Intramuscular betamethasone dipropionate vs. topical beclomethasone dipropionate and placebo in hay fever

A double-blind, double-dummy comparative study was made of 30 adult birch pollen-allergic outpatients with seasonal rhinoconjunctivitis. They were treated with either topically applied beclomethasone dipropionate 100 micrograms in each nostril twice daily for 4 weeks, placebo, or an injection of 2 ml of a suspension containing 5 mg betamethasone dipropionate and 2 mg betamethasone disodium phosphate per ml (Diprospan) immediately prior to the birch pollen season. Placebo- and topical steroid-treated patients experienced an increase in rhinoconjunctivitis symptoms, i.e. nasal blockage, nasal itching, rhinorrhea, sneezing and eye symptoms, and placebo-treated patients used significantly more antihistamine tablets during the pollen season. Diprospan-treated patients experienced fewer symptoms on all measured parameters. We concluded that one injection of Diprospan immediately prior to the birch pollen season produces significantly fewer rhinoconjunctivitis symptoms than does placebo and topical steroid treatment.     

Efficacy of continuous treatment with astemizole (Hismanal) and terfenadine (Seldane) in ragweed pollen-induced rhinoconjunctivitis

Astemizole (Hismanal; Janssen Pharmaceutica Inc., Mississauga, Ontario, Canada) and terfenadine (Seldane; Merrell Dow Pharmaceuticals [Canada], Inc., Concord, Ontario, Canada) were compared for clinical efficacy in a double-blind randomized trial during the ragweed pollen season. Sixty adults, with a history of ragweed-induced rhinoconjunctivitis, were matched according to sensitivity to ragweed pollen. Half took astemizole, 10 mg/day, and the rest took terfenadine, 60 mg twice daily. Medications were started 1 week before and continued daily until 1 week after the ragweed pollen season (7 weeks). If the trial medication was insufficient to keep symptoms well controlled, a steroid nasal spray and/or eye drops were used in the minimum dose that would ensure symptoms were not troublesome. Subjects completed a diary of nocturnal and daytime nasal and eye symptoms and recorded the amount of concomitant medications used. Astemizole showed greater efficacy than terfenadine in controlling rhinorrhea; in addition, the astemizole group used less nasal spray. Other nasal symptoms, eye symptoms, and use of eye drops were similar in the two groups. Skin test sensitivity to serial dilutions of histamine and ragweed extract was determined 1 and 7 weeks after the start of the trial medication. More tachyphylaxis to histamine was shown by the subjects taking terfenadine, as demonstrated by a larger increase in skin sensitivity over the study period. However, a similar change was not observed for ragweed skin sensitivity. These results suggest that when the medication is started before and continued daily throughout the pollen season, astemizole is more efficacious than terfenadine in controlling nasal symptoms, but there is little difference for eye symptoms.(ABSTRACT TRUNCATED AT 250 WORDS)     

Treatment of hay fever with loratadine - a new non-sedating antihistamine

The efficacy and safety of loratadine, a new orally active specific H1-receptor blocking antihistamine with poor penetration into the CNS, was evaluated in a double blind comparative study. One hundred and seven hay fever patients, sensitive to birch pollen, were randomized into three parallel groups receiving loratadine 40 mg once daily, clemastine 1 mg twice daily, or placebo during the birch pollen season. Both active treatments showed reduction of symptoms in comparison with placebo, but the results were more pronounced with loratadine treatment, which significantly reduced the overall allergic condition as well as all separate allergic rhino-conjunctivitis symptoms except nasal stuffiness. Compared with placebo the sedation rate was significantly higher with clemastine treatment (P less than 0.05) but not with loratadine. Loratadine was thus concluded to be efficacious in hay fever treatment with a sedation rate not differing from placebo.     

A clinical comparison of budesonide nasal aerosol, terfenadine and a combined therapy of budesonide and oxymetazoline in adult patients with perennial rhinitis.

