Postoperative care for Samter's triad patients undergoing endoscopic sinus surgery: a double-blinded, randomized controlled trial. Quality of life is improved by endoscopic surgery and fluticasone in nasal polyposis with asthma. Functional endoscopic sinus surgery improved asthma symptoms as well as PEFR and olfaction in patients with nasal polyposis. Treatment of recurrent chronic hyperplastic sinusitis with nasal polyposis. Long-term study of fluticasone propionate aqueous nasal spray in acute and maintenance therapy of nasal polyposis. Clinical performance of fluticasone propionate nasal drops. Efficacy of topical corticosteroid powder for nasal polyps: a double-blind, placebo-controlled study of budesonide. Sensitivity of a new grading system for studying nasal polyps with the potential to detect early changes in polyp size after treatment with a topical corticosteroid (budesonide). A randomized controlled trial showing efficacy of once daily intranasal budesonide in nasal polyposis. Onset of symptomatic effect of mometasone furoate nasal spray in the treatment of nasal polyposis. A randomized trial of intranasal beclomethasone dipropionate after polypectomy. Treatment of nasal polyposis and chronic rhinosinusitis with fluticasone propionate nasal drops reduces need for sinus surgery. A randomized controlled trial of mometasone furoate nasal spray for the treatment of nasal polyposis. Fluticasone propionate aqueous nasal spray in the treatment of nasal polyposis. Intranasal fluticasone propionate for chronic eosinophilic rhinitis in patients with aspirin-induced asthma. Efficacy and tolerability of budesonide aqueous nasal spray treatment in patients with nasal polyps. The effect of budesonide (Rhinocort) in the treatment of small and medium-sized nasal polyps. Prevention of relapses of nasal polyposis with intranasal triamcinolone acetonide after polyp surgery: a prospective double-blind, placebo-controlled, randomised study with a 9-month follow-up. Effect of Beconase nasal spray on olfactory function in post-nasal polypectomy patients: a prospective controlled trial. Efficacy and tolerability of fluticasone propionate nasal drops 400 microgram once daily compared with placebo for the treatment of bilateral polyposis in adults. Budesonide nasal spray as prophylactic treatment after polypectomy (a double blind clinical trial). The efficacy and safety of once-daily mometasone furoate nasal spray in nasal polyposis: a randomized, double-blind, placebo-controlled study. Effective treatment of mild-to-moderate nasal polyposis with fluticasone delivered by a novel device. Effect of corticosteroids on wound healing after endoscopic sinus surgery. Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery. Efficacy of an aqueous and a powder formulation of nasal budesonide compared in patients with nasal polyps. Infections after endoscopic polypectomy using nasal steroids. Prophylactive treatment with flunisolide after polypectomy. Dose-related efficacy and tolerability of fluticasone propionate nasal drops 400 microg once daily and twice daily in the treatment of bilateral nasal polyposis: a placebo-controlled randomized study in adult patients. Functional endoscopic sinus surgery: 5 year follow up and results of a prospective, randomised, stratified, double-blind, placebo controlled study of postoperative fluticasone propionate aqueous nasal spray. Effect of fluticasone in severe polyposis. A double-blind comparison of intranasal budesonide with placebo for nasal polyposis. Treatment of nasal polyps with intranasal beclomethasone dipropionate aerosol. Flunisolide nasal spray 0.025% in the prophylactic treatment of nasal polyposis after polypectomy. A randomized, double blind, parallel, placebo controlled study.
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.
                Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc. The aim was to investigate the health impact of nasal polyposis with asthma and to study effects of endoscopic sinus surgery (ESS), and addition of fluticasone propionate nasal drops (FPND), on health related quality of life (HRQoL).
                Prospective study of 68 patients with nasal polyposis and asthma. Effects were measured with Study 36-Item Short Form (SF-36). A randomized, double-blind, placebo-controlled 14-weeks phase measuring additive effects of FPND 400 µg twice daily (b.i.d.) was included.
                HRQoL was significantly decreased in both Physical Component Summary, PCS, (45 vs 48, p=0.049) and Mental Component Summary, MCS, (43 vs 51, p<0.001) vs reference population. ESS significantly improved PCS, (p=0.027) and MCS (p=0.021) after five weeks. We found significant additional benefit of FPND on three domains (RP, p=0.002; VT, p=0.007; SF, p=0.002). The increase in HRQoL with FPND reached reference population levels in all domains, as well as in both PCS (50, p=0.003) and MCS (52, p=0.002), five weeks after ESS.
                FPND 400 µg b.i.d. can be added to ESS in order to improve, and to reach population levels of, HRQoL already five weeks post-ESS. Physicians should evaluate HRQoL and consider ESS with nasal steroids early in their treatment of these patients. Nasal polyposis is a disease known to be associated with asthma. The management is anti-inflammatory, with topical and oral corticosteroids as the first-line treatment. The effect of surgical treatment on lower airway inflammation has not been sufficiently studied.
                The aim of this study is to investigate the effects of functional endoscopic sinus surgery (FESS) as well as fluticasone proprionate nasal drops (FPND) 400 microg b.i.d. on nasal and lower airway parameters in asthmatics with nasal polyposis.
                This was a prospective 21-week study of 68 patients with asthma and nasal polyposis, on the benefits of FESS on nasal '(butanol test, subjective olfaction, peak nasal inspiratory flow, congestion, rhinorrhoea, and polyp score)', and on the lower airway parameters (dyspnea, cough, mean daily peak expiratory flow rate (PEFR), and lung function tests). It also included a randomized, double-blind, placebo-controlled 14 weeks phase on FPND.
