Comparison of once- versus twice-daily use of beclomethasone dipropionate aqueous nasal spray in the treatment of allergic and non-allergic chronic rhinosinusitis. Fluticasone propionate aqueous nasal spray does not influence the recurrence rate of chronic rhinosinusitis and nasal polyps 1 year after functional endoscopic sinus surgery. Efficacy of endonasal neomycin-tixocortol pivalate irrigation in the treatment of chronic allergic and bacterial sinusitis. Cytokine profile in paranasal effusions in patients with chronic sinusitis using the YAMIK sinus catheter with and without betamethasone. Intrasinus administration of topical budesonide to allergic patients with chronic rhinosinusitis following surgery. Topical corticosteroids in chronic rhinosinusitis: a randomized, double-blind, placebo-controlled trial using fluticasone propionate aqueous nasal spray. Relative importance of antibiotic and improved clearance in topical treatment of chronic mucopurulent rhinosinusitis. A controlled study. Effect of corticosteroids on wound healing after endoscopic sinus surgery. Efficacy and tolerability of budesonide aqueous nasal spray in chronic rhinosinusitis patients. Influence of topical steroid treatment on maxillary sinusitis.
The aim of the study was to assess the efficacy and safety of nasal aqueous beclomethasone dipropionate (BDP), 400 micro g/day, given via a metered pump in a once-daily or twice-daily regimen following a double-blind, parallel group design over a 12-week period. Adult patients (n=112) with allergic or non-allergic chronic rhinosinusitis recorded their nasal and ocular symptoms for the 7-day run-in period and for the first 4 weeks of treatment. At baseline and after 4 weeks the airways' resistance via active anterior rhinomanometry and the volume and area section via acoustic rhinometry were measured. Morning serum cortisol was measured at baseline and at week 12. Adverse events were to be reported at each visit. Of the 112 randomised patients, three did not enter the ITT analysis and another 13 in total discontinued the treatment. Significant improvements over the baseline were reported in both groups for the primary variable sum of nasal scores (-53.7% in the once-daily group and -59.7 in the twice-daily group), as well as for each nasal and ocular symptoms, without differences between the groups. Because of a wider variability than expected, the 95% confidence interval (C.I.) for the difference between the least square means exceeded the pre-defined limit of +/-10% of the reference mean. Similar improvements in both groups were also reported for the nasal airway patency's parameters. The total number of drug-related adverse events was 26 in the once-daily group and 32 in the twice-daily group, with most of the events consisting of local effects at the site of application. No signs of adrenal suppression were observed, and serum morning cortisol values did not significantly change. The once-daily BDP dosing (400 micro g/day) therefore has a similar efficacy and safety profile as the same daily dose given in a twice-daily regimen. Local corticosteroids are widely used in the treatment of nasal polyps and chronic rhinosinusitis both before and after nasal surgery. Their efficacy after functional endoscopic sinus surgery (FESS) has not been fully established by placebo-controlled trials.
                This double-blind placebo-controlled randomized study was performed in order to investigate whether fluticasone propionate aqueous nasal spray (FPANS) reduces the recurrence rate of nasal polyps and chronic rhinosinusitis during the first year after FESS.
                The trial looked at 162 patients aged 18 years and older requiring FESS for chronic rhinosinusitis or nasal polyps. After FESS combined with peri-operative systemic corticosteroids, patients were randomized and given FPANS 400 microg b.i.d., FPANS 800 microg b.i.d. or placebo b.i.d. for the duration of 1 year. Patients were withdrawn from the trial (but still included in the study for statistical purposes) if there were recurrent or persistent diseases, defined as progressive regrowth of nasal polyps, recurrent signs and symptoms of chronic sinusitis combined with abnormalities on computed tomography scan and persistent complaints for at least 2 months after FESS.
                A significant reduction of symptoms was seen after FESS. After 1 year, 46 patients had been withdrawn from the trial because of recurrent diseases and 32 patients because of persistent symptoms. No differences in the number of patients withdrawn because of recurrent or persistent diseases were found between the patients treated with FPANS and patients treated with placebo. We were also unable to find a positive effect of FPANS compared with placebo in several subgroups such as patients with nasal polyps, high score at FESS or no previous sinus surgery.