The efficacy of budesonide, terfenadine and a combination of budesonide and oxymetazoline in the treatment of perennial rhinitis was evaluated by a double blind, parallel group study. Adult patients with perennial rhinitis were randomized into three groups. Group 1 patients received budesonide nasal aerosol 400 micrograms/day for 21 days and oxymetazoline nasal drops for the first three days. Group 2 and 3 patients received budesonide 400 micrograms/day and terfenadne tablet 60 mg twice/day respectively. Nasal symptoms were assessed by the patients before and daily during the treatment period using a simple scoring system. One hundred and forty-two patients were recruited and 130 completed the study. Budesonide, but not terfenadine, significantly reduced all nasal symptoms from baseline (p less than 0.05). Terfenadine could significantly relieve the nasal blockage (p less than 0.05) more than other nasal symptoms. Budesonide with or without oxymetazoline nasal drops provided a better control of nasal symptoms than terfenadine (p less than 0.05). Budesonide with oxymetazoline for the first three days showed a faster relief of nasal blockage than budesonide alone (p less than 0.05). Mild and transient adverse effects were encountered in all three groups. It is concluded that nasal symptoms of perennial rhinitis are more adequately controlled by budesonide than by terfenadine.     

A double-blind comparison of fluticasone propionate aqueous nasal spray,terfenadine tablets and placebo in the treatment of patients with seasonal allergic rhinitis to grass pollen

Fluticasone Propionate Aqueous Nasal Spray (FPANS) contains a topically active glucocorticoid fluticasone propionate which has been used successfully for the treatment of seasonal allergic rhinitis. This multicentre, randomized, double-blind, double-dummy, placebo-controlled, parallel group study was designed to compare the efficacy and tolerability of FPANS with terfenadine tablets or placebo in controlling the symptoms of allergic rhinitis to grass pollen. Two hundred and fourteen patients were treated for 6 weeks during the grass pollen season with either FPANS 200 μg once daily, terfenadine tablets (60 mg) twice daily or placebo. Efficacy was evaluated by the analysis of symptom-free days and median symptom scores. Patients receiving FPANS had significantly more days free of nasal blockage on waking (P = 0·012) and during the day (P = 0·01) and of rhinorrhoea (P = 0·027) than those receiving terfenadine. Additionally, in terms of absolute efficacy, patients receiving FPANS demonstrated significantly more days free of the above symptoms (P = 0·017, P = 0·028, P = 0·004, respectively) and of sneezing (P < 0·001) than those receiving placebo. There were no significant differences in symptoms of nasal itching, eye symptoms, of symptoms of drowsiness between the three treatment groups. Patients in the FPANS group had significantly lower median symptom scores for nasal blockage on waking (P < 0·001) and during the day (P < 0·018) than those in the terfenadine group and significantly lower scores for nasal blockage on waking (P < 0·001), sneezing (P < 0·013) and rhinorrhoea (P = 0·005) than those in the placebo group. The use of rescue medication was similar in all three treatment groups. Adverse events were similar in nature and frequency in all three treatment groups, most were mild and considered by the investigator at each centre unlikely to be related or unrelated to the study treatment. There were very few clinically significant laboratory abnormalities observed in any group. It is concluded that FPANS (200 μg once daily) is an effective and well-tolerated treatment for seasonal allergic rhinitis and is significantly more effective than terfenadine (60 mg twice daily) in controlling nasal blockage at all times of the day and rhinorrhoea.     

Immunotherapy of tree pollen allergy with a modified alginate conjugated birch pollen extract compared to an aluminium adsorbed extract

The safety and efficacy of two birch pollen extracts, one chemically conjugated to alginate (Anjuvac) the other adsorbed to aluminium hydroxide (Alutard), were investigated in an open multicentre comparative study of 63 birch pollen allergic patients. Both extracts decreased the nasal symptoms during the birch pollen season. The changes in specific IgE and IgG were much the same in both treatment groups. The adverse reactions recorded were mild in both groups, but more frequent in the Anjuvac group, probably because of a more aggressive dose schedule though there were twice as many asthmatics in the Anjuvac group. The two investigated allergen extracts were useful alternatives for immunotherapy.     

