Jet-nebulized beclomethasone dipropionate in the management of bronchial asthma

The efficacy of jet nebulized beclomethasone dipropionate (BDP) in the management of asthma was evaluated in 18 children, 2-26 months old (mean 10 months). The children were selected on the basis of the severity of their symptoms and the lack of effect of conventional treatment. The effect of BDP was evaluated by comparing clinical data before and after the initiation of treatment. Fifteen of the 18 patients experienced a significant clinical improvement during treatment with BDP. BDP "nebulizer solution" is a valuable contribution to the management of severe asthma in young asthmatics.     

Comparison of dose-response effects of inhaled beclomethasone dipropionate and budesonide in the management of asthma

The dose-response effects of inhaled beclomethasone dipropionate (BDP) and budesonide (BUD) administered b.i.d. with the aid of metered dose aerosols were studied in 128 patients (67 men and 61 women, mean age 53 years) suffering from asthma bronchiale. The study was designed as a multi-centre, double-blind, four-period cross-over study, followed by a single-blind double placebo period. BDP was administered in doses of 400 and 1000 micrograms, and BUD in doses of 400 and 800 micrograms. The results in terms of peak expiratory flow (PEF) in the morning and evening, daily symptoms score and use of inhaled beta 2-agonists did not reveal any clinically significant differences between the drugs or between high (800 micrograms BUD, 1000 micrograms BDP) and low (400 micrograms BUD/BDP) doses. However, statistically significant differences were recorded for the corresponding parameters when comparing the placebo with preceding steroid periods. Adverse effects consisting mainly of oropharyngeal candidiasis, hoarseness and cough occurred in 54 of 468 treatment months (12%). The carry-over effects of inhaled steroids are longer lasting than was previously assumed.     

Monitoring adherence to beclomethasone in asthmatic children and adolescents through four different methods

Background:  Suboptimal adherence to inhaled steroids is a known problem in children and adolescents, even when medications are administered under parental supervision. This study aimed to verify the adherence rate to beclomethasone dipropionate (BDP) by four currently available methods.
Methods:  In this concurrent cohort study, 102 randomly selected asthmatic children and adolescents aged 3–14 years were followed for 12 months. Adherence rate was assessed every 2 months by self and/or parent report, pharmacy dispensing data, electronic device (Doser^®; Meditrack Products, Hudson, MA, USA) monitor, and canister weight.
Results:  Mean adherence rates to BDP by self and/or parent report, pharmacy records, Doser, and canister weight were 97.9% (95% CI 88.0–98.6), 70.0% (95% CI 67.6–72.4), 51.5% (95% CI 48.3–54.6), and 46.3% (95% CI 44.1–48.4), respectively. Agreement analysis between (Doser) and canister weight revealed a weighted kappa equal to 0.76 (95% CI 0.65–0.87).
Conclusions:  Adherence was a dynamic event and rates decreased progressively for all methods over the 12-month follow-up. Canister weight and electronic monitoring measures were more accurate than self/parent reports and pharmacy records. Rates obtained by these two methods were very close and statistical analysis also showed a substantial agreement between them. As measurements by canister weight are less costly compared with currently available electronic devices, it should be considered as an alternative method to assess adherence in both clinical research and practice.     