                Functional endoscopic sinus surgery significantly improved mean asthma symptom scores and daily PEFR and all nasal parameters including subjective and objective olfaction tests. This is the first study that shows the benefits of FESS on butanol tests in patients with nasal polyposis. We found no significant difference between topical treatment with FPND or placebo in the nasal or lower airway variables.
                Functional endoscopic sinus surgery improved nasal and asthma symptoms in patients with nasal polyposis. Functional endoscopic sinus surgery could be considered early in the natural course of nasal polyposis with concomitant asthma, as well as a second-line treatment in nasal polyposis patients with a reduced sense of smell. The potential benefits of FPND 400 microg b.i.d. were probably overshadowed by FESS. To demonstrate the long-term efficacy of intranasal furosemide, an inhibitor of the sodium chloride cotransporter channel at the basolateral surface of the respiratory epithelial cell, vs no therapeutic intervention vs intranasal mometasone furoate, a corticosteroid, in preventing relapses of chronic hyperplastic sinusitis with nasal polyposis.
                Randomized prospective controlled study. Patients were examined every 6 months during follow-up (range, 1-9 years).
                One hundred seventy patients with bilateral obstructive or minimally obstructive chronic hyperplastic sinusitis with nasal polyposis.
                All patients were surgically treated in the ENT Department, University of Siena Medical School. One month after surgery, group 1 patients (n = 97) started treatment with intranasal furosemide, group 2 (n = 40) received no therapeutic treatment, and group 3 (n = 33) were treated with mometasone.
                Clinical and instrumental evaluation of postoperative outcomes.
                Seventeen (17.5%) of 97 patients in group 1, 12 (30.0%) of 40 patients in group 2, and 8 (24.2%) of 33 patients in group 3 experienced nasal polyposis relapses. We noted a prevalence of early-stage relapse in patients treated with furosemide or mometasone, whereas patients who did not receive any treatment experienced more severe grades of chronic hyperplastic sinusitis with nasal polyposis (P<.005).
                Use of intranasal furosemide represents a valid therapeutic treatment in the prevention of chronic hyperplastic sinusitis with nasal polyposis. Topical steroids are first-line medication to control nasal polyposis (NP), a disease with long-term clinical course.
                The aim of this study was to evaluate the efficacy and safety of fluticasone propionate aqueous nasal spray (FPANS) 200 microg twice a day (bd) after 1 month of treatment, and to compare FPANS 200 microg bd and FPANS 200 microg once a day (od) in maintenance and long-term treatment.
                Double-blind, placebo-controlled, 8-month study with three treatment periods (1-month acute period followed with 1-month maintenance period and 6-month follow-up period) was carried out. Group 1 received FPANS 200 microg bd, during acute, maintenance and follow-up periods, Group 2 received FPANS 200 microg bd during acute period and FPANS 200 microg od during maintenance and follow-up periods, and Group 3 received placebo during acute and maintenance periods and FPANS 200 microg bd during follow-up period. Endpoints were change from baseline in clinic peak nasal inspiratory flow (PNIF), domiciliary evening PNIF, intensity of symptoms and polyposis grade.
                After acute period and maintenance periods, FPANS 200 microg bd was significantly more effective than placebo on all endpoints and more effective than FPANS 200 microg od after 1-month maintenance period on clinic PNIF, evening PNIF, obstruction, percentage of days with no sense of smell and percentage of nights with no disturbances. The two doses were similar on other endpoints. After the 6-month follow-up period, there was no difference between the two doses of FPANS at all efficacy endpoints. The safety profile of FPANS did not highlight any new or unanticipated adverse events.
                The study demonstrated the efficacy of FPANS 200 microg bd in acute treatment and FPANS 200 microg od as a sufficient dose to maintain a long-term efficacy in the treatment for NP. The efficacy and safety of fluticasone propionate (FP) nasal drops were investigated in two multicentre, randomized, placebo-controlled trials. Patients received FP 400 microg once or twice daily for 12 weeks and then FP 400 microg once daily for a further 12 weeks. FP 400 microg significantly reduced polyp size and improved peak nasal inspiratory flow, rhinitis symptoms and sense of smell when administered twice daily. Significant reductions in polyp size were not achieved with once daily administration, but clinical benefits were observed for peak nasal inspiratory flow. Both dosing regimens were well tolerated, with an overall incidence of adverse events which was similar to placebo. Budesonide has been used for a number of years as a topical nasal corticosteroid in the treatment of nasal allergy and nasal polyps. Recently, a new device for powder insufflation where no constituents or preservatives are included has been developed (Rhinocort Turbuhaler, Astra Draco AB, Sweden). The present investigation was designed in order to study the efficacy of topical budesonide powder as the only treatment of nasal polyps. A total of 126 patients entered the study. The medical history and clinical recordings included symptoms and signs, a semiquantitative test of smell and measurement of nasal expiratory peak flow index. Medication was either 200 or 400 micrograms of budesonide powder b.i.d. or placebo. After 1 month an overall assessment of treatment efficacy was made to determine whether the treatment had been a success or a failure. The results showed a statistically significant improvement of symptoms and signs in the actively treated groups. The increase in expiratory peak flow index was about 60% in the actively treated groups as opposed to 16% in the placebo group. The overall assessment of treatment efficacy showed success in about 82% of actively treated patients as opposed to about 43% in the placebo group. It is concluded that budesonide powder is useful in the treatment of nasal polyps. We have previously compared