Comparison of the efficacy and side effects of aqueous steroid nasal spray (budesonide) and allergen-injection therapy (Pollinex-R) in the treatment of seasonal allergic rhinoconjunctivitis

The efficacy and side effects of two approaches to the treatment of ragweed pollen-induced rhinoconjunctivitis were compared in a double-blind, parallel-group trial. Sixty ragweed-sensitive adults were randomized either to a course of four Pollinex-R hyposensitization injections during the 6 weeks before the ragweed-pollen season, or to budesonide aqueous nasal steroid spray, 400 micrograms daily, throughout the season. A double-dummy technique was used to achieve blinding. During the ragweed-pollen season, troublesome nasal symptoms were treated with terfenadine, 60 mg, when treatment was needed, up to 240 mg daily, and eye symptoms were treated with naphazoline eye drops, when treatment was needed, up to four times daily. Every day, subjects recorded the severity of nasal and eye symptoms and medication use in a diary. Fourteen of the subjects receiving Pollinex-R were unable to complete the course of injections because of systemic or large local reactions. Eight subjects withdrew during the pollen season because of severe rhinitis; all subjects had received Pollinex-R. Subjects in the budesonide-treated group had minimal nasal symptoms and used very little terfenadine, compared with subjects in the Pollinex-R-treated group (p less than 0.0001). Eye symptoms and eye drop use were similar in the two treatment groups. No clinically important side effects were reported by the subjects receiving budesonide. The results of this study suggest that aqueous budesonide nasal spray is markedly more effective than Pollinex-R in controlling symptoms of seasonal rhinitis while the side effects and inconvenience of immunotherapy are avoided.     

Comparison of nasal immunohistology in patients with seasonal rhinoconjunctivitis treated with topical steroids or specific allergen immunotherapy

BACKGROUND: Specific allergen immunotherapy (SIT) and nasal steroids (NS) are considered effective anti-inflammatory treatments for allergic rhinitis, although their mechanism of action differs. OBJECTIVE: The aim of this study was to examine the effect of treatment with NS and SIT on different populations of inflammatory cells in the nasal mucosa and to compare cell numbers before and during the birch pollen season in patients with seasonal allergic rhinitis. METHODS: In a randomized, double-blind, double dummy comparative study, 41 patients with seasonal rhinoconjunctivitis were treated with birch SIT or NS (budesonide 400 microg daily). Treatment with NS started before the birch pollen season and at the same time SIT-treated patients reached the maintenance dose. Nasal biopsies for immunohistochemistry were obtained before the season and start of the treatments and at the peak of the pollen season during treatment. RESULTS: Symptoms of rhinoconjunctivitis increased significantly in both groups during the pollen season but less in the NS-treated group and the difference between the treatment groups was significant at the end of the season (P = 0.03). Immunohistochemistry of nasal biopsies from NS-treated patients showed significantly fewer CD1a+, IgE+ and Fc epsilonRI+ cells during the season compared with preseason (P = 0.02, P = 0.001 and P = 0.0004, respectively) and with seasonal values of the SIT-treated group (P = 0.002, P = 0.002 and P = 0.0004 respectively). CONCLUSION: Treatment with NS but not SIT decreased the numbers of CD1a+, IgE+ and Fc epsilonRI+ cells during the birch pollen season. Our data indicate that treatment with NS has a broader anti-inflammatory range than SIT.     

