IgE and the allergy-asthma connection in the 23-year follow-up of Brown University students.

The Hygiene Hypothesis helps to explain the increased epidemiology of atopy, especially asthma and hay fever. This hypothesis depends on two major immunological pathways, the Th1 and the Th2 pathways, which are mutually inhibitory, with the Th2 pathway being the dominant one in fetal life and the newborn. The Th1 leads to a cellular delayed hypersensitive response while the Th2 pathway leads to increased IgE, eosinophilia, atopy, and airway/hyperresponsiveness. The ever-increasing vaccines for immunization against viral and bacterial microorganisms together with better public health hygiene procedures introduce a bias in favor of the inhibition of the Th1 pathway, thereby allowing the Th2 pathway, with its IgE hypersensitivity, to predominate. We have attempted to correlate this new hypothesis with data from our Brown University college student longitudinal study. In this study, our data have demonstrated that allergen sensitization (positive pollen skin tests reactions) leads to an increased risk factor for developing asthma. Most of our asthmatic patients in our longitudinal study had positive allergy skin tests. Also, students born in months with high concentrations of atmospheric ragweed pollen had an increased risk of developing sensitization to ragweed and later to develop hay fever, which may lead to asthma. There is a strong association of asthma with hay fever (a classic IgE disease). Also, hay fever patients have three times the risk for developing asthma than controls. There appear to be several factors needed to express the phenotype of allergic asthma: elevated IgE, eosinophilia, airway hyperresponsiveness, exposure to allergens, and the predominance of the Th2 pathway of immunologic reactions.

Natural history of asthma: a 23-year followup of college students.

OBJECTIVE: A 23-year followup study of 1,601 college students who were initially evaluated for evidence of asthma and allergic rhinitis by direct interviews, physical examination, laboratory tests, and repeated questionnaires was conducted. METHODS AND RESULTS: The individuals were located through addresses from the alumnae office. Of these, 1,021 (64%) returned their completed questionnaires and these included 738 (72%) who had allergy skin tests as freshmen. A similar proportion of our total population of 1,021 were skin tested as freshmen compared with the original study population of 1,836 in the freshmen year (72% versus 68%). This difference was not statistically significant. Among these 738 alumnae, with a mean age of 40 years, there were a total of 84 with a history of asthma. At the time of the 23-year followup, 44 (52%) were considered to have active asthma and 40 (48%) were symptom free. A majority (85%) of those with inactive asthma were symptom free for 5 years or longer. Of those with active asthma, 50% felt they were improved, 39% unchanged, 9% felt worse, and 2% were unknown. Atopy was a non-prognostic indicator of asthma outcome as determined by scratch skin testing as college freshmen. New asthma occurred in 36 (5.2%) of those at risk to develop new asthma in this 23-year period for a rate of 0.23% per year. CONCLUSION: This 23-year followup study demonstrates that the cumulative prevalence of asthma continues to increase as the individuals become older. The asthma symptoms were no longer present or were improved in about three-fourths of the asthma subjects in this 40-year-old age group. Of the remainder, most symptoms were unchanged and a small number felt worse.

The course of asthma parallels that of allergic rhinitis: a 23-year follow-up study of college students.

