Subjective and objective assessments in patients with seasonal allergic rhinitis: effects of therapy with mometasone furoate nasal spray.

BACKGROUND: Efficacy of topical nasal steroid therapy for allergic rhinitis is usually evaluated by patient and clinician assessments of subjective symptom changes in diaries and at clinical interviews. OBJECTIVE: We sought to complement the subjective measures with objective measures of nasal cytology, biochemistry, and function. METHODS: In this double-blind, randomized study patients with seasonal allergic rhinitis (SAR) 12 years of age or older received 200 microg mometasone furoate nasal spray (n = 80) or placebo spray (n = 41) once daily for 2 weeks. Subjective assessments by clinician and patient comprised symptom/sign scores and overall therapeutic response evaluations. Objective measures included nasal cytology, nasal biochemistry, nasal airway resistance (NAR), mucociliary clearance, and olfactory functions. RESULTS: Mometasone furoate produced a significantly greater decrease than placebo in subjective measures of SAR for total symptom score (-46% vs -30%, p < 0.05), total nasal score (-47% vs -30%, p < 0.024), individual nasal symptom scores, and overall therapeutic response. The objective measures of eosinophil, basophil, and neutrophil counts and mucociliary clearance were significantly better in mometasone furoate- than in placebo-treated patients. Similarly, within-treatment statistically significant improvements were produced by mometasone furoate but not by placebo sprays for levels of eosinophilic cationic protein, tryptase and albumin, NAR, and odor identification. Significant positive correlations were found between NAR and nasal stuffiness and between eosinophils, basophils, and neutrophils and both eosinophilic cationic protein and albumin. CONCLUSION: Subjective measures of SAR were significantly improved in the mometasone furoate group by comparison with placebo-treated patients. Objective assessments supported the subjective findings because within-treatment measures were frequently significantly improved after mometasone furoate treatment but not after placebo treatment.

Ipratropium nasal spray in children with perennial rhinitis.

OBJECTIVE: To compare the efficacy and safety of ipratropium nasal spray and placebo administered twice each day for 4 weeks in pediatric patients with perennial rhinitis who had rhinorrhea as a major complaint. METHODS: This was a multicenter, double-blind, parallel group study. Patients aged 6 to 18 years with symptoms of perennial nonallergic (PNAR) or perennial allergic rhinitis (PAR) were randomized to receive ipratropium (42 micrograms per nostril) or placebo nasal spray, double-blind, twice each day for 4 weeks. Efficacy was evaluated by nasal symptoms, especially anterior rhinorrhea, and quality of life. Previous caregivers for rhinitis and medications used in the past were also evaluated. RESULTS: A total of 202 patients were empanelled, 162 with PAR, 40 with PNAR; of these 151 with mild-severe rhinorrhea were evaluated for efficacy. Treatment with ipratropium reduced symptoms of rhinorrhea primarily in patients with PNAR. In patients with PAR this response was less pronounced, and was seen as a modest decrease in the severity of rhinorrhea noted in the first 2 weeks of treatment. Quality of life assessments confirmed that rhinorrhea was bothersome to these pediatric patients, and suggested that treatment with ipratropium nasal spray was associated with an improvement, especially in the patients with PNAR. There were few adverse events; these were similar in the two treatment groups. CONCLUSIONS: Ipratropium nasal spray 0.03% administered at a dose of 42 micrograms/nostril bid is a safe and effective new therapy for control of anterior rhinorrhea in pediatric patients with PNAR. Twice daily administration is adequate for patients with PNAR, but patients with PAR might benefit from more frequent administration (e.g., tid).

Histamine levels and nasal cytology in children with chronic otitis media and rhinitis.

