pulmicort 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

Allergic rhinitis (AR) is a highly prevalent inflammatory condition with substantial direct and indirect costs. Intranasal corticosteroids are recommended as first-line therapy for moderate to severe persistent AR. Intranasal budesonide is effective and well tolerated; budesonide aqueous nasal spray (BANS) offers several advantages of potential importance to patients, including once-daily dosing at a low volume of spray in a formulation that is free of chlorofluorocarbon propellants, alcohol, benzalkonium chloride, and scents.. This article reviews the findings of randomized, blinded studies assessing the efficacy, safety profile, quality-of-life effects, patient preference, and cost-effectiveness of once-daily BANS in the treatment of AR.. A MEDLINE search (1966-April 2003) was conducted to identify potentially relevant English-language articles. Pertinent abstracts from recent allergy society meetings were also identified. The search strategy employed the medical subject heading terms budesonide, intranasal corticosteroid, or nasal steroid and allergic rhinitis. Selected studies were randomized, controlled clinical trials of once-daily BANS in patients with AR.. Based on the results of randomized, double-blind, controlled trials, once-daily BANS is an effective treatment for both seasonal and perennial AR at doses as low as 64 microg (one 32-microg spray per nostril). BANS was well tolerated in these studies, with an adverse-event profile similar to that of placebo, and caused no clinically meaningful suppression of hypothalamic-pituitary-adrenal axis function at doses 4-fold higher than the recommended starting dose. Once-daily administration of BANS 64 microg was similar in efficacy to mometasone furoate nasal spray 200 microg once daily; comparable doses of BANS and fluticasone propionate nasal spray (FPNS) were similar in efficacy as well. Based on specific sensory attributes, patients preferred BANS to FPNS at the recommended once-daily starting doses. BANS was associated with more days of treatment per prescription at a lower cost per day compared with other intranasal corticosteroids.. Based on the studies reviewed, BANS administered once daily is an effective and well-tolerated treatment for seasonal and perennial AR in both children and adults. Due to its sensory attributes, efficacy, safety profile, and relatively low cost, BANS may help improve patient adherence.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Budesonide; Drug Administration Schedule; Humans; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

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

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

The clinical manifestations of allergic rhinitis are the result of an immune-mediated process after exposure of a sensitized individual to airborne allergens. The primary symptomatology includes nasal congestion, rhinorrhea, nasal and conjunctival pruritus, and sneezing. Principles of management include allergen avoidance, palliative therapy, immunotherapy, and pharmacotherapy. Oral decongestants stimulate alpha-adrenergic receptors in the nasal cavity, resulting in vasoconstriction and decreased edema. Oral antihistamines block histamine1 (H1) receptors, and may relieve rhinorrhea, sneezing, and nasal and conjunctival pruritus. Topical decongestants have a local effect on adrenergic receptors in the nasal mucosa, resulting in rapid, marked vasoconstriction. Intranasal corticosteroids inhibit mediator release from mast cells and basophils, and reduce edema of the nasal mucosa. Dexamethasone sodium phosphate, beclomethasone dipropionate, and flunisolide are currently available for intranasal administration. Cromolyn sodium inhibits allergen-induced degranulation and mediator release from sensitized cells, and is useful primarily as a prophylactic agent. Several agents, including the corticosteroids budesonide and flucortin butylester, the mast cell-stabilizing agent nedocromil sodium, the anticholinergic agent ipratropium bromide, and the H1 receptor antagonist levocabastine are being investigated for intranasal use in the management of allergic rhinitis.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Budesonide; Glucocorticoids; Histamine H1 Antagonists; Humans; Ipratropium; Nedocromil; Piperidines; Pregnenediones; Quinolones; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Budesonide is a non-halogenated glucocorticosteroid which has been shown to possess a high ratio of topical to systemic activity compared with a number of reference corticosteroids such as beclomethasone dipropionate, flunisolide, and triamcinolone acetonide. It appears to undergo extensive first-pass metabolism to metabolites of minimal activity which accounts for the low level of systemic activity. The majority of therapeutic trials in asthma have been of short term duration and have demonstrated that conventional doses of inhaled budesonide (200 to 800 micrograms/day) and beclomethasone dipropionate (400 to 800 micrograms/day) are of similar efficacy in both adults and children with moderate to severe asthma. Other studies have compared high doses of inhaled budesonide (400 to 3200 micrograms/day in 4 divided doses) with both alternate day (7.5 to 60 mg) and daily (7.5 to 40 mg) oral prednisone in patients with severe or unstable asthma. In the small number of such trials to date, inhaled budesonide was superior to prednisone with respect to the level of asthma control and the lesser influence on adrenal function. Long term open studies have similarly shown that inhaled budesonide can be gradually substituted for oral prednisone in steroid-dependent patients, often with a concomitant improvement in pulmonary function and asthma control. Intranasal budesonide (200 to 400 micrograms/day) relieves nasal symptoms in patients with seasonal allergic, perennial allergic and vasomotor rhinitis. In comparative studies in patients with seasonal rhinitis it has been shown to be of similar efficacy as intranasal flunisolide and intranasal beclomethasone dipropionate and superior to intranasal sodium cromoglycate (cromolyn sodium) and the antihistamine dexchlorpheniramine. Following inhalation, the most commonly reported side effects have been candidiasis, dysphonia and sore throat, while after intranasal administration the most frequent adverse reactions have been nasal stinging, throat irritation, dry nose and slight nasal bleeding. At usual dosages, both formulations of budesonide appear to have little or no effect on adrenal function. Thus, at this stage in its development budesonide has been shown to offer an effective alternative to oral or other inhaled corticosteroids in the management of asthma and rhinitis. However, its relative efficacy and tolerability during long term use, compared with beclomethasone dipropionate, remains to be clarified.

Topics: Administration, Topical; Adrenal Glands; Adult; Anaphylaxis; Animals; Anti-Inflammatory Agents; Asthma; Budesonide; Child; Clinical Trials as Topic; Cricetinae; Glucocorticoids; Humans; Intestinal Absorption; Kinetics; Male; Pregnenediones; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Rhinitis, Vasomotor; Tissue Distribution

Budesonide, a poorly water-soluble corticosteroid, is currently marketed as a suspension. Budesolv is a novel aqueous formulation containing dissolved budesonide showing increased local availability in preclinical models. Budesolv contains ~85% less corticosteroid than the marketed comparator.. The study (EudraCT:2018-001324-19) was designed to assess non-inferiority of Budesolv compared to Rhinocort® Aqua 64 (RA) and early onset of action.. In a three-way cross-over double-blinded randomized trial, Budesolv 10 was compared to RA and placebo in grass pollen allergic rhinoconjunctivitis volunteers (n = 83 (ITT); n = 75 (PP)). On day 1, participants entered the Vienna Challenge Chamber (VCC) for 6 hours; first treatment took place at 1:45 hours after entry. Participants treated themselves for further 6 days; on day 8, the last treatment was applied before entering the VCC. Subjective symptom scores, nasal airflow and nasal secretion were measured regularly during allergen challenge.. Budesolv 10 was equally effective compared to RA with respect to TNSS and nasal airflow after eight days of treatment with a strongly reduced dose (more than 80% reduction). After first dose, only Budesolv 10 showed a significant reduction of nasal and respiratory symptoms starting 90 minutes (P < .05) and 15 minutes (P < .05) after application onwards, respectively, demonstrating an early onset of efficacy. A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (P < .05) after application.. The novel preservative-free, aqueous low-dose budesonide formulation is highly efficacious even after an initial single treatment. Thus, Budesolv 10 appears to be an effective acute treatment for allergic rhinitis as well as for AR comorbidities like mild asthma and conjunctivitis.

Topics: Administration, Intranasal; Adult; Anti-Allergic Agents; Austria; Budesonide; Cross-Over Studies; Double-Blind Method; Drug Compounding; Female; Glucocorticoids; Humans; Male; Middle Aged; Nasal Sprays; Rhinitis, Allergic, Seasonal; Solubility; Time Factors; Treatment Outcome; Young Adult

Although intranasal steroids and anti-cysteinyl-leukotriene-receptor antagonists are efficacious in the treatment of seasonal allergic rhinitis (SAR), combinations of these agents have not unequivocally been demonstrated to be superior to the individual drugs. We aimed to compare the efficacy and potential mechanisms of budesonide nasal spray (BD), oral montelukast (MNT), and combination therapy comprising a half-dose of budesonide plus montelukast (hBD+MNT) in SAR patients.. We performed a single-center, randomized, open-label study in SAR subjects (n = 100). Participants were randomized to receive BD (256 μg), MNT (10 mg), or hBD (128 μg)+MNT for 14 days. Symptom severity scores, nasal cavity volume (NCV), fraction of exhaled nitric oxide (FeNO), eosinophil cationic protein (ECP), histamine and cysteinyl-leukotrienes (CysLTs), and T-cell subsets were assessed before and after treatment.. All treatments significantly improved symptoms from baseline; however, hBD+MNT produced significantly greater improvements in nasal congestion compared with BD or MNT alone. The BD and hBD+MNT groups had fewer patients with uncontrolled symptoms and improved NCV to a greater level than the MNT group. FeNO was decreased to a significantly greater extent from baseline after hBD+MNT treatment than after BD and MNT treatments. ECP, histamine, and CysLTs showed significantly greater decreases after BD and hBD+MNT treatments than after MNT treatment. BD decreased T-helper 1 (Th1) and Th2 cells and increased T-regulatory (Treg) cells in nasal mucosa and MNT decreased Th1 cells and increased Treg cells in peripheral blood, and this trend was reflected with hBD+MNT.. The hBD+MNT combination may have an overall better efficacy profile than BD and MNT monotherapy for treatment of SAR.

Topics: Acetates; Administration, Intranasal; Adolescent; Adult; Anti-Inflammatory Agents; Budesonide; Cyclopropanes; Drug Therapy, Combination; Female; Humans; Leukotriene Antagonists; Male; Middle Aged; Quinolines; Rhinitis, Allergic, Seasonal; Sulfides; Treatment Outcome; Young Adult

Topics: Administration, Intranasal; Budesonide; Double-Blind Method; Glucocorticoids; Humans; Leukotriene Antagonists; Loratadine; Quality of Life; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Terfenadine

Although allergen avoidance can lead to significant improvements in symptoms of allergic rhinitis, there are very few studies in this area. Sunglasses could be effective for protection of eyes from pollen as a cheap, comfortable, and simple avoidance option for allergens. The aim of this study is to determine if wearing sunglasses can decrease ocular symptoms.. Ocular symptomatic patients (39 total) who had a confirmed history of seasonal rhinitis by skin prick tests and negative skin prick tests for perennial allergens were included in the study. The duration of the study was 4 weeks with 3 required visits. At the onset of the 1-week run-in period, patients were randomized and divided into 2 groups. Group I (n = 18) received topical aqueous nasal budesonide regularly and loratadine once daily as a rescue medication. Group II (n = 21) wore sunglasses during daytime as an addition to this medication. Subjective data included a daily diary recording nasal and ocular symptom scores and antihistamine need during the study period.. Sunglasses significantly reduced ocular symptoms (p = 0.002) and use of antihistamines (p = 0.009).. Sunglasses are an inexpensive and simple treatment for patients with allergic conjunctivitis.

Topics: Adult; Anti-Inflammatory Agents; Budesonide; Conjunctivitis, Allergic; Eye Protective Devices; Female; Histamine H1 Antagonists, Non-Sedating; Humans; Loratadine; Male; Pollen; Rhinitis, Allergic, Seasonal; Treatment Outcome; Young Adult

The mechanisms through which rhinitis affects asthma have not been completely elucidated. We explored whether the effect of nasal treatment on asthma control and respiratory-related quality of life (HRQoL) is mediated by inflammatory changes of the upper and lower airways.. Allergic rhinitics with mild asthma were randomized to a 14-day treatment period with either nasal budesonide 100 μg, 1 puff per nostril twice a day, or placebo. Clinical, functional, and biological evaluations were performed before and after treatment.. Twenty subjects (M/F: 10/10; age: 31 ± 15 years; mean ± SD) were enrolled, and a total of 17 individuals completely participated in the study. Lung function was within the normal range. The total asthma control test (ACT) score was 20 ± 5.3 and the RHINASTHMA Global Summary (GS) was 44 ± 15. The percentage proportion of eosinophils in nasal lavage was 9.9% and significantly correlated with spirometric parameters reflecting peripheral airway function (for FEF(50): r = 0.48, p = .03; for FEF(25): r = 0.47, p = .03). The pH of the exhaled breath condensate (EBC) was 7.33 ± 0.4. After nasal treatment, the percentage proportion of eosinophils fell significantly (p = .002), and changes in percentage proportion of eosinophils were associated with changes both in the ACT score (r = 0.76, p = .04) and in the RHINASTHMA GS (r = 0.77, p = .02). The increase in the pH of the EBC was not associated with changes in the ACT score or with the RHINASTHMA GS.. These findings confirm that, in subjects with allergic rhinitis with mild asthma, nasal inflammation impacts on asthma control and HRQoL. The improved control of respiratory symptoms obtained with nasal corticosteroids seems to be mediated by functional changes in the peripheral airways.

Topics: Administration, Intranasal; Adult; Asthma; Budesonide; Eosinophils; Female; Glucocorticoids; Humans; Male; Maximal Midexpiratory Flow Rate; Nasal Cavity; Nasal Lavage; Quality of Life; Respiratory Function Tests; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Surveys and Questionnaires; Vital Capacity

To investigate the effects of prophylactic drugs on allergic rhinitis.. Thirty patients diagnosed as allergic rhinitis based on mugwort allergen were randomly divided into three groups: budesonide group (n = 10), saline group (n = 10) and control group (n = 10). The patients in budesonide group and saline group respectively received budesonide nasal spray (64 microg per, 256 microg once daily) and saline nasal spray twice daily starting two weeks before the date which the patient onset last year and continuing up to the end of the pollen season. The patients in control group were treated without any processing. The nasal symptom scores and attack times of the three groups was recorded.. During the pollen season, 2 patients attacked in the budesonide group (20%), and all the patients attacked in saline group and control group (100%). Statistical significance was found among the three groups (P < 0.01), and between budesonide group and the other two groups (P < 0.01). The budesonide group had lower symptom score than the other two groups and a postponed attack time. All the differences had Statistical significance (Value of chi-square statistic = 21. 558, P < 0.01, Fisher exact test P < 0.01).. Prophylactic administration of budesonide, starting two weeks before the date which the patient onset may release symptom and even avoid the attack of the allergic rhinitis based on mugwort allergen.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Female; Humans; Male; Middle Aged; Pollen; Rhinitis, Allergic, Seasonal; Young Adult

It is widely assumed that apoptosis of eosinophils is a central component of resolution of allergic airway disease. However, this has not been demonstrated in human allergic airways in vivo. Based on animal in vivo observations we hypothesised that steroid-induced resolution of human airway eosinophilic inflammation involves inhibition of CCL5 (RANTES), a CC-chemokine regulating eosinophil and lymphocyte traffic, and elimination of eosinophils without evident occurrence of apoptotic eosinophils in the diseased tissue.. To determine mucosal eosinophilia, apoptotic eosinophils, general cell apoptosis and cell proliferation, and expression of CCL5 and CCL11 (eotaxin) in human allergic airway tissues in vivo at resolution of established symptomatic eosinophilic inflammation.. Twenty-one patients with intermittent (birch and/or grass) allergic rhinitis received daily nasal allergen challenges for two seven days' periods separated by more than two weeks washout. Five days into these "artificial pollen seasons", nasal treatment with budesonide was instituted and continued for six days in a double blinded, randomized, placebo-controlled, and crossover design. This report is a parallel group comparison of nasal biopsy histochemistry data obtained on the final day of the second treatment period.. Treatments were instituted when clinical rhinitis symptoms had been established. Compared to placebo, budesonide reduced tissue eosinophilia, and subepithelial more than epithelial eosinophilia. Steroid treatment also attenuated tissue expression of CCL5, but CCL11 was not reduced. General tissue cell apoptosis and epithelial cell proliferation were reduced by budesonide. However, apoptotic eosinophils were not detected in any biopsies, irrespective of treatment.. Inhibition of CCL5-dependent recruitment of cells to diseased airway tissue, and reduced cell proliferation, reduced general cell apoptosis, but not increased eosinophil apoptosis, are involved in early phase steroid-induced resolution of human allergic rhinitis.

