Intranasal fluticasone propionate is more effective than terfenadine tablets for seasonal allergic rhinitis

BACKGROUND: We compared the efficacy and tolerability of the intranasal corticosteroid fluticasone propionate with that of the antihistamine terfenadine in patients with seasonal allergic rhinitis. METHODS: Two hundred thirty-two adults and adolescents with seasonal allergic rhinitis received intranasal fluticasone propionate (200 micrograms once daily), terfenadine tablets (60 mg twice daily), or placebo for 2 weeks in a double-blind, randomized, parallel-group study. Main outcome measures were clinician- and patient-rated individual and total nasal symptom scores (based on ratings of nasal obstruction, sneezing, nasal itching, and rhinorrhea); clinician-rated overall response to therapy; changes in nasal inflammatory cell counts; adverse events; and morning plasma cortisol concentrations. RESULTS: Both clinician- and patient-rated total and individual nasal symptom scores were significantly lower in the fluticasone group than in either the terfenadine group or the placebo group at nearly every measured time point throughout the treatment period. After 2 weeks of therapy, clinician-rated total nasal symptom scores decreased by 49% in the fluticasone group compared with 27% in the terfenadine group and 19% in the placebo group. In general, therapy with terfenadine was not statistically distinguishable from that with placebo based on patient-rated total or individual nasal symptom scores. According to clinician ratings, 64% of fluticasone-treated patients compared with 49% and 44% of patients treated with terfenadine and placebo, respectively, experienced significant or moderate improvement. A greater percentage of fluticasone-treated patients compared with either terfenadine- or placebo-treated patients experienced reductions in intranasal eosinophil and basophil counts after 2 weeks of therapy. No unusual or serious drug-related adverse events were reported. Morning plasma cortisol concentrations after 2 weeks of therapy did not differ among groups. CONCLUSION: Fluticasone aqueous nasal spray, a well-tolerated corticosteroid preparation that can be administered once daily, is more effective than terfenadine tablets or placebo in controlling symptoms of seasonal allergic rhinitis.     

Intranasal azelastine. A review of its efficacy in the management of allergic rhinitis

Azelastine, a phthalazinone compound, is a second generation histamine H1 receptor antagonist which has shown clinical efficacy in relieving the symptoms of allergic rhinitis when administered as either an oral or intranasal formulation. It is thought to improve both the early and late phase symptoms of rhinitis through a combination of antihistaminic, antiallergic and anti-inflammatory mechanisms. Symptom improvements are evident as early as 30 minutes, after intranasal administration of azelastine [2 puffs per nostril (0.56mg)] and are apparent for up to 12 hours in patients with seasonal allergic rhinitis (SAR). The effect on nasal blockage is variable: in some studies objective and/or subjective assessment showed a reduction in blockage, whereas in other studies there was no improvement. Intranasal azelastine 1 puff per nostril twice daily is generally as effective as standard doses of other antihistamine agents including intranasal levocabastine and oral cetirizine, ebastine, loratadine and terfenadine at reducing the overall symptoms of rhinitis. The relative efficacies of azelastine and intranasal corticosteroids (beclomethasone and budesonide) remain unclear. However, overall, the corticosteroids tended to improve rhinitis symptoms to a greater extent than the antihistamine. Azelastine was well tolerated in clinical trials and postmarketing surveys. The most frequently reported adverse events were bitter taste, application site irritation and rhinitis. The incidence of sedation did not differ significantly between azelastine and placebo recipients and preliminary report showed cardiovascular parameters were not significantly altered in patients with perennial allergic rhinitis (PAR). Conclusion: Twice-daily intranasal azelastine offers an effective and well tolerated alternative to other antihistamine agents currently recommended for the symptomatic relief of mild to severe SAR and PAR in adults and children (aged > or = 12 years in the US; aged > or = 6 years in some European countries including the UK). The rapid onset, confined topical activity and reduced sedation demonstrated by the intranasal formulation of azelastine may offer an advantage over other antihistamine agents, although this has yet to be confirmed.     