OBJECTIVE: Nasal and middle ear diseases are frequent health problems for young children. In some of these patients, allergic reactions may be contributing factors. The objective of this study was to determine whether the histamine level in nasal mucosal scrapings may be used as a marker for this subset of children. METHODS: A total of 50 children, aged 2 through 7 years, was categorized into five groups of ten subjects as: normal, allergic rhinitis, nonallergic rhinitis, allergic with otitis media and nonallergic with otitis media by history, physical examination, allergy skin testing, nasal cytology, and tympanometry. Nasal mucosal scrapings were obtained using the Rhino-probe technique. Eosinophils, basophilic cells, neutrophils, and bacteria in nasal cytograms were quantified. Histamine levels were measured by radioimmunoassay, the values normalized to the total protein content assayed by enzyme-linked immunoassay, and expressed in pcg/micrograms of total protein. RESULTS: The mean histamine level for each group was: normal = 0.20, allergic rhinitis = 10.14, nonallergic rhinitis = 0.13, allergic with otitis media = 5.34, nonallergic with otitis media = 0.24 pcg/micrograms of total protein. Mean levels of histamine were statistically significantly higher in the allergic groups than in the nonallergic and normal groups (P < .05). Allergic groups had significantly more eosinophils and basophilic cells in the nasal cytograms than the nonallergic groups. By contrast, the cytograms of children with nonallergic rhinitis and nonallergic otitis had significantly more neutrophils than the normal and allergic groups. CONCLUSION: We conclude that measuring histamine in nasal mucosal scrapings could be useful in the evaluation of young children with rhinitis and otitis and in determining which patients may have allergic disease.

Nasal cytology in patients with allergic rhinitis: effects of intranasal fluticasone propionate.

BACKGROUND: Nasal cytograms of patients with allergic rhinitis contain increased numbers of eosinophils and basophilic cells. Neutrophils are also more numerous in cytograms of allergic persons. Topical intranasal corticosteroid therapy for allergic rhinitis has been shown to decrease the numbers of some inflammatory cell types. Fluticasone propionate aqueous nasal spray, a potent synthetic corticosteroid preparation, is effective therapy for seasonal and perennial allergic rhinitis. METHODS: Nasal mucosal scrapings were obtained with a Rhinoprobe (Apotex Scientific, Inc. Arlington, Texas) before and after therapy with fluticasone propionate aqueous nasal spray at several doses in patients with either seasonal allergic rhinitis (2 to 4 weeks' therapy) or perennial allergic rhinitis (24 weeks' therapy). More than 1000 paired nasal cytograms obtained from patients participating in five multicenter studies were evaluated. RESULTS: The percentage of patients with nasal eosinophils (p < 0.01, most studies) and basophilic cells (p < 0.05, most studies) decreased significantly after treatment with fluticasone propionate compared with placebo-treated patients. Similar findings were observed with beclomethasone dipropionate in one study. The number of neutrophils remained relatively unchanged after treatment with the intranasal corticosteroids or placebo. CONCLUSIONS: These findings suggest that the therapeutic benefits of topical intranasal fluticasone propionate and beclomethasone dipropionate for the therapy of seasonal and perennial allergic rhinitis are reflected by the decrease in inflammatory cells in the nasal mucosa.

A 1-week dose-ranging study of inhaled salmeterol in patients with asthma.

STUDY OBJECTIVE: A dose-ranging study was conducted to evaluate the efficacy and safety of a new long-acting, selective beta 2-adrenoceptor agonist, salmeterol. DESIGN: Adolescents and adults (N = 160) with mild-to-moderate asthma received salmeterol (10.5, 21, 42, or 84 micrograms) or placebo by metered-dose inhaler twice daily for 1 week. Twelve-hour serial spirometry measurements were performed on the first and last days of treatment, and patients recorded their peak expiratory flow (PEF) twice daily on diary cards. RESULTS: On day 1, salmeterol produced greater bronchodilation than placebo (p = 0.001), and both the 42-micrograms and 84-micrograms doses of salmeterol were significantly more effective in improving FEV1 responses than the two lower doses of salmeterol (p < 0.05). After 1 week of treatment, all but the 21-micrograms dose of salmeterol remained statistically superior to placebo (p < 0.01), but significant differences between salmeterol doses were no longer evident, despite an apparent dose-response effect. Only the 42-micrograms and 84-micrograms doses of salmeterol sustained bronchodilation for 12 h in the majority of patients at both treatment days. The degree of improvement in morning and evening PEF was also found to be dose related. There was no significant difference among treatment groups in the overall incidence of adverse events; however, pharmacologically predictable events (eg, tremor) occurred significantly more often with salmeterol, 84 micrograms. CONCLUSIONS: Salmeterol, 42 micrograms, was similar in efficacy to 84 micrograms but was associated with a lower incidence of adverse events. Salmeterol, 42 micrograms twice daily, is a safe and effective dosage for patients with mild-to-moderate asthma who are persistently symptomatic and require maintenance bronchodilator therapy.

Intranasal flunisolide spray as an adjunct to oral antibiotic therapy for sinusitis.