丙酸倍氯米松纳米微囊的肺内分布及清除的研究

目的研究丙酸倍氯米松（BDP）纳米微囊的肺内分布及清除特征，探讨BDP纳米微囊的肺沉积及缓释作用。方法①采用W／O／W乳化法和蒸法去溶剂法，以聚乳酸-聚乙醇酸的共聚物（PLGA）为囊材，制备BDP-PLGA纳米微囊并用扫描电镜测粒径及观察表面特征。②豚鼠雾化吸入^3H-BDP-PLGA纳米微囊，取肺组织切片，荧光显微镜下观察肺内分布。③56只昆明种小鼠随机分成2组（^3H-BDP组和^3H-BDP-PLGA纳米微囊组）。气管内给药后不同时间点取肺组织，通过液体闪烁计数器测放射性剂量。结果①BDP-PLGA纳米微囊呈表面光滑的球形，中位粒径220．4nm。豚鼠雾化吸入包有荧光素钠的纳米微囊后，下呼吸道末端及肺泡均可观察到沉积的荧光颗粒，并可维持数天。②肺内药物含量，给药后1、15min，BDP组与其PLGA纳米微囊组无统计学意义，随着时间的延长，BDP—PLGA纳米微囊组高于BDP组。结论①BDP-PLGA纳米微囊粒径小，雾化吸入后，在外周肺组织有广泛的沉积。②与原型药相比，BDP-PLGA纳米微囊在小鼠体内有良好的释药特征，随着囊壁的降解，逐步释放出药物。延长药物在肺内停留时间，在不增加剂量的情况下，更长时间发挥局部抗炎作用。     

Comparison of the effects on bronchial hyperresponsiveness of antiallergic agents and beclomethasone dipropionate in long-term bronchial asthma

The effect of antiallergic agents (DSCG (disodium cromoglycate), ketotifen, and ibudilast) and beclomethasone dipropionate inhaler (BDI) on bronchial hyperresponsiveness to histamine inhalation was retrospectively assessed in 72 asthmatic patients with more than a year's duration of the disease. Decrease in bronchial hyperresponsiveness to histamine was observed in 10 out of the 33 (30%) antiallergic-agents-treated patients (group A, mean duration = 7.8 months), in 12 of 19 (63.2%) BDI-treated patients (group B, 6.2 months), but only 2 of the 20 (10%) control patients (group C, 7.8 months). Improvement of histamine PC₂₀ was from 310 to 597 μg/ml ( P <0.01) in group A, from 308 to 1622 μg/ml ( P <0.0005) in group B, and from 575 to 525 μg/ml (NS) in group C. A significant decrease in the peripheral eosinophil count was observed only in group B. The improvement in bronchial hyperresponsiveness was parallel with that of asthmatic symptoms; the percentage of patients becoming symptom-free rose from 12 to 42%, 5 to 89%, and 5 to 20% in groups A, B, and C, respectively. Out of 11 unimproved patients in group A, 7 showed a significant improvement in their histamine PC₂₀ by BDI treatment (mean PC₂₀: 311 → 1828 μg/ml). These results suggest that BDI might be more effective than antiallergic agents in the treatment of patients with long-standing bronchial asthma.     

Oral beclomethasone dipropionate in gastrointestinal graft-versus-host disease

Beclomethasone dipropionate is a corticosteroid with topical activity for inflammatory disorders at mucosal surfaces. Oral beclomethasone dipropionate (orBec^®) has demonstrated activity in gastrointestinal acute graft-versus-host disease (aGVHD) associated with hematopoietic cell transplantation. Since the GI tract is the dominant aGVHD target in many patients, oral beclomethasone dipropionate reduces the requirement for systemic immunosuppressive drugs in treating aGVHD. In this patient population, reduced exposure to systemic corticosteroids is associated with fewer infections and, possibly, preserved graft-versus-tumor effects, yielding a statistically significant improvement in survival in a randomized, multicenter clinical trial.     

Effects of fluticasone propionate and beclomethasone dipropionate on parameters of inflammation in peripheral blood of patients with asthma

