(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 Rhinitis--Allergic--Seasonal

Topics: Administration, Intranasal; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Chronic Disease; Diagnosis, Differential; Drug Administration Schedule; Fluocinolone Acetonide; Fluticasone; Glucocorticoids; Humans; Nurse Practitioners; Nurse's Role; Patient Satisfaction; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Severity of Illness Index; Triamcinolone

We performed a systematic review of randomized, controlled trials to determine whether intranasal corticosteroids offered an advantage over topical antihistamines in the treatment of allergic rhinitis.. We searched for studies using MEDLINE, Embase, Cinahi, and Cochrane databases, pharmaceutical companies, and references of included trials.. Criteria for considering trials included: 1) published randomized controlled trials; 2) single- or double-blind studies; and 3) presence of one of the following clinical outcomes: nasal symptoms, eye symptoms, global symptoms evaluation of quality of life and side effects.. Nine studies including 648 subjects (mean age 30.4 years, range 13 to 73) with allergic rhinitis were selected. Intranasal corticosteroids produced significantly greater reduction of total nasal symptoms (standardized mean difference -0.36, 95% confidence interval -0.57 to -0.14), sneezing (-0.41, -0.57 to -0.24), rhinorrhea (-0.47, -0.64 to -0.29), itching (-0.38, -0.56 to -0.19), and nasal blockage (-0.86, -1.07 to -0.64) than did topical antihistamines. There was no significant difference between treatments for ocular symptoms (-0.07, -0.27 to 0.12). The effects on sneezing, rhinorrhea, itching, and ocular symptoms were significantly heterogeneous between studies. Other outcomes (total nasal symptom score and nasal blockage) were homogeneous between studies. Subgroup and sensitivity analysis suggested that most of the heterogeneity of outcomes could be explained on the basis of the methodologic quality of studies.. Intranasal corticosteroids produced greater relief of nasal symptoms than did topical antihistamines (topical H1 receptor antagonists). However, there was no difference in the relief of the ocular symptoms.

Topics: Administration, Intranasal; Administration, Topical; Adolescent; Adult; Aged; Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Beclomethasone; Budesonide; Fluocinolone Acetonide; Fluticasone; Glucocorticoids; Histamine H1 Antagonists; Humans; Middle Aged; Phthalazines; Piperidines; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Seasonal; Treatment Outcome

Primary principles relevant to the clinical management of allergic rhinitis include (1) avoidance of allergens and triggering factors, (2) use of appropriate pharmacotherapy, (3) evaluation regarding need for and appropriate use of immunotherapy, and (4) patient education and follow-up. Currently available pharmacotherapeutic options include oral and topical (intranasal) decongestants and corticosteroids, mast cell stabilizers, intranasal anticholinergics, and antihistamines. Future therapeutic options include leukotriene modifiers and anti-IgE antibodies.

Topics: Administration, Intranasal; Beclomethasone; Cromolyn Sodium; Histamine H1 Antagonists; Humans; Immunoglobulin E; Immunotherapy; Nasal Decongestants; Oxymetazoline; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Topical administration of corticosteroids can reduce the total dose of corticosteroid required to treat the patient and minimize side effects. This logic has led to the development of intranasal corticosteroids (INCS) for allergic and perennial rhinitis. The second generation of these compounds includes beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate, mometasone furoate, and triamcinolone acetonide. There is evidence that the INCS are effective in rhinitis; however, there is concern about the potential for these compounds to cause growth suppression. In one study, beclomethasone dipropionate significantly reduced growth in children; however, treatment of children with mometasone furoate nasal spray for 1 year showed no signs of growth suppression. It is evident that the differences among INCS lie in their pharmacokinetics. Structural differences among the various INCS influence their metabolism. The goal of INCS therapy is to have a high ratio of topical to systemic activity. The drug delivery device, absorption of the drug, and drug distribution all contribute to effective topical activity of an INCS. In addition, individual drug metabolism and elimination (half-life and drug clearance) also contribute to the therapeutic index of a drug. Overall, the second-generation INCS cause minimal systemic effects at recommended doses.

Topics: Absorption; Administration, Intranasal; Adrenal Cortex Hormones; Adult; Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Child; Drug Delivery Systems; Fluocinolone Acetonide; Fluticasone; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Structure-Activity Relationship; Tissue Distribution; Triamcinolone Acetonide

Intranasal steroids (INSs) are established as first-line treatment for allergic rhinitis. Extensive use of INSs with few reported adverse events supports the safety of these medications. Nevertheless, the prescription of more potent INSs for consistent and more prolonged use to younger and older patients, often in combination with inhaled corticosteroids, justifies the careful examination of their potential adverse systemic effects. Systemic bioavailability of INSs, by way of nasal and intestinal absorption, can be substantial; but current INSs vary significantly in their degree of first-pass hepatic inactivation and clearance from the body of the swallowed drug. For safety studies of INSs, distinguishing detectable physiologic perturbations from important adverse events is aided by an understanding of normal endocrine physiology and the methods used to test these systems. A review of available information indicates that (1) sensitive tests can measure the effects of INSs on biologic feedback systems, but they do not accurately predict clinically relevant adverse effects; (2) the primary factors that influence the relationship between therapeutic and adverse systemic effects of INSs are dosing frequency and efficiency of hepatic inactivation of swallowed drug; (3) INS treatment in recommended doses does not cause clinically significant hypothalamic-pituitary-adrenal axis suppression; (4) growth suppression can occur with twice-daily administration of certain INSs but does not appear to occur with once-daily dosing or with agents with more complete first-pass hepatic inactivation; (5) harmful effects of INSs on bone metabolism have not yet been adequately studied but would not be expected with the use of an INS dose and dosing frequency that do not suppress basal hypothalamic-pituitary-adrenal axis function or growth; and (6) these conclusions apply to INS treatment alone and in recommended doses-the risk of adverse effects in individual patients who are treated with INSs is increased by excessive dosing or concomitant inhaled corticosteroid or other topical corticosteroid therapy.

Topics: Administration, Intranasal; Androstadienes; Beclomethasone; Budesonide; Endocrinology; Fluocinolone Acetonide; Fluticasone; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Steroids; Triamcinolone Acetonide

Azelastine, a phthalazinone compound, is a second generation histamine H1 receptor antagonist which has shown clinical efficacy in relieving the symptoms of allergic rhinitis when administered as either an oral or intranasal formulation. It is thought to improve both the early and late phase symptoms of rhinitis through a combination of antihistaminic, antiallergic and anti-inflammatory mechanisms. Symptom improvements are evident as early as 30 minutes, after intranasal administration of azelastine [2 puffs per nostril (0.56mg)] and are apparent for up to 12 hours in patients with seasonal allergic rhinitis (SAR). The effect on nasal blockage is variable: in some studies objective and/or subjective assessment showed a reduction in blockage, whereas in other studies there was no improvement. Intranasal azelastine 1 puff per nostril twice daily is generally as effective as standard doses of other antihistamine agents including intranasal levocabastine and oral cetirizine, ebastine, loratadine and terfenadine at reducing the overall symptoms of rhinitis. The relative efficacies of azelastine and intranasal corticosteroids (beclomethasone and budesonide) remain unclear. However, overall, the corticosteroids tended to improve rhinitis symptoms to a greater extent than the antihistamine. Azelastine was well tolerated in clinical trials and postmarketing surveys. The most frequently reported adverse events were bitter taste, application site irritation and rhinitis. The incidence of sedation did not differ significantly between azelastine and placebo recipients and preliminary report showed cardiovascular parameters were not significantly altered in patients with perennial allergic rhinitis (PAR).. Twice-daily intranasal azelastine offers an effective and well tolerated alternative to other antihistamine agents currently recommended for the symptomatic relief of mild to severe SAR and PAR in adults and children (aged > or = 12 years in the US; aged > or = 6 years in some European countries including the UK). The rapid onset, confined topical activity and reduced sedation demonstrated by the intranasal formulation of azelastine may offer an advantage over other antihistamine agents, although this has yet to be confirmed.

Topics: Administration, Intranasal; Adult; Beclomethasone; Budesonide; Child; Drug Tolerance; Glucocorticoids; Histamine H1 Antagonists; Humans; Neutrophils; Phthalazines; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Studies have been conducted in the USA comparing fluticasone propionate aqueous nasal spray 200 micrograms once daily with beclomethasone dipropionate aqueous nasal spray 168 micrograms twice daily, oral terfenadine 60 mg twice daily, or oral astemizole 10 mg once daily given for 2 or 4 weeks during tree, grass or ragweed pollen seasons. All six were multicentre, randomised, placebo-controlled, double-blind, parallel-group studies. Efficacy was evaluated by patient and clinician assessments of individual nasal symptoms and overall response to therapy. Fluticasone propionate was superior to beclomethasone dipropionate in one trial according to patient evaluations of symptoms, but response to fluticasone propionate and beclomethasone dipropionate was similar in the second study. Comparisons with antihistamines showed fluticasone propionate to have greater efficacy. It was more effective than terfenadine in both trials according to evaluations by clinicians and patients. Similar findings were observed in the first astemizole trial. The second astemizole study showed superiority of fluticasone propionate over astemizole in terms of patient and clinician evaluations of overall response to therapy and occasionally in terms of symptom evaluations. There were no significant adverse effects, including effects on plasma cortisol concentrations, noted in any of these comparator studies.

Topics: Administration, Topical; Aerosols; Androstadienes; Anti-Inflammatory Agents; Astemizole; Beclomethasone; Double-Blind Method; Fluticasone; Glucocorticoids; Humans; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Seasonal; Terfenadine

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

Topics: Administration, Intranasal; Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents; Beclomethasone; Betamethasone; Child; Clinical Trials as Topic; Fluocinolone Acetonide; Humans; Middle Aged; Placebos; Research Design; Rhinitis, Allergic, Seasonal

Beclomethasone dipropionate has been demonstrated to be effective in the treatment of seasonal and perennial rhinitis. Comparative studies with other medications are lacking. Adverse reactions are frequent but minor. No alterations of the hypothalamic-pituitary-adrenal axis, nasal mucosal histology or bacterial and fungal flora have been recognized.

Topics: Administration, Topical; Anti-Inflammatory Agents; Beclomethasone; Glucocorticoids; Humans; Hypothalamo-Hypophyseal System; Pituitary-Adrenal System; Placebos; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Sneezing; Time Factors

Topics: Adult; Aerosols; Asthma; Beclomethasone; Bronchitis; Child; Clinical Trials as Topic; Double-Blind Method; Humans; Placebos; Respiratory Hypersensitivity; Rhinitis, Allergic, Seasonal; Time Factors

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

The aim of the present study was to objectively and subjectively evaluate the effects of adding rhinophototherapy to intranasal beclomethasone dipropionate to treat nasal congestion in patients with seasonal allergic rhinitis.. Seventy-five seasonal allergic rhinitis patients were randomly divided into two groups. Patients in Group 1 received intranasal beclomethasone dipropionate for two weeks and patients in Group 2 had rhinophototherapy added to the same medical therapy as Group 1. The effectiveness of treatments was evaluated with the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Nasal Obstruction Symptom Evaluation scale (NOSE) questionnaires and active anterior rhinomanometry.. After treatment, significant improvement was observed in Group 2. Our study shows that adding intranasal phototherapy with a combination of UVA, UVB and visible light therapy to nasal beclomethasone dipropionate treatment objectively improves nasal patency in patients with seasonal allergic rhinitis.. Effetto della rinofototerapia sulla congestione nasale nei pazienti con rinite allergica stagionale.. Valutare in maniera oggettiva e soggettiva gli effetti del dipropionato beclometasone con l’aggiunta della rhinofototerapia nel trattamento della rinite allergica stagionale.. Settantacinque pazienti affetti da rinire allergica stagionale sono stati randomizzati in due gruppi. Gruppo 1, trattamento con dipropionato beclometasone per due settimane. Gruppo 2, rinofototerapia in aggiunta al trattamento del gruppo 1. L’efficacia dei trattamenti è stata valutata con il Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), il Nasal Obstruction Symptom Evaluation scale (NOSE) e la rinomanometria attiva anteriore.. È risultata una differenza statisticamente significativa fra il gruppo 2 e 1 in termini di RQLQ (p = 0,011) e NOSE (p = 0,001). Nel gruppo 2 sono risultate delle differenze nelle resistenze nasali (p = 0,004) prima e dopo il trattamento e nessuna differenza statisticamente significativa nel gruppo 1.. L’aggiunta della fototerapia intranasale con UVA, UVB e luce bianca migliora i sintomi nei pazienti con rinite allergica stagionale.

Topics: Beclomethasone; Double-Blind Method; Humans; Nasal Obstruction; Quality of Life; Rhinitis, Allergic, Seasonal; Rhinomanometry

Some patients with allergic rhinitis (AR) may prefer nonaqueous intranasal corticosteroid aerosols because of unwanted attributes of aqueous formulations. The mandatory removal of chlorofluorocarbon-propelled nonaqueous aerosols from the market limited available treatment options. To fulfill this unmet need, a nonaqueous, hydrofluoroalkane-propelled beclomethasone dipropionate (BDP) nasal aerosol was developed and approved for treatment of AR nasal symptoms. As part of the development program, this dose-ranging study evaluated three doses of BDP nasal aerosol to determine the optimally safe and effective dose for adolescent and adult patients (≥12 years old) with seasonal AR (SAR).. After a 7 to 21 day placebo run-in period, eligible patients with SAR were randomly assigned to once-daily BDP nasal aerosol 80 µg, 160 µg, 320 µg, or placebo. The primary endpoint was the change from baseline in average a.m. and p.m. patient-reported reflective total nasal symptom scores (rTNSS) over 2 weeks. Safety and tolerability were also assessed. A potential study limitation could be lack of objective assessment of AR symptoms.. Significant improvements were seen in average a.m. and p.m. rTNSS (least squares [LS] mean treatment difference, -0.63; 95% CI: -1.13, -0.13; p = 0.013) as well as in average a.m. and p.m. instantaneous TNSS (iTNSS; LS mean treatment difference, -0.60; 95% CI: -1.09, -0.11; p = 0.016) with BDP nasal aerosol 320 µg/day compared with placebo. Although there were numerical improvements from baseline in patient-reported rTNSS and iTNSS with BDP nasal aerosol 80 µg and 160 µg, these doses did not achieve statistical significance compared with placebo. BDP nonaqueous nasal aerosol was well tolerated at all doses tested, with a safety profile comparable to that of placebo.. These data indicate that 320 µg/day of BDP nasal aerosol is the optimally safe and effective dose for the treatment of SAR in adolescent and adult patients. Trial registration NCT: #NCT00854360.

Topics: Administration, Inhalation; Administration, Intranasal; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Beclomethasone; Child; Dose-Response Relationship, Drug; Double-Blind Method; Drug Tolerance; Female; Humans; Male; Middle Aged; Rhinitis, Allergic, Seasonal; Time Factors

Aerosolized intranasal corticosteroid formulations are desirable for many patients with allergic rhinitis (AR), especially children, who wish to avoid the "wet feeling" and "drip down the throat" associated with aqueous formulations. Beclomethasone dipropionate (BDP) hydrofluoroalkane nasal aerosol has been shown to be safe and effective in adolescents and adults with AR.. To evaluate the efficacy and safety of BDP nasal aerosol in pediatric patients with moderate to severe seasonal AR.. In this double-blinded, placebo-controlled study, children (6-11 years of age) with seasonal AR were randomized to once-daily treatment with BDP nasal aerosol 80 μg (n = 239) or 160 μg (n = 242) or placebo (n = 234). The primary end point was change from baseline in average morning and evening reflective total nasal symptom score over the 2-week treatment period.. Treatment with BDP nasal aerosol showed significantly greater improvements in average morning and evening reflective total nasal symptom score vs placebo (80 μg, -0.71; 160 μg, -0.76; P < .001 for the 2 comparisons). Similarly, significantly greater improvements in average morning and evening instantaneous total nasal symptom score were seen with BDP nasal aerosol vs placebo (80 μg, -0.63; 160 μg, -0.73; P < .001 for the 2 comparisons). The incidence of adverse events from BDP nasal aerosol was comparable to that from placebo.. BDP nasal aerosol (80 or 160 μg/d) provided significant and clinically meaningful nasal symptom relief and an established overall safety profile similar to that of placebo, suggesting that it is an effective and well-tolerated treatment option for pediatric patients with moderate to severe seasonal AR.. clinicaltrials.gov Identifier: NCT012073190.

Topics: Administration, Intranasal; Aerosols; Anti-Asthmatic Agents; Beclomethasone; Child; Double-Blind Method; Female; Humans; Male; Nasal Sprays; Placebos; Rhinitis, Allergic, Seasonal; Treatment Outcome

Concomitant use of montelukast and loratadine may improve symptoms of seasonal allergic rhinitis (SAR) more than treatment with either drug alone.. We compared the efficacy of this combination versus placebo, nasal beclomethasone, montelukast, and loratadine in study 1 and versus placebo, montelukast, and loratadine in study 2.. Patients were randomly allocated to double-blind treatment with intranasal beclomethasone 200 mu g/twice daily (study 1 only), placebo, montelukast 10 mg+loratadine 10 mg, montelukast 10 mg, or loratadine 10 mg once daily. The primary endpoint was the Composite Symptom Score (CSS): average of daily diary scores for Daytime Nasal Symptoms and Nighttime Symptoms.. In study 1, improvements in the change from baseline in CSS were seen for montelukast+loratadine (least-squares means [95% CI] = -0.43 [-0.51, -0.35]), beclomethasone (-0.57 [-0.64, -0.49]), montelukast, and loratadine. All treatments were significantly better than placebo; montelukast+loratadine had a significantly greater effect on CSS than montelukast alone but no difference compared to loratadine was detected. Beclomethasone provided significantly greater improvement versus montelukast+loratadine on the primary and secondary endpoints except for the rhinoconjunctivitis quality-of-life score. In study 2, the combination treatment was similar to montelukast, loratadine, and placebo for the primary and secondary endpoints.. In study 1, montelukast+loratadine had a significantly greater effect on CSS than placebo and montelukast alone; however, in all comparisons, nasal beclomethasone had a greater effect on daily symptoms. In contrast, the combination of montelukast+loratadine in study 2 did not provide greater improvement compared with placebo, montelukast, or loratadine monotherapy, perhaps due to a large placebo effect.

