pulmicort and Rhinitis--Allergic--Perennial

Although the question of whether early diagnosis and treatment of pediatric allergic rhinitis (AR) improve disease control is important, a more crucial question is whether we can evaluate the effect of treatment on disease control using an impairment-risk model.. To conduct a systematic review evaluating application of a control model based on domains of impairment and risk (similar to that used for asthma) in pharmacotherapy for children with AR.. We searched the MEDLINE and EMBASE databases (January 1, 1996, through May 31, 2012) for controlled studies lasting 2 weeks or longer in children with confirmed diagnoses of AR, including measures assessing impairment and/or risk of comorbid conditions.. Sixteen controlled clinical trials, including more than 3000 children (aged 2-18 years) with AR (seasonal, n = 2290; perennial, n = 800), met the study criteria. All medication classes improved impairment related to AR, but between-treatment comparisons were limited because of different assessments. Intranasal steroids improved risk outcomes associated with asthma and obstructive sleep apnea. Small single studies suggested possible effects of oral antihistamines on asthma and sleep-disordered breathing. No risk data were available for nasal antihistamines or montelukast sodium.. Treatment of AR, particularly with intranasal steroids, improves disease control in children by reducing disease-associated impairment and risk. All AR medications with proved efficacy probably improve impairment, paralleling symptom reduction. Intranasal steroids may reduce the likelihood of comorbidities that increase health care use. These observations, although limited by different protocols and outcomes measures among studies, support current practice recommendations. Studies that use standardized measures of impairment to permit better comparison and appropriate protocols for risk evaluation are needed.

Topics: Budesonide; Child; Comorbidity; Early Diagnosis; Glucocorticoids; Health Status Indicators; Humans; Quality of Life; Rhinitis, Allergic, Perennial; Sleep Apnea, Obstructive; Surveys and Questionnaires

The connection between asthma and rhinitis is not a new discovery. Significant progress has been made in understanding the relationship of these two conditions, however, and the implications of the asthma-rhinitis link make it increasingly important. Patients who have asthma and rhinitis tend to have more severe disease with higher treatment costs. Treatment of rhinitis may improve asthma control, and early treatment of allergies may prevent the development of asthma. This article more fully explores the epidemiologic, pathophysiologic, and clinical relationships between asthma and rhinitis.

Topics: Anti-Inflammatory Agents; Asthma; Budesonide; Comorbidity; Humans; Immunotherapy; Intercellular Adhesion Molecule-1; Rhinitis, Allergic, Perennial; Vascular Cell Adhesion Molecule-1

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

Inadequately controlled rhinitis is associated with worsening asthma, one of the most common potentially serious causes of pregnancy complications. Recent evidence-based guidelines now stress the importance of inhaled corticosteroids as first-line therapy in controlling asthma during pregnancy, with preference given to budesonide. Both inhaled and intranasal budesonide formulations are rated Pregnancy Category B; all other inhaled and intranasal corticosteroids are rated Pregnancy Category C.. To review data from clinical and epidemiological studies investigating the effects of orally inhaled or intranasal budesonide on pregnancy outcomes.. Clinical and epidemiological studies on the effects of maternal exposure to orally inhaled or intranasal budesonide were identified through searches of the literature indexed on Medline or the Developmental and Reproductive Toxicology (DART) database through January 2005. The search terms used were: 'budesonide' and 'pregnancy'; 'pregnancy complications'; 'teratogens'; 'fetus'; 'embryo'; or 'toxicology'. The search was limited to English-language articles and those evaluating humans. Pertinent abstracts were identified from recent US asthma and allergy meetings.. A total of five articles and three abstracts meeting the search criteria were identified. Retrospective epidemiological studies and a randomized, placebo-controlled, multicenter trial found no clinically or statistically significant effects on fetal outcomes among more than 6600 infants whose mothers were exposed to orally inhaled budesonide during pregnancy. Women who reported use of orally inhaled budesonide either during early pregnancy only or throughout pregnancy gave birth to infants of normal gestational age, birth weight, and length, with no increased rate of stillbirths, multiple births, or congenital malformations. In a retrospective case-control analysis, no association was found between inhaled budesonide or intranasal budesonide and the overall rate of infant cardiovascular defects. However, a marginally increased risk of less severe cardiovascular defects (odds ratio = 1.58, 95% confidence interval 1.02 to 2.46) was observed with intranasal budesonide in one analysis, possibly the result of a random association due to multiple testing or an unidentified confounder.. Maternal exposure to orally inhaled budesonide during pregnancy is not associated with an increased risk of congenital malformations or other adverse fetal outcomes in studies of more than 6600 infants. Data on pregnancy outcomes after maternal exposure to intranasal budesonide are limited, but the totality of evidence, including pharmacological studies showing a much lower systemic exposure after intranasal administration, indicates its safety profile is at least comparable with that of orally inhaled budesonide.

Topics: Abnormalities, Drug-Induced; Administration, Inhalation; Administration, Intranasal; Administration, Oral; Asthma; Bronchodilator Agents; Budesonide; Female; Humans; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Randomized Controlled Trials as Topic; Retrospective Studies; Rhinitis, Allergic, Perennial

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

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

Topics: Administration, Intranasal; Budesonide; Child; Double-Blind Method; Eosinophils; Female; Glucocorticoids; Humans; Male; Nasal Obstruction; Nitric Oxide; Rhinitis, Allergic, Perennial; Sleep

To investigate the clinical efficacy of montelukast plus budesonide nasal spray and desloratadine citrate disodium tablets on moderate and severe persistent allergic rhinitis.. Senenty patients with moderate and severe persistent allergic rhinitis were devided randomly study group (n = 35) and control group (n = 35). The study group were treated with montelukast sodium tablets combined with budesonide nasal spray and desloratadine citrate disodium tablets for 4 weeks, the control group received budesonide nasal spray and desloratadine citrate disodium tablets for 4 weeks. Comparing visual analogue scale (VAS) scores of nasal symptoms, rhino conjunctivitis quality of life questionnaire (RQLQ) scores and total effective rate in two groups at baseline and after treatment.. (1) VAS scores of nasal symptoms: the difference of total nasal symptoms VAS scores or single nasal symptom VAS scores from both groups at 2 weeks and 4 weeks after treatment were statistically significant (P < 0.05); (2) RQLQ scores: the difference of RQLQ scores of 2 group's at baseline and 4 weeks after treatment were statistically significant, the difference of RQLQ scores about nasal symptoms in two groups at 4 weeks after treatment were statistically significant (P < 0.05); (3) The total effective rate was 94.29% in study group but 80.00% in control group, the differences were statistically significant (P < 0.05).. Montelukast plus budesonide nasal spray and desloratadine citrate disodium tablets can work together better on relieving clinical syptoms quickly and promoting the life quality of patients with moderate and severe persistent allergic rhinitis.

Topics: Acetates; Budesonide; Cyclopropanes; Humans; Loratadine; Nasal Sprays; Quinolines; Rhinitis, Allergic, Perennial; Sulfides; Surveys and Questionnaires

We investigated whether nebulization of budesonide via a NasoNeb® device would treat perennial allergic rhinitis.. We performed a parallel, randomized, double-blind, placebo-controlled, pilot study in subjects (n = 40) with perennial allergic rhinitis. After recording baseline symptoms, subjects were randomized to budesonide respules (0.25 mg) or an equivalent placebo for 26 days. Nasal peak inspiratory flow (NPIF) and nasal symptoms (graded on a 0–3 scale) were recorded by the subjects twice daily. Rhinoconjunctivitis quality of life (RQOL) as well as nasal volume, measured by acoustic rhinometry, was obtained at baseline, after 2 weeks, and at the end of treatment.. The average change from baseline in symptoms over the treatment period was greater for the group on budesonide (−3.33) compared to placebo (−1.98) (p = 0.45). When the average change from baseline over the treatment period was compared between the groups, budesonide resulted in higher NPIF (36.4 L/min) than placebo (18.7 L/min), p = 0.094. QOL improved in both groups compared to baseline with no significant difference between the groups. Although acoustic rhinometry indicated a larger volume in the group treated with budesonide on the last trial visit, the differences between the groups were not significant when accounting for the baseline values.. Compared to placebo, administration of nebulized budesonide in subjects with perennial allergic rhinitis resulted in improvements in symptoms and objective measures of nasal congestion which approached but did not achieve statistical significance. A higher dose of active agent, a less effective placebo and a larger number of subjects might have improved statistical significance.

Topics: Administration, Intranasal; Adolescent; Adult; Budesonide; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Pilot Projects; Quality of Life; Rhinitis, Allergic, Perennial; Rhinometry, Acoustic; Treatment Outcome; Young Adult

Investigate the effect of three-grade preventive health education and lifestyle intervention in the treatment of allergic rhinitis (AR).. Two hundred and ten selected cases needed for triple prevention were randomly divided into three groups, each group included 70 cases were undertaken for a three-year randomized controlled study. Group A, treated with Budesonide nasal spray. Group B, combined Budesonide nasal spray with Hydrochloric acid left Kabbah Sting nasal spray. Group C, taking health education management and lifestyle intervention on the basis of group B's therapy. A health lecture or health problems counseling and the dissemination of health education information were undertaken, quarterly. It was mainly for health knowledge awareness, and healthy behaviors formation rate guidance. Lifestyle intervention included a balanced diet, avoiding the allergens of living environment and aerobic exercise (daily 0.5-1.0 h). The score of the signs and symptoms in each group were obtained respectively at the beginning of study, 1 year after intervention and 3 years after intervention, as well as the comparison of patient compliance of follow-up.. The improved score of the signs and symptoms, endoscopy and radiological results were used to evaluate the treatment effect. There was no significant difference among the score of signs and symptoms in three groups. Comparing in group, before intervention,1 year after intervention and 3 years after intervention, the signs and symptoms of patients in three groups had improvement at different degree. The score of four symptoms (rhinobyon, rhinorrhoea, rhinocnesmus, sneezing) and signs were significant lower than before the intervention, there were a significant difference (P < 0.05). There were 8 patients in group A (11.43%), 6 patients in group 13 (8.57%) and 1 patient in group C (1.43%) lost to follow-up at 3 years after the intervention. The patient compliance of group C was significantly higher than groups A and B.. Triple prevention health education for AR can significantly improve the treatment compliance of AR patients for treatment, while ensuring clinical efficacy.

Topics: Adult; Budesonide; Health Education; Humans; Life Style; Middle Aged; Rhinitis, Allergic; Rhinitis, Allergic, Perennial

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 compare effectiveness of levocetirizine and budesonide in treatment of persistent allergic rhinitis (PER) in patients with high and low total symptom scores (TSS).. Randomized, parallel-group study. Patients with PER were randomized to receive levocetirizine 5 mg (n = 50) or budesonide 256 microg (n = 50) daily for 4 week and were followed-up for another 4 weeks post-treatment. TSS combining itching, sneezing, rhinorrhea, daytime and nighttime nasal congestion was recorded daily during and after treatment for an entire period of 8 weeks. Efficacy variables included area under curves depicting reduction and increase in TSSs over time relative to baselines and time to response and symptom relapses.. Symptoms were categorized as high and low using a median TSS of 8 as cutoff. Levocetirizine was as effective in control of high and low symptoms except for time to achieve maximum effect (2 days versus 1 week, respectively, p = 0.002) but was more effective in preventing relapses of high symptoms (p = 0.001). Budesonide was more effective against high than low symptoms (p < 0.001) but showed no difference in preventing relapses. Typical response rate of levocetirizine and budesonide were demonstrated in treatment of high symptoms. Levocetirizine achieved its full effectiveness in 2 days while budesonide required 2 weeks. Budesonide at full effect (after 2 weeks) was superior to levocetirizine (p = 0.004) but comparable for the entire treatment of 4 weeks (p =.059) and was inferior to in preventing relapses (p = 0.001). No such difference could be observed between these drugs in control of low symptoms.. The effectiveness of the drug treatment in the present study is dependent of symptom severity. Levocetirizine bases on its rate of response and relapse was superior to budesonide in treatment of the high symptom group and is comparable in the low symptom group.

Topics: Adult; Aged; Anti-Inflammatory Agents; Area Under Curve; Budesonide; Cetirizine; Female; Histamine H1 Antagonists, Non-Sedating; Humans; Male; Middle Aged; Rhinitis, Allergic, Perennial; Severity of Illness Index; Sneezing; Time Factors; Young Adult

This study was designed to determine whether nasal saline irrigation improved the symptoms and signs of allergic rhinitis (AR) and whether nasal saline irrigation could be used as a complementary management of AR in children while less steroids were used.. 26 children with AR were divided into three groups and were given nasal saline irrigation and/or topical steroid. Symptoms and signs of AR and mucociliary clearance (MCC) were evaluated, and concentration of soluble intercellular adhesion molecule (sICAM)-1 in nasal secretion was detected.. In AR children treated with nasal irrigation and tapered topical steroid at week 8 and week 12, a significant improvement in symptoms and signs was observed, and a significant decrease in the mean values of MCC and the mean concentrations of sICAM-1 in nasal secretions was also detected.. Nasal saline irrigation can be viewed as a good adjunctive treatment option for AR. It permitted the use of less topical steroids for controlling AR in children, which will contribute to fewer side effects and less economic burden.