The purpose of this study is to examine the relationship between the course of asthma and allergic rhinitis among former Brown University students who were diagnosed with these diseases either before or after their freshman year of 1962 or 1963. A total of 738 former students, who were evaluated and underwent skin testing during their freshman year, completed a 23-year follow-up questionnaire inquiring of their history of allergies and asthma and are the focus of this study. The activity of asthma as related to the course of allergic rhinitis (hay fever and/or nonseasonal allergic rhinitis) was examined. Among 44 asthmatic subjects with purely seasonal allergic rhinitis (hay fever and no history of nonseasonal allergic rhinitis), asthma was active in 75% of those with worse hay fever, 70% of those with unchanged hay fever, 50% of those with better (but not symptom-free) hay fever, and 10% of those with symptom-free hay fever. The resolution of asthma symptoms correlated significantly with improvement in hay fever (p = 0.0053). Among 70 asthmatics with any form of allergic rhinitis (hay fever and/or nonseasonal allergic rhinitis), asthma was active in 75.0% of those with worse allergic rhinitis, 66.7% of those with unchanged allergic rhinitis, 53.3% of those with better (but not symptom-free) allergic rhinitis, and 20.0% of those with symptom-free allergic rhinitis. The resolution of asthma symptoms correlated significantly with improvement in allergic rhinitis (p = 0.0052). The activity of allergic rhinitis as related to the course of asthma was also examined. Among 44 asthmatic subjects with purely seasonal allergic rhinitis (hay fever and no history of nonseasonal allergic rhinitis), hay fever was active in 100% of those with worse asthma, 100% of those with unchanged asthma, 90.9% of those with better (but not symptom-free) asthma, and 60.9% of those with symptom-free asthma. The resolution of hay fever symptoms correlated significantly with improvement in asthma (p = 0.0109). Among 71 asthmatic subjects with any form of allergic rhinitis (hay fever and/or nonseasonal allergic rhinitis), allergic rhinitis was active in 91.9% of those with active asthma and 64.7% of those with symptom-free asthma. The resolution of allergic rhinitis symptoms correlated significantly with improvement in asthma (p = 0.0078). In summary, among individuals with asthma and allergic rhinitis, improvement of allergic rhinitis was associated with a resolution of asthma symptoms, whereas a worsening of allergic rhinitis was associated with the persistence of asthma symptoms. Likewise, among asthmatic subjects with allergic rhinitis, improvement of asthma was associated with a resolution of allergic rhinitis symptoms, whereas a worsening of asthma was associated with the persistence of allergic rhinitis symptoms.

Dose-ranging study of a new steroid for asthma: mometasone furoate dry powder inhaler.

A new formulation of mometasone furoate (MF) for administration by dry powder inhaler (DPI) was evaluated for the treatment of asthma. A 12-week, double-blind, placebo-controlled dose-ranging study compared the efficacy and safety of three doses of MF DPI (100, 200 and 400 mcg b.i.d) with beclomethasone dipropionate (BDP) 168 mcg b.i.d. administered by metered dose inhaler in 365 adult or adolescent patients being treated with inhaled glucocorticoids. The mean change from baseline to endpoint (last treatment visit) for forced expiratory volume in 1 sec (FEV1) was the primary efficacy variable. Secondary efficacy variables included other objective measures of pulmonary function [forced vital capacity (FVC), forced expiratory flow 25-75% (FEV25-75%.) and peak expiratory flow rate (PEFR)] as well as subjective measures of therapeutic response (patients' daily evaluation of asthma symptoms and physicians' evaluation). At endpoint, all four active treatments were significantly more effective than placebo (P < 0.01) in improving FEV1 (MF DPI 5 to 7%, BDP 3%, placebo -6.6%) and all other measures of pulmonary function (FVC: MF DPI 4 to 5%, BDP 2%, placebo -4.7%; FEF25-75%: MF DPI 6 to 18%, BDP 7.5%, placebo -9.5%; PEFR (AM): MF DPI 5 to 10%, BDP 5.7%, placebo -7%). A consistent trend was observed for better improvement in patients treated with MF DPI 200 mcg b.i.d. than with MF DPI 100 mcg b.i.d., with no apparent additional benefit of MF DPI 400 mcg b.i.d. Results for the MF DPI 100 mcg b.i.d. and BDP 168 mcg b.i.d. treatment groups were similar. Patients' and physicians' subjective evaluations of symptoms found similar improvement in the MF DPI 200 and 400 mcg b.i.d. treatment groups, which were slightly better than that in the MF DPI 100 mcg b.i.d. group. Symptoms tended to worsen in the placebo group. MF DPI was well tolerated at all dose levels and the most frequently reported treatment-related adverse effects were headache, pharyngitis and oral candidiasis. No evidence of HPA-axis suppression was detected in any treatment group. In summary, all doses of MF DPI were well tolerated and significantly improved lung function and MF DPI 400 mcg (200 mcg b.i.d.) was the optimal dose in this study of patients with moderate persistent asthma.

