Nasal beclomethasone prevents the seasonal increase in bronchial responsiveness in patients with allergic rhinitis and asthma.

Experimental studies have demonstrated that induction of a nasal allergic reaction can lead to an increase in bronchial responsiveness (BR). To assess the clinical relevance of these experimental changes to chronic asthma, we sought to determine the effect of nasal beclomethasone dipropionate (Bdp) on BR in patients with seasonal allergic rhinitis and asthma. Eighteen subjects with histories of seasonal allergic rhinitis and asthma during the fall pollen season with positive skin tests to short ragweed and bronchial hyperresponsiveness to inhaled methacholine were assigned to receive either nasal Bdp (336 micrograms/day) or placebo for the entire ragweed season. Patients recorded daily nasal and chest symptoms, nasal blockage index, oral peak expiratory flow rates, and supplemental medication use. BR to methacholine was measured during the baseline period and 6 weeks into the ragweed season. Although the Bdp group did have a significant improvement in nasal blockage index, there was no improvement in daily asthma symptom scores, oral peak expiratory flow, or asthma medication use. However, subjects treated with Bdp were protected from the increase in BR seen in the placebo group (geometric mean PC20 placebo group: baseline = 0.70, week 6 = 0.29; Bdp group: baseline = 0.80, week 6 = 0.93; intergroup difference, p = 0.022). We conclude that nasal corticosteroid therapy can prevent the increase in BR associated with seasonal pollen exposure in patients with allergic rhinitis and asthma.     

Mechanism of topical glucocorticoid treatment of hay fever: IL-5 and eosinophil activation during natural allergen exposure are suppressed, but IL-4, IL-6, and IgE antibody production are unaffected

BACKGROUND: Allergic rhinitis is traditionally defined as an IgE- and mast cell-mediated hypersensitivity reaction. Allergen challenge models suggest that cytokines and eosinophil mediators may also play roles. However, the causal relationship among inflammatory cells, their products, and patients' symptoms during natural allergen exposure has not been established. OBJECTIVE: We sought to elucidate the mechanisms of seasonal allergic rhinitis and the beneficial effects of topical glucocorticoids. METHODS: Thirty patients with ragweed-induced hay fever and a strongly positive serologic test response for ragweed IgE antibody received budesonide nasal spray or placebo in a randomized, parallel, double-blind study. Nasal wash fluids and sera were collected before and during the hay fever season. The levels of inflammatory mediators and allergen-specific immunoglobulins were measured by immunoassay. The activation markers on blood eosinophils were quantitated by flow cytometry. RESULTS: Compared with placebo-treated patients, budesonide-treated patients had strikingly reduced symptoms. In the placebo group, nasal symptoms correlated with nasal lavage fluid eosinophil-derived neurotoxin and IL-5 levels. At the season peak, the budesonide-treated group had significantly lower nasal fluid eosinophil-derived neurotoxin, IL-5, and soluble intracellular adhesion molecule-1 levels. In the treated group eosinophil expression of CD11b was suppressed at the season peak. In contrast, levels of IL-4 and IL-6 in nasal fluid and the seasonal increases in serum ragweed-specific IgE and nasal fluid IgA antibodies did not differ between groups. CONCLUSION: Eosinophilic inflammation plays a critical role in seasonal allergic rhinitis symptoms. One of the therapeutic effects of glucocorticoids is to suppress this inflammation.     

Serum IgE levels and the use of sodium cromoglycate (BP) in hay fever: a study of forty-six patients from a single general practice

In a double blind trial of nasal spray of sodium cromoglycate (DSCG) for hay fever, fifteen of twenty-three patients taking the drug were helped, compared with thirteen of twenty-three receiving placebo—a statistically insignificant difference. Serum levels of IgE were raised in thirty-eight of forty-four patients examined. There was no significant difference between preseasonal and seasonal serum IgE levels in either of the DSCG or the placebo group. Serum IgE levels were significantly higher in the patients showing peripheral blood or nasal secretion eosinophilia during the hay fever season. There was no significant difference in the frequency of nasal secretion eosinophilia between those taking DSCG and those taking placebo. It is concluded that DSCG spray does not affect serum IgE levels or eosinophilia of either peripheral blood or nasal secretions under the conditions applying in this trial. Neither was DSCG significantly better than placebo in controlling symptoms.     