Topics: Administration, Intranasal; Adult; Anti-Allergic Agents; Antigens, Plant; Apoptosis; Betula; Biopsy; Budesonide; Cell Proliferation; Chemokine CCL11; Chemokine CCL5; Cross-Over Studies; Double-Blind Method; Eosinophilia; Female; Humans; Immunohistochemistry; In Situ Nick-End Labeling; Inflammation; Male; Nasal Lavage Fluid; Nasal Mucosa; Placebo Effect; Poaceae; Pollen; Rhinitis, Allergic, Seasonal; Time Factors; Treatment Outcome; Young Adult

Few studies have compared the effects of immunotherapy and inhaled steroids. The main limitation of such studies is the long duration required to fully appreciate the effects of immunotherapy.. To compare the effects of inhaled budesonide and sublingual immunotherapy (SLIT) in mild persistent asthma for up to 5 years.. Patients with mild persistent asthma and rhinitis due to grass pollen were enrolled in an open randomized controlled trial. After a run-in season, they were randomized to either budesonide, 800 microg/d, in the pollen season or continuous grass SLIT for 5 years. All patients received rescue medications. Symptoms were evaluated by diary cards filled out from May to July at baseline and after 3 and 5 years. In-season nasal eosinophils and bronchial hyperresponsiveness were also assessed.. Fifty-one patients were enrolled and 46 completed the study. The bronchial symptom scores and the use of bronchodilators decreased significantly in both groups, but the improvement was greater in the SLIT patients at 3 and 5 years. The nasal symptom score and the intake of nasal steroids decreased only in the SLIT group, and the difference vs the budesonide group was always significant. In the SLIT group vs the budesonide group, a statistically significant decrease of nasal eosinophils was found at 3 and 5 years (P < .01). The bronchial hyperresponsiveness improved significantly only in the SLIT group.. In patients with grass pollen-induced asthma, in the long term SLIT was equally effective as inhaled budesonide in treating bronchial symptoms and provided an additional benefit in treating rhinitis symptoms and bronchial hyperresponsiveness.

Topics: Administration, Inhalation; Administration, Sublingual; Adolescent; Adult; Allergens; Anti-Inflammatory Agents; Asthma; Budesonide; Desensitization, Immunologic; Female; Follow-Up Studies; Humans; Male; Poaceae; Pollen; Rhinitis, Allergic, Seasonal; Young Adult

Burdensome symptoms of allergic rhinitis (AR) include nasal and ocular symptoms such as itching, tearing and redness. Intranasal corticosteroids are efficacious in the treatment of nasal symptoms of AR.. It was the aim of this study to determine the efficacy of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) in relieving ocular symptoms associated with seasonal AR (SAR).. Ocular symptom data were analyzed for subjects >or=12 years of age, randomized to MFNS 200 mug q.d. (n = 176) or placebo (n = 177) in a placebo-controlled, double-blind clinical trial. Post hoc efficacy analysis assessed the mean change from baseline in subject-reported total ocular symptom scores (TOSS) averaged over the treatment period.. Mean baseline TOSS was 4.91 for the MFNS group and comparable (5.05) for the placebo group - combined average for individual symptoms such as itching, tearing and redness ranged from 0 (no symptoms) to 9 (all symptoms, severe). Mean change from baseline in TOSS averaged over days 1-15 was -1.42 for the MFNS group and -0.94 for the placebo group (p = 0.02), for an observed treatment difference of 0.49 (statistical data rounded to 2 decimal positions). Improvement in individual symptoms (eye itching, tearing and redness) contributed to this treatment effect; the greatest improvement occurred with tearing, which decreased -0.52 from the baseline score 1.59 in the MFNS group and -0.31 from 1.67 in those receiving placebo (p < 0.01), for an observed treatment difference of 0.21. Treatment with MFNS was safe and well tolerated.. MFNS is effective in reducing ocular symptoms of SAR, in addition to its established efficacy in reducing nasal symptoms of SAR.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Androstadienes; Anti-Allergic Agents; Budesonide; Child; Double-Blind Method; Eye Diseases; Female; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Seasonal

beta(2)-Agonists may exert mast cell stabilizing and anti-plasma exudation effects. While available data suggest no or only marginal effects of beta(2)-agonists on symptoms of allergic rhinitis, little is known about whether these drugs may add to the efficacy of anti-rhinitis drugs.. To examine effects of a beta(2)-agonist, alone and in combination with an intranasal glucocorticosteroid, on symptoms and signs of allergic rhinitis.. Patients were examined in a pollen season model. Budesonide 64 microg, alone and in combination with formoterol 9 microg, as well as formoterol 9 microg alone was given in a placebo-controlled and crossover design. After 7 days of treatment, the patients received allergen challenges for 7 days. Symptoms and nasal peak inspiratory flow (PIF) were recorded. Nasal lavages with and without histamine were carried out at the end of each challenge series. These lavages were analysed for tryptase, eosinophil cationic protein (ECP), and alpha(2)-macroglobulin as indices of mast cell activity, eosinophil activity, and plasma exudation, respectively.. Budesonide reduced symptoms of allergic rhinitis and improved nasal PIF in the morning, in the evening as well as post allergen challenge. Formoterol alone did not affect symptoms or nasal PIF and did not affect the efficacy of budesonide. Tryptase, ECP, and alpha(2)-macroglobulin were significantly reduced by budesonide. Formoterol alone did not affect these indices and did not affect the anti-inflammatory effect of budesonide.. The present dose of formoterol does not affect symptoms and inflammatory signs of allergic rhinitis and does not add to the efficacy of topical budesonide.

Topics: Administration, Intranasal; Adolescent; Adult; Allergens; Bronchodilator Agents; Budesonide; Cross-Over Studies; Double-Blind Method; Drug Therapy, Combination; Ethanolamines; Female; Formoterol Fumarate; Humans; Male; Pollen; Rhinitis, Allergic, Seasonal; Severity of Illness Index

beta-Tryptase is a multifunctional mast cell serine protease released during mast cell degranulation and tryptase/trypsin inhibitors are a novel potential therapeutic approach for allergic inflammatory diseases.. This study was performed to assess the effects of RWJ-58643 on nasal symptoms, eosinophil influx, and cytokine and chemokine release following nasal allergen challenge (NAC).. Male patients with grass pollen allergic rhinitis (n=16) out of season received single doses of RWJ-58643 (100, 300, 600 microg) or matched placebo given 30 min before NAC in a double-blind, randomized crossover design. A single dose of 200 microg budesonide was studied in an open-label extension phase. NAC was performed with Timothy grass pollen (ALK) via a nasal device, and nasal lavage was performed at times 0 (pre-drug, pre-allergen), 0.5 (30 min post-drug, pre-NAC) 1.5, 2.5, 4.5, 6.5, 8.5, and 24 h after drug administration. Nasal lavage mediators were analysed using a sensitive multiplexed bead immunoassay system.. Low-dose RWJ-58643 (100 microg) and budesonide (200 microg) significantly reduced symptoms, eosinophils and levels of IL-5 following NAC. However, higher doses of RWJ-58643 (300 and 600 microg) caused a late eosinophilia and preceding increases in IL-5 compared with placebo.. This study suggests that combined beta-tryptase and trypsin inhibition has therapeutic potential in allergic inflammation, however, this property is dose responsive and higher doses are ineffective and may cause eosinophilia.

Topics: Administration, Intranasal; Adult; Allergens; Benzothiazoles; Budesonide; Chemokine CCL11; Chemokine CCL2; Chemokines, CC; Chemotactic Factors, Eosinophil; Cross-Over Studies; Double-Blind Method; Eosinophils; Female; Humans; Inflammation Mediators; Interleukin-5; Interleukin-8; Leukocyte Count; Male; Mast Cells; Middle Aged; Pyrrolidines; Rhinitis, Allergic, Seasonal; Serine Endopeptidases; Thiazoles; Trypsin Inhibitors; Tryptases; Tumor Necrosis Factor-alpha

Allergen-specific immunoglobulins of the Immunoglobulin A (IgA) type have been found in the nasal fluid of patients with allergic rhinitis. IgA may play a protective role, but there are also data which show that allergen-specific IgA can induce eosinophil degranulation. The aim of this study was to quantitate Bet v 1-specific IgA in relation to total IgA in the nasal fluid of children with birch pollen-induced intermittent allergic rhinitis and healthy controls, after allergen challenge and during the natural pollen season. Eosinophil cationic protein (ECP), Bet v 1-specific IgA and total IgA were analyzed in nasal fluids from 30 children with birch pollen-induced intermittent allergic rhinitis and 30 healthy controls. Samples were taken before the pollen season, after challenge with birch pollen and during the pollen season, before and after treatment with nasal steroids. During the pollen season, but not after nasal allergen challenge, Bet v 1-specific IgA increased in relation to total IgA in children with allergic rhinitis. No change was found in the healthy controls. The ratio of Bet v 1-specific IgA to total IgA increased from 0.1 x 10(-3) (median) to 0.5 x 10(-3) in the allergic children, p < 0.001. No change was seen after treatment with nasal steroids, although symptoms, ECP and eosinophils were reduced. In conclusion, allergen-specific IgA in relation to total IgA increases in nasal fluids during the pollen season in allergic children but not in healthy controls. These findings are compatible with the hypothesis that allergen-specific IgA plays a role in the allergic inflammation and further studies are needed to clarify the functional role of these allergen-specific antibodies.

Topics: Adolescent; Allergens; Anti-Inflammatory Agents; Antibody Specificity; Antigens, Plant; Betula; Budesonide; Child; Humans; Immunoglobulin A; Nasal Lavage Fluid; Nasal Mucosa; Nasal Provocation Tests; Plant Proteins; Pollen; Rhinitis, Allergic, Seasonal; Seasons

Nasal lavage is a noninvasive method of obtaining inflammatory exudates following nasal allergen challenge (NAC), and permits cells and released mediators to be evaluated.. To determine the effects of a single dose of topical steroid on eosinophils and levels of chemokines and cytokines in nasal lavage fluid following NAC in patients with allergic rhinitis.. Patients with grass pollen seasonal allergic rhinitis (n = 32) out of the allergy season received either nasal budesonide (100 microg per nostril) or matched placebo before allergen challenge in a double blind two-way crossover design. A semi-automated mixed bead array system was employed to measure multiple chemokines and cytokines in small volumes (50 microl) of nasal lavage supernatants.. Following NAC there was a rapid onset of nasal symptoms together with nasal eosinophilia, and the appearance of IL-5 and IL-13 in lavages between 4 and 8 h. Elevated levels of eotaxin, RANTES, IL-8 and MCP-1 were also detected following allergen challenge. A single dose of nasal budesonide caused a decrease in symptoms (P < 0.05) and nasal eosinophils (P < 0.05) with selective abrogation of IL-5 and IL-13 responses (P < 0.05), but a lack of effect on levels of eotaxin, RANTES, IL-8 and MCP-1.. This study suggests that a single dose of nasal steroid has the capacity to selectively abolish IL-5 and IL-13 responses following NAC. This model should be convenient for testing novel anti-inflammatory and immunoregulatory agents intended for the treatment of allergic rhinitis.

Topics: Administration, Intranasal; Adult; Allergens; Anti-Inflammatory Agents; Budesonide; Female; Humans; Interleukin-13; Interleukin-5; Male; Middle Aged; Nasal Lavage Fluid; Nasal Provocation Tests; Phleum; Pollen; Rhinitis, Allergic, Seasonal; Treatment Outcome

Rhinocort and Eltair are both the patented and generic equivalent of the topical nasal steroid budesonide. A study consisting of 42 patients was conducted at the ENT department of Hospital Ipoh to compare the response of patients who were using Rhinocort prior to Eltair. The results show statistically significant symptomatic response and lower complications with Rhinocort compared to Eltair.

Topics: Administration, Intranasal; Budesonide; Drugs, Generic; Female; Glucocorticoids; Humans; Male; Rhinitis, Allergic, Seasonal; Treatment Outcome

Rofleponide palmitate is an esterified glucocorticosteroid pro-drug with a promising pre-clinical profile designed to deliver topical airway treatment for allergic rhinitis and asthma in a novel manner. Thus, the rofleponide palmitate pro-drug is designed to provide topical exposure of the mucosa to the inactive lipophilic drug, which would be locally metabolized to the more hydrophilic and readily cleared drug rofleponide.. To examine whether rofleponide palmitate affects nasal symptoms and peak inspiratory flow (PIF) in a pollen-season model of allergic rhinitis and to compare any such effects with those of another glucocorticosteroid (i.e., budesonide).. During the pollen-free season, 40 patients with strictly seasonal allergic rhinitis received topical nasal spray treatment with an aqueous solution of rofleponide palmitate 400 microg and an aqueous solution of budesonide 128 microg once daily for 10 days in a double-blind, placebo-controlled, and crossover study. After 3 days of drug treatment, individualized allergen challenges were given once daily for 7 days while the treatment continued. The washout periods between each of the challenge series were 2 weeks. Nasal symptoms and PIF were recorded in the morning and evening, as well as 10 and 20 min after each allergen challenge. The mean recordings obtained during the last 3 days of the allergen-challenge series, when symptoms were established and when the treatment had lasted for 8-10 days, were used in the analysis.. Both active treatments reduced nasal symptoms and improved nasal PIF compared with placebo (P<0.01-0.001). There was no overall difference in efficacy between rofleponide palmitate 400 microg and budesonide 128 microg.. Topical treatment with aqueous solutions of rofleponide palmitate attenuates nasal symptoms and improves nasal PIF in allergic rhinitis. The overall efficacy of 400 microg of rofleponide palmitate is similar to that of 128 microg of budesonide in the pollen-season model used in this study.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Adult; Allergens; Analysis of Variance; Budesonide; Cross-Over Studies; Double-Blind Method; Glucocorticoids; Humans; Male; Middle Aged; Palmitates; Pollen; Prodrugs; Rhinitis, Allergic, Seasonal; Seasons

Intranasal corticosteroids are safe and effective for treating allergic rhinitis in adults. Since children may receive more systemic corticosteroid on a dose-per-weight basis than adults, the safety of corticosteroid therapy in pediatric patients is an important issue.. To determine the effects of treatment with budesonide aqueous nasal spray using the recommended once-daily dose for adults and children 6 years and older on hypothalamic-pituitary-adrenal (HPA) axis function in pediatric patients with allergic rhinitis.. In a 6-week, multicenter, double-blind, placebo-controlled study, 78 patients aged 2 to 5 years with allergic rhinitis were treated with budesonide aqueous nasal spray (64 microg/d) or placebo. Mean change in morning plasma cortisol levels from baseline to study end 0, 30, and 60 minutes after low-dose (10-microg) cosyntropin stimulation and mean change in the difference from 0 to 30 minutes and from 0 to 60 minutes after cosyntropin stimulation were used to evaluate HPA axis function.. Mean change from baseline to study end in plasma cortisol levels 0, 30, and 60 minutes after cosyntropin stimulation and the difference from 0 to 30 minutes and from 0 to 60 minutes were not significantly different between the treatment and placebo groups (P > .05 for all). At the end of the study, 3 budesonide aqueous nasal spray and 6 placebo patients were classified as having subnormal HPA axis function. The safety and tolerability profile of budesonide aqueous nasal spray was comparable to that of placebo.. Administration of budesonide aqueous nasal spray for 6 weeks was well tolerated and safe and had no measurable suppressive effects on HPA axis function in patients aged 2 to 5 years with allergic rhinitis.

Topics: Aerosols; Budesonide; Child, Preschool; Double-Blind Method; Female; Humans; Hypothalamo-Hypophyseal System; Male; Patient Compliance; Pituitary-Adrenal System; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Previous studies involving adults have demonstrated that airway glucocorticosteroids inhibit plasma exudation and eosinophil activity in allergic rhinitis. This study explores the possibility that plasma exudation, exudative responsiveness, and the occurrence of eosinophil activity-related proteins are glucocorticosteroid-sensitive nasal mucosal indices in allergic children. Using a placebo-controlled, parallel-group design effects of nasal budesonide (64 microg per nasal cavity b.i.d) were determined in children with seasonal allergic rhinitis. Nasal lavage fluid levels of eotaxin, eosinophil cationic protein (ECP), and alpha2-macroglobulin, indicating plasma exudation, were determined, the latter with and without challenge with topical histamine. Nasal lavage fluid levels of alpha2-macroglobulin and ECP increased significantly during the pollen season, and the acute plasma exudation response to histamine was significantly greater during than outside the season. There was a trend towards a seasonal increase in nasal lavage fluid levels of eotaxin. Budesonide significantly inhibited the seasonal increase in alpha2-macroglobulin as well as the exudative hyperresponsiveness to histamine. Any tendency of increases in mucosal output of eotaxin and ECP was abolished by the glucocorticosteroid treatment. We conclude that mucosal exudation of plasma, as a global sign of active inflammatory processes, is a glucocorticosteroid-sensitive facet of allergic rhinitis in children. Exudative hyperresponsiveness, potentially caused by several weeks of mucosal inflammation, emerges as a significant feature of allergic rhinitis in children, and its development is prevented by local treatment with a glucocorticosteroid drug. The seasonal increase in ECP and the trend for an increase in eotaxin were absent in the glucocorticosteroid-treated subjects.

