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.     

Beclomethasone dipropionate aqueous nasal spray for seasonal allergic rhinitis in children

A 3-week double-blind, parallel group study comparing the effectiveness and safety of an aqueous formulation of beclomethasone dipropionate (BDP-AQ) versus placebo was undertaken in 101 patients. Children aged 5 to 13 years with a diagnosis of seasonal allergic rhinitis received one spray in each nostril twice daily of either BDP-AQ (42 micrograms/spray) or an identical placebo spray. Patient assessment at the end of treatment indicated statistically significant improvement in nasal symptoms for BDP-AQ patients. The physicians overall evaluation of treatment indicated that the BDP-AQ-treated patients experienced significantly greater (P = .012) improvement as compared with placebo-treated patients. There was no difference in the incidence of adverse events between the two treatments. The results demonstrate the effectiveness and safety of BDP-AQ nasal spray in the treatment of seasonal allergic rhinitis in children.     

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.     

An open comparison of dosage frequencies of beclomethasone dipropionate in seasonal allergic rhinitis

In an open group-comparative study, 123 adult patients with seasonal allergic rhinitis were allocated at random to one of three treatment groups; each of which received a daily dose of 400 μg beclomethasone dipropionate as (1) one puff in each nostril four times daily, (2) two puffs in each nostril twice daily and (3) four puffs in each nostril once per day. The result of treatment was assessed on daily symptom scores and the use of antihistamine tablets. There were no statistically significant differences between the three groups. The results indicate that it is unnecessary to give beclomethasone dipropionate nasal spray four times daily, and treatment in the morning and in the evening is recommended.     

Treatment of nasal polyps with intranasal beclomethasone dipropionate aerosol

In a double-blind trial thirty-five patients with moderately-severe nasal polyposis were treated with intranasal beclomethasone dipropionate aerosol for 3 weeks. The dose given (400 γg/day) had only local effect on the symptoms. Judged by diary card scores the nasal symptoms were reduced to 52% of the pre-trial level for the whole group. Corrected for the placebo effect the percentage was 68. The reduction of symptoms was equally apportioned to the three symptoms, sneezing, nasal secretion and blockage. The treatment was tolerated well, and it is concluded that intranasal treatment with beclomethasone dipropionate aerosol offers most patients with nasal polyps a good response without any risk of systemic steroid side-effects.     

The effect of beclomethasone dipropionate aerosol on allergen induced nasal stenosis

Nasal resistance to air flow has been used to evaluate the effect of beclomethasone dipropionate aerosol on allergen induced nasal stenosis. Sixteen patients with allergic-rhinitis due to pollen were investigated in a randomized double-blind cross-over study with beclomethasone dipropionate aerosol and placebo aerosol. Only patients reacting to challenge were chosen. The study was carried out in the pollen-free season. After I week on either active or placebo aerosol a basic resistance value was determined followed by allergen challenge. Nasal resistance was determined 15 min and 7 hr after challenge. The aerosols were changed and after another week the procedure was repeated. There was significant preference (P<0.01) for beclomethasone dipropionate aerosol.     

Beclomethasone dipropionate nasal aerosol spray in allergic rhinitis: a comparison of three delivery systems

In this 3-way crossover study, the currently marketed beclomethasone dipropionate aerosol canister was sprayed intranasally through three different delivery adapters by 48 adult patients with allergic rhinitis. The adapters were evaluated and compared for force of spray, ease of use, preferred length of nozzle, and effectiveness. While all three were considered effective for symptom relief, there was a clear preference for both of the new longer, snout-like nozzle adapters over the currently available delivery system.     

Relationships between allergic inflammation and nasal airflow in children with seasonal allergic rhinitis.

BACKGROUND: Allergic rhinitis is characterized by a T(H)2-dependent inflammation. Nasal obstruction is a typical symptom of allergic rhinitis. OBJECTIVE: To evaluate the possible relationships among nasal symptoms, allergic inflammation, including inflammatory cells and cytokine pattern, and nasal airflow in children with seasonal allergic rhinitis. METHODS: Children with seasonal allergic rhinitis and moderate-severe nasal obstruction were evaluated during the pollen season. Total symptom score, rhinomanometry, nasal lavage, and nasal scraping were evaluated in all patients. Inflammatory cells were counted by conventional staining; interleukin 5 (IL-5) and IL-8 levels were measured by immunoassay on fluids recovered from nasal lavage. RESULTS: Twenty children (11 boys and 9 girls; mean +/- SD age, 12.9 +/- 1.7 years) participated in this study. Eosinophil levels were significantly associated with total symptom score (r = 90.6%, P < .001), IL-5 (r = 94.9%, P < .001), and nasal flow (r = -93.6%, P < .001). No association was elicited with IL-8 (r = 9.4%, P = .69). In a multivariate analysis that included eosinophils, neutrophils, and IL-5, eosinophil levels were shown to be the only independent predictor of nasal flow. CONCLUSIONS: This study demonstrates the close connection between T(H)2 cytokines and eosinophil infiltration. In addition, there is clear evidence concerning the relationship among nasal symptoms, eosinophil infiltration, and nasal airflow. These findings constitute evidence of the relationship between nasal airflow impairment and eosinophilic inflammation in children with seasonal allergic rhinitis.     