Local intranasal immunotherapy for ragweed allergic rhinitis I. Clinical response

Local nasal immunotherapy (LNIT) of ragweed allergic rhinitis was studied in a double-blind controlled trial. Sixty-seven subjects were divided into three groups. Twenty-one received unmodified ragweed extract (RW), 24 received a glutaraldehyde polymer of ragweed extract (PRW), and 22 received placebo. Mean symptom/medication scores during the season were 2.12, 2.76, and 3.93 for the RW, PRW, and placebo groups, respectively. Both the RW- and the PRW-treated group scores were significantly lower than those of the placebo group (p < 0.01, and p < 0.025, respectively). The results of the patients' self-evaluations indicated that therapy was effective in 71%, 59%, and 41 %for the RW-, PRW-, and placebo-treated groups, respectively. Adverse reactions to treatment were limited to the upper respiratory tract and were noted by all patients. They were significantly more severe in the RW-treated patients than those in the PRW- or placebo-treated groups. We conclude that LNIT is an effective therapy for ragweed allergic rhinitis. The use of a PRW decreased adverse reactions significantly while slightly decreasing the therapeutic benefit.     

Multicenter placebo-controlled study of nedocromil sodium 1% nasal solution in ragweed seasonal allergic rhinitis

An 8-week double-blind study was carried out in 177 ragweed patients with seasonal allergic rhinitis to compare nedocromil sodium 1% nasal solution (Tilarin, QID, Fisons plc) and placebo. Symptoms of rhinitis were significantly reduced by nedocromil sodium during the peak 3-week pollen season (P = .001 for diary summary score) and the active treatment was rated effective by 74% of patients.     

Does nasal provocation play a role in the diagnosis and management of ragweed-induced allergic rhinitis?

Twenty-seven patients with ragweed allergic rhinitis were evaluated before the season by allergen-induced nasal reactivity. Symptom scores were recorded during the season, and repeat nasal challenges performed at the end. Nasal response to ragweed insufflation did not predict seasonal symptoms. No change in threshold reactivity occurred at the end of the season, once peak symptoms had passed. In the evaluation of patients with allergic rhinitis, specific nasal challenge did not help predict seasonal clinical symptoms.     

Treatment of Seasonal Allergic Rhinitis with Budesonide and Disodium Cromoglycate

The aim of this study was to compare the efficacy and side effects of budesonide and disodium cromoglycate (DSCG) in seasonal allergic rhinitis. In a double-blind, double-dummy comparative study, 43 patients with seasonal allergic rhinitis were either treated with budesonide (200 micrograms b.d.) or DSCG (5.2 mg 5 times daily). After a 1 week run-in period treatment was given for 3 weeks. The patient scorings for nasal secretion, nasal itching, sneezing bouts and total nasal symptoms were significantly different between the treatment groups during the whole treatment period. The scorings for nasal blockage were significantly different during the last 2 weeks of treatment. All differences were in favour of budesonide treatment. The patients' assessment of the treatment favoured budesonide (P less than 0.02). Side effects were few and mild, but one patient from the budesonide group stopped treatment because of headache.     

Allergen injection therapy with glutaraldehyde-modified--ragweed pollen-tyrosine adsorbate. A double-blind trial.