Comparison of cefuroxime axetil and amoxicillin/clavulanate in the treatment of acute bacterial sinusitis.

This double-masked, multicenter, randomized clinical trial compared the efficacy and tolerability of cefuroxime axetil and amoxicillin/clavulanate in the treatment of acute bacterial maxillary sinusitis. A total of 263 patients with acute bacterial maxillary sinusitis were randomly assigned to receive 10 days of treatment with either cefuroxime axetil 250 mg twice daily (n = 132) or amoxicillin/clavulanate 500/125 mg 3 times daily (n = 131). Patients' responses to treatment were assessed once during treatment (6 to 8 days after the start of treatment), at the end of treatment (1 to 3 days posttreatment), and at follow-up (26 to 30 days after cessation of treatment). Clinical success, defined as cure or improvement, was equivalent in the cefuroxime axetil and amoxicillin/ clavulanate groups at the end-of-treatment and follow-up assessments. Patients in both groups showed improvements in symptoms of acute sinusitis at the during-treatment visit. Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related adverse events than treatment with cefuroxime axetil (29% vs 17%), primarily reflecting a higher incidence of gastrointestinal adverse events (23% vs 11%), particularly diarrhea. Two patients in the cefuroxime axetil group and 8 patients in the amoxicillin/clavulanate group withdrew from the study due to adverse events (P = 0.06). These results indicate that cefuroxime axetil 250 mg twice daily is as effective as amoxicillin/clavulanate 500 mg 3 times daily in the treatment of acute sinusitis and produces fewer gastrointestinal adverse events. cefuroxime axetil, amoxicillin/clavulanate, acute sinusitis.

Ipratropium bromide nasal spray 0.03% and beclomethasone nasal spray alone and in combination for the treatment of rhinorrhea in perennial rhinitis.

BACKGROUND: Perennial rhinitis is a common condition that affects up to 10% to 20% of the population. Multiple agents are frequently administered since no single agent provides complete relief. Studies assessing the benefit/risk of combined therapy are important especially for newly approved agents such as ipratropium bromide nasal spray 0.03%, a topical anticholinergic agent, approved specifically for the treatment of rhinorrhea in allergic and non-allergic perennial rhinitis. OBJECTIVE: To compare the efficacy and safety of the combined use of ipratropium bromide nasal spray 0.03% (42 microg per nostril tid) and beclomethasone dipropionate nasal spray (84 microg per nostril bid) against that of either active agent alone for the treatment of rhinorrhea. DESIGN: Multicenter, 6-week, double-blind, randomized active- and placebo-controlled, parallel trial. SETTING: Allergist and general practitioner clinical practices. PATIENTS: Five hundred thirty-three patients with perennial rhinitis (279 allergic and 274 non-allergic), 8 to 75 years of age, who had at least a mild degree of severity of rhinorrhea for a minimum of 2 hours per day during the 1 week screening period as well as congestion or sneezing also of at least mild severity. INTERVENTION: Either (1) ipratropium bromide nasal spray 0.03% (42 microg per nostril tid) plus beclomethasone dipropionate nasal spray (84 microg per nostril bid), (2) ipratropium bromide nasal spray 0.03% (42 microg per nostril tid) alone, (3) beclomethasone dipropionate nasal spray (84 microg per nostril bid) alone, or (4) vehicle [matching placebo nasal spray for the ipratropium bromide (2 sprays per nostril tid)] or beclomethasone dipropionate (2 sprays per nostril bid). MAIN OUTCOME MEASURE: Severity and duration of rhinorrhea, and patient and physician global assessment of control of rhinorrhea. RESULTS: Ipratropium bromide nasal spray plus beclomethasone nasal spray was more effective than either active agent alone or vehicle in reducing the average severity and duration of rhinorrhea during 4 weeks of treatment. The advantage of ipratropium bromide plus beclomethasone nasal spray was evident by the first day of combined treatment and continued throughout the 2-week treatment period. Ipratropium bromide nasal spray had a faster onset of action during the first week of treatment and reduced the duration of rhinorrhea more than beclomethasone. Beclomethasone nasal spray was more effective in reducing the severity of congestion and sneezing than ipratropium. In patients who had not responded well to a nasal steroid prior to participation in the study based on a questionnaire administered at screening, ipratropium bromide was as effective in the steroid non-responders as steroid responders, whereas beclomethasone was more effective in steroid responders. Combined active therapy was well tolerated with no increase in adverse events over that seen previously with ipratropium bromide or beclomethasone nasal spray alone. CONCLUSIONS: The combined use of ipratropium bromide nasal spray with beclomethasone dipropionate nasal spray is more effective than either active agent for the treatment of rhinorrhea, and does not result in a potentiation of adverse drug reactions. Ipratropium bromide nasal spray 0.03% alone should be considered in patients for whom rhinorrhea is the primary symptom, and its use in combination with a nasal steroid should be considered in patients where rhinorrhea is one of the predominant symptoms, or in patients with rhinorrhea not fully responsive to other therapy.