Mometasone furoate. A review of its intranasal use in allergic rhinitis

Mometasone furoate is a synthetic corticosteroid which has been evaluated for intranasal use in the treatment of adults and children with allergic rhinitis. In several large, well-controlled clinical trials, mometasone furoate 200 micrograms administered once daily as an aqueous intranasal spray was significantly more effective than placebo in controlling the symptoms associated with moderate to severe seasonal or perennial allergic rhinitis. Mometasone furoate was as effective as twice-daily beclomethasone dipropionate or once-daily fluticasone propionate in the treatment of perennial allergic rhinitis, and was as effective as twice-daily beclomethasone dipropionate and slightly more effective than once-daily oral loratadine in the treatment of seasonal allergic rhinitis. Mometasone furoate was also as effective as twice-daily beclomethasone dipropionate or once-daily budesonide, and significantly more effective than placebo in the prophylaxis of seasonal allergic rhinitis. The onset of action of mometasone furoate was approximately 7 hours in patients with seasonal allergic rhinitis. Mometasone furoate was as well tolerated as beclomethasone dipropionate, fluticasone propionate and budesonide in clinical trials, with an overall incidence of adverse events similar to placebo. Adverse events were generally mild to moderate and of limited duration. The most common adverse events associated with mometasone furoate therapy were nasal irritation and/or burning, headache, epistaxis and pharyngitis. Intranasal or oral mometasone furoate had no detectable effect on hypothalamic-pituitary-adrenal axis function in studies of < or = 1 year in duration. CONCLUSIONS: Mometasone furoate is a well tolerated intranasal corticosteroid with minimal systemic activity and an onset of action of < or = 7 hours. It is effective in the prophylaxis and treatment of seasonal allergic rhinitis and the treatment of perennial allergic rhinitis in patients with moderate to severe symptoms.     

The efficacy of fluticasone propionate aqueous nasal spray for allergic rhinitis and its relationship to topical effects

Fluticasone propionate aqueous nasal spray is an intranasal corticosteroid for the treatment of patients with allergic rhinitis. This double-masked, double-dummy, parallel-group study was conducted to confirm that the efficacy of fluticasone propionate nasal spray is attributable to topical rather than systemic effects. A total of 304 patients with documented seasonal allergic rhinitis were randomly assigned to receive fluticasone propionate nasal spray 200 micrograms once daily (n = 77), oral fluticasone propionate 5 mg once daily (n = 73), oral fluticasone propionate 10 mg once daily (n = 77), or placebo (n = 77) for 14 days. Plasma fluticasone propionate concentrations were determined at baseline and after 14 days of treatment (day 15). Nasal symptoms were recorded daily by patients and assessed weekly by clinicians. On day 15, more patients in the oral fluticasone propionate 5-mg or 10-mg groups, compared with patients in the fluticasone propionate nasal spray group or the placebo group, had detectable plasma fluticasone propionate concentrations, and mean concentrations were higher in the oral fluticasone propionate groups. Both clinician- and patient-rated total and individual nasal symptom scores for obstruction, rhinorrhea, sneezing, and itching were significantly lower in the fluticasone propionate nasal spray group compared with either of the oral fluticasone propionate groups or the placebo group. With few exceptions, oral fluticasone propionate (5 mg or 10 mg) was not significantly different from placebo on any measures of efficacy. These findings indicate that the efficacy of fluticasone propionate nasal spray (200 micrograms once daily) in the treatment of allergic rhinitis results from direct topical effects rather than from indirect effects after systemic absorption.     

Suppression of human melanoma metastasis following introduction of chromosome 6 is independent of NME1 (Nm23)

BACKGROUND: Nasal immunotherapy with single allergen extracts, following premedication with cromolyn, has been reported to be effective in treating seasonal and perennial allergic rhinitis. METHODS: We conducted a double-blind, placebo-controlled study to assess the efficacy, tolerability, and mechanism of action of nasal immunotherapy for allergic rhinitis caused by weed pollens from three unrelated families. Twenty-seven weed-allergic patients underwent baseline nasal provocation and titrated skin test with a mixed weed extract containing ragweed, sage, and Chenopod extracts. Patients were randomized to receive either mixed weed extract or placebo. Nasal immunotherapy was self-administered daily to alternate nostrils preceded by 5.2 mg intranasal cromolyn. Beginning with 1:2500 wt/vol the concentration was increased to 1:10 wt/vol over an average period of 36 days. The maintenance dose (1:10 wt/vol) was administered daily for 12 to 16 weeks through the weed pollen season. Patients recorded nasal and eye symptoms and the use of rescue medications throughout the study. A nasal lavage for cytokine levels and nasal scraping with Rhinoprobe for nasal cytology were performed at the peak of the weed season. Nasal provocation and titrated skin tests with mixed weed extract were repeated after the weed season. Nasal lavage and scraping were also performed before and 24 hours after the final nasal provocation. RESULTS: During the peak weeks of the weed season the group receiving mixed weed extract by nasal instillation, compared with those treated with placebo, had significantly lower total nasal symptom scores, total eye symptom scores, and symptom medication scores. There were no significant differences in the nasal cytology or cytokines levels between the two groups, except for elevated IL-10 in the nasal lavage in the treated group at the peak of the season. Nasal symptoms and medication use were higher preseasonally in the active treatment group. CONCLUSION: Nasal immunotherapy with aqueous mixed weed extract administered with cromolyn sodium pretreatment for 17 to 21 weeks was effective in reducing both nasal and ocular symptoms of weed pollen-induced allergic rhinitis. There were increased nasal symptoms in the treated group preseasonally.     