The effect of a preseasonal course of four injections of glutaraldehyde-modified—ragweed pollen-tyrosine adsorbate (MRTA), in a total dose of 7,000 Noon pollen units, was compared with a tyrosine base placebo in a double-blind trial in 43 matched patients with ragweed pollen-induced allergic rhinitis. During the pollen season, troublesome symptoms were treated with a standardized therapeutic regimen. The minimum medication requirement that adequately controlled symptoms was used as the main indicator of severity of the allergic rhinitis. Consequently, the symptom scores were similar in both treatment groups; however, the MRTA-treated group required approximately 50% less medication than the placebo group (p < 0.05). Subjective improvement was reported by 67% of the MRTA group and 38% of the placebo group (0.05 < p < 0.1). Serum concentrations of IgE and IgG antibodies to ragweed increased in response to MRTA (p < 0.02) but not in response to placebo. Side effects of MRTA included generalized urticaria in 2, mild asthma in 1, and large late swellings at the injection site which necessitated stopping the injections in 6 patients. MRTA was superior to placebo in reducing the severity of ragweed pollen-induced allergic rhinitis and was associated with a modest incidence of side effects.     

Clinical evaluation of intranasal topical flunisolide therapy in allergic rhinitis.

A double-blind, vehicle control, parallel clinical trial evaluated the effectiveness and safety of the local application of flunisolide, a potent new topical steroid, in the treatment of ragweed hay fever. Fifty patients with well-defined, poorly controlled ragweed allergy were studied during the 1974 ragweed season. Analysis of the data showed that the active drug group had a significant decrease in individual symptoms of sneezing, nasal stuffiness, and nasal secretions, compared with the placebo group. Antihistamine usage was statistically decreased in the active drug over placebo group. There was no evidence of adrenal suppression. This study indicates that intranasal administration of flunisolide in adult patients is both efficacious and safe in the treatment of seasonal allergic rhinitis.     

Evaluation of the cause of nasal and ocular symptoms associated with lawn mowing

A number of individuals with perennial or seasonal rhinoconjunctivitis state that their symptoms may suddenly worsen on exposure to lawn mowing. Many allergists have believed that this was related to the agitation of molds deposited on the grass. We studied 50 consecutive new patients with rhinitis using history, skin testing, total and specific IgE assays, and nasal smears. Twenty-five patients gave histories of minimal or no change in their nasal symptoms with exposure to lawn mowing, whereas 11 patients had definite, but mild, symptoms, and 14 patients had severe symptoms. Positive skin tests to grasses, trees, and weed pollens were more frequent in those patients with symptoms exacerbated by lawn mowing (p less than 0.03). Symptomatic patients also had higher serum concentrations of total IgE (p less than 0.008) and grass-pollen specific IgE (p = 0.0004). The frequencies of positive skin tests to ragweed pollens, house dust, molds, and grass leaves, as well as the percentage of nasal eosinophils, were not different in the symptomatic and asymptomatic groups. No significant association was found between symptoms and IgE antibodies to molds or grass-leaf extract. We believe that the increased nasal and ocular symptoms coincident with lawn mowing are allergic phenomena significantly associated with skin test sensitivity and specific IgE antibodies to grass pollens but not with sensitivity or specific IgE to molds or grass-leaf extract.     

Attenuation of allergen sensitivity early in the course of ragweed immunotherapy

During the course of an open immunotherapy (IT) study of ragweed (RW)-allergic patients, nasal mediator release was studied by provocation testing. All subjects had a history of seasonal RW rhinitis, positive skin puncture test to RW, and RW-specific IgE by RAST. Nasal challenge was performed with serial dilutions of RW extract, before and after 12 weekly injections, providing a cumulative dose of 0.22 microgram of Amb a I. Serum IgE and IgG and basophil histamine release with RW were also measured. By 12 weeks of IT, when only 1% of the usual maintenance level dose had been administered, mean histamine release and TAME-esterase activity in nasal washes decreased significantly (p less than 0.05 and p less than 0.01). Prostaglandin D2 release did not change. Skin sensitivity decreased (p less than 0.05), whereas RW-specific IgE increased (p less than 0.05). No significant change in basophil histamine release was observed for RW or a control antigen. Only six of 40 subjects had an RW-specific IgG rise greater than 0.05 microgram/ml. Changes in nasal sensitivity did not correlate with the increases in IgE or IgG or with the change in skin test sensitivity. These present data indicate that there is a significant decline in nasal sensitivity to inhaled RW very early in the course of IT. There is, however, no indication of a relationship between the decreased nasal sensitivity and the production of RW-specific IgG antibodies.     