                This placebo-controlled study does not show that treatment with FPANS up to 1 year after FESS had a positive effect compared with placebo. 60 patients, aged 15-51 years, with chronic allergic or bacterial maxillary sinusitis, were entered in a controlled, double-blind study comparing the efficacy of endonasal irrigations of tixocortol pivalate (Pivalone)-neomycin and neomycin. The treatment lasted 11 days and was administered once daily. A ventilometric measurement of sinus pressure was performed every two endonasal irrigations to assess treatment efficacy. The percentage of nasal deobstruction was significantly higher with tixocortol pivalate-neomycin than with neomycin alone by the fifth examination (9th day) regardless of the etiology of the sinusitis (allergic or bacterial). After 11 days of treatment, significantly better results were obtained in cases of bacterial sinusitis (94% deobstruction with tixocortol pivalate-neomycin versus 74% with neomycin) than in cases of allergic sinusitis (69% deobstruction with tixocortol pivalate-neomycin versus 36% with neomycin). Recently, the YAMIK sinus catheter (YAMIK) has been reported to be a useful therapeutic device in the treatment of sinusitis. The present study was conducted to compare its delivery of either a normal saline (NS) or a betamethasone solution (0.4 mg/ml) into the paranasal sinuses of 25 patients (39 sides) with chronic sinusitis. The following parameters were evaluated: (1) subjective nasal clinical symptoms (nasal discharge, nasal obstruction, postnasal drip and headache), (2) X-ray photographs (ethmoid and maxillary sinuses) and (3) cytokine levels (IL-1beta, IL-8 and TNF-alpha) by enzyme-linked immunosorbent assay. The total nasal symptom scores significantly decreased after the first therapy, and the total X-ray photograph scores significantly decreased after therapy with either NS or the betamethasone solution. In both NS and betamethasone patients, the levels of IL-1beta and IL-8 had significantly decreased by the 3rd and 2nd weeks after therapy, respectively. In contrast, the TNF-alpha level decreased after the first therapy with betamethasone solution and remained unchanged after therapy with NS. These findings suggest that evacuation of the pathological effusions in sinuses may exert a beneficial effect by reducing the levels of IL-1beta and IL-8, and we speculate that removal of pathological effusions from the sinuses may provide treatment through different mechanisms than those that occur in treatment with betamethasone. Whether instillation into the maxillary sinus of topical budesonide affected the immune response and improved allergic patients with chronic rhinosinusitis that had persistence of symptoms despite appropriate surgical intervention was assessed.
                Double-blind placebo-controlled.
                Twenty-six patients with allergy to house dust mites who had previously had surgery and who had persistent symptoms of disabling rhinorrhea or pressure-pain resistant to oral antibiotics and intranasal corticosteroids were recruited. During the double-blind study, patients instilled 256 microg budesonide daily or placebo through an intubation device (maxillary antrum sinusotomy tube) into one of the maxillary sinuses for 3 weeks before clinical assessment and a second biopsy.
                We found an improvement in the symptom scores in 11 of the 13 patients who received budesonide; we also found a decrease in CD-3 (P = .02) and eosinophils (P = .002), and a decrease in the density of cells expressing interleukin4 (P = .0001) and interleukin-5 messenger RNA (P = .006) after treatment.