Natural history of hay fever: a 23-year follow-up of college students.

The purpose of this study is to examine the natural history of hay fever among former college students who were diagnosed with this disease either before or after their freshman year. The diagnosis of hay fever or seasonal allergic rhinitis was based on a history of watery, itchy eyes, rhinorrhea, and sneezing occurring for at least 2 consecutive years during the same seasonal period. A total of 738 former Brown University students (69% males and 31% females) who were evaluated and underwent skin testing during their freshman year completed a 23-year follow-up questionnaire inquiring of their history of allergies and asthma. The mean age of this group at the time of the follow-up study was 40 years. During the 23 years subsequent to the original study, 131 developed new hay fever in addition to the 175 who had hay fever as college freshman, totaling 306. At the time of the 23-year follow-up, improvement was noted by 84.8% (28/33) of those with hay fever onset 1-5 years, 63.6% (56/88) of those with onset 6-12 years, 55.6% (40/72) of those with onset 13-19 years, and 38.7% (41/106) of those with onset 20 years and older. Among those with an unknown age of onset, 42.9% (3/7) reported improvement of hay fever symptoms. The trend of increasing percentage of improvement with younger age of onset of hay fever is of statistical significance (p value of < 0.0001) using the chi-squared test for trend. A total of 54.9% (168/306) had noted improvement, of which 22.9% (70/306) reported being symptom free and 32.0% (98/306) reported being better but not symptom free. Of the remaining 45.1% (138/306), the hay fever was unchanged in 33.3% (102/306), worsened in 9.2% (28/306), and unknown in 2.6% (8/306). This study suggests that over a long period of time, hay fever symptoms will improve in the majority of individuals.

Intranasal budesonide aqueous pump spray (Rhinocort Aqua) for the treatment of seasonal allergic rhinitis. Rhinocort Aqua Study Group.