Bronchial inflammation plays a central role in asthma. We investigated whether parameters of inflammation were increased in peripheral blood. Furthermore, we tested whether fluticasone propionate (FP), a new inhaled corticosteroid (ICS), and beclomethasone dipropionate (BDP) affected these parameters. FP 750 μg/day and BDP 1500 μg/day were compared in a randomized, crossover study consisting of two 6-week treatment periods, each preceded by a 3-week placebo period. Twenty-one patients with symptomatic asthma completed the study. The results were compared with those of six normal subjects (controls). Immunophenotyping of inflammatory cells was performed in whole blood, and serum eosinophil cationic protein (ECP) was measured. With regard to clinical efficacy, ICS increased PCjo histamine by more than 1.9 doubling doses and FEV, by more than 0.34 1. The number of CD3/HLA-DR+ lymphocytes was significantly increased in asthmatics compared to the normal subjects, both after placebo (P<0.01) and after therapy (P<0.05). The CD3/HLA-DR-H lymphocytes decreased significantly after treatment with FP (P<0.05). Serum ECP was elevated in patients without ICS and decreased after treatment with BDP (P<0.001). In conclusion, the number of CD3/HLA-DR-I- lymphocytes and serum ECP levels were raised in the peripheral blood of symptomatic asthmatics, and decreased by clinically effective doses of ICS. In this respect, FP 750 ng/day was at least as effective as BDP 1500 μg/day.     

Efficacy response of inhaled beclomethasone dipropionate in asthma is proportional to dose and is improved by formulation with a new propellant

BACKGROUND: This study tested the hypothesis that there would be improved asthma control with increasing doses of beclomethasone dipropionate (BDP) formulated in hydrofluoroalkane-134a (HFA-BDP) and the standard chlorofluorocarbon propellants (CFC-BDP). Because HFA-BDP has improved lung deposition compared with CFC-BDP, this study also tested the hypothesis that HFA-BDP would provide more effective control of asthma than CFC-BDP. METHODS: In this multicenter, randomized, parallel-group blinded study, asthmatic subjects who had deterioration in asthma control after discontinuation of inhaled corticosteroids were randomized to receive one of 6 possible treatments: 100 microg/d, 400 microg/d, or 800 microg/d of HFA-BDP or 100 microg/d, 400 microg/d, or 800 microg/d of CFC-BDP for 6 weeks. Changes in spirometry, daytime asthma symptom and nighttime asthma-related sleep disturbance scores, morning and evening peak expiratory flows, and daily use of inhaled beta-agonist for symptom control on diary cards were assessed over 6 weeks of treatment. RESULTS: Three hundred twenty-three patients were randomized to the 6 treatment groups, which had similar demographics and baseline lung function. There were significantly larger changes from baseline at week 6 in FEV(1) percent predicted with increasing doses of both HFA-BDP and CFC-BDP. The FEV(1) percent predicted dose-response curve for HFA-BDP was shifted to the left compared with the dose-response curve for CFC-BDP. By using the Finney bioassay method, it was calculated that 2.6 times as much CFC-BDP would be required to achieve the same improvement in FEV(1) percent predicted as HFA-BDP (95% confidence interval, 1.1-11.6). All treatment groups except the 100 microg/d CFC-BDP group tolerated study drug well. Ten (17%) of 59 patients in this group reported an acute asthma episode, increased asthma symptoms (6 of the 8 reports of increased asthma symptoms were classified as severe), or both, and 8 patients withdrew from the study (3 for adverse events related to asthma). CONCLUSIONS: Increasing doses of inhaled corticosteroids lead to improved lung function and asthma control. Moreover, the reformulation of BDP in HFA enables effective asthma control at much lower doses than CFC-BDP.     

Comparison between sodium cromoglycate (MDI: metered-dose inhaler) and beclomethasone dipropionate (MDI) in treatment of adult patients with mild to moderate bronchial asthma A double-blind, double-dummy randomized, parallel-group study

This study compared the efficacy and tolerability of sodium cromoglycate (SC) and beclomethasone dipropionate (BDP) in adult patients with bronchial asthma inadequately treated with bronchodilators alone. The study was a double-blind, randomized, double-dummy, parallel-group study. Patients with mild to moderate symptomatic asthma, inadequately treated with bronchodilators only, were, after a 2–week run-in (base-line) period, randomized to 8 weeks of treatment with either SC 10 mg four times daily or BDP 100 μg four times daily. Salbutamol metered-dose inhaler was given as relief medication. A total of 37 patients were randomized for treatment, 19 patients in the SC group and 18 patients in the BD group. Efficacy and safety were determined by daily record card data: morning and evening peak-expiratory-flow rates (PEER), daytime and nighttime asthma symptom scores, and rescue salbutamol use. At clinic visits, FEV₁ and FVC were measured, as were the physician's and the patient's assessment of the medication at the end of the study. The safety and tolerability of the trial medication were assessed by monitoring adverse events throughout the study. A clinically and statistically significant improvement of the asthma in FEV₁, symptom scores, rescue medication, and global opinion of efficacy was observed, and both groups provided equivalent efficacy. The morning PEFR as well as the evening PEFR for both groups improved, but was statistically significant only for the BDP group (M-PEFR). Both drugs were well tolerated with only a few minor adverse events. This trial shows that SC and BDP are equally effective anti-inflammatory treatments for mild to moderate bronchial asthma in adults.     

