary-Adrenal System; Retrospective Studies; Rhinitis; Sinusitis; Sodium Chloride; Treatment Outcome

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

Recent studies have shown that the pH of exhaled breath condensate (EBC) could be predictive of asthma exacerbation. Moreover, it has been documented that both allergic rhinitis and atopic dermatitis constitute risk factors for the occurrence of asthma in a progression of disease known as atopic march. The aim of our study was to establish if condensate pH could be used as a valuable mean of monitoring of asthma in atopic children. We studied 34 atopic children with acute asthma, 70 with stable asthma, 35 children with allergic rhinitis, and 17 with atopic dermatitis. Thirty healthy children were used as controls. All children underwent skin prick tests and lung function tests. Exhaled breath condensate samples were collected with a condensing device and de-aerated with argon. The pH of EBC was measured using a pH meter. Children with acute asthma were treated with inhaled steroids and bronchodilators. We found that the pH of condensate in patients with acute asthma was lower than that of patients with stable asthma, rhinitis, and controls (7.25 vs. 7.32, p < 0.05; 7.25 vs. 7.48, p < 0.02; 7.25 vs. 7.78, p < 0.0001, respectively). Patients with stable asthma, rhinitis, and eczema had also lower pH than that of controls (7.32, 7.48, and 7.44 vs. 7.78; p < 0.0001, p < 0.006, p < 0.04, respectively). Patients with acute asthma normalized their pH after treatment (7.82 vs. 7.25; p < 0.0001). Finally, patients with acute asthma showed a positive correlation between pH and lung functional parameters (forced expiratory volume in 1 s; r = 0.39, p = 0.04). Our study shows that EBC pH measurement may be a promising marker for assessing airway inflammation and monitoring response to anti-inflammatory treatment in asthmatic children. Furthermore, we report the first evidence of airways acidification in children with allergic rhinitis and atopic dermatitis. Therefore, EBC pH assessment may be useful in the evaluation of progression of the atopic march toward the development of asthma later in life. Further studies are recommended in order to confirm this indication.

Topics: Adolescent; Albuterol; Asthma; Breath Tests; Bronchodilator Agents; Budesonide; Case-Control Studies; Child; Child, Preschool; Dermatitis, Atopic; Female; Humans; Hydrogen-Ion Concentration; Male; Respiratory Function Tests; Rhinitis; Severity of Illness Index; Skin Tests

To evaluate the clinical outcome and changes in allergen-specific antibodies during sublingual immunotherapy (SLIT) in house dust mite (HDM)-allergic asthma patients and to compare levels of allergen-specific antibodies in HDM-allergic patients before and after treatment with that of healthy controls.. Thirty-one asthma patients allergic to HDM were studied. Patients in groups I (n=17) and II (n=14) received SLIT with a standardized Dermatophagoides pteronyssinus plus Dermatophagoides farinae 50/50 extract for 6 and 12 months, respectively. A group of healthy children (n=8) were enrolled as controls. Patients in both groups were evaluated at the start and at the end of treatment according to daily symptom and medication scores, lung function and skin prick tests, PC20, blood eosinophil count, and Der-p-1-specific IgE, IgA, IgG1 and IgG4 levels.. Drug consumption decreased significantly in both groups. Furthermore, PC20 and forced expiratory flow between 25 and 75% of vital capacity of patients in group II improved significantly. Although specific IgA, IgG1 and IgG4 levels did not change throughout the treatment period, total eosinophil count and specific IgE decreased significantly in both groups. According to baseline measurements, specific IgA levels of patients in groups I and II were significantly lower than that of controls. This difference disappeared at the end of the treatment period in both groups.. SLIT seems to be effective in ameliorating clinical symptoms, drug consumption and bronchial hyperreactivity, and results in downregulation of Der-p-1-specific IgE production. Furthermore, at the end of SLIT, specific IgA levels, which were decreased compared to healthy controls initially, did no longer differ between patients and controls.

Topics: Administration, Sublingual; Asthma; Bronchial Provocation Tests; Budesonide; Case-Control Studies; Child; Eosinophils; Humans; Hypersensitivity; Immunoglobulins; Immunotherapy; Nose; Pulmonary Ventilation; Pyroglyphidae; Rhinitis; Skin Tests; Turkey

A 78-year-old woman suffered a generalized eczematous hypersensitivity reaction following the use of an intranasal budesonide inhaler. Patch testing demonstrated positive reactions to both budesonide and triamcinolone. Her eczema responded to emollients, betamethasone dipropionate ointment and cessation of her intranasal budesonide inhaler.