Topics: Administration, Topical; Adolescent; Allergens; alpha-Macroglobulins; Anti-Inflammatory Agents; Betula; Blood Proteins; Bronchitis; Budesonide; Chemokine CCL11; Chemokines, CC; Child; Child Welfare; Double-Blind Method; Eosinophil Granule Proteins; Female; Glucocorticoids; Histamine; Humans; Inflammation Mediators; Male; Nasal Lavage Fluid; Nasal Mucosa; Nasal Provocation Tests; Pollen; Rhinitis, Allergic, Seasonal; Ribonucleases; Seasons; Severity of Illness Index; Treatment Outcome

Intranasal corticosteroids are effective for the treatment of allergic rhinitis. Sensory attributes associated with these sprays may affect patient preference and adherence to treatment regimens.. These 2 studies compared patients' perceptions of and preferences for specific sensory attributes of budesonide aqueous nasal spray (BANS) and fluticasone propionate nasal spray (FPNS).. In 2 multicenter, randomized, single-blind (patient), single-dose, 2-period, 1-day crossover studies, adults with mild to moderate allergic rhinitis received single doses of BANS (one 32-pg spray per nostril in both studies, 64-microg total dose) and FPNS (two 50-microg sprays per nostril in study 1, 200-pg total dose; one 50-microg spray per nostril in study 2, 100-microg total dose). Study 1 compared the once-daily recommended starting doses of BANS and FPNS, and study 2 compared BANS with half the once-daily recommended dose of FPNS to balance the number of actuations for delivery of study drug. Patients completed the 23-item Sensory Perceptions Questionnaire and indicated their product preference (if any).. A total of 110 women and 71 men in study 1 and 136 women and 54 men in study 2 were randomized to treatment. None had previously used BANS or FPNS. In both studies, fewer patients perceived scent or taste (both P < 0.001 in both studies), forceful spray (P < 0.001 in both studies), and a wet feel in both the nose and throat (study 1, P < 0.004; study 2, P < 0.002) with BANS than with FPNS. In addition, more patients in both studies liked the spray force (study 1, P < 0.01; study 2, P < 0.001) and moisture content in the throat (study 1, P < 0.001; study 2, P < 0.006) of BANS and indicated a greater overall satisfaction with the sensory features of BANS than those of FPNS (study 1, P < 0.001; study 2, P < 0.015). In analyses that included all responding patients, 54.4% of patients in study 1 preferred BANS and 37.8% preferred FPNS (P < 0.022). In study 2, 47.4% preferred BANS and 41.1% preferred FPNS (not significant). Of the 92.2% of patients in study 1 and 88.4% in study 2 who specified a product preference, 59.0% preferred BANS and 41.0% preferred FPNS in study 1 (P = 0.021), and 53.6% preferred BANS and 46.4% preferred FPNS in study 2 (not significant).. On the basis of perceptions of specific sensory attributes reported after 1 administration in these 2 studies, BANS was rated as more pleasing and preferred over the recommended QD starting dose of FPNS, and was also rated as more pleasing than half the QD recommended starting dose of FPNS.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Aged, 80 and over; Androstadienes; Anti-Inflammatory Agents; Budesonide; Cross-Over Studies; Female; Fluticasone; Humans; Male; Middle Aged; Pharmaceutical Solutions; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Surveys and Questionnaires

Symptoms of seasonal allergic rhinitis may vary greatly. Hence, for research purposes, there is a need for disease-like models of allergic rhinitis. In a preliminary study, involving 7 days' challenge with allergen, promising symptom consistency was obtained and dose-response to a glucocorticosteroid could, in part, be demonstrated.. To establish this model of seasonal allergic rhinitis and test the hypothesis that mometasone furoate is more potent than budesonide as an antirhinitis drug.. Thirty-eight patients with seasonal allergic rhinitis received treatment with spray-formulations of placebo, budesonide 64 microg, budesonide 256 microg, and mometasone furoate 200 microg in a double-blind, crossover design. After 3 days' treatment, individualized nasal allergen-challenges were administered daily for 7 days while the treatment continued. Nasal symptoms and peak inspiratory flow (PIF) were recorded.. During the last 3 days of allergen challenge without active treatment, consistent around-the-clock symptoms were recorded and recordings during these days were used in the analysis. With few exceptions the active treatments reduced nasal symptoms and improved nasal PIF (P values <0.001 to 0.05). Budesonide caused dose-dependent improvements in evening symptoms, morning nasal PIF, and nasal PIF recorded 10 minutes after allergen-challenge (P values <0.05). Budesonide 256 microg produced greater improvement than mometasone furoate 200 microg for nasal PIF 10 minutes after allergen-challenge (P < 0.05).. The present allergen challenge method, producing consistent symptoms and nasal PIF data, emerges as a model of seasonal allergic rhinitis well suited for exploring potency and efficacy of drug intervention. The present data do not support the view that mometasone furoate is a more potent antirhinitis drug than budesonide.

Topics: Administration, Topical; Adult; Anti-Allergic Agents; Anti-Inflammatory Agents; Budesonide; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Models, Immunological; Mometasone Furoate; Nasal Provocation Tests; Pregnadienediols; Rhinitis, Allergic, Seasonal

To assess change in symptoms, quality of life (QOL), and performance ability before, during, and after treatment with budesonide in a group of Olympic and Paralympic athletes with seasonal allergic rhinoconjunctivitis (SAR/C).. Because budesonide has already been proven to be an effective and well-tolerated treatment of SAR/C(1), an open-label treatment format was used.. The study was community-based with participating athletes preparing for Olympic competition.. Olympic and Paralympic athletes were screened for the presence of SAR/C using history and positive skin test results for pollen allergens.. All were offered treatment with intranasal budesonide, applied to each nostril, once daily for eight weeks.. Symptom and medication diaries were completed before treatment and after 4 and 8 weeks of treatment. Similarly, Quality of Life (QOL) was measured with the Rhinoconjunctivitis Quality of Life Questionnaire. As a secondary outcome measure, the ability to train and compete was assessed using a performance diary.. Of the 236 athletes eligible for the study, 145 (61%) agreed to participate. Forty-six percent of the athletes who were dispensed treatment did not return questionnaires. For those returning questionnaires, scores between baseline (week 0) and weeks 4 and 8 were calculated for total symptoms, QOL, and performance scores. There were statistically significant improvements in symptoms, QOL, and performance scores in athletes who used intranasal budesonide.. SAR/C is a common condition and has demonstrable negative effects on athletes. Better education of coaches and athletes is necessary to ensure that the condition is correctly diagnosed and treated, with safe, effective, permitted medication.

Topics: Administration, Intranasal; Adult; Air Pollution; Analysis of Variance; Australia; Budesonide; Conjunctivitis, Allergic; Female; Humans; Male; Pollen; Psychomotor Performance; Quality of Life; Rhinitis, Allergic, Seasonal; Seasons; Severity of Illness Index; Sports; Surveys and Questionnaires; Treatment Outcome

Intranasal glucocorticosteroids are effective in seasonal allergic rhinitis. This study compared the efficacy of budesonide (Rhinocort Turbuhaler) and fluticasone propionate (Flixonase) in this respect.. Patients (n = 280) were randomized to receive budesonide, 140 microg (delivered dose) once daily, fluticasone, 200 microg once daily, or matching placebos for 5 weeks. The primary efficacy variable was the change in combined nasal symptom (nasal blockage, runny nose, sneezing) scores. Quality of life was measured in 121 patients by means of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and the Short-form Health Survey (SF-36).. Both steroids significantly reduced combined nasal symptoms, compared with placebo. There was no significant difference between the two treatments. Substantial or total symptom control was achieved in 89.9% of the budesonide-treated patients, compared with 88.7% with fluticasone and 42.7% with placebo. Four of the five domains of the RQLQ were significantly improved with budesonide, whereas with fluticasone only two domains were improved. Budesonide significantly improved scores in five out of eight domains of the SF-36, whereas no domains were improved with fluticasone.. There was no significant difference in efficacy between budesonide and fluticasone in this study. However, greater improvements in quality of life were seen with budesonide than with fluticasone.

Topics: Adolescent; Adult; Aged; Androstadienes; Anti-Allergic Agents; Budesonide; Female; Fluticasone; Humans; Male; Middle Aged; Quality of Life; Rhinitis, Allergic, Seasonal; Treatment Outcome

Quality of life (QOL) is known to be an important clinical endpoint in determining medication efficacy; however, the predictive value of QOL indices for response to medication or placebo has not been tested.. To determine whether a correlation between measures of QOL and response to medication/placebo exists in an evaluation of budesonide for allergic rhinitis.. Two hundred nine participants completed the 36-item short-form health QOL survey at screening for entry into a study examining the onset of action of budesonide in an allergen challenge system. During the treatment phase, symptom assessments were recorded hourly after dosing of double-blind medication. Participants were determined to be responders or nonresponders to study medication. A responder was defined as a participant who rated medication effectiveness as fair to excellent with regard to symptom relief, for three consecutive hourly assessments during the study day or one whose total symptom score decreased by > or =25% for three consecutive hourly assessments. Baseline QOL scores were compared between responders and nonresponders.. Differences were noted among responders and nonresponders on the basis of whether budesonide or placebo was received. Ratings of general health perception, pain, physical function, and role limitation due to physical health were significantly lower among participants who responded to placebo, compared with placebo nonresponders. In addition, the overall physical health and 36-item short-form health survey averages were significantly lower. Differences between responders and nonresponders to budesonide did not reach statistical significance.. Lower baseline QOL scores were associated with a clinically significant response to placebo in a trial of treatment for allergic rhinitis. QOL may be a factor in participant response to medication in clinical studies and, hence, a predictor of outcome.

Topics: Budesonide; Double-Blind Method; Forecasting; Humans; Placebos; Quality of Life; Rhinitis, Allergic, Seasonal; Treatment Outcome

Allergic rhinitis and asthma commonly coexist and are both mediated by similar inflammatory mechanisms. Leukotriene antagonists may therefore be an alternative to corticosteroid therapy.. To compare oral montelukast with inhaled plus intranasal budesonide in patients with seasonal allergic rhinitis and asthma.. A single-blind double-dummy placebo-controlled crossover study was performed comparing once daily 10 mg oral montelukast with 400 microg inhaled plus 200 microg intranasal budesonide in 12 patients with allergic rhinitis and asthma: mean (S.E.) age 34.0 years (2.7), forced expiratory volume in 1 s (FEV1) 91.2 (3.8)% predicted. Each treatment was for 2 weeks with a 1-week placebo run-in and washout. Measurements were made after each active treatment and placebo for: adenosine monophosphate bronchial challenge, exhaled and nasal nitric oxide. Patients also recorded their domiciliary peak expiratory flow, nasal peak inspiratory flow, asthma and seasonal allergic rhinitis symptoms.. There were no significant differences between the placebos for any measurement. For adenosine monophosphate PC20, geometric mean fold differences (95% confidence interval (CI) for difference) were 6.4 (2.2-18.6) for placebo vs. budesonide, 2.9 (1.0-8.4) for placebo vs. montelukast, and 2.1 (1.1-4.5) for budesonide vs. montelukast. For exhaled nitric oxide (p.p.b.) there was significant (P < 0.05) suppression with both montelukast (10.9) and budesonide (10.1) compared with placebo (18.8). For nasal nitric oxide and nasal peak flow there were only significant differences with budesonide compared with placebo. Both treatments reduced total seasonal allergic rhinitis symptoms but only budesonide had a significant effect on nasal symptoms.. Once-daily inhaled plus intranasal budesonide and once daily montelukast showed comparable efficacy on lower airway, but only the budesonide had significant efficacy on upper airway inflammatory markers. Both treatments significantly reduced allergic rhinitis symptoms.

Topics: Acetates; Administration, Oral; Administration, Topical; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Biomarkers; Budesonide; Confidence Intervals; Cross-Over Studies; Cyclopropanes; Humans; Quinolines; Rhinitis, Allergic, Seasonal; Single-Blind Method; Sulfides

Eotaxin is a chemokine that attracts and activates eosinophils. The present study examines the occurrence of eotaxin in nasal mucosal surface liquids in patients with seasonal allergic rhinitis without allergen exposure and during repeat allergen challenge with and without topical glucocorticosteroid treatment. The number of subepithelial eosinophils and mucosal outputs of bulk plasma (alpha2-macroglobulin) and eosinophil cationic protein (ECP) are also examined.. Twelve patients underwent daily allergen challenges for 6 days. Separately, 14 patients, who were receiving budesonide and placebo in a parallel group design, also underwent allergen challenge for 6 days. Nasal biopsies were obtained before and 24 h after the allergen challenge series, and lavages were carried out before and 15 min after selected allergen challenges.. At baseline nasal lavage fluid levels of eotaxin correlated to levels of alpha2-macroglobulin and ECP. After the first allergen challenge there was a correlation between nasal lavage fluid levels of eotaxin and ECP. Repeat allergen exposure increased the mucosal output of eotaxin (P <0.05) and ECP (P <0.01) as well as eosinophil numbers (P <0.01), but no correlation was found between increased eosinophil numbers and eotaxin. Budesonide reduced eotaxin levels during repeat allergen challenge (P <0.05).. Repeat allergen exposure in allergic rhinitis is associated with increased mucosal output of eotaxin. Topical budesonide attenuates this effect, suggesting the possibility that inhibitory effects on mucosal eotaxin may contribute to anti-eosinophilic actions of topical glucocorticosteroids.

Topics: Administration, Intranasal; Administration, Topical; Adolescent; Adult; Allergens; alpha-Macroglobulins; Anti-Inflammatory Agents; Blood Proteins; Budesonide; Chemokine CCL11; Chemokines, CC; Chemotactic Factors, Eosinophil; Cytokines; Double-Blind Method; Eosinophil Granule Proteins; Female; Glucocorticoids; Humans; Male; Nasal Lavage Fluid; Nasal Mucosa; Poaceae; Pollen; Rhinitis, Allergic, Seasonal; Ribonucleases

Both domiciliary and laboratory measures of nasal function have been used to evaluate treatment response in allergic airways disease; however, these measures have not been compared.. To determine the relationship of domiciliary measures (daily symptoms, peak inspiratory nasal flow, and nasal oral index) and laboratory measures (rhinomanometry, acoustic rhinometry) in assessing treatment response with topical steroids and specific inflammatory mediator blockage.. Twenty-one patients with seasonal allergic rhinitis and asthma were enrolled into a single-blind, placebo-controlled, crossover study comparing 2 weeks of 1) 400 microg inhaled plus 200 microg intranasal budesonide once daily and 2) 10 mg montelukast plus 10 mg cetirizine once daily. Before each treatment, patients received 7 to 10 days of placebo period. Laboratory measurements were made of nasal resistance by posterior rhinomanometry, and nasal volume between 0 and 5 cm by acoustic rhinometry after both placebo and active treatment periods. Daily domiciliary recordings were made of allergic rhinitis nasal symptoms scores and peak nasal and oral inspiratory flow rate (enabling the calculation of a nasal/oral index) throughout the study.. There were significant (P < 0.05) improvements for all allergic rhinitis symptoms with both therapies, after factoring for pollen count. Spearman's rank correlation for comparison among nasal symptoms and the objective responses were: nasal inspiratory flow rate (R = -0.50, P = 0.02); nasal/oral index (R = -0.55 P = 0.01); rhinomanometry (R = 0.24, P = 0.30); and acoustic rhinometry (R = -0.21, P = 0.36).. Both treatments were effective in managing allergic rhinitis symptoms, and patients' symptoms were more closely associated with domiciliary measurements of nasal flow than laboratory measurements of nasal function.

Topics: Acetates; Administration, Inhalation; Administration, Intranasal; Adult; Airway Resistance; Anti-Allergic Agents; Anti-Inflammatory Agents; Asthma; Budesonide; Cetirizine; Cross-Over Studies; Cyclopropanes; Female; Glucocorticoids; Histamine H1 Antagonists; Humans; Leukotriene Antagonists; Male; Nasal Obstruction; Quinolines; Rhinitis, Allergic, Seasonal; Rhinomanometry; Rhinometry, Acoustic; Sulfides

The cost-benefit of intranasal steroids for the treatment of seasonal allergic rhinitis is unknown.. To determine the cost-benefit of intranasal budesonide for seasonal allergic rhinitis.. Subjects who were symptomatic for a baseline period of 7 to 10 days were randomized to receive intranasal budesonide by Turbuhaler (400 microg) (n = 121) or aqueous spray (256 microg) (n = 121) once daily for 4 weeks. A willingness-to-pay questionnaire that measured benefits of treatment was administered before and at study completion. Costs were collected and compared with benefits.. Subjects were willing to spend on average $15.89/wk (range $1 to $75) to alleviate the problems of seasonal ragweed rhinitis. Eighty percent of subjects felt that, with treatment, rhinitis had less of an impact on their lives, compared with previous years. The mean willingness-to-pay for the drug used during another ragweed season was $12.95/wk. This was 92% (95% CI, 85% to 100%) of the pre-treatment estimate. There was no relationship between an indirect assessment of income and willingness-to-pay estimates. The benefit was greater than the cost by a mean of $5.80/wk (95% CI, $3.52 to 8.08), P < .0001. There was no difference in costs, willingness-to-pay, or cost-benefit comparing delivery modes. A sensitivity analysis revealed the conclusions were robust.. Intranasal budesonide is cost-beneficial in the treatment of seasonal allergic rhinitis and a willingness-to-pay questionnaire may provide a useful method to assess a therapy's benefit.