different scoring systems for endoscopic staging of nasal polyps. Of the five methods evaluated, we found that two were better than the others with regard to reproducibility and agreement between physicians. One method was lateral imaging, developed by the authors, and the other was a scoring system developed by Lildholdt et al. The main objective of the present study was to compare the sensitivity of these two methods. Another aim was to study the effect on nasal polyposis of topical nasal corticosteroids over a 2-week period. Patients with bilateral nasal polyposis (n = 100) were randomized to a 2-week treatment with a topical corticosteroid (budesonide aqueous nasal spray: 128 microg b.i.d.) or placebo in a double-blind manner. Nasal symptoms were scored before treatment and after 3, 7 and 14 days of treatment, and the patients underwent nasal endoscopy at clinical visits. Patients treated with active substance had an improvement in their symptoms, an effect already detectable after 3 days of treatment, compared with those who received placebo. In addition, a statistically significant decrease in polyp size could be registered after 14 days using lateral imaging but not with the other scoring system. In conclusion, lateral imaging was more sensitive and could detect effects earlier than the other scoring system and can be recommended for the endoscopic staging of nasal polyps in clinical studies. A randomized, double-blind, placebo-controlled trial was performed to assess the efficacy of once daily budesonide in patients with nasal polyps. After a 2-week run-in period, 157 patients with symptomatic bilateral nasal polyposis were randomized to receive budesonide, 140 micrograms once or twice daily or 280 micrograms once daily (delivered doses) via Turbuhaler, or placebo for 8 weeks. Polyp size was assessed endoscopically and, in two centres, by magnetic resonance imaging (MRI). Nasal symptoms (blocked nose, runny nose, sneezing) were recorded daily, and patients provided an overall assessment of efficacy at the end of the study. Budesonide, 280 micrograms/day (280 micrograms o.d. and 140 micrograms twice daily), significantly reduced polyp size, compared with placebo, whereas budesonide, 140 micrograms once daily, had no significant effect. Nasal polyp mass score, measured by MRI, was also significantly reduced in patients receiving 280 micrograms/day. All three doses of budesonide significantly reduced symptom scores, and there were no significant differences between the groups. Overall, approximately 70% of patients receiving budesonide, 280 micrograms/day, reported substantial or total control of symptoms, compared with 45% of placebo-treated patients. It is concluded that budesonide, 280 micrograms once daily, reduces polyp size and relieves symptoms in patients with nasal polyposis. The efficacy of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) for treatment of nasal polyposis was demonstrated in 2 large clinical trials.
                To evaluate the onset of MFNS symptomatic effect, data from the 2 trials were pooled and analyzed to determine the first day subjects experienced significant symptom relief.
                Subjects with nasal polyposis randomized to MFNS 200 microg twice daily or placebo scored symptoms on a 3-point scale (0 = none; 3 = severe) and measured peak nasal inspiratory flow immediately before the morning dose. Onset of symptomatic effect was defined as the first day a statistically significant (P < .05) lasting response was observed for MFNS compared with placebo.
                A total of 447 subjects with bilateral nasal polyps and clinically significant nasal congestion/obstruction were analyzed. Compared with placebo, MFNS 200 microg twice daily demonstrated statistically significant (P < .05) relief of anterior rhinorrhea by day 2 (-10.9% vs +5.7%), nasal congestion by day 3 (-15.1% vs -7.6%), postnasal drip by day 5 (+1.1% vs +4.6%), and sense of smell by day 13 (-9.6% vs -5.6%). Significant improvement in peak nasal inspiratory flow was seen by day 2 (increase of 6.22 L/min vs 1.48 L/min for placebo; P = .03).
                Mometasone furoate nasal spray 200 microg twice daily rapidly improves the symptoms of nasal polyposis, leading to lasting relief of most major symptoms within 2 (24 hours after the first dose) to 5 days of initiating therapy. Beneficial effects of intranasal beclomethasone dipropionate (Bdp) in patients with nasal polyposis have been reported earlier. This study was carried out to investigate whether long-term treatment with Bdp after polypectomy could prevent formation of new polyps and reduce the number of surgical removals. Forty consecutive patients without laboratory or other clinical signs of allergy but with severe nasal polyposis were included in the study. Twenty patients were treated with intranasal Bdp and twenty patients received no treatment after polypectomy. All patients were followed for at least 2.5 years. The size of the polyps that recurred was estimated at different time-intervals by the examining doctor. After six months there was already a significant difference in favour of the group treated with intranasal Bdp. Further results of the study and the clinical implications are discussed. Steroid treatment is the mainstay of therapy for nasal polyps and rhinosinusitis. Oral steroids have considerable systemic side effects, and nasal sprays do not sufficiently reach the middle meatus, where polyps originate. Nasal drops might be a more useful formula to deliver steroids into the middle meatus.
                We sought to investigate whether treatment with fluticasone propionate nasal drops (FPNDs) can reduce the need for surgery, as measured by signs and symptoms of nasal polyposis and chronic rhinosinusitis, in patients who are on the waiting list for functional endoscopic sinus surgery (FESS).
                Fifty-four patients (28 male) with severe nasal polyposis, chronic rhinosinusitis, or both indicated for FESS were included in a 12-week, double-blind, placebo-controlled study. Use of intranasal steroid spray was stopped at least 4 weeks before randomization. Signs and symptoms were recorded before, during, and at the end of the study period. At the end of the study, a computed tomographic scan was performed, and the need for operation was reassessed by using a standardized scoring method.