Topics: Administration, Topical; Adolescent; Aerosols; Anti-Inflammatory Agents; Budesonide; Child; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Synergism; Glucocorticoids; Humans; Intercellular Adhesion Molecule-1; Mucociliary Clearance; Nasal Lavage; Nasal Mucosa; Osmolar Concentration; Rhinitis, Allergic, Perennial; Sodium Chloride; Treatment Outcome

To observe the therapeutical effect on allergic rhinitis with asthma by different ways of inhaling corticosteroids.. Ninety patients suffering from allergic rhinitis with asthma were classified into three groups in random and treated with budesonide (BUD) by nasal spray, inhaling and nasal spray-inhaling combined administration for 12 weeks, respectively. The concentration of serum total IgE, eosinophil cationic protein (ECP) and IL-5, pulmonary functions were examined before and after treatment.. The improvement of symptom scores of rhinitis and asthma in three groups were significant (P < 0.05). The concentration of serum total IgE, ECP and IL-5 in three groups decreased greatly after treatment (P < 0.05). There were significant improvement in FEV1, FEV1/FVC and FEF25%-75% in inhaling group before and after treatment (P < 0.05): FEV1 from (2.04 +/- 0.45) L to (2.47 +/- 0.54) L, FEV1/FVC from (72.73 +/- 5.59)% to (75.42 +/- 5.94)% and FEF25%-75% from 1.69 +/- 0.52 to 2.06 +/- 0.77. There was also significant improvement in nasal spray-inhaling combined groups before and after treatment (P < 0.05): FEV1 from (2.32 +/- 0.56) L to (2.76 +/- 0.58) L, FEV1/FVC from (73.80 +/- 4.17)% to (76.04 +/- 4.49)% and FEF25%-75% from 2.09 +/- 0.45 to 2.34 +/- 0.64. The significant difference of FEV1 among the three treatment groups was observed (P = 0.041).. The symptoms of rhinitis and asthma in three groups by three ways of inhaling BUD were greatly improved, no significant difference in symptom scores and serum parameters was found.

Topics: Adrenal Cortex Hormones; Adult; Asthma; Budesonide; Eosinophil Cationic Protein; Female; Humans; Immunoglobulin E; Interleukin-5; Male; Middle Aged; Rhinitis, Allergic, Perennial; Treatment Outcome; Young Adult

Measurement of exhaled nitric oxide (eNO) is a simple and noninvasive method for assessment of inflammatory airway diseases. eNO is elevated in adolescent patients with perennial allergic rhinitis and related to bronchial hyperresponsiveness. The aim of this study was to investigate whether oral loratadine, montelukast, nasal budesonide or nasal sodium cromoglycate could reduce airway inflammation as indicated by decrease of eNO in children with perennial allergic rhinitis as demonstrated by eNO levels.. A randomized and investigator-blinded study was conducted in a hospital-based outpatient clinic. Children with perennial allergic rhinitis were divided into four groups and treated by loratadine, loratadine with nasal sodium cromoglycate, loratadine with oral montelukast, and loratadine with nasal budesonide, respectively. Allergic rhinitis scores, eNO and peak expiratory flow were measured before and 2, 4, 6 and 8 weeks after treatment.. Results showed that eNO in children with perennial allergic rhinitis was reduced by nasal budesonide and oral montelukast within 2 weeks (24.56 +/- 14.42 vs 18.42 +/- 12.48, P < 0.001, in budesonide group; 27.81 +/- 13.4 vs 19.09 +/- 10.45, P < 0.001, in montelukast group), but not in the loratadine and cromoglycate groups. In contrast, loratadine or sodium cromoglycate also did not decrease eNO levels although they could decrease the symptom scores.. It was concluded that four common treatment modalities could effectively release symptom scores, but decrease of airway inflammation as determined by decrease of eNO might be only achieved by nasal budesonide and montelukast, but not nasal sodium cromoglycate and loratadine. Children with perennial allergic rhinitis with high eNO levels may require oral montelukast or nasal budesonide treatment to prevent airway hyperresponsiveness.

Topics: Acetates; Administration, Intranasal; Administration, Oral; Adolescent; Anti-Allergic Agents; Anti-Asthmatic Agents; Breath Tests; Budesonide; Child; Child, Preschool; Cromolyn Sodium; Cyclopropanes; Drug Therapy, Combination; Female; Follow-Up Studies; Glucocorticoids; Humans; Leukotriene Antagonists; Loratadine; Male; Nitric Oxide; Peak Expiratory Flow Rate; Quinolines; Rhinitis, Allergic, Perennial; Single-Blind Method; Sulfides; Treatment Outcome

While it is widely accepted that inhaled glucocorticosteroids represent an effective treatment for allergic rhinitis, little is known on the specific effects of this therapeutic approach in other upper airway disorders of childhood. The aim of the study was to evaluate the improvement of clinical symptoms and changes in local cellular inflammatory reaction induced by budesonide inhalation suspension in children with recurrent nasal infections using budesonide inhalation suspension delivered by Rinowash, a nebulizer designed to treat upper airway structures.. In a randomized, controlled-open study, 14 children (5.88+/-0.56 years of age) with recurrent upper airway infections and chronic nasal obstruction were enrolled and randomly treated for 7-10 days either with budesonide inhalation suspension (250 microg/bidie) (nine patients) or with saline solution (five patients). Before and after treatment, inflammatory cells in nasal brushing and nasal symptom score were evaluated.. Out of the nine patients treated with budesonide, two were excluded from the analysis because of acute respiratory infections requiring systemic antibiotic treatment. A significant decrease in nasal brushing neutrophil percentage was observed after treatment with budesonide (P=0.016) but not after saline solution treatment (P=1.00). No significant changes in nasal brushing mononuclear cell or eosinophil proportions were observed after treatment with budesonide inhalation suspension or saline solution (P=NS, each comparison). Treatment with budesonide, but not with saline solution, was associated with a significant reduction in nasal obstruction (P=0.016).. These preliminary data indicate that short-term treatment with budesonide inhalation suspension, used for an indication out of label, may significantly reduce local neutrophilic inflammation and nasal obstruction in children with recurrent upper airway infections.

Topics: Administration, Inhalation; Anti-Inflammatory Agents; Antigens, Dermatophagoides; Budesonide; Child; Child, Preschool; Chronic Disease; Female; Humans; Immunization; Immunoglobulin E; Male; Nasal Obstruction; Neutrophils; Prevalence; Recurrence; Respiratory Tract Infections; Rhinitis, Allergic, Perennial; Time Factors

Recent guidelines recommend intranasal corticosteroids as first-line treatment for managing persistent symptoms of moderate to severe allergic rhinitis (AR). However, in children, long-term continual treatment with corticosteroids has raised concerns about potential growth suppression.. To evaluate the effects of the recommended once-daily dose of budesonide aqueous nasal spray on growth velocity, as measured with stadiometry, in children with perennial AR.. In this double-blind, placebo-controlled, multicenter study, 229 prepubertal children (mean age, 5.9 years; age range, 4-8 years) with perennial AR were randomized (2:1) to receive budesonide aqueous nasal spray, 64 microg (32 microg per nostril) once daily, or placebo for 1 year. The change from baseline in growth velocity, height after treatment, and the percentage of patients whose percentile for height decreased from baseline to the end of treatment were evaluated.. Growth velocity was not significantly different between the 2 groups. The least-squares mean +/- SE growth velocity during treatment was 5.91 +/- 0.11 cm per year for children receiving budesonide and 6.19 +/- 0.16 cm per year for those receiving placebo. The mean difference in growth velocity between the 2 groups was 0.27 +/- 0.18 cm per year (95% confidence interval, -0.07 to 0.62 cm per year). After treatment, the mean +/- SD height was 128.8 +/- 8.7 cm for children receiving budesonide and 128.2 +/- 8.8 for those receiving placebo. The percentage of children whose percentile for height decreased during treatment was not significantly different between the 2 groups (budesonide, 59%, placebo, 54%; P = .64). The incidence and types of adverse events and the mean 24-hour urinary cortisol-creatinine ratio were similar for the 2 groups.. Treatment with budesonide aqueous nasal spray, 64 microg once daily, for 1 year did not suppress growth velocity compared with placebo and was well tolerated in prepubertal children with perennial AR.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Body Height; Budesonide; Child; Child, Preschool; Female; Humans; Male; Rhinitis, Allergic, Perennial; Time Factors

To compare the effects of desloratadine, an H1-blocking antihistamine, and budesonide, an intranasal corticosteroid, on nasal peak inspiratory flow (NPIF) in patients with seasonal allergic rhinitis.. We performed a randomized, double-blind, double-dummy, parallel study comparing oral desloratadine, 5 mg/d (n = 31), and budesonide, 32 mug/d per nostril (n = 30), for 2 weeks during the spring allergy season.. Subjects recorded NPIF and nasal symptoms twice daily. Baseline measurements were obtained before initiation of treatment. The Rhinoconjunctivitis Quality of Life Questionnaire was completed at baseline and after treatment.. Desloratadine and budesonide caused a significant increase in NPIF compared with baseline on the evening of the first dose (P < .01). Budesonide, however, led to a significantly greater increase in NPIF than did desloratadine when the change from baseline was compared for the entire treatment period (median, 475 vs 150 L/min; P = .01). Both treatments resulted in clinically significant reductions of the individual domains and overall scores on the Rhinoconjunctivitis Quality of Life Questionnaire (P < .01). There was a significant reduction in total symptom scores (P < or = .01) compared with baseline during all treatment days in both treatment groups, with no statistically significant differences between treatments (median, -60.0 vs -59.5; P = .67).. Both treatments led to significant improvements in NPIF, but the improvement was greater with the intranasal corticosteroid. Both treatments improved quality of life and reduced symptoms. The difference between the objective and subjective outcomes probably reflects the small sample size, the low pollen counts for the season, and the greater variability in subjective compared with objective measures.

Topics: Administration, Intranasal; Administration, Oral; Adolescent; Adult; Budesonide; Cross-Sectional Studies; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Loratadine; Male; Middle Aged; Probability; Pulmonary Ventilation; Quality of Life; Respiratory Mechanics; Rhinitis, Allergic, Perennial; Severity of Illness Index; Statistics, Nonparametric; Treatment Outcome

A single blind parallel group study was conducted to evaluate the effects of oral choline [given as tricholine citrate (TRI)] in patients with allergic rhinitis, and compare its efficacy with intranasal budesonide (BUD).. The study was conducted at the Department of Respiratory Medicine, Vallabhbhai Patel Chest Institute, Delhi, India from February 2001 to April 2002. Sixty patients were randomized into 2 groups after a run-in period of 2 weeks. Group A received intranasal BUD 200 microg twice daily and group B received TRI 500 mg thrice daily. The patients were reviewed every 2 weeks up to 8 weeks. The mean individual symptom score, total symptom score and drug score were significantly reduced in both groups (p<0.05) compared to baseline values, with maximum effect occurring within 4 weeks of therapy.. Budesonide showed statistically significant reduction (p<0.05) in all the outcome parameters, when compared to TRI. Crossover study between the 2 treatment groups also showed similar results. Seventy-six percent of patients with BUD and 43% of patients with TRI found the drug to be effective.. Both intranasal BUD and oral TRI are effective in relieving symptoms of allergic rhinitis. Budesonide was found to be the statistically superior drug.

Topics: Administration, Inhalation; Administration, Oral; Adolescent; Adult; Anti-Inflammatory Agents; Budesonide; Choline; Cross-Over Studies; Humans; Middle Aged; Rhinitis, Allergic, Perennial; Single-Blind Method

The aim of this study was to compare the decongestant properties and tolerability of oral cetirizine and pseudoephedrine in a prolonged release form with those of nasal (aqueous spray) budesonide.. Thirty-six individuals experiencing allergic rhinitis to house dustmites (HDM) participated in a study according to a randomized, crossover, two-period, two-treatment design with at least a 2-week washout period between treatments. In each period of 4 consecutive days, medications were taken twice daily. On day 1, immediately after the first intake of medication, individuals were exposed to HDM extract in the Vienna Challenge Chamber (VCC) for 5 hours. The primary efficacy parameter was nasal congestion, assessed by active anterior rhinomanometry and rating of nasal cavity photos.. Rhinomanometry and nasal cavity photos both indicated that cetirizine/pseudoephedrine efficacy was statistically superior to budesonide in the management of nasal congestion during VCC sessions. The efficacy of cetirizine/pseudoephedrine was similar to that of budesonide from the end of day 1 up to day 4 when individuals were exposed to their natural environment post exposure to the aeroallergens. This study confirms the efficacy of cetirizine/pseudoephedrine and budesonide in the management of nasal congestion associated with allergic rhinitis. Both medications were well-tolerated. Cetirizine/pseudoephedrine was more effective than budesonide during HDM exposure, whereas budesonide became as effective as cetirizine/pseudoephedrine several hours post exposure to the allergens.