Topics: Acetates; Adolescent; Adult; Aged; Aged, 80 and over; Beclomethasone; Cyclopropanes; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Leukotriene Antagonists; Loratadine; Male; Middle Aged; Quinolines; Rhinitis, Allergic, Seasonal; Sulfides; Treatment Outcome; Young Adult

CD4+ T cells constitute a major source of cytokines in allergic diseases such as allergic rhinitis. Interleukin (IL)-16 selectively recruits CD4+ cells.. We evaluated the effect of natural allergen exposure during a grass-pollen season on IL-16 expression and number of CD4+ cells in nasal mucosa. Patients with allergic rhinitis (n=16) were treated with either a nasal glucocorticoid beclomethasone (BDP; 400 microg/day) or placebo, and gave nasal biopsies prior to and during the grass-pollen season. The evaluated markers in allergic rhinitis patients were also compared to those in healthy control subjects (n=5).. Prior to the pollen season, the expression of IL-16, but not the number of CD4+ cells, was significantly higher in patients with allergic rhinitis than in healthy control subjects. The grass-pollen season further increased IL-16 expression and also increased the number of CD4+ cells in placebo-treated, but not in BDP-treated, allergic rhinitis patients. The pollen-season-induced change in IL-16 expression and in CD4+ cells was significantly more pronounced in placebo- than in BDP-treated patients. There was a significant correlation between the change in IL-16 expression and the number of CD4+ cells.. These data suggest that local upregulation of IL-16 expression contributes to the inflammation observed in seasonal allergic rhinitis. Hypothetically, inhibition of IL-16 expression can be one of several mechanisms by which nasal glucocorticoids achieve their anti-inflammatory effect in allergic rhinitis.

Topics: Administration, Topical; Adolescent; Adult; Allergens; Anti-Inflammatory Agents; Antibody Specificity; Beclomethasone; Biopsy; CD4 Lymphocyte Count; Double-Blind Method; Environmental Exposure; Female; Glucocorticoids; Humans; Immunoglobulin E; Interleukin-16; Male; Nasal Mucosa; Poaceae; Pollen; Rhinitis, Allergic, Seasonal; Sensitivity and Specificity; Skin Tests

We had previously observed that changes in nasal cytology were associated with specific clinical patterns in cross-sectional studies of allergy clinic patients. In the present study, we sought to determine whether specific cytologic changes occurred with antiinflammatory therapy in a controlled setting in a prospective manner.. To examine changes in nasal leukocytes and epithelial cells associated with topical beclomethasone treatment in allergic rhinitis patients. Specifically we tested the hypothesis that number of nasal leukocytes relative to epithelial cell numbers are altered by topical beclomethasone treatment.. Adult volunteers (n=26) with symptoms consistent with allergic rhinitis and positive aeroallergen skin tests were enrolled for treatment with either beclomethasone or placebo nasal spray. Sprays were allocated in a double-blind manner and were prescribed to be administered over a 2-week period. Baseline quality of life, nasal cytograms, and mucosal physical appearance scores were obtained at baseline and at the end of the treatment period. Changes in various nasal leukocytes and epithelial cell types were analyzed for association with active treatment using bivariate and multivariate analysis.. Total leukocytes showed greater decreases with beclomethasone treatment than with placebo. Total epithelial cells on the other hand showed an increase with active treatment compared with placebo treatment. In multivariate analysis, the changes in both total leukocytes and total epithelial cells showed independent associations with beclomethasone treatment. Combining these two variables into a single leukocyte per epithelial ratio resulted in variable with values showing a significant decreases associated with beclomethasone treatment compared with placebo treatment (P = .03).. The administration of topical corticosteroids results in decreases in total leukocytes and this decrease is of enhanced significance when adjusted for the quantities of associated epithelial cells. Further investigation relating to the quantities of total nasal leukocytes in inflammatory nasal diseases may be helpful in gauging disease activity and monitoring treatment modalities.

Topics: Administration, Topical; Adult; Aged; Analysis of Variance; Beclomethasone; Double-Blind Method; Eosinophils; Epithelial Cells; Humans; Leukocytes; Middle Aged; Nasal Mucosa; Respiratory Hypersensitivity; Rhinitis, Allergic, Seasonal

It has been reported that intranasal corticosteroids can influence bronchial hyperresponsiveness (BHR) in asthmatic subjects with seasonal rhinitis. The purpose of the present study was to evaluate the effect of intranasal fluticasone propionate and beclomethasone dipropionate on BHR and bronchial calibre (forced expiratory volume in one second, FEV(1)) in children and young adults with seasonal rhinitis and mild asthma during two consecutive grass pollen seasons.. In the first pollen season 25 patients aged 8-28 years were included in a double blind, placebo controlled study. The active treatment group used fluticasone aqueous spray 200 microgram once daily. In the second pollen season 72 patients aged 8-28 years participated in a double blind, placebo controlled study of a similar design to that of the previous year except that an additional treatment group of patients using beclomethasone 200 microg twice daily was included. FEV(1) was measured before and after three and six weeks of treatment; BHR to methacholine (PD(20)) was measured before and after six weeks of treatment.. In the first season the mean (SD) logPD(20) of the patients decreased significantly both in the fluticasone group (from 2.43 (0.8) microgram to 1.86 (0.85) microgram) and in the placebo group (from 2.41 (0.42) microgram to 1.87 (0.78) microgram) without any intergroup difference in the change in logPD(20). In the second pollen season the mean logPD(20) in the fluticasone, beclomethasone, and placebo groups did not change significantly.. Intranasal steroids did not influence BHR during two grass pollen seasons in children and young adults with seasonal rhinitis and mild asthma.

Topics: Administration, Intranasal; Adolescent; Adult; Allergens; Androstadienes; Anti-Allergic Agents; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Child; Double-Blind Method; Female; Fluticasone; Forced Expiratory Volume; Humans; Male; Patient Compliance; Pollen; Rhinitis, Allergic, Seasonal; Treatment Outcome

Allergic rhinitis is a common disease characterized by infiltration of eosinophils into the nasal mucosa during the periods of symptoms. Among chemokines, which attract cells to the site of inflammation, eotaxin is relatively specific for eosinophils.. We examined the influence of grass pollen season on nasal eotaxin expression in patients with seasonal allergic rhinitis, as well as the effect of a nasal glucocorticoid on this eotaxin expression.. Nineteen patients with allergic rhinitis received treatment with either nasal beclomethasone (400 microgram/day) or placebo over a grass pollen season. In these patients, nasal biopsies were taken prior to and during the peak of the pollen season and stained immunohistochemically for eotaxin and EG2 + eosinophils. Five healthy subjects served as controls and gave nasal biopsies once prior to the pollen season.. Prior to pollen season, there was no significant difference in nasal eotaxin expression between patients with allergic rhinitis and healthy subjects. Grass pollen season induced significant increase in eotaxin expression in placebo-treated (P = 0.04; n = 9) but not in beclomethasone-treated rhinitis patients (P = 0.8; n = 10). During peak grass pollen season, the eotaxin expression in placebo-treated patients was significantly higher compared with healthy subjects outside season (P = 0.03). There was no significant correlation between the expression of eotaxin and the number of EG2 + eosinophils in nasal mucosa. The serum levels of eotaxin in rhinitis patients remained stable over the pollen season.. Expression of eotaxin in nasal mucosa of grass-pollen allergic rhinitis patients is upregulated during pollen season and treatment with a nasal glucocorticoid protects against this upregulation.

Topics: Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents; Beclomethasone; Chemokine CCL11; Chemokines, CC; Cytokines; Double-Blind Method; Eosinophils; Female; Glucocorticoids; Humans; Male; Nasal Mucosa; Rhinitis, Allergic, Seasonal; Up-Regulation

A prospective multicentre study involving 219 patients with seasonal or aperiodic rhinitis was performed to assess the acceptability of a local treatment combining antihistamine (azelastine) and corticoid (beclomethasone) drugs. The drugs were administered either together (morning and evening, with a 5-minute interval) or separately (azelastine in the morning and evening, and beclomethasone later during the morning and in the afternoon) for 15 days. Treatment acceptability was measured by a nine-fold questionnaire (7-point scale, mean score per question). Patient participation, protocol and therapy compliance, and treatment efficacy and tolerance were also studied. The acceptability of the association was satisfactory (mean score for general facility of treatment: 4.7/6) and did not differ between administration schedules. Patients found treatment easy, and were not bothered by the bulk of the bottles or the risk of mixing them up. This acceptability was confirmed by the low percentage (4%) of patients refusing to be included in the study (refusing any treatment by nasal spray). The general acceptability was confirmed by the results for therapy compliance, general efficacy and tolerance: 94.9% of the patients took more than 75% of the administrations prescribed, 77.6% of the patients and 85.2% of the practitioners judged treatment efficacy as good or excellent, and 84.6% of the patients and 91.4% of the practitioners judged tolerance as good or excellent. Moreover, most of the adverse events consisted of minor signs of local intolerance, and were identical to those observed when the two treatments were administered alone.

Topics: Administration, Inhalation; Adult; Beclomethasone; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Patient Acceptance of Health Care; Phthalazines; Prospective Studies; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Treatment Outcome

Allergic rhinitis is an inflammatory disorder associated with local leukotriene release during periods of symptoms. Therefore, it has been suggested that antileukotrienes may be beneficial in the treatment of this disease. Leukotriene receptor antagonists have recently become available for asthma treatment, but little is known of their effects on allergic rhinitis. We have evaluated the effects of the leukotriene receptor antagonist zafirlukast versus placebo in patients with allergic rhinitis during the grass pollen season, using the nasal glucocorticoid beclomethasone dipropionate (BDP) as a positive treatment control. Thirty-three patients with seasonal allergic rhinitis were in a double-blind, double-dummy fashion randomized to treatments with oral zafirlukast (20 mg twice a day), intranasal beclomethasone dipropionate (200 microg twice a day), or placebo. The treatment was initiated 3 wk prior to the expected beginning of the grass pollen season. Patients completed a daily symptom-score list for sneezing, rhinorrhea, nasal itch, and nasal blockage during the 50-d treatment period. Nasal biopsies for quantification of local tissue eosinophilia (immunohistochemistry; EG2) were taken 1 mo before initiation of treatment and immediately after the peak of grass pollen season. Patients receiving treatment with zafirlukast had degrees of nasal symptoms similar to those in the placebo group, whereas the BDP group had significantly less symptoms compared with both treatments (p = 0.01 and p = 0.005, respectively). The numbers of activated eosinophils in the nasal tissue increased significantly during the pollen season in both the zafirlukast and the placebo groups, but not in the BDP group. These results obtained with a limited number of patients do not support any clinical efficacy of regular treatment with an oral antileukotriene in seasonal allergic rhinitis but rather favor the use of a nasal glucocorticoid.

Topics: Administration, Intranasal; Adolescent; Adult; Beclomethasone; Cell Count; Double-Blind Method; Eosinophils; Female; Glucocorticoids; Humans; Indoles; Leukotriene Antagonists; Male; Middle Aged; Nasal Mucosa; Phenylcarbamates; Rhinitis, Allergic, Seasonal; Sulfonamides; Tosyl Compounds

Although generic formulations of drugs are chemically equivalent, they may not be bioequivalent to the innovator. Since bioequivalence of intranasal corticosteroids has been difficult to demonstrate by pharmacokinetic methods, clinical trials have been necessary to compare generic and innovator agents.. We therefore designed a multicenter, randomized double-blind, parallel-group placebo-controlled study to examine the therapeutic equivalence of generic beclomethasone diproprionate to the innovator.. A total of 518 patients, ages 12 to 60, with ragweed-induced seasonal allergic rhinitis from eight centers were randomized to receive intranasal generic or innovator beclomethasone 42 microg, 84 microg or placebo twice daily for 6 weeks. Efficacy was assessed by means of rhinitis symptom scores as recorded in patient diaries. Adverse events were recorded throughout the study to assess safety.. Mean rhinitis composite symptom scores (congestion, postnasal drip, runny nose, and sneezing) were significantly lower in patients receiving 42 microg (P = .0003) or 84 microg (P = .0001) beclomethasone twice daily compared with placebo. Generic beclomethasone was equivalent therapeutically to the innovator in alleviating nasal congestion (42 microg and 84 microg doses), postnasal drip (84 microg dose), runny nose (84 microg dose), sneezing (42 microg and 84 microg doses) and mean composite (42 microg and 84 microg doses) symptom scores during the 6-week study period. Similar and equivalent efficacy was also demonstrated during the 5-day period of peak pollen counts at each site. The type and incidence of drug-related adverse events were similar for both beclomethasone treatment groups and did not differ significantly from placebo in severity and frequency.. Generic beclomethasone was therapeutically equivalent to the innovator in regards to both efficacy and side effect profile in the treatment of ragweed-induced allergic rhinitis.

Topics: Administration, Intranasal; Adult; Beclomethasone; Double-Blind Method; Female; Humans; Male; Placebos; Rhinitis, Allergic, Seasonal; Therapeutic Equivalency

Azelastine hydrochloride is an H1-receptor antagonist with antiinflammatory properties that is available in the US as Astelin Nasal Spray for the treatment of seasonal allergic rhinitis. The symptoms of seasonal allergic rhinitis can initially be treated with monotherapy using either an antihistamine or an intranasal corticosteroid. Patients whose symptoms do not respond adequately are often prescribed a combination of both an antihistamine and an intranasal corticosteroid.. Three multicenter, randomized, double-blind studies were conducted to determine whether patients with moderate-to-severe symptoms of seasonal allergic rhinitis who had responded inadequately to monotherapy with either an oral antihistamine or an intranasal corticosteroid, and who were candidates for combination therapy with both an oral antihistamine and an intranasal corticosteroid, could be effectively treated with azelastine nasal spray monotherapy.. Following a 1- to 2-week washout period, patients were randomized to 7 days of double-blind treatment with either azelastine nasal spray (2 sprays per nostril bid, 1.1 mg/day) monotherapy or combination therapy with oral loratadine (Claritin, one 10-mg tablet/day) plus intranasal beclomethasone dipropionate monohydrate (Beconase AQ, 2 sprays per nostril bid, 336 microg/day). Efficacy was determined at the end of the study by both a physician assessment of the need for additional anti-rhinitis medication and a patient global evaluation of therapeutic effectiveness. The three studies were conducted at 71 investigational sites during the 1998 spring allergy season. Three separate studies were conducted to verify the reproducibility of the new study design.. In all three studies a total of 1,070 patients were randomized to double-blind treatment. There were no statistically significant differences in the percentage of patients treated with azelastine nasal spray versus patients treated with a combination of loratadine tablets and beclomethasone nasal spray who did not require additional anti-rhinitis medication (32% to 45% and 39% to 46%, respectively). The patient global evaluation indicated that 77% to 84% of the patients treated with azelastine nasal spray had symptomatic improvement and 85% to 90% of the patients treated with loratadine tablets and beclomethasone nasal spray had symptomatic improvement. The most commonly reported adverse experience with azelastine nasal spray was a transient aftertaste (8%), while the most commonly reported adverse experience with loratadine tablets and beclomethasone nasal spray in combination was headache (6%).. Based on the percentage of patients not requiring additional antirhinitis medication and the patient assessment of efficacy, azelastine nasal spray monotherapy was as effective as the combination of oral loratadine plus intranasal beclomethasone in treating moderate-to-severe symptoms of seasonal allergic rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Beclomethasone; Child; Double-Blind Method; Drug Therapy, Combination; Female; Headache; Histamine H1 Antagonists; Humans; Lipoxygenase Inhibitors; Loratadine; Male; Middle Aged; Phthalazines; Rhinitis, Allergic, Seasonal; Tablets; Taste; Therapeutic Equivalency; Time Factors

Previous investigations have suggested that nasal secretions, obtained by lavage or scraping, and the nasal submucosa, sampled by biopsy, are two distinct compartments. We investigated the effect of intranasal corticosteroids on antigen-induced eosinophil influx into both compartments. We performed a double-blind, placebo-controlled study in 15 patients with seasonal allergic rhinitis. Beclomethasone dipropionate, 84 microg twice a day, was delivered to one nostril while the other nostril received placebo for 1 wk. Subjects were then challenged with grass or ragweed extracts on each inferior turbinate. Nasal scrapings from both inferior turbinates were obtained before and 24 h after challenge, and bilateral inferior turbinate biopsies were obtained 24 h after challenge, with the subjects still receiving treatment. Intranasal steroids led to a significant reduction in sneezes and eosinophil influx in nasal secretions without affecting the number of eosinophils in the submucosa. Furthermore, intranasal steroids had no effect on the numbers of submucosal EG2+ (activated eosinophils) or CD25+ (IL-2-receptor-bearing) cells, nor did they decrease the endothelial expression of vascular cell adhesion molecule-1 (VCAM-1). These data show that pretreatment with intranasal steroids successfully inhibited the clinical response to allergen and reduced eosinophils in the superficial compartment of the nasal mucosa, but it had no effect on inflammation in the deeper compartment. This might be related to a different distribution of the active medication and antigen into the nasal mucosa or to a specific effect of the active medication on the epithelium resulting in inhibited migration of eosinophils across this layer.