                FESS was no longer required in 13 of 27 patients treated with FPNDs versus 6 of 27 in the placebo group (P < .05). Six patients from the placebo group dropped out versus 1 from the FPND group. Symptoms of nasal obstruction, rhinorrhea, postnasal drip, and loss of smell were reduced in the FPND group (P < .05). Peak nasal inspiratory flow scores increased significantly (P < .01). Polyp volume decreased in the FPND group (P < .05), and computed tomographic scores improved in both groups (P < .05).
                Treatment with FPNDs in patients indicated for FESS can reduce the need for surgery. To evaluate the efficacy and safety of mometasone furoate nasal spray (NS) for the treatment of nasal polyposis.
                Randomized, double-blind, placebo-controlled, parallel-group, multicenter study.
                A total of 24 centers in 17 countries.
                A total of 310 subjects 18 years or older with bilateral nasal polyps.
                (1) A 200-microg dose of mometasone furoate NS in the morning and matching placebo in the evening; (2) 200-microg doses of mometasone furoate NS in the morning and evening; or (3) matching placebo in the morning and evening. All 3 regimens were administered as a nasal spray for 4 months.
                Primary end points were change from baseline to last assessment in physician-assessed bilateral polyp grade and change from baseline in subject-assessed congestion and/or obstruction score averaged over the first month of treatment. Analysis of variance was used for all efficacy end points except for change in bilateral polyp grade, for which baseline polyp grade was added as a covariate to the analysis of variance model to account for any between-group baseline differences in this variable.
                Mometasone furoate NS doses of 200 microg administered once or twice daily produced greater reductions in bilateral polyp grade at the end point than placebo, with differences reaching statistical significance with twice-daily dosing (P = .04). Over 1 month, both mometasone furoate NS regimens produced statistically superior improvements from baseline in congestion and/or obstruction score vs placebo (P = .01 for once-daily dosing; P<.001 for twice-daily dosing). The drug was well tolerated.
                Mometasone furoate NS is an effective and well-tolerated treatment for bilateral nasal polyposis in adults, reducing nasal polyp size and symptoms of nasal congestion and/or obstruction. Topical glucocorticoids are the medical treatment of choice in a majority of patients suffering from nasal polyposis. Fluticasone propionate is a fluorinated steroid reported to be highly effective when used topically in the nose for seasonal and perennial allergic and nonallergic rhinitis.
                To evaluate the efficacy and tolerability of intranasal fluticasone propionate in the treatment of long-standing polyposis.
                Fifty-five patients with long-standing nasal polyposis were treated over a 26-week period with fluticasone propionate aqueous nasal spray 200 micrograms bid, beclomethasone dipropionate aqueous nasal spray 200 micrograms bid or placebo, administered intranasally in an aqueous spray in a double-blind, placebo-controlled parallel-group design at a single center. The primary efficacy endpoint was the physicians' assessment of symptoms and polyp score. Peak nasal inspiratory flow was performed twice daily and on every visit to evaluate the effect of the corticosteroids on nasal air flow.
                A significant difference in the primary efficacy endpoint between fluticasone propionate aqueous nasal spray and beclomethasone dipropionate aqueous nasal spray compared with placebo was seen after 14 weeks of treatment. This was further verified by the peak nasal inspiratory flow results. There was some evidence of earlier onset in the fluticasone propionate aqueous nasal spray group compared with the beclomethasone dipropionate aqueous nasal spray group after 4 weeks in terms of the primary efficacy endpoint. From the daily record cards patients receiving fluticasone propionate aqueous nasal spray had a significantly higher percentage of days on which they required no rescue medication (P < .009) and a higher percentage of days with an overall nasal blockage score on waking of < 2 (P < .013) when compared with placebo-treated patients. No other statistically significant results were found between the two active compounds.
                Fluticasone propionate aqueous nasal spray 200 micrograms bid and beclomethasone dipropionate aqueous nasal spray 200 micrograms bid are effective in treating the symptoms of nasal polyps, with some evidence that fluticasone propionate aqueous nasal spray has a faster onset of action and is tolerated at least as well as beclomethasone dipropionate aqueous nasal spray at the same dose. We performed a double-blind, crossover, placebo-controlled study on the effect of fluticasone propionate (FP) treatment on chronic eosinophilic rhinosinusitis in 15 patients with aspirin-induced asthma (AIA). There were 10 women and five men aged 32-60 years; average: 45 years. After a 10-day run-in period, patients underwent two 4-week treatment courses (FP vs placebo), separated by a 2-week washout interval. Clinical activity of FP was evaluated by daily measurement of peak nasal inspiratory flow (PNIF) and a scoring system of subjective symptoms. Nasal challenges with E-lysine aspirin, using active anterior rhinomanometry, were performed at the entry and on the last day of each treatment period. Weekly mean values of symptom scores were generally lower and PNIF measurements higher during treatment with FP than with placebo. This difference was statistically significant for most recorded parameters for the whole 4-week FP treatment. On average, the reactions evoked by aspirin nasal challenge were significantly shorter and milder after treatment with FP than with placebo. In 8/13 patients, FP completely prevented aspirin-precipitated nasal reaction, whereas protection after placebo was observed in only 2/12 subjects (P = 0.004). We conclude that intranasal FP is an effective therapy for chronic eosinophilic rhinitis in patients with AIA. To assess the efficacy and tolerability of once-daily treatment with budesonide aqueous nasal spray in patients with nasal polyps.
                Randomized, double-blind, placebo-controlled, parallel-group study.
                Sixteen hospital clinics.
                One hundred eighty-three patients with moderate-sized nasal polyps causing clinically significant symptoms during a 1-week run-in period.
