(9R)-9-chloro-11-17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10-13-16-trimethyl-6-7-8-11-12-14-15-16-octahydrocyclopenta[a]phenanthren-3-one and Nasal-Polyps

This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Topical (intranasal) corticosteroids are used with the aim of reducing inflammation in the sinonasal mucosa in order to improve patient symptoms.. To assess the effects of different types of intranasal steroids in people with chronic rhinosinusitis.. The Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 7); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 11 August 2015.. Randomised controlled trials (RCTs) with a follow-up period of at least three months comparing first-generation intranasal corticosteroids (e.g. beclomethasone dipropionate, triamcinolone acetonide, flunisolide, budesonide) with second-generation intranasal corticosteroids (e.g. ciclesonide, fluticasone furoate, fluticasone propionate, mometasone furoate, betamethasone sodium phosphate), or sprays versus drops, or low-dose versus high-dose intranasal corticosteroids.. We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - epistaxis (nosebleed). Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse event of local irritation. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.. We included nine RCTs (911 participants), including four different comparisons. None of the studies evaluated our first primary outcome measure, disease-specific HRQL. Fluticasone propionate versus beclomethasone dipropionate We identified two small studies (56 participants with polyps) that evaluated disease severity and looked at the primary adverse effect: epistaxis , but no other outcomes. We cannot report any numerical data but the study authors reported no difference between the two steroids. The evidence was of very low quality. Fluticasone propionate versus mometasone furoate We identified only one study (100 participants with polyps) that evaluated disease severity (nasal symptoms scores), which reported no difference (no numerical data available). The evidence was of very low quality. High-dose versus low-dose steroidsWe included five studies (663 participants with nasal polyps), three using mometasone furoate (400 µg versus 200 µg in adults and older children, 200 µg versus 100 µg in younger children) and two using fluticasone propionate drops (800 µg versus 400 µg). We found low quality evidence relating to disease severity and nasal polyps size, with results from the high-dose and low-dose groups being similar. Although all studies reported more improvement in polyp score in the high-dose group, the significance of this is unclear due to the small size of the improvements.The primary adverse effect, epistaxis , was more common when higher doses were used (risk ratio (RR) 2.06, 95% confidence interval (CI) 1.20 to 3.54, 637 participants, moderate quality evidence). Most of the studies that contributed data to this outcome used a broad definition of epistaxis, which ranged from frank bleeding to bloody nasal discharge to flecks of blood in the mucus. Aqueous nasal spray versus aerosol spray We identified only one poorly reported study (unclear number of participants for comparison of interest, 91 between three treatment arms), in which there were significant baseline differences between the participants in the two groups. We were unable to draw meaningful conclusions from the data.. We found insufficient evidence to suggest that one type of intranasal steroid is more effective than another in patients with chronic rhinosinusitis, nor that the effectiveness of a spray differs from an aerosol. We identified no studies that compared drops with spray.It is unclear if higher doses result in better symptom improvements (low quality evidence), but there was moderate quality evidence of an increased risk of epistaxis as an adverse effect of treatment when higher doses were used. This included all levels of severity of epistaxis and it is likely that the proportion of events that required patients to discontinue usage is low due to the low numbers of withdrawals attributed to it. If epistaxis is limited to streaks of blood in the mucus it may be tolerated by the patient and it may be safe to continue treatment. However, it may be a factor that affects compliance.There is insufficient evidence to suggest that the different types of corticosteroid molecule or spray versus aerosol have different effects. Lower doses have similar effectiveness but fewer side effects.Clearly more research in this area is needed, with specific attention given to trial design, disease-specific health-related quality of life outcomes and evaluation of longer-term outcomes and adverse effects.

Topics: Administration, Intranasal; Adult; Beclomethasone; Child; Chronic Disease; Fluticasone; Humans; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Randomized Controlled Trials as Topic; Rhinitis; Sinusitis; Steroids

This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. The use of topical (intranasal) corticosteroids has been widely advocated for the treatment of chronic rhinosinusitis given the belief that inflammation is a major component of this condition.. To assess the effects of intranasal corticosteroids in people with chronic rhinosinusitis.. The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 8); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 11 August 2015.. Randomised controlled trials (RCTs) with a follow-up period of at least three months comparing intranasal corticosteroids (e.g. beclomethasone dipropionate, triamcinolone acetonide, flunisolide, budesonide) against placebo or no treatment in patients with chronic rhinosinusitis.. We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - epistaxis. Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse events of local irritation or other systemic adverse events. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.. We included 18 RCTs with a total of 2738 participants. Fourteen studies had participants with nasal polyps and four studies had participants without nasal polyps. Only one study was conducted in children. Intranasal corticosteroids versus placebo or no intervention Only one study (20 adult participants without polyps) measured our primary outcome disease-specific HRQL using the Rhinosinusitis Outcome Measures-31 (RSOM-31). They reported no significant difference (numerical data not available) (very low quality evidence).Our second primary outcome, disease severity , was measured using the Chronic Sinusitis Survey in a second study (134 participants without polyps), which found no important difference (mean difference (MD) 2.84, 95% confidence interval (CI) -5.02 to 10.70; scale 0 to 100). Another study (chronic rhinosinusitis with nasal polyps) reported an increased chance of improvement in the intranasal corticosteroids group (RR 2.78, 95% CI 1.76 to 4.40; 109 participants). The quality of the evidence was low.Six studies provided data on at least two of the individual symptoms used in the EPOS 2012 criteria to define chronic rhinosinusitis (nasal blockage, rhinorrhoea, loss of sense of smell and facial pain/pressure). When all four symptoms in the EPOS criteria were available on a scale of 0 to 3 (higher = more severe symptoms), the average MD in change from baseline was -0.26 (95% CI -0.37 to -0.15; 243 participants; two studies; low quality evidence). Although there were more studies and participants when only nasal blockage and rhinorrhoea were considered (MD -0.31, 95% CI -0.38 to -0.24; 1702 participants; six studies), the MD was almost identical to when loss of sense of smell was also considered (1345 participants, four studies; moderate quality evidence).When considering the results for the individual symptoms, benefit was shown in the intranasal corticosteroids group. The effect size was larger for nasal blockage (MD -0.40, 95% CI -0.52 to -0.29; 1702 participants; six studies) than for rhinorrhoea (MD -0.25, 95% CI -0.33 to -0.17; 1702 participants; six studies) or loss of sense of smell (MD -0.19, 95% CI -0.28 to -0.11; 1345 participants; four studies). There was heterogeneity in the analysis for facial pain/pressure (MD -0.27, 95% CI -0.56 to 0.02; 243 participants; two studies). The quality of the evidence was moderate for nasal blockage, rhinorrhoea and loss of sense of smell, but low for facial pain/pressure.There was an increased risk of. Most of the evidence available was from studies in patients with chronic rhinosinusitis with nasal polyps. There is little information about quality of life (very low quality evidence). For disease severity, there seems to be improvement for all symptoms (low quality evidence), a moderate-sized benefit for nasal blockage and a small benefit for rhinorrhoea (moderate quality evidence). The risk of epistaxis is increased (high quality evidence), but these data included all levels of severity; small streaks of blood may not be a major concern for patients. It is unclear whether there is a difference in the risk of local irritation (low quality evidence).