Topics: Administration, Intranasal; Adult; Allergens; Anti-Inflammatory Agents; Beclomethasone; Biopsy; Cell Movement; Chemotaxis, Leukocyte; Double-Blind Method; Eosinophilia; Epithelium; Female; Glucocorticoids; Humans; Immunization; Leukocyte Count; Male; Middle Aged; Nasal Lavage Fluid; Nasal Mucosa; Placebos; Poaceae; Receptors, Interleukin-2; Rhinitis, Allergic, Seasonal; Sneezing; Turbinates; Vascular Cell Adhesion Molecule-1

This study compared a new intranasal anti-allergic drug, azelastine (0.56 mg bid) with intranasal beclomethasone (0.2 mg bid) and placebo in the treatment of symptoms associated with seasonal rhinitis. After administering placebo for 3-5 days as a "run-in" period, eligible patients were randomized to treatment for 2 weeks: 83 patients received azelastine, 83 beclomethasone and 77 placebo. Each of six symptoms was assessed daily using a four-point scale. Total symptom scores showed that azelastine-treated patients experienced a more rapid onset of overall symptom relief than beclomethasone-treated patients. This was significant on day 1 (P < 0.003) and continued until day 5. By the end of the 2-week study period, the beclomethasone-treated group showed greater improvement than both the azelastine and placebo groups (P = 0.002 and P = 0.0001, respectively). In contrast, visual analogue scales at this time showed no significant differences between the azelastine and beclomethasone treatment groups, with both groups demonstrating significant reductions in total symptom scores compared to placebo (P = 0.0004 and P = 0.0001, respectively). Differing sensitivities were found in the four-point scales reported by the patients and the investigators and the patients' visual analogue scales in the measurement of symptom severity. However, all three techniques confirmed that both azelastine nasal spray and beclomethasone nasal spray were effective treatments for seasonal rhinitis. While a greater improvement in overall symptoms was found for the beclamethasone-treated patients compared to azelastine-treated patients, diary card data confirmed the more immediate onset of symptom relief provided by azelastine. No serious adverse events were found in the present study and included no complaints of drowsiness.

Topics: Administration, Intranasal; Adult; Anti-Allergic Agents; Beclomethasone; Double-Blind Method; Female; Humans; Male; Middle Aged; Phthalazines; Rhinitis, Allergic, Seasonal; Treatment Outcome

The study of the IgE response to seasonal antigen exposure is limited by its occurrence once a year and by the variability of patient exposure to pollens. To overcome these problems, we investigated whether nasal challenge with antigen causes an increase in serum anti-ragweed IgE levels. We challenged individuals with ragweed allergy intranasally with nanogram quantities of ragweed antigen extract and measured their serum anti-ragweed IgE levels before and at weekly intervals after challenge. In a series of studies we found that there was a reproducible rise in antigen-specific serum IgE levels beginning the first week after challenge that plateaued at about 180% of baseline levels during the fourth week and remained elevated for 8 weeks. Not all individuals showed this response. The magnitude of the allergen-specific IgE response to nasal challenge appeared to be greater than the response to seasonal exposure. Treatment with intranasal beclomethasone before challenge did not affect the response. The results demonstrate a human in vivo model for the study of the antigen-specific secondary IgE response to allergen.

Topics: Administration, Intranasal; Allergens; Anti-Asthmatic Agents; Antibody Formation; Antibody Specificity; Antigens; Beclomethasone; Double-Blind Method; Humans; Immunoglobulin E; Nasal Provocation Tests; Placebos; Pollen; Rhinitis, Allergic, Seasonal

Recent in vitro findings show that glucocorticoids in combination with IL-4 can induce the synthesis of IgE, indicating that glucocorticoids may promote allergy.. A double-blind, placebo-controlled study was performed to evaluate the effect of an intranasal glucocorticoid on the levels of birch pollen-specific IgE antibodies in serum from patients with allergic rhinitis.. Eighteen patients with allergic rhinitis received treatment with an intranasal glucocorticoid (beclomethasone dipropionate, 400 microg/day) or placebo for 5 weeks, starting from the beginning of the birch pollen season. Blood samples for anti-birch IgE evaluation were taken before treatment was initiated and at 2 and 5 weeks after the beginning of the study.. The beclomethasone group (n = 9) had significantly lower symptom scores when compared with the placebo group (n = 9) (0.86 +/- 0.26 vs 2.79 +/- 0.76, p value = 0.01). Both the treatment group and the placebo group showed a trend of an increase in anti-birch IgE levels 2 weeks after the beginning of the treatment (from 33.1 +/- 13.1 kU/L to 44.9 +/- 20.9 kU/L in the beclomethasone group and from 53.2 +/- 18.9 kU/L to 64.1 +/- 22.1 kU/L in the placebo group). Treatment with beclomethasone returned anti-birch IgE levels to baseline by the end of the study, whereas in the placebo group the anti-birch IgE levels continued to increase (final values, 33.1 +/- 11.9 kU/L vs 72.6 +/- 23.2 kU/L, respectively). The change in IgE antibody levels in the placebo group was significantly higher than that in the beclomethasone group. No statistically significant changes in total IgE or soluble CD23 levels were detected.. We conclude that treatment with an intranasal glucocorticoid initiated at the beginning of the pollen season inhibits the induced increase in specific IgE.

Topics: Administration, Intranasal; Adolescent; Adult; Anti-Inflammatory Agents; Antibodies, Anti-Idiotypic; Antibody Specificity; Beclomethasone; Female; Glucocorticoids; Humans; Immunoglobulin E; Male; Middle Aged; Receptors, IgE; Rhinitis, Allergic, Seasonal

60 patients aged 16 to 46 years with seasonal allergic rhinitis were selected for study. Daily symptom scores of seasonal allergic rhinitis and nonspecific bronchial hyperresponsiveness to histamine (PC20H in mg/ml) before, during the pollen season and after 3 weeks of treatment with loratadine, beclomethasone dipropionate were evaluated. The control group received oxymetazoline. Nonspecific bronchial hyperresponsiveness for 11 patients (18.3%) before the seasons was observed. At the beginning of the season frequency of nonspecific bronchial hyperresponsiveness increased to 26.3% and to 36.8% after 3-week treatment course. Bronchial hyperresponsiveness was not related to any of the way of treatment. The patients treated with beclomethasone dipropionate and oxymetazoline showed significant relief of nasal symptoms. The patients without bronchial hyperresponsiveness showed lower value of symptom scores.

Topics: Adolescent; Adult; Anti-Allergic Agents; Beclomethasone; Bronchial Hyperreactivity; Female; Humans; Loratadine; Male; Middle Aged; Nasal Decongestants; Oxymetazoline; Rhinitis, Allergic, Seasonal

The use of intranasally administered corticosteroid sprays is an established treatment option for seasonal allergic rhinitis.. In this double-blind, placebo-controlled, multicenter study, 438 patients with moderate to severe symptoms of seasonal allergic rhinitis were treated for 4 weeks with double-strength beclomethasone dipropionate (BDP) aqueous nasal spray (84 micrograms/spray: BDP-ds), once daily; regular-strength BDP (42 micrograms/spray: BDP-rs), twice daily; high-strength BDP (336 micrograms/spray: BDP-hs), once daily; or placebo. BDP-hs was included as a safety comparison group. All treatments were given as two sprays per nostril.. Physician-rated nasal symptom scores were significantly improved in all three active treatment groups compared with those of the placebo group within the initial 3 days of treatment. Improvement was maintained throughout the 4-week treatment period. BDP-ds and BDP-rs were equivalent at all time points. The BDP-ds, BDP-rs, and BDP-hs groups had greater numbers of patients with a good or excellent therapeutic response at end point than the placebo group. All treatments were well-tolerated, and no unexpected adverse events were reported. No effects on laboratory evaluations or vital signs were evident for any treatment group.. The results of this study show that BDP-ds given once a day and BDP-rs given twice a day in the same total daily dose are comparably safe and effective in the treatment of patients with seasonal allergic rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Beclomethasone; Child; Chlorpheniramine; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Patient Satisfaction; Rhinitis, Allergic, Seasonal; Solutions

Mometasone furoate aqueous nasal spray (Nasonex) was compared with beclomethasone dipropionate (BDP) aqueous nasal spray in a double-blind, randomized, placebo-controlled, double-dummy, parallel-group study of adults with moderate to severe seasonal allergic rhinitis. Patients allergic to at least one tree and/or grass aeroallergen received one of the following regimens for up to 4 weeks; mometasone furoate 100 micrograms once daily [OD] (n = 126) or 200 micrograms OD (n = 126), BDP 200 micrograms twice daily (n = 126), or only placebo spray (n = 123). Physician-rated nasal and total symptom scores, and global evaluation of overall condition and therapeutic response by physicians and patients, showed that the three active treatments were equally effective, and all three were significantly superior to placebo at most time points. Overall, mometasone furoate 200 micrograms OD demonstrated somewhat greater numerical, but not statistical, superiority to mometasone furoate 100 micrograms OD at the earliest evaluation time point. At the end of treatment, complete or marked relief was obtained in 77% of patients with mometasone furoate 100 micrograms/day, 79% with mometasone furoate 200 micrograms/day, and 74% with BDP, compared with 54% of placebo vehicle control patients. Mometasone furoate and BDP were equally well tolerated. It was concluded that mometasone furoate adequately controls symptoms of moderate to severe seasonal allergic rhinitis, offers the advantage of OD treatment, and is well tolerated.

Topics: Administration, Inhalation; Administration, Topical; Adolescent; Adult; Aged; Anti-Allergic Agents; Anti-Inflammatory Agents; Beclomethasone; Double-Blind Method; Female; Glucocorticoids; Humans; Loratadine; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Seasonal

Topical nasal corticosteroids have become a mainstay of treatment for the symptoms of seasonal allergic rhinitis (SAR). It is likely that topical corticosteroids, by blocking an initial influx of inflammatory cells in the nasal mucosa induced by aeroallergens, may have a preventive effect on nasal allergy symptoms when administered before the pollen season.. This study was designed to assess the efficacy and safety of an 8-week course of mometasone furoate nasal spray (MFNS), 200 micrograms once daily, in the treatment of SAR compared with beclomethasone dipropionate aqueous nasal spray (BDP), 168 micrograms twice daily, and placebo vehicle, when treatment is initiated before the anticipated onset of the ragweed season.. Three hundred forty-nine patients with SAR to ragweed pollen from nine centers in the Northeast and Midwest of the United States were randomized to one of the three intranasal study medications (MFNS, 200 micrograms once daily, BDP, 168 micrograms twice daily, or placebo vehicle), starting 4 weeks before the estimated start of the ragweed season.. The proportion of "minimal symptom" days (total nasal symptom score < or = 2) was statistically significantly higher in both the MFNS and BDP groups when compared with the placebo vehicle group (p < 0.01). The two active treatment groups were not statistically significantly different from each other. MFNS and BDP displayed a similar safety profile that did not differ from placebo.. This suggests that MFNS, 200 micrograms (once daily), is a useful therapy in the prophylactic treatment of SAR.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Beclomethasone; Double-Blind Method; Glucocorticoids; Humans; Immunosuppressive Agents; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Seasonal

This international, multicentre, randomized, double-blind, double-dummy, parallel-group trial was undertaken to compare the efficacy and tolerability of once-daily astemizole-D (10 mg astemizole plus 240 mg pseudoephedrine) with beclomethasone nasal spray (0.05 mg/ml) two puffs/nostril administered twice daily in a total of 204 patients with seasonal allergic rhinitis. Treatment duration was 4 weeks. Although investigator assessments of symptom severity were generally comparable in the two treatment groups throughout the trial, statistically significant differences in favour of astemizole-D for sneezing and ocular symptoms were apparent at the end of the 4-week treatment period (P < 0.05). Patient diary data support these findings, with significant differences in favour of the antihistamine/decongestant combination reported for ocular symptoms after 2 weeks of treatment (P < 0.05) and non-significant trends for sneezing after 2 weeks and ocular symptoms over the entire treatment period (P = 0.07). Use of rescue medication for ocular symptoms was also significantly lower in the astemizole-D treatment group (P < 0.05). A wide range of adverse experiences were reported, however, there were no statistically significant differences in the type or incidence of those between the two treatment groups. In conclusion, astemizole-D appears to be at least as effective and well tolerated as intranasal beclomethasone in the treatment of seasonal allergic rhinitis, providing at least comparable relief from all nasal symptoms including congestion and significantly greater relief from ocular symptoms than the topical steroid.

Topics: Administration, Intranasal; Administration, Oral; Adolescent; Adult; Aged; Astemizole; Beclomethasone; Child; Double-Blind Method; Drug Tolerance; Female; Humans; Male; Middle Aged; Nasal Decongestants; Nebulizers and Vaporizers; Rhinitis, Allergic, Seasonal; Treatment Outcome

We compared the effect of nasal azelastine (0.56 mg/day), nasal beclomethasone dipropionate (BDP, 200 micrograms/day) and matched placebo on seasonal symptoms, nasal cytology, and the increase in bronchial responsiveness occurring during pollen season in a group of subjects with history of allergic rhinitis to grass pollens only.. The study was completed by nine subjects in the azelastine group, 13 subjects in the BDP group, and 13 subjects in the placebo group. Treatments were randomly administered for 6 weeks. Each subject recorded daily nasal, eye and chest symptoms and additional treatment requirement for the entire pollen season. Each subject performed nasal lavage 4 weeks into the pollen season. Bronchial responsiveness to methacholine was measured before and 4 weeks into the pollen season. Response was expressed as provocative dose causing a 20% fall in forced expiratory volume in 1 second in micromoles.. Azelastine-treated subjects had significantly fewer nasal symptoms during week 4 (p < 0.05), and BDP-treated subjects had fewer nasal symptoms during week 4 (p < 0.05) and week 5 (p < 0.05) compared with subjects given placebo. Both treatments significantly reduced the need for additional medications. BDP, but not azelastine, treatment significantly reduced the percent of eosinophils recovered in nasal lavage (p < 0.05). Neither azelastine nor BDP protected against the increase in bronchial responsiveness to methacholine occurring during the pollen season.. We demonstrated that both azelastine and BDP are effective treatments for nasal symptoms of seasonal allergic rhinitis after 4 weeks of therapy. However, we were not able to demonstrate an antiinflammatory activity of nasally administered azelastine. Nasal therapy with azelastine and BDP did not block the increase in bronchial responsiveness to methacholine caused by seasonal allergen exposure.

Topics: Administration, Intranasal; Adolescent; Adult; Beclomethasone; Bronchi; Bronchial Provocation Tests; Bronchodilator Agents; Double-Blind Method; Female; Humans; Male; Methacholine Chloride; Nasal Lavage Fluid; Phthalazines; Poaceae; Pollen; Rhinitis, Allergic, Seasonal

In order to compare the clinical efficacy and safety of beclomethasone dipropionate nasal spray (BDNS) manufactured in Chongqing Glaxo Limited (Group A) and Glaxo UK (Group B), a randomised double-blind parallel group study was performed. A total of 204 patients with seasonal or perennial allergic rhinitis were recruited into the study for a period of 2 weeks. Overall efficacy (excellent/good) was 88% for Group A (excellent 55%) and 90% for Group B (excellent 51%) respectively. Side effects were similar for both groups where dry nose was the most common complaint (4.9% for both groups). However, there was no statistical difference (P > 0.05) between the two groups either in efficacy or side effects. Pollen count was monitored throughout the study period. Pollen season was divided into three periods, i.e. the beginning, the peak and the end. There was no statistical difference (P > 0.05) between the two groups in any period.

Topics: Administration, Intranasal; Adolescent; Adult; Anti-Inflammatory Agents; Beclomethasone; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

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

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

Nasal cytograms of patients with allergic rhinitis contain increased numbers of eosinophils and basophilic cells. Neutrophils are also more numerous in cytograms of allergic persons. Topical intranasal corticosteroid therapy for allergic rhinitis has been shown to decrease the numbers of some inflammatory cell types. Fluticasone propionate aqueous nasal spray, a potent synthetic corticosteroid preparation, is effective therapy for seasonal and perennial allergic rhinitis.. Nasal mucosal scrapings were obtained with a Rhinoprobe (Apotex Scientific, Inc. Arlington, Texas) before and after therapy with fluticasone propionate aqueous nasal spray at several doses in patients with either seasonal allergic rhinitis (2 to 4 weeks' therapy) or perennial allergic rhinitis (24 weeks' therapy). More than 1000 paired nasal cytograms obtained from patients participating in five multicenter studies were evaluated.. The percentage of patients with nasal eosinophils (p < 0.01, most studies) and basophilic cells (p < 0.05, most studies) decreased significantly after treatment with fluticasone propionate compared with placebo-treated patients. Similar findings were observed with beclomethasone dipropionate in one study. The number of neutrophils remained relatively unchanged after treatment with the intranasal corticosteroids or placebo.. These findings suggest that the therapeutic benefits of topical intranasal fluticasone propionate and beclomethasone dipropionate for the therapy of seasonal and perennial allergic rhinitis are reflected by the decrease in inflammatory cells in the nasal mucosa.

Topics: Administration, Intranasal; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Double-Blind Method; Fluticasone; Glucocorticoids; Humans; Nasal Mucosa; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Topical corticosteroids are widely regarded as the reference standard in allergic rhinitis therapy because they are well tolerated and effective against all rhinitis symptoms. We evaluated the efficacy, onset of action, and safety of two dosing regimens of the new corticosteroid fluticasone propionate compared with that of beclomethasone dipropionate in patients with moderate to severe seasonal allergic rhinitis.. In this double-blind, randomized multicenter trial, 110 adolescents and 128 adults were treated for 4 weeks with one of the following regimens: fluticasone aqueous nasal spray 100 micrograms twice daily or 200 micrograms once daily, beclomethasone aqueous nasal spray 168 micrograms twice daily, or placebo.. Patient-rated scores for nasal obstruction, rhinorrhea, and combined nasal symptoms indicated that the two fluticasone regimens were equally effective and that both were superior to beclomethasone during most of the study (P < or = .05) and to placebo throughout the study (P < or = .01). Both fluticasone regimens also demonstrated significant clinical efficacy by 24 hours after the first dose. Clinician-rated mean total nasal symptoms scores for all three active treatments were superior to placebo at most time points but were not significantly different from each other. All treatments were well tolerated, with similar incidence and type of adverse events in all treatment groups and no apparent effects on hypothalamic-pituitary-adrenal (HPA) axis function.. Fluticasone aqueous nasal spray was effective in relieving nasal symptoms in adolescents and adults with seasonal allergic rhinitis. Fluticasone administered once or twice daily was superior to beclomethasone administered twice daily in relieving nasal obstruction and rhinorrhea and in reducing nasal symptoms more quickly.