                Patients were randomized to receive 1 of the following 4 budesonide aqueous nasal spray treatments: 128 microg once daily in the morning and placebo in the evening, 128 microg twice daily, 256 microg once daily in the morning and placebo in the evening, or placebo for 8 weeks. Nasal polyp size was scored and peak nasal inspiratory flow was measured at clinic visits at the beginning and end of the run-in period and after 4 and 8 weeks' treatment. Patients recorded daily peak nasal inspiratory flow, symptom scores (ie, blocked nose, runny nose, and sneezing) and sense of smell on diary cards.
                Mean change in nasal polyp size at the end of treatment; mean changes in combined and individual symptom scores.
                All doses of budesonide aqueous nasal spray significantly (P<.01) reduced polyp size; no significant differences were noted between the 4 treatment groups. The mean improvement in clinic peak nasal inspiratory flow at 8 weeks was 65.9 L/min with budesonide aqueous nasal spray, 128 microg twice daily; 71.6 L/min with budesonide aqueous nasal spray, 256 microg once daily; and 54.6 L/min with budesonide aqueous nasal spray, 128 microg once daily (all P<.001 vs placebo). Combined and individual symptom scores and sense of smell improved significantly in all budesonide-treated groups; the effect on symptoms became apparent within 1 to 2 days of the first dose. Budesonide aqueous nasal spray was well tolerated.
                Doses of budesonide aqueous nasal spray, 128 microg once daily, were found to be effective in the treatment of nasal polyps, and doses of budesonide aqueous nasal spray, 256 microg once daily, did not show any significant additional efficacy. The objectives of this study were to determine if the size of nasal polyps could be assessed in a reproducible way and to study the effect of budesonide in patients suffering from eosinophilic nasal polyposis with small and medium sized polyps. Ninety-one patients entered the study. Budesonide 200 micrograms b.i.d. (aerosol or aqua) and placebo (aerosol or aqua) were compared in a 3-month double-blind, multi-centre, randomized study. Efficacy was measured by an assessment of polyp size, nasal peak-flow index and the patient's assessment of nasal symptoms. The conclusions were that the size of polyps could be assessed in a reproducible way, and that budesonide delivered either as a water-based suspension or as an aerosol is effective in the treatment of patients with small and medium sized polyps. To determine whether intranasal triamcinolone acetonide prevents the regrowth of nasal polyps after polyp surgery.
                Randomised, double-blind, placebo-controlled, prospective study.
                Helsinki University Central Hospital.
                Sixty patients with nasal polyps entered the study. Patients were included upon arrival for elective polyp operations determined according to our standard clinical criteria. The recurrence of nasal polyposis was followed up for 9 months after surgical treatment at 3-month intervals.
                Anterior rhinoscopy, nasal endoscopy, olfactory threshold measurement, active anterior rhinomanometry and acoustic rhinometry were performed at every follow-up visit.
                On the whole, there was a significant inter-group difference in the change in polyp size of acetylsalicylic acid (ASA)-tolerant patients during the follow-up. In patients with acetylsalicylic acid intolerance, there was no inter-group difference (P = 0.28). No significant differences were noted for nasal resistance, nasal cavity volume, sense of smell and nasal symptoms.
                Triamcinolone acetonide prevents regrowth of nasal polyps after polyp surgery in acetylsalicylic acid-tolerant patients, but not in acetylsalicylic acid-intolerant patients.
                © 2012 Blackwell Publishing Ltd. Numerous studies have postulated the possible benefit of corticosteroids on olfaction in patients with nasal/sinus disease. Twenty-nine patients with bilateral nasal polyps were included in our study using strict selection criteria to reduce other aetiologies of olfactory dysfunction. The University of Pennsylvania Smell Identification Test (UPSIT) was performed pre-operatively on the right and left nostrils separately. Following intranasal polypectomy the patients received a six-week course of beclomethasone nasal spray (Beconase) to one nostril only, with the other acting as a control. The UPSIT scores were again obtained for each nostril separately. Wilcoxon Signed Rank test revealed no statistically significant difference in UPSIT scores between treated and untreated nostrils (p = 0.31; power 70 per cent; ES = 0.47). We conclude that topical beclomethasone does not improve olfaction following nasal polypectomy. Chronic eosinophilic rhinosinusitis underlies a range of respiratory disorders including nasal polyposis. Surgical and medical methods are used to control polyps, with topical steroids commonly being used for their anti-inflammatory properties. Fluticasone propionate nasal drops (FPND) is a formulation developed specifically for an effective and well tolerated corticosteroid treatment of nasal polyposis.
                To assess efficacy and tolerability of FPND in the treatment of bilateral nasal polyposis in adults.
                This multicentre, randomized, parallel-group study compared FPND 400 microgram once daily (o.d.) with placebo for 12 weeks in adult patients with mild to moderate bilateral polyposis. The primary efficacy endpoint was visual assessment of polyp size by the physician at monthly clinic visits. Nasal blockage, rhinitis, peak nasal inspiratory flow (PNIF), olfactory function and requirement for polypectomy were also assessed at visits. The patients kept diary card records of symptoms, PNIF, and use of rescue antihistamine. Additional safety data were provided by a 12-week open extension, when all patients received FPND 400 microgram o.d.
                After 12 weeks double-blind treatment with FPND (n = 52) or placebo (n = 52), polyp size was reduced in 27% and 16% of patients, respectively; clinical reduction of nasal blockage significantly favoured FPND over placebo (55% vs 22%; P = 0.002), and clinic PNIF had increased significantly with FPND (by 52 L/min vs -3 L/min for placebo; P < 0.001). Diary card measurements showed significant benefits of FPND vs placebo for daily PNIF, nasal blockage, rhinitis and use of loratadine rescue medication. Both treatments were well tolerated and no serious adverse events occurred during randomized treatment. Epistaxis was more frequent with FPND than placebo but was generally mild and did not result in withdrawals. Mean serum cortisol levels did not change significantly with either treatment.