Nedocromil sodium is rapidly effective in the therapy of seasonal allergic rhinitis

BACKGROUND: Nedocromil sodium has proven to be efficacious in prophylactic and long-term therapy for the treatment of seasonal allergic rhinitis. We examined the speed of onset of intranasal nedocromil sodium (1%) for relief of symptoms due to ragweed allergic rhinitis. METHODS: In a double-blind, placebo-controlled trial, 104 patients received either nedocromil sodium or placebo four times daily. Patients spent 10 hours per day for 2 consecutive days in Iowa City Park during the peak of ragweed season. Only patients who had significant symptoms during 3 hourly baseline assessments received drug. Symptom scores for stuffy nose, runny nose, itchy nose, and sneezing and global symptom summary scores were recorded at 19 hourly time points during the 2 days. In the evening patients recorded symptom scores for the postexposure period. RESULTS: In comparison with placebo, nedocromil significantly improved rhinitis symptoms as evidenced by lower symptom summary scores within 2 hours (p = 0.016). Further, this reduction in rhinitis symptoms was maintained throughout the 2-day pollen exposure period. After patients left the study site, postexposure symptom summary scores were also significantly lower in patients treated with nedocromil compared with those treated with placebo (p < 0.007). CONCLUSIONS: Nedocromil significantly relieved preexisting seasonal allergic rhinitis symptoms during peak pollen exposures within 2 hours of the first dose, and the therapeutic benefits were maintained on a dosing regimen of four times a day.     

Fluticasone propionate aqueous nasal spray is safe and effective for children with seasonal allergic rhinitis

INTRODUCTION: Fluticasone propionate aqueous nasal spray, a new topical corticosteroid preparation, is effective when given as 200 micrograms once daily in patients (> 12 years of age) with seasonal allergic rhinitis. STUDY OBJECTIVE: To evaluate the efficacy and safety of fluticasone proprionate aqueous nasal spray in children aged 4 to 11 years with seasonal allergic rhinitis. STUDY DESIGN: Multicenter, randomized, double-blind, placebo-controlled, parallel-group. PATIENTS: Two hundred fifty children aged 4 to 11 years with moderate-to-severe nasal symptoms, a positive skin test reaction to a late-summer or autumn allergen, a history of seasonal allergic rhinitis, and documentation of an unsatisfactory response to conventional treatment. INTERVENTIONS: Children were randomly assigned to receive fluticasone propionate, either 100 micrograms or 200 micrograms, or placebo, given by intranasal spray once daily in the morning for 14 days. MEASUREMENTS AND RESULTS: Severity of nasal symptoms (obstruction, rhinorrhea, itching, and sneezing) was recorded on visual analog scales by investigators at weekly visits and by patients (or adult guardian) daily in the evening. According to investigator and patient ratings, both fluticasone propionate 100 micrograms/d and 200 micrograms/d lowered total nasal symptom scores when compared with placebo. Both dosages of fluticasone propionate were more effective than placebo on the basis of investigator-rated overall clinical evaluation of efficacy at the end of treatment, with significant improvement (as opposed to moderate or mild improvement, no change or worsening) noted in 21% to 29% of the active-treatment groups vs 9% in the placebo group. There were no significant differences between the two fluticasone propionate dosages in any efficacy measurement. Morning plasma cortisol concentrations and frequency of drug-related adverse events were similar in the fluticasone propionate and placebo groups. CONCLUSION: In children as young as 4 years, 100 micrograms of fluticasone propionate aqueous nasal spray given once daily is as effective as 200 micrograms given once daily, the usual adult dose for the treatment of seasonal allergic rhinitis. Both fluticasone propionate dosages were well tolerated and neither dosage appears to interfere with the hypothalamic-pituitary-adrenal axis in children.     

