Beclomethasone Dipropionate Nasal Aerosol Research Articles

Beclomethasone Dipropionate Nasal Aerosol in Patients with Perennial Allergic Rhinitis (BALANCE) study: 6-month results.

Perennial allergic rhinitis (PAR) exerts significant quality-of-life and economic burdens on society. Beclomethasone dipropionate (BDP) nasal aerosol is the first nonaqueous, hydrofluoroalkane-propelled intranasal corticosteroid approved for patients in the United States to treat PAR and seasonal allergic rhinitis. To evaluate real-world effectiveness of BDP nasal aerosol from the patient's perspective by using a postmarketing observational registry. Patients (N = 824) from 43 U.S. study sites completed monthly patient-reported outcome instruments, including the Rhinitis Control Assessment Test (primary outcome variable), Treatment Satisfaction Questionnaire for Medication, Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Allergy-Specific, Pittsburgh Sleep Quality Index, and Mini Rhinoconjunctivitis Quality of Life Questionnaire for 6 months. The primary outcome assessment (Rhinitis Control Assessment Test score) (N = 527) indicated significant symptomatic improvement over baseline beginning at month 1 (p < 0.001), with >78.8% of respondents who achieved clinically meaningful improvement over 6 months. Secondary outcome measures Mini Rhinoconjunctivitis Quality of Life Questionnaire (p < 0.001), Pittsburgh Sleep Quality Index (p < 0.001), and Treatment Satisfaction Questionnaire for Medication-9 scales of effectiveness (p < 0.001), global satisfaction (p = 0.001), and patient-rated convenience (p = 0.03), significantly increased from baseline to month 6. Five of seven measurements of the Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Allergy-Specific, with the exception of work time missed and class time missed, were significantly (p < 0.001) improved in patients treated with BDP compared with baseline. Treatment with nonaqueous BDP nasal aerosol in a real-world setting significantly improved PAR symptoms and measures of quality of life, work, and school-related activities, and is associated with high patient satisfaction, reduced productivity loss and activity impairment, and improvement in sleep quality.

No hypothalamic-pituitary-adrenal function effect with beclomethasone dipropionate nasal aerosol, based on 24-hour serum cortisol in pediatric allergic rhinitis

BackgroundIntranasal corticosteroids are the mainstay of allergic rhinitis (AR) treatment. Their potential to suppress the hypothalamic-pituitary-adrenal axis should be evaluated, especially after long-term daily use in children. ObjectiveTo evaluate the effects of treatment with non-aqueous beclomethasone dipropionate (BDP) nasal aerosol on hypothalamic-pituitary-adrenal axis function in children with perennial AR. MethodsIn this double-blinded, placebo-controlled, parallel-group study, patients (6–11 years old) with perennial AR were randomized (2:1) to BDP nasal aerosol at 80 μg/day (n = 67) or placebo (n = 32). The primary end point was change from baseline in 24-hour serum cortisol (SC) weighted mean for BDP nasal aerosol and placebo after 6 weeks of treatment, which was analyzed in the per-protocol population. ResultsThe per-protocol population included 97 patients (BDP nasal aerosol, n = 66; placebo, n = 31). Baseline geometric mean SC weighted mean values were similar in the 80-μg/day BDP nasal aerosol and placebo groups (5.97 and 6.47 μg/dL, respectively). After 6 weeks’ treatment, geometric mean values were 6.19 and 7.13 μg/dL, respectively, with no decrease from baseline in either group. Geometric mean SC ratio of BDP nasal aerosol at 80 μg/day to placebo was 0.91 (95% confidence interval 0.81–1.03), indicating predefined noninferiority. SC concentration-time profiles were similar for the placebo and 80-μg/day BDP nasal aerosol groups at baseline and week 6. BDP nasal aerosol at 80 μg/day was generally well tolerated. ConclusionIn pediatric patients with perennial AR, 24-hour SC profiles were comparable for BDP nasal aerosol and placebo, indicating that once-daily BDP nasal aerosol treatment did not significantly affect hypothalamic-pituitary-adrenal axis function. Trial RegistrationClinicalTrials.gov; NCT01697956.