                This study showed FPND 400 microgram o.d. to be an effective and well tolerated treatment for bilateral nasal polyposis in adults. This double-blind parallel-group study compared the effect of budesonide with placebo, in the prophylaxis of nasal polyp recurrence after evulsion. Seventy-three patients with first time or recurrent polypectomy were enrolled. At revisits 3 and 6 months after evulsion, the budesonide-treated patients had significantly lower polyp scores than the placebo-treated patients. Only patients with recurrent nasal polyposis benefited from the budesonide treatment, whereas no effect was evident in patients with first time evulsion. In subjects with mild-to-moderate nasal polyposis, treatment with mometasone furoate nasal spray (MFNS) 200 microg once daily (QD) significantly decreases nasal congestion, reduces polyp size, and improves quality of life.
                To evaluate the efficacy and safety of MFNS, administered QD in the morning, in subjects with mild-to-moderate nasal polyposis.
                This randomized, double-blind, double-dummy, placebo-controlled clinical trial enrolled subjects with mild-to-moderate nasal polyposis at 12 centers in Denmark, Finland, Norway, and Sweden. Inclusion criteria were: age > or = 18 years, a diagnosis of bilateral nasal polyps, and clinically significant nasal congestion. Following a 2-4-week run-in period, subjects were randomized to receive MFNS 200 microg QD or matching placebo for 16 weeks.
                A total of 298 subjects were randomized to treatment. Of those subjects included in the intent-to-treat efficacy analysis (n = 291), a statistically greater proportion of the MFNS group than the placebo group had improvements in investigator-assessed nasal congestion score between baseline and end point (the primary outcome) (74.3% vs 46.8%; p < 0.001). Significant benefits of MFNS were also seen for secondary end points, including polyp size, sense of smell, peak nasal inspiratory flow, therapeutic improvement, and quality-of-life measures. MFNS was well tolerated, with no unusual or unexpected adverse events. To assess the efficacy and safety of fluticasone propionate administered using OptiNose's novel delivery device (Opt-FP) in subjects with bilateral mild-to-moderate nasal polyposis.
                A prospective, multicentre, randomized, double-blind, placebo-controlled, parallel group study was conducted in adult subjects (n = 109) with mild-to-moderate bilateral nasal polyposis. Subjects received Opt-FP 400 microg or placebo twice daily for 12 weeks. Endpoints included endoscopic assessment of polyp size using Lildholdt's Scale, peak nasal inspiratory flow (PNIF), symptom scores and use of rescue medication.
                The proportion of subjects with improvement in summed polyp score >or= 1 (Lildholdt\'s Scale) was significantly higher with Opt-FP compared with placebo at 4, 8 and 12 weeks (22% vs 7%, p = 0.011, 43% vs 7%, p < 0.001, 57% vs 9%, p < 0.001). After 12 weeks the summed polyp score was reduced by 35% (-0.98 vs +0.23, p < 0.001). PNIF increased progressively during Opt-FP treatment (p < 0.05). Combined symptom score, nasal blockage, discomfort, rhinitis symptoms and sense of smell were all significantly improved. Rescue medication use was lower (3.1% vs 22.4%, p < 0.001). Opt-FP was well tolerated.
                Fluticasone propionate (400 microg b.i.d.) administered using OptiNose's breath actuated bi-directional delivery device was an effective and well tolerated treatment for mild-to- moderate bilateral nasal polyposis. 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. To evaluate the effect of mometasone furoate on prevention or reduction of nasal polyp relapse and worsening of symptoms after functional endoscopic sinus surgery (FESS).
                Randomized, double-blind, placebo-controlled, multicenter study.
                Ten ear, nose, and throat clinics in Sweden.
                Adult subjects with bilateral nasal polyps fulfilling the criteria for surgery who underwent FESS.
                Two weeks after FESS, subjects were randomized to receive mometasone furoate nasal spray, 200 microg once daily, or placebo.
                Time to relapse, defined as an increase of 1 point or more on a 0- to 6-point endoscopic polyp scale.
                In the per-protocol population (n = 104), median time to relapse was 173 and 61 days for the mometasone and placebo groups, respectively (P = .007; hazard ratio [95% confidence interval], 0.72 [0.55-0.93]). In the intent-to-treat population (n = 159), median time to relapse was greater than 175 days in the mometasone group and 125 days in the placebo group (P = .049; hazard ratio, 0.79 [0.62-0.99]). The most common adverse event was epistaxis, with 6 cases reported in the mometasone group and 3 in the placebo group.