Topics: Administration, Intranasal; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Cost-Benefit Analysis; Double-Blind Method; Female; Glucocorticoids; Health Care Costs; Humans; Male; Middle Aged; Rhinitis, Allergic, Seasonal

Intranasal budesonide aqueous nasal spray (BANS) is recognized as an efficacious treatment for seasonal allergic rhinitis (SAR), but the time to onset of action is not known.. The primary objective was to evaluate the time at which the onset of action of BANS in the symptomatic relief of seasonal allergic rhinitis becomes evident within 12 hours after a single dose in a controlled ragweed pollen exposure setting.. The study was of a double-blind, randomized, parallel-group design, testing BANS (64 microgram and 256 microgram) and placebo on ragweed-sensitive subjects with symptoms for at least 1 year by using a controlled pollen challenge system (Environmental Exposure Unit). The efficacy variables were the combined nasal score (the sum of blocked nose, runny nose, and sneezing-itchy nose), individual nasal symptoms, overall evaluation of treatment efficacy reported by participants on diaries, and peak nasal inspiratory flow (PNIF).. A total of 217 participants were treated with BANS or placebo. At 7 to 12 hours, BANS was better than placebo in reducing combined nasal and blocked nose symptoms. For PNIF, the time to onset of action was shortest for 256 microgram of BANS relative to placebo (3 hours, P =.003). BANS 64 microgram was better than placebo in reducing the individual scores of blocked nose, runny nose, and sneezing-itchy nose from 3 to 5 hours after administration. Treatment efficacy was higher for those receiving BANS compared with placebo starting at 5 hours. All treatments were well tolerated, and no specific adverse events occurred.. The onset of action of intranasal BANS was 7 hours according to combined nasal and blocked nose symptom scores. Evidence of earlier response was observed at 3 hours for runny nose and PNIF.

Topics: Administration, Intranasal; Adult; Budesonide; Double-Blind Method; Humans; Inspiratory Capacity; Patient Satisfaction; Rhinitis, Allergic, Seasonal; Therapeutic Equivalency; Time Factors

To compare the antiasthmatic efficacy of inflammatory mediator blockade versus topical corticosteroid therapy in patients with seasonal allergic rhinitis (SAR) and asthma, 14 patients were enrolled into a single-blind, double-dummy, placebo-controlled crossover study comparing 2 wk therapy of (1) 400 microgram orally inhaled budesonide plus 200 microgram intranasal budesonide (BUD) or (2) 10 mg oral montelukast plus 10 mg oral cetirizine (ML + CZ). Before each treatment period, patients received 7 to 10 d placebo washout. All treatments were given once daily in the morning. Throughout the study, patients recorded the following domiciliary measures: peak expiratory flow (PEF), rescue inhaler requirement, asthma symptoms, and daily activity score. Laboratory measurements were made at trough of adenosine monophosphate (AMP) bronchial challenge and exhaled nitric oxide (NO). Compared with pooled placebo (PL), there were significant (p < 0.05) improvements in all domiciliary measures with both treatments (mean PEF [L/min] PL: 463; BUD: 478; ML + CZ: 483). For geometric mean AMP PC(20) (mg/ml), there was an improvement (p < 0.05), compared with PL (47), for ML + CZ (133) but not for BUD (51); whereas for NO (ppb) there was significant suppression with BUD (7.6) but not ML + CZ (11.5) compared with PL (13.6). In conclusion, both combined mediator blockade and combined topical corticosteroids are equally effective antiasthma therapy in patients with asthma and SAR.

Topics: Acetates; Administration, Inhalation; Administration, Oral; Anti-Asthmatic Agents; Asthma; Bronchial Provocation Tests; Budesonide; Cetirizine; Cross-Over Studies; Cyclopropanes; Double-Blind Method; Drug Therapy, Combination; Forced Expiratory Volume; Humans; Inflammation Mediators; Leukotriene Antagonists; Quinolines; Rhinitis, Allergic, Seasonal; Sulfides

It has been difficult to demonstrate dose-dependent clinical effects of anti-allergic glucocorticosteroid drugs in allergic rhinitis.. To determine dose-dependent effects on rhinitis symptoms of clinical doses of the glucocorticosteroid budesonide in a standardized daily allergen challenge model.. Twenty-five patients with seasonal allergic rhinitis were examined outside the pollen season. The highest 256 microg once daily and lowest 64 microg once daily clinically recommended doses of budesonide aqueous nasal spray and placebo were given in a double-blind, placebo-controlled, randomized, and crossover design with 4 weeks' washout between treatments. After 1 week's treatment, the patients received individually titrated nasal allergen challenges once every morning for 8 days while treatment continued. Nasal symptoms were scored in diary cards. Nasal symptoms from the 6th to the 8th challenge days were used in the analysis.. The provocation model produced clinically relevant, and around the clock well tolerable rhinitis symptoms, suggesting that after several days of repeated allergen challenges, a season-like, transient allergic disease condition had been established. Both 64 microg and 256 microg of budesonide aqueous nasal spray reduced nasal symptoms. Budesonide 64 microg reduced total nasal symptoms scores from 5.19 +/- 0.5 to 4.23 +/- 0.53 (P < .05), and budesonide 256 microg reduced total nasal symptoms scores to 3.41 +/- 0.51 (P < .001). A significant difference in nasal symptoms after challenge between budesonide aqueous nasal spray 64 microg and 256 microg (P = .03), indicated a dose-dependent effect.. A dose-dependent, symptom-reducing effect of once-daily treatment with topical aqueous nasal sprays of budesonide for two weeks was demonstrated, suggesting that this model is relevant for assessments of dose-dependent effects of anti-inflammatory drugs.

Topics: Administration, Intranasal; Adult; Budesonide; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Nasal Provocation Tests; Rhinitis, Allergic, Seasonal; Therapeutic Equivalency

The nasal antiinflammatory effects produced by maintenance treatment with topical steroids include reduced production of cytokines. The present study explored nasal mucosal effects induced during the first 9 h after a single dose of topical budesonide. Nine subjects with allergic rhinitis due to birch or timothy pollen were given budesonide (256 microg; Rhinocort Aqua) or placebo in a double-blind, randomized, crossover (4 wk washout) manner. Nasal allergen challenges were performed 30 min after the steroid/placebo pretreatment. Before and 30 min, 1, 3, 5, 7, and 9 h after challenge, filter paper strips were placed on the nasal septum and inferior turbinates for 10 min to sample undiluted mucosal fluids. Strips were then extracted in 1 ml buffer for cytokine analysis (ELISA). Allergen challenge produced acute nasal symptoms that peaked at 30 min and then tapered off. Conversely, both GM-CSF and IL-5 were increased only at 3, 5, 7 and 9 h (p < 0.05 compared with baseline). Budesonide did not affect the nasal symptoms but inhibited (p < 0. 05; compared with placebo treatment) the allergen challenge-induced mucosal output of GM-CSF and IL-5. These data demonstrate that GM-CSF and IL-5 are induced in a nonsymptomatic, late phase response to nasal allergen challenge, and that this cytokine response is prevented by single dose budesonide pretreatment.

Topics: Administration, Intranasal; Adult; Allergens; Anti-Inflammatory Agents; Budesonide; Cross-Over Studies; Double-Blind Method; Female; Glucocorticoids; Granulocyte-Macrophage Colony-Stimulating Factor; Humans; Interleukin-5; Male; Nasal Mucosa; Nasal Provocation Tests; Pollen; Rhinitis, Allergic, Seasonal

Immunotherapy has been shown to reduce allergen sensitivity to allergens such as cat and dust mite. The aim of this study was to investigate the effect of cat or dust mite immunotherapy on bronchial hyperreactivity and the need for inhaled corticosteroids in children with asthma, cat or dust mite allergy, and hay fever.. Twenty-nine children, 7 to 16 years old, completed the 3-year study. They were randomly allocated to receive cat/dust mite or placebo and birch/timothy immunotherapy.. Before immunotherapy was begun and then once each year, bronchial histamine challenges were performed. Bronchial allergen challenge with the perennial allergen was done before and after the 3-year study. Pharmacotherapy was given according to a standardized protocol.. PC20 allergen increased significantly in both the active immunotherapy group (P <.001) and in the placebo-pollen group (P <.05). PC20 histamine increased continuously in the active immunotherapy group (P <.05 and P =.002 after 1 and 3 years, respectively) and had also increased after 3 years in the placebo-pollen group (P <.05). The difference between the 2 groups was significant for PC20 allergen (P =.001) but not for PC20 histamine. There was no significant change in the dose of inhaled budesonide needed for symptom control in either of the groups.. Pollen immunotherapy combined with inhaled corticosteroids results in improvement of both cat/dust mite bronchial sensitivity and hyperresponsiveness to histamine. The combination of cat or dust mite, pollen immunotherapy, and inhaled budesonide enhances this improvement. Cat immunotherapy also induces cat allergen tolerance.

Topics: Adolescent; Animals; Asthma; Bronchial Hyperreactivity; Bronchial Provocation Tests; Bronchodilator Agents; Budesonide; Cats; Child; Desensitization, Immunologic; Double-Blind Method; Dust; Histamine Release; Humans; Immunoglobulin E; Immunoglobulin G; Mites; Pollen; Rhinitis, Allergic, Seasonal

Th-2 type cytokine production (Interleukin-4 [IL-4] and interleukin-5 [IL5]) has been demonstrated to play a significant role in the pathophysiology of allergic rhinitis (AR), and the treatment of AR with topical corticosteroids has been shown to reduce the expression of Th-2 type cytokines in vivo. However, the contribution and expression of Th-2 type cytokine receptors in AR and their response to corticosteroid treatment remain to be clarified. Objectives of the current study are 1. To examine the expression of the cytokine IL-4 and IL-5 receptors (IL-4R and IL-5R) in a nasal allergen challenge model and to contrast this with the expression of the receptor for the Th-1 type cytokine, interferon-gamma receptor (IFN-gammaR), and 2. to examine the effects of pretreatment with topical corticosteroid before allergen challenge on the expression of these same receptors.. Randomized prospective study involving 14 ragweed-allergic subjects evenly divided between placebo and corticosteroid pretreatment.. Immunocytochemistry (alkaline phosphatase-antialkaline phosphatase labeling [APAAP] technique) was used to stain nasal biopsy specimens before and after allergen challenge. Antibodies used included anti-CD3, CD4, CD8, major basic protein (MBP), IL-4R, IL-5R, and IFN-gammaR.. Following allergen challenge, we observed a significant increase in the Th-2 type cytokine receptors (IL-4R and IL-5R; P<.05), as well as a significant decrease in the expression of the Th-1 type cytokine receptor (IFN-gammaR; P<.05). Pretreatment with topical corticosteroids before nasal allergen challenge resulted in decreased expression of IL-4R (P<.05) and IL-5R (P<.05) and increased expression of IFN-gammaR (P<.05). Further, IL-4R and IL-5R expression correlated with eosinophil infiltration in the tissues.. We have demonstrated that in AR, cytokine receptors for IL-4, IL-5, and IFN-gamma follow a similar pattern to their ligands. In addition, pretreatment with topical corticosteroids was shown to alter the cytokine receptor expression pattern from a Th-2 profile more toward a Th-1 profile.

Topics: Administration, Topical; Anti-Inflammatory Agents; Antibodies, Monoclonal; Antigens, CD; Biopsy; Budesonide; Humans; Prospective Studies; Receptors, Cytokine; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Severity of Illness Index; Th1 Cells; Th2 Cells; Turbinates

Mometasone furoate (MF) aqueous nasal spray is a potent intranasal glucocorticoid with low systemic bioavailability. Knemometry has been shown to be a sensitive method of detecting systemic effects of exogenous steroids in children.. We sought to assess whether MF (100 or 200 microg) or budesonide intranasal aqueous spray (400 microg) influences the short-term lower leg growth rate in children with seasonal or perennial allergic rhinitis.. MF, budesonide, and placebo were administered once daily for 2 weeks to 22 children aged 7 to 12 years (mean, 10 years) in a randomized, double-blind, crossover study. Lower leg measurements were done before and after each 2-week treatment period. Two-week washout intervals separated each treatment period.. There were no significant differences in lower leg growth rates among the MF 200 microg (0.95 +/- 0.79 mm; mean +/- SD), budesonide 400 microg (0.73 +/- 0.61 mm), or placebo (0.69 +/- 0.70 mm) groups. The growth rate of the group receiving a 100-microg dose of MF (1.16 +/- 0.67 mm) was greater than that for the group receiving placebo (P =.024) or budesonide (P =.033). No statistically significant sequence effect (P =.11), carry-over effect (P =.24), overall treatment effect (P =.086), or period effect (P =.065) was detected.. No short-term adverse effects on linear lower leg growth rates were detected after once daily MF or budesonide at clinically relevant doses.

Topics: Administration, Intranasal; Anti-Allergic Agents; Anti-Inflammatory Agents; Budesonide; Child; Cross-Over Studies; Double-Blind Method; Female; Glucocorticoids; Growth; Humans; Leg; Male; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Time Factors; Treatment Outcome

This study compares the effects of two topical nasal treatments for allergic rhinitis, budesonide and levocabastine, on symptom development during seasonal pollen exposure. Additionally, the protective effects of drug treatments on allergen-challenge-induced responses (symptoms and microvascular exudation of plasma) are examined late into the pollen season. Forty-four patients with seasonal allergic rhinitis to birch pollen participated in this single-blind, randomized, and placebo-controlled study. Topical nasal treatment with either levocabastine (200 microg b.i.d.; n = 16), budesonide (200 microg b.i.d.; n = 16), or placebo (n = 12) was instituted before the start of the pollen season and continued for 5 weeks until the end of the birch pollen season. The participants kept diaries for scores of nasal and ocular symptoms. Nasal allergen challenges with increasing doses of a birch pollen extract (10[2], 10[3], and 10[4] SQ-U) were carried out both before, when patients were asymptomatic and without treatment, and late into the pollen season. A nasal lavage followed each challenge, and the lavage fluid levels of albumin were measured as an index of the acute inflammatory response of the allergic mucosa. The birch pollen season was rather mild, producing only small increases in nasal symptoms. Budesonide treatment reduced the total nasal symptoms compared to placebo (P<0.01) and to levocabastine (P<0.05), while levocabastine treatment did not differ significantly from placebo. Ocular symptoms and use of rescue medication did not differ between placebo and the active treatments. At the end of the pollen season, both treatments reduced allergen-challenge-induced nasal symptoms compared to placebo (P<0.01). Only budesonide reduced allergen-challenge-induced increments of albumin levels in postchallenge nasal lavage fluids (P<0.05, in comparison with placebo). The results suggest that budesonide reduces both seasonal and allergen-challenge-induced nasal symptoms, while levocabastine is effective against allergen-challenge-induced symptoms also during the season. In addition, the topical steroid treatment, but not the antihistamine, inhibits the inflammatory exudation evoked by allergen challenge in patients with active seasonal disease.

Topics: Administration, Intranasal; Adult; Anti-Inflammatory Agents; Budesonide; Capillary Permeability; Female; Glucocorticoids; Histamine H1 Antagonists; Humans; Male; Middle Aged; Piperidines; Rhinitis, Allergic, Seasonal; Single-Blind Method

It has previously been demonstrated that topical nasal treatment with glucocorticosteroids has significant effects on the bronchial airways. Less is known about effects on nasal disease by topical bronchial treatment with these drugs. The present study examined effects on nasal allergic disease of inhaled budesonide (avoiding nasal deposition of the drug). Patients with seasonal allergic rhinitis, but without asthma, were thus given inhalations of budesonide (600 microg b.i.d.) or placebo. The aim of the design was to allow the study of eosinophilic airway disease in a part of the airway other than the directly treated locus. Moderate to high birch pollen levels were recorded during the study season, and nasal symptoms were significantly increased in both treatment groups, although they were milder in patients receiving budesonide than in the placebo group (p<0.05). Nasal brush eosinophils and nasal lavage fluid levels of eosinophil cationic protein as well as blood eosinophils were increased during the season (p<0.05), but these increases were prevented by the inhaled budesonide. Nasal lavage fluid levels of alpha2-macroglobulin were particularly elevated in the placebo group but did not differ between patients receiving placebo and budesonide. Budesonide prevented the seasonal development of increased bronchoconstrictor responses to methacholine challenge (p<0.05). In conclusion, budesonide reduced the seasonal eosinophilia both in the circulation and in the nose along with an attenuation of seasonal nasal symptoms. Hence, at a daily dose of 600 microg b.i.d., known to cause no, or minimal, adverse effects, inhaled budesonide produces clinically significant anti-inflammatory effects in the entire airways, including the nasal mucosa, which is not exposed topically to the drug. We suggest that nasal and systemic anti-eosinophil actions are produced at commonly employed dose levels of orally inhaled budesonide.

Topics: Administration, Inhalation; Administration, Topical; alpha-Macroglobulins; Anti-Inflammatory Agents; Blood Proteins; Bronchial Provocation Tests; Budesonide; Double-Blind Method; Eosinophil Granule Proteins; Eosinophils; Glucocorticoids; Humans; Inflammation Mediators; Leukocyte Count; Nasal Lavage Fluid; Nasal Mucosa; Rhinitis, Allergic, Seasonal; Ribonucleases

Intranasal corticosteroids are regarded as the first-line treatment for allergic rhinitis, but few studies have directly compared their systemic effects.. The purpose of this study was to compare the systemic bioactivity of aqueous formulations of intranasal budesonide, mometasone furoate (MF), and triamcinolone acetonide (TAA) in terms of adrenal, bone, and white blood cell markers.. Twenty patients with allergic rhinitis, mean age (SE) 35.7 (3.5) years were studied in a single-blind, randomized, 4-way crossover design, with treatments separated by 7-day washout periods, comparing placebo with budesonide 200 micro(g) once daily, MF 200 micro(g) once daily, and TAA 220 micro(g) once daily. After 5 days of treatment at steady-state, serial blood and urine samples were taken for 24 hours. Collective and fractionated measurements (daytime, overnight, and 8 AM) were done on plasma cortisol and urine cortisol/creatinine excretion. Plasma osteocalcin and blood eosinophil counts were measured at 8 AM.. There was no significant difference between placebo and the active treatments with any of the markers of adrenal suppression. Mean values (SE) for 24-hour area under the curve plasma cortisol (nmol/L.hr) were placebo, 6312.9 (564.4); budesonide, 5908.8 (496.8); MF, 6374.1 (509.9); and TAA, 6239.2 (552.0). Twenty-four hour urinary cortisol/creatinine ratio (nanomoles per millimoles) showed placebo, 9.2 (0.5); budesonide, 8.5 (0.5); MF, 8.6 (0.4); and TAA, 8.6 (0.4). The diurnal circadian rhythm was unaffected, and there were only occasional patients with abnormally low cortisol values. There was also no suppression in terms of osteocalcin (placebo, 1.27 nmolL; budesonide, 1.22 nmol/L; MF, 1.33 nmol/L; and TAA, 1.24 nmol/L) and blood eosinophil count (placebo, 0.29 x 10(9)/L; budesonide, 0.27 x 10(9)/L; MF, 0.25 x 10(9)/L; and TAA, 0.24 x 10(9)/L).. Neither budesonide, MF, nor TAA produced significant systemic suppression of adrenal, bone, or white blood cell markers at the doses studied. This reflects the good safety profile of these aqueous intranasal formulations when taken at clinically recommended doses.