A clinical comparison of intranasal budesonide with beclomethasone dipropionate for perennial non-allergic rhinitis: a 12 month study

To evaluate possible differences in efficacy and safety between budesonide and beclomethasone dipropionate when used intranasally in the treatment of perennial non-allergic rhinitis, a 12-month open study was undertaken in 24 patients suffering from perennial non-allergic rhinitis. Both drugs were applied intranasally from pressurised aerosols at a daily dosage of 400 micrograms. On entry and at visits after 1, 2, 4, 6, 9 and 12 months, rhinoscopy was performed and the severity of nasal symptoms graded according to a four-point rating scale. All nasal symptoms were reduced from baseline during the treatment period in both groups. Tachyphylaxis was not observed. No clinically significant changes in haematology or blood chemistry parameters were observed in either group, and analysis of plasma cortisol levels revealed no influence of either drug on the hypothalamic-pituitary-adrenal axis. Local adverse reactions were uncommon and mild. Budesonide and beclomethasone dipropionate used intranasally at 400 micrograms per day were found to be safe, and budesonide was found to have a significantly higher (p < 0.05) efficacy than beclomethasone dipropionate in alleviating symptoms of perennial non-allergic rhinitis.     

The relationships between nasal hyperreactivity, quality of life, and nasal symptoms in patients with perennial allergic rhinitis

BACKGROUND: A clinical test that could inform the clinician about the severity of a patient's nasal symptoms and health-related quality of life (QOL) would be very useful. OBJECTIVE: We attempted to determine whether, in patients with perennial allergic rhinitis, nasal challenge with histamine could be used to estimate daily symptoms and QOL. METHODS: Forty-eight patients with perennial allergic rhinitis were challenged with histamine to determine nasal hyperreactivity. Nasal response was monitored by the number of sneezes, the amount of secretion, and a symptom score. Daily nasal symptoms were recorded during the 2 preceding weeks. Patients also completed a rhinitis QOL questionnaire. RESULTS: Responsiveness to histamine and total daily nasal symptoms were moderately correlated (r = 0.51, p = 0.001). Comparison of total daily nasal symptoms with the overall QOL score showed a moderate correlation (r = 0.59, p < 0.001). Nasal response to histamine and overall QOL score were also correlated (r = 0.43, p = 0.002). However, overall QOL and daily nasal symptoms could be predicted by wide 95% confidence intervals only for each decade of nasal responsiveness to histamine (expressed as a composite symptom score). CONCLUSION: In patients with perennial allergic rhinitis nasal hyperreactivity as determined by histamine challenge, QOL, and daily nasal symptoms are moderately correlated. Therefore nasal histamine challenge can be used as a tool for estimating the severity of daily nasal symptoms and QOL, although it cannot predict nasal symptoms and QOL very accurately.     

Effect of topical steroids on nasal nitric oxide production in children with perennial allergic rhinitis: a pilot study

It has been hypothesized that concentrations of exhaled nitric oxide (NO) may be related to the extent of cytokine-mediated airway inflammation. Recent findings indicate the nasal airways as an important site of NO production. Our objective was to evaluate whether children with allergic rhinitis show different nasal NO levels when compared with normal healthy subjects and the effect of topical steroids and anti-histamine therapy. We have measured the concentration of NO drawn from the nose of 21 children (5-17 years old) affected by perennial allergic rhinitis (house dust mite) out of therapy for at least 3 weeks. Thirteen children were then treated with nasal beclomethasone dipropionate (BDP) (400 micrograms daily) and eight subjects with nasal anti-histamine levocabastine (200 micrograms daily). Measurements were performed before and after 10 days of treatment. As a control group we evaluated 21 healthy children aged 5-15 years. To measure NO we used a chemiluminescence analyser. Before treatment the whole group of children with allergic rhinitis showed a mean (+/- SEM) nasal NO concentration of 267 +/- 18 ppb, significantly higher (P < 0.01) than the control group (186 +/- 15 ppb). The group of children treated with BDP showed, after 10 days of therapy, a significant (P < 0.05) decrease of nasal NO concentration (271 +/- 21 ppb vs. 212 +/- 20 ppb). Indeed, in the group treated with levocabastine, nasal NO concentrations did not present a significant difference (P not significant) compared with baseline (261 +/- 33 ppb and 252 +/- 31 ppb, respectively). These data suggest that (1) children with allergic rhinitis have higher levels of nasal NO than non-atopic controls and (2) intranasal steroid therapy significantly reduces nasal NO production in children with allergic rhinitis. We speculate that the allergic inflammatory response may influence the nasal NO levels and that NO measurements may be a useful marker of nasal inflammation.     