BACKGROUND: The diagnosis of sinusitis is difficult and there are few controlled studies of customary therapies. In particular, the possible role of topical intranasal steroid as an adjunct to antibiotic treatment has not been evaluated. METHODS: The study was a multicenter, double-blind, randomized, parallel trial in which patients aged 14 years or older were recruited from allergy practices. All patients had maxillary sinusitis documented by radiographs. Treatment consisted of amoxicillin/clavulanate potassium 500 mg combined with nasal spray of either 100 micrograms flunisolide or placebo to each nostril three times a day for 3 weeks (phase I) followed by administration of flunisolide or placebo nasal spray alone three times a day for 4 weeks (phase II). RESULTS: Clinical symptoms and signs decreased significantly in both treatment groups during phase I (p < 0.01). There was a trend to greater improvement in the patients treated with flunisolide, but only the decrease in turbinate swelling/obstruction was statistically significant at the end of phase I when compared with placebo (p = 0.041). Patients' global assessment of overall effectiveness of treatment was higher for flunisolide than placebo after phase I (p = 0.007) and after phase II (p = 0.08). Maxillary sinus radiographs showed improvement in both treatment groups during phase I (p < 0.004) with somewhat greater regression of abnormal findings in patients treated with flunisolide after phase II (p = 0.066). However, 80% of radiographs were still abnormal at the end of phase I. All types of inflammatory cells were significantly decreased in nasal cytograms in patients treated with flunisolide in comparison with those treated with placebo. Flare-up of sinusitis during phase II occurred in 26% of with those treated with placebo. Flare-up of sinusitis during phase II occurred in 26% of patients treated with flunisolide and 35% of those treated with placebo and tended to be more severe in the latter, although these differences were not statistically significant. Adverse events, mainly gastrointestinal symptoms and headache, were similar in both groups and more frequent in phase I than in phase II, (42 vs 15 patients); these side effects were probably due to the antibiotic. CONCLUSION: The addition of flunisolide topical nasal spray as an adjunct to antibiotic therapy was most effective in global evaluations, tended to improve symptoms, to decrease inflammatory cells in nasal cytograms, to normalize ultrasound scans, and to aid regression of radiographic abnormalities compared with placebo spray.

Ipratropium bromide aqueous nasal spray for patients with perennial allergic rhinitis: a study of its effect on their symptoms, quality of life, and nasal cytology.

Ipratropium bromide is an anticholinergic agent with topical activity that has been studied as a freon-propelled aerosol spray for therapy of nonallergic rhinitis. This is the first report of its use both as an aqueous nasal spray and in perennial allergic rhinitis. In this study 123 patients who had symptoms of perennial allergic rhinitis were randomized to receive ipratropium bromide 21 micrograms or 42 micrograms or placebo, one spray per nostril three times a day for 4 weeks. Patients maintained daily diaries of duration and severity of nasal symptoms and were evaluated weekly. Mean duration and severity of rhinorrhea was decreased in both ipratropium bromide treatment groups by comparison with placebo, with consistently greatest improvement in the group treated with ipratropium bromide 42 micrograms per nostril three times a day. No statistically significant differences occurred among treatment groups in duration or severity of postnasal drip, congestion, or sneezing. Seventy percent of patients treated with 42 micrograms of ipratropium bromide thought it had good or excellent effect on rhinorrhea (p less than 0.05 vs placebo); significantly more patients thought that it had improved the quality of life (p = 0.02). No changes occurred in nasal cytology, and no significant local or systemic adverse events occurred. These data indicate that ipratropium bromide significantly decreases the rhinorrhea of perennial allergic rhinitis.

Long-term comparison of three combinations of albuterol, theophylline, and beclomethasone in children with chronic asthma.

Three combination regimens, (1) inhaled albuterol (ALB) with oral theophylline (THEO), (2) inhaled ALB with inhaled beclomethasone dipropionate (BDP), or (3) inhaled ALB, inhaled BDP, and oral THEO, were evaluated and compared as optimal pharmacotherapy for chronic asthma in 111 children. In this double-blind, parallel-group, multicenter study, children, aged 6 to 16 years with moderately severe asthma (unstable despite daily medications), were treated with one of the combinations for 12 weeks. Patients were evaluated every 4 weeks by spirometry and serum THEO measurement. Patients kept daily symptom diaries, measured peak flow rates twice daily, and recorded adverse events. Treatment groups did not differ in disease or demographic characteristics at study entry. All three combination treatments provided and maintained significant improvement in FVC, FEV1, and FEF25%-75% volume points, and compared with that of pretreatment, with no significant differences between treatments. Throughout the 12-week treatment period, however, patients receiving BDP had lower symptom scores, fewer had more than one asthma attack, fewer required "bursts" of prednisone (p = 0.001), and fewer required rescue medication (p = 0.009). Significantly more patients receiving BDP said that they felt better than they did at the beginning of the study compared with the number of patients not receiving BDP (p = 0.002). Adverse events were similar among treatment groups.