                Topical budesonide delivered through a maxillary antrum sinusotomy tube can control chronic rhinosinusitis that persists after surgery. Chronic rhinosinusitis (CRS) is a recalcitrant inflammatory process which has a marked detrimental impact on quality of life. At the present there is no cure for this condition, measures are taken to stop progression, and provide symptomatic relief. Topical corticosteroids are commonly prescribed in the management of CRS, but few trials show effectiveness in clinical settings. We set up a randomized, double-blind, placebo-controlled trial to study the effectiveness of a topical corticosteroid agent--fluticasone propionate aqueous nasal spray (FPANS) in patients with CRS. We measured symptoms, diary card, and rigid endoscopy scores, acoustic rhinometry, middle meatal swabs, blood tests--CRP, ESR, WBC, and eosinophil count. Measurements were done at the start of the trial, at 8 weeks, and 16 weeks where possible. Twenty-two patients completed the trial, 9 received FPANS, and 13 had placebo. There was no difference between the 2 groups on all counts. When patients were considered as one group, there was an improvement in the diary card scores (p = 0.054), comparing baseline to 8 or 16 weeks. There was no evidence that the regular use of topical corticosteroid increased the risk of developing an infection. An important observation was that the topical corticosteroid did not precipitate acute sinusitis. There is compelling evidence that topical corticosteroids down-regulate cytokine expression, and it is likely that a larger, and longer multi-centre trial may prove their efficacy in CRS. 50 patients with chronic mucopurulent rhinosinusitis were randomly allocated to treatment with nasal sprays of dexamethasone, tramazoline, and neomycin, dexamethasone and tramazoline with no antibiotic, or matched placebo (propellant alone) four times daily to both nostrils for 2 weeks. The patients were assessed in a double-blind manner for symptomatic response and improvement in nasal mucociliary clearance, nasal airway resistance, sinus radiographs, and intranasal bacteriology and appearance. Both active preparations (with antibiotic 14 of 20 patients responded; without antibiotic 12 of 20 patients responded) were more effective than the placebo (2 of 10 patients responded). There was no significant difference in response between the active preparations with and without antibiotic. Thus, in treatment of chronic mucopurulent rhinosinusitis, reduction of the inflammatory response and decongestion make topical antibiotic unnecessary, probably by allowing host clearance mechanisms to recover. Approximately 20% patients with chronic rhinosinusitis undergoing Functional Endoscopic Sinus Surgery (FESS) experience impaired wound healing, leading to recurrences of sinusitis and polyps.
                We investigated the efficacy of oral+ local steroids in wound healing, following FESS in subjects with a chronic rhinosinusitis with/without nasal polyps. Ninety-nine subjects were randomised to receive 6 months' treatment with mometasone furoate nasal spray (MFNS) 200 microg bid or placebo in double-blind manner approximately 2 weeks after FESS. Postoperative mean total score for several endoscopic parameters scores assessed at 6 months was calculated as the primary efficacy end-point. An endoscopic combination score (for inflammation, oedema, and polyps), a total symptoms score, and percent subjects requiring rescue medication, were assessed as secondary end-points.
                MFNS led to greater, although not significant, reductions in total endoscopic scores in all subjects, compared with placebo. The combination scores, however, indicated significantly improved healing with MFNS than with placebo for all subjects (median scores: 0.0 vs 2.0, p = 0.02), and particularly for subjects with nasal polyps (median scores: 2.0 vs 4.0, p = 0.03). The total symptom scores and percent subjects requiring rescue medication were similar in the two groups. MFNS was well tolerated.
                These results suggest that treatment with MFNS following sinus surgery may improve wound healing, particularly in subjects with nasal polyps. 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. The clinical efficacy and adverse effects of budesonide administered as a nasal aerosol in addition to sinus washings and erythromycin therapy was assessed by comparison with placebo in a randomized, double-blind study of 40 patients with chronic or recurrent maxillary sinusitis. Most of the patients had been referred for operative treatment. Corticosteroid therapy, 400 micrograms daily, or placebo was continued for 3 months. Budesonide and antral irrigations reduced nasal symptoms more effectively than placebo, and there was a significantly greater reduction in facial pain and sensitivity in the budesonide group than in the placebo group. During the treatment period, mucosal thickening as evaluated by radiology decreased more clearly in the budesonide group than in the placebo group, but the difference did not reach statistical significance. The most frequently isolated bacteria were Staphylococcus aureus, Staphylococcus epidermidis and Haemophilus influenzae. Only 2 of 20 Haemophilus strains were beta-lactamase producers. The cellular picture was dominated by neutrophils in all secretions. There was no significant difference in clinical outcome between the two groups. Topical steroid therapy did not cause any adverse effects.