Budesonide in grass pollen rhinitis.

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

Intranasal budesonide for the treatment of perennial rhinitis in Thai patients

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.     

A clinical comparison of budesonide nasal aerosol, terfenadine and a combined therapy of budesonide and oxymetazoline in adult patients with perennial rhinitis.

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.     

The effect of budesonide on the cytokine pattern in patients with perennial allergic rhinitis.

BACKGROUND: 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. OBJECTIVE: To evaluate cytokine pattern and symptoms in patients with perennial allergic rhinitis before and after treatment with intranasal budesonide. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.     

A comparison of topical budesonide and oral montelukast in seasonal allergic rhinitis and asthma

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

A randomized comparison of the effects of budesonide and mometasone furoate aqueous nasal sprays on nasal peak flow rate and symptoms in perennial allergic rhinitis.

BACKGROUND: Using conventional methods, it has been difficult to show differences in efficacy between intranasal corticosteroids in perennial rhinitis. OBJECTIVE: To compare the effects of budesonide and mometasone on nasal symptoms and nasal airflow in perennial allergic rhinitis. METHODS: 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). RESULTS: 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. CONCLUSION: 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.     

Knemometric assessment of systemic activity of once daily intranasal dry-powder budesonide in children

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 μg or placebo. Fourteen children in the budesonide 200-μg group, 13 in the 400-μg group, and 10 in the placebo group completed the study. In the placebo and budesonide 200-μg 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-μg 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-μg administered intranasally from a dry-powder inhaler.     

Short-term lower leg growth rate in children with rhinitis treated with intranasal mometasone furoate and budesonide.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: No short-term adverse effects on linear lower leg growth rates were detected after once daily MF or budesonide at clinically relevant doses.     

Comparison of the efficacy of budesonide and fluticasone propionate aqueous nasal spray for once daily treatment of perennial allergic rhinitis

Background: 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. Objective: The purpose of this study was to assess the efficacy and safety of treatment with once daily budesonide aqueous nasal spray. Methods: 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). Results: 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. Conclusions: Once daily budesonide aqueous nasal spray, 256 μg, was significantly better in controlling the symptoms of perrenial allergic rhinitis than once daily fluticasone propionate, 200 μg, especially nasal blockage. Both treatments were superior to placebo. Budesonide may have a faster onset of action than fluticasone. (J Allergy Clin Immunol 1998;102:902-8.)     

Early treatment of perennial rhinitis with budesonide or cetirizine and its effect on long-term outcome

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.     

The clinical efficacy of budesonide in hay fever treatment is dependent on topical nasal application

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

Growth velocity in children with perennial allergic rhinitis treated with budesonide aqueous nasal spray.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.     

Eosinophils, secretory responsiveness and glucocorticoid-induced effects on the nasal mucosa during a weak pollen season

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

Safety of nasal budesonide in the long-term treatment of children with perennial rhinitis

BACKGROUND: Intranasal budesonide is an efficacious treatment for perennial allergic rhinitis. Long-term effects on safety, particularly in children, need further investigation. OBJECTIVE: To investigate the long-term safety of intranasal budesonide in children. METHODS: 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. RESULTS: 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. CONCLUSION: 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.     

Once daily triamcinolone acetonide nasal spray is effective for the treatment of perennial allergic rhinitis

A randomized, double-blind, placebo-controlled, parallel group study was conducted in 11 centers to evaluate the safety and efficacy of a once-a-day regimen of 110 micrograms, 220 micrograms; and 440 micrograms of triamcinolone acetonide intranasal aerosol versus placebo in relieving the symptoms of rhinitis in 305 adult and older pediatric patients with perennial allergic rhinitis. Nasal stuffiness, nasal discharge, sneezing, nasal itching and the nasal index (the sum of the mean scores of the first three symptoms) averaged over the first 6 weeks and second 6 weeks of the study were significantly reduced in patients who received the 220 micrograms/day and the 440 micrograms/day dosages. The 110 micrograms/day group had a reduction in these nasal symptoms, but only the sneezing and nasal index were significantly (P less than .05) better than placebo. During the last 6 weeks of the study, patients were allowed to take oral back-up medication for their nasal symptoms; all three groups receiving triamcinolone nasal aerosol took less back-up medication than did the placebo group. There were no significant adverse effects or laboratory abnormalities noted during this study. Intranasal triamcinolone acetonide 220 micrograms and 440 micrograms, used once-a-day for 12 weeks is clinically and statistically superior to placebo for the treatment of perennial allergic rhinitis.     