Topics: Administration, Intranasal; Adolescent; Adrenal Cortex Hormones; Adult; Beclomethasone; Budesonide; Child; Chronic Disease; Fluticasone; Humans; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Placebos; Quality of Life; Randomized Controlled Trials as Topic; Rhinitis; Severity of Illness Index; Sinusitis; Steroids

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

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

Substantial advances have been achieved during the last decade in our understanding of the biological bases of the sense of smell, as well as in the clinical identification, diagnosis, and management of dysosmia. Nasal obstruction can result from inflammatory, neoplastic, traumatic, and developmental alterations within the nasal cavity. All these processes, if they result in bilateral restriction of airflow to the olfactory neuroepithelium, presumably alter the ability to smell. Rhinitis, nasal polyposis, and rhinosinusitis are accompanied by decreased ability to smell. Benign and malignant neoplasms can obstruct the nasal chamber and thereby alter airflow to the olfactory receptors without damaging the olfactory neuroepithelium. The purpose of this synthesis is to provide an advanced review of the literature in order to describe the basis of smell alterations in nasal polyposis and chronic rhinosinusitis.

Topics: Anti-Inflammatory Agents; Beclomethasone; Chronic Disease; Humans; Nasal Polyps; Olfaction Disorders; Otorhinolaryngologic Surgical Procedures; Paranasal Sinus Diseases; Prednisolone; Therapeutic Irrigation

Corticosteroids have a multifactorial effect initiated by their binding to a specific cytoplasmic glucocorticoid receptor. At the cellular level there is a reduction in the number of antigen-presenting cells, in the number and activation and T cells, in the number of epithelial mast cells, and in the number and activation of eosinophils. Steroids have a proven effect on symptoms and signs in non-allergic rhinosinusitis with eosinophilia and in nasal polyposis. Topically applied drugs, studied in many controlled trials, reduce rhinitis symptoms, improved nasal breathing, reduce the size of polyps and their recurrence, but have a poor effect on the sense of smell and no direct effect on sinus pathology. Systemic steroids, less well studied, appear to have an effect on all types of symptoms and pathology, the sense of smell included. A short course of systemic steroids is as effective as polypectomy with a snare. Individualized management of nasal polyposis and non-allergic rhinosinusitis with eosinophilia may consist of long-term topical steroids, short-term systemic steroids, or surgery, in various combinations.

Topics: Administration, Topical; Adrenal Cortex Hormones; Antigens, CD; Beclomethasone; Betamethasone; Eosinophils; Humans; Nasal Mucosa; Nasal Polyps; Rhinitis; Sinusitis

Topics: Administration, Topical; Anti-Inflammatory Agents; Beclomethasone; Child; Fluocinolone Acetonide; Humans; Nasal Polyps; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

From the experience above, it may be concluded that corticosteroid therapy in allergic disease has become more effective than ever before. The expected variations in usage of new important pharmacologic agents is seen with special clarity in the use of corticosteroids. The wide acclaim for the "miracle drug of the 1950's", which followed penicillin of the 1940's, soon gave away to anguish about side-effects that threatened to abolish its use entirely in the late 1950's. The 1960's brought alternate day therapy for chronic usage and recognition that short term usage was relatively safe. The 1970's saw proliferation of topically active steroids similar to those so important to the practice of Dermatology in the previous decade. Results in treating asthma and nasal diseases have been excellent and extensive research for adverse effects has been largely unrevealing.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Asthma; Beclomethasone; Cataract; Cushing Syndrome; Humans; Hypersensitivity; Hypersensitivity, Immediate; Long-Term Care; Nasal Polyps; Osteonecrosis; Osteoporosis; Prednisone; Rhinitis; Sleep Initiation and Maintenance Disorders; Stress, Physiological

The article is a short review of some aspects of the surface structure of the human nose. It deals with the morphology of the surface epithelium in nasal allergy, viral and bacterial infection. Kartagener's triad and in rhinitis patients continuously treated with topically active steroids.

Topics: Bacterial Infections; Basement Membrane; Beclomethasone; Cilia; Common Cold; Humans; Kartagener Syndrome; Nasal Mucosa; Nasal Polyps; Nose Diseases; Rhinitis; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

At doses similar to those used in the treatment of chronic bronchial asthma, intranasal beclomethasone dipropionate is effective in alleviating nasal symptoms of seasonal allergic and perennial rhinitis in about three-quarters of patients. Eye symptoms are not relieved. The carry-over effect of the evening dose is useful in preventing early morning attacks of sneezing. Intranasal beclomethasone dipropionate is useful in controlling symptoms persisting after polypectomy and may possibly delay or eliminate the need for the surgical removal of nasal polyps, which may shrink after several weeks or months of treatment.

Topics: Administration, Intranasal; Adrenal Glands; Adult; Beclomethasone; Child; Chronic Disease; Clinical Trials as Topic; Cromolyn Sodium; Drug Evaluation; Humans; Hydrocortisone; Methylprednisolone; Nasal Polyps; Placebos; Rhinitis, Allergic, Seasonal; Seasons

This was a prospective double blind comparative study on 40 patients. It compared the effects of the leukotriene receptor antagonist montelukast and beclomethasone nasal spray on the post-operative course of patients with sinonasal polyps. All patients underwent endoscopic sphenoethmoidectomy and were randomized post-operatively into two groups. Group I: 20 patients (9 females and 11 males) age 17 to 67 (32.4 +/- 9.5 years), receiving 10 mg montelukast orally daily and Group II: 20 patients (6 females and 14 males) age 17 years to 57 years (33.5 +/- 11.9 years), receiving 400 ug beclomethasone local sprays daily. All patients were followed up for 1 year and a symptom score was recorded throughout this period. There was a significant reduction in symptom scores in both groups throughout the study period. In the montelukast group improvement was more marked in itching, post-nasal discharge and headache. The control of sneezing and rhinorrhea was comparable in both groups with a marginal advantage of montelukast. Steroids had a more marked effect on smell disturbances and obstruction. There was no difference in the recurrence rate or in the need for rescue medications between both groups. Both drugs seem to have a complementary action and further studies are needed to determine which patients should receive which treatment.

Topics: Acetates; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Beclomethasone; Chi-Square Distribution; Cyclopropanes; Double-Blind Method; Female; Glucocorticoids; Headache; Humans; Leukotriene Antagonists; Male; Middle Aged; Nasal Polyps; Olfaction Disorders; Postoperative Care; Postoperative Complications; Prospective Studies; Pruritus; Quinolines; Sneezing; Sulfides

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

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

To determine the effects of a standardized therapeutic protocol (short-term oral administration of prednisolone and daily intranasal spray of beclometasone) on stage I nasal polyposis over a follow-up period of 3 years.. Assessments (evaluation of nasal function and drug consumption) were conducted at baseline and every 3 months on 54 consecutive patients with stage I nasal polyposis during 3 years.. Over the follow-up period of 3 years, this dual modality proved to be successful in 87% of the subjects; only 13% had to undergo surgery after its failure. The average symptom reduction reached an improvement rate varying from 66 to 94.8%, according to the symptom type. The daily dosage of prednisolone and beclometasone was progressively decreased, while the gain in nasal comfort was being preserved.. Management of stage I nasal polyps should be primarily medical.