                Postoperative use of mometasone furoate, 200 microg once daily, provided a statistically significant longer time to relapse of nasal polyps than did placebo in subjects with bilateral nasal polyposis who had undergone FESS. The ability of mometasone to prevent or prolong the time to relapse among subjects undergoing FESS is important because this may prolong the time to subsequent surgery.
                clinicaltrials.gov Identifier: NCT00731185. Nasal polyps are commonly treated surgically. Intranasal administration of topical corticosteroids has gained increased acceptance as a treatment alternative. The aim of our study was to compare the efficacy of treatment of two formulations of budesonide with placebo on nasal polyps. At four Danish clinics 138 patients suffering from moderate or severe nasal polyps were randomized to a twice daily treatment with Rhinocort Aqua 128 micrograms, Rhinocort Turbuhaler 140 micrograms or placebo (Astra Draco, Sweden) for 6 weeks. Polyp size (primary efficacy variable), nasal symptoms, sense of smell, and patients' overall evaluation of treatment of efficacy were assessed by scores. Polyp size was reduced significantly in both budesonide treated groups compared with placebo, but there was no statistical difference between the two actively treated groups. Patients' nasal symptom scores was significantly more reduced in the Aqua compared to the Turbuhaler treated group, and both reduced symptom scores were significantly better compared to placebo. Sense of smell was significantly improved in the actively treated groups compared to placebo. The proportion of patients rating substantial or total control over symptoms after 6 weeks treatment was 60.9% and 48.2% in the Aqua and Turbuhaler-treated groups, respectively, which was significantly better compared with 29.8% in the placebo-treated group. Rhinocort Aqua and Rhinocort Turbuhaler were equally well tolerated. Topical nasal steroids such as beclomethasone dipropionate and fluticasone propionate have been widely used in the treatment of rhinitis and polyposis. An increase in infection has occurred with the use of fluticasone propionate after endoscopic polypectomy.
                The purpose of this study was to determine the prevalence of nasal and paranasal infections with the use of topic nasal steroids after endoscopic polypectomy and to compare the recurrence rates of the polyposis.
                We conducted a prospective, comparative, open, experimental, longitudinal study at an academic tertiary referral medical center.
                One hundred sixty-two patients in whom endoscopic polypectomy had been indicated were randomly divided into 3 groups of 54 patients each. The patients from the first group were treated with saline lavage only. Patients from the second group also received fluticasone propionate 400 microg/day in nasal spray after lavage. Patients from the third group received beclomethasone dipropionate 600 microg/day after lavage. The prevalence of infections and recurrence of polyposis was compared in the 3 groups.
                Three patients, 2 in the placebo group and 1 in the beclomethasone group, developed infections during the first 3 months after surgical procedure. The recurrence of polyps in the group without steroids was 44%. In contrast, 15% from the patients treated with fluticasone showed recurrence of polyposis; furthermore, 26% of the patients treated with beclomethasone showed recurrence of polypsosis, with a minimum follow-up of 12 months.
                The use of nasal steroids does not seem to increase the prevalence of infections after endoscopic polypectomy. Twenty-two patients with nasal polyps completed a double-blind study with a new topical corticosteroid, flunisolide. Treatment during three months after operation gave, in comparison with placebo, a statistically significant effect on the symptom of stuffy nose, and on the sum of scores for stuffy nose, runny nose and sneezing. There was no significant effect on rhinomanometry. Side effects were negligible. Three patients in the placebo-group required a further operation within one year but none in the flunisolide group. Prophylactic treatment with flunisolide can be recommended as a complement to other treatment after surgery of nasal polyps. Topical corticosteroids are the accepted medical adjunct to surgery in patients suffering from nasal polyposis. Fluticasone propionate (FP) is a potent, topically active corticosteroid which has been formulated as nasal drops specifically for the treatment of polyposis.
                To evaluate dose-related efficacy and tolerability of FP nasal drops (FPND) in the treatment of mild to moderate bilateral polyposis; in a double-blind, placebo-controlled, multicentre international study.
                Adult patients (n = 142) with bilateral nasal polyps were randomized to receive either FPND 400 microg once daily (o.d.), FPND 400 microg twice daily (b.i.d.) or placebo for 12 weeks. The majority then entered a further 12 week open period during which all patients received FPND 400 microg o.d. The primary efficacy endpoint was the physicians' visual assessment of polyp size. Secondary clinical endpoints were nasal blockage and overall rhinitis (0-3 scores), peak nasal inspiratory flow (PNIF), olfactory function tests, and requirement for polypectomy. The patients also kept twice daily records of symptom scores, peak nasal inspiratory flow (PNIF) and use of rescue medication.
                At the end of the 12 week randomized treatment period, polyp size was reduced significantly by FPND 400 microg b.i.d. as compared with placebo (P = 0.006). Clinical assessments of nasal blockage and overall rhinitis showed significant improvements at several stages of treatment with both doses of FPND. Clinic PNIF was also improved significantly by both doses of FPND in comparison with placebo, and FPND 400 microg b.i.d. was significantly more effective than 400 microg o.d. (P = 0.045). Patient diary card scores supported the clinical assessments. Two patients on placebo required polypectomy and all treatments were well tolerated with a similar incidence of adverse events.
                FPND 400 microg once or twice daily is an effective and well-tolerated treatment for bilateral nasal polyposis. One hundred nine patients with chronic rhinosinusitis underwent functional endoscopic sinus surgery. Seventy seven patients had polyposis. The population was studied prospectively for 5 years postoperatively. Seventy two patients attended the 5 year follow-up visit. At 1, 2, 3, 4 and 5 years of follow-up all outcome measures except olfactory detection thresholds (visual analogue scores, endoscopic findings, nasal mucociliary clearance times, total nasal volumes) were significantly improved compared to preoperative baseline values. Olfactory detection thresholds were significantly improved at 1 and 2 years postoperation. Patient symptom scores were improved in a greater percentage of patients than more objective outcome measures. Thirty eight patients required a total of 88 postoperative rescue medication courses with prednisolone and antibiotic. Twelve patients failed the study as they required at least 1 rescue medication course a month for 2 consecutive months. We demonstrated an 89% 5 year "survival" rate with regards to the risk of failure. The patients were also entered into a randomised, stratified, prospective, double-blind, placebo controlled study of fluticasone propionate aqueous nasal spray 200 mcg twice daily, commencing 6 weeks after FESS, with a 5 year follow-up. The change in overall visual analogue score was significantly better in the FPANS group at 5 years. The changes in endoscopic oedema and polyp scores and in total nasal volumes were significantly better in the FPANS group at 4 years but not 5 years. Last value carried forward analysis demonstrated that changes in endoscopic polyp score and in total nasal volume was significantly better in the FPANS group at 5 years. Significantly more prednisolone rescue medication courses were prescribed in the placebo group. Of the 12 patients who failed the study, 10 were in the placebo group. This difference nearly achieved significance. To investigate the effect of intranasal corticosteroids in the treatment of polyps in patients with severe polyposis listed for surgical treatment and to determine the treatment effect on the progression of the disease.