Efficacy of azelastine nasal spray in seasonal allergic rhinitis patients who remain symptomatic after treatment with fexofenadine.

BACKGROUND: Currently available oral second-generation antihistamines do not provide adequate symptom relief for many allergy patients. OBJECTIVE: To determine the ability of azelastine nasal spray to improve rhinitis symptoms in patients with seasonal allergic rhinitis who remained symptomatic after treatment with fexofenadine. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled, 2-week study in patients with moderate-to-severe seasonal allergic rhinitis. The study began with a 1-week, open-label lead-in period, during which patients received fexofenadine, 60 mg twice daily. Patients who improved less than 25% to 33% with fexofenadine were randomized to treatment with (1) azelastine nasal spray, 2 sprays per nostril twice daily; (2) azelastine nasal spray, 2 sprays per nostril twice daily, plus fexofenadine, 60 mg twice daily; or (3) placebo (saline) nasal spray and placebo capsules twice daily. The primary efficacy variable was the change from baseline to day 14 in the total nasal symptom score (TNSS), consisting of runny nose, sneezing, itchy nose, and nasal congestion symptom scores. RESULTS: A total of 334 patients who remained symptomatic after treatment with fexofenadine were included in the efficacy analysis. After 2 weeks of treatment, azelastine nasal spray (P = .007) and azelastine nasal spray plus fexofenadine (P = .003) significantly improved the TNSS compared with placebo. Azelastine nasal spray monotherapy was as effective as the combination of azelastine nasal spray plus fexofenadine as measured by the TNSS and individual symptoms of the TNSS. CONCLUSIONS: Azelastine nasal spray is effective monotherapy for patients who remain symptomatic after treatment with fexofenadine and should be considered in the initial management of patients with seasonal allergic rhinitis.     

Amb a 1-immunostimulatory oligodeoxynucleotide conjugate immunotherapy decreases the nasal inflammatory response

BACKGROUND: Amb a 1-immunostimulatory phosphorothioate oligonucleotide conjugate (AIC) is a novel immunotherapeutic compound consisting of purified Amb a 1 from short ragweed proteins covalently linked to an immunostimulatory phosphorothioate oligodeoxyribonucleotide. In sensitized animals AIC can stimulate an Amb a 1-specific T(H)1 response and decrease pulmonary reactivity to ragweed challenge. Clinical trials have documented reduced allergic response to AIC in comparison with licensed ragweed extract. OBJECTIVES: We sought to determine the in vivo effect of short-course immunotherapy with AIC on eosinophilia and cytokine mRNA expression in the nasal mucosa of ragweed-sensitive patients. METHODS: Ragweed-sensitive patients with allergic rhinitis were treated with 6 escalating doses of AIC (0.06-12 microg, n = 28) or placebo (n = 29) at weekly intervals immediately before the 2001 ragweed season. Symptom scores and medication use were recorded for the 2001 and 2002 ragweed seasons for all patients. A subset of patients (12 receiving AIC and 7 receiving placebo) consented to have nasal biopsy specimens taken before immunization and before and after the first ragweed season. The preseason and postseason biopsy specimens were taken 24 hours after ragweed allergen challenge and compared with the initial unchallenged biopsy specimen to assess cytokine and inflammatory cell responses by using immunocytochemistry and in situ hybridization. RESULTS: AIC was safe and well tolerated by all patients. There was no difference between the AIC and placebo groups in the number of allergen-induced major basic protein-, IL-4-, IL-5-, or IFN-gamma-positive cells in the mucosa in the first weeks after AIC immunization. On rechallenge and rebiopsy after the end of the 2001 ragweed season, however, AIC-treated patients had a significantly reduced increase in eosinophils and IL-4 mRNA-positive cells and an increased number of IFN-gamma mRNA-positive cells compared with placebo-treated patients. No difference between treatment groups was observed in symptom scores or medication use during the first ragweed season. During the second ragweed season, however, there was a significant decrease in chest symptoms and a trend toward reduced nasal symptoms in the AIC-treated group. CONCLUSION: Short-course immunotherapy with AIC can modify the response of nasal mucosa to allergen challenge by increasing T(H)1 cytokine production and decreasing T(H)2 cytokine production and eosinophilia. This modification was not immediate but was observed 4 to 5 months after completion of immunotherapy and seasonal ragweed-pollen exposure. The T-cell subset shift after immunization and seasonal exposure was followed by evidence of clinical efficacy in the second ragweed season without additional AIC immunizations.     