Topics: Administration, Intranasal; Administration, Oral; Beclomethasone; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Middle Aged; Nasal Polyps; Prednisolone; Severity of Illness Index; Therapeutic Irrigation; Time Factors; Treatment Outcome

The management of nasal polyps is undoubtedly a controversial subject. The medical treatment remains the undisputed therapeutic mainstay but most of the publications are aimed at the registration of new molecules from the pharmaceutical industry which explains why they are confined to a single agent.. The aim of this study is focused on the evaluation of a dual modality on a series of 152 subjects treated according to a standardized protocol combining a short-term administration of prednisolone and the daily intranasal spraying of beclomethasone.. Over the follow-up period of one year, this modality proved to be successful in 68.5% of the subjects; only 31.5% had to undergo surgery after its failure. In the former group, after a six months period, the average symptom reduction reached an improvement rate varying from 35 to 80%, according to the symptom type. During the ensuing six months follow-up period, the improvement was maintained. The average utilization of prednisolone and beclomethasone was assessed for each individual patient.. Management of nasal polyps should be primarily medical. Resorting to surgical procedures should not be envisaged before a six months trial of dual steroid therapy under strict compliance to treatment.

Topics: Administration, Intranasal; Administration, Oral; Beclomethasone; Drug Therapy, Combination; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Middle Aged; Nasal Polyps; Prednisolone; Time Factors

To assess the hypothalamic-pituitary-adrenal (HPA) axis after long-term intranasal corticosteroid treatment in nasal polyposis.. A short synacthen test was performed in 24 patients who received the highest dose of inhaled beclomethasone among a population of 392 patients treated for nasal polyposis with inhaled corticosteroid therapy and short-term oral corticosteroids.. Mean yearly dose of oral prednisone administered in short-term treatment was 371 mg/year. The amount of short-term oral prednisone decreased during the treatment. Mean daily dose of inhaled beclomethasone was 2861 micrograms/day, decreasing during treatment. Morning plasma cortisol was normal in all patients before and after stimulation (163 +/- 44 and 1 +/- 60 micrograms/ml respectively). Nolomethasone dose and plasma cortisol level before or after stimulation.. The high dose of inhaled beclomethasone used to treat nasal polyposis does not affect the HPA axis. Some authors in the literature contest the validity of short synacthen test to detect HPA axis suppression. This test does however detect severe impairments of the HPA axis in outpatients.

Topics: Administration, Inhalation; Administration, Oral; Anti-Inflammatory Agents; Beclomethasone; Cosyntropin; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Nasal Polyps; Prednisone; Regression Analysis; Treatment Outcome

The clinical efficacy of a topical preparation consisting of beclomethasone dipropionate (BDP) powder and a mucous membrane adhesive agent (hydroxypropylcellulose, HPC) for nasal polyps was examined. For 1 week, in 31 patients with bilateral nasal polyposis, the clinical efficacy of the topical BDP-HPC powder treatment was examined. The effect of this treatment on the histology of the nasal polyps was also investigated. The controls were six patients with bilateral nasal polyposis, who underwent identical surgery without prior use of the topical steroid therapy. Polyp shrinkage and improvement of some nasal symptoms (rhinorrhea, ease of noseblowing, and nasal blockage) were observed with the topical treatment. Significant clinical improvement (P < 0.05) was seen in the group treated with topical BDP HPC powder compared with the untreated control group. Histological examination of the excised nasal polyps in both groups demonstrated no clear differences attributable to BDP HPC powder. The topical treatment of nasal polyps with BDP HPC powder is a useful conservative therapy.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Beclomethasone; Cellulose; Female; Humans; Male; Middle Aged; Nasal Polyps; Pharmaceutical Preparations; Powders; Severity of Illness Index; Treatment Outcome

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.

Topics: Administration, Intranasal; Adult; Aged; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Disease Progression; Double-Blind Method; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Nasal Polyps; Pilot Projects; Treatment Outcome

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.

Topics: Administration, Intranasal; Adult; Aged; Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents; Beclomethasone; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Nasal Polyps; Placebos

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

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

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.

Topics: Administration, Intranasal; Adult; Aerosols; Aged; Beclomethasone; Female; Humans; Male; Middle Aged; Nasal Polyps; Postoperative Period; Prospective Studies; Smell

The study was designed to measure the effect of inhaled beclomethasone on patients with severe symptomatic rhinosinusitis and nasal polyposis following 12 weeks of therapy. Only one of eight patients had improved nasal symptoms and a reduction in the degree of nasal obstruction. Except for an occasional patient intranasal beclomethasone in the recommended dosage is not effective in the management of chronic severe symptomatic rhinosinusitis.

Topics: Administration, Intranasal; Adult; Aerosols; Aged; Beclomethasone; Clinical Trials as Topic; Female; Humans; Male; Maxillary Sinus; Middle Aged; Nasal Polyps; Sinusitis; Tomography, X-Ray Computed

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.

Topics: Administration, Intranasal; Adult; Aged; Beclomethasone; Clinical Trials as Topic; Female; Humans; Male; Middle Aged; Nasal Polyps; Neoplasm Recurrence, Local; Postoperative Care

The etiology of perennial non-allergic rhinitis and nasal polyposis is still not properly understood. Non-specific hyperreactivity forms a major significant symptom. Topical steroids have been used in the treatment of these diseases for about ten years. Their mode of action is still largely unknown. Various test methods in clinical trials can improve our knowledge. The effect of budesonide given intranasally as an aerosol was tested in 22 patients with perennial rhinitis. In another trial the effect of beclomethasone dipropionate (BDP) was compared when given as an aerosol and as a powder. Today we know not only that budesonide and the two forms of BDP are clinically efficacious but also that intranasal steroid treatment can reduce metacholine-induced nasal secretion, reduce the sensitivity of mucosal irritant receptors, and lower the number of basophilic as well as eosinophilic cells in the nasal secretion.

Topics: Administration, Topical; Beclomethasone; Budesonide; Humans; Nasal Polyps; Nose Diseases; Pregnenediones; Respiratory Hypersensitivity; Rhinitis, Allergic, Perennial

Steroid-dependent, chronic asthmatic patients with severe rhinitis or nasal polyps are often candidates for treatment with intranasal topical corticosteroids, such as flunisolide. The possibility of additive adrenal suppression, when flunisolide, beclomethasone and prednisone are given together, has not previously been studied. The need to asses the risk is suggested by reports of additive adrenal suppression when aerosol and oral steroids are used together to treat asthma, and by the demonstrably higher systemic availability of aerosol steroid given intranasally rather than via the lung. We performed a double-blind, placebo-controlled crossover assessment of the efficacy and safety of 3 weeks of intranasal flunisolide spray treatment (300 micrograms/day) in nineteen steroid-dependent chronic asthmatic subjects, who also had nasal polyps or severe rhinitis. During the study, their doses of prednisone and beclomethasone, used for asthma, were held stable. Morning serum cortisol levels and 24-hr urinary-free cortisol excretion were essentially the same after the placebo, and the flunisolide treatments. The intranasal flunisolide improved their nasal symptoms significantly (P less than 0.05). Local complications were negligible. Given conventional steroid doses like those used in this study, there appears to be no important risk to endogenous adrenal function from combining the use of intranasal, flunisolide spray with administration of other steroids by other routes, when this is deemed clinically necessary. If higher doses are used, the possibility of some additive adrenal suppressive effect cannot be excluded.