Efficacy and safety of beclomethasone dipropionate nasal aerosol in children with perennial allergic rhinitis

BackgroundBeclomethasone dipropionate (BDP) nasal aerosol (non-aqueous) is approved for management of seasonal and perennial allergic rhinitis (PAR) in adolescents and adults. ObjectiveTo evaluate the efficacy and safety of BDP nasal aerosol at 80 μg/day in children with PAR. MethodsThis 12-week, phase 3, double-blinded, placebo-controlled, parallel-group study randomized 547 children (4–11 years old) with PAR to once-daily BDP nasal aerosol at 80 μg/day or placebo. The primary end point was change from baseline in average morning and evening reflective total nasal symptom score (rTNSS) during the first 6 weeks of treatment in patients 6 to 11 years old. Changes from baseline in average morning and evening instantaneous TNSS (iTNSS) in children 6 to 11 years old and average rTNSS and iTNSS in children 4 to 11 years old were assessed during the first 6 weeks of treatment. ResultsImprovements were significantly greater with BDP nasal aerosol than with placebo during the first 6 weeks of treatment in children 6 to 11 years old in average morning and evening rTNSS and iTNSS (mean treatment difference −0.66 [P = .002] and −0.58 [P = .004], respectively). Improvements in average morning and evening rTNSS and iTNSS also were significantly greater in patients 4 to 11 years receiving BDP nasal aerosol than with placebo during the first 6 weeks of treatment (P = .002 and P = .004, respectively). Similar improvements were seen during 12 weeks of treatment. The safety profile of BDP nasal aerosol was comparable to that of placebo. ConclusionThe BDP nasal aerosol at 80 μg/day in children 4 to 11 years old was well tolerated and effective in controlling nasal symptoms of PAR. Trial Registrationwww.clinicaltrials.gov, identifier NCT01783548.

Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol Is Effective in Improving Total Nasal Symptom Scores (TNSS) in Children with Perennial Allergic Rhinitis (PAR) Regardless of Baseline Symptom Severity

Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol Is Effective in Improving Total Nasal Symptom Scores (TNSS) in Children with Perennial Allergic Rhinitis (PAR) Regardless of Baseline Symptom Severity

Once-Daily Treatment with Beclomethasone Dipropionate (BDP) Nasal Aerosol Is Effective in Improving Total Nasal Symptom Scores (TNSS) in Children with Seasonal Allergic Rhinitis (SAR) Regardless of Baseline Symptom Severity

Once-Daily Treatment with Beclomethasone Dipropionate (BDP) Nasal Aerosol Is Effective in Improving Total Nasal Symptom Scores (TNSS) in Children with Seasonal Allergic Rhinitis (SAR) Regardless of Baseline Symptom Severity

Patient satisfaction with beclomethasone dipropionate nasal aerosol device with integrated dose counter during daily use

Some patients with allergic rhinitis (AR) may prefer a "dry" intranasal corticosteroid aerosol to avoid certain sensory perceptions such as the "wet feeling in the nose" and the "dripping down the throat" associated with aqueous nasal sprays. A nonaqueous hydrofluoroalkane-propelled beclomethasone dipropionate (BDP) nasal aerosol with an established efficacy and safety profile was approved to treat the nasal symptoms associated with AR in adult and adolescent patients. This study was designed to evaluate ease of use and patient satisfaction with the BDP nasal aerosol device in patients with perennial AR (PAR). In this phase 3, randomized, double-blind, parallel-group, placebo-controlled study, eligible patients (≥12 years of age) with PAR were randomly assigned to receive BDP nasal aerosol at 320 micrograms/day or placebo for 6 weeks. At the end of the treatment period, patients assessed device ease of use and satisfaction with the device using a questionnaire with a 5-point representative scale (not at all, not very, neither nor, somewhat, very [certain/easy/satisfactory]). Nearly all patients (89.7%) reported that the BDP nasal aerosol device with integrated dose counter was "very easy" or "somewhat easy" to use. The majority of patients (87.5%) also indicated that it was "very easy" or "somewhat easy" to tell when the device was empty, compared with only 42.3% who were "very certain" or "somewhat certain" of being able to tell when previously used aqueous nasal spray devices were empty. Overall, patient satisfaction with the BDP nasal aerosol device was high: 65.7% responded that they were "very satisfied" or "somewhat satisfied" and only 3.6% were "not satisfied at all" or "not very satisfied." These results indicate that the majority of patients considered the BDP nasal aerosol device easy to use and reported a high degree of satisfaction with the device compared with other nasal sprays they had used in the past.