Efficacy of azelastine nasal spray in patients with an unsatisfactory response to loratadine.

OBJECTIVE: To evaluate the effectiveness and safety of azelastine nasal spray, desloratadine, and the combination of azelastine nasal spray plus loratadine compared with placebo in patients with seasonal allergic rhinitis who had an unsatisfactory response to loratadine. METHODS: This was a 2-week, multicenter, placebo-controlled, randomized, double-blind study in patients with moderate-to-severe symptoms of seasonal allergic rhinitis. Following a 1-week, open-label lead-in period, during which the patients received loratadine 10 mg daily, those patients who met the symptom qualification criteria (<25% to 33% improvement taking loratadine) were randomized to treatment with azelastine nasal spray 2 sprays per nostril, twice daily, azelastine nasal spray 2 sprays per nostril, twice daily, plus loratadine 10 mg daily, desloratadine 5 mg daily plus placebo (saline) nasal spray, or placebo (saline) nasal spray/placebo capsules. The primary efficacy variable was the change from baseline to day 14 in the total nasal symptom score, consisting of runny nose, sneezing, itchy nose, and nasal congestion symptom scores recorded twice daily (AM and PM) in patient diary cards. RESULTS: A total of 428 patients with an unsatisfactory response to loratadine completed the double-blind treatment period. After 2 weeks of treatment, azelastine nasal spray (P < 0.001), azelastine nasal spray plus loratadine (P < 0.001), and desloratadine (P = 0.039) significantly improved the total nasal symptom score compared with placebo. CONCLUSIONS: Azelastine nasal spray is an effective treatment for patients with seasonal allergic rhinitis who do not respond to loratadine and is an alternative to switching to another oral antihistamine or to using multiple antihistamines.     

Safety of the intranasal toll-like receptor 4 agonist CRX-675 in allergic rhinitis.

BACKGROUND: CRX-675 is an aqueous formulation of a toll-like receptor 4 agonist and an inducer of TH1 responses. Studies in allergic dogs showed that pretreatment with CRX-675 reduced nasal congestion induced by allergen challenge. OBJECTIVE: To study the safety of intranasal CRX-675 treatment in patients with seasonal allergic rhinitis. METHODS: We conducted a single-center, randomized, double-blind, placebo-controlled, dose-escalating safety trial of single doses of CRX-675 given intranasally before intranasal ragweed challenges. Patients with ragweed-induced seasonal allergic rhinitis received increasing concentrations of ragweed to determine the dose that would result in a 30% reduction in nasal volume (PD30) during screening. Two weeks later, each patient was rechallenged with their assigned PD30 ragweed dose. Fourteen days later, patients were treated with either placebo (n = 16) or CRX-675 (2, 20, 100, or 200 microg intranasally, n = 12 per arm) 24 hours before a subsequent PD30 ragweed challenge. Patients were rechallenged with ragweed 14 days thereafter. RESULTS: No serious or severe adverse events were reported. Most adverse events were mild (grade 1) and either were considered unrelated to CRX-675 or resolved without intervention. The adverse event profile of CRX-675-treated patients was similar to that of placebo-treated patients, and no dose-related toxic effects were observed. There was no clear trend in the ability of CRX-675 to inhibit nasal allergen challenge responses, but improvement in nasal symptom scores was observed at 100 microg. CONCLUSIONS: This preliminary trial suggests that intranasally applied CRX-675 is safe at the doses tested. Appropriate dosing and timing will ultimately define its potential therapeutic role for allergies.     