Topics: Administration, Intranasal; Administration, Oral; Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Drug Therapy, Combination; Female; Fluocinolone Acetonide; Humans; Hydrocortisone; Male; Middle Aged; Nasal Polyps; Prednisone; Rhinitis, Allergic, Perennial

The purpose of this work was to examine in a double blind study the ability of beclomethasone dipropionate to prevent recurrence of nasal polyps in patients in whom radical ethmoidectomy had been performed immediately before. It analyzes the results in terms of the patients subjective symptoms, clinical status and rhinomanometry. After the follow-up period of one year 86% of the patients in the beclomethasone group and 60% in the placebo group had no subjective nasal symptoms. In clinical examination polyps were absent in 54% in the beclomethasone group and in 13% in the placebo group. Rhinomanometrically there was normal nasal patency in 68% in the beclomethasone and in 33% in the placebo group.

Topics: Administration, Intranasal; Adult; Aged; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Ethmoid Sinus; Female; Humans; Male; Manometry; Middle Aged; Nasal Polyps; Placebos; Recurrence

Topics: Adult; Aerosols; Atrophy; Beclomethasone; Chronic Disease; Clinical Trials as Topic; Common Cold; Hemorrhage; Humans; Infections; Nasal Polyps; Nose; Rhinitis; Rhinitis, Allergic, Seasonal

A double-blind cross-over study of the effect of insufflation of beclomethasone dipropionate 400 microgram per day for four weeks showed favourable results, as verified statistically, concerning nasal blockage at the end of the treatment period. Rhinomanometry also showed that the nasal patency was significantly improved during the beclomethasone period. There was also a tendency, though not statistically significant, for nasal secretion to react favourable. The polyps did not disappear during the active treatment period and short-term treatment with beclomethasone aerosol can thus only be used as an adjuvant to other models of therapy, whether medical or surgical, in nasal polyps. No clinical side-effects of any importance were observed during the study.

Topics: Administration, Intranasal; Adult; Aerosols; Aged; Airway Obstruction; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Evaluation Studies as Topic; Humans; Manometry; Middle Aged; Nasal Polyps

Beclomethasone dipropionate aerosol (BDA), 50 mug four times daily sprayed into each nostril, was compared with placebo in a double-blind crossover trial in 26 patients with perennial rhinitis. Patients received BDA for 3 weeks and placebo for 3 weeks; the order of administration was randomized. Response was assessed with daily symptom score cards and twice weekly measurements of nasal airway inspiratory resistance at a standard flow rate of 0.4 L/sec. Symptom score and nasal resistance during BDA treatment were significantly lower than those duirng placebo treatment (p less than 0.02 and p less than 0.05, respectively) in the third week. Eighteen of the patients expressed a preference for BDA, 6 for placebo, and 2 for neither (p less than 0.05). Acceptable symptomatic improvement (moderate or marked) was achieved by 54%. Mild side effects were noted by 5 patients; these included nasal irritation and bleeding in 2, aerosol-induced sneezing in 2, and headache in 1. These side effects occurred in 3 patients who used BDA, 1 who used placebo, and 1 who used both. After a 6-mo follow-up period, in which the dose of BDA was adjusted and concurrent initial oral prednisone was administered to patients who were treatment failures, 73% of the patients obtained moderate or marked symptomatic improvement. No further side effects were noted during this time. Results in those in whom a possible allergic component could be identified were not different from those of the whole group. We conclude that BDA is a useful addition to the therapy of perennial rhinitis.

Topics: Administration, Intranasal; Aerosols; Airway Resistance; Asthma; Beclomethasone; Dust; Female; Humans; Immunoglobulin E; Male; Mites; Nasal Polyps; Rhinitis, Allergic, Seasonal

Topics: Adult; Aged; Beclomethasone; Clinical Trials as Topic; Female; Glucocorticoids; Humans; Male; Methylprednisolone; Middle Aged; Nasal Polyps

At doses similar to those used in the treatment of chronic bronchial asthma, intranasal beclomethasone dipropionate is effective in alleviating nasal symptoms of seasonal allergic and perennial rhinitis in about three-quarters of patients. Eye symptoms are not relieved. The carry-over effect of the evening dose is useful in preventing early morning attacks of sneezing. Intranasal beclomethasone dipropionate is useful in controlling symptoms persisting after polypectomy and may possibly delay or eliminate the need for the surgical removal of nasal polyps, which may shrink after several weeks or months of treatment.

Topics: Administration, Intranasal; Adrenal Glands; Adult; Beclomethasone; Child; Chronic Disease; Clinical Trials as Topic; Cromolyn Sodium; Drug Evaluation; Humans; Hydrocortisone; Methylprednisolone; Nasal Polyps; Placebos; Rhinitis, Allergic, Seasonal; Seasons

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.

Topics: Adult; Aerosols; Aged; Beclomethasone; Clinical Trials as Topic; Female; Humans; Male; Middle Aged; Nasal Polyps

Topics: Administration, Intranasal; Adult; Beclomethasone; Clinical Trials as Topic; Humans; Methylprednisolone; Nasal Polyps; Rhinitis, Allergic, Seasonal

Study of the association between immunoglobulin-G (IgG) subclass deficiency and nasal polyposis.. Longitudinal study (5 years) in a prospective cohort of 161 nasal polyposis patients. Analysis of the association between humoral immunodeficiency, rhinologic symptoms, endoscopy score and prescribed doses of local and systemic corticosteroids.. The prevalence of IgG subclass deficiency was 13.7% (22/161). One patient was diagnosed with common variable immunodeficiency (CVID). No significant differences were observed between the groups with and without pre-treatment deficiency for symptom severity, endoscopic score or local or systemic corticosteroid regimens at baseline or during the 5 years, following initiation of medical and surgical treatment. Only the Lund-Mackay CT score was significantly higher in the pre-treatment deficiency group.. There was no correlation between the presence of humoral deficiency and either symptom evolution after medical and surgical treatment or the dose of corticosteroids needed to control disease. Thus, a link between IgG subclass deficiency and nasal polyposis seems unlikely.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Beclomethasone; Common Variable Immunodeficiency; Female; Glucocorticoids; Humans; IgG Deficiency; Longitudinal Studies; Male; Middle Aged; Nasal Obstruction; Nasal Polyps; Olfaction Disorders; Prospective Studies; Young Adult

Allergy does not modify the symptoms and steroid consumption (oral and local) of nasal polyposis (NP) patients after functional endoscopic sinus surgery (FESS).. To assess the role of allergy in the evolution after FESS of patients presenting with the diagnosis of NP.. This was a prospective study of 63 consecutive patients with NP (57% males, mean age 45.8 years), who were analyzed to detect whether the results of a surgical treatment of NP were influenced by the presence of positive allergic tests (Phadiatop). Three nasal criteria were scored: nasal obstruction, posterior rhinorrhea, and the loss of smell. The frequency of asthma was evaluated. Medical treatment of NP after FESS consisted of washing of the nasal cavities, steroid spray, and oral steroid administration. The amount of consumption of steroids (prednisolone and beclomethasone) was studied.. Decrease of all nasal symptoms was not statistically different in the two groups of patients with and without allergy. Cumulative consumption of prednisolone and beclomethasone after surgery was similar in the two groups.