Eosinophil markers in seasonal allergic rhinitis

Background The purpose was to study activation markers of the eosinophil granulocytes in seasonal allergic rhinitis, and the impact of topical steroid therapy thereupon.
Methods Sixty-three rhinitis patients with monoallergy to grass were examined before and at peak pollen season. Blood eosinophil count, eosinophil cationic protein (ECP), and eosinophil peroxidase (EPO) in serum and nasal lavage fluid were measured. During the season, patients were randomized to treatment with intranasal fluticasone propionate 0.1 mg o.d. ( n =26), 0.2 mg o.d. ( n =25), or placebo (n = 12). Six healthy persons served as controls.
Results During the season, all parameters, except nasal lavage ECP, increased in the placebo group (P<0.001 – P<0.05). Significant differences were seen between the steroid grotips and the placebo group for all parameters (P<0.001–F<0.05). Higher eosinophil count (P<0.05), serum EPO (F<0.02), and nasal lavage EPO (P<0.05) were found in patients before season than in controls. The following winter, 44 patients returned for repeated measurement. Lower levels of nasal lavage EPO were observed for patients than levels at the beginning of the season (P<0.0001).
Conclusions Intranasal fluticasone propionate reduced inflammation of the nasal mucosa, demonstrated locally by nasal lavage ECP and EPO, and systemically by blood eosinophils, serum ECP, and serum EPO. EPO seemed more sensitive than ECP as indicator of allergic inflammation. EPO demonstrated some perennial eosinophil activity in hay fever patients, increasing locally during spring.     

A comparison of budesonide and beclomethasone dipropionate nasal aerosols in ragweed-induced rhinitis

The clinical potency of budesonide, a new glucocorticosteroid, was compared in a randomized double-blind study with beclomethasone dipropionate in the treatment of seasonal allergic rhinitis during the ragweed-pollen season. Sixty-one subjects were matched according to their skin sensitivity to ragweed-pollen extract and the severity of ragweed-induced rhinitis during the previous season. Thirty subjects received budesonide, and 31 received beclomethasone dipropionate, 50 micrograms per actuation. A double-dummy technique was used to achieve blinding, since the aerosol canisters and adaptors were dissimilar. Subjects were instructed to keep rhinitis well controlled by starting intranasal trial medication as soon as symptoms became troublesome, two puffs into each nostril, when it was needed, up to four times per day. If this became inadequate, subjects received supplementary chlorpheniramine maleate, 4 mg. Nasal symptoms (none = 0, mild = 1, moderate = 2, and severe = 3) and all medication use were recorded daily in a diary. Budesonide demonstrated better clinical potency than beclomethasone in that less was needed to maintain good control of nasal symptoms. Side effects were mild and transient for both groups.     

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

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

Effect of beclomethasone dipropionate on nasal metachromatic cell sub-populations

Abstract. The effect has been investigated of local administration of beclomethasone dipropionate (BDP) on cell numbers of nasal epithelial metachromatic cell (NMC) sub-populations. Twenty-one patients with perennial allergic rhinitis were studied in four groups according to the duration of treatment or after treatment with BDP. Nasal scrapings were taken after 1 week (Group 1) or 2 weeks (Group 2) of BDP treatment, or after discontinuing BDP for 1 week (Group 3) or 2 weeks (Group 4). Cells were fixed with Mota's lead acetate or 10% buffered formalin followed by toluidine blue staining to count the number of NMC and to classify these according to morphological subtypes (basophils or mast cells). Formalin-sensitive mast cells and basophils in nasal scrapings were reduced more than formalin-resistant mast cells with BDP treatment. Formalin-sensitive mast cells were also more prompt to recover from BDP than formalin-resistant mast cells. The results suggest that the formalin-sensitive NMC is a sub-population of cells which responds to BDP treatment in allergic rhinitis.     

Flunisolide nasal spray for the treatment of children with seasonal allergic rhinitis.

Forty-eight children with seasonal allergic rhinitis received either 150 microgram/day of flunisolide (a new topical steroid) or placebo. Those receiving flunisolide had a significantly shorter daily duration of sneezing, stuffy nose, runny nose and throat itch. Total or substantial control of their symptoms was reported by 67% of the flunisolide group and 25% of the placebo group.     

A clinical trial of beclomethasone dipropionate aerosol in children and adolescents with asthma

A double-blind cross-over trial lasting 4 weeks of beclomethasone dipopionate aerosol in thirty-nine children and young people with asthma already on oral corticosteroid treatment showed a significant beneficial effect which in most cases was maintained on continued open treatment for a further 4 weeks. An overall assessment based on several clinical observations and measurements suggested that twenty-four (62%) were improved while having beclomethasone dipropionate. After a month on known beclomethasone dipropionate fifteen patients had stopped oral corticosteroid treatment and five had reduced the dose without relapse. Response to treatment was not related to total IgE levels. No serious side effects were noted.     