Topics: Administration, Topical; Adolescent; Adult; Aged; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Child; Double-Blind Method; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Rhinitis, Allergic, Seasonal

We performed two seasonal studies to evaluate the effect of continuous treatment with intranasal steroids, beginning approximately 1 week before the appearance of ragweed pollen, on the level of ragweed-specific IgE antibodies in serum. In both studies the control groups showed the anticipated rise in ragweed-specific IgE antibodies after the ragweed season. In the first study, employing aqueous beclomethasone dipropionate (168 micrograms twice daily), no rise occurred in serum ragweed IgE after seasonal exposure and the level actually decreased in eight of 12 treated subjects. In the second study, with triamcinolone acetonide (220 micrograms twice daily), the expected rise in ragweed IgE antibody was also reduced, although less dramatically, probably as a result of the lower potency of the dose delivered. Our studies not only support the benefits of intranasal steroids in the treatment of seasonal allergic rhinitis but also suggest that specific IgE production may be down-regulated by their continuous use, which may alter the subsequent clinical course of the disease.

Topics: Administration, Intranasal; Adult; Antibodies, Anti-Idiotypic; Antibody Formation; Beclomethasone; Double-Blind Method; Humans; Immunoglobulin E; Middle Aged; Radioallergosorbent Test; Rhinitis, Allergic, Seasonal; Seasons; Triamcinolone Acetonide

The objective of this study was to compare regular and "as required" (prn) use of aqueous beclomethasone dipropionate nasal spray (Beconase AQ nasal spray) in the treatment of ragweed pollen-induced rhinitis and to examine possible predictors of unsatisfactory symptom control in the group of patients who used it on a prn basis.. Sixty adults with ragweed pollen-induced rhinitis, who had participated in previous hay fever studies or who responded to media notices, were enrolled in the study. The study design was a randomized, unblinded, parallel group comparison between regular use (400 micrograms daily) and prn use of Beconase AQ spray during the 6 weeks of the ragweed pollen season. Patients recorded daily symptoms and medication use in diaries. The Rhinoconjunctivitis Quality of Life Questionnaire was administered, and patient satisfaction with symptom control was assessed at clinic visits.. Symptoms and quality of life tended to be better in the regular group, but differences were not statistically significant. Twenty-seven percent of patients in the prn group reported unsatisfactory control of symptoms; they experienced significantly worse symptoms and quality of life than the remainder of the prn group and used significantly more Beconase. No obvious predictors of unsatisfactory control were identified. Patients who achieved satisfactory control in the prn group had symptom and quality of life scores that were very similar to those of the regular group.. Most patients can use Beconase AQ as needed successfully for the treatment of hay fever, but there may be an apparently unpredictable minority who do not achieve satisfactory symptom control or quality of life with this approach and who require regular treatment.

Topics: Adolescent; Adult; Aerosols; Aged; Analysis of Variance; Beclomethasone; Female; Humans; Male; Middle Aged; Pollen; Quality of Life; Regression Analysis; Rhinitis, Allergic, Seasonal; Severity of Illness Index; Time Factors

The effect of treatment of allergic rhinitis with intranasal corticosteroids on lower airway responsiveness was assessed in a randomized, double-blind, placebo-controlled, crossover study. Twenty-one young patients with perennial allergic rhinitis and asthma, with documented lower airway hyperresponsiveness (PC20 methacholine < 8 mg/ml), were treated with intranasal aqueous beclomethasone dipropionate and placebo, each given for 4 weeks. Patients recorded rhinitis and asthma symptom scores and monitored peak expiratory flow rates every morning and evening. Patients recorded global assessment of rhinitis and global asthma symptom scores at the beginning and end of each treatment. PC20 methacholine was performed at baseline and at the end of each treatment period. Intranasal beclomethasone dipropionate significantly reduced global rhinitis symptom scores (p = 0.05) after 4 weeks of treatment. Global asthma scores did not change significantly (p = 0.2). Geometric mean PC20 methacholine improved significantly after 4 weeks of intranasal beclomethasone, but not after placebo (p = 0.04). Daily morning and evening rhinitis symptom scores were lower in patients treated with intranasal corticosteroids over the first 4 weeks of treatment, but carryover effect of steroids precluded comparative analysis of the second 4-week block (morning p = 0.06, evening p = 0.03). Morning asthma scores tended to decrease (p = 0.07). Evening asthma scores were significantly decreased at weeks 2 and 3 (p = 0.001, p = 0.02, respectively). No change in peak expiratory flow rate was seen. This study confirms that treatment of inflammation in the upper airways indirectly improves asthma symptoms and decreases bronchial hyperreactivity. Ignoring inflammation in the upper airway may lead to suboptimal results in asthma treatment.

Topics: Administration, Intranasal; Adolescent; Analysis of Variance; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Child; Circadian Rhythm; Double-Blind Method; Humans; Methacholine Chloride; Rhinitis, Allergic, Seasonal; Time Factors

Thirty-nine children with grass pollen hay fever were randomly treated with nasal inhaled beclomethasone dipropionate (BDP) 200 or 400 microg/day or sodium cromoglycate (SCG) 30 mg/day for 2 months during the pollen season. Serum osteocalcin (OC), parathyroid hormone (PTH), total alkaline phosphatase (AP), bone alkaline phosphatase (BAP) and type I collagen telopeptide (ICTP) were measured immediately before, 1 and 2 months after treatment and 1 week after stopping the therapy. No significant changes in OC, PTH, AP, BAP and ICTP serum level occurred within each group. Minor and probably clinically insignificant between group differences were occasionally found. Our study shows that BDP nasal spray has no significant effect on common markers of bone metabolism.

Topics: Administration, Intranasal; Adolescent; Aerosols; Alkaline Phosphatase; Beclomethasone; Biomarkers; Bone and Bones; Bone Remodeling; Child; Collagen; Collagen Type I; Cromolyn Sodium; Female; Glucocorticoids; Humans; Isoenzymes; Male; Osteocalcin; Parathyroid Hormone; Peptides; Pollen; Rhinitis, Allergic, Seasonal

Nasal washings (NW) have been used by many investigators as a readily available biologic fluid for studying the mechanism of allergic reactions. These fluids have been analyzed for the presence of various mediators, including cytokines. Recently, histamine releasing factors (HRF) have been detected in the NW. The objective of this study was to investigate the effect of treatment with topical corticosteroids on the recovery of these cytokines from the NW obtained from patients with allergic rhinitis. A group of 30 patients with ragweed pollen allergy were given either beclomethasone dipropionate (BDP) or placebo for 1 wk in a double-blind randomized manner. NW were performed twice before the start of the treatment period and were repeated twice at the end of the study. HRF activity was measured in the NW. Patients maintained a daily symptom score. The activity of HRF decreased significantly (mean +/- SD, pre = 37.2 +/- 21.3% versus post = 23.8 +/- 20.1%; p less than 0.01) in the BDP group, as did the mean symptom score (5.1 +/- 1.4 versus 1.5 +/- 1.5, p less than 0.01) at the end of the treatment period. In contrast, there was no significant change in HRF recovery (32.8 +/- 25.6% versus 33.8 +/- 25.3%; p less than 0.05) or symptom score (4.8 +/- 1.8 versus 5.4 +/- 1.9; p greater than 0.05) in the placebo group. There was a significant correlation between the net changes in symptom scores and the net differences in HRF activity. We speculate that the reduction in HRF in the nasal mucosa may contribute to the clinical efficacy of topical corticosteroids.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Aerosols; Beclomethasone; Cytokines; Double-Blind Method; Female; Histamine Release; Humans; Male; Nasal Mucosa; Rhinitis, Allergic, Seasonal; Therapeutic Irrigation

Topics: Administration, Intranasal; Administration, Oral; Adult; Beclomethasone; Double-Blind Method; Female; Histamine Antagonists; Humans; Loratadine; Male; Rhinitis, Allergic, Seasonal

We have undertaken a double blind placebo controlled study of the effect of nasal beclomethasone on the tendency to wheeze in 20 unselected hay fever sufferers, half with a history of previous seasonal wheezing. We found no difference between either bronchial hyperresponsiveness, as measured by methacholine challenge, home-monitored PEFR, nor recorded wheeze nor cough between treated and placebo groups although the numbers were small. All were allowed the antihistamine cetirizine hydrochloride 10 mg daily. Eighteen out of the 19 patients had either bronchial hyperresponsiveness (PD20 methacholine < 8 mumol or a > 2 doubling dose change in their PD20 during the pollen season). We have shown a significant positive correlation between a hay fever score (HFS) (created by taking the sum of the home scored; nasal discharge, nasal blockage, eye irritation, sneeze and antihistamine use) and peak seasonal specific IgE to mixed grass pollen (Spearman correlation coefficient 0.5 P < 0.02). There was also a positive correlation between the rise in specific IgE from pre to peak season and the HFS, correlation coefficient 0.6 P = 0.03).

Topics: Administration, Intranasal; Adult; Asthma; Beclomethasone; Bronchial Provocation Tests; Double-Blind Method; Humans; Immunoglobulin E; Middle Aged; Respiratory Sounds; Rhinitis, Allergic, Seasonal

Experimental studies have demonstrated that induction of a nasal allergic reaction can lead to an increase in bronchial responsiveness (BR). To assess the clinical relevance of these experimental changes to chronic asthma, we sought to determine the effect of nasal beclomethasone dipropionate (Bdp) on BR in patients with seasonal allergic rhinitis and asthma. Eighteen subjects with histories of seasonal allergic rhinitis and asthma during the fall pollen season with positive skin tests to short ragweed and bronchial hyperresponsiveness to inhaled methacholine were assigned to receive either nasal Bdp (336 micrograms/day) or placebo for the entire ragweed season. Patients recorded daily nasal and chest symptoms, nasal blockage index, oral peak expiratory flow rates, and supplemental medication use. BR to methacholine was measured during the baseline period and 6 weeks into the ragweed season. Although the Bdp group did have a significant improvement in nasal blockage index, there was no improvement in daily asthma symptom scores, oral peak expiratory flow, or asthma medication use. However, subjects treated with Bdp were protected from the increase in BR seen in the placebo group (geometric mean PC20 placebo group: baseline = 0.70, week 6 = 0.29; Bdp group: baseline = 0.80, week 6 = 0.93; intergroup difference, p = 0.022). We conclude that nasal corticosteroid therapy can prevent the increase in BR associated with seasonal pollen exposure in patients with allergic rhinitis and asthma.

Topics: Administration, Intranasal; Asthma; Beclomethasone; Bronchi; Bronchial Provocation Tests; Double-Blind Method; Forced Expiratory Volume; Humans; Medical Records; Peak Expiratory Flow Rate; Pollen; Rhinitis, Allergic, Seasonal; Seasons

Fluticasone propionate was compared with beclomethasone dipropionate for the treatment of allergic rhinitis in a multicenter, double-blind, randomized, placebo-controlled study during the mountain cedar (Juniperus ashei) pollination season in central Texas. Adults (n = 313) with moderate to severe symptoms were treated with fluticasone propionate aqueous nasal spray 200 micrograms once a day or beclomethasone dipropionate aqueous nasal spray 168 micrograms twice a day or placebo for 2 weeks. Fluticasone propionate administered once daily and beclomethasone dipropionate administered twice daily were equally effective as assessed by clinician- and patient-rated scores for nasal obstruction, rhinorrhea, sneezing, and nasal itching throughout the treatment and follow-up periods. Both regimens were more effective than placebo. Adverse events were related to topical administration and were similar in frequency and nature in all three treatment groups. Fluticasone propionate and beclomethasone dipropionate displayed a similar safety profile that did not differ from placebo. We conclude that fluticasone propionate aqueous nasal spray administered as 200 micrograms once daily in the morning is as safe and effective as beclomethasone dipropionate aqueous nasal spray administered as 168 micrograms twice daily for seasonal allergic rhinitis.

Topics: Administration, Topical; Adolescent; Adult; Aged; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Drug Administration Schedule; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Rhinitis, Allergic, Seasonal

The aim of the study was to compare the efficacy and side-effects of oral antihistamine and nasal glucocorticoid therapy in seasonal allergic rhinitis. In a double-blind, double-dummy, group-comparative study, 60 birch and grass pollen allergic patients were treated with either loratadine (10 mg daily) or beclomethasone dipropionate (BDP) (100 micrograms in each nostril twice daily) during a 3 weeks' study period. Grading of 4 nasal and 3 non-nasal symptoms was performed at 4 weekly visits, and patients recorded daily symptoms and possible adverse experiences in a diary. Patients treated with BDP showed significantly less nasal blockage than those receiving loratadine (P less than 0.05), but there was no difference (P greater than 0.05) in other nasal symptoms (sneezing, itching and discharge). Patients treated with loratadine showed a statistically significantly greater relief in eye symptoms as compared with BDP (P less than 0.05). The side-effects caused by the 2 treatments were few and insignificant. We conclude that loratadine and intranasal BDP were effective in the treatment of seasonal allergic rhinitis, but the spectrum of individual symptoms controlled was different for the 2 drugs.

Topics: Administration, Intranasal; Administration, Oral; Adult; Aged; Beclomethasone; Cyproheptadine; Double-Blind Method; Eye; Female; Histamine Antagonists; Histamine H1 Antagonists; Humans; Loratadine; Male; Middle Aged; Nose; Poaceae; Pollen; Pruritus; Rhinitis, Allergic, Seasonal; Sneezing; Time Factors; Trees

Patients with ragweed-induced seasonal allergic rhinitis were assigned randomly to be challenged intranasally either with ragweed or histamine while asymptomatic before the ragweed season. After initial challenge, all were treated either by placebo (P), beclomethasone dipropionate (BE), 400 micrograms daily, or budesonide (BU), 1200 micrograms daily, intranasally for 14 days. Repeat challenge was then compared with the previous ones in order to assess the effects of both usual (400 micrograms) and high doses (1200 micrograms) of topical steroids on both allergen-induced and nonspecific (histamine) nasal reactivity. Incremental doses of either histamine or ragweed were insufflated intranasally until a positive response defined the threshold reactivity. Reactions were assessed by a combination of changes in flow rates (rhinomanometry), secretions (mL), and sneezes with ten minutes of challenge. There was no difference in initial threshold reactivities among the treatment groups. Neither BE nor BU changed reactivity to ragweed. There were no adverse reactions except epistaxis in two BU patients. Histamine challenges disclosed a change in threshold reactivity, BU (P much less than .01) greater than BE (P much less than .05), compared with placebo. In summary, even high doses (1200 micrograms) of topical steroids had minimal effects on the early response to intranasal ragweed challenge. In contrast, both usual and high doses affected nonspecific histamine reactivity; this may contribute to some of the clinical improvement noted in symptoms of allergic rhinitis.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Child; Dose-Response Relationship, Drug; Female; Glucocorticoids; Histamine; Humans; Male; Middle Aged; Nasal Provocation Tests; Pollen; Pregnenediones; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

to determine the effect of alternative regimens of nasal steroid administration on symptoms and quality of life.. randomized, double-blind, parallel-group comparison.. sixty ragweed-sensitive adults recruited from participants of previous studies and through media advertising.. 200 micrograms of aqueous beclomethasone diproprionate nasal spray, twice daily, from 1 week before until 1 week after the ragweed-pollen season (regular) or 100 micrograms of the spray, taken as required, up to 400 micrograms daily; troublesome nasal symptoms were treated, in both groups, by increasing the daily dose to 800 micrograms until symptoms were controlled. If this treatment was insufficient, 120 mg of terfenadine, daily, was added.. One subject in the "as required"-treated group withdrew with uncontrolled nasal symptoms. In the remaining subjects, sneezing, stuffy nose, and rhinorrhea, measured by a daily diary, were significantly better controlled in the regular-treated group (p less than 0.025). Impairment of quality of life, including sleep disturbance, nonhay fever symptoms, practical problems, and uncomfortable emotions were greater in the as required-treated group (p less than 0.001). Subjects in the regular-treated group required less additional terfenadine (0.27 tablets per subject versus 1.40; p = 0.022). Eye symptoms and eye-drop use were similar in the two treated groups.. In patients with seasonal allergic rhinitis, regular use of inhaled steroids results in fewer symptoms and better quality of life than when the spray is taken only as required.

Topics: Adolescent; Adult; Aerosols; Beclomethasone; Child; Drug Administration Schedule; Female; Humans; Male; Rhinitis, Allergic, Seasonal

A 3-week double-blind, parallel group study comparing the effectiveness and safety of an aqueous formulation of beclomethasone dipropionate (BDP-AQ) versus placebo was undertaken in 101 patients. Children aged 5 to 13 years with a diagnosis of seasonal allergic rhinitis received one spray in each nostril twice daily of either BDP-AQ (42 micrograms/spray) or an identical placebo spray. Patient assessment at the end of treatment indicated statistically significant improvement in nasal symptoms for BDP-AQ patients. The physicians overall evaluation of treatment indicated that the BDP-AQ-treated patients experienced significantly greater (P = .012) improvement as compared with placebo-treated patients. There was no difference in the incidence of adverse events between the two treatments. The results demonstrate the effectiveness and safety of BDP-AQ nasal spray in the treatment of seasonal allergic rhinitis in children.

Topics: Adolescent; Age Factors; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Random Allocation; Rhinitis, Allergic, Seasonal; Time Factors

Forty-four patients, with symptoms of nasal obstruction, sneezing, itching and/or rhinorrhea, were entered into a placebo-controlled, double-blind study to evaluate the clinical efficacy of a topical antihistamine drug, levocabastine, applied 4 times a day for 14 days. At the end of the treatment the placebo patients were treated with levocabastine and the levocabastine patients were treated with beclomethasone dipropionate in a single-blind design for another 14 days. This study showed that levocabastine is significantly more active than placebo with reference to nasal discharge and sneezing. Placebo application improved the symptom score. Levocabastine could not be proved to be more effective against nasal obstruction than placebo in the double-blind trial. In the single-blind set-up, levocabastine resulted in an additional improvement in the score for obstruction, after the placebo period. Although the allergic group tended to respond better, no statistically significant difference could be detected between allergic and non-allergic patients. After treatment with levocabastine, beclomethasone dipropionate administration could not improve the results for nasal discharge and sneezing. For nasal congestion, beclomethasone dipropionate proved to be superior to levocabastine.