Intranasal fluocortin butyl in patients with perennial rhinitis: a 12-month efficacy and safety study including nasal biopsy.

Fluocortin butyl (FCB) is a recently developed topical intranasal corticosteroid that is inhaled as a powder and has been demonstrated to be well tolerated and to improve symptoms and signs of perennial rhinitis in previous short-term studies. This multicenter, open-label study evaluated the efficacy and safety of FCB during a 12-month treatment period in patients with perennial rhinitis. Treatment was initiated with one inhalation of FCB in each nostril three times a day (total dosage, 3 mg/day). In subsequent months, one third of the patients was maintained at the dosage of 3 mg/day, one third at a lower dosage of 2 mg/day, and the remaining one third of the patients at a larger dosage of 4 to 8 mg/day. Of 109 patients enrolled in the study, 90 patients (82.6%) completed all 12 months of treatment. Symptom and sign scores decreased significantly (p less than 0.001) at the 2-month evaluation compared to scores at baseline, and the improvement was maintained throughout the 12-month study period. After 12 months, greater than 80% of the patients had substantial control of symptoms. Specimens of nasal biopsies, performed at the beginning and end of treatment, revealed a decrease in eosinophils and other cellular infiltrates, a slight tendency of an increase in mast cell counts, and a trend toward normalization of the nasal mucosa. There were few adverse effects. Mean plasma cortisol levels were normal before and after corticotropin stimulation at baseline and after 12 months of FCB therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Comparison of intranasal cromolyn sodium, 4%, and oral terfenadine for allergic rhinitis: symptoms, nasal cytology, nasal ciliary clearance, and rhinomanometry.

Topical intranasal cromolyn sodium, 4% solution, and oral terfenadine, 60 mg tablets, both relieve symptoms of allergic rhinitis with few or no adverse effects, but no comparison of their relative efficacy has been reported. In this double-blind, double-dummy study, 79 patients, ages 12-56 years with symptoms of allergic rhinitis, were randomized to receive either active cromolyn sodium, 1 spray in each nostril QID, or active terfenadine BID along with the appropriate placebo spray or tablet for 4 weeks following a 1-week baseline qualification period. Patients' daily symptom scores were reviewed weekly and constituted the primary efficacy measures. Changes in nasal cytology, nasal ciliary clearance, and rhinomanometry were also assessed. The presence of adverse effects and the overall score of medication efficacy at the end of each week was recorded. The cromolyn sodium and terfenadine groups had comparable baseline scores for severity of allergic rhinitis symptoms and both treatments resulted in significant improvement (P less than .0001) with no statistical difference between them for total symptom scores at the end of 4 weeks. Eosinophils in nasal samples were decreased significantly in the cromolyn treated group with no significant change in the terfenadine-treated group. There were no significant differences between treatment groups in ciliary clearance or rhinomanometry. Adverse effects were uncommon and mild. We conclude that cromolyn sodium and terfenadine are comparably effective and well-accepted treatments for allergic rhinitis.

Vocal cord dysfunction in a child with asthma.

Vocal cord dysfunction is uncommon in children. We present the case of a 12-year-old boy with a history of mild, intermittent asthma from 7 to 10 years of age. Subsequently, severe, rapid-onset attacks of respiratory distress occurred with increasing frequency. After a life-threatening attack of airway obstruction with 3 minutes of apnea, he was hospitalized for diagnostic studies. Although pulmonary function tests were normal, laryngoscopy under general anesthesia revealed extremely severe vocal cord spasm induced by minimal contact of the laryngoscope. It required intravenous lidocaine and muscle relaxant to reverse. Spasm was not demonstrable one week later on repeat laryngoscopy and bronchoscopy. No structural abnormalities were seen. There was considerable family stress exacerbated by anxiety about the patient's illness. Parents were told that the condition was different from asthma and probably functional in origin. There have been no further episodes, possibly due to counseling and education in relaxation techniques as well as oral pharmacotherapy for asthma with avoidance of inhaled medications.

A dose-ranging study of fluticasone propionate aqueous nasal spray for seasonal allergic rhinitis assessed by symptoms, rhinomanometry, and nasal cytology.