Topics: Administration, Intranasal; Administration, Oral; Adult; Anti-Allergic Agents; Budesonide; Cetirizine; Cross-Over Studies; Delayed-Action Preparations; Drug Combinations; Ephedrine; Female; Histamine H1 Antagonists, Non-Sedating; Humans; Male; Nasal Decongestants; Pulmonary Ventilation; Rhinitis, Allergic, Perennial; Rhinomanometry

Nasal obstruction is recognized as an important cause of sleep disordered breathing. Congestion of the nasal mucosa and obstruction are common symptoms of allergic rhinitis. Daytime sleepiness is a common finding in symptomatic allergic rhinitis. Effective therapy of the nasal congestion of allergic rhinitis should alter sleep patterns in patients with symptomatic allergic rhinitis.. To measure objective changes in polysomnograms (sleep studies) of children with allergic rhinitis before and after therapy with intranasal budesonide and to measure changes in the quality of life of these patients during treatment.. Open clinical trial with objective measurements (polysomnography) and subjective data (Rhinitis Quality of Life Questionnaire [RQLQ]). Evaluations were performed before, during, and at completion of therapeutic intervention.. The 14 studied children tolerated the procedures and treatment without problems. The mean number of sleep arousals per hour (all apneas and hypopneas) decreased from a baseline of 8.4 to 1.2 (P = .005) after treatment. The change was mainly in hypopneic episodes (7.5-0.9, P = .003). Objective responses on the RQLQ showed improvements consistent with improved sleep and lessened rhinitis symptoms.. Decreasing the nasal congestion associated with allergic rhinitis can improve sleep measured by objective sleep studies and lead to improvement in daytime quality of life.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Budesonide; Child; Child, Preschool; Female; Humans; Male; Pilot Projects; Polysomnography; Quality of Life; Rhinitis, Allergic, Perennial; Sleep Apnea Syndromes; Statistics, Nonparametric

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

Evidence in vitro suggests that benzalkonium chloride, a preservative in many intranasal preparations, interferes with ciliary function and thus could potentially interfere with mucociliary transport, the mechanism for clearing secretions from the nasal cavity.. We performed a parallel randomized study with 10 subjects in each arm comparing Rhinocort AQUA (an intranasal steroid [budesonide] spray without benzalkonium chloride) and Nasonex (an intranasal steroid [mometasone furoate] spray with benzalkonium chloride). Before and after 2 weeks of treatment, subjects completed a Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and underwent a measurement of nasal clearance of a radioactive colloidal spray into the nose.. The groups were matched at entry for nasal clearance, even though there was variability among subjects. The amount of change after 2 weeks of treatment (Delta before versus after treatment) showed a significant difference in nasal clearance favoring budesonide. After 2 weeks of treatment, both budesonide and mometasone demonstrated overall improvement in quality of life as assessed by the RQLQ. Both treatments were well tolerated.. Our study extends the observation in vitro that demonstrates the adverse effect of benzalkonium chloride on cilia to a measurement in vivo of clearance. The effects after 2 weeks might not reflect changes after longer periods of treatment.. To determine the clinical significance of the small improvement in mucociliary transport will require large clinical trials.

Topics: Administration, Intranasal; Adult; Anti-Inflammatory Agents; Budesonide; Female; Humans; Male; Mometasone Furoate; Mucociliary Clearance; Nasal Obstruction; Pregnadienediols; Quality of Life; Rhinitis, Allergic, Perennial

Improving quality of life is considered to be a major endpoint and motivation for clinical intervention in patients with perennial allergic rhinitis (PAR). In addition to classical symptoms of congestion, pruritus, and rhinorrhea, patients will often complain of not being able to sleep well at night and of feeling fatigued during the day. Like sleep apnea, PAR has also been shown to cause sleep disturbance and consequently worsen daytime fatigue and somnolence.. It is proposed that by decreasing nasal obstruction due to allergic rhinitis by treating with the topical steroid budesonide, symptoms of daytime fatigue and somnolence can be improved.. Twenty-two subjects were enrolled in a double-blind, placebo-controlled, crossover study using Baalam's design. Patients were treated with either budesonide 128 g/day or placebo. Subjective data include the Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, Rhino-conjunctivitis Quality of Life Questionnaire, and a daily diary recording nasal symptoms, sleep problems, and daytime fatigue.. The results illustrated that the topical nasal corticosteroid significantly improved daytime fatigue (P = 0.03), somnolence (P = 0.02), and quality of sleep (P = 0.05) compared to placebo in patients suffering from PAR.. Budesonide is able to improve congestion, sleep, and daytime somnolence.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Budesonide; Cross-Over Studies; Disorders of Excessive Somnolence; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Nasal Obstruction; Quality of Life; Rhinitis, Allergic, Perennial; Surveys and Questionnaires; Treatment Outcome

Intranasal budesonide is an efficacious treatment for perennial allergic rhinitis. Long-term effects on safety, particularly in children, need further investigation.. To investigate the long-term safety of intranasal budesonide in children.. In an open trial, 78 children (5-15 years) with perennial rhinitis were treated with intranasal budesonide pressurized metered dose inhaler 200 microg twice daily (delivered daily dose 256 microg) for 12 months; 43 children stayed in the study for 12 additional months and were switched to aqueous suspension (400 microg delivered daily dose) for 6 months. Statural growth, bone age, ophthalmologic and rhinoscopic status, cortisol and biochemical analyses in blood and urine were monitored during the first and second years, and adverse events (AEs) were continuously recorded.. No significant effects on statural growth and bone age, compared with reference values, were observed. Morning plasma cortisol and 24-h urinary cortisol were not changed during treatment. Patients reported 195 AEs, most commonly nasal dryness (30%), blood-tinged secretions (21%) and, among non-nasal AEs, headache (13%). Rhinoscopy revealed no signs of mucosal atrophy, ulceration, or candidiasis but some nasal dryness. No treatment-related ophthalmological or biochemical aberrations were found. Reduction of blood eosinophils and nasal symptom scores, compared with pre-treatment values, indicated the efficacy of budesonide treatment.. Long-term treatment for 1-2 years with intranasal budesonide 256-400 microg daily in children with perennial rhinitis revealed no negative effects on growth or endogenous cortisol production. Local side-effects were mild and patient symptoms decreased.

Topics: Administration, Intranasal; Adolescent; Body Height; Body Weight; Bone Development; Budesonide; Child; Child, Preschool; Female; Glucocorticoids; Humans; Hydrocortisone; Male; Rhinitis, Allergic, Perennial; Time Factors

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

Intranasal corticosteroid preparations can relieve symptoms of allergic rhinitis. Different aqueous corticosteroid forms have been developed for intranasal use. The objectives of this study were to compare efficacy and safety between fluticasone propionate and budesonide in the treatment for patients with allergic rhinitis.. The study was conducted in a prospective and randomized manner; a total of 24 adult patients were enrolled. All patients received MAST allergen test at entry and again at 2 months after treatments. Fourteen patients received fluticasone propionate 200 microg once daily, and 10 patients received budesonide 200 microg twice daily. To investigate the efficacy of fluticasone propionate and budesonide, a subjective scoring system was designed to evaluate the symptom improvement of patients. Adverse events were recorded on a diary card then were analyzed. Mann-Whitney U test and Kruskal-Wallis 1-way analysis of variance were used for statistical analysis.. Analysis on patient-based symptom scores revealed that both fluticasone propionate and budesonide were equally efficacious in improving the symptoms of nasal blockage, sneezing, nasal itching, and watery rhinorrhea. There were no significant side effects reported for both groups during this follow-up period. However, analysis showed that the fluticasone propionate group demonstrated significantly greater improvement in some MAST allergen tests (Candida, mite, house dust; P < 0.05).. Clinically, fluticasone propionate 200 microg once daily was efficacious as budesonide 200 microg twice daily in the relief of allergic rhinitis symptoms. However, fluticasone propionate can achieve greater immunologic improvement. Both preparations showed no evidence of short-term side effects.

Topics: Administration, Intranasal; Adolescent; Adult; Androstadienes; Anti-Inflammatory Agents; Budesonide; Drug Administration Schedule; Female; Fluticasone; Humans; Immunoglobulin E; Lectins, C-Type; Male; Membrane Glycoproteins; Prospective Studies; Receptors, Immunologic; Rhinitis, Allergic, Perennial; Trans-Activators

A T(H)2-polarized cytokine pattern has been demonstrated in allergic rhinitis. Budesonide represents an effective topical corticosteroid in the management of allergic rhinitis.. To evaluate cytokine pattern and symptoms in patients with perennial allergic rhinitis before and after treatment with intranasal budesonide.. All patients received budesonide aqueous nasal spray or placebo for 2 weeks. The study was double-blind, parallel group, placebo controlled, and randomized. Nasal lavage was performed in all patients before and after treatment. A panel of cytokines, including interleukin 4 (IL-4), IL-5, and IL-6, was measured by immunoassay on fluids recovered from nasal lavage. Total symptom score (including rhinorrhea, nasal itching, sneezing, and nasal obstruction) was evaluated before and after treatment.. Twenty patients with perennial allergic rhinitis were evaluated (13 men and 7 women; mean age, 24.7 years). Budesonide aqueous nasal spray treatment showed a significant decrease of IL-4 (P = .007), IL-5 (P = .04), and IL-6 levels (P = .009). Budesonide aqueous nasal spray treatment also induced significant symptom relief (P = .006). Placebo treatment did not significantly affect the evaluated parameters.. This study shows that budesonide aqueous nasal spray is effective in exerting immunomodulatory activity by reducing cytokine pattern and relieving symptoms. These findings are evidence of the effects of intranasal budesonide in treating perennial allergic rhinitis.

Topics: Adolescent; Adult; Anti-Inflammatory Agents; Budesonide; Cytokines; Double-Blind Method; Female; Humans; Interleukin-4; Interleukin-5; Male; Rhinitis, Allergic, Perennial; Seasons; Severity of Illness Index; Statistics as Topic; Treatment Outcome

Whether instillation into the maxillary sinus of topical budesonide affected the immune response and improved allergic patients with chronic rhinosinusitis that had persistence of symptoms despite appropriate surgical intervention was assessed.. Double-blind placebo-controlled.. Twenty-six patients with allergy to house dust mites who had previously had surgery and who had persistent symptoms of disabling rhinorrhea or pressure-pain resistant to oral antibiotics and intranasal corticosteroids were recruited. During the double-blind study, patients instilled 256 microg budesonide daily or placebo through an intubation device (maxillary antrum sinusotomy tube) into one of the maxillary sinuses for 3 weeks before clinical assessment and a second biopsy.. We found an improvement in the symptom scores in 11 of the 13 patients who received budesonide; we also found a decrease in CD-3 (P = .02) and eosinophils (P = .002), and a decrease in the density of cells expressing interleukin4 (P = .0001) and interleukin-5 messenger RNA (P = .006) after treatment.. Topical budesonide delivered through a maxillary antrum sinusotomy tube can control chronic rhinosinusitis that persists after surgery.

Topics: Administration, Intranasal; Adult; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Double-Blind Method; Endoscopy; Female; Glucocorticoids; Humans; Intubation; Male; Maxillary Sinus; Maxillary Sinusitis; Middle Aged; Postoperative Complications; Rhinitis, Allergic, Perennial; Self Administration; Therapeutic Irrigation

Budesonide aqueous nasal spray is a topical corticosteroid which at doses of 64 to 256 microg once daily has been found to be effective in the treatment of seasonal allergic rhinitis in adults and children.. This study was conducted to determine the efficacy of budesonide aqueous nasal spray, 128 microg once daily, in children with perennial allergic rhinitis.. This double-blind, randomized, placebo-controlled, parallel-group, multicenter study compared the efficacy and safety of budesonide aqueous nasal spray, 128 microg once daily intranasally, with placebo in 202 patients (aged 6 to 16 years) with perennial allergic rhinitis. Efficacy was evaluated daily by measurement of peak nasal inspiratory flow (PNIF), nasal symptom scores over 12 hours, and an overall evaluation of treatment efficacy. In a subset of patients (n = 76), quality of life was measured by validated questionnaires.. Budesonide, 128 microg once daily, was significantly more effective than placebo in improving the PNIF, combined and individual nasal symptom scores, and the overall evaluation of treatment efficacy. The onset of action was found to occur within the first 12-hour time interval evaluated for combined nasal symptoms and within 48 hours for PNIF. Budesonide was associated with reduced percentage of eosinophils in brush samples and reduced intake of rescue medication in comparison with placebo. Quality of life scores were reduced, but the differences did not reach significance.. Budesonide aqueous nasal spray, 128 microg once daily, is effective in children with perennial allergic rhinitis. Efficacy was demonstrated within 12 hours.

Topics: Administration, Intranasal; Adolescent; Aerosols; Anti-Allergic Agents; Budesonide; Child; Double-Blind Method; Eosinophilia; Female; Humans; Kinetics; Male; Nasal Cavity; Quality of Life; Rhinitis, Allergic, Perennial; Treatment Outcome

Perennial rhinitis is a common disease that has many similarities with bronchial asthma. Early treatment with inhaled steroids has improved asthma symptoms, lung function, and bronchial hyperreactivity, but it has not been studied in perennial rhinitis.. The main objective was to determine whether early introduction of long-term daily intranasal steroid treatment would have a positive effect on the clinical course and outcome of perennial rhinitis compared with the effect of an antihistamine. A secondary objective was to compare the clinical efficacy of intranasal budesonide and oral cetirizine.. One hundred forty-three adult patients with newly detected perennial allergic or nonallergic eosinophilic rhinitis of 1 to 3 years' duration were randomized to receive budesonide dry powder, 400 microg (delivered dose of 280 microg) intranasally, or cetirizine, 10 mg orally, once daily for 1 year. At the end of the double-blind treatment period, medication was stopped, and the patients were followed for another year, during which time they could use 14-day courses of intranasal budesonide as needed to control rhinitis relapses. The main outcome measures were the time to first relapse and the number of relapses during the second year. Nasal symptom scores, nasal smear eosinophilia, and nasal peak expiratory flow were used to compare the clinical efficacy of the 2 treatments.. During the randomized phase of the study, budesonide was significantly more effective than cetirizine in relieving nasal symptoms. Nasal peak expiratory flow improved significantly in budesonide-treated patients compared with in patients receiving cetirizine. After discontinuation of randomized treatment, 38% of budesonide-treated and 56% of cetirizine-treated patients had a relapse within the first month (P =.04). The median time to first relapse was longer in budesonide-treated patients than in cetirizine-treated patients (62 vs 20 days), although the difference was not significant. Fourteen-day courses of budesonide provided effective control of relapses; the mean number of relapses was 4.0 versus 5.4 in the groups previously treated with budesonide or cetirizine, respectively. Both treatments were well tolerated throughout the study.. Budesonide is significantly more effective than cetirizine in controlling perennial rhinitis. After stopping treatment, budesonide better prevents relapses for 1 to 2 months compared with cetirizine. Periodic therapy with budesonide may be sufficient to control symptoms in most patients who have relapses.

