Ketotifen in pollen-induced asthma: a double blind placebo-controlled study

Twenty-nine children with an average age of 10.5 years were studied with respect to the protective effect of ketotifen on pollen-induced bronchial asthma. All of them were sensitive to deciduous tree pollen, the diagnosis being verified by bronchial challenge. The children were stratified in matched pairs and randomly allocated to two treatment groups, placebo or ketotifen 1 mg twice daily. The study was double-blind and was performed during the whole of the deciduous tree pollen season. Daily pollen counts were made, allergic symptoms were noted, additional medication was given and the expiratory pulmonary flow was recorded. During the birch pollen peak the ketotifen group showed significantly fewer, and less severe asthma and rhinoconjunctivitis than the placebo group. The anti-asthmatic medication was also used significantly less than in the placebo group. Ketotifen appeared to have good protective properties in the treatment of pollen-induced asthma and rhinoconjunctivitis.     

Randomized, double-blind, parallel groups, placebo-controlled study of efficacy and safety of Rynatan in the treatment of allergic rhinitis using an acute model

We conducted a randomized, double-blind, parallel groups, placebo-controlled acute study of Rynatan (8 mg chlorpheniramine tannate, 25 mg pyrilamine tannate, 25 mg phenylephrine tannate) in 104 volunteers with allergic rhinitis. Subjects reported to City Park on a Saturday morning during the height of the grass pollen season in late spring and remained in the park for eight hours that day and on the following day. Cards were completed hourly to evaluate symptoms of allergic rhinitis and adverse experiences caused by therapy. The first three cards completed on Saturday morning were used to demonstrate that each subject had had at least minimal symptoms of allergic rhinitis and to determine baseline symptoms. Rynatan or placebo was given at noon and 7:30 PM that day and at 8:30 AM the next day. Subjects completed symptom cards hourly until 4:30 PM on Saturday, three cards that evening, and eight cards hourly the next day until 4:30 PM. The group receiving Rynatan had significantly more allergic rhinitis symptom relief than the placebo group (P = .003). More subjects in the Rynatan group (34/52) reported global symptom improvement than did subjects in the placebo group (18/52, P = .002). There were no significant severe adverse experiences and no statistically significant differences between treatment groups in incidence or severity of drowsiness, dizziness, jitteriness, headache, or nausea. We conclude that Rynatan is safe and effective in treating acute symptoms of allergic rhinitis in otherwise healthy adult subjects.     

Efficacy of combination treatment with anti-IgE plus specific immunotherapy in polysensitized children and adolescents with seasonal allergic rhinitis

BACKGROUND: Specific immunotherapy (SIT) and treatment with monoclonal anti-IgE antibody have complementary modes of action. OBJECTIVE: The purpose of this study was to determine whether combined therapy could provide better efficacy than either treatment alone. METHODS: We conducted a randomized, double-blinded trial to assess the efficacy and safety of subcutaneously administered anti-IgE (omalizumab) or placebo in children and adolescents with seasonal allergic rhinitis in both a birch pollen season and a grass pollen season (sequential seasons together lasting an average of 84 days). There were 4 treatment arms. Each subject was started on SIT-birch or SIT-grass, and anti-IgE or placebo was started before and maintained during the anticipated pollen seasons (a total of 24 weeks). The primary efficacy variable was symptom load, the sum of daily symptom severity score plus rescue medication use. RESULTS: A total of 221 subjects (intent-to-treat population) aged 6 to 17 years were analyzed for efficacy. Combination therapy reduced symptom load over the 2 pollen seasons by 48% (P <.001) over SIT alone. When analyzed separately by season, the 2 groups receiving unrelated SIT were considered placebo controls. In the grass season, symptom loads were as follows: unrelated (birch) SIT + placebo, 0.89 (reference value); unrelated (birch) SIT + anti-IgE, 0.49 (-45%); SIT-grass + placebo, 0.61 (-32%); SIT-grass + anti-IgE, 0.26 (-71%). CONCLUSION: Anti-IgE therapy conferred a protective effect independent of the type of allergen. Additional clinical benefit was demonstrated in both pollen seasons, whether there was coverage by SIT or not. This combination might prove useful for the treatment of allergic rhinitis, particularly for polysensitized patients.     