To determine the relative efficacy, compare the incidence of adverse events, and ascertain the systemic glucocorticoid effect of the nasal application of several doses of budesonide, 406 patients with seasonal ragweed-induced allergic rhinitis were randomized in a double-blind, parallel group design to receive intranasal budesonide aqueous pump spray (Rhinocort Aqua) 32 micrograms, 64 micrograms, 128 micrograms, 256 micrograms, or placebo once daily for 4 weeks. A total of 231 adults and 175 children participated in the study conducted at 14 centers in two geographic regions, the Midwest and the Northeast United States, during the 1994 ragweed season. Pollen counts were collected at each site by the Rotorod method. The primary efficacy parameter was the change from baseline nasal index score (NIS) for the overall study population--defined as the sum of scores for nasal congestion, runny nose, and sneezing. The study was powered only to evaluate the overall study population for statistical significance. Significant differences in NIS were observed in each active treatment group compared with placebo (p < or = 0.003). Compared with placebo, budesonide aqueous spray significantly reduced individual symptoms of runny nose and sneezing at all doses (p < or = 0.008), and nasal congestion and nasal itching at all doses except 64 micrograms (p < or = 0.022). In the Midwest pollen belt where the 1994 ragweed season was representative of a typical pollen season, it was possible to establish a dose-response relationship for comparison of budesonide aqueous spray 256 micrograms versus 32 micrograms (p = 0.017). The incidence of adverse events was similar between budesonide aqueous-treated and placebo-treated patients. Importantly, there was no effect of budesonide aqueous spray on basal or ACTH-stimulated plasma cortisol levels in either adults or children at the end of 4 weeks of treatment. Intranasal budesonide aqueous pump spray, administered once daily, was efficacious and was generally well tolerated in both adults and children with seasonal allergic rhinitis.

Co-existence of asthma and allergic rhinitis: a 23-year follow-up study of college students.

The purpose of this study is to examine the co-existence of asthma and allergic rhinitis among former college students who were diagnosed with these diseases either before or after their freshman year. A total of 738 former Brown University students (69% males and 31% females) who were evaluated and underwent skin testing during their freshman year completed a 23-year follow-up questionnaire inquiring of their history of allergies and asthma. The mean age of the participants at the time of the follow-up study was 40 years. In this group, the cumulative incidence of asthma was 11.3% (84/738), hay fever was 41.5% (306/738), and nonseasonal allergic rhinitis was 14.0% (103/738). The cumulative incidence of allergic rhinitis (hay fever) and/or nonseasonal allergic rhinitis (was 45.8% (338/738). Among the 84 individuals with a cumulative incidence of asthma, 63 (75.0%) had a history of hay fever, 27 (32.1%) had a history of nonseasonal allergic rhinitis, and 72 (85.7%) had a history of allergic rhinitis. Among the 306 participants with a cumulative incidence of hay fever, 63 (20.6%) had a history of asthma. Twenty-seven (26.2%) of the 103 individuals with a history of nonseasonal allergic rhinitis had a cumulative incidence of asthma. Among the 338 individuals with a cumulative incidence of allergic rhinitis 72 (21.3%) had a history of asthma. Among the participants with a history of both asthma and hay fever, 44.8% developed hay fever first, 34.5% developed asthma first, and 20.7% developed both diseases at the same time. Among the individuals with a history of asthma and nonseasonal allergic rhinitis, 38.5% developed nonseasonal allergic rhinitis first, 30.8% developed asthma first, and 30.8% developed both diseases at the same time. This study further demonstrates the frequent co-existence of asthma and allergic rhinitis. Among asthmatics, allergic rhinitis occurred in 85.7%. Only 14.3% of asthmatics did not have allergic rhinitis. Among individuals with allergic rhinitis, asthma occurred in 21.3%. Also, allergic rhinitis often precedes or occurs at the same time as asthma.

Ipratropium bromide nasal spray 0.03% provides additional relief from rhinorrhea when combined with terfenadine in perennial rhinitis patients; a randomized, double-blind, active-controlled trial.