Topics: Administration, Intranasal; Administration, Oral; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Cetirizine; Double-Blind Method; Female; Histamine H1 Antagonists; Humans; Male; Middle Aged; Rhinitis, Allergic, Perennial; Time Factors; Treatment Outcome

Using conventional methods, it has been difficult to show differences in efficacy between intranasal corticosteroids in perennial rhinitis.. To compare the effects of budesonide and mometasone on nasal symptoms and nasal airflow in perennial allergic rhinitis.. Four hundred thirty-eight patients (age > 18 years old) were randomized to budesonide, 256 microg or 128 microg, mometasone furoate 200 microg, or placebo, once daily for 4 weeks. Efficacy was evaluated by nasal index score (NIS; the sum of scores for blocked nose, runny nose, and itchy nose/sneezing) and peak nasal inspiratory flow (PNIF).. All three active treatments significantly reduced the NIS compared with placebo. There was no significant difference between the treatments, although the effect of budesonide, 256 microg, tended to be greater than that of the other regimens. PNIF was significantly improved with all three active treatments: the effect of budesonide 256 microg on morning and evening PNIF was significantly greater than that of mometasone furoate and 128 microg budesonide. Budesonide had a rapid onset of action, showing a significantly greater effect on evening PNIF than mometasone furoate during the first 10 days. For all active treatments, significant improvements in NIS were seen within 4 hours of the first dose. All three treatments were well tolerated.. The objective parameter PNIF was capable of demonstrating greater efficacy of budesonide 256 microg compared with budesonide 128 microg and mometasone furoate 200 microg, whereas the combined nasal symptom score could only distinguish active treatment from placebo.

Topics: Administration, Intranasal; Adult; Aged; Budesonide; Female; Humans; Hungary; Inspiratory Capacity; Male; Middle Aged; Mometasone Furoate; Nose; Portugal; Pregnadienediols; Rhinitis, Allergic, Perennial; Spain; Sweden

Previous studies comparing the corticosteroids fluticasone propionate (FP) and budesonide (BUD) in both perennial and seasonal rhinitis have shown no consistent difference between treatments. However, the therapeutic outcomes may have been influenced by study design.. To compare the effect of FP aqueous nasal spray (ANS; 200 microg/day) with BUD reservoir powder device (RPD; 200 microg/day) on rhinitis symptoms, productivity loss and device preference in patients with perennial rhinitis.. After a 2-week run-in period, 440 patients were randomized to receive either FPANS, BUD RPD or matched placebo (ANS or RPD) for 8 weeks, followed by an open-label 4-week follow-up treatment with FPANS. Patients completed diary card visual analogue scores for nasal symptoms, and questionnaires on satisfaction with the treatment and preferred choice of device.. During weeks 1-4, the visual analogue total nasal symptom scores (VATNS) in the FPANS group were significantly lower than scores in the BUD RPD group (mean difference = -17.8; 95% CI = -34.4, -1.3; P = 0.036). FPANS also significantly reduced the VATNS compared with the ANS placebo at all time-points assessed (P < or = 0.005). BUD RPD did not significantly differ from the RPD placebo at weeks 5-8 (P = 0.167), or the ANS placebo at any time-point (P < or = 0.151). Over the 8-week treatment period FPANS was significantly more effective than BUD RPD at reducing sneezing (mean difference = -4.4; 95% CI = -8.6, -0.3; P = 0.036) and nasal itching (mean difference = -5.3; 95% CI = -9.9, -0.8; P = 0.022), and was significantly superior to the ANS placebo for all symptoms assessed at weeks 1-4 and 1-8 (P < 0.016). At the same time-points BUD RPD was no better at alleviating nasal itching than the RPD placebo (P < or = 0.306), and compared with the ANS placebo, significantly reduced only one symptom; nasal blockage (P < or = 0.016). After 8 weeks of treatment, patients preferred the ANS device to the RPD (P < 0.001), and at 12 weeks a significantly greater number of patients were satisfied with FPANS treatment compared with BUD RPD (P = 0.0019) or the respective placebos (P = 0.0001).. FPANS and BUD RPD are effective therapies with a good safety profile for the treatment of perennial rhinitis but, in this direct placebo-controlled comparison, FPANS was more efficacious than BUD RPD, and the patients preferred the ANS device to the RPD.

Topics: Administration, Inhalation; Administration, Intranasal; Adolescent; Adult; Androstadienes; Anti-Inflammatory Agents; Budesonide; Child; Confidence Intervals; Double-Blind Method; Female; Fluticasone; Follow-Up Studies; Glucocorticoids; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Patient Satisfaction; Powders; Rhinitis, Allergic, Perennial; Therapeutic Equivalency; Treatment Outcome

Some antihistamines are capable of inducing decreased expression of adhesion molecules in nasal and conjunctival tissues of allergic rhinoconjunctivitis patients. This study aimed to determine if one month of therapy with loratadine 10 mg once daily would also induce any decrease in serum levels of soluble ICAM-1 (sICAM-1) or VCAM-1 (sVCAM-1).. 40 monosensitized House Dust Mite (HDM) mild-to-moderate allergic rhinitis patients were included in the study. During the study, twenty patients randomly received 10 mg loratadine daily, the other twenty did not take any antihistamine. All patients were treated with nasal budesonide daily and sodium cromoglycate nasal spray when needed. Serum soluble ICAM-1 and VCAM-1 levels were determined by immunoenzimatic assay before and in the end of the study period.. After one month of loratadine sVCAM-1 levels had a significant decrease (from 724.8 to 625 ng/ml) while sICAM-1 levels had a slight but not significant increase. Control patients did not have significant variations in sVCAM-1 or sICAM-1 serum levels. During regular antihistamine therapy patients improved their clinical scores.. Loratadine 10 mg daily during one month induced a decrease in sVCAM-1 but not in sICAM-1 levels in HDM allergic rhinitis patients.

Topics: Animals; Anti-Allergic Agents; Budesonide; Cromolyn Sodium; Drug Therapy, Combination; Histamine H1 Antagonists; Humans; Intercellular Adhesion Molecule-1; Loratadine; Mites; Rhinitis, Allergic, Perennial; Solubility; Vascular Cell Adhesion Molecule-1

To determine if rebound congestion can be reduced with concomitant nasal steroid spray usage.. Randomized, double blind, controlled single center study.. Twenty subjects with perennial allergic rhinitis with nasal congestion.. All subjects received 3 weeks of twice-daily oxymetazoline. After 2 weeks, subjects were randomized to 2 additional weeks of concomitant budesonide aqueous nasal spray (n = 9) or placebo (n = 10). In the sixth week, all sprays were stopped.. Both groups showed subjective and objective evidence of rebound congestion 24 hours after cessation of oxymetazoline (P < 0.05). Subjective rebound congestion resolved in 48 hours in the budesonide aqueous nasal spray group but persisted for over 1 week in the placebo group.. Rebound congestion is objectively present in patients with perennial allergic rhinitis after 3 weeks of oxymetazoline spray. Rebound congestion is reduced by concomitant budesonide aqueous nasal spray use.. This study supports the common clinical practice of nasal steroid sprays to ameliorate rebound congestion concomitant with and after cessation of topical decongestant sprays.

Topics: Adult; Anti-Inflammatory Agents; Budesonide; Double-Blind Method; Female; Humans; Male; Middle Aged; Nasal Decongestants; Oxymetazoline; Respiratory System Agents; Rhinitis, Allergic, Perennial

An economic evaluation was performed analyzing direct medical costs in Canada for the treatment of perennial allergic rhinitis (PAR) with budesonide aqueous nasal spray and fluticasone propionate nasal spray. Three hundred fourteen patients with at least a 1-year history of PAR were randomized into a double-blind, parallel-group study of 6 weeks' duration. The treatments were daily doses of budesonide 256 microg, fluticasone propionate 200 microg, or placebo. Both active treatments produced significantly lower mean scores for overall nasal symptoms compared with placebo, and both were well tolerated. Budesonide was significantly more effective than fluticasone in reducing "blocked nose.". A retrospective cost-effectiveness analysis utilizing the clinical trial data was performed on the total costs of (1) budesonide-based and (2) fluticasone-based treatment strategies, including the relative importance of the drug costs in both strategies.. The average treatment cost per patient in Canada over 12 months in the budesonide group was CAD 389.85 which was 23.3% lower than in the fluticasone group, which was CAD 508.06, due to lower drug acquisition costs (for the year 1998).. Budesonide aqueous nasal spray was shown to be more cost-effective than fluticasone propionate nasal spray in the treatment of perennial allergic rhinitis. This result is valid in the province of Ontario, Canada and in many other settings with the same structure of relative prices. The result is mainly driven by a difference in drug cost.

Topics: Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents; Budesonide; Canada; Cost-Benefit Analysis; Double-Blind Method; Fluticasone; Health Care Costs; Humans; Retrospective Studies; Rhinitis, Allergic, Perennial

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

Topics: Administration, Intranasal; Adolescent; Adult; Androstadienes; Anti-Inflammatory Agents; Budesonide; Double-Blind Method; Fluticasone; Glucocorticoids; Humans; Randomized Controlled Trials as Topic; Reproducibility of Results; Rhinitis, Allergic, Perennial; Single-Blind Method; Treatment Outcome

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

The standard treatment of allergic rhinitis and asthma consists of topical corticosteroids administered intranasally and inhaled through the mouth. Although this therapy is highly effective, and side-effects are few and mild, it may be possible further to improve the therapeutic index and patient compliance with the treatment. In the present study, we evaluated a nasal inhalation system used for the simultaneous treatment of rhinitis and asthma. In principle, it results in an airway deposition of the corticosteroid similar to that of inhaled allergens. Twenty-four children with perennial rhinitis and asthma inhaled budesonide through the nose from a pressurized aerosol, attached to a spacer device, in a double-blind, placebo-controlled, crossover study. Compared with placebo, budesonide treatment resulted in a significant reduction of nasal symptoms (P<0.01) and of asthma symptoms (P<0.05), and in an increase of nasal peak inspiratory flow (P < 0.001) and of oral peak expiratory flow (P=0.01). There were no differences between budesonide and placebo in local side-effects, such as dry nose, nosebleed, and hoarseness. We conclude that nasal inhalation of a corticosteroid from a spacer offers a simple and effective treatment for both rhinitis and asthma in children, but it is an open question whether the nasal inhalation system can improve the ratio of antirhinitis/antiasthma effects to side-effects.

Topics: Administration, Inhalation; Administration, Intranasal; Adolescent; Anti-Inflammatory Agents; Asthma; Budesonide; Child; Cross-Over Studies; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Rhinitis, Allergic, Perennial

Intranasal corticosteroids are among the most effective treatments for perennial allergic rhinitis (PAR). Some individuals unable to tolerate aerosols may prefer an aqueous nasal spray.. To determine the efficacy, safety, and antiinflammatory effects of an intranasal aqueous pump spray formulation of budesonide.. Four hundred seventy-eight patients [257 adults, 221 children (6 to 17 years)] with PAR were randomized to budesonide aqueous pump spray (Rhinocort Aqua) 32, 64, 128, or 256 microg, or placebo once daily for 6 weeks. Patients recorded nasal/ocular symptom severity daily. Nasal cytology was evaluated at baseline and end of treatment. The study was powered only to evaluate the overall population for significance.. Following 6 weeks of treatment, significant differences from baseline in nasal index score (NIS)--sum of blocked nose, runny nose, and sneezing scores--were observed in the 32-, 64-, and 256-microg aqueous budesonide groups compared with placebo (P < or = .031). No dose response was found for changes in NIS. Significant reductions from baseline NIS were observed with 256-microg aqueous budesonide compared with placebo in the first 24 hours following treatment (P = .004). Aqueous budesonide also significantly reduced individual nasal symptoms in two or more of the active treatment groups (P < or = .035). Patients' overall treatment efficacy assessments showed significantly greater symptom control with aqueous budesonide (P < or = .006), and overall quality of life improved. Significantly greater decreases in eosinophils and basophils were found in aqueous budesonide-treated groups (P < or = .007). The frequency of adverse events was similar among all treatments.. Once daily aqueous budesonide is well tolerated and effective in relieving nasal symptoms and inflammation associated with PAR.

Topics: Administration, Intranasal; Adolescent; Adult; Anti-Inflammatory Agents; Budesonide; Child; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Nasal Mucosa; Quality of Life; Respiratory Tract Infections; Rhinitis, Allergic, Perennial; Treatment Outcome; Water

Mast cells are known to accumulate in tissue during allergic inflammation. However, the chemotaxins responsible are undefined. Using a modified Boyden chamber and the human mast-cell line HMC-1, we first identified mast-cell chemotactic activity in nasal lavage fluid collected before the pollen season after allergen provocation of allergic patients (n=29) (mean migratory response compared to medium control was 121%, range 85-198%). Mast-cell chemotactic activity was also detected in lavage fluid collected after allergen provocation at the end of a Swedish birch-pollen season from three different treatment groups: topical steroid treatment with budesonide; the topical antihistamine, levocabastine; and placebo. There was no significant difference in mast-cell chemotactic activity between nasal lavage fluid collected from the placebo group (mean=102%), the budesonide-treated group (mean=114%), or the levocabastine group (mean=125%). Stem cell factor (SCF), a known mast-cell chemotaxin, was present in the nasal lavage fluids from all three groups, and correlated with the mast-cell chemotactic activity (r=0.67, P<0.01). The mast-cell chemotactic activity was inhibited (range 5-100%) in some, but not all, nasal lavage fluids by a polyclonal antibody directed against SCF. This report describes the presence of mast-cell chemotactic activity in nasal lavage fluid during an allergic reaction. These findings show that SCF may play a pivotal role in the recruitment of mast cells in allergic rhinitis.