Pharmacotherapy in the elderly--pharmacokinetic and pharmacodynamic considerations]

OBJECTIVE: N-acetyl-aspartyl-glutamic acid (NAAGA) was effective in the treatment of allergic rhinitis, with an action on early allergen-induced nasal symptoms and mediator release. The aim of this study was to evaluate the clinical activity of NAAGA and its effects on the late antigen-induced reaction in the nose. METHODS: Ten patients with allergic seasonal rhinitis were included in this randomized double-blind crossover trial of a 6% wt/vol solution of NAAGA (daily dosage 84 mg) versus placebo (lactose). The drug and placebo were administered intranasally five times daily for 1 week, with a 2-week interval between treatments. RESULTS: Treatment with NAAGA, but not with placebo, significantly reduced the late antigen-induced nasal symptoms, mainly nasal obstruction. Eosinophil numbers in the nasal lavages collected 6 h and 24 h after challenge were significantly lower after NAAGA than after placebo. Active treatment also significantly reduced the neutrophil count 6 h after antigen challenge, and significantly lowered eosinophil cationic protein and myeloperoxidase levels in nasal lavages 6 h and 24 h after antigen challenge. CONCLUSION: These results indicate that treatment for 1 week with NAAGA can reduce the late antigen-induced reaction in the nose. This is accompanied by a reduction in eosinophil and neutrophil recruitment and release of eosinophil cationic protein and myeloperoxidase.     

The localization and functional significance of arylsulfatases in parasitic sarcosporidian protozoa in the tissue-cyst life cycle phase

Ten patients with perennial allergic rhinitis and 10 healthy subjects were studied to determine most discriminative nasal irrigation fluid marker(s) and to compare samples that were collected at baseline and over a 1-hour period, every 15 minutes. The latter were pooled and designated 1-hour sample. In the nasal irrigation we investigated the following inflammatory cells and soluble mediators: eosinophils, neutrophils, granulocyte-macrophage colony-stimulating factor, interleukin-4, interleukin-6, interleukin-8, ECP, EPX, MPO, leukotriene C4, leukotriene B4, prostaglandin E2, tryptase and fibrinogen. Patients with PAR were then treated for 2 weeks with the topical nasal steroid. The only marker that discriminated patients with perennial allergic rhinitis and healthy subjects was eosinophil count (EO%): correspondingly 14.01 +/- 5.8 and 0.18 +/- 0.09, (M +/- SD). Difference between the studied groups did not depend on the time of irrigation, baseline or 1-hour. EO% was also the only marker of a clinically successful treatment with the nasal steroid, 14.01 +/- 5.8 and 0.87 +/- 0.4, before and after treatment respectively. We conclude that EO% is the most sensitive inflammatory marker of perennial allergic rhinitis, and that baseline nasal irrigation can be used to study nasal mucosal inflammation.     