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.     

Double-blind crossover trial comparing beclomethasone dipropionate and sodium cromoglycate in perennial allergic rhinitis

A double-blind crossover trial comparing the clinical efficacy of intranasal beclomethasone dipropionate and intranasal sodium cromoglycate was carried out in fourteen patients with perennial rhinitis due to animal danders. Intranasal beclomethasone dipropionate was significantly more effective than intranasal sodium cromoglycate in relieving nasal obstruction, nasal discharge and sneezing. Eleven patients reported preference for beclomethasone dipropionate and three had no preference for either drug.     

Effect of nasal triamcinolone acetonide on seasonal variations of bronchial hyperresponsiveness and bronchial inflammation in nonasthmatic children with seasonal allergic rhinitis.

BACKGROUND: Recent evidence suggests that patients with allergic rhinitis have lower airway inflammation and a higher prevalence of bronchial hyperresponsiveness (BHR) regardless of asthma. OBJECTIVE: To investigate markers of lower airway inflammation in nonasthmatic children with seasonal allergic rhinitis (SAR) before and during pollen season and the effect of nasal triamcinolone acetonide on seasonal variations in these parameters. METHODS: Thirty-two nonasthmatic children with SAR in response to grass and/or weed pollens were recruited and separated into 2 groups. Group 1 was treated with triamcinolone acetonide (220 microg once daily) for 6 weeks, and group 2 received no intranasal corticosteroid treatment. Bronchial responsiveness to methacholine [concentration that caused a decrease in forced expiratory volume in 1 second of 20% (PC20)], eosinophil counts in sputum and peripheral blood, and eosinophil cationic protein (ECP) levels in sputum and serum were measured before and during grass pollen season. RESULTS: Twenty-eight patients completed the study. During the pollen season, methacholine PC20 significantly decreased in both groups when compared with the corresponding preseasonal values (P = .01 and P = .003, respectively). The mean percentage of sputum eosinophils increased significantly during the pollen season compared with preseasonal values in group 1 and group 2 (12.7% +/- 2.1% vs 16.5% +/- 2.1%, P = .007, and 11.0% +/- 2.0% vs 20.2% +/- 1.4%, P = .003, respectively). Median [interquartile ranges (IQR)] sputum ECP levels were significantly higher during the pollen season when compared with the preseasonal values in group 1 and group 2 [7.5 microg/L (3.5-36.0 microg/L) vs 35.5 microg/L (13.0-71.7 microg/L), P = .04, and 18.0 microg/L (6.0-36.0 microg/L) vs 69.0 microg/L (39.0-195.0 microg/L), P = .003, respectively], as were the serum ECP levels [6.0 microg/L (2.0-13.0 microg/L) vs 19.0 microg/L (14.0-43.5 microg/L), P = .004, and 6.0 microg/L (3.0-7.0 microg/L) vs 18.0 microg/L (6.0-36.0 microg/L), P = .001, respectively]. Although the mean number of eosinophils in blood increased during the pollen season in both groups, it was only significant in group 2 (70.0 +/- 20.0 vs 161.6 +/- 29.0, P = .02). CONCLUSIONS: Although prophylactic nasal corticosteroid treatment provides significant reduction of nasal symptoms and rescue antihistamine use, there is no significant prevention in the seasonal increase of bronchial inflammation and methacholine BHR.     

Double-blind comparison between beclomethasone dipropionate as aerosol and as powder in patients with nasal polyposis

Beclomethasone dipropionate as a pressurized aerosol is effective in nasal polyposis, but the efficacy is only moderate. In these partly-blocked noses, it seems possible that the insufflated drug in powder form is better distributed over the mucous membrane than the pressurized aerosol. To test this hypothesis, we treated forty-two patients with nasal polyposis with intranasal beclomethasone dipropionate as a powder and as a pressurized aerosol in a double-dummy, cross-over design. There was no difference between the treatments in sixteen patients, while in twelve cases there was a preference for beclomethasone dipropionate as aerosol, and in fourteen, for the powder form. Fourteen found the aerosol most irritating and nineteen, the powder. Thus, in a group of polyp patients there were no significant differences between the two application forms, but possibly there is a need for both aerosol and powder, as there appeared to be differences in the individual responsiveness to the two types of intranasal medication;. Blind microscopy of wiped nasal-smears before and after beclomethasone dipropionate treatment showed a reduction of basophilic cells, and counting of sneezes after medication demonstrated a reduction in the number of sneezes. These results suggest that a reduction of epithelial mediator-cells and of irritant receptor-sensitivity are of importance for the efficacy of topical steroids in rhinitis.