Long-term asthma control with oral montelukast and inhaled beclomethasone for adults and children 6 years and older

BACKGROUND: Leukotriene receptor antagonists have demonstrated clinical benefits in chronic asthma studies of up to 3 months in duration. The effects of these agents over extended periods of time have not been reported. OBJECTIVE: To describe the long-term effect of oral montelukast, a potent and specific cysteinyl leukotriene receptor antagonist, compared with inhaled corticosteroids in both adult and paediatric patients with chronic asthma. METHODS: Male and female patients with chronic, stable asthma (adults aged 15-85 years, children aged 6-14 years), who had completed double-blind, placebo-controlled clinical studies, participated in three extension studies with oral montelukast taken once daily (10 mg tablet for adults, 5 mg chewable tablet for paediatric patients) or inhaled corticosteroids (beclomethasone 200 microg twice daily for adults, beclomethasone 100 microg or equivalent three times daily for children). A double-blind adult extension study was 37 weeks in duration; open-label adult extension studies were 156 (adults) and 112 (paediatric) weeks in duration. A total of 436, 374, and 245 patients entered these extension studies, respectively. RESULTS: Treatment with both montelukast and inhaled corticosteroids resulted in improvement in multiple parameters of asthma control. Improvements in daytime symptom scores were generally comparable among treatment groups. No tachyphylaxis to the effects of montelukast was evident. In the adult open-label study, however, the effect of beclomethasone on mean forced expiratory volume in 1 second (FEV1) gradually decreased from start of the study to the end of the follow-up treatment period. CONCLUSION: Both montelukast and inhaled corticosteroids were effective in controlling mild to moderate chronic asthma; the relative effectiveness of montelukast and beclomethasone were similar in open-label conditions. The hypothesis, that clinical practice conditions (e.g., adherence) may have a significant impact on the effectiveness of these therapies, should be tested in future clinical trials.     

In vitro effect of beclomethasone dipropionate and flunisolide on the mobility of human nasal cilia

Human nasal cilia were perfused with aqueous solutions of two corticosteroid aerosols, beclomethasone dipropionate (BPD) and flunisolide, with the main preservative of flunisolide, propylene glycol, and with placebo. The concentration used were BPD 0.1 mg/ml, 0.05 mg/ml, 0.005 mg/ml and 0.0005 mg/ml, flunisolide 0.25 mg/ml, 0.05 mg/ml, 0.025 mg/ml and 0.00025 mg/ml, and propylene glycol 20 mg/ml and 200 mg/ml. A dose-related decrease in ciliary beating frequency (CBF) was seen after perfusion with both BDP and flunisolide as well as propylene glycol. The decrease in CBF following perfusion with propylene glycol was partially reversible upon re-perfusion with medium alone, whereas the decrease seen after BDP and flunisolide was irreversible. Although previous studies have shown no adverse effect on the mucous membrane except for the areas hit by the impact of the sprays, our results suggest that caution should be taken when the dose and/or the length of treatment is considered, and that the effect of administration of these drugs on CBF in vivo needs to be investigated.     