Topics: Allergens; Budesonide; Cell Line; Chemotactic Factors; Chemotaxis, Leukocyte; Enzyme-Linked Immunosorbent Assay; Humans; Mast Cells; Nasal Lavage Fluid; Nasal Provocation Tests; Piperidines; Pollen; Rhinitis, Allergic, Perennial; Single-Blind Method; Stem Cell Factor

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

Allergic rhinitis is usually treated with oral antihistamines or nasal steroids. Topically active nasal antihistamine is a new treatment modality for allergic rhinitis. The efficacy in comparison to well established topical treatment alternatives is not fully known.. To compare the efficacy of intranasally administered azelastine to budesonide, at their respectively recommended dosage, on the symptoms of perennial rhinitis patients.. A placebo-controlled, randomized, parallel group study was conducted to compare the efficacy and tolerability of intranasal budesonide aqueous suspension (256 microg once daily) with azelastine hydrochloride nasal spray (280 microg twice daily (560 microg/day)) and with placebo in the treatment of perennial allergic rhinitis. The 195 patients (with at least a 2-year history of perennial allergic rhinitis) recorded individual nasal symptom scores, the degree of symptom control achieved and any adverse events experienced over a 2-week baseline period and a 6-week treatment period.. Following treatment, the reductions in mean combined and individual nasal symptom scores from baseline values were significantly greater in the budesonide group compared with the placebo group (P < .0001 for all variables except runny nose P = .01). In patients treated with budesonide, there were also significantly larger reductions from baseline values in combined nasal symptom scores (P < .01) and in scores for all individual nasal symptoms (P < or = .05) compared with those treated with azelastine. The reductions from baseline in both combined and individual nasal symptom scores did not differ between azelastine and placebo. The study medications were well tolerated, producing no unexpected or serious treatment-related adverse events.. A once-daily dose of 256 microg of intranasal budesonide aqueous suspension is significantly more effective at relieving the symptoms of perennial allergic rhinitis compared with a twice daily dose of 280 microg of azelastine nasal spray.

Topics: Administration, Inhalation; Adolescent; Adult; Aged; Budesonide; Double-Blind Method; Drug Tolerance; Female; Humans; Male; Middle Aged; Nasal Obstruction; Phthalazines; Rhinitis, Allergic, Perennial

Intranasal corticosteroids, such as budesonide and fluticasone propionate, are widely prescribed in the treatment of perennial allergic rhinitis. Once daily budesonide dry powder and fluticasone propionate aqueous suspension have been found to provide similar efficacy in controlling symptoms of perennial allergic rhinitis.. The purpose of this study was to assess the efficacy and safety of treatment with once daily budesonide aqueous nasal spray.. This study involved a multicenter, blinded, randomized, parallel-group, placebo-controlled trial of adults with perrenial allergic rhinitis. Patients (n = 273) recorded daily nasal symptoms for 8 to 14 days (baseline) and 6 weeks (treatment).. Budesonide decreased combined symptoms to a significantly greater extent than did fluticasone (P =.03); both treatments significantly decreased mean combined nasal symptoms scores compared with placebo. Of the 3 nasal symptoms assessed (ie, nasal blockage, runny nose, and sneezing), nasal blockage was significantly (P =. 009) more decreased with budesonide compared with fluticasone. Both treatments also significantly improved runny nose and sneezing compared with placebo. Improvement in combined nasal symptom scores of the budesonide-treated group reached statistical significance within 36 hours compared with placebo (P =.01); in those patients treated with fluticasone, significant improvement compared with placebo was first observed within 60 hours. Adverse events were mild and transient.. Once daily budesonide aqueous nasal spray, 256 microgram, was significantly better in controlling the symptoms of perrenial allergic rhinitis than once daily fluticasone propionate, 200 microgram, especially nasal blockage. Both treatments were superior to placebo. Budesonide may have a faster onset of action than fluticasone.

Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Aged; Androstadienes; Anti-Allergic Agents; Budesonide; Double-Blind Method; Drug Administration Schedule; Endoscopy; Female; Fluticasone; Humans; Male; Middle Aged; Rhinitis, Allergic, Perennial

There is circumstantial evidence that the incidence of allergic rhinitis is becoming increasingly common. There may also be a need for more potent drugs with minimal local and systemic side effects. This study has compared the efficacy and safety of budesonide delivered as nasal dry powder with fluticasone propionate aqueous nasal spray in the treatment of perennial allergic rhinitis. Ninety-eight patients participated in a randomized, parallel group and partly blinded study. Treatment consisted of budesonide dry powder (Rhinocort Turbuhaler) at once daily doses of 200 micrograms (n = 24) or 400 micrograms (n = 22), fluticasone propionate (200 micrograms) once daily (n = 25), and placebo for budesonide dry powder (n = 27). A six-week treatment period was preceded by a two-week baseline period without treatment. Efficacy was assessed by daily subjective scoring of nasal symptoms. Safety was assessed by rhinoscopy, analysis of urine cortisol, and questioning of adverse events. All active treatments were significantly superior to placebo in controlling nasal symptoms. No significant differences in efficacy were found between the two budesonide regimens and fluticasone propionate. Adverse events were few and minor, and non-significantly distributed between treatments. In conclusion, this study shows that budesonide dry powder administered from Turbuhaler (200 or 400 micrograms) and fluticasone propionate aqueous spray (200 micrograms) administered in once daily doses, are effective and safe treatments of perennial allergic rhinitis. These novel treatments may enhance the current available alternatives in clinical practice.

Topics: Administration, Topical; Adult; Aerosols; Androstadienes; Anti-Inflammatory Agents; Budesonide; Female; Fluticasone; Glucocorticoids; Humans; Male; Powders; Pregnenediones; Rhinitis, Allergic, Perennial; Time Factors

This was an open, randomized, cross-over study comparing the efficacy and acceptability of aqueous nasal suspensions of budesonide, 200 micrograms b.i.d. and beclomethasone dipropionate (BDP), 100 micrograms q.i.d., each given for 6 weeks to patients with perennial rhinitis and a history of allergy. Forty men and women aged 18-65 years with perennial rhinitis diagnosed at least 1 year previously, were recruited for study provided they had at least two of the following symptoms of rhinitis--blocked nose, runny nose, itching nose or sneezing. They were requested to record the presence or absence of nasal and ocular symptoms on a severity scale of 0-3 (none, mild, moderate, severe) in daily diary cards. The sum of the nasal scores was calculated to give the total nasal symptom score. Mean individual symptom scores and total symptom score were calculated for each treatment. Thirty-seven patients completed the study. The mean total nasal symptom score was significantly lower during budesonide (2.13) than during BDP (2.75), P = 0.001. There were significantly fewer reports of blocked nose (P = 0.004), runny nose (P = 0.0005) and sore eyes (P = 0.047) during budesonide treatment compared with BDP. Four patients reported adverse events during budesonide treatment (two had nosebleeds and two nasal dryness) and three patients during BDP treatment (two had nasal dryness and one gastric discomfort). A significantly greater proportion of patients stated a preference for budesonide than for BDP on the basis of effect (P = 0.0001), side-effects (P = 0.01), and overall (P = 0.0001).

Topics: Administration, Intranasal; Adolescent; Adult; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Cross-Over Studies; Drug Tolerance; Female; Glucocorticoids; Humans; Male; Middle Aged; Pregnenediones; Rhinitis, Allergic, Perennial; Severity of Illness Index

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 aims of the study were to compare the efficacy and side effects of intranasal budesonide as a dry powder and as a freon propelled pressurized aerosol in the treatment of perennial rhinitis and to validate a perennial rhinitis quality of life questionnaire. The design was a single-blind, randomized, parallel group comparison of two active treatments over a 6-week period. Sixty adults with symptomatic perennial rhinitis, stratified for atopy, received 400 micrograms intranasal budesonide administered daily either as one inhalation/nostril/day of pure drug powder or two puffs/nostril/day of drug delivered by a freon propelled aerosol. Subjects kept daily symptom diaries and, at each clinic visit, rhinitis quality of life and adverse experiences were recorded. Fifty-eight subjects completed the study. During the 6 weeks, there were significant improvements in symptoms and quality of life in both treatment groups. The improvements tended to be slightly greater in the aerosol group but the differences did not reach significance. Most frequently reported adverse experiences were headache and nosebleed, which were equally distributed in the two groups. We conclude that budesonide taken 400 micrograms daily for 6 weeks was associated with improvements in perennial rhinitis with little evidence of any difference in efficacy or side effects between the powder and aerosol. The questionnaire is a valid instrument for assessing quality of life in perennial rhinitis clinical trials.

Topics: Adult; Aerosols; Aged; Bronchodilator Agents; Budesonide; Female; Humans; Male; Middle Aged; Patient Compliance; Powders; Pregnenediones; Quality of Life; Rhinitis, Allergic, Perennial; Single-Blind Method; Surveys and Questionnaires

The efficacy and tolerability of azelastine (CAS 58581-89-8) nasal spray (0.14 mg/nostril b.i.d.) and budesonide (CAS 51333-22-3) nasal aerosol (0.05 mg/nostril b.i.d.) were compared in a 6-week, multicentre, parallel group study of 193 patients suffering from perennial allergic rhinitis. Total rhinitis symptoms complex (TSC) scores derived from 10 rhinitis symptoms improved during treatment by a mean of 11.4 +/- 6.8 with azelastine and 10.8 +/- 6.4 with budesonide. Response rates, defined as a decrease in TSC of at least 50% at the end of therapy, was 79% with azelastine and 73% with budesonide. There were no significant differences between the treatment groups with respect to either target variable. Objective measurements of nasal flow rate showed a return to normal values during the 6-week therapy. Signs of rhinitis identified by rhinoscopic examination improved in parallel to symptoms. Both medications were well tolerated. The incidence of adverse events of possibly causal relationship to therapy was low. The most frequent event in azelastine treated patients was the experience of an "unpleasant" taste or smell. Occasional epistaxis occurred in both treatment groups but more frequently with budesonide. Results indicate that with the dose used azelastine nasal spray is an effective treatment for perennial allergic rhinitis comparable to that of budesonide nasal aerosol.

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Aged; Bronchodilator Agents; Budesonide; Female; Humans; Male; Middle Aged; Phthalazines; Pregnenediones; Rhinitis, Allergic, Perennial

Sixty-nine outpatients with symptomatic perennial rhinitis were recruited to this double-blind, parallel-group study to compare budesonide nasal spray with oral astemizole. Following a 1-week run-in on placebo, 67 patients achieved a mean daily total symptom score of at least 4 (scoring for each symptom was 0 = none, 1 = mild, 2 = moderate, 3 = severe), and were randomized to study treatments - 33 to budesonide, 100 micrograms in each nostril morning and evening, and 34 to astemizole, one 10-mg tablet each morning, for a period of 4 weeks. No antihistamine preparations other than eye drops and no corticosteroids were permitted during the active treatment period. Patients recorded symptoms of blocked nose, runny nose, sneezing, itchy nose, sore eyes or runny eyes in diary cards each evening before retiring. Diary card data showed that there was significantly greater improvement in blocked nose, runny nose and runny eyes during the first 2 weeks of budesonide treatment than during the same period on astemizole. A similar, although non-significant, trend was observed for sneezing and itchy nose, but there was no apparent difference in the reporting of sore eyes. After 4 weeks, blocked nose and runny nose remained significantly less troublesome in the budesonide group. Both treatments were well-tolerated and no major adverse effects were reported. Patient ratings for treatment efficacy were significantly higher for budesonide than astemizole at both 2 weeks and 4 weeks.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Astemizole; Budesonide; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Pregnenediones; Rhinitis, Allergic, Perennial

A randomized double blind placebo controlled cross-over study comparing budesonide 400 micrograms and budesonide 800 micrograms daily in 59 patients is presented. Nasal obstruction was the predominant symptom and was subjectively and objectively improved by both doses of budesonide (P less than 0.001). No significant difference was found between the two treatments. Both patient subgroups with non-allergic, non-eosinophilic rhinitis and perennial allergic rhinitis benefitted from therapy. Basal and stimulated plasma cortisol levels remained unchanged with either dose of budesonide, and no increase in adverse effects occurred with higher dose therapy.

Topics: Administration, Intranasal; Adult; Aerosols; Anti-Inflammatory Agents; Budesonide; Double-Blind Method; Eosinophilia; Female; Glucocorticoids; Humans; Male; Pregnenediones; Rhinitis, Allergic, Perennial; Rhinitis, Vasomotor

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

The efficacy of budesonide, terfenadine and a combination of budesonide and oxymetazoline in the treatment of perennial rhinitis was evaluated by a double blind, parallel group study. Adult patients with perennial rhinitis were randomized into three groups. Group 1 patients received budesonide nasal aerosol 400 micrograms/day for 21 days and oxymetazoline nasal drops for the first three days. Group 2 and 3 patients received budesonide 400 micrograms/day and terfenadne tablet 60 mg twice/day respectively. Nasal symptoms were assessed by the patients before and daily during the treatment period using a simple scoring system. One hundred and forty-two patients were recruited and 130 completed the study. Budesonide, but not terfenadine, significantly reduced all nasal symptoms from baseline (p less than 0.05). Terfenadine could significantly relieve the nasal blockage (p less than 0.05) more than other nasal symptoms. Budesonide with or without oxymetazoline nasal drops provided a better control of nasal symptoms than terfenadine (p less than 0.05). Budesonide with oxymetazoline for the first three days showed a faster relief of nasal blockage than budesonide alone (p less than 0.05). Mild and transient adverse effects were encountered in all three groups. It is concluded that nasal symptoms of perennial rhinitis are more adequately controlled by budesonide than by terfenadine.