Topics: Administration, Intranasal; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Piperidines; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Topics: Administration, Topical; Adult; Beclomethasone; Female; Humans; Male; Mast Cells; Nasal Mucosa; Rhinitis, Allergic, Seasonal; Seasons

Although three effective topical treatments for allergic rhinitis are available, little information to assist the clinician in choosing among them has been reported. Therefore, we conducted a randomized clinical trial to compare beclomethasone nasal solution, flunisolide, and cromolyn with placebo in 120 patients with hay fever during the ragweed season of 1984. We found that all three agents were superior to placebo (P less than 0.001) and that the glucocorticoids were more effective than cromolyn (P less than 0.001). Surprisingly, we also found that these intranasal treatments considerably reduced the symptoms of seasonal asthma. Further study of this therapeutic advantage is needed.

Topics: Administration, Intranasal; Adolescent; Adult; Beclomethasone; Child; Clinical Trials as Topic; Cromolyn Sodium; Female; Fluocinolone Acetonide; Humans; Male; Middle Aged; Random Allocation; Rhinitis, Allergic, Seasonal

Forty-one patients were treated during the birch pollen season for three weeks in a randomized, double-blind placebo controlled preliminary study. Ten patients were treated with beclomethasone dipropionate aerosol 400 micrograms once daily, 10 patients with placebo once daily, 10 patients with 400 micrograms beclomethasone dipropionate in the morning and placebo in the evening and 11 patients with 200 micrograms beclomethasone twice daily. The severity of the nasal symptoms was compared before the trial, during the pollen season without treatment, at the time of peak pollen counts and at the end of the treatment. Symptoms were equally controlled by beclomethasone dipropionate 400 micrograms once daily (two puffs of 100 micrograms per nostril), and 200 micrograms twice daily (two puffs of 50 micrograms per nostril twice). All active drug regimens were better than placebo. In conclusion, this study shows that one-dose beclomethasone dipropionate of 400 micrograms is effective in the treatment of seasonal allergic rhinitis.

Topics: Adult; Aerosols; Beclomethasone; Clinical Trials as Topic; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Pollen; Rhinitis, Allergic, Seasonal

The clinical potency of budesonide, a new glucocorticosteroid, was compared in a randomized double-blind study with beclomethasone dipropionate in the treatment of seasonal allergic rhinitis during the ragweed-pollen season. Sixty-one subjects were matched according to their skin sensitivity to ragweed-pollen extract and the severity of ragweed-induced rhinitis during the previous season. Thirty subjects received budesonide, and 31 received beclomethasone dipropionate, 50 micrograms per actuation. A double-dummy technique was used to achieve blinding, since the aerosol canisters and adaptors were dissimilar. Subjects were instructed to keep rhinitis well controlled by starting intranasal trial medication as soon as symptoms became troublesome, two puffs into each nostril, when it was needed, up to four times per day. If this became inadequate, subjects received supplementary chlorpheniramine maleate, 4 mg. Nasal symptoms (none = 0, mild = 1, moderate = 2, and severe = 3) and all medication use were recorded daily in a diary. Budesonide demonstrated better clinical potency than beclomethasone in that less was needed to maintain good control of nasal symptoms. Side effects were mild and transient for both groups.

Topics: Administration, Inhalation; Beclomethasone; Budesonide; Conjunctivitis; Cough; Female; Humans; Male; Middle Aged; Pregnenediones; Rhinitis, Allergic, Seasonal

Seventy-four patients with a well documented history of seasonal allergic rhinitis were randomly allocated to receive either astemizole 10 mg orally per day or beclomethasone 100 micrograms in each nostril twice daily on a double-blind double-dummy basis. The patients were studied in a general practice setting and were seen at entry, during the study and at the end of the study by a single observer, the author. Assessment was by diary card incorporating five 10 cm visual analogue scales related to the four symptoms of sneezing, rhinorrhoea, blocked nose and itchy eyes and an overall assessment of hay fever symptoms. Patients were asked if the medication had upset them in any way at each observer assessment. Symptom severity, as recorded by the visual analogue scales, was not significantly different for sneezing, rhinorrhoea, blocked nose or overall between the two groups but the symptom scores for itchy eyes were significantly better for the astemizole group. Adverse effects were minimal and of a minor nature only. There was no real difference between the two groups regarding adverse effects. The study suggests that oral astemizole is at least as good as nasal beclomethasone in the maintenance treatment of hay fever and that it offers the additional advantage of improved control of eye symptoms.

Topics: Administration, Intranasal; Administration, Oral; Adult; Astemizole; Beclomethasone; Benzimidazoles; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Random Allocation; Rhinitis, Allergic, Seasonal

The currently available beclomethasone dipropionate (BDP) metered-dose nasal aerosol spray is considered uncomfortable by some patients because of the force of delivery. It was compared for efficacy and acceptability in a double-blind study with a new aqueous suspension BDP spray for the treatment of seasonal allergic rhinitis in 44 symptomatic patients aged 12 to 43 years. After 7 days of baseline evaluation, every patient was given both an aerosol canister and an aqueous spray bottle each containing either BDP, 42 mcg per spray, or placebo (P). For 15 days the patient sprayed each nostril twice a day with one spray of suspension (BDP or P) followed 5 minutes later by one spray of aerosol (P or BDP). Patients were evaluated before the study medications were started (day 1) and on days 4, 8, and 15 for nasal and eye symptoms. Nasal cytologic specimens were examined on days 1 and 15, and rhinomanometry was performed on days 1, 8, and 15 of the study. Topical BDP by both methods of delivery was rapidly effective in decreasing mean nasal obstruction, rhinorrhea, sneezing, and itching symptoms as well as mean eye symptoms with no statistically significant differences between them. Nasal airflow increased with both treatments; rhinomanometry significantly correlated with subjective nasal obstruction scores. Of 34 patients with nasal eosinophils, 74% had fewer eosinophils after treatment. Most patients (84%) preferred the aqueous spray over the pressurized aerosol.

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Allergens; Asthma; Beclomethasone; Humans; Nasal Mucosa; Pollen; Rhinitis, Allergic, Seasonal

From the start of the Astemizole clinical investigations, until now the results of 39 trials including more than 2300 patients are available. These results show that Astemizole is an effective and safe Histamine-H1-antagonist for the therapy of hayfever, chronic allergic rhinitis, allergic conjunctivitis, chronic urticaria and allergic bronchitis in adults and children. Astemizole was superior to placebo and the classical antihistamines like Clemastine, Terfenadine, Ketotifen, Mequitazine, pheniramine and Chlorphenamine.

Topics: Astemizole; Beclomethasone; Benzimidazoles; Bronchitis; Clinical Trials as Topic; Conjunctivitis; Double-Blind Method; Drug Therapy, Combination; Histamine H1 Antagonists; Humans; Hypersensitivity; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Urticaria

Forty-nine patients participated in a randomized double-blind, parallel group comparison of beclomethasone dipropionate aqueous nasal spray with terfenadine tablets in the treatment of hay fever. Symptom scores for nasal and ocular symptoms as well as grass pollen counts were registered daily for at least 1 month. Evaluation of daily symptom scores and the physicians' and patients' assessments of treatment demonstrated that both treatments were effective in controlling the symptoms of hay fever, with a similar incidence of side-effects. The beclomethasone dipropionate group, in general, had lower nasal symptom scores than the terfenadine group and this reached statistical significance on high pollen count days. In contrast, the terfenadine group had lower eye symptom scores than the other group and these were statistically significant during the first half of the study period. However, the use of additional medication for control of eye symptoms was similar in both groups. It is concluded that treatment with both beclomethasone dipropionate and terfenadine throughout the season was effective in controlling hay fever symptoms, but beclomethasone dipropionate is likely to provide better overall control since it prevented breakthrough of troublesome nasal symptoms during high pollen count days.

Topics: Administration, Intranasal; Administration, Oral; Adolescent; Adult; Beclomethasone; Benzhydryl Compounds; Clinical Trials as Topic; Double-Blind Method; Female; Histamine H1 Antagonists; Humans; Male; Middle Aged; Random Allocation; Rhinitis, Allergic, Seasonal; Terfenadine; Time Factors

A formulation of 2% cromolyn sodium (CS) ophthalmic solution without the preservative, 2-phenylethanol, was compared with placebo in 58 patients with seasonal allergic conjunctivitis. Selection was based on history and positive skin tests. Neither immunotherapy nor use of antihistamines was allowed. This study was double-blinded and stratified by RAST scores to assure comparable groups. Either CS or placebo was used six times daily. Patients were observed weekly for 5 weeks during the peak of the fall weed-pollen exposure. Nasal symptoms were treated as required with beclomethasone nasal spray, and uncontrolled ocular symptoms were treated with boric acid and ephedrine solution. Nasal and ocular symptoms were recorded. There was a significant suppression of eye symptoms in the group receiving CS ophthalmic solution (p less than 0.02) during weeks 2, 4, and 5. There was a trend for nasal symptoms and the requirement for nasal beclomethasone to be less in patients receiving CS.

Topics: Adolescent; Adult; Beclomethasone; Child; Clinical Trials as Topic; Conjunctivitis, Allergic; Cromolyn Sodium; Double-Blind Method; Female; Humans; Male; Middle Aged; Ophthalmic Solutions; Patient Compliance; Radioallergosorbent Test; Random Allocation; Rhinitis, Allergic, Seasonal

Topics: Adolescent; Adult; Aerosols; Beclomethasone; Female; Humans; Male; Rhinitis, Allergic, Seasonal

Topics: Adult; Airway Resistance; Anti-Inflammatory Agents; Beclomethasone; Double-Blind Method; Female; Humans; Hydrocortisone; Male; Nasal Cavity; Random Allocation; Rhinitis, Allergic, Seasonal

A multi-centre, double-blind, parallel group study was carried out in 38 patients with seasonal rhinitis to compare a new aqueous nasal spray of beclomethasone dipropionate with the conventional pressurized nasal spray. Beclomethasone dipropionate (200 micrograms) was administered twice daily for a treatment period of 2 weeks. Both treatments were found to be equally effective and well tolerated. It is suggested, therefore, that the new aqueous nasal spray provides an alternative method of intranasal administration of the steroid for patients who may prefer an aqueous product.

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Beclomethasone; Child; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Random Allocation; Rhinitis, Allergic, Seasonal; Time Factors

Forty patients with seasonal rhinitis and a proven sensitivity to pollens were studied for 2 weeks during the pollen season of 1982. The study was carried out according to a double-blind, double-dummy design. All patients received 100 micrograms beclomethasone dipropionate (BDP) into each nostril twice daily (400 micrograms/day) on a randomized basis, from either the aqueous nasal spray or the pressurized nasal spray (Beconase Nasal Spray). Analysis of patients' symptom scores, additional symptomatic medication and physicians' assessment indicated that both treatments were equally effective in controlling the symptoms of seasonal rhinitis. Any adverse events reported were considered to be clinically insignificant. BDP aqueous nasal spray was therefore found to be an effective and acceptable therapy in the management of seasonal rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Beclomethasone; Child; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Pressure; Rhinitis, Allergic, Seasonal

Sixty-nine patients were entered into a randomized, single-blind, parallel group study. Patients had a history of moderate to severe seasonal allergic rhinitis and all patients commenced treatment before the start of the pollen season. Treatment was with either flunisolide or beclomethasone dipropionate, both being administered as 2 sprays to each nostril twice daily for 7 weeks. Assessments of signs and symptoms of hay fever were made at admission and after 3 and 7-weeks' treatment. Patients were asked to keep a daily record of the severity of their symptoms. The overall effect of treatment was evaluated by both the patient and physician. Side-effects were elicited by indirect questioning. Sixty patients completed the study. Four patients from the flunisolide group and 2 from the beclomethasone group were lost to follow-up. Two further patients withdrew from the flunisolide group and 1 from the beclomethasone group. Analysis of results did not reveal any statistically significant differences between the treatments. Minor side-effects were reported by 1 patient from each treatment group. Both treatments proved to be effective in the treatment of hay fever and were equally well tolerated.

Topics: Administration, Intranasal; Adult; Beclomethasone; Clinical Trials as Topic; Female; Fluocinolone Acetonide; Humans; Male; Middle Aged; Random Allocation; Rhinitis, Allergic, Seasonal; Time Factors

Topics: Administration, Topical; Anti-Inflammatory Agents; Beclomethasone; Child; Child, Preschool; Female; Fluocinolone Acetonide; Humans; Male; Rhinitis, Allergic, Seasonal

In order to evaluate the effects of flunisolide and beclomethasone dipropionate nasal sprays on seasonal allergic rhinitis, 45 patients were included in an open parallel comparative trial. The study design was open because of the different dosage schedules for the two preparations. Strict criteria were set up for patient selection, and all patients were carefully examined and assessed before and after the 4-week trial period. Throughout the whole treatment each patient kept a detailed daily record. A substantial or complete control of symptoms was achieved in 18 of the 21 patients on flunisolide and in 20 of the 22 on beclomethasone dipropionate. No serious side effects were observed. Thus it can be concluded that both test drugs are effective and well tolerated in the treatment of seasonal allergic rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Analysis of Variance; Beclomethasone; Clinical Trials as Topic; Fluocinolone Acetonide; Histamine H1 Antagonists; Humans; Nasal Mucosa; Rhinitis, Allergic, Seasonal; Sneezing

Seventy patients with seasonal allergic rhinitis and with positive skin test to birch pollen were treated during the birch pollen season for three weeks in a randomized, double-blind placebo controlled, multicenter study. Nineteen patients were treated with beclomethasone dipropionate aerosol (50 micrograms/puff) one puff per nostril X 4 (daily dose 400 micrograms), 20 patients with beclomethasone dipropionate aerosol two puffs per nostril X 2 (daily dose 400 micrograms), 15 patients with placebo one puff per nostril X 4, and 16 patients with placebo two puffs per nostril X 2. Efficacy of the therapy was assessed through rhinoscopy (swelling and secretion of the mucous membrane) and measuring the nasal peak expiratory flow (NPEF) before, during and at the end of the trial. Nasal symptoms and the use of antihistamine tablets were recorded for five days before the trial and daily throughout the trial. Atmospheric pollen concentrations were recorded daily and the treatment was started two days after the air pollen counts had exceeded 10/m3. The severity of the nasal symptoms was compared in the statistical analysis before the trial, during the pollen season without treatment and at the time of peak pollen counts during the treatment. Both active regimens controlled the symptoms effectively (p less than 0.01) and both placebos showed no significant effect on the symptoms. In rhinoscopy, both active drugs reduced the swelling of the mucous membrane and the difference was significant (p less than 0.05). No statistical differences were found in the NPEF or in the use of antihistamine tablets between the four groups. In conclusion this study showed that two-dose beclomethasone dipropionate with a daily dose of 400 micrograms is effective in the treatment of seasonal allergic rhinitis.

Topics: Administration, Intranasal; Adult; Aerosols; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Pollen; Rhinitis, Allergic, Seasonal; Trees

Fifty-two patients with seasonal allergic rhinitis were admitted to a randomized clinical comparison between budesonide (Rhinocort) and beclomethasone dipropionate (Becotide Nasal). All patients were sensitive to birch pollen, which was confirmed by a skin prick test. The drugs were administered intranasally 200 micrograms b.i.d. Symptoms were assessed over four weeks starting with a run-in period of one week. Daily pollen counts were recorded throughout the trial and showed a rather mild birch pollen season. The patients diary cards revealed a beneficial therapeutic effect of the two drugs. No statistically significant differences between the drugs were seen except with regard to sneezing symptoms, where the Rhinocort-treated patients showed less symptoms (p less than 0.05). Side effects were few and transient with both drugs.

Topics: Administration, Topical; Adolescent; Adult; Aerosols; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Clinical Trials as Topic; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Middle Aged; Nasal Provocation Tests; Pregnenediones; Random Allocation; Rhinitis, Allergic, Seasonal

This study was undertaken in order to develop a method for comparing the value of different forms of treatment for hay fever. A cross-over trial was carried out in sixty-one patients, comparing four treatments: topical corticosteroids, topical cromoglycates, placebo tablets and oxatomide (a new oral treatment with antihistamine and cromoglycate-like properties). Three methods were used to compare these treatments: (1) post-treatment symptom questionnaires; (2) daily analogue line scores of symptoms; and (3) nasal FEV1. Of these, daily analogue line diary scores, with an analysis which took into account variation in pollen count, proved to be the most sensitive. By employing this diary method, it was shown that all three active treatments were significantly better than placebo and that topical corticosteroids were significantly better than topical cromoglycates. The activity of oxatomide was found to be not significantly different from that of steroids or cromoglycate, but it was associated with more frequent side-effects. It is suggested that daily diaries, combining symptom relief and freedom from side effects into a single score of 'usefulness' adjusted for pollen count, are suitable means for comparing treatments for hay fever.

Topics: Adult; Airway Resistance; Beclomethasone; Clinical Trials as Topic; Cromolyn Sodium; Female; Forced Expiratory Volume; Humans; Male; Patient Compliance; Piperazines; Placebos; Pollen; Rhinitis, Allergic, Seasonal; Self-Assessment

Forty-two subjects took part in a double-blind, double-dummy, parallel group study to compare the efficacy and tolerance of a nasal spray containing an aqueous suspension of beclomethasone dipropionate with the conventional pressurized spray in controlling the symptoms of seasonal rhinitis. Each patient received 100 micrograms beclomethasone dipropionate into each nostril twice daily for 14 days. Evaluation of daily symptom scores, and the physician's and subjects' assessment of treatment, demonstrated that both sprays were equally effective in alleviating symptoms and with a similar low incidence of side-effects. The aqueous spray may be considered an effective alternative treatment in the management of seasonal rhinitis.