Efficacy and safety of ciclesonide, 200 microg once daily, for the treatment of perennial allergic rhinitis.

BACKGROUND: Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis (AR). OBJECTIVE: To evaluate the efficacy, safety, and quality-of-life benefits of intranasal ciclesonide, 200 microg once daily, for the treatment of perennial AR (PAR). METHODS: In this multicenter, randomized, double-blind, placebo-controlled study, adults and adolescents with at least a 2-year history of PAR received intranasal ciclesonide, 200 microg, or placebo once daily for 6 weeks. Patient-evaluated total nasal symptom scores (TNSSs), physician-assessed overall nasal signs and symptoms severity scores, and Rhinoconjunctivitis Quality of Life Questionnaire scores were evaluated. RESULTS: Patient baseline characteristics were similar in the ciclesonide (n = 238) and placebo (n = 233) groups and were consistent with moderate PAR severity. Ciclesonide therapy significantly reduced average morning and evening reflective TNSSs compared with placebo (P < .001) and significantly reduced average morning and evening instantaneous TNSSs (P = .001) over 6 weeks of treatment. At the end point, a greater decrease from baseline was observed in physician-assessed overall nasal signs and symptoms severity for the ciclesonide group compared with the placebo group (P = .051). An appreciable improvement in combined Rhinoconjunctivitis Quality of Life Questionnaire scores at the end point was also observed in the ciclesonide group (P = .01 vs placebo). The frequency of adverse events was similar between treatment groups. CONCLUSIONS: In this study, intranasal ciclesonide treatment was associated with significant reductions in nasal symptoms and appreciable improvements in health-related quality of life in adult and adolescent patients with PAR. Ciclesonide was well tolerated, with a safety profile comparable with that of placebo.     

Powder administration of pure budesonide for the treatment of seasonal allergic rhinitis

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

Clinical evaluation of triamcinolone acetonide nasal aerosol in children with perennial allergic rhinitis

Triamcinolone acetonide aerosol (TAA), a topical corticosteroid, now available for intranasal use, has been shown to be highly effective in the treatment of both seasonal and perennial allergic rhinitis (PAR) in adults. To evaluate the efficacy and safety of TAA in children, 210 patients (ages 4 to 12 years) with PAR were randomly assigned to one of three treatment groups (placebo, TAA 82.5 micrograms/day, or TAA 165 micrograms/day). Medication was given tid over 12 weeks in a double-blind fashion. Response to medication was evaluated using symptom scoring, physician evaluation, and, in 44 patients, nasal airflow determinations by anterior rhinomanometry. The higher dose of TAA (165 micrograms/day) significantly improved rhinitis symptoms relative to placebo: the total nasal symptom score and most individual symptom scores (eg, nasal stuffiness, itch, sneezing) were significantly better, duration of rhinitis symptoms (hours per day) was significantly reduced, and nasal airflow in a subset of patients showed significant improvement. The lower dose of TAA (82.5 micrograms/day) was superior to placebo by the same parameters as the higher dose, but this improvement was not as consistently significant as the higher dose. There were no clinically significant adverse events; nasal irritation and epistaxis were rare with a similar incidence among treatment groups. In conclusion, TAA at 165 micrograms/day was effective in controlling the symptoms of PAR and in improving nasal airflow in pediatric patients; the lower dose (82.5 micrograms/day) was marginally effective. Both doses were safe and well-tolerated in the children studied.     

Treatment of Seasonal Allergic Rhinitis with Budesonide and Disodium Cromoglycate

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

Ipratropium bromide (Atrovent nasal spray) reduces the nasal response to methacholine.

We investigated the efficacy of local ipratropium bromide on methacholine-induced nasal secretions in a double-blind, placebo-controlled experiment. Twenty subjects with perennial rhinitis received a total intranasal dose of 21, 42, 84, and 168 micrograms of ipratropium bromide or placebo in each nostril. One hour later, filter paper disks were used to deliver increasing doses of methacholine and to collect secretions from the left septum. Concomitantly, symptoms of rhinorrhea and nasal congestion were scored. Compared with doses of placebo, all doses of ipratropium bromide significantly reduced the methacholine-induced increase in nasal secretion weights and symptoms of rhinorrhea (p less than 0.01). The highest dose was significantly more effective than the lower doses in reducing secretion weights (p = 0.01). We speculate that ipratropium bromide may prove beneficial for the treatment of rhinorrhea in perennial rhinitis. Furthermore, increasing the delivered dose to 168 micrograms may increase efficacy without augmenting side effects.