Topics: Administration, Inhalation; Administration, Topical; Aged; Anti-Inflammatory Agents; Budesonide; Cross Reactions; Eczema; Female; Glucocorticoids; Humans; Hypersensitivity, Immediate; Patch Tests; Rhinitis; Triamcinolone

Airway hypersecretion is a common finding in rhinitis and asthma in which proinflammatory cytokines are upregulated. The effect of inflammation on glandular secretion remains unclear.. We sought to investigate the effect of proinflammatory cytokines and eosinophil products in in vitro lactoferrin glandular secretion from human nasal mucosa and the role of corticosteroids and IL-10 in modulating this effect.. Nasal explants from patients undergoing turbinectomies were incubated in a controlled atmosphere (50% N(2), 5% CO(2), and 45% O(2)) at 37 degrees C. Nasal explants were incubated with or without IL-1beta, IL-4, IL-5, IL-8, eotaxin, GM-CSF, TNF-alpha, eosinophil cationic protein (ECP), IL-10, and budesonide in a time-course and dose-response fashion. Lactoferrin concentrations in culture supernatants were measured by means of ELISA.. ECP (up to 30%) caused a dose-related stimulation of lactoferrin secretion. TNF-alpha (20 ng/mL) induced a significant increase of lactoferrin release from 8 hours (27.7% +/- 17.8%, P <.05) to 24 hours (40.8% +/- 17.2%, P <.01) compared with that found in media-treated explants. At 24 hours, TNF-alpha caused a dose-related stimulation of lactoferrin secretion (up to 35%). IL-1beta (65.3% +/- 15.2%, P <.05) and GM-CSF (15.7% +/- 6.7%, P <.05), both at 20 ng/mL, exerted a stimulatory effect only at 24 hours, and IL-4, IL-5, IL-8, and eotaxin had no significant effect. Budesonide caused a dose-related inhibition of lactoferrin secretion induced by IL-1beta (down to -76%) and TNF-alpha (down to -70%), whereas IL-10 had no effect.. ECP and some proinflammatory cytokines (IL-1beta, TNF-alpha, and GM-CSF) may contribute to glandular hypersecretion in the inflamed nose. Corticosteroids may reduce nasal hypersecretion by blocking the direct effect of proinflammatory cytokines on glandular output.

Topics: Adult; Anti-Inflammatory Agents; Blood Proteins; Budesonide; Culture Techniques; Cytokines; Dose-Response Relationship, Drug; Eosinophil Granule Proteins; Female; Granulocyte-Macrophage Colony-Stimulating Factor; Humans; Interleukin-1; Interleukin-10; Kinetics; Lactoferrin; Male; Nasal Mucosa; Peroxidase; Rhinitis; Ribonucleases; Tumor Necrosis Factor-alpha

Topics: Adrenal Cortex Hormones; Anti-Inflammatory Agents; Asthma; Budesonide; Dermatitis, Allergic Contact; Drug Eruptions; Humans; Hydrocortisone; Patch Tests; Rhinitis

Topical nasal corticosteroid therapy produces clinical improvement in patients with nasal polyposis. To examine the mechanisms of steroid effect, we quantified the number of inflammatory cell types as well as the expression of relevant cell markers in nasal polyps from steroid treated patients (n = 11) and polyps from untreated patients (n = 10) judged to require polypectomy for symptomatic relief. We found that the majority of eosinophils in these tissues were in the stromal layers, and that the proportion of activated eosinophils (EG2+ versus total eosinophil count) was significantly lower in polyps from patients treated with the topical nasal steroid budesonide, 200 to 400 micrograms/d for 1 mo, than in polyps from untreated patients. We also found that in polyps from treated patients, the superficial stromal layer (SSL) and deep stromal layer (DSL) both contained a significantly lower tissue density of lymphocytes of CD3, CD4, and CD8 subsets. Treatment was also associated with a lower, albeit nonsignificant, expression of ICAM-1 and HLA-DR in the epithelium. The tissue density of CD14+ cells (monocyte/macrophage) and of tryptase+ cells (mast cells) was the same in the two groups. These findings demonstrate tissue effects of topical corticosteroid treatment which may point to the mechanisms of therapeutic benefit. In addition, these observations illustrate the value of markers that indicate cell functional activity rather than just cell numbers.

Topics: Administration, Intranasal; Budesonide; Eosinophils; Female; Glucocorticoids; Histocytochemistry; Humans; Immunohistochemistry; Male; Middle Aged; Nasal Polyps; Pregnenediones; Rhinitis; Statistics, Nonparametric

Topics: Adult; Aerosols; Bronchodilator Agents; Budesonide; Dermatitis, Contact; Drug Hypersensitivity; Female; Humans; Nasal Mucosa; Nasopharyngitis; Pregnenediones; Rhinitis; Skin Tests

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Budesonide; Dermatitis, Allergic Contact; Drug Eruptions; Glucocorticoids; Humans; Male; Pregnenediones; Rhinitis

Failure to get relief from topical steroid nasal spray is often blamed on poor administration knowledge. In a population of patients referred to the rhinitis clinic who have failed to get relief from topical steroid nasal spray when prescribed by the general practitioner, lack of patient education only accounts for 28 per cent of patient treatment failures and other factors e.g. poor compliance, erroneous diagnosis or severity of rhinitis will be responsible for the rest. Information leaflets are considered to be a good idea by nearly all patients but this study demonstrates that they would only be of therapeutic benefit to a minority of patients.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Female; Fluocinolone Acetonide; Glucocorticoids; Humans; Male; Middle Aged; Patient Education as Topic; Pregnenediones; Rhinitis; Self Administration