Topics: Adult; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Combined Modality Therapy; Cross-Sectional Studies; Endoscopy; Ethmoid Sinusitis; Female; Follow-Up Studies; Humans; Male; Middle Aged; Nasal Obstruction; Nasal Polyps; Olfaction Disorders; Postoperative Complications; Prednisolone; Recurrence; Respiratory Hypersensitivity

This prospective study is the first in the literature to present long-term results of a combined medical and surgical treatment in patients with nasal polyposis (NP) including strict inclusion criteria, analysis of the results in terms of clinical amelioration, polyp size reduction, and steroid consumption. The results of the present study show that combined surgery and corticosteroid therapy is effective in the treatment of NP.. Most publications on outcome after functional endoscopic sinus surgery (FESS) include patients with various pathologies. The aim of this study was to provide reference information for FESS in patients with NP with strict inclusion and exclusion criteria.. This was a prospective study involving 194 consecutive patients. Clinical symptoms, polyp size, and steroid consumption were evaluated before and after FESS (mean follow-up, 74 months). An actuarial analysis using the Kaplan Meier life table method was performed with regard to the 3- and 5-year symptoms control rates.. All symptoms were improved after FESS. The 5-year actuarial nasal obstruction control rate was 65.8%. The 5-year actuarial severe posterior rhinorrhea control rate was 82.9%. The 5-year actuarial smell loss and anosmia control rates were 17.7% and 65.8%, respectively. Polyp volume and steroid consumption decreased significantly after FESS.

Topics: Administration, Inhalation; Administration, Oral; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Beclomethasone; Combined Modality Therapy; Dose-Response Relationship, Drug; Drug Administration Schedule; Endoscopy; Female; Follow-Up Studies; Humans; Male; Middle Aged; Nasal Obstruction; Nasal Polyps; Postoperative Care; Prednisolone; Prospective Studies; Tomography, X-Ray Computed

Bronchial hyperresponsiveness (BHR) is not a risk factor for surgery in patients with nasal polyposis (NP).. Management of NP should be primarily medical, and surgery should not be envisaged before a trial of dual steroid therapy. In patients with severe NP resistant to a strict medical treatment, endoscopic sinus surgery is performed, but no prognostic factor for efficacy of surgery is obvious. Some authors suggest that asthma could be a major risk for ineffectiveness of surgery. The aim of this study was to evaluate whether the presence of BHR can be considered a risk factor for ineffectiveness of surgery.. Surgery (with associated medical treatment) was evaluated over a mean follow-up period of 74 months. A total of 63 subjects without and 131 subjects with BHR were operated according to a standardized protocol.. The present study shows that combined surgery and corticosteroid therapy is effective in the treatment of severe NP, producing significant and long-term improvements in symptoms and in the size of nasal polyps. BHR did not influence the outcome. Moreover, the mean amount of prednisolone and beclomethasone necessary after surgery was similar in the two groups.

Topics: Administration, Intranasal; Beclomethasone; Bronchial Hyperreactivity; Combined Modality Therapy; Endoscopy; Female; Follow-Up Studies; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Nasal Polyps; Otorhinolaryngologic Surgical Procedures; Prevalence; Time Factors; Treatment Outcome

Allergy does not modify the symptoms of nasal polyposis, either initially or after a 1-year medical treatment.. To assess the role of allergy in the symptoms and treatment of patients presenting with the diagnosis of nasal polyposis.. Two simultaneous studies were carried out. In the first study, 180 consecutive patients with nasal polyposis (60% males, mean age = 48.4 years) were analyzed to detect whether the severity of their symptoms correlated with the presence of positive allergic tests. In the second study, 74 consecutive patients (57.5% males, mean age = 48.3 years) were analyzed to detect whether the results of a 1-year medical treatment of nasal polyposis were influenced by the presence of positive allergic tests (Phadiatop). Five nasal criteria were scored: nasal obstruction, anterior and posterior rhinorrhea, facial pain, and the loss of sense of smell. The frequency of asthma was evaluated. Treatment of nasal polyposis consisted of washing of the nasal cavities, steroid spray, and oral steroid administration. The amount of steroid consumption (prednisolone and beclomethasone) was studied.. In the first study, mean scores of nasal symptoms did not differ between the two groups of patients with and without allergy. The prevalence of asthma (p = 0.03) was higher in the group with than without allergy. In the second study, decrease of all nasal symptoms was not statistically different in the two groups. Cumulative consumption of prednisolone and beclomethasone between baseline and year 1 were similar in the two groups.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Asthma; Beclomethasone; Bronchial Provocation Tests; Comorbidity; Cross-Sectional Studies; Drug Hypersensitivity; Follow-Up Studies; Forced Expiratory Volume; Humans; Immunoglobulin E; Methacholine Chloride; Nasal Obstruction; Nasal Polyps; Olfaction Disorders; Prednisolone; Prospective Studies; Rhinitis, Allergic, Perennial

Management of nasal polyposis should be primarily medical. Resorting to intranasal ethmoidectomy should not be envisaged before a trial of dual steroid therapy. Nevertheless, no risk factor for steroid insensitivity in patients with nasal polyposis is actually defined. The aim of this study is to evaluate whether the presence of asthma and/or non-specific bronchial hyperresponsiveness (BHR) can be considered a risk factor for steroid insensitivity.. This study focused on the evaluation of a dual modality, topical and systemic, over a follow-up period of 3 years. A total of 55 subjects with and 45 subjects without BHR were treated according to a standardized therapeutic protocol combining short-term oral administration of prednisolone and a daily intranasal spray of beclomethasone.. Over the follow-up period of 3 years, this dual modality proved to be successful in 93.4% of subjects without BHR and without aspirin idiosyncrasy, in 82.2% of subjects with BHR and without aspirin idiosyncrasy and in 60% of subjects with BHR and aspirin idiosyncrasy. The percentage of patients who underwent surgery after the failure of medical treatment was significantly larger in patients with than without BHR (p < 0.05) and in patients with than without aspirin idiosyncrasy (p < 0.02).. The presence of BHR and/or aspirin idiosyncrasy can be considered a major risk factor for steroid insensitivity in patients with nasal polyposis.