Beclomethasone dipropionate nasal aerosol with an integrated dose counter: Functionality and performance

Consistent medication delivery is critical for disease control including symptom management of allergic rhinitis (AR). Available aqueous intranasal corticosteroid devices lack an accurate dose (actuation) counter, which may lead patients to prematurely discard a unit or use a unit beyond its labeled number of actuations, therefore impacting patient adherence. Beclomethasone dipropionate (BDP) nasal aerosol, a nonaqueous hydrofluoroalkane formulation in a device with a novel integrated dose counter and an established efficacy/safety profile, was approved to treat AR-associated nasal symptoms in adolescent and adult patients. This study was designed to evaluate performance of the BDP nasal aerosol device with an integrated dose counter in perennial AR (PAR) patients. In a 6-week, double-blind, placebo-controlled study in PAR patients (≥12 years), patients were randomized to receive once-daily BDP nasal aerosol at 320 micrograms or placebo. In addition to assessing the primary efficacy end point, patients evaluated the performance of the device and reliability, accuracy, and functionality of the dose counter. Concordance between daily patient-reported actuations and dose counter readings was assessed by classifying discrepancies into four categories: "fire not count," "count not fire," "count unknown fire," and "count up unknown fire." Analysis was performed for the total device completer population (n = 374), which included all randomized patients completing ≥80% of actuations during the last 4 weeks of treatment. Low discrepancy rates were shown for all discrepancy categories. Of 41,891 patient-reported actuations, only 159 discrepancies (diary versus counter) were noted, resulting in an overall discrepancy rate of 0.38 per 100 actuations. The medically important discrepancy rate of "fire not count" was low (0.09 per 100 actuations). Overall, 79.1% of patients reported zero discrepancies, 9.4% reported one discrepancy, and 6.4% reported two discrepancies. These results showed the functionality and reliability of the BDP nasal aerosol device with an integrated dose counter in a clinical setting. (ClinicalTrials.gov identifier: NCT01134705.).

Efficacy and safety of beclomethasone dipropionate nasal aerosol in pediatric patients with seasonal allergic rhinitis

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

Efficacy, safety, and optimal dose selection of beclomethasone dipropionate nasal aerosol for seasonal allergic rhinitis in adolescents and adults

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

Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol Provides Long-Term and Sustained 24-Hour Nasal Symptom Relief in Patients with Perennial Allergic Rhinitis

Patients with perennial allergic rhinitis (PAR) suffer from nasal symptoms requiring year-round treatment. Symptoms are often most severe in the morning, making 24-hour duration of effect a critical component of once-daily treatments. This study assessed the 24-hour duration of nasal symptom relief following treatment with a nonaqueous, hydrofluoroalkane-propelled aerosol formulation of beclomethasone dipropionate (BDP nasal aerosol). In this double-blind, placebo-controlled study, eligible patients (≥12 years of age) were randomly assigned 4:1 to once-daily treatment with BDP nasal aerosol 320 μg or placebo. The primary efficacy measure was patient-reported 24-hour reflective total nasal symptom score (rTNSS) over the first 30 weeks (previously reported). Weekly averages of patient-reported am instantaneous TNSS (iTNSS) over the entire 52-week treatment period were also assessed and reported here. BDP nasal aerosol resulted in greater improvements in weekly patient-reported am iTNSS compared with placebo from week 1, which were maintained through 52 weeks of treatment. The least-square mean treatment differences from placebo for BDP nasal aerosol ranged from a minimum of –0.60 (P<0.001) at week 1 to a maximum of –1.33 (P=0.005) at week 40, and the effect was maintained to week 52 (–1.15; P=0.019). BDP nasal aerosol was well tolerated during long-term treatment, and the overall safety profile was comparable to that of placebo. The clinically meaningful improvements in morning instantaneous total nasal symptom score reported in this 52-week study support both the 24-hour and long-term sustained efficacy of once-daily BDP nasal aerosol 320 μg for the treatment of PAR.