Levocabastine versus cetirizine for perennial allergic rhinitis in children

OBJECTIVE: To compare the efficacy and safety of levocabastine nasal spray asid cetirizine oral for the treatment of perennial allergic rhinitis in children. MATERIAL AND METHODS: In this randomized, prospective experimental, open clinical trial. We studied 30 children with ages between 6 and 16 years with perennial allergic rhinitis. Group 1, 17 subjects (7 female, 10 male) received cetirizine once daily, 5 mg children weientig less dian 30 k asid 10 mg in children weighing more trw' 30 k during 15 days. Group 2, 13 subjects (7 male, 6 female) received levocabastine 2 puffs BID on each nostril during tbe same time. A nasal symptoms score, nasal peal: flow vid eosinophils in a nasal smear were performed before and after treatment. RESULTS: There were no statistical differences in age, weight, height and arid duration of symptoms. Both groups showed improvement of symptoms via nasal peak flow with no differences between them (intergroup); nasal eosinophils remained unchanged. We for third statistical differences pre vid postreatment in each group (intragroup): Group 1, nasal congestion p = 0.002, ocular itch p = 0.01, sneezing p = 0.007, nasal secretion p = 0.01, nasal itch O = 0.009, total points O = 0.0005. Group 2, nasal congestion O = 0.02, ocular itch p = 0.05, sneezing p = 0.01, nasal secretion p = 0.01, nasal itch p = 0.04, total points p = 0.005. Significant differences were found in nasal peal' flow in Group 1 (p = 0.01) but no differences in eosinophils between file two groups. Side effects: 3 subjects in Group 1 (drowsiness, 1 appetite increase said 1 rhinorrea with epistaxis) vide 1 in Group 2 sensation of facial edema. CONCLUSION: Bofil drugs are effective the clinical relief of symptoms of perennial allergic rhinitis in children vied levocabastine has less side effects.     

Fluticasone propionate nasal spray is more effective and has a faster onset of action than placebo in treatment of rhinitis medicamentosa

BACKGROUND: Controversy still exists about the treatment of rhinitis medicamentosa and treatment has never been objectively evaluated. OBJECTIVE: To study the effect of fluticasone propionate aqueous nasal spray compared to placebo nasal spray in the treatment of rhinitis medicamentosa. METHODS: A parallel randomized, double-blind study was conducted to evaluate the treatment of rhinitis medicamentosa. Two groups containing 10 patients with rhinitis medicamentosa in each group stopped their overuse of nasal vasoconstrictor spray immediately and were treated with either fluticasone propionate nasal spray once daily 200 micrograms, or placebo nasal spray for 14 days. The nasal mucosal swelling was recorded with rhinostereometry, acoustic rhinometry and a peak inspiratory flow meter. Nasal stuffiness was estimated on a visual analogue scale in the morning and in the evening of each day. RESULTS: The mucosal swelling decreased after 7 and 14 days of treatment with fluticasone propionate as well as placebo, but the reduction was significantly greater after treatment with fluticasone propionate. The symptom scores for nasal stuffiness showed a marked reduction during the treatment period in both groups, but there was a faster onset of symptom reduction after treatment with fluticasone propionate. CONCLUSION: Fluticasone propionate is more effective and has a faster onset of action than placebo in the treatment of rhinitis medicamentosa. An adequate treatment of these patients consists of a combination of vasoconstrictor withdrawal and a topical corticosteroid to alleviate the withdrawal process.     

Eosinophil markers in seasonal allergic rhinitis. Intranasal fluticasone propionate inhibits local and systemic increases during the pollen season

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 groups and the placebo group for all parameters (P<0.001-P<0.05). Higher eosinophil count (P<0.05), serum EPO (P<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.     

Nedocromil sodium 1% nasal spray in the treatment of allergic rhinitis caused by Dermatophagoides pteronyssinus

We have evaluated the efficacy of Nedocromil sodium 1% nasal solution in 36 patients (20 females and 16 males, mean age 29.5 years) suffering from perennial allergic rhinitis caused by Dermatophagoides pteronyssinus. Nedocromil sodium was given four times a day for 2 months. On a daily card patients had to report the severity of the considered symptoms (runny, nose, sneezing, itchy nose and stuffy nose) following an arbitrary score from 0 to 3 (0 = no symptom, 1 = mild, 2 = moderate, 3 = severe). Clinical evaluation was performed after 1 month and at the end of the treatment. We observed a statistically significant decrease of the considered symptoms already after a one month therapy. This improvement was higher after two months (p < 0.001). No side effects have been reported and no concomitant symptomatic therapy was needed. Nedocromil sodium is therefore a safe and efficacious drug in the treatment of allergic rhinitis caused by Dermatophagoides pteronyssinus.     