Topics: Administration, Oral; Aerosols; Anti-Asthmatic Agents; Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Agents, Hormonal; Aspirin; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Drug Hypersensitivity; Drug Resistance; Ethmoid Sinus; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Middle Aged; Nasal Polyps; Prednisolone; Risk Factors; Tablets; Therapeutic Irrigation; Tomography, X-Ray Computed; Treatment Outcome

The management of nasal polyposis is undoubtedly a controversial subject. The part played by surgery seems to be steadily growing, if the number of published reports dedicated to this approach is any yardstick. Although the medical treatment remains the undisputed therapeutic mainstay, trials dedicated to the long-term assessment of its overall efficacy are scarce.. Retrospective medical record review.. The aim of the study is focused on the evaluation of a dual modality, topical and systemic, over a follow-up period of 3 years. In all, 100 patients were treated according to a standardized therapeutic protocol combining short-term oral administration of prednisolone and daily intranasal spray of beclomethasone.. Over the follow-up period of 3 years, this dual modality proved to be successful in 85% of the patients; only 15% had to undergo surgery after its failure. The average symptom reduction reached an improvement rate varying from 58% to 80%, according to the symptom type. The daily dosage of prednisolone and beclomethasone was progressively decreased while the gain in nasal comfort was being preserved.. Management of nasal polyps should be primarily medical. Resorting to surgical procedures should not be envisaged before a trial is conducted of dual steroid therapy under a regimen of strict compliance to treatment.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Beclomethasone; Female; Follow-Up Studies; Humans; Male; Middle Aged; Nasal Polyps; Prednisone

Nasal polyposis is treated by surgery and/or by medication but in parts without permanent remission. Fibroblasts and their proliferation are involved in the complex mechanism of polyp genesis. Therefore we have analysed the influence of 12 medications on fibroblasts from nasal polyps growing in vitro.. Nasal polyps, obtained during usual surgical procedure, are enzymatically digested and cultured in serum containing media. The growing cells are identified as fibroblasts using flow cytometry with a AS02-FITC antibody (Dianova). The analysis is achieved with 5 - 6 different fibroblast cultures in each medicament tested, mostly using concentrations of the active substance from 0.006 to 1.333 mg/ml. The fibroblasts are cultured 4 days in the presence of active substances or as controls. Finally the cells are trypsinated and counted.. Mometason, Beclomethason, Fluticason, Verapamil and Timolol are the group with the strongest reduction of fibroblasts. Mometason shows a reduction to 6 % of controls at a concentration of 30 micro g/ml whereas the reduction at this concentration amounts to 30 - 60 % in the other members of this group. Mesazalin, Methylprednisolone and Pentoxifylline demonstrate the smallest influence; Prednisolon-21-hydrogen-succinate, Pilocarpin, Piroxicam and Diclofenac show an effect on a middle level.. A strong reduction of fibroblasts from nasal polyps in vitro is possible with usual rhinological medicaments but also with unusual substances in this field.

Topics: Administration, Topical; Adrenergic beta-Antagonists; Androstadienes; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Antirheumatic Agents; Beclomethasone; Calcium Channel Blockers; Cells, Cultured; Culture Media; Diclofenac; Fibroblasts; Fluticasone; Glucocorticoids; Hematologic Agents; Humans; In Vitro Techniques; Mesalamine; Methylprednisolone; Mometasone Furoate; Muscarinic Agonists; Nasal Polyps; Pentoxifylline; Pilocarpine; Piroxicam; Prednisolone; Pregnadienediols; Time Factors; Timolol; Verapamil

Nasal polyposis accounts for 40% of chronic nasal disease. The part played by surgery seems to be steadily growing if the number of publications dedicated to this approach is any yardstick. The medical treatment remains however the undisputed therapeutic mainstay but trials dedicated to the assessment of its overall efficacy are rather scarce. The aim of this study is focused on the evaluation of a dual modality, topical and systemic, over a follow-up period of three years. A total of 100 subjects were treated according to a standardized therapeutic protocol combining a short-term oral administration of a corticosteroid (prednisolone) and a daily intranasal spray of an other steroid (beclomethasone). Over the follow-up period of three years, this dual modality proved to be successful in 85% of the subjects; only 15% had to undergo surgery after its failure. The average symptom reduction reached an improvement rate varying from 58 to 80%, according to the symptom type. The daily dosage of prednisolone and beclomethasone was progressively decreased while the gain in nasal comfort was being preserved. Management of nasal polyps should be primarily medical. Resorting to surgical procedures should not be envisaged before a trial of dual steroid therapy under strict compliance to treatment. The single character of this long follow-up and the importance of the series of patients included in the protocol make all the originality of this work which shows for the first time the long-term improvement after medical treatment.

Topics: Administration, Intranasal; Administration, Oral; Adult; Beclomethasone; Cohort Studies; Combined Modality Therapy; Drug Evaluation; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Male; Middle Aged; Nasal Polyps; Paranasal Sinus Neoplasms; Polyps; Prednisolone; Treatment Outcome

To investigate the protein expression of B-cell lymphoma/leukemia-2(Bcl-2) and B-cell lymphoma/leukemia-x long(Bcl-x1) in eosinophils in nasal polyps and the influence of beclomethasone dipropionate on the expression.. Using May-Grünwald-Giemsa (MGG) method and immunohistochemical method, the protein expression of Bcl-x1 and Bcl-2 in eosinophils in nasal polyps from patients treated with beclomethasone dipropionate treatment and patients without any treatment was compared.. (1) Nasal polyp tissues from patients without treatment had more eosinophils than those from patients with treatment(P < 0.01). (2) No protein expression of Bcl-2 was observed in all 52 patients. (3) 20.0% patients with treatment had the expression of Bcl-x1, whereas 48.1% patients without treatment had the expression. The difference between these two groups was significant(P < 0.05).. These data suggest that Bcl-x1 may act as an anti-apoptotic molecule in eosinophils and corticosteroids induce eosinophil apoptosis through suppressing the expression of Bcl-x1.

Topics: Adolescent; Adult; Apoptosis; bcl-X Protein; Beclomethasone; Eosinophils; Female; Humans; Male; Middle Aged; Nasal Polyps; Proto-Oncogene Proteins c-bcl-2

The outcome of asthma and/or nonspecific bronchial hyperresponsiveness (BHR) associated with nasal polyposis (NP) is uncertain. Over a 4-yr period, we investigated the long-term changes of pulmonary function and BHR in 46 patients with NP. Each subject was assessed for nasal symptoms and tested for allergy skin prick tests, serum total IgE, spirometry, and carbachol challenge at baseline before initiating any treatment (T0). Nasal symptoms evaluation, spirometric measurements, and carbachol challenge were repeated at T1 and at T2 (respectively, 12.7 +/- 0.9 and 47.9 +/- 2. 2 mo after T0). In addition, bronchodilator response was measured at T2. At T0, 25 patients exhibited BHR and 16 of 25 were asthmatic. All patients were treated first with topical steroids for 6 wk (beclomethasone 600 microg/d). Eighteen patients were successfully treated with topical steroids (topical steroids responders). Intranasal ethmoidectomy was performed in 28 patients who did not improve with topical steroids alone (topical steroids nonresponders). Nasal score improved at T1 and remained improved at T2 as compared with T0 in both groups (p < 0.005). Topical steroids nonresponders demonstrated a significant decrease of FEV(1), FEV(1)/FVC ratio, and FEF(25-75) at T1 (p < 0.05) and at T2 (p < 0.0005), whereas no significant change was observed in FEV(1) and FEV(1)/FVC ratio in responders. DeltaFEV(1) (%) between T2 and T0 was not related to the presence of asthma, BHR, or atopy. Bronchodilator response at T2 was similar in the two groups. BHR did not significantly change over the 4-yr follow-up period in the two groups. No change in pulmonary symptoms and/or asthma severity occurred. Our results show that nonreversible airflow obstruction appears over a 4-yr follow-up period in topical steroids nonresponders patients with NP requiring nasal surgery. The long-term contribution of these changes to the development of respiratory symptoms in patients with NP remains to be documented.