Topics: Administration, Intranasal; Adrenal Cortex Function Tests; Adult; Anti-Inflammatory Agents; Biomarkers; Budesonide; Circadian Rhythm; Cross-Over Studies; Female; Humans; Hydrocortisone; Leukocyte Count; Male; Mometasone Furoate; Osteocalcin; Osteogenesis; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Single-Blind Method; Triamcinolone Acetonide

We studied the activity of a topical form of a corticosteroid (budesonide) and an antihistamine (azelastine) in the treatment of seasonal allergic rhinitis by including an assessment of mediator concentrations and the percentage of eosinophils in the nasal secretions before and after the treatment. Nasal allergen challenge (NAC) during the season was performed to mimic an acute attack of allergic rhinitis and to objectively evaluate the effect of the drugs on the early-phase reaction. The study compared in a randomized way (2 parallel groups) the effect of budesonide (Rhinocort Aqua) and azelastine (Allergodil nasal spray) in a group of 14 patients during the pollen season. The study showed that azelastine significantly reduced sneezing, total nasal resistance and increased nasal airflow even when significant increases in histamine, tryptase and leukotriene C4 (LTC4) concentrations in nasal secretions were evidenced immediately after NAC. Budesonide showed a strong (p<0.05) decrease in infiltration and activation of eosinophils, and on tryptase and LTC4 release after NAC. These effects (not for LTC4) lasted at least for 1 week after therapy. Azelastine is a powerful topical antihistamine, while budesonide appears to be a potent long-acting anti-inflammatory agent.

Topics: Adolescent; Adult; Allergens; Budesonide; Eosinophils; Female; Humans; Hypersensitivity, Immediate; Inflammation Mediators; Leukocyte Count; Male; Middle Aged; Nose; Phthalazines; Pollen; Rhinitis, Allergic, Seasonal; Seasons

The authors present the results of the rhinomanometry examinations before and after Rhinocort-Nasal Aerosol or Rhinocort-Nasal Turbuhaler inhalations. 79 patients with allergic rhinitis were observed. 56 out of them were treated by Aerosol and 23 by Turbuhaler. The improvement was found in 78.6% of the patients in the first group and 86.9% in the second one. Rhinocort-Nasal Turbuhaler was generally better tolerated by patients.

Topics: Administration, Inhalation; Adolescent; Anti-Inflammatory Agents; Budesonide; Child; Humans; Manometry; Rhinitis, Allergic, Seasonal; Treatment Outcome

Two experiments were performed during the pollen season to study the activity of different antiallergic drugs in the treatment of seasonal allergic rhinitis. Nasal allergen challenge (NAC) was performed to mimic an acute attack of allergic rhinitis and to objectively evaluate the effect of the drugs on the early-phase reaction during the season. The first study assessed the effect of H1 (Cetirizine 10 mg a day) and of a combination of H1 (Cetirizine 10 mg) plus H2 (Cimetidine 800 mg a day) antagonists on nasal symptoms, mediator release and eosinophil count in a group of 16 patients with seasonal allergic rhinitis. During the same season a second study compared in a randomized way (2 parallel groups) the effect of Budesonide (Rhinocort Aqua) and Azelastine (Allergodil nasal spray) in a group of 14 patients. Results showed that both antihistamines, applied topically of dosed orally, reduced sneezing even when significant increases of histamine concentration in nasal secretions were evidenced immediately after NAC. When a combination of Cetirizine and Cimetidine was administered, a significant (p < 0.01) reduction of nasal airway resistance and increase of nasal airflow after NAC were demonstrated as well. In addition, topical application of Budesonide showed a strong (p < 0.01) effect on the infiltration and activation of eosinophils during the season, and on tryptase release after NAC. These effects lasted at least for one week after therapy.

Topics: Adult; Airway Resistance; Anti-Allergic Agents; Bronchodilator Agents; Budesonide; Cimetidine; Female; Histamine H2 Antagonists; Humans; Male; Middle Aged; Mucus; Nasal Provocation Tests; Phthalazines; Pregnenediones; Rhinitis, Allergic, Seasonal

The study investigated the effect of the oral H1-blocker terfenadine on allergen challenge in subjects with nasal allergy in comparison with the topical steroid, budesonide. A randomized, placebo-controlled, double-blind, crossover study with 3 experimental days was performed outside the pollen season. Seventeen nonsmokers with hay fever (symptoms, positive skin prick test, and RAST against timothy) were treated for 14 days before each experimental day, where the response to nasal challenge with four different concentrations of timothy was measured every 15 min for 6 h. The nasal cavity dimensions were measured by acoustic rhinometry and the olfactory function as the threshold for the sense of smell of butanol. Nasal symptoms were determined by questionnaires. Both terfenadine and budesonide dry powder had an effect on the hay fever symptoms during nasal pollen challenge. Terfenadine was more efficient than budesonide against histamine-mediated symptoms such as sneezing and itching. Budesonide increased nasal airway dimensions better than terfenadine (P < 0.01). A marked effect of budesonide was seen 1-2 h after challenge, suggesting an effect on "early late phase" reaction in the nose. In 7/17 subjects, a significant (P < 0.05) improvement of olfactory function after budesonide treatment was seen. In conclusion, topical steroid (budesonide) is superior to antihistamine (terfenadine) in treatment of nasal congestion in hay fever, especially for the postchallenge reaction, and may, in some cases, relieve the decreased sense of smell during pollen challenge.

Topics: Administration, Inhalation; Administration, Topical; Adult; Allergens; Anti-Inflammatory Agents; Bronchodilator Agents; Budesonide; Cross-Over Studies; Double-Blind Method; Female; Glucocorticoids; Histamine H1 Antagonists; Humans; Male; Nasal Mucosa; Nasal Obstruction; Nasal Provocation Tests; Powders; Pregnenediones; Rhinitis, Allergic, Seasonal; Smell; Terfenadine

The new dry-powder inhaler system, Turbuhaler, has proved to be equivalent to metered-dose inhalers when used in the nose, and the objective of this study was to investigate the efficacy, dose-response effects, and safety of budesonide powder given in the morning during the grass pollen season to patients with grass-pollen-induced allergic rhinitis. Of 190 randomized patients, 186 were treated and 180 completed this double-blind study, which comprised a 4-week treatment period, preceded by a 1-week run-in period. The patients were randomized to three parallel treatment groups: budesonide 400 micrograms, budesonide 200 micrograms, or placebo once in the morning. Assessment of efficacy, by comparing changes in mean scores of nasal symptoms from run-in to treatment, showed a statistically significant effect for all symptoms with active treatments, as compared with placebo. The mean reduction of symptom severity was more pronounced in the 400-micrograms group than in the 200-micrograms group, and this difference was statistically significant for runny nose (P < 0.02) and combined nasal symptoms (P < 0.02). Nasal peak-inspiratory flow improved significantly in both budesonide-treated groups, as compared with placebo (P < 0.01 and P < 0.01). During the treatment period, patients on active treatment showed, on average, a reduction of all nasal symptoms, whereas the placebo-treated patients, on average, showed an increase of nasal symptoms. Approximately 40% in the high-dose group felt total control of rhinitis symptoms, as compared with 26% in the low-dose group. There was no difference between budesonide- and placebo-treated groups in side-effects.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Inhalation; Adolescent; Adult; Anti-Inflammatory Agents; Budesonide; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Poaceae; Pollen; Powders; Pregnenediones; 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

While hay fever is a very common experience, its treatment in primary care setting has been little reported in controlled studies.. This study sought to evaluate the patient's assessment of efficacy of an intranasal steroid spray (budesonide) alone or in combination with an antihistamine (terfenadine) against terfenadine alone or placebo alone.. A double-blind parallel group, placebo-controlled trial design was used, comparing the four groups. Each group used an active or placebo spray and active or placebo tablets. Symptom scores were recorded daily in diaries over a 21-day period.. Overall assessment of efficacy by the 106 patients was significantly greater (P < .05) for budesonide versus terfenadine or placebo alone. There was a 40% placebo response. Budesonide was more effective than terfenadine for all individual symptom scores, particularly nasal blockage, against which terfenadine was ineffective. Adverse effects were mild and transient for all groups.. Budesonide alone is a highly effective treatment for hay fever with few side effects.

Topics: Adolescent; Adult; Budesonide; Double-Blind Method; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Male; Pregnenediones; Rhinitis, Allergic, Seasonal; Terfenadine

Budesonide and disodium cromoglycate (DSCG) are commonly used agents for the treatment of seasonal allergic rhinitis. The comparative efficacy, however, of these agents in the pediatric population has not been reported.. The efficacy of nasally administered budesonide (400 micrograms/day, administered twice daily) was compared with that of DSCG (31.2 mg/day, administered six times per day) for the treatment of seasonal allergic rhinitis in children.. A single-blind parallel group study was carried out in 56 children (mean age 12 years) with seasonal allergic rhinitis. Treatment was for 3 weeks, during which patients assessed nasal symptoms, eye symptoms, and overall efficacy.. Over the 3-week period, mean scores for the nasal symptoms of blocked nose, itchy nose, and sneezing were significantly lower with budesonide therapy than with DSCG. P values were .021, .0032, and .0016, respectively. Both treatment groups reported reduced scores for runny nose and eye symptoms; no statistically significant difference was observed between budesonide and DSCG. The global efficacy assessment scores show significantly more patients benefited from budesonide therapy than from DSCG treatment.. The results suggest that nasally administered budesonide has greater efficacy than DSCG in the treatment of seasonal allergic rhinitis in children.

Topics: Adolescent; Allergens; Budesonide; Child; Cromolyn Sodium; Female; Humans; Male; Pollen; Pregnenediones; Rhinitis, Allergic, Seasonal

The efficacy and safety of Horacort in the treatment of patients with asthma and allergic rhinitis were assessed. The studies were carried out on the group of 47 patients, 32 with mild to moderate bronchial asthma and 15 patients suffering from allergic seasonal or perrenial rhinitis. The asthmatic patients after two weeks run-in period were treated with Horacort (2 puffs bd) during eight weeks. Following randomly selected 16 persons were treated with Pulmicort and other 16 persons took placebo. Patients suffering from allergic rhinitis after one week run-in period were treated with Horacort (2 puffs bd) during four weeks and following with placebo during a next month. The excellent and good clinical results were observed in above 75% patients with bronchial asthma and allergic rhinitis. We observed a decrease in symptoms score, bronchial hyperreactivity, fenoterol consumption, eosinophil number and increase in spirometric parameters. A tolerance of Horacort was very good, only two patients in asthma group had a hoarseness and one with rhinitis epistaxis during therapy.

Topics: Adult; Aerosols; Aged; Asthma; Bronchodilator Agents; Budesonide; Female; Humans; Male; Middle Aged; Pregnenediones; Rhinitis, Allergic, Seasonal; Treatment Outcome

Systemic activity of the intranasal glucocorticosteroid budesonide administered once daily from a dry-powder inhaler (Turbuhaler) was assessed by knemometry. Lower leg length was measured weekly in 38 children aged 7-15 (mean 11.3) years with allergic or perennial rhinitis. The design was a randomized, double-blind, parallel-group study. After 4 weeks' run-in, the children were allocated to 4 weeks' treatment with either budesonide 200 or 400 micrograms or placebo. Fourteen children in the budesonide 200-micrograms group, 13 in the 400-micrograms group, and 10 in the placebo group completed the study. In the placebo and budesonide 200-micrograms groups, growth velocities during run-in (0.36 and 0.28 mm/week, respectively) and treatment periods (0.34 and 0.27 mm/week, respectively) were almost identical. In the budesonide 400-micrograms group (run-in: 0.40 mm/week), a nonsignificant reduction in mean growth velocity of 0.18 mm/week was seen (P = 0.11). There were no statistically significant differences among the run-in mean lower leg growth velocities (F = 1.12; P = 0.34), among growth velocities during treatment (F = 1.10; P = 0.34), or among the run-in and treatment growth velocities in the three groups (F = 1.19; P = 0.32). These results provide good evidence that systemic activity is low in children with allergic or perennial rhinitis treated with once daily budesonide in doses of 200- and 400-micrograms administered intranasally from a dry-powder inhaler.

Topics: Administration, Inhalation; Administration, Topical; Adolescent; Anthropometry; Anti-Inflammatory Agents; Budesonide; Child; Double-Blind Method; Drug Administration Schedule; Female; Glucocorticoids; Growth; Humans; Leg; Male; Powders; Pregnenediones; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

The mucosal plasma exudate with its proteins, enzymes, derived peptides, and matrix molecules is an important factor in inflammatory airway diseases. This study investigated whether topical glucocorticosteroid treatment influences mucosal exudation of bulk plasma (fibrinogen) and the generation of plasma-derived mediators (bradykinins) in seasonal allergic rhinitis. Twenty-two patients with birch-pollen-induced allergic rhinitis participated in a double-blind, randomized, placebo-controlled study during the birch pollen season in 1989. After a 2-week run-in period, the participants received treatment with budesonide (200 micrograms per nasal cavity and day) or placebo. The patients kept a diary to record their daily nasal symptoms (itching, sneezing, nasal blockage, and secretion). The amount of birch pollen in the air was determined with the aid of a Burkhard pollen trap. A nasal lavage was performed once a week, and the levels of bradykinins and fibrinogen were determined in the lavage fluid samples. The birch pollen season was very mild, resulting in only minor nasal symptoms. In spite of the low pollen exposure, treatment with budesonide reduced the lavage fluid levels of both bradykinins and fibrinogen. The present results show that topical glucocorticosteroid treatment attenuates plasma exudation and the generation of plasma-derived mediators in seasonal allergic rhinitis. This action may not result from simple vascular antipermeability effects of the drug but may rather reflect the anti-inflammatory efficacy of topical glucocorticoids in the airway mucosa.

Topics: Administration, Topical; Adolescent; Adult; Allergens; Anti-Inflammatory Agents; Bradykinin; Budesonide; Double-Blind Method; Female; Fibrinogen; Glucocorticoids; Humans; Male; Nasal Lavage Fluid; Nasal Mucosa; Pollen; Pregnenediones; Rhinitis, Allergic, Seasonal

The efficacy and safety of a new antiallergic drug, intranasal azelastine (CAS 58581-89-8), in the treatment of seasonal allergic rhinitis was investigated in a 16 patient double-blind comparison with placebo and another 36 patient open comparison with budesonide (CAS 51333-22-3). Efficacy was assessed in terms of 13 signs and symptoms of allergic rhinitis and tolerability on the basis of spontaneously reported adverse events. In the first study, compared to placebo a one week's treatment with azelastine resulted in substantial relief of sneezing (p = 0.009), nasal itching (p = 0.009), swelling of the nasal mucosa (p = 0.067) and rhinorrhoea (p = 0.262) in patients having the above symptoms at baseline of at least moderate to severe intensity. According to the judgement of the supervising physician, 7/8 azelastine-treated patients but none receiving placebo responded well to therapy (p = 0.001). In the second study a two weeks' treatment with intranasal azelastine was found not to differ significantly from budesonide 67% of patients showed improvement in principal signs of rhinitis after one week's therapy irrespective of treatment. Nasal symptoms, including nasal obstruction, were most markedly improved by both treatments. Azelastine, but not budesonide, also relieved ocular symptoms associated with rhinitis. Adverse events did not occur more frequently under azelastine than under placebo treatment and were often of uncertain relationship to treatment.

Topics: Administration, Intranasal; Adult; Aerosols; Bronchodilator Agents; Budesonide; Double-Blind Method; Female; Histamine H1 Antagonists; Humans; Male; Middle Aged; Phthalazines; Pregnenediones; Rhinitis, Allergic, Seasonal

The effect of intranasal budesonide delivered from a new dry powder inhaler (Rhinocort Turbuhaler) was evaluated in a randomized, double blind, group parallel study of 83 children aged 4-16 years with seasonal allergic rhinitis. The doses 100 and 200 micrograms taken once daily in each nostril were compared with placebo. A one week run-in period was followed by a 4 weeks treatment period. Diary recordings of nasal symptoms, p.r.n. use of terfenadine tablets were made at home and rhinoscopy performed at hospital before and at the end of each treatment period. Total or substantial control of symptoms was achieved in 41% of the children in the 400 micrograms group (p < 0.05 compared with placebo), in 33% in the 200 micrograms group (p = 0.07 compared with placebo) and in 14% in the placebo group. The 400 micrograms but not the 200 micrograms group was statistically significantly better than placebo for most of the clinical effect parameters studied. The treatment was well tolerated and a battery of laboratory tests including cortisol excretion in the urine was not influenced by the various treatments. These results indicate that 400 micrograms budesonide given once daily from a Rhinocort Turbuhaler is clinically effective and safe in children with rhinitis. Further studies are needed to evaluate if this inhaler is preferable to other inhalers currently used for the treatment of rhinitis.