Increased levels of vascular endothelial growth factor in induced sputum in asthmatic patients

BACKGROUND: Vascular endothelial growth factor (VEGF) is highly expressed in the airway of asthmatic patients. As VEGF increases airway vascular permeability, consequent thickening of the airway wall mucosa may lead to narrowing of the airway lumen. OBJECTIVE: We evaluated the relationship between VEGF levels in induced sputum and eosinophilic inflammatory profiles, and the degree of airway vascular permeability in asthmatic patients and we evaluated the effect of inhaled corticosteroids on VEGF levels in induced sputum. METHODS: Induced sputum specimens were obtained from 28 glucocorticosteroids free asthmatics and 11 healthy control subjects. We examined VEGF levels and airway vascular permeability index in induced sputum. After the initial sputum induction, 21 asthmatics received 8-week inhaled beclomethasone dipropionate (BDP, 800 micro g/day) therapy, then sputum induction was repeated. RESULTS: The VEGF levels in asthmatics were significantly higher than in healthy control subjects (P < 0.0001). The VEGF levels were negatively correlated with forced expiratory volume of 1 s (FEV1, % predicted, r = - 0.68, P < 0.001), the percentage of eosinophils (r = 0.51, P < 0.01) and ECP levels (r = 0.39, P < 0.05). Moreover, the VEGF levels were significantly correlated with airway vascular permeability index (r = 0.61, P < 0.001). After 8-week inhaled BDP therapy, the VEGF levels were significantly decreased compared to pretreatment levels (P < 0.0001) and the VEGF levels were significantly correlated with airway vascular permeability index even in post-treatment asthmatics (r = 0.62, P < 0.01). CONCLUSION: The VEGF levels in induced sputum were increased in asthmatics and its levels were associated with degree of airway narrowing and airway vascular permeability. These findings provide strong evidence that VEGF may play an important role in the pathogenesis of bronchial asthma.     

Longitudinal evaluation of bone mass in asthmatic children treated with inhaled beclomethasone dipropionate or cromolyn sodium

Inhaled corticosteroids are recommended as first-line therapy in patients with moderate to severe asthma. The use of these agents in the milder form of asthma is controversial because of their potential adverse effects, especially in growing children. We investigated 49 asthmatic children (38 treated with beclomethasone dipropionate (BDP) at a daily dose of 276 ±125 ng/day and 11 treated with cromolyn sodium (CS) at a daily dose of 30 ±10 mg/day) for 7.4 months, with bone-mass measurements at baseline and after the treatment period. Evaluation of changes in cortical and trabecular bone mass (bone mineral density [BMD]; m/cm²) was performed by absorptiometry at the proximal forearm and at the lumbar spine, respectively. Furthermore, to correct for bone size changes due to growth, we calculated volumetric BMD (VOL-BMD; mglcm³). At the end of the treatment period, the children who had received regular inhaled BDP had grown as well as children treated with CS, from 120±1.4 to 123±1.3 cm and from 118±3,2 to 120,3±2.8 cm, respectively. No children showed deviation from their percentile level of growth. Trabecular and cortical BMD increased after 7 months of follow-up in both groups to the same extent. When BMD was adjusted for body size (VOL-BMD; mg/cm²), bone mass was found not to have changed after BDP or CS treatment course within and between the two groups.     

A placebo-controlled study of fluticasone propionate aqueous nasal spray and beclomethasone dipropionate in perennial rhinitis: efficacy in allergic and non-allergic perennial rhinitis

Background: Fluticasone propionate is a new potent, topically active corticosteroid with ncgligahle oral bioavailability. Data on its comparative efficacy in perennial allergic and non-allergic rhinitis are limited. Objective: To compare the efficacy and safety of fluticasone propionate aqueous nasal spray (FPANS) 200μg once or twice daily with beclomethasone dipropionate aqueous nasal spray (BDP) 200μg twice daily and placebo in patients with allergic and nonallergic perennial rhinitis. Methods: The 12-week study had a multicenlre, double-blind, randomized, parallel group design. Efficacy was assessed from symptom scores recorded on daily diary cards. Results: FPANS 200μg once or twice daily was significantly better than placebo but not better than BDP in relieving the nasal symptoms of rhinitis. FPANS at either dose was equally effective in the treatment of allergic and non-allergic perennial rhinitis. There were few adverse events and no treatment-related abnormalities in laboratory measurements in either FPANS-treated group. Comparisons between treatment groups indicated that FPANS was as well tolerated as placebo and BDP at the doses studied. Conclusions: In the majority of patients FPANS 200μg once daily is as effective as BDP 200μg twice daily in the relief of perennial allergic rhinitis.     