Topics: Administration, Intranasal; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Combined Modality Therapy; Ethmoid Sinus; Female; Follow-Up Studies; Humans; Immunoglobulin E; Intradermal Tests; Lung Volume Measurements; Male; Middle Aged; Nasal Polyps; Prospective Studies; Respiratory Hypersensitivity; Spirometry

Nasal epithelial cells maintain eosinophil survival by secreting granulocyte/macrophage colony-stimulating factor (GM-CSF). Corticosteroids antagonize eosinophil viability induced by GM-CSF. We investigated the effect of topical corticosteroids and nedocromil sodium on the release of GM-CSF from nasal polyp epithelial cells. Epithelial cells were obtained from 19 patients undergoing nasal polypectomy and cultured. After reaching confluence, cultured cells were stimulated with 10% foetal calf serum in the absence and presence of four topical corticosteroids and nedocromil sodium for 48 h. GM-CSF was measured by enzyme linked immunosorbent assay (ELISA). Fluticasone propionate was the most potent inhibitor of GM-CSF release (IC25 = 46 pM) closely followed by budesonide (IC25 = 4 nM), beclomethasone dipropionate (IC25 = 40 nM) and triamcinolone acetonide (IC25 = 75 nM). Nedocromil sodium had no effect on GM-CSF release. We conclude that the effect of topical steroids on reducing eosinophil infiltration in nasal polyps may be due in part to downregulation, among other cytokines, of epithelial GM-CSF production which prolongs eosinophil viability. Quantitatively, fluticasone propionate inhibited GM-CSF production more potently than budesonide, beclomethasone dipropionate and triamcinolone acetonide.

Topics: Administration, Topical; Adult; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Cells, Cultured; Eosinophils; Epithelial Cells; Female; Glucocorticoids; Granulocyte-Macrophage Colony-Stimulating Factor; Humans; Male; Nasal Polyps; Nedocromil; Triamcinolone Acetonide

Activated c-fos binds to jun proteins to form the activation protein 1 (AP-1) transcription factor that regulates cytokine and other proinflammatory genes. c-Fos may play a key role in nasal polyp formation. Glucocorticoids may exert their anti-inflammatory effects through an interaction of glucocorticoid receptors with AP-1 that leads to mutual inactivation of both factors, and a "default" termination of AP-1 mediated gene activation. This may explain the beneficial effects of glucocorticoids in the treatment of nasal polyps.. To test this hypothesis in humans in vivo the immunohistochemical expression of c-fos-immunoreactive material (c-fos-irm) was assessed in nasal polyps from eight steroid naive subjects, polyps from eight subjects treated with topical beclomethasone dipropionate (BDP), and normal inferior turbinate nasal mucosa (n = 6).. mRNA for c-fos was detected in all nasal polyps and normal mucosa. In contrast, c-fos-irm was present in all steroid naive subjects but in only two of the eight subjects treated with BDP (p = 0.007, two-tailed Fisher's exact test). c-Fos-irm was expressed solely in epithelial cells and glandular structures; it was expressed in normal epithelium and glands, but the staining intensity was low.. Glucocorticoids appear to modulate expression of c-fos-irm and possibly AP-1 in human airway epithelial cells in vivo.

Topics: Adult; Aged; Aged, 80 and over; Beclomethasone; Epithelium; Female; Gene Expression; Glucocorticoids; Humans; Immunohistochemistry; Male; Middle Aged; Nasal Mucosa; Nasal Polyps; Polymerase Chain Reaction; Proto-Oncogene Proteins c-fos; RNA, Messenger

Nasal polyposis (NP) is commonly associated with nonspecific bronchial hyperresponsiveness (BHR) and/or asthma. The aim of this prospective study was to investigate the changes of pulmonary function and BHR in patients with nasal polyposis. Forty-four consecutive patients with NP were included in the study and were followed for 12 mo. Nonspecific BHR was assessed by a carbachol challenge test to determine the provocating dose (PD20) necessary to decrease FEV1 by 20% from baseline values; 17 of 22 patients who demonstrated BHR also exhibited asthma. Spirometric measurements and carbachol challenge were performed before initiating any treatment and 12 mo later. All patients were treated first with beclomethasone (600 microg/d). Intranasal ethmoidectomy was performed in 23 patients who did not improve when treated with topical steroids alone (nonresponders); in contrast, 21 patients were successfully treated with beclomethasone alone (responders). PD20 significantly decreased in the group of nonresponders (p = 0.018), whereas it remained unchanged in responders (p = 0.95). FEV1 (% pred) and FEF25-75 (% pred) significantly decreased in nonresponders (p < 0.001), whether BHR existed or not, whereas no significant change was observed in responders. Our results demonstrate that nonresponders who required nasal surgery exhibited an enhancement of BHR and a slight but significant decrease of FEV1 and FEF25-75 values. However, no change in pulmonary symptoms and/or asthma severity occurred. Clinical and functional follow-up of these patients should assess the long-term evolution of these parameters and their clinical relevance.

Topics: Adolescent; Adult; Aged; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Carbachol; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Maximal Midexpiratory Flow Rate; Middle Aged; Nasal Polyps; Prospective Studies; Pulmonary Ventilation; Vital Capacity

The purpose of this study was to evaluate, in a group of 30 patients, the results of a medical treatment combining an oral corticosteroid (Deflazacort) with a drug applied topically (Beclomethasone dipropionate) following a well-defined protocol, in the prevention of recurrent post-surgical nasal polyposis. In the follow-up at 6, 12 and 24 months, the possible recurrence of polyposis was evaluated as well as the nasal blockage and the olfactory function. After six months the disease recurrence was observed in 33% of the cases, always in its early stages, whereas after one year the percentage rose to 50% (15 patients, of whom only 3 displayed a severe form with considerable reduction of nasal ventilation). At 24 months recurrence was observed in 57% of the patients. However most cases did not show any sign of further progression. Throughout the entire follow-up period under observation only 6 patients (20%) had a severe recurrence which therefore required a revision surgery. The comparison with a control group not undergoing medical therapy after surgery highlighted the significance of the results obtained. Consequently the therapeutic protocol adopted proved to be reliable due to the very high tolerability in all cases and to the high percentage of good or very good short and medium term results observed. No clinical side effects of any importance were observed during the study.