Fluticasone propionate is a new glucocorticosteroid with potent topical activity. In a double-blind, randomized, parallel-group study, 423 adult patients with moderate to severe seasonal allergic rhinitis received placebo or fluticasone propionate aqueous nasal spray at doses of 25, 100, or 400 micrograms twice daily (b.i.d.) for 2 weeks. Efficacy was evaluated by nasal symptom scores, nasal airflow, nasal cytology, and global evaluation. All doses of fluticasone propionate were significantly better than placebo in reducing symptoms of seasonal allergic rhinitis. Patients receiving the largest dose of fluticasone propionate (400 micrograms b.i.d.) had a slightly greater reduction (not significant) in symptom scores than patients receiving the smallest dose (25 micrograms b.i.d.). Symptom improvement was evident within 3 days of treatment. Nasal airflow improved in the groups treated with fluticasone propionate, 100 and 400 micrograms b.i.d. Examination of nasal cytograms revealed a striking decrease in both eosinophils and basophils in all three groups receiving active treatment compared with placebo. There were few adverse events and no treatment-related abnormalities in laboratory assays or evaluations of hypothalamo-pituitary-adrenocortical axis function. Comparison of treatment groups indicated that fluticasone propionate aqueous nasal spray was as safe as placebo at the doses studied.

Evaluation of symptom relief, nasal airflow, nasal cytology, and acceptability of two formulations of flunisolide nasal spray in patients with perennial allergic rhinitis.

A new formulation of intranasal flunisolide containing less propylene glycol was compared with the original formulation for efficacy and acceptability in more than 200 patients with symptoms of perennial allergic rhinitis. In this multicenter, randomized, double-blind, parallel group study, symptomatic patients were treated with either the new or the original formulation of 0.025% solution of intranasal flunisolide for 4 weeks to provide 200 micrograms flunisolide daily. Both formulations were highly effective in decreasing symptom scores as evident from patient diary reports before and after treatment (P less than .001). Similarly, nasal airflow was improved with each treatment as measured by anterior rhinomanometry (P less than .0002) and the number of patients with nasal eosinophilia decreased (P less than .01). Finally, fewer patients using the new formulation reported nasal burning or stinging and the acceptability rating of the new formulation was higher.

A simplified screening test for the diagnosis of allergy.

The Quidel allergy screen is a relatively rapid (less than 2 hours) multiallergen dipstick method for detecting specific immunoglobin E antibodies in serum. It was developed to answer the need of primary physician nonspecialists in allergy for a convenient in-office screening test for diagnosing allergy. The new test was evaluated against the benchmark diagnostic skin tests and the radioallergosorbent serologic tests for sensitivity, specificity, accuracy, and technical feasibility in an office setting. It was found that while the Quidel allergy screen lacks the specificity of the standard tests, its overall sensitivity, as defined by the percentage of patients with positive skin reactions who also tested positive with the Quidel screen (68%), its ease of use, and its rapidity warrant its consideration as a screening tool for confirming a possible case of allergy.

Efficacy of azelastine in perennial allergic rhinitis: clinical and rhinomanometric evaluation.

Azelastine is a chemically novel medication that has been demonstrated to be clinically effective for asthma and seasonal allergic rhinitis. In a 10-week, multicenter, double-blind, placebo-controlled, crossover study, the efficacy and safety of azelastine, 1 mg and 2 mg twice daily, were evaluated in 192 patients with symptoms of perennial allergic rhinitis. Patients maintained daily symptom and adverse-experience diaries and were evaluated every 2 weeks by the investigators. Pseudoephedrine, 30 mg, was provided as backup medication. Amelioration of most individual symptoms and a decrease in the total symptom scores were observed with both dosages of azelastine; greater improvement with 2 mg twice daily than with 1 mg twice daily, was observed. Nasal congestion, as a symptom and as reflected by rhinomanometric assessment, was the least improved parameter. Backup decongestant medication decreased during treatment with azelastine and increased during the placebo regimen. There were no major adverse effects.

Comparison of a new sustained-release theophylline preparation, TheoBeads, with Theo-Dur tablets in children with asthma.