Preseasonal local allergoid immunotherapy to grass pollen in children: a double-blind, placebo-controlled, randomized trial

BACKGROUND: We assessed the efficacy of preseasonal local allergoid immunotherapy in a group of children with asthma and/or rhinitis and/or rhinoconjunctivitis due to grass pollen. METHODS: We randomly assigned 24 children allergic to grass pollen to receive local allergoid immunotherapy for 3 months before the pollen season and 24 such patients to receive identically appearing placebo. The immunotherapy consisted of tablets of monomeric allergoid grass pollen allergens held in the mouth until they dissolved and then swallowed. The study was double-blind. Symptoms and medications were scored on diary cards during the pollen season. Nasal eosinophil cationic protein levels were measured by the monoclonal antibodies EG1 and EG2 outside the pollen season and at low and at high pollen concentration during the pollen season. RESULTS: The active-treatment group had a statistically significant reduction of total symptoms (P<0.05), especially bronchial symptoms (P<0.05), in comparison with the placebo group. Immunotherapy was well tolerated and compliance was good. Nasal levels of EG2 and EG1 increased significantly during the pollen season, but there was no difference between groups. EG2/EG1 increased significantly only in the placebo group during natural allergen exposure (P<0.01). CONCLUSIONS: Our results suggest that this immunotherapy is effective for the treatment of asthma due to grass pollen in children.     

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.     

Seasonal variability of exercise-induced asthma especially outdoors. Effect of birch pollen allergy

A study was made to determine whether natural allergenic exposure modulates exercise-induced asthma. Eighteen asthmatic men, ten non-allergic and eight allergic to birch pollen, underwent heart rate-monitored outdoor exercise tests during both the cold winter season and in the spring, the birch pollen season. The mean fall in FEV1 after the outdoor exercise test increased in the allergic group from 17 +/- 3% in the winter to 27 +/- 6% in the spring, while it decreased in the non-allergic group from 31 +/- 6% to 22 +/- 4%, respectively (P less than 0.01). Initial FEV1 and FCV values remained unchanged in both groups. The non-specific airway responsiveness to histamine did not change significantly in birch pollen allergic or non-allergic subjects during the spring, when compared with the winter values. We conclude that the exercise-induced asthma is aggravated in the birch pollen allergic asthmatics during the pollen season, when compared to the non-birch pollen allergic asthmatics, in whom the exercise-induced bronchoconstriction is attenuated as expected, because of the warmer and more humid weather in the spring.     

Can an antihistamine delay appearance of hay fever symptoms when given prior to pollen season?

Mizolastine is a new, nonsedating antihistamine providing satisfactory symptom relief in allergic conditions. The purpose of this study was to determine whether the onset of hay fever symptoms could be delayed in patients known to suffer seasonal allergic rhinoconjunctivitis symptoms if mizolastine was given before the pollen season. This double-blind study involved 342 patients, randomly allocated to once-daily 10 mg mizolastine ( n = 115), once-daily 120 mg terfenadine ( n = 116), or placebo ( n = 111) groups. All patients started treatment on 1 May, before the onset of the grass pollen season. The prophylactic effect of test drugs was assessed on their ability to delay the time to the first hay fever crisis of the season, which was defined by the occurrence of one of the following events: use of rescue medication, study withdrawal because of treatment failure, or total diary symptom score over 18. Active treatments prolonged the time to the first crisis by approximately 1 week (mizolastine 55 days, terfenadine 57 days) in comparison with placebo (50 days) (survival curve analysis: Logrank test, P = 0.01; Wilcoxon test, P = 0.03). Tolerability was satisfactory and comparable between groups. Thus, mizolastine can be safely used to delay and to treat symptoms of seasonal allergic rhinitis.     