Clinical, functional, and immunologic effects of sublingual immunotherapy in birch pollinosis: a 3-year randomized controlled study

BACKGROUND: Sublingual immunotherapy (SLIT) has been proved effective in allergic rhinitis, but there are few studies assessing its effects on inflammation and on the lower airways. OBJECTIVE: We sought to evaluate at the same time the effects of SLIT on rhinitis symptoms, nasal inflammation, and lower airways function in patients with birch pollinosis. METHODS: Adult patients with rhinitis and asthma monosensitized to birch were evaluated during a run-in pollen season and then randomized to receive openly either drugs alone or drugs plus SLIT and reevaluated in the subsequent 4 pollen seasons. Rhinitis symptoms and consumption of bronchodilators were assessed by means of diary card. A nasal smear for eosinophil count was carried out in and out of pollen seasons, and pulmonary function tests with methacholine challenge were performed at each season. RESULTS: Of 79 enrolled patients, 27 dropped out, with a significantly higher rate of dropouts in the control group. There was a decrease in symptoms and bronchodilator use in the SLIT group versus the control group, becoming significant at the second and third pollen seasons, respectively ( P < .01 at all times). Nasal eosinophils decreased significantly in the active group, starting from the third pollen season ( P < .01). In the SLIT group a significant increase in FEV 1 , specific airways conductance, and maximal expiratory flow at 25% of forced vital capacity was seen starting from the second year and was associated with an increase in the methacholine threshold dose ( P < .01). The differences were significant also at the intragroup comparison over time. CONCLUSION: SLIT achieved a significant clinical benefit in birch pollinosis, reduced the eosinophil infiltration in nasal mucosa, and significantly improved pulmonary function during the pollen seasons.     

A multicenter, open study of the non-sedating antihistamine, terfenadine (Seldane), in the maintenance therapy of seasonal allergic rhinitis

A multicenter open study was conducted throughout the 1984 fall pollen season to assess the possible development of tolerance or loss of efficacy to terfenadine in the maintenance therapy of patients with seasonal pollinosis. Patients with proven allergic pollinosis were entered into a 1-week initial treatment period taking terfenadine 60 mg bid and only those who responded to the initial treatment with "moderate" to "complete" relief continued on terfenadine throughout a 4 to 11-week pollen season for evaluation of continued efficacy. A total of 179 patients from five study centers were enrolled in the initial treatment period and 154 (86%) responded to terfenadine with "moderate" to "complete" relief of symptoms. Of these 154 patients who continued terfenadine treatment, approximately 90% of the patients maintained the same degree of relief throughout the pollen season. All symptoms of seasonal pollinosis including nasal congestion improved significantly the first day of treatment. This improvement in symptoms continued during the first week and remained unabated throughout the pollen season. The incidence of adverse events was low with sedation being reported by only 2.8% of patients at some time point during the study. It is concluded that terfenadine is a safe and effective non-sedating antihistamine in the maintenance therapy of seasonal allergic pollinosis and that tolerance is not noted during continued administration.     

Pollen count, symptom and medicine score in birch pollinosis. A mathematical approach

This study investigates the correlation between the daily birch pollen counts, hay fever symptoms and medicine scores. Fifteen birch pollinosis patients were studied during two consecutive birch pollen seasons. All had a positive history for birch hay fever and a positive skin prick test, nasal provocation test and/or conjunctival provocation test to birch pollen. The patients recorded daily symptom and medicine scores during February through May for two seasons. According to nasal/conjunctival sensitivity and medicine consumption the group was divided into three groups: very sensitive, sensitive, and fairly sensitive. The mathematical calculations were based only on the results from the two most sensitive groups. The relationship between symptom scores and medicine scores as a function of the pollen load was nonlinear. A mathematical model was calculated. It was found that simply adding symptom scores and medicine scores to a total symptom/medication score was not meaningful as a basis for a quantitative analysis. It was further shown that the response caused by a given pollen load decays exponentially with time and that this decay had a characteristic half-life period of about 1-2 days indicating a long-lasting effect, i.e. contribution of the late allergic reaction to symptoms. Both groups showed the development of increased medicine intake during the season for a constant pollen load. This indicates the development of a higher sensitivity to birch pollen during the season. The overall response was divided into characteristic levels based on dose-response relationships, and pollen concentration intervals for forecasting purposes are suggested.     