Topics: Administration, Intranasal; Adult; Aerosols; Beclomethasone; Female; Humans; Male; Middle Aged; Rhinitis, Allergic, Seasonal

Topics: Administration, Topical; Adolescent; Adult; Aerosols; Anti-Inflammatory Agents; Beclomethasone; Clinical Trials as Topic; Female; Fluocinolone Acetonide; Humans; Male; Middle Aged; Nasal Mucosa; Rhinitis, Allergic, Seasonal

Forty-seven informed out-patients with the diagnosis seasonal rhinitis of at least two years' duration took part in a controlled single blind, double observer, parallel four-center study for the purpose to compare efficacy and tolerance of two local corticosteroid nasal sprays: flunisolide 25 micrograms/dose and beclomethasone 50 micrograms/dose. The patients received for four weeks one of the two treatments; flunisolide 50 micrograms in each nostril twice daily or beclomethasone dipropionate 50 micrograms in each nostril four times daily. The study was conducted under the Declaration of Helsinki. Patients were assessed on admission and after two and four weeks. All patients completed the trial. The results showed that both drugs are highly effective in controlling nasal rhinitis symptoms, 21 out of 24 flunisolide treated patients and 21 out of 23 beclomethasone treated stated good to total control after four weeks' treatment during the pollen season. No statistical difference between the two could be discovered in any of the parameters measured. The only side effect recorded was mild transistory stinging in connection with application of the two different sprays. This occurred in a few patients in both groups. The results from the study indicate that the new corticosteroid flunisolide in a dose of 100 micrograms X 2 is comparable to beclomethasone dipropionate 100 micrograms X 4 concerning efficacy and tolerance in prophylactic treatment of seasonal rhinitis.

Topics: Administration, Topical; Adolescent; Adult; Aerosols; Anti-Inflammatory Agents; Beclomethasone; Child; Clinical Trials as Topic; Drug Administration Schedule; Female; Fluocinolone Acetonide; Glucocorticoids; Humans; Male; Random Allocation; Rhinitis, Allergic, Seasonal

Topics: Administration, Intranasal; Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents; Beclomethasone; Betamethasone; Child; Clinical Trials as Topic; Fluocinolone Acetonide; Humans; Middle Aged; Placebos; Research Design; Rhinitis, Allergic, Seasonal

93 patients with seasonal allergic rhinitis took part in a single blind randomized clinical comparison of budesonide and beclomethasone dipropionate (Becotide Nasal). All patients were sensitive to either birch or grass pollen, their sensitivity being confirmed by a skin prick test. The total daily dose was 400 micrograms for both drugs. Budesonide was administered twice a day and Becotide Nasal four times a day. Symptoms were assessed over a four-week period starting with a run-in period of one week. There was no placebo control group. Daily pollen counts were measured throughout the trial. The patients' diary cards revealed that both drugs had a beneficial therapeutic effect, and that budesonide was significantly more active than Becotide Nasal. The side effects of both drugs were few and transient.

Topics: Adolescent; Adult; Beclomethasone; Budesonide; Drug Evaluation; Female; Humans; Male; Middle Aged; Pregnenediones; Rhinitis, Allergic, Seasonal

A double-blind, parallel-design multicentric study, in two phases, was conducted to examine the safety and efficacy of 2-wk treatment with various doses of beclomethasone dipropionate nasal aerosol (BDNA) and placebo in adults with seasonal allergic rhinitis. In phase I, 162 patients received BDNA, 33.5 micrograms/burst (o.d.,b.i.d., t.i.d., q.i.d.), or placebo; in phase II, 189 patients received BNDA 42, micrograms/burst (b.i.d. q.i.d.), or placebo. In both phases, statistically significant (p less than 0.05) differences favoring BDNA over placebo were found for all efficacy measures (global evaluation and total and individual symptom scores). In phase I, response to treatment increased as BDNA dosage increased, with a leveling off at t.i.d. dosage. In both phases, marked improvements were seen by week 1, with maximum improvement during week 2. Eighty-seven patients had adverse reactions-sneezing and nasal burning were most common. No suppression in morning cortisol levels was seen, nor were Candida infections promoted. A 2-wk treatment with BDNA was safe and effective in the treatment of seasonal allergic rhinitis in adults.

Topics: Adult; Aerosols; Beclomethasone; Candida; Clinical Trials as Topic; Double-Blind Method; Humans; Hydrocortisone; Middle Aged; Nasal Mucosa; Pharynx; Rhinitis, Allergic, Seasonal

A trial of flunisolide nasal spray and sodium cromoglycate nasal spray in the treatment of hay fever was carried out during the summer of 1978. Sixty-seven patients all suffering from grass-pollen hay fever were given either flunisolide or sodium cromoglycate nasal sprays for 7 weeks. Patients were seen at 0, 3 and 7 weeks and they also kept a daily record of symptoms. Overall assessment of symptom control and the patients daily records of sneezing showed flunisolide to be significantly superior to sodium cromoglycate. Patients records of symptoms correlated well with daily pollen counts. Side-effects were similar in both treatment groups and consisted mainly of mild naso-pharyngeal irritations.

Topics: Administration, Intranasal; Adolescent; Adult; Beclomethasone; Child; Clinical Trials as Topic; Cromolyn Sodium; Female; Fluocinolone Acetonide; Humans; Male; Pollen; Rhinitis, Allergic, Seasonal

In an open group-comparative study, 123 adult patients with seasonal allergic rhinitis were allocated at random to one of three treatment groups; each of which received a daily dose of 400 micrograms beclomethasone dipropionate as (1) one puff in each nostril four times daily, (2) two puffs in each nostril twice daily and (3) four puffs in each nostril once per day. The result of treatment was assessed on daily symptom scores and the use of antihistamine tablets. There were no statistically significant differences between the three groups. The results indicate that it is unnecessary to give beclomethasone dipropionate nasal spray four times daily, and treatment in the morning and in the evening is recommended.

Topics: Adolescent; Adult; Beclomethasone; Dose-Response Relationship, Drug; Eye Diseases; Female; Humans; Male; Middle Aged; Nasal Mucosa; Pollen; Rhinitis, Allergic, Seasonal

Flunisolide, a derivative of fluocinolone acetonide, is advocated for intranasal inhalation for the treatment of perennial and seasonal allergic rhinitis. It is rapidly absorbed by all routes of administration, but it quickly undergoes extensive first-pass metabolism to a 6 beta-hydroxylated metabolite, which possesses only weak corticosteroid effects. Intranasal flunisolide relieves nasal symptoms (but not eye symptoms) in both perennial and seasonal allergic rhinitis, being most effective in patients who have an allergic component to their rhinitis; and like other corticosteroids it may reduce the need for systemic antihistamines in such patients, expecially during peak pollen periods. A few well designed comparative studies have shown flunisolide to be as effective as intranasal beclomethasone, and (in a single study) more effective than intranasal sodium cromoglycate solution. Only transient side effects have occurred, including nasal stinging and throat irritation. No Candida infections have been clinically apparent in short or longer term trials. Resting morning plasma cortisol levels have not been suppressed by usual therapeutic doses of intranasal flunisolide, but the drug's effects on hypothalamo-pituitary-adrenal (HPA) axis integrity during conditions of stress have not been evaluated.

Topics: Beclomethasone; Chronic Disease; Clinical Trials as Topic; Cromolyn Sodium; Fluocinolone Acetonide; Glucocorticoids; Histamine Antagonists; Humans; Kinetics; Rhinitis; Rhinitis, Allergic, Seasonal

Topics: Adult; Aerosols; Asthma; Beclomethasone; Bronchitis; Child; Clinical Trials as Topic; Double-Blind Method; Humans; Placebos; Respiratory Hypersensitivity; Rhinitis, Allergic, Seasonal; Time Factors

Beclomethasone dipropionate (BDP) was used in a trial to assess the effectiveness of twice daily compared with four times daily dosage in the control of asthma. Prior to the introduction of BDP all but one of the patients were dependent on oral steroids in addition to other therapeutic regimes for adequate control of their asthma. A cross-over design was used with patients randomly allocated to either a twice daily or four times daily initial BDP regime. The trial continued for thirty-two weeks, with patients changing their dose regime at the end of each eight week period. Maintenance steroids were eliminated in all but two of the patients. According to all the criteria used in assessing control of asthma, there were no significant differences between the two regimes, indicating that both were equally effective. Compliance was better with the twice daily regime, and most patients preferred it.

Topics: Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Child; Child Development; Eczema; Female; Humans; Male; Middle Aged; Patient Compliance; Rhinitis, Allergic, Seasonal; Statistics as Topic; Steroids

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Beclomethasone; Child; Clinical Trials as Topic; Female; Humans; Male; Middle Aged; Placebos; Rhinitis, Allergic, Seasonal

As part of a study of the effectiveness of beclomethasone dipropionate in perennial rhinitis five immunologically related parameters were measured. These included skin tests, total IgE, specific IgE, nasal and peripheral blood eosinophil counts. In addition, nasal biopsies were obtained in twenty out of sixty patients. It was apparent that patients with perennial rhinitis formed a heterogeneous group who could be divided into three groups based on the extent of immunological abnormality detected. Group 1 consisted of twenty patients who displayed no abnormality in any of the five parameters studied. Group 2 consisted of twenty-six patients in whom specific IgE was not detected but who had varying degrees of abnormal findings in the other laboratory parameters. The remaining fourteen patients formed a third group in whom specific IgE was detected in addition to abnormalities in other parameters. In general, patients with detectable specific IgE had a higher frequency of abnormal parameters, including abnormal histology of their nasal biopsy, than patients in whom no specific IgE was detected. The heterogeneous nature of perennial rhinitis is discussed. Despite the heterogeneous nature of the total patient group, the majority of patients (80%) treated with beclomethasone dipropionate improved compared to 20% improved in the placebo group. There was no difference in the drug effect between the three groups of patients.

Topics: Adolescent; Adult; Beclomethasone; Female; Humans; Immunoglobulin E; Male; Middle Aged; Nose; Rhinitis, Allergic, Seasonal

Nasal challenge tests were used to compare the protective effect of pre-treatment with HC 20-511 (Ketotifen), a new antiallergic compound, clemastine, DSCG and beclomethasone dipropionate in 14 patients with hay fever. HC 20-511 and clemastine were tested in a double-blind fashion and DSCG and beclomethasone openly. Most of the patients experienced an intense nasal reaction when challenged with pollens without pre-treatment. The intensity of nasal reactions was determined by subjective symptoms, clinical findings and nasal peak expiratory flow values. All the drugs tested relieved the symptoms and signs induced by pollens in nasal challenge tests. This tendency was not, however, statistically significant for any of the drugs. When using the changes in nasal expiratory flow rate as a criterion of protectiveness, the differences among the compounds tested were also slight. HC 20-511 seems to be a promising antiallergic agent. However, long term clinical trials still are needed to establish its efficacy in various allergic disorders.

Topics: Adolescent; Adult; Beclomethasone; Clemastine; Clinical Trials as Topic; Cromolyn Sodium; Double-Blind Method; Female; Humans; Male; Peak Expiratory Flow Rate; Piperidines; Pollen; Pyrrolidines; Respiratory Function Tests; Rhinitis, Allergic, Seasonal; Thiophenes

A double-blind, crossover trial of beclomethasone dipropionate intranasal aerosol was undertaken in 30 children suffering from long-term perennial extrinsic rhinitis refractive to conventional therapy with a success rate of 83%. There were no side effects. Maximum improvement was a seen a week after initiation of the active drug. Nasal blockage and rhinorrhoea were most responsive. It is suggested the beclomethasone dipropionate is an effective and safe treatment of children suffering from extrinsic perennial rhinitis.

Topics: Adolescent; Beclomethasone; Child; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Rhinitis, Allergic, Seasonal; Time Factors

Topics: Administration, Intranasal; Adolescent; Adult; Bacteria; Beclomethasone; Candida albicans; Chronic Disease; Clinical Trials as Topic; Double-Blind Method; Drug Evaluation; Female; Humans; Male; Middle Aged; Placebos; Rhinitis, Allergic, Seasonal

Twenty-two children suffering from severe perennial rhinitis were treated with intranasal beclomethasone dipropionate (300 microgram/day) and an identical placebo aerosol in a double-blind cross-over trial. The results confirmed the value of beclomethasone dipropionate in improving nasal symptoms and signs due to perennial rhinitis, and allergic eye symptoms caused by associated conjunctivitis.

Topics: Administration, Intranasal; Adolescent; Aerosols; Beclomethasone; Child; Chronic Disease; Clinical Trials as Topic; Double-Blind Method; Drug Evaluation; Female; Humans; Male; Placebos; Rhinitis, Allergic, Seasonal

In a double-blind cross over study on 25 children with seasonal allergic rhinitis treatment with Beclomethasone dipropionate (BDP)-Aerosol was found more effective than placebo. 17 children preferred BDP, two the placebo-aerosol, while 6 had no preferrence. During a period with very high pollen concentrations in the air the effect of BDP-therapy was no longer sufficient.

Topics: Adolescent; Aerosols; Air; Beclomethasone; Child; Child, Preschool; Double-Blind Method; Humans; Placebos; Pollen; Rhinitis, Allergic, Seasonal

Topics: Administration, Intranasal; Asthma; Beclomethasone; Clinical Trials as Topic; Humans; Rhinitis, Allergic, Seasonal

Topics: Administration, Intranasal; Adolescent; Adult; Beclomethasone; Child; Clinical Trials as Topic; Eosinophils; Female; Humans; Male; Mucus; Nasal Mucosa; Rhinitis, Allergic, Seasonal

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

The effect of a corticosteroid drug on type I reactions in the nose was studied in eighteen hay fever patients. They were treated with a daily dosage of 800 microng beclomethasone dipropionate intranasally for I week, in a double-blind, placebo-controlled cross-over trial. Allergen challenge on the last day of each treatment period showed that steroid treatment diminished sneezing and rhinorrhoea, but the effect was not statistically significant (P = 0-10). Immediate nasal blockage was unaffected. There is a marked discrepancy between the minor protection offered by beclomethasone dipropionate in type I allergy, as suggested in this study and the marked efficacy of the drug in the treatment of hay fever. It is suggested that two factors may account for this discrepancy. First, the significance of "delayed" reactions for hay fever symptoms. Second, the difference between a single allergen provocation and continuous exposure. It is suggested that a slight steroid inhibition of immediate reactions following allergen provocation is potentiated during natural exposure due to inhibition of the priming of the end-organ.

Topics: Administration, Intranasal; Adult; Allergens; Beclomethasone; Clinical Trials as Topic; Humans; Hypersensitivity, Immediate; Pollen; Rhinitis, Allergic, Seasonal

Forty-four children with perennial allergic rhinitis who had failed to respond to conventional therapy, including sodium cromoglycate insufflation and hyposensitization, were treated with beclomethasone aerosol given intranasally. The study was conducted in a double-blind manner, the patients being allocated active drug or placebo for a 3-week period, followed by a 1-week rest period. The treatments were then crossed over for a period of 3 weeks. After this all children were put on active drug and followed-up at monthly intervals for a period of 3 months. Results were graded as either success of failure, and success had to be an unequivocal vote for the active drug by the patient, parent, and doctor. An overall success rate of 77% was obtained and no untoward or toxic effect was noted in any child. Tetracosactrin tests in 5 children remained normal at the end of the study period. We found intranasal beclomethasone dipropionate to be the most effective drug we have used for treating perennial allergic rhinitis in children.

Topics: Aerosols; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Female; Humans; Male; Rhinitis, Allergic, Seasonal

The effect of locally acting intra-nasal beclomethasone dipropionate was observed in 42 patients suffering from seasonal allergic rhinitis and 50 patients suffering from perennial rhinitis. The study consists of three parts: 1) a simple double-blind trial in seasonal rhinitis, 2) a double-blind crossover trial in perennial rhinitis, 3) a 1-year follow-up of the perennial group. The active drug was significantly superior to placebo when comparing subjective symptoms, nasal resistance and secretion eosinophilia in the patients. In long-term use it was possible to reduce the initial dose considerably. On objective examination no significant changes were seen in the epithelium following long-term use. No suppression of the hypothalamic-pituitary-adrenal axis was observed after 1 year's regular use of beclomethasone dipropionate. The side effects were mild, the most common complaint being irritation of the nasal mucous membrane, apparently caused by the propellant gas.

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Aged; Beclomethasone; Child; Clinical Trials as Topic; Drug Evaluation; Female; Follow-Up Studies; Humans; Male; Middle Aged; Nasal Mucosa; Rhinitis, Allergic, Seasonal; Seasons; Time Factors

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

Thirty-five patients with seasonal allergic rhinitis were treated in a double-blind comparative trial in and East London Group Practice with either beclomethasone dipropionate (50 micrograms in each nostril four times a day) or a placebo aerosol preparation identical in appearance. There was a statistically significant difference in favour of intranasal beclomethasone dipropionate (P less than 0-05).

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Beclomethasone; Child; Clinical Trials as Topic; Female; Histamine H1 Antagonists; Humans; Male; Methylprednisolone; Middle Aged; Placebos; Rhinitis, Allergic, Seasonal

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Beclomethasone; Child; Chlorpheniramine; Clinical Trials as Topic; Drug Therapy, Combination; Female; Histamine H1 Antagonists; Humans; Male; Methylprednisolone; Rhinitis, Allergic, Seasonal

Following a short-term clinical trial reported elsewhere, beclomethasone dipropionate aerosol has been given to 15 children with asthma for between 2 1/2 and 3 years except for a short placebo period after the first year. Month-by-month records of wheezing, peak flow rate, and other treatments used are presented for the first 17 months, adrenocortical function tests are reported for the first 2 years, and growth is recorded for 2 1/2-3 years. The short-term clinical benefits of the treatment are confirmed in the longer term, adrenocortical function appears to be unchanged, and growth proceeds along expected lines. The main disadvantage seems to be worsening of eczema and allergic rhinitis in those children who have ceased using corticotrophin or oral steroids for the control of asthma. It is concluded that in the long term beclomethasone dipropionate aerosol provides safe and effective day-to-day control of asthma in children, although occasional recourse to systemic steroid therapy cannot be avoided. Oral candidasis has not been a clinical problem.