Improvement of Nasal Congestion and Sleep Quality Following Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol in Patients with Seasonal Allergic Rhinitis

Improvement of Nasal Congestion and Sleep Quality Following Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol in Patients with Seasonal Allergic Rhinitis

Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol Effectively Improves the Symptom of Itchy Ear or Palate Associated with Seasonal Allergic Rhinitis

Intranasal corticosteroids relieve nasal and ocular symptoms associated with seasonal allergic rhinitis (SAR); however, their effects on other bothersome symptoms such as itching of ears/palate have not been extensively evaluated. The effect of beclomethasone dipropionate (BDP) nasal aerosol treatment on relief of itching of ears/palate in patients with SAR is reported here.

Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol 320 μg Provides 24-Hour Nasal Symptom Relief in Patients with Seasonal Allergic Rhinitis

Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol 320 μg Provides 24-Hour Nasal Symptom Relief in Patients with Seasonal Allergic Rhinitis

Once-daily treatment with beclomethasone dipropionate nasal aerosol does not affect hypothalamic-pituitary-adrenal axis function

BackgroundIntranasal corticosteroids are effective in controlling allergic rhinitis (AR) symptoms; however, chronic administration of corticosteroids may suppress hypothalamic-pituitary-adrenal (HPA)-axis function. ObjectiveTo evaluate the effects of 6 weeks of treatment with beclomethasone dipropionate (BDP) hydrofluoroalkane nasal aerosol on HPA-axis function in subjects with perennial AR (PAR). MethodsIn this randomized, double-blind, placebo- and active-controlled study, subjects aged 12 to 45 years were randomized to receive BDP nasal aerosol 320 μg/day (n = 50), placebo (n = 46), or placebo/prednisone (prednisone 10 mg/day for the last 7 days of the treatment period [n = 11]). The primary end point was change from baseline in 24-hour serum cortisol (SC) weighted mean (expressed as geometric mean ratio [GMR]) in the BDP and placebo group after 6 weeks of treatment. ResultsGeometric SC-weighted mean values were similar in the BDP and placebo groups at baseline (9.04 and 8.45 μg/dL, respectively) and after 6 weeks (8.18 and 8.01 μg/dL, respectively). After 6 weeks of treatment, BDP was noninferior to placebo with respect to the ratio from baseline in SC-weighted mean (GMR: 0.96 [95% CI: 0.87, 1.06]). In contrast, 7 days of prednisone treatment substantially reduced geometric SC-weighted mean values from baseline (approximate 3-fold reduction [from 7.33 to 2.31 μg/dL]) compared with placebo. BDP nasal aerosol was well tolerated, and the safety profile was similar to that of placebo. ConclusionTreatment with BDP nasal aerosol, 320 μg once daily, was not associated with HPA-axis suppression in adolescent and adult subjects with PAR. Trial RegistrationClinicaltrials.gov Identifier: NCT01133626.