Intramuscular betamethasone dipropionate vs. oral prednisolone in hay fever patients

In a double-blind group comparative study, 36 adult, birch pollen-allergic outpatients with seasonal rhinoconjunctivitis, were treated with either oral prednisolone 7.5 mg daily for 3 weeks or an injection with 2 ml suspension of betamethasone dipropionate and betamethasone disodium phosphate (Diprospan) immediately prior to the birch pollen season. Both treatments were able to prevent an increase in symptoms from the nose and the eyes during the 3-week birch pollen season. There was no significant difference in symptom score or nasal peak flow between the two treatments. However, there was a significant suppression of adrenal gland function after oral prednisolone treatment in contrast to Diprospan treatment. Unless there are contraindications for treatment with depot steroid injections (children, pregnant women, patients suffering from peptic ulcer, tuberculosis, eye disease, herpes, hypertension or diabetes) it seems to be a reasonable alternative to oral prednisolone in hay fever patients.     

Albumin, bradykinins, and eosinophil cationic protein on the nasal mucosal surface in patients with hay fever during natural allergen exposure

This study examined plasma- and eosinophil-derived products in nasal lavage fluids obtained from patients with hay fever during natural allergen exposure. Nine patients with strictly seasonal allergic rhinitis and five normal, nonallergic subjects (control group) were studied. Nasal lavages were performed twice weekly, starting 1 week before the expected birch-pollen season and continuing for 6 weeks, thereby covering the entire birch-pollen season. Nasal symptoms and pollen counts were recorded daily. The lavage fluid was analyzed for it content of albumin, bradykinins, and eosinophil cationic protein (ECP). During the pollen season, each of these solutes was significantly increased in the nasal lavage fluid from the allergic patients (p less than 0.05) but not from the control subjects. Albumin, bradykinins, and ECP generally correlated better between themselves than with symptoms and pollen counts. We conclude that natural exposure to allergens induces plasma exudation and increased levels of ECP on the human nasal mucosa.     

Loratadine and terfenadine in perennial allergic rhinitis

The efficacy of loratadine and terfenadine in perennial allergic rhinitis was evaluated in a double-blind, selected cross-over study consisting of two phases. During the first phase, 76 patients with perennial allergic rhinitis, 8–67 years old, were included in the study. Of these, 41 patients received loratadine 10 mg daily, and 35 patients received terfenadine 60 mg twice daily, for 2 weeks. According to symptoms and side-effects, 32 patients were classified as responders to loratadine, and 28 patients as responders to terfenadine. All observed symptoms were significantly reduced in both treatment groups, but with no significant differences between the two groups. Side-effects were few and mild. In patients with normal IgE, loratadine was significantly superior to terfenadine in relieving nasal secretion, whereas terfenadine was significantly superior to loratadine in relieving nasal congestion. In patients with increased IgE, patients treated with loratadine showed significantly greater reduction in sneezing than patients treated with terfenadine. A positive correlation between total IgE and reduction in overall symptoms was found for patients treated with loratadine, whereas a negative correlation was found for patients treated with terfenadine. During the second study phase, the nonresponders received the other drug for 2 weeks. All seven nonresponders to terfenadine responded to loratadine after crossing over, whereas four of nine nonresponders to loratadine responded to terfenadine. Nonresponders to one drug may respond to the other drug. Thus, more than one antihistamine drug should be tried in perennial allergic rhinitis if the first fails.     