                A double-blind, randomized, parallel-group, placebo-controlled, 12-week study at a single center.
                A tertiary referral center in London, England.
                Thirty-four patients with severe polyposis listed for endoscopic surgical treatment.
                By random allocation, fluticasone propionate aqueous nasal spray (FPANS), 200 microg twice a day; beclomethasone dipropionate aqueous nasal spray, 200 microg twice a day; or placebo nasal spray twice a day was administered. Patients received 2 actuations to each nostril in the morning and in the evening.
                Efficacy end points were the need for polypectomy at the end of treatment, the results of acoustic rhinometry, the polyp score, the peak nasal inspiratory flow rate, and an assessment of symptoms.
                The polyp score was significantly decreased in the FPANS-treated group (P < or = .01). The nasal cavity volume was significantly increased in both the FPANS-treated group and the group receiving beclomethasone compared with placebo (P < or = .01) at the end of treatment. The percentage change in the mean morning peak nasal inspiratory flow rate was greater in the FPANS-treated group, with a significant effect observed at week 2 (P = .01). Nasal blockage was significantly decreased in both active groups compared with the group receiving placebo. No significant difference was observed between the treatment groups in the number of patients requiring polypectomy.
                Fluticasone and beclomethasone aqueous nasal sprays are effective in treating the symptoms of severe nasal polyps. There was some evidence that the group treated with FPANS responded more quickly to intervention and that the magnitude of the response was greater than in the group receiving beclomethasone. Intranasal budesonide, 400 micrograms two times a day, was evaluated in 36 patients referred for treatment of nasal polyposis. The age range was 20 to 68 years. Polypectomy was done 5.6 (mean) times previously. After a 5-week, treatment-free, baseline period, patients were treated in a double-blind fashion with either budesonide or placebo during 4 weeks. After this treatment period, placebo-treated patients started receiving budesonide in an open trial for an additional 4 weeks. The patients rated their nasal symptoms daily. Nasal examinations and nasal inspiratory flow rate (IFR) measurements were done at clinic visits. After 3 and 4 weeks of treatment, the response to budesonide was significantly greater than response to placebo. The greater reduction in nasal blockage caused by polyps, observed on physical examination, p = 0.005, was mirrored by an increase in nasal IFR (p = 0.0001). Patient rating of the severity and frequency of nasal blockage were reduced more by budesonide than by placebo (p less than or equal to 0.0005). Switching placebo-treated patients to budesonide treatment resulted in a reduction of nasal blockage (p less than 0.001) and an increase in nasal IFR (p less than 0.001). The results demonstrate that topical nasal budesonide, 400 micrograms two times a day, is an effective treatment of nasal polyps. In a double-blind trial thirty-five patients with moderately-severe nasal polyposis were treated with intranasal beclomethasone dipropionate aerosol for 3 weeks. The dose given (400 mug/day) had only local effect on the symptoms. Judged by diary card scores the nasal symptoms were reduced to 52% of the pre-trial level for the whole group. Corrected for the placebo effect the percentage was 68. The reduction of symptoms was equally apportioned to the three symptoms, sneezing, nasal secretion and blockage. The treatment was tolerated well, and it is concluded that intranasal treatment with beclomethasone dipropionate aerosol offers most patients with nasal polyps a good response without any risk of systemic steroid side-effects. This double blind, parallel study compared flunisolide 2 X 25 mcg in each nostril twice daily, with placebo in the prophylaxis of nasal polyposis recurrence after surgery. The treatment lasted for 12 months. The study was conducted according to the recommendations of the Declaration of Helsinki, and the patients gave verbal consent to participate. The study was reviewed by the Norwegian Medicines Control Authority. Forty-one patients with first or recurrent polypectomy were enrolled. Thirty-seven patients completed the 12 months' period. Four patients dropped out prematurely for reasons unrelated to the test drug. Flunisolide was significantly superior to placebo in preventing recurrence of polyps during 6 to 12 months' treatment, both with respect to number (p = 0.05) and size (p = 0.03) of polyps. Nasal symptoms of sneezing and stuffiness decreased significantly for flunisolide treated patients during treatment. In the placebo group, there was a significant increase in stuffiness throughout the year. For runny nose, there was no difference between the treatments. Six flunisolide patients and 10 placebo patients reported side effects during the one year treatment, transient mild itching being the most common complaint. Three cases of secretion with bloody traces were reported. No patient withdrew for drug related reasons. In this study, flunisolide was significantly more effective than placebo in preventing recurrence of nasal polyposis during one year's treatment after polypectomy.
Topical corticosteroids are a beneficial treatment for CRSwNP and the adverse effects are minor, with benefits outweighing the risks. They improve symptoms, reduce polyp size and prevent polyp recurrence after surgery. Patients having sinus surgery may have a greater response to topical corticosteroids but further research is required.