Topics: Adolescent; Adrenal Cortex Function Tests; Aerosols; Asthma; Beclomethasone; Body Height; Body Weight; Child; Clinical Trials as Topic; Cosyntropin; Female; Humans; Male; Methylprednisolone; Placebos; Rhinitis, Allergic, Seasonal

The effect of beclomethasone dipropionate (Becotide) intranasally in vasomotor rhinitis has been studied on 39 adult volunteers in a double-blind cross-over study during 9 weeks in February-April 1975. The dose of beclomethasone dipropionate was 300 mug/day. Twenty-five patients preferred the beclomethasone dipropionate period, 5 patients the placebo period, and 9 patients had no preference. About three-quarters (74 per cent) of the patients considered themselves free of symptoms or greatly improved after the treatment with beclomethasone dipropionate. Statistical calculation of the daily nasal symptoms score confirms the improvement. The speediest effect was registered for sneezing, followed by nasal catarrh, nasal itching, and blocking. No changes in the levels of cortisol occurred during the treatment. The bacteriological and mycological findings (analysed with regard to Candida albicans) were fairly constant.

Topics: Adult; Aged; Beclomethasone; Clinical Trials as Topic; Drug Evaluation; Female; Humans; Hydrocortisone; Male; Methylprednisolone; Rhinitis, Allergic, Seasonal

Twenty-one patients with vasomotor rhinitis, with no relevant allergens known, completed a special double-blind trial of beclomethasone dipropionate aerosol (BDA) and placebo intra-nasally. Each patient took 200, 400 and 800 mug BDA and placebo during four consecutive 2-week periods and in different sequences. The symptom scores of the last week of each period of nasal blockage, watery secretion and sneezing were significantly reduced by all doses of BDA as compared with placebo. There were no differences between the effects of the different doses of BDA except for secretion, which was reduced more by using 800 than 200 mug. Cortisol in serum and 17-hydroxycorticosteroids in 24-hour urine were not significantly changed by BDA treatment and no increased frequency of pathogenic bacteria or fungi could be demonstrated in the nasal secretion. For treatment of patients with vasomotor rhinitis, intra-nasal BDA in a daily dose of 200 mug can be recommended when antihistamines, sympathomimetic drugs and sodium cromoglycate are not sufficiently effective.

Topics: 17-Hydroxycorticosteroids; Adolescent; Adult; Beclomethasone; Clinical Trials as Topic; Drug Evaluation; Female; Humans; Hydrocortisone; Male; Methylprednisolone; Middle Aged; Rhinitis, Allergic, Seasonal

Treatment with beclomethasone dipropionate aerosol (BDA), 50 mug four times daily in each nostril, was compared with placebo therapy in a double-blind non-crossover trial of 30 matched patients with allergic rhinitis induced by ragweed pollen. The trial was started at the beginning of the ragweed season and continued for 42 days. Response to treatment was assessed from information on daily diary cards, weekly objective measurements of nasal patency and measurement of total eosinophil count (TEC) before treatment and at week 4. Patients in the BDA group had significantly less (P less than 0.05) sneezing, rhinorrhea and nasal stuffiness at 36 days, cough at 10 days and antihistamine consumption at 17 days. There was no significant difference between the groups in eye symptoms, nasal airway inspiratory resistance, maximum inspiratory nasal flow or TEC. Overall comparison with previous pollen seasons by the patients indicated moderate to great improvement in 86% of the BDA group and in 13% of the placebo group (P less than 0.01). Minor side effects were noted by two patients in each group.

Topics: Adult; Airway Resistance; Beclomethasone; Clinical Trials as Topic; Eosinophils; Female; Humans; Leukocyte Count; Male; Methylprednisolone; Placebos; Rhinitis, Allergic, Seasonal

Some of the problems within the research field of allergology are discussed. The main topic is the new treatment of allergic nasal diseases with a local glucocorticosteroid. Beclomethasone dipropionate (Beconase) can be given intranasally without any risk of systemic side-effects. The drug is found very effective in the treatment of hay fever, vasomotor rhinitis and nasal polypi in adults. In a double-blind crossover trial with 19 hay fever children, aged 8-16 years, 18 preferred the active drug, none preferred the placebo and one had no preference. It is concluded that 400 mug beclomethasone dipropionate a day is a safe and very effective treatment of nasal hay fever symptoms in children.

Topics: Adolescent; Age Factors; Beclomethasone; Child; Clinical Trials as Topic; Humans; Methylprednisolone; Placebos; Rhinitis, Allergic, Seasonal

The therapeutic effect of nasally applied Beconase (beclomethasone diproprionate) was investigated by a double blind trial of 32 patients with clinically manifest grass pollen rhinitis. A daily protocol showed a considerable improvement of the nasal symptoms and the general condition of the patient. The requirement of supplementary antihistamines decreased considerably whereas the conjunctival symptoms remained unaffected. In the course of the 2 week treatment period there was no certain evidence of local side effects.

Topics: Administration, Intranasal; Adult; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Eosinophils; Female; Humans; Leukocyte Count; Male; Nasal Mucosa; Rhinitis, Allergic, Seasonal

In a controlled, double-blind study 20 children and adults, suffering from summer hay fever, were treated intranasally with a daily dose of 200 mug, 300 mug or 400 mug beclomethasone dipropionate (Beconase, Becotide Nasal) or with placebo for 2 weeks during the hay fever season. No beneficial effect of the placebo treatment was observed. In patients treated with 200 mug and 300 mug beclomethasone dipropionate a day there was a moderate decrease in nasal symptom scores and in use of antihistamine tablets. As the results indicated 400 mug a day to have the most pronounced effect on nasal symptoms, this dosage is recommended for children as well as adults suffering from summer hay fever.

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Beclomethasone; Child; Clinical Trials as Topic; Dose-Response Relationship, Drug; Female; Histamine H1 Antagonists; Humans; Male; Methylprednisolone; Middle Aged; Placebos; Rhinitis, Allergic, Seasonal; Time Factors

Eighteen children suffering from hay fever were treated with intra-nasal beclomethasone dipropionate (400 mug/day) and an identical placebo aerosol in a double-blind cross-over trial. 17 of the children preferred the intranasal beclomethasone dipropionate, one had no preference, none preferred the placebo. The effect on the nasal symptoms was impressive. Symptom scores decreased, on average, to 12% and the number of antihistamine tablets taken to 18% of the pretreatment amount. Some beneficial effect on eye symptoms was also discernible, possibly due to an indirect influence from the nasal mucosa via the nasolacrimal reflex. Adrenal function was not affected. It was concluded that 400 mug beclomethasone dipropionate given intranasally daily for some weeks is an effective and safe treatment for hay fever in children.

Topics: Adolescent; Aerosols; Beclomethasone; Benzhydryl Compounds; Child; Clinical Trials as Topic; Eye Manifestations; Female; Histamine H1 Antagonists; Humans; Male; Methylprednisolone; Placebos; Rhinitis, Allergic, Seasonal

Topics: Adolescent; Adult; Allergens; Animals; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Cromolyn Sodium; Desensitization, Immunologic; Drug Hypersensitivity; Female; Histamine Release; Humans; Male; Middle Aged; Physical Exertion; Rats; Rhinitis, Allergic, Seasonal; Stimulation, Chemical

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

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

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

Topics: Administration, Intranasal; Adult; Aerosols; Aged; Asthma; Beclomethasone; Bronchitis; Chronic Disease; Clinical Trials as Topic; Cough; Female; Humans; Male; Methylprednisolone; Middle Aged; Rhinitis; Rhinitis, Allergic, Seasonal

Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Female; Humans; Methylprednisolone; Middle Aged; Pregnancy; Rhinitis, Allergic, Seasonal; Steroids; Substance-Related Disorders

The effect of beclomethasone dipropionate (Becotide) intranasally on hay-fever has been studied in 38 adult volunteers with grass pollen allergy. The trial was carried out as an open assessment with simultaneous pollen count during the months of June and July, 1974. With the dose 300 mug/day intranasally, 95 per cent of the subjects regarded the treatment as successful for the nasal symptoms. No effect on eye symptoms was recorded, and no evident side-effects were noted.

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Aged; Beclomethasone; Child; Clinical Trials as Topic; Female; Humans; Male; Methylprednisolone; Middle Aged; Rhinitis, Allergic, Seasonal; Seasons; Skin Tests; Surveys and Questionnaires; Time Factors

Topics: Administration, Intranasal; Adolescent; Aerosols; Airway Resistance; Beclomethasone; Child; Female; Humans; Hypersensitivity; Male; Methylprednisolone; Mites; Nose; Placebos; Pollen; Rhinitis; Rhinitis, Allergic, Seasonal

Topics: Adolescent; Adult; Aerosols; Beclomethasone; Child; Dose-Response Relationship, Drug; Female; Humans; Male; Methylprednisolone; Rhinitis, Allergic, Seasonal

Topics: Administration, Topical; Adolescent; Adult; Aerosols; Aged; Anti-Inflammatory Agents; Beclomethasone; Chronic Disease; Clinical Trials as Topic; Epistaxis; Female; Glucocorticoids; Histamine H1 Antagonists; Humans; Male; Middle Aged; Nasal Mucosa; Placebos; Respiratory Therapy; Rhinitis, Allergic, Seasonal; Sneezing; Time Factors

Topics: Administration, Topical; Adolescent; Adrenal Glands; Adrenocorticotropic Hormone; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Body Height; Child; Child, Preschool; Clinical Trials as Topic; Eczema; Female; Growth; Humans; Hydrocortisone; Male; Prednisone; Rhinitis; Rhinitis, Allergic, Seasonal; Time Factors

Topics: Adult; Aerosols; Beclomethasone; Clinical Trials as Topic; Eye; Glucocorticoids; Humans; Methylprednisolone; Nose; Placebos; Respiratory Therapy; Rhinitis, Allergic, Seasonal

Topics: Administration, Oral; Administration, Topical; Adrenal Insufficiency; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Clinical Trials as Topic; Glucocorticoids; Humans; Pharyngitis; Placebos; Prednisone; Respiratory Function Tests; Respiratory Tract Infections; Rhinitis, Allergic, Seasonal; Substance Withdrawal Syndrome; Substance-Related Disorders

Topics: Administration, Topical; Adolescent; Adrenal Cortex Hormones; Adrenocorticotropic Hormone; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Eczema; Female; Humans; Hydrocortisone; Male; Methylprednisolone; Recurrence; Rhinitis, Allergic, Seasonal; Spirometry

The effect of a daily dose of 400 mug beclomethasone dipropionate aerosol intranasally has been investigated in a double-blind cross-over trial in 29 patients with hay fever. The effect on the nasal symptoms was so pronounced in 25 patients that further symptomatic treatment was unnecessary. Beclomethasone dipropionate aerosol had, on the other hand, no direct effect on itching in the eyes, which is in accordance with the fact that biochemical investigations did not show any sign of suppression of the adrenal function. It is concluded that beclomethasone dipropionate aerosol intranasally is an effective and apparently harmless way of controlling the nasal symptoms in hay fever.

Topics: 17-Ketosteroids; Administration, Intranasal; Adolescent; Adrenal Glands; Adult; Aerosols; Anti-Inflammatory Agents; Beclomethasone; Clinical Trials as Topic; Eye Diseases; Female; Glucocorticoids; Humans; Male; Methylprednisolone; Pruritus; Rhinitis, Allergic, Seasonal

Topics: Administration, Intranasal; Aerosol Propellants; Aerosols; Anti-Allergic Agents; Beclomethasone; Drug Approval; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Pregnenediones; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; United States; United States Food and Drug Administration

Although nasal challenge with allergen has often been used to evaluate the efficacy of therapeutic modalities used for the treatment of allergic rhinitis, the reproducibility of this model in quantitatively evaluating efficacy has not been rigorously examined.. To examine the reproducibility of the suppressive effects of an intranasal corticosteroid on the clinical and biochemical outcomes of a nasal allergen challenge during two identical treatment periods using the same subjects.. In a single-blind study, 25 seasonal allergic subjects with positive skin tests to grass or ragweed were studied outside of their pollen season. Subjects underwent a baseline, three-dose allergen challenge. Beginning 1 week later, subjects received two 7-day courses of intranasal beclomethasone (168 microg b.i.d.) separated by a 1-month washout period. Nasal challenges with allergen were performed after each treatment period. The nasal allergic response was evaluated by counting sneezes, recording symptom scores and measuring levels of albumin (an index of vascular permeability), lysozyme (an index of serous glandular secretion) and kinins (proinflammatory peptides) in recovered nasal lavages.. Compared with the baseline challenge, each course of beclomethasone significantly reduced sneezing, symptom scores, albumin and kinins, but not lysozyme. Reproducibility analysis of the net changes from diluent challenge in the two beclomethasone treatment periods, showed the following intraclass correlation coefficients: sneezing (0.92), lysozyme (0.82), symptom scores (0.72), albumin (0.64) and kinins (0.28).. We conclude that the nasal challenge model is a reproducible method to evaluate the efficacy of anti-allergic medications. For nasal corticosteroid trials, sneezing, symptom scores and albumin levels are recommended as the most reproducibly suppressive outcome measures.

Topics: Administration, Intranasal; Adult; Albumins; Allergens; Ambrosia; Anti-Asthmatic Agents; Beclomethasone; Clinical Trials as Topic; Female; Glucocorticoids; Humans; Kinins; Male; Muramidase; Nasal Lavage Fluid; Nasal Provocation Tests; Poaceae; Reproducibility of Results; Rhinitis, Allergic, Seasonal; Sneezing; Treatment Outcome

(1) Seasonal allergic rhinitis, otherwise known as hayfever, is a harmless condition, although it can cause major discomfort and interfere with activities of daily living. We conducted a review of the literature, based on our in-house methodology, to determine the risk-benefits of treatments used in this setting. (2) Placebo-controlled trials show that sodium cromoglicate relieves symptoms, especially if it is used before symptoms appear. Adverse effects are rare with sodium cromoglicate nasal solutions and eye drops. (3) Nasal steroids have well-documented efficacy. Beclometasone is the best choice. Adverse effects include epistaxis, nasal irritation and, occasionally, systemic disorders. (4) Oral antihistamines are less effective than nasal steroids. They also provoke adverse effects, especially drowsiness. Nasal azelastine seems to have a similar efficacy as oral antihistamines. (5) The adverse effects of systemic steroids must not be overlooked, especially with long-term use. Oral administration is an alternative for severe symptoms that do not respond to other treatments, although this is rarely the case. Long-acting intramuscular steroids carry an increased risk of adverse effects. (6) Despite evaluation in several randomised controlled trials, there is no firm evidence that homeopathic preparations have any specific efficacy in allergic rhinitis. (7) Vasoconstrictors, ipratropium and montelukast, have negative risk-benefit balances in hay fever. (8) When a single allergen is responsible (grasses, ragweed, birch), clinical trials suggest that specific desensitisation can provide a modest improvement. However, this treatment carries a risk of local adverse effects, as well as a risk of rare but severe anaphylactic reactions, especially in patients who also have unstable severe asthma. (9) Sublingual desensitisation seems to be even less effective than subcutaneous desensitisation in adults. Follow-up is too short to know whether there is a risk of severe anaphylactic reactions. The results of paediatric studies are even less convincing. (10) In practice, when drug therapy is needed to relieve symptoms of seasonal allergic rhinitis, sodium cromoglicate is the first-line treatment. If a nasal steroid solution is chosen, it should be used for the shortest possible period.

Topics: Acetates; Adrenal Cortex Hormones; Adult; Allergens; Asthma; Beclomethasone; Child; Cost-Benefit Analysis; Cromolyn Sodium; Desensitization, Immunologic; Female; Histamine H1 Antagonists; Homeopathy; Humans; Ipratropium; Male; Pollen; Pregnancy; Quinolines; Rhinitis, Allergic, Seasonal; Steroids; Vasoconstrictor Agents

We recently reported that CD4+ T cells that have been activated in vivo or in vitro contain elevated cyclic adenosine monophosphate (cAMP) phosphodiesterase (PDE) activity. Since both phosphodiesterase inhibitors and glucocorticoids have anti-inflammatory activity, we sought to investigate the effect of beclomethasone on PDE activity.. PDE activity was measured in CD4+ T cells after 24 h of culture with beclomethasone. Cells were obtained from the peripheral blood of nonatopic persons (nCells), pre-seasonal (pCells), seasonal (within the first 2 weeks; sCells) and mid-seasonal (mCells) allergic rhinitics and asymptomatic allergic asthmatics (aCells). In addition, the effect of beclomethasone on Th2 cell lines and cells that had been activated in vitro with PHA or interleukin (IL)-2 was determined.. PDE activity was decreased in a concentration-dependent manner by incubation of mCells, Th2 lines and PHA or IL-2-activated CD4+ T cells with beclomethasone (p < 0.05). However, beclomethasone did not modulate PDE activity in nCells, pCells, sCells, or aCells.. Beclomethasone only decreases cAMP PDE activity in CD4+ T cells when it is increased by cell activation either in vitro or in vivo.

Topics: Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; CD4-Positive T-Lymphocytes; Cell Line; Cells, Cultured; Cyclic AMP; Female; Humans; Hypersensitivity, Immediate; Interleukin-2; Lymphocyte Activation; Male; Middle Aged; Phosphoric Diester Hydrolases; Phytohemagglutinins; Rhinitis, Allergic, Seasonal; Th2 Cells

The use of intranasal steroids for the treatment of allergic and vasomotor rhinitis has doubled during the past 5 years. The number of reported cases of nasal septum perforation has increased correspondingly. The mechanism behind this is unknown, and steroid-induced septum perforation is rarely described in the literature. In order to describe the course of events and to form an idea of the extent of the problem, we have reviewed the cases reported at our clinic and compiled reports on side-effects from the Swedish Medical Products Agency. In our department we found 32 patients with septum perforation (21 women and 11 men). The most common risk factor for septum perforation was steroid treatment, 11 cases (10 women, 1 man, average age 33 years, range 19-49 years). The information obtained from the Swedish Medical Products Agency showed that 38 cases of steroid induced septum perforation had been reported during the past 10 years. The number of side-effects per million Defined Daily Dose (DDD) was averaged to 0.21. The risk of perforation is greatest during the first 12 months of treatment and the majority of cases involves young women. We conclude that septum perforation due to nasal sprays are underreported in Sweden and that perforations are most likely to appear in young females during their first months of medication.