Cross-reactivity between deciduous trees during immunotherapy. I. In vivo results

Thirty-nine children with rhinoconjunctivitis due to birch pollinosis were given immunotherapy for 3 years with a potent, purified pollen preparation made from either birch alone or from a mixture of birch, alder and hazel. The therapy was evaluated with self-evaluation after each season, daily symptom score during the season, conjunctival provocation test and skin-prick test. All children but one considered that their condition had been improved by the treatment. Symptom scores decreased slightly more in the group treated with the mixture than in the group treated with birch only due to symptoms decreasing faster in the mixture treated group after each pollen peak (P< 0.001). The sensitivity of the conjunctiva and the skin decreased significantly in both groups but without any significant differences between the groups. After 3 years the conjunctival sensitivity correlated strongly to eye symptoms during the season. Immunotherapy with a mixture of birch, alder and hazel appears to be at least as effective as a preparation made from birch only when treating birch pollinosis even in a region where birch is totally dominating among the pollens from deciduous trees.     

Topical levocabastine versus sodium cromoglycate in allergic conjunctivitis

The aim of this study was to evaluate the effect of levocabastine, a new H1-blocking antihistamine for topical use, in comparison with sodium cromoglycate on conjunctival symptoms of birch pollinosis. The two drugs were compared in a randomized double-blind comparative study over 5 weeks in 37 children and adolescents (6-19 years of age) with birch pollen conjunctivitis. Nasal symptoms occurred in 31 of the children and were treated with beclomethasone dipropionate nasal spray. An oral antihistamine was offered as rescue medication for eye symptoms. Initially, the patients received placebo four times a day for a 7-day run-in period. Conjunctival symptoms were recorded daily on diary cards on a 100 mm visual analogue scale. The pollen counts indicated a short but intensive birch pollen season. There was no statistically significant difference between the two treatment groups with regard to eye symptom scores before and during active treatment. However, the patients' evaluation of the efficacy of the therapy was in favour of levocabastine (P less than 0.01). Topical levocabastine, an H1-blocker, applied twice daily, seems to protect from symptoms of allergic conjunctivities as favourably as sodium cromoglycate applied four times a day. There was no difference in number or character of reported adverse reactions between the two treatment groups.     

Preseasonal intranasal immunotherapy in birch-alder allergic rhinitis

A double-blind, placebo-controlled study was carried out to test the clinical efficacy and safety of local nasal immunotherapy (LNIT) in powder form. Twenty-two patients suffering from allergic rhinitis strictly associated with early spring symptoms, with positive skin prick tests and RAST for birch-alder, all responders to a specific nasal provocation test (NPT), received randomly active or placebo treatment for 4 months. Immunotherapy consisted of administration of a set of capsules containing progressively increasing amounts of birch ( Betula pendula ) and speckled alder ( Alnus incana ) allergens in powder form with controlled granulometry. The active (birch-alder) and placebo (lactose) group completed the treatment according to a similar schedule. During the pollen season (March-April), the patients who took the active treatment reported less sneezing and rhinorrhea than the placebo group, on the basis of a symptoms score, and the differences were statistically significant; the need for drugs (terfenadine) was also significantly reduced. These findings agreed well with the results of specific NPT after the treatment; only patients in the active group had a higher threshold dose of nasal specific reactivity to birch-alder allergens than in tests before the LNIT.     

A comparison of topical levocabastine and sodium cromoglycate in the treatment of pollen-provoked allergic conjunctivitis

A total of 71 patients with documented birch and grass pollen allergy participated in this randomized, double-blind, parallel-group study initiated to compare the long-term therapeutic efficacy of twice daily levocabastine, a new topical H₁-receptor blocker, with that of sodium cromoglycate four times daily in the treatment of pollen-provoked conjunctivitis. There was no statistically significant difference in therapeutic efficacy between the two treatment groups, although a positive trend in favour of levocabastine was observed. Global evaluations of therapeutic efficacy were similar in both treatment groups. A total of 94% of levocabastine-treated patients rated treatment to be excellent or good compared with 86% of patients in the sodium cromoglycate group. Moreover, there were no significant differences in the severity of allergic symptoms reported on the patient diary cards. Patients were permitted to use rescue medication (oral terfenadine and betamethasone nasal spray) if symptoms became severe. The use of rescue medication was lower in the levocabastine group than in the sodium cromoglycate group. The mean number of days on which rescue medication was used was 12.8 and 26.9 in the two groups, respectively. The incidence, and type, of adverse reactions was similar in both patient groups. Levocabastine is well-tolerated and at least as effective as sodium cromoglycate in the treatment of pollen-provoked conjunctivitis.     