Onset of action of aqueous beclomethasone dipropionate nasal spray in seasonal allergic rhinitis

Beclomethasone dipropionate nasal spray is widely used in the treatment of seasonal allergic rhinitis; however, the time of onset of action has not been determined. This study assessed the onset of action, level of relief, and efficacy of beclomethasone nasal spray in patients with seasonal allergic rhinitis. In a double-blind, randomized, placebo-controlled, parallel-group, multicenter, 7-day study, symptomatic patients were administered two inhalations of beclomethasone dipropionate (n = 80) or placebo (n = 81) into each nostril twice daily. Patients assessed the onset of action and level of relief at 6, 24, and 48 hours and at days 3 and 7. Investigators evaluated symptoms at days 0, 3, and 7 and response to therapy at days 3 and 7. The difference in the cumulative number of patients reporting relief of symptoms was statistically significant in favor of beclomethasone dipropionate by hour 24 (P = 0.05). Patients in the beclomethasone dipropionate group experienced a greater level of relief than patients receiving placebo at hour 24, and improvement increased over the 7-day study compared with a decrease in relief in the placebo group. Beclomethasone dipropionate was significantly more effective than placebo in reducing symptoms (P < or = 0.02), and patients in the beclomethasone dipropionate group showed a more favorable response to treatment than did patients in the placebo group (P < 0.01). Adverse events were minor in both groups. Beclomethasone dipropionate nasal spray produced significant onset of relief of symptoms the first day of treatment; improvement was sustained and increased over the course of the study.     

Soluble intercellular adhesion molecule-1 level in sera is elevated in perennial allergic rhinitis

Soluble intercellular adhesion molecule-1 (sICAM-1) in sera was measured in some allergic disorders, but serum sICAM-1 levels in perennial allergic rhinitis remain to be determined. Our study was aimed at elucidating whether the serum sICAM-1 levels in patients with perennial allergic rhinitis are different from those in nonatopic healthy volunteers and whether immunotherapy can modulate sICAM-1 levels. Serum sICAM-1 was determined in 20 nonallergic volunteers and 137 patients with perennial allergic rhinitis by a sandwich enzyme-linked immunosorbent assay. Our study demonstrated that the level of sICAM-1 in untreated patients is significantly elevated, as compared with nonatopic subjects. Immunotherapy could decrease sICAM-1 in perennial allergic rhinitis, but this suppressive effect became apparent only after many years of immunotherapy. In patients on immunotherapy, a close correlation was observed between sICAM-1 and nasal symptom scores. To take these lines of evidence together, a decrease in sICAM-1 might be related to the working mechanism of immunotherapy, and serum sICAM-1 could be used to monitor the effect of immunotherapy.     

Serologic study of the working mechanisms of immunotherapy for children with perennial allergic rhinitis

BACKGROUND: Recent double-blind placebo-controlled trials have clearly shown the efficacy of immunotherapy for perennial allergic rhinitis. However, the exact working mechanisms related to the clinical effect of immunotherapy remain unclear. OBJECTIVES: To monitor the changes over time in immunologic parameters in children who received immunotherapy for perennial allergic rhinitis, and to elucidate the working mechanisms of immunotherapy related to its clinical efficacy. DESIGN: Nineteen children with perennial allergic rhinitis due to Dermatophagoides farinae enrolled in this prospective open study. Venous blood was collected to determine levels of specific IgE, specific IgG4, soluble interleukin 2 receptor, interleukin 4, soluble intercellular adhesion molecule 1, and soluble vascular cell adhesion molecule 1 at enrollment and 1, 2, 3, 5, and 10 years after enrollment. RESULTS: Immunotherapy affected serum levels of specific IgE, specific IgG4, soluble interleukin 2 receptor, interleukin 4, and soluble intercellular adhesion molecule 1, but not soluble vascular cell adhesion molecule 1. The rates of increase of levels of specific IgG4 and the rates of decrease of levels of soluble interleukin 2 receptor were correlated with the rates of decrease of symptom scores during the first 3 years of treatment, but not after 5 years. The rates of decrease in levels of soluble intercellular adhesion molecule 1 were correlated with the rates of decrease in symptom scores at 3 and 5 years after the beginning of the course of immunotherapy. The rates of decrease in levels of specific IgE and interleukin 4 were correlated with the rates of decrease in symptom scores after 5 and 10 years of treatment, but not during the first 3 years. CONCLUSION: Each modulation in levels of specific IgE, specific IgG4, soluble interleukin 2 receptor, interleukin 4, and soluble intercellular adhesion molecule 1 contributed to the clinical effect of immunotherapy in particular phases of treatment for children with perennial allergic rhinitis.