Topics: Administration, Intranasal; Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Aerosols; Aged; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Child; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Nasal Septum; Nose Diseases; Retrospective Studies; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Rhinitis, Vasomotor; Sex Factors; Sweden; Time Factors

Full and accurate diagnosis of allergic rhinitis is important as a basis for treatment decisions, as many nasal disorders have similar signs and symptoms. Optimal allergen avoidance is the starting point of treatment, so causative allergens need to be identified. Oral antihistamines are effective in relieving the majority of symptoms of allergic rhinitis and allergic conjunctivitis, but provide only partial relief from nasal congestion. Topical alpha-adrenergic decongestants help to relieve congestion, but prolonged use leads to rhinitis medicamentosa. Systemic decongestants are less effective than topical agents and their use is limited by systemic and central side-effects. The value of leukotriene antagonists has yet to be fully evaluated. Intranasal ipratropium bromide helps to control watery secretions, and an aerosol may be more effective than an aqueous solution. Topical glucocorticosteroids, such as triamcinolone, are the most potent and effective agents available for treating allergic rhinitis. The available evidence indicates that there is very little systemic absorption. Sodium cromoglycate is effective in allergic rhinitis, though less so than topical steroids, and has the least adverse effects among the antiallergic agents. Immunotherapy can be effective and may be indicated in individuals who cannot avoid the causative allergen. Special considerations apply to the treatment of allergic rhinitis in elderly or pregnant patients. Finally, patients with long-standing allergic conditions should be re-assessed regularly.

Topics: Adult; Age Factors; Aged; Beclomethasone; Child; Female; Histamine H1 Antagonists; Humans; Ipratropium; Male; Middle Aged; Nasal Decongestants; Pregnancy; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Triamcinolone Acetonide

To explore the potential association of allergic rhinitis and sinusitis.. Prospective clinical trial.. Academic tertiary referral center.. Ten subjects with symptomatic ragweed allergy during the peak of the ragweed season.. We obtained a paranasal sinus computed tomographic scan on all volunteers and had them complete a modified Rhinitis Quality of Life Questionnaire. All subjects were then treated with intranasal aqueous beclomethasone dipropionate (168 micrograms twice a day) and completed the Rhinitis Quality of Life Questionnaire weekly until the end of the study.. Six of 10 of the subjects had sinus mucosal thickening on computed tomographic scan. All subjects improved symptomatically. A second computed tomographic scan was obtained after the pollen season in 5 patients with mucosal abnormalities, while the patients continued treatment with intranasal steroids and symptomatically improved. The sinus mucosal abnormalities persisted in all patients.. Despite the 60% incidence of abnormalities on the computed tomographic scans of the subjects with ragweed allergy during the season, these abnormalities appear, at most, to contribute minimally to the patient's symptoms, since resolution of symptoms was not accompanied by a reduction in sinus mucosal abnormalities.

Topics: Administration, Inhalation; Administration, Topical; Adult; Anti-Inflammatory Agents; Beclomethasone; Glucocorticoids; Humans; Paranasal Sinuses; Prospective Studies; Quality of Life; Rhinitis, Allergic, Seasonal; Sinusitis; Surveys and Questionnaires; Tomography, X-Ray Computed

Topics: Administration, Intranasal; Aerosols; Anti-Inflammatory Agents; Beclomethasone; Fluocinolone Acetonide; Glucocorticoids; Humans; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Triamcinolone

To determine whether the provision of appropriate medication and comprehensive information before the ragweed pollen season enables patients to manage their hay fever successfully, achieving satisfactory symptom control and quality of life, to examine patient characteristics that may predict successful symptom management and to learn which factors patients consider when making treatment choices.. Single-group prospective cohort management study.. Ninety adults sensitive to ragweed pollen recruited from those who had participated in previous clinical studies and from those who responded to advertisements in the local media.. Aqueous beclomethasone dipropionate nasal spray and comprehensive information about optimal therapy (starting before the ragweed pollen season and continued throughout at a dose of 400 micrograms/d) and how it may be used less intensively with an as-required regimen.. Symptom control, patient satisfaction, quality of life and medication use.. More than 80% of the patients reported very good symptom control and were very satisfied. In all, 62% chose to use less than the optimal daily dose. Patients who had less than optimal symptom control used significantly less of the nasal spray than those with very good control either because they wanted to keep medication use to a minimum or because they were unable to remember to take their medication. The only significant predictor of inadequate control was an acknowledged inability to remember to take medication. Symptoms and trust in the practitioner were the primary factors perceived by the patients to determine their treatment choices.. When provided with aqueous beclomethasone dipropionate nasal spray and comprehensive information on the drug and dosing, most patients are successful in managing their hay fever.

Topics: Administration, Intranasal; Adult; Beclomethasone; Cohort Studies; Female; Humans; Male; Middle Aged; Patient Satisfaction; Prospective Studies; Rhinitis, Allergic, Seasonal; Self Administration; Treatment Outcome

The efficacy and side effects of the oral H1-antihistamine, astemizole, were compared with those of nasal beclomethasone in 158 adult birch-pollen allergic hay fever patients. 148 patients completed the 5-week, controlled trial which took place in Stockholm, May 1986, during the birch pollen season. Daily pollen counts were found to be at a rather low level throughout the study period. The effect and tolerability of both drugs were found to be excellent, although beclomethasone reduced nasal symptoms (sneezing, rhinorrhoea, blocked nose) significantly more effectively than astemizole. Eye symptoms were mild and equal in both groups. The results indicate that oral astemizole is an effective non-sedating antihistamine, though less so than nasal beclomethasone, in the treatment of nasal hay fever symptoms.

Topics: Administration, Oral; Adolescent; Adult; Astemizole; Beclomethasone; Benzimidazoles; Body Weight; Female; Histamine H1 Antagonists; Humans; Male; Middle Aged; Rhinitis, Allergic, Seasonal

Topics: Administration, Intranasal; Aerosols; Beclomethasone; Body Temperature; Child; Dose-Response Relationship, Drug; Female; Humans; Male; Nasal Cavity; Rhinitis, Allergic, Seasonal; Thermometers

The histamine concentration and content in nasal secretion and the volume of nasal secretion in nasal washing samples were measured under different conditions in 28 patients with allergic rhinitis sensitive to birch pollen. The mean histamine concentration was significantly lower after intranasal birch pollen challenge (2.08 micrograms/ml) than in prechallenge samples (6.96 micrograms/ml), and was also significantly lower in untreated patients during the birch pollen season (2.30 micrograms/ml) than off-season (7.18 micrograms/ml). The same relationship was found between the histamine content of the secretion samples obtained on these occasions. The mean secretion volume was greater after than before challenge, but not significantly higher during the season than off-season. A partial reversion of the changes in histamine concentration and content that occurred during the season was observed during intranasal corticosteroid therapy. The concentration and content of histamine in nasal secretion from symptomatic patients after intranasal histamine challenge did not differ significantly from those in asymptomatic subjects before challenge. It was concluded that although the histamine level in nasal secretion can be used as a marker of changes in the severity of allergic rhinitis, it is not ideal for this purpose.

Topics: Beclomethasone; Histamine; Nasal Mucosa; Pollen; Rhinitis, Allergic, Seasonal

Allergic rhinitis is the most common of all allergic disorders. After summarising the clinical features and diagnostic approach with regard to differential diagnosis, we will discuss the therapeutic modalities. As with all long-term therapy measures, it is essential to persuade both the child and the parents to participate in the treatment and to get their co-operation.

Topics: Asthma; Beclomethasone; Child; Cromolyn Sodium; Desensitization, Immunologic; Humans; Ketotifen; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Topics: Adolescent; Adult; Beclomethasone; Child; Female; Humans; Male; Middle Aged; Rhinitis, Allergic, Seasonal

This is the second of two reviews of hay fever. The first article dealt with prevalence and natural history, historical background and mechanisms. This article outlines the clinical features of hay fever, examines the correlation of symptoms with pollen count and describes current views of diagnosis and investigation. History and examination, skin testing, the radio-immunosorbent test (RIST) and radio allergosorbent test (RAST) and the correlation between RAST and skin testing are described. Some consideration is given to the part played by nasal challenge tests and measurements of nasal airways resistance. The section on treatment includes some general considerations, avoidance measures, anti-histamines, nasal steroids, sodium cromoglycate, systemic steroids, nasal vasoconstrictors, hyposensitisation and eye preparations. The final section is centred on future developments.

Topics: Adrenocorticotropic Hormone; Airway Resistance; Beclomethasone; Betamethasone; Bronchial Provocation Tests; Cromolyn Sodium; Desensitization, Immunologic; Histamine H1 Antagonists; Humans; Nasal Decongestants; Pollen; Radioallergosorbent Test; Radioimmunosorbent Test; Rhinitis, Allergic, Seasonal; Skin Tests; Triamcinolone Acetonide

Topics: Beclomethasone; Child; Cromolyn Sodium; Desensitization, Immunologic; Humans; Manometry; Mucus; Nasal Mucosa; Nasal Provocation Tests; Rhinitis, Allergic, Seasonal

Topics: Adrenal Cortex Hormones; Beclomethasone; Cromolyn Sodium; Fluocinolone Acetonide; Histamine H1 Antagonists; Humans; Rhinitis, Allergic, Seasonal; Sympathomimetics

A total of 50 patients with hay fever of perennial rhinitis were treated for 14 days with beclomethasone dipropionate nasal spray. Dosage was one puff (50 micrograms) in each nostril four times a day to a total daily dose of 400 micrograms. Rhinomanometry was used to determine the efficacy of beclomethasone dipropionate in immediate type allergic responses provoked by a nasal challenge with either grass pollen or house dust/house mite allergen. Treatment with beclomethasone dipropionate nasal spray resulted in a significant increase in tolerance to both house dust/house mite allergen (P = 0.01) and grass pollen allergen (P = 0.005). Passive anterior rhinomanometry would seem to offer an easy suitable technique for measuring nasal resistance during nasal provocation tests.

Topics: Beclomethasone; Dust; Humans; Manometry; Nasal Provocation Tests; Pollen; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

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

Our recent studies of nasal histamine sensitivity in nasal allergy are presented. The sensitivity differed according to the site and size of the nasal mucosa and was correlated with the degree of provocation reaction to antigen. This sensitivity appears to be established in childhood and strongly correlated with the increased sensitivity of histamine receptors as well as the autonomic nervous system dysfunction of the nose.

Topics: Adolescent; Adult; Aged; Airway Resistance; Beclomethasone; Child; Child, Preschool; Cromolyn Sodium; Drug Hypersensitivity; Histamine; Histamine H1 Antagonists; Humans; Middle Aged; Nasal Mucosa; Nasal Provocation Tests; Rhinitis, Allergic, Seasonal

Topics: Aerospace Medicine; Beclomethasone; Cromolyn Sodium; Fluocinolone Acetonide; Humans; Rhinitis, Allergic, Seasonal

Topics: Aerosols; Asthma; Beclomethasone; Humans; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

The protective effects of disodium cromoglycate (DSCG) and beclomethasone dipropionate (BDA) on the late nasal mucosa response to allergen challenge (LNR) were investigated in 42 patients with allergic rhinitis. The 42 patients, selected from a group of 370 patients, developed a total of 52 later nasal responses (LNR), 13 of which were isolated later responses (ILNR) and 29 of which were dual responses (DNR), i.e., where the later response (DLNR) has been preceded by an immediate response (INR). Significant protective effects on the immediate and on the late nasal mucosa responses were seen following the use of DSCG. The late response, being a part of the dual response was decreased by DSCG to a higher degree than the isolated late response. Although BDA also decreased the late response, the isolated late response was decreased to a greater degree than that demonstrated as a part of the dual response. The immediate response was not influenced by BDA at all. It is suggested that DSCG should be used as a drug of first choice to control the allergic rhinitis symptoms. However, in the presence of the later nasal response, BDA should be added, at least at the beginning of the treatment and during the period of peak exposure to allergen, i.e., the pollen season.

Topics: Administration, Intranasal; Allergens; Animals; Beclomethasone; Cats; Cattle; Cricetinae; Cromolyn Sodium; Dogs; Guinea Pigs; Humans; Hypersensitivity, Immediate; Mice; Nasal Mucosa; Nasal Provocation Tests; Rats; Rhinitis, Allergic, Seasonal; Time Factors

This study deals with the comparative investigation of the protective effects of disodium cromoglycate (DSCG) Rynacrom, Intal and beclomethasone dipropionate aerosol (BDA); Aldecin Beconase on the immediate nasal mucosa response to allergen challenge due to the immediate hypersensitivity (Type I allergy) in 50 patients suffering from allergic rhinitis. DSCG demonstrated distinct protective effects on the immediate nasal mucosa response to allergen challenge in all patients investigated, while BDA failed to demonstrate any protective effects on the immediate nasal mucosa response to allergen challenge in any of the patients studied.

Topics: Administration, Intranasal; Allergens; Beclomethasone; Cromolyn Sodium; Humans; Hypersensitivity, Immediate; Nasal Mucosa; Nasal Provocation Tests; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Skin Tests

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Beclomethasone; Double-Blind Method; Drug Evaluation; Female; Humans; Male; Middle Aged; Rhinitis, Allergic, Seasonal

Topics: Aminophylline; Asthma; Autoantibodies; Beclomethasone; Cromolyn Sodium; Histamine H1 Antagonists; Humans; Immune Complex Diseases; Myasthenia Gravis; Plasmapheresis; Receptors, Neurotransmitter; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Beclomethasone; Cromolyn Sodium; Histamine H1 Antagonists; Humans; Nasal Decongestants; Rhinitis, Allergic, Seasonal; Sympathomimetics

Topics: Beclomethasone; Cromolyn Sodium; Humans; Respiratory Hypersensitivity; Rhinitis, Allergic, Seasonal; Rhinitis, Vasomotor

Topics: Beclomethasone; Glucocorticoids; Humans; Respiratory Hypersensitivity; Rhinitis, Allergic, Seasonal; Rhinitis, Vasomotor

Topics: Adolescent; Adult; Beclomethasone; Child; Chronic Disease; Evaluation Studies as Topic; Female; Humans; Male; Middle Aged; Nose Diseases; Rhinitis; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

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

Topics: Administration, Intranasal; Beclomethasone; Humans; Rhinitis, Allergic, Seasonal

Variations in nasal resistance (NR) which was induced by positional change of the head were examined in 15 normal subjects and 15 patients with allergic rhinitis. Nasal symptoms were also observed in 15 patients and nasal symptom scores were calculated. Concerning the postural variations of NR, patients with allergic rhinitis showed much more remarkable change than normal subjects. Nasal symptom scores of all patients decreased after nasal insufflation of Beclomethasone Dipropionate for 2 weeks. Coincidence between improvement in postural variations of NR and that of nasal symptom score was not always seen in each patient. However, as a mean value of 15 patients, postural variations of NR improved after nasal insufflation of Beclomethasone Dipropionate.

Topics: Adult; Airway Resistance; Beclomethasone; Female; Humans; Male; Nose; Posture; Rhinitis, Allergic, Seasonal

The effect of intranasal beclomethasone dipropionate on adrenal function was assessed in patients with allergic rhinitis. Beclomethasone dipropionate is an effective preparation and therapeutic doses of 400 microgram/day do not cause adrenal suppression after 12 weeks of use.

Topics: Adrenal Glands; Adult; Beclomethasone; Humans; Hydrocortisone; Male; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Topics: Beclomethasone; Female; Humans; Male; Rhinitis, Allergic, Seasonal

Topics: Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Desensitization, Immunologic; Humans; Hypersensitivity; Respiratory Insufficiency; Rhinitis, Allergic, Seasonal; Tracheitis

Topics: Adolescent; Asthma; Beclomethasone; Bronchi; Bronchial Diseases; Bronchitis; Child; Child, Preschool; Cough; Drug Tolerance; Female; Follow-Up Studies; Humans; Male; Nasal Cavity; Rhinitis, Allergic, Seasonal; Spasm

Topics: Beclomethasone; Chronic Disease; Drug Tolerance; Humans; Laryngitis; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Pharyngitis; Rhinitis, Allergic, Seasonal

Topics: Asthma; Beclomethasone; Drug Tolerance; Humans; Nasal Cavity; Rhinitis; Rhinitis, Allergic, Seasonal

Topics: Adolescent; Asthma; Beclomethasone; Child; Child, Preschool; Drug Evaluation; Female; Humans; Male; Nose; Respiratory Therapy; Rhinitis, Allergic, Seasonal

Topics: Administration, Intranasal; Adult; Aged; Airway Obstruction; Asthma; Beclomethasone; Humans; Middle Aged; Peak Expiratory Flow Rate; Rhinitis, Allergic, Seasonal; Seasons

Topics: Beclomethasone; Humans; Nasal Mucosa; Rhinitis, Allergic, Seasonal

Topics: Aerosols; Beclomethasone; Humans; Rhinitis; Rhinitis, Allergic, Seasonal

Topics: Administration, Topical; Adrenal Cortex Hormones; Beclomethasone; Humans; Rhinitis, Allergic, Seasonal

Topics: Beclomethasone; Chromones; Histamine H1 Antagonists; Humans; Immunotherapy; Methylprednisolone; Rhinitis, Allergic, Seasonal; Sympathomimetics

Topics: Administration, Intranasal; Adrenal Glands; Adrenal Insufficiency; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Humans; Hydrocortisone; Male; Propionates; Respiratory Therapy; Rhinitis, Allergic, Seasonal

Topics: Aerosols; Asthma; Beclomethasone; Glucocorticoids; Humans; Methylprednisolone; Respiratory Therapy; Rhinitis, Allergic, Seasonal