Clinical efficacy of budesonide Turbuhaler® compared with that of beclomethasone dipropionate pMDI with volumatic spacer

A total of 102 patients had their asthma treatment with beclomethasone dipropionate (BDP) optimized in order to achieve the best possible control of symptoms. Thereafter, the BDP doses were gradually reduced over a 2-year period (1988–90) to the lowest possible without deterioration of their asthmatic condition. In the beginning of 1990, treatment was changed in 76 patients (group A) to the nearest possible dose of budesonide delivered via Turbuhaler® Twenty-six randomly selected patients (25% of the study population; group B) continued treatment with BDP. In both groups, dose reductions were tried during 1990–2 every third month as long as the patients remained symptom-free and without significant decreases in FEV₁ or PEF. In group A, the maintenance dose could be reduced from 1003.9 ± 325.4 μg BDP (mean ± SD) to 602.9 ± 454.4 μg budesonide Turbuhaler ( P <0.001). In group B, no significant dose reduction was possible; the mean dose was ± SD 1067.3 ± 36.6 μg in 1990, and 1019.2 ± 324.7 μg in 1992. The results indicate that, in efficacy, 0.6 mg budesonide Turbuhaler corresponds to approximately 1.0 mg BDP with volumatic spacer. This difference is probably due to an improved pulmonary delivery of budesonide with Turbuhaler.     

Comparison of roflumilast, an oral anti-inflammatory, with beclomethasone dipropionate in the treatment of persistent asthma

BACKGROUND: Roflumilast is an oral, once-daily phosphodiesterase 4 inhibitor with anti-inflammatory activity in development for the treatment of asthma. Roflumilast was compared with inhaled beclomethasone dipropionate (BDP) in patients with asthma. METHODS: In a double blind, double-dummy, randomized, noninferiority study, 499 patients (forced expiratory volume in 1 s [FEV1] = 50-85% predicted) received roflumilast 500 microg once daily or BDP 200 microg twice daily (400 microg/day) for 12 weeks. Lung function and adverse events were monitored. RESULTS: Roflumilast and BDP significantly improved FEV1 by 12% (270 +/- 30 ml) and 14% (320 +/- 30 ml), respectively (P < 0.0001 vs baseline). Roflumilast and BDP also significantly improved forced vital capacity (FVC) (P < 0.0001 vs baseline). There were no significant differences between roflumilast and BDP with regard to improvement in FEV1 and FVC. Roflumilast and BDP showed small improvements in median asthma symptom scores (-0.82 and -1.00, respectively) and reduced rescue medication use (-1.00 and -1.15 median puffs/day, respectively; P < 0.0001 vs baseline). These small differences between roflumilast and BDP were not considered clinically relevant. Both agents were well tolerated. CONCLUSIONS: Once daily, oral roflumilast 500 microg was comparable with inhaled twice-daily BDP (400 microg/day) in improving pulmonary function and asthma symptoms, and reducing rescue medication use in patients with asthma.     

Steroid-dependent asthma treated with inhaled beclomethasone dipropionate in children.

The efficacy of beclomethasone diproprionate aerosal (BDA) was studied in 27 steroid-dependent asthmatic children. In the double-blind portion of the study BDA was found to be superior to placebo. The benefits of BDA therapy were sustained through the two-year, open-label portion of the study. Adverse effects were few and minor. Transfer from oral corticosteroid therapy to BDA was carried out uneventfully and was not associated with untoward effects.     