Efficacy and safety of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with seasonal allergic rhinitis

An aerosol formulation may be preferred by some allergic rhinitis (AR) patients, to avoid the "wet feeling" and nasal runoff associated with aqueous nasal corticosteroid sprays. Beclomethasone dipropionate (BDP) hydrofluoroalkane nasal aerosol is a recently developed, nonaqueous, nonchlorofluorocarbon formulation of BDP for the treatment of AR. This study was designed to evaluate the efficacy, safety, and quality-of-life benefits of BDP nasal aerosol in subjects with seasonal AR (SAR). Eligible subjects (≥12 years of age) enrolled in this 2-week study were randomized to either BDP nasal aerosol at 320 μg/day (n = 169) or placebo (n = 171). Efficacy assessments included reflective and instantaneous total nasal symptom scores (rTNSS and iTNSS, respectively), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, reflective and instantaneous total ocular symptom scores (rTOSS and iTOSS, respectively), and physician-assessed total nasal symptom score (PNSS). Safety and tolerability were also assessed. Subjects receiving BDP nasal aerosol showed a significantly greater improvement from baseline in average A.M. and P.M. rTNSS versus placebo (treatment difference, -0.91; 95% confidence interval, -1.3, -0.5; p < 0.001) over 2 weeks of treatment. Greater improvements in rTNSS with BDP nasal aerosol compared with placebo were evident by day 2 and were maintained throughout the treatment period. Similarly, significant improvements were seen with BDP nasal aerosol in iTNSS (p < 0.001) and RQLQ score (p = 0.005) compared with placebo. Treatment with BDP nasal aerosol also resulted in greater improvements in rTOSS (p = 0.002), iTOSS (p = 0.003), and PNSS (p < 0.001) relative to placebo. BDP nasal aerosol was well tolerated and the overall safety profile was similar to placebo. Results from this clinical study indicated that BDP nasal aerosol provided significant AR symptom relief and was well tolerated in patients with SAR with an overall safety profile similar to placebo. Clinicaltrials.gov identifier: NCT01024608.

Safety and efficacy of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with perennial allergic rhinitis

Intranasal corticosteroids are recommended as first-line therapy for the treatment of the symptoms of persistent allergic rhinitis (AR). Since the phase-out of chlorofluorocarbon nasal aerosols, intranasal corticosteroids have been available only as aqueous nasal sprays. This study was designed to assess the efficacy, safety, and quality-of-life benefits of beclomethasone dipropionate (BDP) hydrofluoroalkane nasal aerosol in subjects with perennial AR (PAR). After a 7- to 21-day placebo run-in period, eligible subjects aged ≥12 years with PAR were randomized to 6 weeks of once-daily treatment with BDP nasal aerosol at 320 μg or placebo. Reflective and instantaneous total nasal symptom scores (rTNSS and iTNSS, respectively), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, and physician-assessed total nasal symptom score were evaluated. The primary end point was change from baseline in average morning (A.M.) and evening (P.M.) subject-reported rTNSS over the 6-week treatment period. Safety and tolerability were also assessed. Treatment with BDP nasal aerosol showed significantly greater improvement in average A.M. and P.M. rTNSS compared with placebo (mean treatment difference, -0.84; 95% confidence interval, -1.2, -0.5; p < 0.001). Greater improvements in rTNSS were reported as early as day 1 and were maintained throughout the 6-week treatment period with the exception of day 2. Greater improvements were seen for all four individual nasal symptoms (nasal congestion, nasal itching, rhinorrhea, and sneezing) with BDP nasal aerosol compared with placebo. Similarly, significant improvements were seen in average A.M. and P.M. iTNSS (p < 0.001) and RQLQ score (p = 0.001) with BDP nasal aerosol compared with placebo. In addition, BDP nasal aerosol treatment was well tolerated, and its safety profile was comparable to that of placebo. This clinical study indicated that treatment with BDP nasal aerosol provides statistically significant and clinically meaningful nasal symptom relief accompanied by improved quality of life in subjects with PAR. Additionally, treatment with BDP nasal aerosol was well tolerated with a safety profile comparable to that of placebo. This study was part of the clinical trial NCT01134705 registered in www.ClinicalTrials.gov.

Efficacy and safety of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with seasonal allergic rhinitis

Efficacy and safety of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with seasonal allergic rhinitis

Multicentric study of beclomethasone dipropionate nasal aerosol in adults with seasonal allergic rhinitis

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