Topics: Adrenal Cortex Hormones; Adult; Beclomethasone; Betamethasone; Female; Humans; Male; Middle Aged; Nasal Polyps; Pregnenediones

A follow-up study on 180 patients treated for the first time for nasal polyps was performed. The follow-up period was from 1 to 8 years with a median of 57 months. The majority of patients had postoperative topical steroid treatment. 65.6% of patients had one polypectomy, 17.8% had two polypectomies, 10% had 3, 2.8% had 4, and 3.9% of patients had 5-10 polypectomies performed during the follow-up period. Patients without asthma, acute recurrent or chronic sinusitis, acetylsalicylic acid intolerance, or allergy had fewer polypectomies and less topical steroid treatment than patients with these characteristics. The recurrence profile between the first and second polypectomy described with the life-table method showed a slow decline in the number of patients with only one polypectomy. The time span needed before significant clinical symptoms occurred after the first polypectomy indicates that not all primary polyp patients are prone to recurrence. Nasal polyps is probably a manifestation of different clinical and aetio-pathogenetic entities. Further identification of such entities is needed to improve treatment strategy.

Topics: Adolescent; Adult; Aerosols; Aged; Aged, 80 and over; Beclomethasone; Budesonide; Child; Combined Modality Therapy; Denmark; Female; Fluocinolone Acetonide; Follow-Up Studies; Humans; Male; Middle Aged; Nasal Polyps; Pregnenediones; Recurrence

Nasal polyposis appears frequently in C. F. patients. Our study intends to evaluate the efficacy of topical beclomethasone dipropionate (BMD) when administered in a position designed to increase exposure of nasal and paranasal sinuses mucosa to the drug. 14 patients were analysed: the size of the polyps was assessed by rhinoscopy and rhinomanometry at the beginning and at the end of the therapy. Our findings show that nasal polyps can be successfully treated medically in a significant number of C. F. patients.

Topics: Administration, Intranasal; Beclomethasone; Child; Cystic Fibrosis; Female; Humans; Male; Nasal Polyps

The authors report the subjective results on the use of intranasal beclomethasone dipropionate in patients with cystic fibrosis. This medication has demonstrated positive results for these patients, whether polyps are present or not, and its use should be considered whenever symptoms of obstruction are present.

Topics: Administration, Intranasal; Adolescent; Beclomethasone; Child; Child, Preschool; Cystic Fibrosis; Drug Evaluation; Humans; Nasal Polyps

Topics: Administration, Intranasal; Beclomethasone; Child; Cystic Fibrosis; Humans; Nasal Polyps; Posture

Topics: Acute Disease; Adrenal Cortex Hormones; Adult; Beclomethasone; Cromolyn Sodium; Eosinophilia; Female; Histamine H1 Antagonists; Humans; Nasal Polyps; Prednisone; Pregnancy; Pregnancy Complications; Rhinitis; Rhinitis, Allergic, Seasonal; Vasoconstrictor Agents

Nasal polyposis is a recurrent disorder requiring numerous surgical polypectomies. Topical nasal steroidal inhalers such as beclomethasone dipropionate (BDP) and flunisolide nasal solution have greatly changed the therapeutic strategy for controlling polypoid formation in the nasal cavities. The judicious use of short courses of oral corticosteroids combined with oral nasal decongestants lessens the need for repeated polypectomies. Nasal douching with normal saline improves nasal ventilation.

Topics: Administration, Intranasal; Administration, Oral; Adolescent; Adrenal Cortex Hormones; Adult; Anti-Inflammatory Agents; Beclomethasone; Child; Female; Fluocinolone Acetonide; Glucocorticoids; Humans; Male; Nasal Decongestants; Nasal Polyps; Respiratory Hypersensitivity; Respiratory Tract Infections; Therapeutic Irrigation

Beclomethasone dipropionate as a pressurized aerosol is effective in nasal polyposis, but the efficacy is only moderate. In these partly-blocked noses, it seems possible that the insufflated drug in powder form is better distributed over the mucous membrane than the pressurized aerosol. To test this hypothesis, we treated forty-two patients with nasal polyposis with intranasal beclomethasone dipropionate as a powder and as a pressurized aerosol in a double-dummy, cross-over design. There was no difference between the treatments in sixteen patients, while in twelve cases there was a preference for beclomethasone dipropionate as aerosol, and in fourteen, for the powder form. Fourteen found the aerosol most irritating and nineteen, the powder. Thus, in a group of polyp patients there were no significant differences between the two application forms, but possibly there is a need for both aerosol and powder, as there appeared to be differences in the individual responsiveness to the two types of intranasal medication. Blind microscopy of wiped nasal-smears before and after beclomethasone dipropionate treatment showed a reduction of basophilic cells, and counting of sneezes after medication demonstrated a reduction in the number of sneezes. These results suggest that a reduction of epithelial mediator-cells and of irritant receptor-sensitivity are of importance for the efficacy of topical steroids in rhinitis.

Topics: Adult; Aerosols; Aged; Beclomethasone; Double-Blind Method; Female; Humans; Male; Middle Aged; Nasal Polyps; Powders; Rhinitis, Allergic, Perennial

Topics: Beclomethasone; Cromolyn Sodium; Desensitization, Immunologic; Eosinophils; Histamine H1 Antagonists; Humans; Medical History Taking; Nasal Decongestants; Nasal Polyps; Radioallergosorbent Test; Rhinitis, Allergic, Seasonal; Skin Tests

After one year's use of beclomethasone dipropionate aerosol, 43 of 61 asthmatic patients who were originally dependent on oral corticosteroids were able to reduce and 38 to completely eliminate use of oral corticosteroids. Most patients maintained or improved their pulmonary functions. Exacerbation of rhinitis during oral corticosteroid withdrawal and emergence of nasal polyps were problems for 25 patients. Exacerbation of asthma with upper respiratory infection was an important event: 21 patients required supplemental oral corticosteroids to control asthma. Oral candidiasis occurred in only three patients.

Topics: Administration, Oral; Aerosols; Asthma; Beclomethasone; Humans; Nasal Polyps; Pharyngitis; Prednisone; Respiratory Function Tests; Rhinitis; Substance Withdrawal Syndrome

Seventeen patients had severe nasal polyposis. Local treatment with beclomethasone dipropionate caused marked reduction in the size of polyps and the nasal obstruction, and the effect continued throughout the treatment period. In all cases roentgenographic examination showed clouding of the nasal cavity and the paranasal sinuses, especially of the maxillary and ethmoidal sinuses. After three months of treatment, no change in the opacity of the sinuses was found. In spite of that, the symptomatic effect of the treatment was successful.

Topics: Adult; Aged; Beclomethasone; Female; Humans; Male; Methods; Middle Aged; Nasal Cavity; Nasal Polyps; Paranasal Sinuses; Radiography

Rhinoscopic examination and histological studies of the nasal mucosa in patients with perennial allergic rhinitis and nasal polyposis treated with beclomethasone dipropionate aerosol provided no evidence that this form of treatment, given for one year, produced any harmful effects, such as atrophic rhinitis.

Topics: Aerosols; Beclomethasone; Eosinophils; Epithelium; Humans; Irritants; Nasal Mucosa; Nasal Polyps; Nose Neoplasms; Regional Blood Flow