Topics: Administration, Inhalation; Adolescent; Budesonide; Child; Child, Preschool; Double-Blind Method; Female; Humans; Male; Powders; Pregnenediones; Rhinitis, Allergic, Seasonal

Topical steroids are known to be effective in allergic inflammatory airway diseases. However, progress in the treatment of these diseases has also called for the use of unadulterated drugs, without lubricants and preservatives. Rhinocort Turbuhaler, a multi-dose inhaler containing budesonide as a pure powder, is a newly developed device without any carrier gas, preservatives or lubricants. The efficacy and tolerance of this product were evaluated in 60 patients with birch pollen rhinitis. After a run-in period of 1 week the patients received once daily for 4 weeks either budesonide pure powder (400 micrograms) or placebo in a double-blind randomized fashion. Assessment of efficacy was made by comparing scores for different nasal and eye symptoms. The additional use of antihistamine tablets was assessed. In 22 of the patients nasal peak inspiratory flow rate was measured before and after 1 week of treatment. Budesonide was significantly more effective than placebo in controlling the nasal symptoms (P-values ranging from 0.011-0.045). The use of antihistamine tablets was significantly lower in the budesonide group (P = 0.012). The nasal inspiratory flow rate was increased after 1 week of treatment in the budesonide treated group of patients as compared with placebo (P = 0.007). No differences were observed between the groups with regard to eye symptoms or adverse effects. The results show that budesonide delivered from a dry powder inhaler is an effective and well tolerated treatment of seasonal allergic rhinitis.

Topics: Administration, Inhalation; Adolescent; Adult; Bronchodilator Agents; Budesonide; Double-Blind Method; Female; Humans; Male; Middle Aged; Powders; Pregnenediones; Rhinitis, Allergic, Seasonal

To determine the relative efficacy, to compare the incidence of adverse experiences, and to assess the systemic glucocorticoid effect of nasal preparations of budesonide, 200 micrograms bid, and placebo, 50 adult patients with seasonal allergic rhinitis due to grass pollen were studied in a stratified, double-blind parallel group design. After a 2-week baseline period, budesonide nasal spray, 100 microgram per nostril twice a day, was compared with placebo nasal spray over a 4-week treatment period. Supplementary treatment with chlorpheniramine, 4-mg tablets, was permitted when necessary to control symptoms. Daily symptom and medication diaries were kept by the patients. Investigator assessments of symptoms and side effects were made at clinic visits at 2-week intervals. At baseline and again towards the end of the study, blood samples were drawn for the determination of plasma cortisol levels and 24-hour urine samples collected for the measurement of 17-hydroxycorticosteroid output. Of the 24 men and 26 women entering, 49 completed the study. Symptom scores for sneezing, stuffy nose, and nasal secretion all decreased dramatically from baseline when budesonide treatment was started. The decrease in symptoms was greater for budesonide than for placebo (P < .001). There was no difference between budesonide and placebo with regard to eye itch and rescue medication used. Morning nasal washes were taken during the grass season before treatment was started and 16 to 17 days after. They showed a significant decrease in TAME esterase levels in secretions in the budesonide treated patients (P = .03) but not in the placebo-treated patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adolescent; Adult; Budesonide; Double-Blind Method; Female; Glucocorticoids; Histamine; Humans; Male; Middle Aged; Nasal Mucosa; Peptide Hydrolases; Pregnenediones; Rhinitis, Allergic, Seasonal

The effectiveness of the intranasal glucocorticosteroid budesonide was investigated in children with grass pollen-induced rhinitis during a pollen season. The trial was of a randomized, double-blind, placebo-controlled, parallel-group design with a one-week run-in period and a three-week treatment period. Twenty-four children received treatment with budesonide 200 micrograms bid and 27 children with placebo, administered by a nasal aerosol. Concomitant terfenadine, as required, was allowed in both groups. Recordings of nasal symptom severity, use of terfenadine and adverse effects were made in diaries. Nasal symptoms were significantly less severe in patients treated with budesonide as compared with placebo-treated patients. An overall assessment of treatment effect made by the children was significantly in favour of budesonide, and the consumption of terfenadine was significantly larger in the placebo than in the budesonide group. These results provide good evidence that intranasal budesonide is effective in seasonal rhinitis in children.

Topics: Administration, Intranasal; Adolescent; Air Pollutants; Allergens; Bronchodilator Agents; Budesonide; Child; Double-Blind Method; Endoscopy; Female; Humans; Male; Pollen; Pregnenediones; Rhinitis, Allergic, Seasonal; Severity of Illness Index; Treatment Outcome

In order to evaluate the maxillary ostial function a double-blind, group comparative study with intranasal budesonide and placebo was carried out in 20 adult patients suffering from seasonal rhinitis. The trial started with an entry visit 3 weeks before pollen peak with clinical assessments (physical examination and ostial diameter measurements) followed by a 3-week treatment period. Treatment was either intranasal budesonide 200 micrograms b.i.d. or matching placebo b.i.d. The trail ended at pollen peak with clinical assessment. The results showed normal ostial diameters in the patients suffering from seasonal rhinitis. There were no statistical significant differences in ostial diameter change between the treatment groups except between budesonide and placebo in sitting position at measurement time 0 min. It seems that pollen does not reach the ostial region.

Topics: Administration, Intranasal; Adult; Airway Resistance; Bronchodilator Agents; Budesonide; Double-Blind Method; Female; Humans; Male; Maxillary Sinusitis; Middle Aged; Pregnenediones; Rhinitis, Allergic, Seasonal

A randomized, parallel group, double-blind multi-centre study was carried out in 342 patients with symptomatic seasonal allergic rhinitis to assess the efficacy and tolerability of intranasal budesonide administered either as a single morning dose of 400 micrograms or as a 200 micrograms twice-daily dose, morning and evening, for 4 weeks. Both treatments improved the symptoms of seasonal allergic rhinitis; specific nasal symptom scores recorded daily by the patient being reduced. The proportions of patients symptom free after 4-weeks' treatment were 46% in the 400 micrograms once-daily group and 54% in the 200 micrograms twice-daily group, with total daily symptom scores recorded by diary cards reduced by 79% and 80%, respectively. The differences between the groups were not statistically significant. Sub-group analysis of patients allergic to grass pollen (n = 166) showed similar total symptom scores at each level of grass pollen exposure (no significant difference between treatment groups). Patients assessed both treatments to be effective (no significant difference between groups), with 65% of patients questioned stating a preference for a once-daily treatment given equal symptom control. Both treatments were equally well tolerated and few side-effects were reported.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Child; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Pollen; Pregnenediones; Rhinitis, Allergic, Seasonal; Severity of Illness Index; United Kingdom

This study examined the seasonal effects on eosinophils and secretory responsiveness of the nasal mucosa in 22 patients with allergic rhinitis due to birch pollen (11 patients received placebo and 11 budesonide, 200 micrograms once daily in each nostril). The pollen counts during the study season were too low to produce a significant symptomatology. Hence, our findings demonstrate threshold alterations of the airway mucosa in allergic rhinitis and their inhibition by anti-inflammatory drug intervention. The patients were monitored for 8 weeks with daily recordings of pollen counts and symptom scores. Once every week a series of laboratory tests was carried out: the local eosinophil influx was determined using a Rhinobrush technique; the levels of eosinophil cationic protein (ECP) were analysed in nasal lavage fluids; and the secretory response to intranasal methacholine was measured. Treatments started after a 2-week run-in period. The proportion of eosinophils increased markedly in the placebo group and was elevated also during the last two study weeks when the pollen counts were practically nil. The secretory responsiveness to methacholine increased during the pollen season and returned to baseline towards the end of the study period. The topical glucocorticoid treatment reduced the proportion of eosinophils, the ECP levels, and the secretory response to methacholine compared to placebo. We conclude that the increased traffic and activity of eosinophils and less conspicuously the increased secretory responsiveness are expressions of the mucosal inflammation that precede the development of symptoms in seasonal allergic rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Anti-Inflammatory Agents; Budesonide; Cell Count; Double-Blind Method; Eosinophils; Female; Glucocorticoids; Humans; Male; Methacholine Chloride; Nasal Mucosa; Nasal Provocation Tests; Pollen; Pregnenediones; Rhinitis, Allergic, Seasonal

The objective of this study was to compare the efficacy and safety of a pure powder formulation of budesonide, delivered from a new multi-dose dispenser for nasal drug application, with the commercially available budesonide pressurized aerosol, and with placebo. Of 116 patients with grass pollen-induced allergic rhinitis, 112 finished the study, which comprised a 4-week treatment period, preceded by a 1-week run-in period. The patients were randomized to four parallel treatment groups: budesonide powder 400 micrograms daily; budesonide powder 800 micrograms daily; budesonide aerosol 400 micrograms daily; and placebo powder. Treatment was given once daily in the morning. The study was double-blind regarding comparison between budesonide powder and placebo. Assessment of efficacy, made by comparing mean scores of nasal symptoms and use of rescue medication, showed equal efficacy of all three budesonide groups compared with placebo. There were no differences between budesonide-and placebo-treated groups with regard to side effects. Budesonide treatment had no demonstrable effect on the HPA-axis assessed by measurement of 24-h urine cortisol. We conclude that budesonide, delivered as pure powder from a multi-dose dispenser, is effective and safe for the treatment of seasonal allergic rhinitis. This new formulation is a good alternative to the commercially available preparations, as it does not contain carrier gas, preservatives or lubricants.

Topics: Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents; Budesonide; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Powders; Pregnenediones; Rhinitis, Allergic, Seasonal

Sixty patients with seasonal allergic rhinitis due to birch pollen were enrolled in an open, randomized parallel group study. Efficacy and side effects were studied after intranasal administration of budesonide given as a freon propellant aerosol or as dry powder with a sniff actuated inhalation device. Medication started a few days before the actual peak pollen season and lasted for three weeks. The dose was 400 micrograms once daily. Efficacy was assessed daily by patient-rated symptoms scores and by nasal peak inspiratory flow measurements at the visits to the clinic. Safety was assessed by monitoring clinical adverse events. No clear changes in nasal symptom scores or nasal peak flow occurred during the pollen season in either treatment group as compared to the pretreatment period, although the pollen season was very difficult in Finland during the study, ad 12000 grains per m3. Substantial or total control of symptoms was achieved in 93% of the patients in the aerosol group and in 79% in the powder group. Side effects were minimal in both groups. We conclude that dry powder administration of budesonide is as effective and well tolerated as the aerosol in the treatment of seasonal allergic rhinitis.

Topics: Administration, Inhalation; Administration, Topical; Adult; Aerosols; Anti-Inflammatory Agents; Budesonide; Female; Glucocorticoids; Humans; Male; Powders; Pregnenediones; Rhinitis, Allergic, Seasonal

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

A double-blind, parallel-group, multi-centre study was carried out in 248 patients with symptomatic seasonal allergic rhinitis to assess the effectiveness and tolerability of intranasal aqueous budesonide given as a single daily dose each morning of 400 micrograms compared with the conventional dosage regimen of 200 micrograms twice daily. After a 1-week run-in period during which only oral terfenadine was allowed for intolerable symptom relief, symptomatic patients were allocated at random to receive budesonide in one or other dosage regimen for 3 weeks. The results of assessments made by the physician at clinic visits and by patients recording daily data on diary record cards showed that specific nasal symptom incidence and severity were significantly (p less than 0.001) reduced in both treatment groups. The proportions of patients symptom-free at 3 weeks were 40% in the 400 micrograms once daily and 45% in the 200 micrograms twice daily group; in addition, mean nasal symptom scores from the daily diary cards were significantly (p less than 0.001) reduced in both groups, with a reduction in total symptom scores of 53% and 60%, respectively. The differences between the groups were not statistically significant. Total symptom scores were significantly (p less than 0.01) reduced in both dosage groups at all levels of pollen exposure. Patients rated treatment overall as being highly effective, mean scores being very similar in both groups, and tolerability was similar and good whether budesonide was given as a 400 micrograms once daily dose or as 200 micrograms twice daily. Assuming equal symptom control, 74% of patients stated they would prefer once daily to twice daily treatment.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Aged, 80 and over; Budesonide; Child; Double-Blind Method; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Middle Aged; Pregnenediones; Rhinitis, Allergic, Seasonal

The efficacy and side effects of two approaches to the treatment of ragweed pollen-induced rhinoconjunctivitis were compared in a double-blind, parallel-group trial. Sixty ragweed-sensitive adults were randomized either to a course of four Pollinex-R hyposensitization injections during the 6 weeks before the ragweed-pollen season, or to budesonide aqueous nasal steroid spray, 400 micrograms daily, throughout the season. A double-dummy technique was used to achieve blinding. During the ragweed-pollen season, troublesome nasal symptoms were treated with terfenadine, 60 mg, when treatment was needed, up to 240 mg daily, and eye symptoms were treated with naphazoline eye drops, when treatment was needed, up to four times daily. Every day, subjects recorded the severity of nasal and eye symptoms and medication use in a diary. Fourteen of the subjects receiving Pollinex-R were unable to complete the course of injections because of systemic or large local reactions. Eight subjects withdrew during the pollen season because of severe rhinitis; all subjects had received Pollinex-R. Subjects in the budesonide-treated group had minimal nasal symptoms and used very little terfenadine, compared with subjects in the Pollinex-R-treated group (p less than 0.0001). Eye symptoms and eye drop use were similar in the two treatment groups. No clinically important side effects were reported by the subjects receiving budesonide. The results of this study suggest that aqueous budesonide nasal spray is markedly more effective than Pollinex-R in controlling symptoms of seasonal rhinitis while the side effects and inconvenience of immunotherapy are avoided.

Topics: Aldehydes; Allergens; Antigens, Plant; Budesonide; Conjunctivitis, Allergic; Desensitization, Immunologic; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Glucocorticoids; Glutaral; Humans; Injections; Nebulizers and Vaporizers; Plant Extracts; Pollen; Pregnenediones; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Seasonal; Skin Tests; Time Factors; Tyrosine

The inflammatory response of airway mucosa to allergen exposure is a complex phenomenon featuring symptoms, the influx of inflammatory cells, the release of mediators, and changes in local reactivity. These features and their pharmacological modifications can be successfully studied in nasal challenge models. We performed a nasal allergen challenge followed by a rechallenge with allergen 24 h later in order to monitor changes in specific reactivity due to the initial allergen challenge. Symptoms were monitored, as was the generation of TAME-esterase activity in nasal lavage fluids. Prior to each challenge a nasal brush specimen was taken. In a double blind, cross-over, double-dummy manner the patients were pretreated with placebo, a single dose of 200 micrograms of budesonide (topical corticosteroid) given 2 h prior to rechallenge with allergen or 600 mg ibuprofen (cyclooxygenase inhibitor) given per os t.i.d. to steady state starting 24 h prior to the initial allergen challenge. Treatment with ibuprofen induced a slightly lower composite symptom score (P less than 0.05) at the initial allergen challenge when compared with placebo. No differences were noted in the relevant TAME-esterase activities. The allergen challenge resulted in significantly increased proportions of eosinophils in the brush specimens 24 h after the initial allergen challenge (P less than 0.001) with no differences between the different treatment alternatives. At rechallenge there was a reduction in the symptoms of secretion and nasal blockage in both groups receiving active treatment compared with placebo (P less than 0.05), whereas the number of sneezes was not affected and no differences were noted in TAME-esterase activity.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Topical; Adolescent; Adult; Analysis of Variance; Anti-Inflammatory Agents; Budesonide; Double-Blind Method; Eosinophils; Female; Glucocorticoids; Humans; Ibuprofen; Male; Nasal Mucosa; Peptide Hydrolases; Pregnenediones; Prostaglandin-Endoperoxide Synthases; Rhinitis, Allergic, Seasonal

Glucocorticoid sprays are increasingly used for the treatment of allergic rhinitis and asthma. This therapy is highly effective, and side effects are few and mild. It was the aim of the present study to evaluate a physiological nasal inhalation technique, which results in airway deposition of the steroid molecule similar to that of inhaled allergen particles. Thirty adults with grass pollen-induced rhinitis and asthma inhaled the steroid molecule budesonide through the nose from a pressurized aerosol attached to a spacer device. Compared with inhalation of placebo, the treatment resulted in a significant reduction of nasal symptoms (P = 0.005), of bronchial symptoms (P = 0.005), but not of eye symptoms. In addition, nasal peak inspiratory flow (P = 0.0003) and oral peak expiratory flow (P = 0.02) increased. There was no difference between budesonide and placebo with regard to local side effects, such as nose bleeding, hoarseness, and irritation in mouth and throat. It is concluded that nasal inhalation of a steroid from a spacer offers effective therapy of pollen rhinitis and asthma without significant local side effects. This therapeutic modality may have advantages over the ordinarily used nasal and bronchial spray treatment in patients with both rhinitis and asthma, especially when conventional spray therapy is associated with local side effects.