Medical treatment of perennial rhinitis is aimed at providing symptomatic relief of individual symptoms. Multiple agents are administered when no single agent provides complete relief. Studies assessing the benefit/risk of combined therapy are important, especially for newly available agents such as ipratropium bromide nasal spray, a topical anticholinergic agent approved for the treatment of rhinorrhea in allergic and nonallergic perennial rhinitis. The objective was to determine whether the combined use of ipratropium bromide nasal spray 0.03% (42 mcg per nostril) administered three times daily with a nonsedating antihistamine (terfenadine, 60 mg administered twice daily) is safe and provides greater clinical benefit than use of the placebo nasal spray plus terfenadine. Our method was a multicenter, 6-week, double-blind, randomized, active-controlled, crossover trial of 205 patients with perennial rhinitis (114 allergic and 91 nonallergic), 18 to 75 years of age, who had clinically significant rhinorrhea. After a 1-week run-in period, patients were treated for 2 weeks with one of the two treatment regimens, followed by a 1-week washout period, and then were treated for another 2 weeks with the other treatment regimen. Daily diary symptoms scores of rhinorrhea, congestion, and sneezing were obtained, as well as biweekly patient and physician global assessments of treatment effectiveness of each of the nasal symptoms. Ipratropium bromide nasal spray plus terfenadine was more effective than vehicle plus terfenadine in reducing the average severity (38% versus 28%) and duration (46% versus 30%) of rhinorrhea during the 2 weeks of treatment from baseline (p < 0.05). The advantage of ipratropium bromide nasal spray plus terfenadine was evident by the second day of treatment and continued throughout the 2-week treatment period. Of patients who responded more to one treatment than another, 69% responded to ipratropium bromide nasal spray plus terfenadine, compared to 31% to vehicle plus terfenadine (p < 0.05). Both physicians and patients rated control of rhinorrhea and sneezing by ipratropium bromide nasal spray plus terfenadine as superior to vehicle plus terfenadine (p < 0.05). The symptom of congestion was controlled equally well by both treatments. Combined active therapy was well tolerated with no increase in adverse events over that seen previously with ipratropium bromide nasal spray alone. The combination of ipratropium bromide nasal spray with terfenadine is more effective than vehicle plus terfenadine for the treatment of rhinorrhea, and does not result in a potentiation of adverse drug reactions.

Epidemiology of nasal polyps.

Nasal polyps are found in 36% of patients with aspirin intolerance, 7% of those with asthma, 0.1% in children, and about 20% in those with cystic fibrosis. Other conditions associated with nasal polyps are Churg-Strauss Syndrome, allergic fungal sinusitis, and cilia dyskinetic syndrome, (Kartagener's) and Young Syndrome. Nasal polyps are statistically more common in nonallergic asthma versus allergic asthma (13% vs 5%, P < 0.01). About 40% of patients with surgical polypectomies have recurrences. There appears to be a hereditary factor for developing nasal polyps. A classification system for staging nasal polyps is proposed in order to standardize treatment, consider differential diagnosis, and harvest meaningful comparative research information.

Nasal polyps and immunoglobulin E (IgE).

Nasal polyps are usually found in nonallergic individuals. However, when nasal polyps and atopy occur together, a special interaction exists. Total and specific immunoglobulin E (IgE) are found in significantly greater concentration in nasal polyp tissue than in serum and tonsil tissue. Immunoglobulin A (IgA) is also more concentrated in nasal polyps than serum. Patients with nasal polyps and allergies seem to have a greater recurrence rate after surgical polypectomy. Frequently, polyp recurrence occurs during specific pollen seasons in sensitive individuals. Upper respiratory infections are also a precipitating factor for recurrence. Nasal ciliary beat frequency is inhibited in patients with chronic sinusitis, allergic nasal reactions, and nonspecific nasal eosinophilia syndromes: nonallergic rhinitis with eosinophils (NARES) and blood eosinophilic nonallergic rhinitis (BENARS). Nasal polyps are frequently associated with these conditions, which may predispose the nasal mucosa to infections and increased risk for developing nasal polyps. When nasal polyps and allergies occur together, it is important to treat the allergic condition. This takes the form of identifying the allergens, eliminating them from the environment (if possible) using antihistamines/decongestants, and nasal antiinflammatory drugs such as topical steroids. Hyposensitization may be considered in resistant cases.

Hereditary factor for nasal polyps.