Onset of action of intranasal budesonide (Rhinocort aqua) in seasonal allergic rhinitis studied in a controlled exposure model

BACKGROUND: Intranasal budesonide aqueous nasal spray (BANS) is recognized as an efficacious treatment for seasonal allergic rhinitis (SAR), but the time to onset of action is not known. OBJECTIVE: The primary objective was to evaluate the time at which the onset of action of BANS in the symptomatic relief of seasonal allergic rhinitis becomes evident within 12 hours after a single dose in a controlled ragweed pollen exposure setting. METHODS: The study was of a double-blind, randomized, parallel-group design, testing BANS (64 microgram and 256 microgram) and placebo on ragweed-sensitive subjects with symptoms for at least 1 year by using a controlled pollen challenge system (Environmental Exposure Unit). The efficacy variables were the combined nasal score (the sum of blocked nose, runny nose, and sneezing-itchy nose), individual nasal symptoms, overall evaluation of treatment efficacy reported by participants on diaries, and peak nasal inspiratory flow (PNIF). RESULTS: A total of 217 participants were treated with BANS or placebo. At 7 to 12 hours, BANS was better than placebo in reducing combined nasal and blocked nose symptoms. For PNIF, the time to onset of action was shortest for 256 microgram of BANS relative to placebo (3 hours, P =.003). BANS 64 microgram was better than placebo in reducing the individual scores of blocked nose, runny nose, and sneezing-itchy nose from 3 to 5 hours after administration. Treatment efficacy was higher for those receiving BANS compared with placebo starting at 5 hours. All treatments were well tolerated, and no specific adverse events occurred. CONCLUSIONS: The onset of action of intranasal BANS was 7 hours according to combined nasal and blocked nose symptom scores. Evidence of earlier response was observed at 3 hours for runny nose and PNIF.     

Omalizumab, an anti-IgE antibody, in the treatment of adults and adolescents with perennial allergic rhinitis.

BACKGROUND: Treatment with omalizumab, an anti-IgE antibody, improves symptoms and quality of life in patients with seasonal allergic rhinitis but has not previously been investigated in patients with perennial symptoms. OBJECTIVE: To investigate the efficacy, safety, and tolerability of omalizumab in the treatment of perennial allergic rhinitis (PAR). METHODS: Two hundred eighty-nine patients (aged 12 to 70 years) with moderate-to-severe symptomatic PAR were randomized to 16 weeks' double-blind subcutaneous treatment with either placebo (n = 145) or omalizumab (at least 0.016 mg/kg/IgE [IU/mL] per 4 weeks; n = 144). The primary efficacy variable was the mean daily nasal severity score, as determined from patient daily diary cards. Secondary efficacy variables included use of rescue antihistamine, rhinoconjunctivitis-specific quality of life (RQoL), and patients' evaluation of treatment efficacy. Safety and tolerability were evaluated from adverse event reports and laboratory safety parameters. RESULTS: Throughout 16 weeks of treatment, the mean daily nasal severity score was significantly lower in omalizumab-treated patients than with placebo (P < 0.001). The improvement in symptoms when taking omalizumab was paralleled by a reduction in use of rescue antihistamine (P < or = 0.005 overall) and improved RQoL relative to placebo. Patients' evaluation of treatment efficacy significantly favored omalizumab over placebo (P = 0.001). Omalizumab therapy was well tolerated. There were no safety concerns. CONCLUSIONS: Omalizumab was safe and well tolerated in the treatment of patients with PAR, providing effective control of symptoms and improved RQoL while simultaneously minimizing reliance on rescue antihistamines.     