Topics: Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents; Asthma; Budesonide; Denmark; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Medical Records; Middle Aged; Nebulizers and Vaporizers; Patient Compliance; Pollen; Pregnenediones; Rhinitis, Allergic, Seasonal

This double-blind, placebo-controlled group-comparative study in patients with seasonal allergic rhinitis was performed to investigate the possible influence of natural allergen exposure on the differentiation of goblet cells in the nasal mucosa. Furthermore, the effect of topical steroid treatment on such a putative influence was evaluated. Twenty adult patients with seasonal allergic rhinitis due to birch pollen were studied. Mucosal samples were obtained by scrapings before and during the pollen season and processed to evaluate the number of goblet cells/mm of intact epithelial lining. No statistically significant differences were found neither when comparing the number of goblet cells before and during the season nor when comparing the 2 treatment groups. In conclusion, the allergic inflammation could not be shown to accelerate the differentiation of goblet cells, and the beneficial effect of topical steroid treatment could not be explained by a prevention of increased goblet cell density.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Budesonide; Clinical Trials as Topic; Double-Blind Method; Exocrine Glands; Female; Glucocorticoids; Humans; Male; Mucus; Nasal Mucosa; Pollen; Pregnenediones; Rhinitis, Allergic, Seasonal

During the last decade topical glucocorticoids have been established as the first hand choice for the treatment of allergic rhinitis. Although they are clinically effective, their precise mode of action has not been sufficiently clarified. In order to evaluate whether the clinical effect is dependent on the topical administration a randomized, double-blind, double-dummy study was performed. Ninety-eight patients with allergic rhinitis due to birch pollen were recruited at two centres in southern Sweden. The patients received one of the following three treatment alternatives: 200 micrograms of nasally applied budesonide twice daily, 250 micrograms of budesonide given orally twice daily or a placebo. The selection of the doses was based on previous pharmacokinetic studies giving almost equal plasma levels of the nasally and orally administered budesonide. To evaluate the possible clinical efficacy of the treatment, the patients kept a diary in order to register symptoms according to a 0-4 scale. After a run-in week with no treatment the patients entered the treatment period which lasted for 3 weeks. A total of 96 patients completed the study. The symptom data showed that topically applied budesonide was clinically effective with a pronounced reduction in all the nasal symptoms registered and compared with placebo treatment there was a statistically significant difference in favour of the budesonide treatment (P less than 0.001). The nasal symptoms of the patients receiving oral budesonide did not differ from those receiving placebo. Intranasally administered budesonide proved to be significantly more effective than orally applied budesonide (P less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Intranasal; Administration, Oral; Adolescent; Adult; Aerosols; Anti-Inflammatory Agents; Budesonide; Capsules; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Pregnenediones; Random Allocation; Rhinitis, Allergic, Seasonal

Thirty patients with seasonal allergic rhinitis entered a double blind study comparing budesonide (nasal spray, 400 micrograms/d) and i.m. injection of 80 mg methylprednisolone acetate. Symptoms were assessed over a "run in" period of 3-7 days followed by a treatment period of 3 weeks. Pollen counts were evaluated daily. Both the systemic and topical corticosteroid treatment resulted in a significant improvement of nasal and ocular symptoms and were accompanied by reduced antihistamine intake. A comparison of the two treatments in relation to the pollen count yielded statistically significantly fewer nasal symptoms, such as itching, secretion, and sneezing in the budesonide-treated group. Nasal blockage and ocular symptoms remained unchanged, but the use of eyedrops was significantly reduced in the methylprednisolone-treated group. Side effects of both treatments were mild and the incidence negligible. Methylprednisolone-treated patients had a significantly lower cortisol value after 7 days but still had a normal response to ACTH-stimulation. We conclude that the acute symptoms of allergic rhinitis are at least as well ameliorated by regular topical application of budesonide as by a single injection of methylprednisolone acetate. The accompanying allergic conjunctivitis may require additional treatment.

Topics: Administration, Intranasal; Administration, Topical; Aerosols; Anti-Inflammatory Agents; Budesonide; Clinical Protocols; Delayed-Action Preparations; Humans; Hydrocortisone; Methylprednisolone; Methylprednisolone Acetate; Pollen; Pregnenediones; 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

The aim of this study was to compare the efficacy and side effects of budesonide and disodium cromoglycate (DSCG) in seasonal allergic rhinitis. In a double-blind, double-dummy comparative study, 43 patients with seasonal allergic rhinitis were either treated with budesonide (200 micrograms b.d.) or DSCG (5.2 mg 5 times daily). After a 1 week run-in period treatment was given for 3 weeks. The patient scorings for nasal secretion, nasal itching, sneezing bouts and total nasal symptoms were significantly different between the treatment groups during the whole treatment period. The scorings for nasal blockage were significantly different during the last 2 weeks of treatment. All differences were in favour of budesonide treatment. The patients' assessment of the treatment favoured budesonide (P less than 0.02). Side effects were few and mild, but one patient from the budesonide group stopped treatment because of headache.

Topics: Adolescent; Adult; Airway Resistance; Budesonide; Clinical Trials as Topic; Cromolyn Sodium; Double-Blind Method; Female; Humans; Male; Middle Aged; Patient Acceptance of Health Care; Pregnenediones; Random Allocation; Rhinitis, Allergic, Seasonal

A comparative study was carried out in 118 patients suffering from seasonal allergic rhinitis in order to evaluate possible differences between two different preparations of budesonide with regard to effect and adverse reactions. The glucocorticoid was supplied either as a freon propellant device (Rhinocort) or as a water solution in a mechanical pump spray. The freon aerosol was administered in a daily dosage of 400 micrograms. The water solution was administered in daily dosages of 400 micrograms or 200 micrograms. The patients scored their nasal and ocular symptoms daily for 1 month, and pollen counts were registered over the same period. The drugs employed in the study provided good control of the nasal symptoms. The daily dosage of 400 micrograms in both preparations proved more efficacious than the daily 200 micrograms dose in the nasal pump spray. No difference was found between the delivery systems when the same daily dosage was used. The number of adverse reactions was low and insignificant in all 3 treatment groups.

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Aged; Anti-Inflammatory Agents; Budesonide; Clinical Trials as Topic; Female; Glucocorticoids; Humans; Male; Middle Aged; Pregnenediones; Rhinitis, Allergic, Seasonal; Solutions

Budesonide is a non-halogenated glucocorticosteroid which has been shown to possess a high ratio of topical to systemic activity compared with a number of reference corticosteroids such as beclomethasone dipropionate, flunisolide, and triamcinolone acetonide. It appears to undergo extensive first-pass metabolism to metabolites of minimal activity which accounts for the low level of systemic activity. The majority of therapeutic trials in asthma have been of short term duration and have demonstrated that conventional doses of inhaled budesonide (200 to 800 micrograms/day) and beclomethasone dipropionate (400 to 800 micrograms/day) are of similar efficacy in both adults and children with moderate to severe asthma. Other studies have compared high doses of inhaled budesonide (400 to 3200 micrograms/day in 4 divided doses) with both alternate day (7.5 to 60 mg) and daily (7.5 to 40 mg) oral prednisone in patients with severe or unstable asthma. In the small number of such trials to date, inhaled budesonide was superior to prednisone with respect to the level of asthma control and the lesser influence on adrenal function. Long term open studies have similarly shown that inhaled budesonide can be gradually substituted for oral prednisone in steroid-dependent patients, often with a concomitant improvement in pulmonary function and asthma control. Intranasal budesonide (200 to 400 micrograms/day) relieves nasal symptoms in patients with seasonal allergic, perennial allergic and vasomotor rhinitis. In comparative studies in patients with seasonal rhinitis it has been shown to be of similar efficacy as intranasal flunisolide and intranasal beclomethasone dipropionate and superior to intranasal sodium cromoglycate (cromolyn sodium) and the antihistamine dexchlorpheniramine. Following inhalation, the most commonly reported side effects have been candidiasis, dysphonia and sore throat, while after intranasal administration the most frequent adverse reactions have been nasal stinging, throat irritation, dry nose and slight nasal bleeding. At usual dosages, both formulations of budesonide appear to have little or no effect on adrenal function. Thus, at this stage in its development budesonide has been shown to offer an effective alternative to oral or other inhaled corticosteroids in the management of asthma and rhinitis. However, its relative efficacy and tolerability during long term use, compared with beclomethasone dipropionate, remains to be clarified.

Topics: Administration, Topical; Adrenal Glands; Adult; Anaphylaxis; Animals; Anti-Inflammatory Agents; Asthma; Budesonide; Child; Clinical Trials as Topic; Cricetinae; Glucocorticoids; Humans; Intestinal Absorption; Kinetics; Male; Pregnenediones; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Rhinitis, Vasomotor; Tissue Distribution

The effectiveness of budesonide, a new non-halogenated glucocorticoid administered by nasal inhaler, was evaluated in a double blind comparison with placebo in patients presenting with hay fever. Patients were supplied with antihistamine tablets and eye drops for use when they considered that their symptoms were inadequately controlled by their inhaler. Patients recorded the severity of their symptoms in a daily diary card and visited their general practitioner for assessment weekly for four weeks. All nasal symptoms of hay fever were appreciably reduced in the group taking budesonide and, although their eye symptoms were more severe than in the group taking placebo, they did not use appreciably more eye drops than the latter. The placebo group used appreciably more antihistamine tablets than those in the budesonide group. No patients were withdrawn from the budesonide group because of treatment failure or unacceptable side effects. The results suggest that budesonide is an acceptable and effective treatment for the nasal symptoms of hay fever.

Topics: Administration, Intranasal; Adolescent; Adult; Budesonide; Clinical Trials as Topic; Double-Blind Method; Glucocorticoids; Humans; Pregnenediones; Random Allocation; Rhinitis, Allergic, Seasonal

A group comparative study was carried out in 60 patients suffering from seasonal allergic rhinitis in order to evaluate the effects and side effects of the recently introduced glucocorticoids budesonide and flunisolide delivered as nasal sprays. Symptom scores for nasal and ocular symptoms as well as pollen counts were registered daily for one month. Both treatments provided excellent control of nasal symptoms. However, a significantly higher number of patients in the flunisolide group complained about nasal irritation.

Topics: Adolescent; Adult; Aerosols; Budesonide; Epistaxis; Female; Fluocinolone Acetonide; Humans; Male; Middle Aged; Pregnenediones; Random Allocation; Rhinitis, Allergic, Seasonal

It was the aim of the study 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, 61 adult grass pollen allergic patients were either treated with dexchlorpheniramine maleate sustained release tablets (6 mg b.d.), or with budesonide nasal spray (200 micrograms b.d.). After a 1-week run-in period, treatment was given for 3 weeks in the grass pollen season. Patients treated with budesonide showed significantly less nasal blockage than those who received dexchlorpheniramine (P less than 0.05), but there was no difference in the number of sneezes and nose blowings. Patients treated with budesonide and a larger quantity of antihistamine-vasoconstrictor eye drops (P less than 0.01). Drowsiness occurred in the group that was treated with dexchlorpheniramine, but mainly during the first week of treatment. The side effects caused by the budesonide spray were few and insignificant. The patients' overall assessment of the treatment favoured the glucocorticoid spray (P = 0.06).

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Anti-Inflammatory Agents; Budesonide; Chlorpheniramine; Circadian Rhythm; Clinical Trials as Topic; Delayed-Action Preparations; Double-Blind Method; Female; Glucocorticoids; Histamine H1 Antagonists; Humans; Male; Middle Aged; Pregnenediones; Rhinitis, Allergic, Seasonal; Sneezing

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

Glucocorticoids were previously considered not to affect the immediate allergic reaction. However, in a nasal allergen challenge, an inhibitory effect on the nasal symptoms induced at the challenge has been shown to occur in patients treated with a recently developed glucocorticoid, budesonide, for 1 week prior to the challenge. This treatment was also found to reduce tissue histamine levels in the nasal mucosa. Mast cells in the mucosa were therefore studied with a view to finding out whether this reduction could be due to a reduction of mast cells. A double-blind study was performed in 14 asymptomatic patients. Nasal biopsies were made before and after 1 week's treatment with either budesonide or placebo. The number of mast cells was counted in two Epon sections after the specimens had undergone specific staining with toluidine blue. No quantitative or qualitative morphological changes in the mast cells were found as a result of treatment.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Budesonide; Cell Count; Female; Glucocorticoids; Humans; Male; Mast Cells; Nasal Mucosa; Pregnenediones; Rhinitis, Allergic, Seasonal

The influence on nasal allergen challenge of three different doses of budesonide and placebo administered three hours before or twice daily for one week before challenge was investigated out of season in twelve patients suffering from allergic rhinitis due to grass or brich pollen. Budesonide and placebo administered three hours before challenge significantly reduced the fall in nasal peak flow, sneezes and secretion. After one week's treatment only budesonide caused further significant decrease in sneezes and secretion and a significant increase in nasal peak flow before and after challenge. No dose-response relation was found. In twelve healthy subjects one week's treatment with budesonide significantly increased nasal peak flow compared to placebo.

Topics: Adult; Budesonide; Female; Humans; Male; Nasal Provocation Tests; Nose; Pregnenediones; Pulmonary Ventilation; Rhinitis, Allergic, Seasonal

In a nasal allergen challenge test, the effect of the glucocorticosteroid budesonide on the pollen allergic type I reaction was investigated. Placebo and two different doses of budesonide were given intranasally for one week before the challenge. The study was designed as a double-blind cross-over trial. Treatment for one week with the active steroid significantly reduced the nasal secretion compared with placebo, as measured with the aid of a symptom score, and significantly reduced the induced nasal blockage measured objectively by rhinomanometry. No difference was found between the two doses of budesonide, 400 micrograms and 100 micrograms daily, used in the study.

Topics: Adolescent; Adult; Budesonide; Female; Humans; Hypersensitivity, Immediate; Male; Manometry; Nasal Provocation Tests; Pregnenediones; 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

The possible mode of action of the lately demonstrated steroid effect on the immediate type allergic reaction was investigated. The influence of a topical steroid, budesonide, on the effects that released mediators have on the nasal mucosa was also studied. A nasal histamine challenge study was performed in a double-blind, cross-over fashion, a 1-week pretreatment with budesonide or placebo preceding the challenge. Symptoms were recorded by means of symptom score as well as objectively via rhinomanometry. In contrast to a previous allergen challenge study, the steroid was found to have minimal effect on the histamine-induced nasal symptoms. It is therefore concluded that other modes of steroid action must also be involved in the steroid effect on the immediate type allergic reaction.

Topics: Administration, Topical; Adult; Airway Resistance; Anti-Inflammatory Agents; Budesonide; Female; Glucocorticoids; Histamine; Humans; Hypersensitivity, Immediate; Male; Nasal Mucosa; Nasal Provocation Tests; Pregnenediones; Rhinitis, Allergic, Seasonal; Sneezing

In a nasal allergen challenge test, the effect of the glucocorticosteroid, Budesonide, on the pollen allergic type I reaction has been investigated. Placebo and two different dosages of budesonide were administered intranasally for 1 week before the challenge was performed. The study was designed as a double-blind cross-over trial. One week of treatment with the active steroid significantly reduced the nasal secretion compared to placebo as measured with the aid of a symptom score, and significantly reduced the induced nasal blockage measured objectively by means of rhinomanometry. No difference was found between the two dosages of budesonide, 400 micrograms and 100 micrograms daily, used in the study.

Topics: Administration, Intranasal; Adolescent; Adult; Allergens; Anti-Inflammatory Agents; Budesonide; Female; Glucocorticoids; Humans; Male; Nasal Provocation Tests; Pollen; Pregnenediones; Rhinitis, Allergic, Seasonal

The clinical effects of intranasal budesonide (16 alpha, 17 alpha (22 R,S) propylmethylenedioxypregana-1-4-diene-11beta 21 diol-3, 20 dione)) - a new non-halogenated glucocorticoid - were evaluated in a double-blind comparison with placebo, in patients with pronounced hay fever. Aerosolized budesonide, using a daily dosage of either 400 microgram or 200 microgram, showed a highly significantly reduction in the nasal symptoms as compared with placebo. No significant difference could be demonstrated between the effects of 400 microgram and 200 microgram per day, suggesting that the lower dosage is adequate. No significant effect on the eye symptoms and no fall in plasma cortisol values were observed with either dosage. Only mild side effects were reported.

Topics: Administration, Intranasal; Adolescent; Adult; Asthma; Budesonide; Clinical Trials as Topic; Double-Blind Method; Female; Histamine H1 Antagonists; Humans; Hydrocortisone; Male; Middle Aged; Ophthalmic Solutions; Placebos; Pollen; Pregnenediones; Rhinitis, Allergic, Seasonal

Twenty-nine patients with seasonal rhinitis completed a double-blind study comparing budesonide nasal spray 200 micrograms b.i.d. with placebo. The patients were randomly assigned into two parallel groups. Symptoms were assessed over a treatment period of 3 weeks. There were statistically significant differences in favour of budesonide on all measurements. Side effects were mild and the incidence was low.