Topics: Adolescent; Adult; Aerosols; Aged; Benzhydryl Compounds; Bronchodilator Agents; Budesonide; Double-Blind Method; Drug Therapy, Combination; Female; Histamine H1 Antagonists; Humans; Male; Middle Aged; Nasal Decongestants; Oxymetazoline; Pregnenediones; Rhinitis, Allergic, Perennial; Terfenadine

It was our aim to study the effect of nasal allergen provocation on the concentration of eosinophil cationic protein (ECP) in nasal lavage fluid, with and without glucocorticoid pretreatment. Twenty grass-pollen sensitive volunteers were provoked outside the pollen season on 2 consecutive days after pretreatment for 2 weeks with the glucocorticoid, budesonide, as a nasal spray (400 micrograms/day) and with placebo with a double-blind, crossover design. Nasal lavage fluid was repeatedly collected during a 10-hour period to study both early and late-phase responses. 99mTechnetium-albumin was added to the lavage fluid, making it possible to calculate the amount of secretion and the degree of dilution. The results were as follows: (1) There was no correlation between ECP concentration and dilution factor in the individual samples. (2) The mean concentration of ECP in lavage fluid from untreated, prechallenge noses was 400 micrograms/L. (3) The ECP level did not increase during the early phase response. (4) There was a late occurring increase in the ECP concentration (6 to 24 hours). (5) This increase was completely inhibited by budesonide pretreatment. (6) The glucocorticoid therapy also reduced the prechallenge ECP concentration. In conclusion, allergen provocation in the nose results in a late occurring increase of ECP in nasal lavage fluid, and one of the therapeutic effects of topical glucocorticoid therapy may be an inhibition of the allergen-induced increase of this cytotoxic molecule.

Topics: Adult; Blood Proteins; Budesonide; Clinical Trials as Topic; Double-Blind Method; Eosinophil Granule Proteins; Female; Humans; Male; Nasal Mucosa; Pregnenediones; Rhinitis, Allergic, Perennial; Ribonucleases; Therapeutic Irrigation

The efficacy and safety of intranasal budesonide were evaluated in a placebo-controlled double-blind study of 51 children (6 to 18 years) and 48 adults with perennial (allergic or nonallergic) rhinitis. The trial commenced with a 2-week baseline period without treatment for perennial rhinitis. This was followed by a treatment period of 4 weeks. Treatment was either intranasal budesonide 200 micrograms bid or matching placebo bid. Nasal symptoms were rated daily on a scale from 0 (absent) to 3 (severe). Safety was monitored by laboratory assessments (hematology, blood chemistry, urinalysis) as well as by rhinoscopy and recording of adverse events. Budesonide reduced the nasal symptoms as compared with baseline. The reduction was greater than in the placebo group and symptoms were improved significantly on budesonide treatment compared with placebo. Laboratory assessments demonstrated no differences between budesonide and placebo. Adverse responses to intranasal budesonide were few and minor, and compliance was high. Intranasal budesonide, 200 micrograms bid, thus appears to be efficacious, highly acceptable, and safe for the treatment of perennial rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Budesonide; Child; Double-Blind Method; Glucocorticoids; Humans; Patient Compliance; Pregnenediones; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Perennial

Airway challenges with allergen are frequently followed by an increase in responsiveness to both specific and unspecific stimuli. This phenomenon in the lower airways has been linked to the presence of a late phase response to allergen challenge. One of the hallmarks of the late phase response is a tissue infiltration of granulocytes, specifically the eosinophils. A hypothesis for the increase in responsiveness has been that local activation of these eosinophils with subsequent release of the toxic granular constituents leads to a decrease in the barrier function of the airway epithelium. The aim of the present study was to further explore this hypothesis. Ten patients with previously demonstrated nasal allergen-induced hyperresponsiveness participated in a double-blind cross-over study involving pretreatment for various periods with topical glucocorticosteroids. The patients were challenged intranasally with allergen on one day, rechallenge 24 h later and the increase in responsiveness noted. In a nasal lavage performed immediately prior to challenge the number of eosinophilic granulocytes and the level of eosinophilic cationic protein (ECP) was determined. As expected, the placebo-treated patients demonstrated an increase in nasal responsiveness at rechallenge accompanied by a tendency for an increase in eosinophils as well as ECP in the lavage preceding the rechallenge compared with the initial allergen challenge 24 h previously. The amount of ECP found in the lavage on the second day correlated with the TAME-esterase activity, a marker of ongoing inflammatory activity (r = 0.64; P less than 0.05) in the same lavage, suggesting participation of the eosinophilic granulocyte in the inflammatory response to allergen.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Blood Proteins; Budesonide; Clinical Trials as Topic; Double-Blind Method; Eosinophil Granule Proteins; Eosinophils; Female; Glucocorticoids; Humans; Male; Nasal Mucosa; Pregnenediones; Random Allocation; Rhinitis, Allergic, Perennial; Ribonucleases; Therapeutic Irrigation

A long-term safety study of intranasally administered budesonide, a topical glucocorticoid, has been performed. 104 patients with perennial rhinitis, allergic or non-allergic, participated in a multicentre study in seven ENT-clinics utilising an identical protocol. A budesonide dosage of 400 micrograms/day was used as starting dose, but the patients were at liberty to reduce the daily dose to 200 micrograms. The patients were observed at intervals up to 12 months. At the entry and follow-up visits the following parameters were recorded: rhinoscopic findings, nasal symptom scores, blood chemistry, hematology, urinalysis and determination of plasma cortisol levels before and after stimulation with ACTH (Synacthen). Nasal biopsies taken from 50 of the patients at the beginning and completion of the study were examined in a blinded way by an independent pathologist. The analysis revealed no histopathological changes of the nasal mucosa. At rhinoscopy no signs of atrophy or candida were reported. Lividity of the nasal mucosa was significantly reduced during the trial, which was also the case for nasal congestion and secretion. All nasal symptom parameters assessed by the patients were significantly reduced from baseline during the follow-up period. No clinically significant changes in the hematological and blood chemistry parameters were observed. Plasma cortisol analysis before and after challenge with ACTH revealed no influence on the hypothalamic pituitary adrenal axis. No tachyphylaxis was observed; on the contrary, there was a clear tendency for reduction of the daily dose of budesonide necessary to keep the patients symptom-free.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Aged; Budesonide; Clinical Trials as Topic; Consumer Product Safety; Female; Follow-Up Studies; Humans; Male; Middle Aged; Pregnenediones; Rhinitis, Allergic, Perennial

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 influence of mouth breathing on craniofacial development has previously been demonstrated. Recent investigations do indicate, however, that head posture also might be related to craniofacial morphology. The aim of the present study was to analyze the effect of a topical steroid spray (Budesonide) on nasal respiratory resistance and head posture in children with asthma and nasal obstruction. Thirty-seven children, 8 to 15 years of age, with bronchial asthma, perennial allergic rhinitis, and subjectively assessed mouth breathing were selected for the study. Rhinomanometric and cephalometric analyses were performed. Head posture was defined as the position of the head relative to the cervical column and to the true vertical. After the first examination the children were randomly allocated to two groups, of which one group was treated intranasally with Budesonide (N = 18) and the other with placebo (N = 19), for a double-blind study. After one month of treatment, there was a statistically significant decrease in nasal resistance (p less than 0.001) and an increased flexing of the head (p less than 0.01) (paired t tests) in the children under active treatment. No significant changes were seen in the placebo group. The results indicate that Budesonide nasal spray is capable of reducing nasal obstruction in allergic children and that a reduced nasal resistance leads to a decrease in craniocervical angulation. The clinical importance of these results is yet to be clarified.

Topics: Adolescent; Airway Resistance; Asthma; Budesonide; Cephalometry; Child; Double-Blind Method; Female; Head; Humans; Male; Nose; Pregnenediones; Rhinitis, Allergic, Perennial

A recently synthesized, non-halogenated steroid, budesonide, with high local anti-inflammatory properties, but with low systemic effect, was tested as a nasal spray in the treatment of patients with perennial rhinitis. Used in a dose of 200 micrograms and 400 micrograms budesonide per day in a double-blind cross-over study in 36 patients it was found to have an excellent and dose-dependent effect on nasal blockage and discharge as well as on sneezing bouts. Budesonide caused a considerable decrease in the nasal symptoms in 21 patients with demonstrable cutaneous and RAST allergy, as well as in a group of 15 patients without. The same alleviation of symptoms was noted in 22 patients with nasal eosinophilia but not in a group of 14 patients without. To determine possible adverse reactions during long term treatment, 15 patients with perennial rhinitis used budesonide as a nasal spray for more than two years. No adverse reactions serious enough to discontinue the treatment were noted in any of the patients. Haematologic parameters as well as adrenal gland function were monitored throughout the first 1.5 years. No depression was noted. Biopsy specimens of the nasal mucosae did not show any significant evidence of increased metaplasia.

Topics: Budesonide; Clinical Trials as Topic; Dose-Response Relationship, Drug; Eosinophilia; Humans; Pregnenediones; Rhinitis, Allergic, Perennial

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

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

A recently synthetized, highly active, non-halogenated steroid, budesonide, in the form of a nasal spray was tested on 21 patients with an allergy demonstrated by means of cutaneous or RAST tests and 15 patients without allergy; these patients were further divided into two groups, 22 with nasal eosinophillia and 14 patients without. There was a significant effect on both patients with vasomotor as well as allergic rhinitis, and in patients with nasal eosinophilia, while this was not the case in the group without eosinophilia. Nasal eosinophilia must be considered an inexpensive and important diagnositic tool for the clarification of perennial rhinitis.

Topics: Adolescent; Adult; Budesonide; Clinical Trials as Topic; Double-Blind Method; Eosinophilia; Female; Humans; Male; Middle Aged; Pregnenediones; Radioallergosorbent Test; Rhinitis, Allergic, Perennial; Rhinitis, Vasomotor

39 patients with seasonal rhinitis entered a double-blind study comparing nasal sprays of budesonide 400 micrograms/day and placebo. Symptoms were assessed over a treatment of of three weeks. There were statistically significant differences in favour of the active spray on all measures of assessment. Side effects were mild and the incidence was negligible.

Topics: Adolescent; Adult; Budesonide; Clinical Trials as Topic; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Placebos; Pregnenediones; Rhinitis, Allergic, Perennial

Evaluate the impact of perennial allergic rhinitis (PAR) on the health-related quality of life (HRQL) and measure performance issues that are of major concerns for PAR patients, as well as determining the effect of intra-nasal steroids (INS) on PAR and associated congestion, sleep complaints, and daytime sleepiness.. This study was a cross-sectional study. A total of 78 PAR patients underwent otorhinolaryngological examination and skin test. All participants filled in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ), the Stanford Sleepiness Scale (SSS), and the Epworth Sleepiness Scale (ESS). Participants were asked to undergo treatment with Budesonide (BUD) topical aqueous nasal spray for eight weeks. After the treatment period, all participants were again asked to answer the three questionnaires.. The results of this study found statistically significant improvements in the overall NRQLQ score (p < 0.001) and individual NRQLQ domain scores (p < 0.05) after INS treatment. A statistically significant reduction in symptom severity in the four NRQLQ domains before and after treatment was found (p < 0.05), except for restlessness, post-nasal drip, and avoiding symptom triggers (p = 0.575, 0.172, and 0.705, respectively). There was a statistically significant difference in ESS and SSS scores before and after treatment (p < 0.001).. PAR has a significant impact on sleep quality and, as a result, a lower QOL. This study demonstrates that INS is an effective modality in the treatment of PAR and positively impacts patients' QOL by improving nasal symptoms, daytime fatigue, and somnolence, and sleep quality.

Topics: Administration, Intranasal; Budesonide; Cross-Sectional Studies; Humans; Quality of Life; Rhinitis; Rhinitis, Allergic, Perennial; Sleep Quality

Recurrence of allergic fungal rhinosinusitis (AFRS) is well recognized. However, there is scarcity in the literature describing involvement of the non-diseased sinuses. We aimed to evaluate the recurrence forms of unilateral AFRS as well as to study the possible predictor factors of developing the disease in the contralateral side. Patients with exclusive unilateral AFRS from (2010 to 2015) were enrolled in multi-institutional case-control study. All patients were evaluated after endoscopic sinus surgery for recurrence. Patient's records were reviewed for demographics, medical treatment, and clinical, radiological, and surgical data. A total of 68 patients were identified. Delayed contralateral involvement after the initial surgery was found in 30.8% with mean duration of recurrence 16.9 months. A significant association was found with the presence of pre-operative contralateral symptoms and signs of inflammation (OR 3.49, 95% CI 1.19-10.22, p value 0.02). Post-operative use of budesonide irrigation was associated with less contralateral involvement (OR 0.11, 95% CI 0.01-0.87, p value 0.01). Association of other variables like: comorbidities, perioperative use of systemic steroid, radiological signs, extent of surgery, additional surgery to the contralateral side, and post-operative use of systemic steroids did not show statistical significance. Involvement of the contralateral sinuses in 30% of unilateral AFRS cases is considered significant. The non-diseased sinuses should be involved in the routine endoscopic examination and post-operative treatment. Further studies are necessary to investigate the possibility of prophylactic surgical intervention of the non-diseased sinuses.