The purpose of this study is to determine whether a hereditary factor exists for nasal polyps. Fifty patients (27 male, 23 female; age range 14-86 years) had a personal history of nasal polyps. These were confirmed by physician reports, polypectomy pathology reports, or direct visualization. These 50 patients were questioned concerning the existence of a familial history (parents, siblings, or children) of nasal polyps. A control group of 30 patients without nasal polyps was obtained by matching sex, age, personal history of atopy, and allergy skin test results to patients with a personal history of nasal polyps. Familial history of nasal polyps was obtained from the control group by direct interview. Seven of 50 (14%) of the group with nasal polyps had a familial history of nasal polyps. Of those seven, three patients had more than one immediate family member with a positive family history (two patients with two family members (sister, mother; 2 sisters) and one patient with three family members (3 brothers)). Among the control group, 0 of 30 (0%) had a familial history of nasal polyps. This difference is statistically significant (P value is 0.0414). This study suggests that there exists a hereditary factor for development of nasal polyps.

Double-strength beclomethasone dipropionate (84 micrograms/spray) aqueous nasal spray in the treatment of seasonal allergic rhinitis.

BACKGROUND: The use of intranasally administered corticosteroid sprays is an established treatment option for seasonal allergic rhinitis. METHODS: In this double-blind, placebo-controlled, multicenter study, 438 patients with moderate to severe symptoms of seasonal allergic rhinitis were treated for 4 weeks with double-strength beclomethasone dipropionate (BDP) aqueous nasal spray (84 micrograms/spray: BDP-ds), once daily; regular-strength BDP (42 micrograms/spray: BDP-rs), twice daily; high-strength BDP (336 micrograms/spray: BDP-hs), once daily; or placebo. BDP-hs was included as a safety comparison group. All treatments were given as two sprays per nostril. RESULTS: Physician-rated nasal symptom scores were significantly improved in all three active treatment groups compared with those of the placebo group within the initial 3 days of treatment. Improvement was maintained throughout the 4-week treatment period. BDP-ds and BDP-rs were equivalent at all time points. The BDP-ds, BDP-rs, and BDP-hs groups had greater numbers of patients with a good or excellent therapeutic response at end point than the placebo group. All treatments were well-tolerated, and no unexpected adverse events were reported. No effects on laboratory evaluations or vital signs were evident for any treatment group. CONCLUSIONS: The results of this study show that BDP-ds given once a day and BDP-rs given twice a day in the same total daily dose are comparably safe and effective in the treatment of patients with seasonal allergic rhinitis.

Triamcinolone acetonide Aqueous nasal spray in patients with seasonal ragweed allergic rhinitis: a placebo-controlled, double-blind study.

Because some patients may prefer aqueous nasal sprays and once-daily dosing for relief of seasonal allergic rhinitis symptoms, a new aqueous formulation of triamcinolone acetonide (TAA Aqueous) was developed. We conducted a randomized, placebo-controlled, double-blind study to compare the efficacy and safety of once-daily administration of 220 micrograms/d of TAA Aqueous for 1 week, followed by either 220 micrograms/d or 110 micrograms/d for an additional 2 weeks, with that of placebo in 429 patients with seasonal allergic rhinitis. Patients recorded the severity of symptoms (nasal stuffiness, discharge, sneezing, nasal index [the sum of the first three variables], nasal itching, and eye symptoms) on daily diary cards. Patients' and physicians' global evaluations of efficacy were made at the end of the 3-week study period. Both regimens of TAA Aqueous significantly improved symptoms compared with placebo at most time points. Patients demonstrated significant improvements in nasal symptoms as early as the first day of treatment (within 12 to 16 hours based on treatment in the morning and symptom assessment at bedtime). Although TAA Aqueous 220 micrograms/d provided numerically greater reductions in nasal symptoms compared with 110 micrograms/d, these differences in efficacy over the last 2 weeks were not statistically significant. The incidence of adverse effects with both TAA Aqueous regimens was low and comparable to that of placebo. In summary, during the first week of therapy, TAA Aqueous 220 micrograms/d significantly reduced nasal symptoms. During the last 2 weeks of therapy, the 110 micrograms/d regimen of TAA Aqueous was effective as continued therapy for most patients. Both the 110 micrograms/d and 220 micrograms/d regimens of TAA Aqueous provided significantly better relief of nasal symptoms than did placebo.