Topics: Administration, Intranasal; Adolescent; Adult; Budesonide; Child; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Placebos; Pregnenediones; Rhinitis, Allergic, Seasonal; Steroids

For locally acting drugs, an extended residence time in the nasal cavity is desirable and related to a prolonged effect. We sought to develop a model for comparative determination of intranasal pharmacokinetics. We embedded human respiratory tissue into a solid matrix and coated the surface with artificial nasal fluid. Nasal spray suspensions of fluticasone propionate (FP) and budesonide (Bud) as well as a solution of azelastine hydrochloride (AZ) were applied onto the surface and removed after 30 min to simulate mucociliary clearance. As exemplary anti-inflammatory measure, we evaluated the inhibition of IL-8 release from epithelial cells. FP and Bud were initially bound to the same extent to the tissue gel while AZ displayed a more 4-fold higher binding than FP or Bud. After equilibrium with plasma, approximately 5-fold higher tissue concentrations of AZ compared to FP and 77-fold higher levels in relation to Bud were determined. This tissue retention revealed an excellent correlation with the volume of distribution of the respective drugs (r=0.9999, p ≤ 0.05). The inhibitory effect of FP on IL-8 release was approximately 5-fold more pronounced compared to AZ. The present model realistically mirrors conditions in vivo where solubility and tissue absorption of intranasally applied drugs compete with mucociliary clearance mechanisms.

Topics: Adenocarcinoma; Adenocarcinoma of Lung; Administration, Inhalation; Administration, Intranasal; Aerosols; Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents; Budesonide; Cell Line, Tumor; Delayed-Action Preparations; Epithelial Cells; Fluticasone; Glucocorticoids; Histamine Antagonists; Humans; Interleukin-8; Lung; Lung Neoplasms; Mucociliary Clearance; Nasal Lavage Fluid; Nasal Sprays; Phthalazines; Rhinitis, Allergic, Seasonal

Topics: Adult; Breath Tests; Bronchial Provocation Tests; Bronchitis; Budesonide; Cupressus; Female; Humans; Immunoglobulin E; Male; Nitric Oxide; Pulmonary Eosinophilia; Rhinitis, Allergic, Seasonal; Skin Tests; Sputum

Topics: Administration, Inhalation; Budesonide; Cross Reactions; Glucocorticoids; Humans; Hypersensitivity, Delayed; Male; Middle Aged; Mucositis; Patch Tests; Rhinitis, Allergic, Seasonal

Topics: Acetates; Administration, Inhalation; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Double-Blind Method; Drug Therapy, Combination; Humans; Leukotriene Antagonists; Quinolines; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Seasonal; Sulfides; Time Factors

The Clinical Outcomes with Montelukast as a Partner Agent to Corticosteroid Therapy (COMPACT) trial demonstrated that montelukast added to budesonide (MNT + BD) was as efficacious as double the dose of budesonide (dBD) in improving morning peak expiratory flow (AM PEF) in adult asthmatics. Recent studies have demonstrated that montelukast is also effective in treating daytime and nighttime allergic rhinitis (AR) symptoms in asthmatic patients. This analysis was designed to examine whether asthmatic patients with comorbid AR respond differently than patients without comorbid AR in terms of asthma control (lung function).. There were 216 asthmatic patients in the MNT+BD group and 184 patients in the dBD group with AR. Treatment differences in the change from baseline in AM PEF were compared. Least square (LS) mean and 95% confidence interval (CI) were derived from an anova model adjusting for baseline and study site.. There was a 9.2% increase in AM PEF from baseline in the MNT+BD group compared with a 6% increase in the dBD group. The LS mean difference [(MNT+BD)-dBD] was 14.2 l/min (P=0.028). Other secondary endpoints were similar between groups.. In the subgroup of asthmatic patients with AR, a combined treatment approach that included montelukast and budesonide provided significantly greater efficacy in reducing airflow obstruction compared with doubling the dose of budesonide. These results support recommendations by the Allergic Rhinitis and its Impact on Asthma initiative that suggest a unified approach aimed at treating the airway inflammation common to both diseases is beneficial for the large proportion of asthmatics who also suffer from AR.

Topics: Acetates; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Lung; Male; Peak Expiratory Flow Rate; Quinolines; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Sulfides

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Androstadienes; Anti-Allergic Agents; Budesonide; Drug Administration Schedule; Fluticasone; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Triamcinolone Acetonide

Topics: Acetates; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Drug Therapy, Combination; Germany; Glucocorticoids; Humans; Leukotriene Antagonists; Multicenter Studies as Topic; Quinolines; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Sulfides

Topics: Administration, Inhalation; Adrenal Cortex Hormones; Budesonide; Child; Dermatitis, Allergic Contact; Diagnosis, Differential; Erythema; Humans; Male; Nose; Patch Tests; Rhinitis, Allergic, Seasonal

Glucocorticosteroid (GCS) inhibition of cytokine production is a major anti-inflammatory mechanism. However, increased production of pro-inflammatory cytokines during allergic airway inflammation has been proposed to reduce GCS effects. This study aimed to investigate whether allergic airway inflammation due to natural allergen exposure might decrease the sensitivity of granulocyte-macrophage colony-stimulating factor (GM-CSF) production to GCS in blood cells. Blood samples were collected from patients with seasonal allergic asthma (n = 10) and rhinitis (n = 8) and healthy subjects (n = 9), before, during, and after the birch pollen season. Whole blood cultures were stimulated with LPS (10 ng/ml) and treated with budesonide (10(-11)-10(-7) M) for 20 h. GM-CSF levels were analysed using immunoassay. Birch pollen exposure did not alter LPS-stimulated GM-CSF production, although disease symptoms and blood eosinophils increased in the patients. There were no significant differences in budesonide inhibition of GM-CSF production by blood cells of asthma and rhinitis patients compared with cells of healthy subjects before, during or after the birch pollen season and no change in response to allergen exposure. A concentration of 1 nM budesonide inhibited GM-CSF production by more than 50% at all time points. In conclusion, natural allergen exposure did not reduce the sensitivity of GM-CSF production to GCS inhibition in blood cells of seasonal allergic asthma and rhinitis patients.

Topics: Adult; Allergens; Asthma; Budesonide; Cell Count; Cells, Cultured; Cytokines; Eosinophils; Glucocorticoids; Granulocyte-Macrophage Colony-Stimulating Factor; Humans; Male; Middle Aged; Rhinitis, Allergic, Seasonal

Topics: Administration, Intranasal; Adult; Aerosols; Androstadienes; Anti-Inflammatory Agents; Budesonide; Child; Female; Fluticasone; Humans; Male; Mometasone Furoate; Nasal Polyps; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Singapore; Sinusitis; Triamcinolone Acetonide

Topical treatment with glucocorticoids (GCs) is known to decrease eosinophils but not neutrophils in patients with allergic rhinitis.. We sought to examine whether the differential effects of GC treatment on eosinophils and neutrophils are mirrored by differential effects on T(H)1/T(H)2 cytokines and the neutrophil-associated cytokines IL-1beta and TNF-alpha.. Differential counts of eosinophils and neutrophils in nasal fluids from 60 children with seasonal allergic rhinitis treated with a topical GC were examined after staining with May-Grünwald-Giemsa stain. Nasal fluid levels of IFN-gamma, IL-4, IL-6, IL-10, IL-1beta, and TNF-alpha were examined with ELISA, and IgE and eosinophil cationic protein (ECP) levels were examined with RIA.. After GC treatment, there was a statistically significant decrease of the T(H)2 cytokines IL-4, IL-6, and IL-10, as well as ECP and IgE. By contrast, there were no significant changes of the levels of IFN-gamma, IL-1beta, TNF-alpha, or neutrophils. In the GC-treated patients IL-1beta and TNF-alpha levels correlated with neutrophils and ECP, and IL-1beta correlated with eosinophils. Furthermore, ECP correlated with both eosinophils and neutrophils. Neither IL-1beta nor TNF-alpha correlated with IgE. Patients with high neutrophil counts after GC treatment were found to have significantly higher eosinophil counts and ECP than patients with low counts.. The beneficial effects of topical treatment with GC in patients with allergic rhinitis could be attributed to downregulation of T(H)2 cytokines, with an ensuing decrease of eosinophils, ECP, and IgE. It is possible that neutrophils could counteract the beneficial effects of GCs by releasing the proinflammatory cytokines IL-1beta and TNF-alpha.

Topics: Administration, Topical; Anti-Inflammatory Agents; Blood Proteins; Budesonide; Child; Cytokines; Eosinophil Granule Proteins; Eosinophils; Glucocorticoids; Humans; Immunoglobulin E; Interferon-gamma; Interleukin-1; Interleukin-10; Interleukin-4; Interleukin-6; Leukocyte Count; Nasal Mucosa; Neutrophils; Rhinitis, Allergic, Seasonal; Ribonucleases; Th2 Cells; Tumor Necrosis Factor-alpha

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Budesonide; Dose-Response Relationship, Drug; Humans; Rhinitis, Allergic, Seasonal; Steroids

Quality of life (QOL) issues resulting from participation in an allergy research trial, or indeed any clinical trial, is not documented in the medical literature.. To determine whether participating in a trial where allergic symptoms are induced has a significant impact on subjects' QOL, and to quantify extent and duration.. Subjects were recruited from a trial utilizing a controlled allergen environment to assess anti-allergic medications. A QOL survey (consisting of the Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ] & the SF-36) was completed at screening, on study day, and approximately 2 weeks post-study. Follow-up was sought from subjects' whose QOL was significantly worse than baseline.. Of 219 trial participants, 206 completed both screening and study surveys; 141 returned at least one follow-up survey; and 136 constructed the final dataset. Mean overall scores at follow-up via RQLQ were significantly better than screening (P < .001). Significant decreases in QOL from baseline on study day occurred in social function on the SF-36 (P = .026) and in domains of sleep (P = .019), non-nasal symptoms (P = .05), ocular symptoms (P < .001), and nasal symptoms (P < .001) on the RQLQ. Average post-study follow-up was 17.1 days (range = 5 to 55 days).. Subjects participating in a trial involving allergic symptom induction experienced a decrease of QOL in parameters specific to rhinoconjunctivitis and social function. Subjects' QOL returned to or improved over baseline within 2 1/2 weeks. Positive QOL findings are important to studies where symptoms are induced and also have relevance to standard Phase 3 drug trials.

Topics: Allergens; Anti-Allergic Agents; Bronchodilator Agents; Budesonide; Clinical Trials as Topic; Conjunctivitis; Follow-Up Studies; Histamine H1 Antagonists; Humans; Quality of Life; Rhinitis, Allergic, Seasonal; Surveys and Questionnaires

The objectives of this study were to measure interleukins 5 and 8 (IL-5 and IL-8) in relation to eosinophils and neutrophils, in nasal lavage fluids from 60 school children with allergic rhinitis, and to determine the influence of treatment with a topical steroid (budesonide) on the levels of the two cytokines. Highly sensitive enzyme immunoassays were used to analyze IL-5 and IL-8. IL-5 levels and relative eosinophil counts in nasal lavage fluid increased significantly in patients with allergic rhinitis during the pollen season, compared with values obtained before the start of the season, and decreased significantly after treatment with budesonide. By contrast, no significant changes in IL-8 or neutrophils were found during the pollen season, nor did they decrease following treatment. In the untreated patients, IL-5 levels correlated significantly with eosinophil counts but not with neutrophil counts, whereas IL-8 levels correlated with neutrophil counts but not with eosinophil counts. After budesonide treatment, the correlation between IL-8 and neutrophils remained, and a correlation between IL-8 and eosinophils emerged. These findings support the concepts that IL-5 has a key role in regulating eosinophils and that IL-8 is important for the regulation of neutrophils. Whereas IL-5 and relative eosinophil counts are profoundly affected by topical steroid treatment, IL-8 and neutrophils are not demonstrably affected by such treatment. It is possible that neutrophils, through the release of IL-8, could be chemotactic for eosinophils in steroid-treated patients.

Topics: Adolescent; Adult; Allergens; Anti-Inflammatory Agents; Budesonide; Child; Enzyme-Linked Immunosorbent Assay; Eosinophils; Humans; Interleukin-5; Interleukin-8; Leukocyte Count; Nasal Lavage Fluid; Neutrophils; Pollen; Prospective Studies; Rhinitis, Allergic, Seasonal

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

Mast cells are increased in nasal polyp (Np) and allergic rhinitis (AR) tissue and are suppressed by topical corticosteroid treatment. Stem cell factor (SCF), a mast cell growth and survival factor, may explain these phenomena.. We investigated structural cell gene expression and production of SCF in nasal tissues in patients who had received and who had not received in vivo intranasal corticosteroid therapy.. Northern blot analyses for messenger RNA and ELISA for biologically active SCF protein from cultured Np epithelial cells and fibroblasts were performed. Immunostaining for SCF in cultured and tissue nasal structural cells in the presence or absence of steroid treatment was also performed.. We detected significant expression of SCF mRNA and protein by cultured Np epithelial cells and Np fibroblasts; Np fibroblast SCF supported the differentiation of mast cells in vitro. There were more immunoreactive SCF-positive Np epithelial cells in patients with AR than in control subjects (97.2 +/- 2.8 vs 45.6 +/- 22.0%; p < 0.0001). SCF that could be immunostained was significantly diminished overall in Np structural cells in the group given in vivo steroid treatment, with a modest (trend to significant) effect on any given cell type analyzed. In vitro treatment with budesonide of SCF-producing fibroblasts demonstrated inhibition of unstimulated, primary Np fibroblasts but not of IL-1-stimulated fibroblasts or transformed cell lines.. Human Np and AR tissue structural cells express and produce increased SCF. Our in vitro studies suggest that intranasal steroids blunt SCF expression in Nps, an effect that may be responsible for a decrease in mast cells and symptoms.

Topics: Administration, Topical; Adrenal Cortex Hormones; Adult; Anti-Inflammatory Agents; Blotting, Northern; Budesonide; Cells, Cultured; Chymases; Epithelial Cells; Epithelium; Female; Fibroblasts; Gene Expression; Humans; Immunohistochemistry; Interleukin-1; Male; Mast Cells; Middle Aged; Nasal Polyps; Pregnenediones; Rhinitis, Allergic, Seasonal; RNA, Messenger; Serine Endopeptidases; Stem Cell Factor; Tryptases

Topics: Administration, Inhalation; Administration, Intranasal; Aerosols; Anti-Inflammatory Agents; Asthma; Bronchodilator Agents; Budesonide; Glucocorticoids; Humans; Nasal Polyps; Pregnenediones; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Topics: Administration, Intranasal; Adult; Anti-Inflammatory Agents; Budesonide; Child; Clinical Trials as Topic; Glucocorticoids; Humans; Pregnenediones; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

The therapeutic influence of Budesonide in 51 patients with pollen allergy were described. The preparation improved the symptoms after 2 weeks of therapy. The side effects were absent.

Topics: Adult; Budesonide; Female; Glucocorticoids; Humans; Male; Pregnenediones; Rhinitis, Allergic, Seasonal

Symptomatic seasonal allergic rhinitis has previously been found to be associated with a redistribution of mast cells from the subepithelial stroma to the epithelial lining and the surface of the nasal mucosa. The present study was designed in order to elucidate the interaction between topical glucocorticosteroids, effective in the treatment of allergic rhinitis, and the migration of mast cells described earlier. Six patients treated prophylactically in the nose with budesonide were studied. Imprints and biopsies from the nasal mucosa were taken 2-3 weeks before and 2-3 weeks into the birch pollen season. The biopsies were used for light microscopy and tissue histamine determination. The morphologic studies showed, also in the actively treated patients, an increased number of metachromatically stained cells on the nasal mucosal surface of the same order of magnitude as previously reported for untreated patients. We did, however, find a decrease in the histamine content of the nasal mucosa, which was not associated with a decrease in the number of mast cells. Together with similar previous findings in the unstimulated allergic nasal mucosa these results suggest that glucocorticosteroids induce a decrease in the mast cell histamine pool, possibly due to an inhibition of the intracellular synthesis of histamine. This effect might contribute to the clinically beneficial effect of topical glucocorticosteroids in the treatment of hay fever.

Topics: Administration, Topical; Adult; Budesonide; Female; Histamine; Humans; Male; Mast Cells; Nasal Mucosa; Pregnenediones; Rhinitis, Allergic, Seasonal

Topics: Administration, Intranasal; Adult; Budesonide; Drug Eruptions; Facial Dermatoses; Female; Humans; Pregnenediones; Rhinitis, Allergic, Seasonal

The possible mode of action of the recently demonstrated steroid effect on the immediate type allergic reaction has been studied. The influence of a topical steroid, budesonide, on the nasal mucosal histamine content and anti-IgE induced histamine release was studied in an open study. A 1-week treatment with budesonide, used locally in the nose, was administered to 22 hay fever patients who were studied out of the pollen season. There was a decrease of histamine content after steroid treatment and also a blockade of the anti-IgE mediated histamine release, as shown in an in vitro release procedure. This steroid effect may partly explain the effect of steroids on the immediate reaction, as it has been demonstrated in allergen challenge studies.

Topics: Adolescent; Adult; Antibodies, Anti-Idiotypic; Budesonide; Female; Histamine; Histamine Release; Humans; Immunoglobulin E; Male; Nasal Mucosa; Organ Size; Pregnenediones; Rhinitis, Allergic, Seasonal