Topics: Adult; Budesonide; Case-Control Studies; Female; Glucocorticoids; Humans; Male; Mycoses; Paranasal Sinuses; Recurrence; Retrospective Studies; Rhinitis, Allergic, Perennial; Sinusitis; Therapeutic Irrigation

Topics: Budesonide; Child; Crocus; Food Hypersensitivity; Humans; Male; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Spices

Th17 cells and IL-17A play a role in the development and progression of allergic diseases. We analyzed the IL-17A levels in sputum supernatants (Ss), nasal wash (NW) and plasma (P) from Healthy Controls (HC) and children with Asthma/Rhinitis. We tested the expression of IL-17A, RORγ(t) and FOXP3 in peripheral blood T-lymphocytes from intermittent and mild-moderate asthma. The effect of Budesonide and Formoterol was tested "in vitro" on IL-17A, RORγ(t) and FOXP3 expression in cultured T-lymphocytes from mild-moderate asthma/persistent rhinitis patients, and on nasal and bronchial epithelial cells stimulated with NW and Ss from mild-moderate asthma/persistent rhinitis. Further, the effect of 12 weeks of treatment with Budesonide and Formoterol was tested "in vivo" in T-lymphocytes from mild-moderate asthma/persistent rhinitis patients. IL-17A was increased in Ss, NW and P from children with mild-moderate asthma compared with intermittent and HC. In cultured T-lymphocytes IL-17A and RORγ(t) expression were higher in mild-moderate asthma/persistent rhinitis than in mild-moderate asthma/intermittent rhinitis, while FOXP3 was reduced. Budesonide with Formoterol reduced IL-17A and RORγ(t), while increased FOXP3 in cultured T-lymphocytes from mild-moderate asthma/persistent rhinitis, and reduced the IL-8 release mediated by IL-17A present in NW and Ss from mild-moderate asthma/persistent rhinitis in nasal and bronchial epithelial cells. Finally, Budesonide with Formoterol reduced IL-17A levels in P and Ss, CD4(+)IL-17A(+)T-cells, in naïve children with mild-moderate asthma/persistent rhinitis after 12 weeks of treatment. Th17 mediated immunity may be involved in the airway disease of children with allergic asthma and allergic rhinitis. Budesonide with Formoterol might be a useful tool for its therapeutic control.

Topics: Administration, Inhalation; Adolescent; Adrenergic beta-2 Receptor Agonists; Anti-Asthmatic Agents; Asthma; Budesonide; Case-Control Studies; Cells, Cultured; Child; Ethanolamines; Female; Forkhead Transcription Factors; Formoterol Fumarate; Humans; Interleukin-17; Interleukin-8; Male; Nasal Lavage Fluid; Nuclear Receptor Subfamily 1, Group F, Member 3; Rhinitis, Allergic, Perennial; Sputum; Th17 Cells

Although CD23-dependent transcytosis of IgE and IgE-derived immune complexes across respiratory epithelial cells is likely to play a pivotal role in the initiation and development of airway allergic inflammation, there is currently a lack of physiological support for this phenomena to suggest that the targeting of CD23 could be used as a means of therapeutic intervention. The present study was designed to detect the CD23 expression in the nasal mucosa of allergic rhinitis (AR) murine model by immunohistochemistry and western blotting, and to investigate whether intranasal anti-CD23 treatment could inhibit allergen-induced upper airway inflammation in the AR model. This is the first report to show that CD23 was constitutively expressed in murine nasal epithelial cells, and its expression was significantly up-regulated in the AR murine model. In vivo, the up-regulation of CD23 expression was correlated with increased serum IL-4 levels. Following intranasal anti-CD23 treatment, nasal symptoms were alleviated and histopathologic examination showed a significant decrease in eosinophilic infiltration. Meanwhile, ELISA analysis showed levels of serum leukotriene C4 (LTC4), eosinophil cation protein (ECP), ovalbumin (OVA)-specific IgE and IL-4 also significantly decreased, as were LTC4 and OVA-specific IgE in the nasal lavage fluid. Furthermore, Western blotting analysis showed that ECP expression in the nasal mucosa was down-regulated. Finally, flow cytometric analysis revealed anti-CD23 treatment inhibited Th2 cell responses. These results indicate that intranasal anti-CD23 treatment can reduce allergic responses in a murine model of allergic rhinitis.

Topics: Administration, Intranasal; Allergens; Animals; Budesonide; Disease Models, Animal; Down-Regulation; Eosinophil Cationic Protein; Eosinophils; Epithelial Cells; Female; Hypersensitivity; Immunoglobulin E; Inflammation; Interleukin-4; Leukotriene C4; Mice; Mice, Inbred BALB C; Nasal Mucosa; Ovalbumin; Random Allocation; Receptors, IgE; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Th2 Cells; Up-Regulation

CCR4 is highly expressed on Th2 cells. These cells play an important role in acute inflammatory responses, including those involved in allergic rhinitis. We determined whether disrupting the CCR4 ligand interaction with CCR4 antagonist could alleviate allergic rhinitis in a mouse model.. BALB/c mice were sensitized with ovalbumin and alum by intraperitoneal injection and challenged with intranasally administered ovalbumin. Compound 22, which has been reported as a novel small-molecule antagonist of CCR4, was also administered intranasally. In addition, budesonide, an efficient glucocorticoid, was used as a positive control. The effects of compound 22 were quantified by multiple parameters of allergic responses in both nasal and pulmonary tissues.. Compound 22 significantly improved symptoms of allergic rhinitis and suppressed levels of total IgE of serum. It dramatically reduced the levels of IL-4 in bronchoalveolar lavage fluid and also decreased the number of inflammatory cells in the fluid. The infiltration of inflammatory cells, especially eosinophils, was markedly reduced in the nasal and pulmonary tissues. The number of IL-4+ cells was also significantly reduced in these tissues. Moreover, the numbers of Foxp3+ cells and IL-17+ cells were reduced, though not to a statistically significant degree.. In our research, CCR4 antagonists such as compound 22 were proven for the first time to alleviate murine allergic rhinitis when administered nasally. CCR4 antagonists may have therapeutic potential for the treatment of allergic rhinitis.

Topics: Administration, Intranasal; Alum Compounds; Animals; Bronchoalveolar Lavage Fluid; Budesonide; Chemotaxis; Disease Models, Animal; Female; Glucocorticoids; HEK293 Cells; Humans; Immunization; Immunoglobulin E; Immunologic Factors; Interleukin-4; Mice; Mice, Inbred BALB C; Neutrophils; Ovalbumin; Receptors, CCR4; Rhinitis, Allergic, Perennial; Th2 Cells

This study evaluated the effects on bone mineral status of long-term treatment with intranasal budesonide (INB) spray, using the recommended dose, in pediatric patients with allergic rhinitis (AR). This retrospective, case-control study of 230 prepubertal children with perennial AR, who had used nasal budesonide at a mean daily dose of 100 μg (range, 89-132 μg) for at least 3 years intermittently, was conducted from May 2007 through May 2010. The bone mineral density (BMD) of the lumbar spine was measured by dual-energy X-ray absorptiometry. Levels of serum calcium, phosphorus, alkaline phosphatase (ALP), parathyroid hormone, and osteocalcin were also assessed. The results were compared to sex- and age-matched controls (n = 140), who were newly diagnosed children with AR without any corticosteroid treatment. The 230 study patients (145 boys) were aged from 7 to 11 years. The average age (± SEM) was 8.7 ± 0.7 years; the mean (± SEM) steroid dosage used was 73.5 ± 7.0 μg daily, with 65.2 ± 5.2 g total steroid use during treatment. The 140 control patients (90 boys) were aged from 6 to 11 years. No significant differences were observed in BMD (P > 0.05) between the study and the control groups. Although mean serum ALP level was higher, and cortisol, phosphorus, and osteocalcin levels were lower, in the treatment group, these differences were not statistically significant. The findings suggest that long-term intermittent treatment for 3 years with INB spray, 50 μg twice daily, for children with perennial rhinitis revealed no negative effect on BMD and associated parameters.

Topics: Absorptiometry, Photon; Administration, Intranasal; Alkaline Phosphatase; Anti-Inflammatory Agents; Bone and Bones; Bone Density; Budesonide; Calcium; Case-Control Studies; Child; Female; Humans; Male; Osteocalcin; Parathyroid Hormone; Retrospective Studies; Rhinitis, Allergic, Perennial; Steroids

To study the effects of allergen and corticosteroid on T help 17 (Th17) and orphan nuclear receptor gammat (RORγt) in allergic-rhinitis mice.. Experimental allergic rhinitis (AR) was induced by the extract of dermatophagoides pteronyssinus (DP) including 2% ovalbumin (OVA) sensitization in 30 male mice with DP allergen group (n = 10), intranasal corticosteroid (budesonide, BUD) group (n = 10) or without treatment (model group, n = 10). And another 10 were included into the normal control group. The murine levels of Th17 were measured by flow cytometry (FCM). The expression of RORγt mRNA was measured by reverse transcription-polymerase chain reaction (RT-PCR) while that of RORγt protein in nasal mucosa detected by immunohistochemical staining.. The expression of RORγt in nasal mucosa of AR model was higher than that in the control group (25 ± 5 vs 48 ± 10, P < 0.01). But its expression declined significantly after the administration of local corticosteroid (48 ± 10 vs 31 ± 6, P < 0.01). The levels of RORγt mRNA and Th17 in the AR model group were significantly higher than those in the control group (18.4% ± 1.3% vs 27.5% ± 1.6%, 0.43 ± 0.04 vs 0.64 ± 0.05, both P < 0.01). The levels of RORγt mRNA and Th17 in the spleen of AR mice were significantly reduced by allergen dosing (27.5% ± 1.6% vs 20.0% ± 2.1%, 0.64 ± 0.05 vs 0.54 ± 0.03, both P < 0.01) but not by corticosteroid (P > 0.05).. Allergen may affect the systemic immunity to inhibit the RORγt expression and block the Th17 differentiation in AR model. Local steroid only produces a marked effect through a down-regulated RORγt expression in nasal mucosa.

Topics: Allergens; Animals; Budesonide; Male; Nuclear Receptor Subfamily 1, Group F, Member 3; Rats; Rats, Sprague-Dawley; Rhinitis, Allergic, Perennial; Th17 Cells

Intranasal corticosteroids (INS) are the first line treatment for allergic rhinitis (AR). To guide clinical decision-making, we created a therapeutic index (TIX) for INS reflecting efficacy and safety.. A Medline search (1966 to June 2009) was carried out to identify all placebo-controlled randomized trials, and observational reports for safety issues, with Dexamethasone, Budesonide (BUD), Fluticasone propionate (FP), Fluticasone furoate (FF), Flunisolide, Mometasone furoate (MF), Triamcinolone (TRIAM), and Beclomethasone dipropionate (BDP) as treatment for AR. Data on three efficacy (nasal symptoms, ocular symptoms, global assessment) and three safety outcomes (epistaxis, growth, systemic ocular effects) were extracted. Meta analyses were performed for each INS and outcome and results were categorised into scores by quartiles. Scores of the three efficacy and safety outcomes were summed up to create summation scores for efficacy (ES) and side effects (AES), respectively with a maximum of 9 points. The TIX was then defined as the ratio of ES and AES.. Data of 84 studies were extracted. Based on availability of data, a TIX was calculated for 6 substances. BUD showed the highest efficacy score followed by MF and TRIAM. The lowest scores for side effects were achieved by MF and TRIAM followed by FP. These findings resulted in TIX scores of 7 and 5 for MF and TRIAM, respectively, indicating a high efficacy and low potential of adverse events. Medium scores were reached by BUD and FP and lower scores by BDP and FF.. Although safety and efficacy is proven for all available INS by multiple studies, the systematic aggregation and analysis of data allows for a differentiated summary on clinically important features.

Topics: Administration, Intranasal; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Fluocinolone Acetonide; Fluticasone; Glucocorticoids; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Treatment Outcome; Triamcinolone

Glucocorticoids (GCS) have been shown to induce IgE synthesis in human peripheral blood mononuclear cells (PBMCs) and purified B cells in vitro. However, the differences in immunoglobulin E (IgE) response to GCS between allergic and non-allergic individuals and the mechanism this interaction have not been elucidated.. We aimed to compare the effect of GCS (budesonide) on interleukin (IL)-4-driven IgE production in vitro in allergic and non allergic subjects and assess the engagement of intracellular mechanisms.. The study included 22 patients with allergic asthma and/or allergic rhinitis and 24 healthy volunteers. PBMCs were cultured for 11 days with IL-4 and budesonide and IgE concentrations in supernatants were assessed by immunoassays. T and B cell markers were assessed by flow cytometry.. Budesonide enhanced IgE synthesis to higher extent in healthy donors than in allergic patients (mean increase of 16.5 vs 6.3 kU/L, P< .05 respectively) acting through glucocorticoid receptor. Budesonide significantly increased lymhoplasmocytoid cells percentage in both media-controlled (2.5-fold increase) and IL-4-stimulated PBMCs (2-fold increase). Added to IL-4 budesonide decreased the percentage of both T cells and CD40L(+) T cells, but strongly increased the percentage of B cells. Protein tyrosine kinase (PTK) inhibitor decreased, but NF-κB and protein kinase A (PKA) inhibitors expressed modulatory effects on budesonide-induced IgE synthesis.. Budesonide-induced IgE generation in PBMCs differs in magnitude and seems to involve different mechanisms in atopic and non-atopic subjects.