Comparison of beclomethasone dipropionate aqueous nasal spray, astemizole, and the combination in the prophylactic treatment of ragweed pollen-induced rhinoconjunctivitis

The clinical efficacy and side effect of (1) beclomethasone dipropionate aqueous nasal spray, 400 micrograms daily, (2) astemizole, 10 mg daily, and (3) beclomethasone, 400 micrograms, plus astemizole, 10 mg daily, were compared in a double-blind, randomized, parallel-group trial. Ninety adults were matched into groups of three according to sensitivity to ragweed pollen. One of each of the three subjects was assigned to nasal spray alone, one was assigned to astemizole alone, and one subject was assigned to both medications. Medications were started 1 week before and continued daily until 1 week after the ragweed-pollen season (6 weeks). If rhinoconjunctivitis was inadequately controlled with the trial medications, pressurized steroid nasal spray and/or antihistamine-decongestant eye drops were used in the minimum dose that would ensure relief. Nose and eye symptoms and concomitant medication use were recorded daily in a diary. Sneezing, nasal obstruction, and rhinorrhea were significantly better, and less additional nasal spray was used in subjects taking beclomethasone alone than in subjects taking astemizole alone. Beclomethasone plus astemizole provided no better control of rhinitis than beclomethasone alone. Eye symptoms and eye drop use tended to be less in subjects taking astemizole alone than in subjects taking beclomethasone alone, but the best control of eye symptoms was recorded in the subjects taking both trial medications. Side effects were mild or transient.     

Effects of topical budesonide and levocabastine on nasal symptoms and plasma exudation responses in seasonal allergic rhinitis

This study compares the effects of two topical nasal treatments for allergic rhinitis, budesonide and levocabastine, on symptom development during seasonal pollen exposure. Additionally, the protective effects of drug treatments on allergen-challenge-induced responses (symptoms and microvascular exudation of plasma) are examined late into the pollen season. Forty-four patients with seasonal allergic rhinitis to birch pollen participated in this single-blind, randomized, and placebo-controlled study. Topical nasal treatment with either levocabastine (200 p.g b.i.d.: n = 16), budesonide (200 μg b.i.d.; n = 16), or placebo (n= 12) was instituted before the start of the pollen season and continued for 5 weeks until the end of the birch pollen season. The participants kept diaries for scores of nasal and ocular symptoms. Nasal allergen challenges with increasing doses of a birch pollen extract (10², 10³ and lC SQ-U) were carried out both before, when patients were asymptomatic and without treatment, and late into the pollen season. A nasal lavage followed each challenge, and the lavage fluid levels of albumin were measured as an index of the acute inflammatory response of the allergic mucosa. The birch pollen season was rather mild, producing only small increases in nasal symptoms. Budesonide treatment reduced the total nasal symptoms compared to placebo (P<0.01) and to levocabastine (P<0.05), while levocabastine treatment did not differ significantly from placebo. Ocular symptoms and use of rescue medication did not differ between placebo and the active treatments. At the end of the pollen season, both treatments reduced allergen-challenge-induced nasal symptoms compared to placebo (P<0.01). Only budesonide reduced allergen-challenge- induced increments of albumin levels in postchallenge nasal lavage fluids (P<0.05, in comparison with placebo). The results suggest that budesonide reduces both seasonal and allergen-challenge-induced nasal symptoms, while levocabastine is effective against allergen-challenge-induced symptoms also during the season. In addition, the topical steroid treatment, but not the antihistamine, inhibits the inflammatory exudation evoked by allergen challenge in patients with active seasonal disease.