A double-blind placebo-controlled study of the effect of inhaled beclomethasone dipropionate for 2 years in patients with nonasthmatic chronic obstructive pulmonary disease

Treatment of chronic obstructive pulmonary disease (COPD) with inhaled and oral corticosteroids is common, although their exact role is unclear. Previous studies suggest these drugs may reduce decline in lung function in this group of patients. We report a study investigating the effect of inhaled beclomethasone diproprionate (BDP) on lung function and symptoms in a group of patients with COPD. Treatment was given for 2 years, and the decline in FEV₁ in individual patients calculated over this period. Ninety-eight patients were randomized for the study, 59 completing 2 years of treatment. Patients withdrawn had more severe airflow obstruction. Decline in FEV₁, measured both prior to and after bronchodilator, was less in patients receiving inhaled BDP, although the differences failed to reach statistical significance except in a subgroup of patients with more severe airflow obstruction. Exacerbation rates were also reduced by inhaled BDP, but again the differences failed to reach conventional levels of statistical significance. The results of this study are consistent with previous published work, but further insight into the long-term role of corticosteroids in COPD await the publication of large studies which have recently been completed. Although the changes seen in this study and others are numerically small, the rate of decline in FEV₁ returned to normal levels expected from age-related decline, and hence such treatment combined with other strategies may well have a significant role in the long-term treatment of this condition.     

Effects of treatment with beclomethasone dipropionate in subpopulations of perennial rhinitis patients

The efficacy and safety of beclomethasone dipropionate (BD), 0.05 mg three times daily, sprayed in each nostril was studied in 39 adult patients with perennial rhinitis in a 12 wk, double-blind, vehicle controlled trial. Parameters of IgE-mediated reactivity, including epicutaneous skin testing, total serum IgE, specific serum IgE, and nasal eosinophilia, were assessed. All adverse reactions, including changes in serum cortisol and nasal and pharyngeal Candida infections, were monitored. Sixty-three percent of BD patients achieved total or substantial control of nasal symptoms compared with 25% of controls (p = 0.04). Eighty-three percent of BD-treated, skin test-positive patients improved, while only 14% of BD nonatopics improved (p < 0.05). All BD patients with nasal eosinophilia improved compared with 38% without eosinophilia. Adverse reactions were frequent, minor, and equal in both groups. Serum cortisols were stable and no nasal Candida infections were documented. This study demonstrates the efficacy and safety of BD in treatment of perennial rhinitis, particularly in atopic patients with nasal eosinophilia.     

High-dose inhaled steroids in the management of asthma A comparison of the effects of budesonide and beclomethasone dipropionate on pulmonary function, symptoms, bronchial responsiveness and the adrenal function

Svendsen UG, Frølund L, Heinig JH, Madsen F, Nielsen NH, Weeke B. High-dose inhaled steroids in the management of asthma. A comparison of the effects of budesonide and beclomethasone dipropionate on pulmonary function, symptoms, bronchial responsiveness and the adrenal function.
The efficacy of budesonide (800 μg b.d.) and beclomethasone dipropionate (750 μg b.d.) in controlling the symptoms of asthma, pulmonary function, bronchial responsiveness to histamine, and adrenal function, was assessed in a double-blind, double-dummy cross-over study of 36 adult chronic asthmatic patients. The patients, the majority of whom were assessed to be affected to a severe degree, were insufficiently controlled in their current regimen of inhaled steroids and/or inhaled and oral bronchodilators. A 2 weeks baseline period preceded 6 weeks of treatment with each of the study drugs. Both treatment groups showed improvements from baseline in clinical assessment of lung function carried out after the first 6 weeks of treatment. No significant differences were seen throughout the entire 12 weeks study, when comparing the effects of the treatments on FEV₁ FVC, PEF or the histamine PC₂₀. Asthma severity, symptom score and inhaled bronchodilator use showed the same results after both treatments. It is concluded that inhalations of budesonide and beclomethasone dipropionate in high doses are equally potent in the treatment of severe asthma. There is no significant influence on the adrenal function and no significant side effects during a period equal to that of the present study.