Pentigetide nasal solution: a multicenter study evaluating efficacy and safety in patients with seasonal allergic rhinitis

The safety and efficacy of pentigetide (Pentyde) nasal solution, administered as 1 mg into each nostril four times daily, was compared with placebo for controlling symptoms associated with seasonal allergic rhinitis. This was a randomized, multicenter, double-blind, parallel-group trial involving 431 patients divided equally between pentigetide and placebo treatment. The study was conducted during the 1986 spring allergy season and consisted of 1 week of baseline followed by 2 weeks of treatment. Physicians evaluated the frequency and severity of nasal symptoms at study entry (day 1) and the final visit (day 22). Physicians and patients assessed the global condition of the patient at the end of the study and patients also recorded the severity of symptoms in a daily diary. Pentigetide-treated patients showed a statistically significant greater reduction in the frequency (P = .004) and severity (P = .05) of total nasal symptom score (sneezing, nasal congestion, and rhinorrhea) and in the individual nasal symptom scores compared with placebo-treated patients. Diary results showed consistently lower total nasal symptom scores on each treatment day for pentigetide-treated patients (P = .02). Both the physicians and patients globally rated more pentigetide-treated patients improved than placebo-treated patients. The incidence and types of adverse experiences were similar between treatment groups and there were no reports of sedation or fatigue in the pentigetide group. No clinically significant changes occurred for laboratory tests, physical examination parameters or vital sign measurements. Pentigetide nasal solution was safe and effective for the treatment of seasonal allergic rhinitis.     

Nasal application of a gel formulation of N-acetyl-aspartyl glutamic acid (NAAGA) compared with placebo and disodium cromoglycate in the symptomatic treatment of pollinosis*

A gel formulation of the antiallergic compound N-acetyl-aspartyl glutamic acid (NAAGA) (Rhinaaxia® (R)) has been evaluated in a multicenter, randomized, double-blind, three-arm, parallel-group comparison with placebo gel (P) and disodium cromoglycate (DSCG) in outpatients suffering from seasonal allergic rhinitis (pollinosis). Nose and eye symptoms were assessed daily by the patients on visual analog scales (VAS), and medical examinations were held after 1 week and at the end of the 4-week treatment. The use of rescue medications (H,-antagonist (terfenadine) and soothing eye-drops (Spersallerg®) was recorded as a main assessment indicator of efficacy. For the efficacy analysis, only the periods with relevant pollen concentrations (≥ 50 grains/m₃) were considered. The study extended over the two pollen seasons 1989 and 1990. Of 230 included patients, 190 were suitable for efficacy analysis (R = 63, P = 64, DSCG = 63). The VAS data did not reveal a difference between the treatment groups for nasal symptoms, whereas the use of terfenadine tablets was significantly lower in the Rhinaaxia group than in either the placebo (P= 0.0001) or DSCG group (P= 0.03). The eye symptoms were significantly less severe in the Rhinaaxia group than in both placebo (P= 0.0001) and DSCG (P<0.01) groups. In addition, the use of rescue medication was significantly higher in the placebo than in the Rhinaaxia treatment group (P= 0.0001). The incidence of local untoward effects (itching/burning sensation in the nose) was slightly higher in the Rhinaaxia group, while the overall tolerability assessment was similarly good in all three treatment groups. Rhinaaxia gel given three times daily was shown to achieve a satisfactory symptom relief in everyday treatment with a significantly lower need to resort to rescue medication than with placebo and to have a therapeutic effect like DSCG nasal spray given four times daily.