Topics: Adult; Asthma; B-Lymphocytes; Budesonide; CD40 Ligand; Female; Glucocorticoids; Humans; Hypersensitivity; Immunoglobulin E; Interleukin-4; Leukocytes, Mononuclear; Male; Middle Aged; NF-kappa B; Protein Kinase Inhibitors; Rhinitis, Allergic, Perennial; T-Lymphocytes; Young Adult

Human chemokine-like factor (CKLF1) is a human cytokine that exhibits chemotactic activities on a wide spectrum of leukocytes. One of CKLF1's C-terminal peptides, C19, exerts inhibitory effects on chemotaxis mediated by mouse Ccr3 and Ccr4 and human CCR3 and CCR4. Mouse models of asthma show that C19 can also inhibit the Th2 response. CCR3 and CCR4 are chemokine receptors important to allergic rhinitis, a condition whose pathogenesis is similar to that of asthma. Here, we established a mouse model of allergic rhinitis by repetitive sensitization and intranasal challenge with OVA and assessed whether C19 has therapeutic effects on this model. In this study, both intranasal and intraperitoneal administration of C19 reduced allergic symptoms such as sneezing and rubbing and serum concentration of IgE. C19 showed a strong ability to suppress eosinophil accumulation in nasal mucosa and lung tissues. C19 was able to suppress the Th2 cytokine IL-4 without augmenting the Th1 cytokine IFN-γ in BAL and IL-4(+) cells in the local nasal tissue. In terms of symptom amelioration, IgE reduction, and eosinophilia suppression, C19 was found to be as effective against allergic rhinitis as Budesonide. Moreover, intranasal treatment has a stronger therapeutic effect than other types of administration, and it may be more convenient and safe. For these reasons, C19 may have potential in the treatment of allergic rhinitis.

Topics: Administration, Intranasal; Animals; Anti-Inflammatory Agents; Bronchoalveolar Lavage Fluid; Budesonide; Disease Models, Animal; Eosinophils; Female; Immunoglobulin E; Interferon-gamma; Interleukin-4; Lung; MARVEL Domain-Containing Proteins; Membrane Proteins; Mice; Mice, Inbred BALB C; Nasal Mucosa; Ovalbumin; Peptides; Repressor Proteins; Rhinitis, Allergic, Perennial; Sneezing

Intranasal corticosteroids (INCSs) seem to be the best medication available to control and eliminate symptoms of allergic rhinitis. However, the amounts of nasal steroids prescribed and used were not directly proportional to the number of allergic rhinitis cases in Turkey. Herein, we aimed to clarify the unexpectedly low prescription and use of INCSs in Turkey by checking the outlook of patients' and physicians' perspectives. The patients' perspective on oral and nasal steroids was evaluated with a custom-designed questionnaire drawn up specifically for this preliminary study. The physicians' perspective on prescribing nasal steroids was evaluated with the data obtained from the IMS Health Turkey reports. The findings we obtained in this survey by analyzing data from the self-administered questionnaires showed that among these young people, oral and nasal steroids were on the whole well-known drugs. Hence, even though steroids in general are well-known drugs, the young people we surveyed mainly remained uninformed about their safety. The incidence of using nasal steroids if prescribed is higher than the one with oral steroids; that may be due to the lack of knowledge about nasal steroids. The analysis of the IMS Health Turkey data for nasal steroid prescriptions between 2005 and 2008 shows that the market share has increased steadily. The role of INCSs in the treatment of allergic rhinitis is increasingly being recognized as an appropriate and effective treatment option. However, patients' and parents' concerns over the safety of INCS therapy have frequently resulted in their being positioned as a second-line treatment choice. Physicians need to be aware that patients may have a significant information gap. Instructing the family and caregivers about the correct use of INCS therapy is an important part of treatment.

Topics: Administration, Intranasal; Adult; Androstadienes; Anti-Inflammatory Agents; Attitude of Health Personnel; Budesonide; Drug Prescriptions; Female; Fluticasone; Health Knowledge, Attitudes, Practice; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Rhinitis, Allergic, Perennial; Surveys and Questionnaires; Triamcinolone; Young Adult

Topics: Adrenal Insufficiency; Bronchiolitis Obliterans; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Cushing Syndrome; Drug Interactions; Female; HIV Infections; HIV Protease Inhibitors; Humans; Male; Pulmonary Disease, Chronic Obstructive; Rhinitis, Allergic, Perennial; Ritonavir

There are no studies in Indian literature on compliance to various medications for allergic diseases such as nasal sprays, inhalers, immunotherapy and antihistamines. This study was initiated to cover this lacuna. Eighty young patients suffering from asthma with rhinitis or urticaria between the age group of 10 and 40 years were included in this study. Compliance to medications was carefully observed using dose diaries for a period of one year. The data obtained revealed the highest compliance for sublingual immunotherapy (84.19%) and the lowest for a nasal spray (62.32%). The compliance for a dry powder inhaler was 69.31% and for fexofenadine tablets it was 71.78%. These figures are surprisingly low, especially since this study was conducted in a private clinic.

Topics: Adolescent; Adult; Anti-Allergic Agents; Asthma; Bronchodilator Agents; Budesonide; Child; Ethanolamines; Female; Formoterol Fumarate; Humans; Immunoglobulin E; India; Male; Patient Compliance; Rhinitis, Allergic, Perennial; Skin Tests; Spirometry; Terfenadine; Treatment Outcome; Urticaria

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

The family Dermestidae belongs to the order Coleoptera. Occupational allergy has been described in museum personnel. A 31-year-old male wool worker presenting rhinoconjunctivitis and asthma episodes probably linked to exposure to Dermestidae-infected wool was investigated.. Extracts prepared either from insect bodies or from dust from parasitized wool were used for skin prick testing (SPT), conjunctival and bronchial provocation tests and in vitro determinations.. SPT and provocation tests were positive to both extracts. PEFR measurement demonstrated the association between the patient's symptoms and occupational exposure to Dermestidae. Specific IgE to both extracts was detected and immunoblotting revealed several protein bands from 5 to 200 kDa that were reactive to IgE from the patient's serum.. Dermestidae exposure in wool workers when handling parasitized wool can be a cause of IgE-mediated rhinoconjunctivitis and asthma.

Topics: Adult; Albuterol; Allergens; Animals; Antibody Specificity; Asthma; Bronchial Provocation Tests; Bronchodilator Agents; Budesonide; Coleoptera; Conjunctivitis, Allergic; Dose-Response Relationship, Immunologic; Electrophoresis, Polyacrylamide Gel; Forced Expiratory Volume; Humans; Immunoblotting; Immunoglobulin E; Male; Molecular Weight; Occupational Diseases; Peak Expiratory Flow Rate; Rhinitis, Allergic, Perennial; Skin Tests; Tissue Extracts; Wool

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

Patients using topically applied corticosteroids are at risk of developing allergic contact hypersensitivity.. To assess prevalence of allergic contact hypersensitivity reactions to inhaled or intranasal corticosteroids.. A prospective study of 30 adult patients using inhaled or intranasal corticosteroids for conditions such as allergic rhinitis was performed. We used epicutaneous patch testing to determine the prevalence of allergic contact hypersensitivity to corticosteroids and common additives (propylene glycol and benzalkonium chloride) in inhaled and nasal corticosteroid preparations in this population.. Of 30 patients, 4 (13%) had positive patch test results. 3 (10%) were allergic reactions and 1 (3%) was an irritant reaction. Half of the reactions were to a corticosteroid (budesonide) and half were to a common preservative in nasal preparations (benzalkonium chloride).. This study supports other clinical evidence that contact dermatitis/mucositis from inhaled or intranasal corticosteroid products can occur. The corticosteroids or added agents such as preservatives can be causative and may result in allergic or irritant reactions, which can be relevant to clinical symptoms.

Topics: Administration, Inhalation; Administration, Intranasal; Adult; Asthma; Benzalkonium Compounds; Bronchodilator Agents; Budesonide; Dermatitis, Allergic Contact; Female; Humans; Male; North Carolina; Patch Tests; Preservatives, Pharmaceutical; Prevalence; Rhinitis, Allergic, Perennial

Interleukin (IL)-12 is a relatively new and structurally distinct TH1-associated cytokine produced by B cells and macrophages, which may play a suppressive role in the development of allergic sinonasal mucosal responses.. We investigated the expression of IL-12 (inducible p40 subunit) and its receptor (IL-12R beta2 subunit) in tissue biopsies of naturally exposed patients with allergy-associated (ACS) and nonallergy-associated chronic sinusitis (NCS) and compared it with controls. We also examined IL-12 and IL-12R expression in biopsies from a ragweed allergen challenge model. In the allergen challenge model, the effect of pretreatment with topical corticosteroids on IL-12 and IL-12R expression was assessed.. To detect IL-12 and IL-12R mRNA, we employed the technique of in situ hybridization using digoxigenin-labelled riboprobes.. In both ACS and NCS subjects there was decreased expression of IL-12 as compared with control (P < 0.05). IL-12R (beta2) expression was decreased in ACS subjects as compared with control (P < 0.05), however, there was no significant difference found between NCS subjects and control. In the allergen challenge subjects, there was a significant decrease in IL-12 expression following challenge (P < 0.05). This effect was abrogated by pretreatment of the subjects with topical corticosteroids. However, IL-12R (beta2) expression showed no change following allergen challenge while pretreatment with topical corticosteroids resulted in increased expression of the (beta2) receptor after allergen challenge (P < 0.05).. Our data suggest that IL-12 plays a role in the in vivo suppression of the allergic inflammatory response and that the control of this suppression may be exerted largely via the IL-12 (beta2) receptor.

Topics: Adult; Allergens; Antigens, Plant; Budesonide; Chronic Disease; Female; Humans; Interleukin-12; Male; Middle Aged; Nasal Mucosa; Paranasal Sinuses; Plant Proteins; Pollen; Protein Isoforms; Receptors, Interleukin; Receptors, Interleukin-12; Rhinitis, Allergic, Perennial; Sinusitis

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

Serum eosinophilic cationic protein (ECP) and soluble low affinity receptor for IgE (Fc epsilon RII/sCD23) concentrations were measured in relation to symptom-medication scores, pulmonary function, and total IgE levels in 27 chronic allergic asthmatic children (17 boys, 10 girls), mean age 10.8 years, before and at the end of a three month inhaled corticosteroid (budesonide) treatment period. Serum ECP and sCD23 concentrations were also measured in age matched non-asthmatic controls with allergic rhinitis. All asthma patients had significantly higher serum ECP and sCD23 than the controls, whereas the mean serum IgE was not different. No correlation between total IgE concentrations and serum sCD23 could be detected in either group. At the end of the treatment period, symptom-medication scores and pulmonary function improved. Serum ECP and sCD23 concentrations were reduced; however, total IgE values did not change significantly. A significant relation was found between the improvement of symptom-medication scores and fall in both sCD23 and ECP concentrations. Although there was a significant correlation of pulmonary function values with serum ECP, no such relation was observed for sCD23. It appears that serum sCD23 and ECP concentrations could be good disease markers, particularly in asthma. Monitoring of serum inflammation markers, especially ECP, may be useful in the follow up of asthmatic children on anti-inflammatory treatment.

Topics: Adolescent; Anti-Inflammatory Agents; Asthma; Blood Proteins; Budesonide; Child; Chronic Disease; Eosinophil Granule Proteins; Female; Humans; Inflammation Mediators; Lung; Male; Pregnenediones; Receptors, IgE; Respiratory Function Tests; Rhinitis, Allergic, Perennial; Ribonucleases

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 efficacy and tolerability of a new intranasal glucocorticosteroid, budesonide, was evaluated in 28 Thai adult patients with perennial rhinitis. After one week pre-treatment observation period, the nasal spray was given as two puffs into each nostril twice daily (400 micrograms/day) for four weeks. The severity of all nasal symptoms decreased significantly after 1 week treatment reaching a minimal level after 2 weeks. The amounts of antihistamine tablets taken by the patients were also significantly reduced during the treatment with budesonide. Three patients reported adverse effects which were mild and easily tolerated. Morning plasma cortisol levels measured before and after four-week treatment in 15 patients revealed no significant changes. This study suggests that intranasal budesonide is an effective and well-tolerated treatment for perennial rhinitis.

Topics: Administration, Intranasal; Adolescent; Adult; Anti-Inflammatory Agents; Budesonide; Female; Follow-Up Studies; Humans; Hydrocortisone; Male; Medical Records; Middle Aged; Pregnenediones; Rhinitis, Allergic, Perennial; Thailand

The effects of prolonged treatment with intranasally applied budesonide was studied in twenty-four patients with perennial allergic or non-allergic rhinitis. Patients on continuous treatment were followed up for 5.5 years. At entry and follow-up visits, rhinoscopic findings, nasal symptom scores, blood chemistry, haematology, urine analysis and determination of plasma cortisol levels, before and after stimulation with ACTH (Synacthen, Ciba-Geigy AG, Basel, Switzerland), were registered. Biopsies of the nasal mucosa were taken before entry into the study, after 1 year of treatment, and after varying time intervals ranging from 2.5 to 5.5 years during the treatment. The biopsy specimens were examined blindly by an independent pathologist. The analyses revealed no histopathological changes in the nasal mucosa. All nasal symptom parameters assessed by the patients were significantly reduced from the baseline during the entire follow-up period. No clinically significant changes in the haematological and blood chemistry parameters were observed. Plasma cortisol analyses before and after challenge with ACTH revealed no influence on the hypothalamic pituitary adrenal (HPA) axis. The present study suggests that intranasal budesonide in the dose of 200-400 micrograms/day is also a safe treatment for prolonged treatment of perennial rhinitis.

Topics: Adolescent; Adult; Aerosols; Budesonide; Female; Follow-Up Studies; Humans; Male; Nasal Mucosa; Pregnenediones; Rhinitis, Allergic, Perennial