A new, slow-release theophylline formulation for children, TheoBeads, which has the potential for once-daily dosing, has become available. We report the results of a study of pediatric patients whose medication was changed from Theo-Dur tablets b.i.d. to TheoBeads q.d. Forty-nine children with asthma (aged 6-12 years) were treated with b.i.d. Theo-Dur to produce therapeutic maximum and minimum concentration levels (i.e., 8-20 micrograms/ml). Approximately half the patients were then transferred to TheoBeads given q.d. at the same total daily dose and retitrated; seven patients needed to be changed to b.i.d. dosing due to unacceptable fluctuations. The other half of the patients continued on b.i.d. Theo-Dur. Following at least 5 days of steady-state dosing, serum theophylline levels were assayed over a 24-hour period. It was found that: 1. Children changed to q.d. TheoBeads showed no change in their overall asthma control based on clinical diary entries and peak flow measurements. 2. Lower Cmax and Cmin theophylline levels and a smaller area under the curve were noted for patients taking q.d. TheoBeads compared to those taking b.i.d. Theo-Dur. 3. Administration of TheoBeads q.d. resulted in a significantly larger overall peak-to-trough fluctuation and a higher percentage of patients with subtherapeutic theophylline levels in the second 12-hour period than did b.i.d. Theo-Dur administration. In summary, when children receiving b.i.d. Theo-Dur were transferred to q.d. TheoBeads, they did not maintain even and sustained therapeutic theophylline levels, although asthma control was not adversely affected during the short period of observation.

Outpatient management of asthma with regular nebulized beta agonists: comparison of bitolterol mesylate and isoproterenol.

Nebulized bitolterol solution and isoproterenol solution were compared when used on a regular basis, 2.5 mg three times a day for 1 month by patients with chronic asthma. In this multicenter, double-blind trial; 130 nonsteroid-dependent patients were randomized to receive one of the two treatments concomitantly with their regular asthma medications. On study days, at the beginning of the study and after 2 and 4 weeks, treatments were given in the office or laboratory and patients were monitored with pulmonary function tests for eight hours. Both medications induced rapid bronchodilation that had a longer duration after bitolterol. The incidence of tremor was similar with the two medications. Tachycardia and palpitations were more frequent following isoproterenol. Bitolterol has a much longer duration of action and should be considered as a suitable bronchodilator for regular nebulizer treatment of chronic asthma.

A dose-response study of the bronchodilator action of azelastine in asthma.

Azelastine is an orally effective inhibitor of mediator activity in allergic reactions and has also been demonstrated to have bronchodilator activity. In this randomized, double-blind, placebo-controlled, multicenter study, 150 patients, aged 12 to 60 years, with moderate to severe asthma, received a single oral dose of 2, 4, 8, 12, or 16 mg of azelastine or placebo. Theophylline was stopped 24 hours and other bronchodilators at least 8 hours before the study day. Patients were evaluated for 8 hours after dose by spirometry and were monitored for adverse effects. All doses of azelastine produced bronchodilation with 4 mg greater than 2 mg greater than placebo; higher doses did not increase magnitude or duration of effect. We conclude that azelastine produces significant bronchodilation of long duration. The optimal dose appears to be 4 mg for adolescent and adult patients with asthma.

Clinical, rhinomanometric, and cytologic evaluation of seasonal allergic rhinitis treated with beclomethasone dipropionate as aqueous nasal spray or pressurized aerosol.

The currently available beclomethasone dipropionate (BDP) metered-dose nasal aerosol spray is considered uncomfortable by some patients because of the force of delivery. It was compared for efficacy and acceptability in a double-blind study with a new aqueous suspension BDP spray for the treatment of seasonal allergic rhinitis in 44 symptomatic patients aged 12 to 43 years. After 7 days of baseline evaluation, every patient was given both an aerosol canister and an aqueous spray bottle each containing either BDP, 42 mcg per spray, or placebo (P). For 15 days the patient sprayed each nostril twice a day with one spray of suspension (BDP or P) followed 5 minutes later by one spray of aerosol (P or BDP). Patients were evaluated before the study medications were started (day 1) and on days 4, 8, and 15 for nasal and eye symptoms. Nasal cytologic specimens were examined on days 1 and 15, and rhinomanometry was performed on days 1, 8, and 15 of the study. Topical BDP by both methods of delivery was rapidly effective in decreasing mean nasal obstruction, rhinorrhea, sneezing, and itching symptoms as well as mean eye symptoms with no statistically significant differences between them. Nasal airflow increased with both treatments; rhinomanometry significantly correlated with subjective nasal obstruction scores. Of 34 patients with nasal eosinophils, 74% had fewer eosinophils after treatment. Most patients (84%) preferred the aqueous spray over the pressurized aerosol.