Treatment of ragweed hay fever with intranasally administered disodium cromoglycate*

In a double-blind study the therapeutic effect of a 4% disodium cromoglycate (DSCG) nasal solution was evaluated in thirty-nine patients with acute symptoms of ragweed hay fever. Patients were randomly assigned to the DSCG or placebo group as they presented with allergic rhinitis. Overall, the DSCG was not more effective than placebo in controlling the symptoms of rhinitis or in decreasing the need for concomitant antihistamines or corticosteroids. Among patients with the highest pretreatment serum ragweed-specific IgE (RW IgE) levels, drug-treated patients had some reduction in symptoms as compared to their placebo controls during the peak of the ragweed pollen season. DSCG treatment did not influence the usual seasonal rise in RW IgE. Side effects from both the active and placebo aerosols were frequent but mild. We conclude that DSCG nasal solution used for the treatment of seasonal ragweed allergic rhinitis is relatively ineffective.     

Effect of tree and grass pollens and fungal spores on spring allergic rhinitis: a comparative study.

BACKGROUND: Current literature indicates tree pollen is less important than grass pollen as the cause of spring allergic rhinitis. The role of fungal spores is secondary and uncertain. OBJECTIVE: To assess the relative allergenicity of tree and grass pollen and fungal spores as the cause of spring allergic rhinitis in central Indiana. METHODS: (1) Chart review of 189 Indiana natives with seasonal allergic rhinitis to ascertain clinical sensitivity to tree or grass pollens. (2) A prospective study conducted in the spring of 1997 in 51 patients, correlating patients' symptom and medication scores with daily pollen and spore counts, obtained with a Burkard spore trap. RESULTS: One hundred thirty of 189 patients (69%) reported symptoms before May with positive prick test to at least one tree pollen. One hundred thirty-four patients (71%) had symptoms in May and June with positive test to grass pollen. The ratio between the two groups is 1:1, in contrast to a ratio of 1:4 derived from the literature. The prospective study revealed a symptom score increase parallel to the rise of tree pollen counts beginning in mid-March and reaching a plateau in early May prior to the onset of grass season. Medication use continued to increase and peaked at the height of grass pollination. Spore counts increased in late May and stayed at high levels throughout June, yet symptom and medication scores steadily declined following the peak of grass pollination in early June. CONCLUSIONS: This study suggests that in central Indiana, tree pollen is more important as the cause of spring allergic rhinitis than that suggested by the literature. This study confirmed previous observations that fungal spores are substantially less allergenic than pollens.     

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.     

Controlled trials with four per cent cromolyn spray in seasonal allergic rhinitis*

Thirty-two patients with seasonal allergic rhinitis due to weed pollen were treated beginning prior to the weed pollen season of 1974 with either 4% cromolyn sodium or placebo nasal spray. The patients were followed on treatment with symptom diary cards and bi-weekly physician examinations for a period of 10 weeks. Radioallergosorbent (RAST) titres for the major weeds in the Denver area (ragweed, Russian thistle, and sage) were determined before the weed pollen season, and one and three months after the weed pollen season. There was no significant difference in symptom scores between the 4% cromolyn sodium- and placebo-treated groups, nor objective evidence on bi-weekly examinations by a physician to suggest differences in the two groups. Significant differences in favor of the 4% cromolyn-treated group were noted in the amount of antihistamines taken for symptomatic relief during the weed pollenating season, suggesting some protective effect of the drug. The clinical significance of this finding is not clear. Selecting patients with high baseline RAST titres for one or more of the major weeds did not alter the results of the study. In a second double-blind study twenty-two patients reporting to the allergy clinic with symptomatic seasonal allergic rhinitis due to weeds were randomly assigned to receive 4% cromolyn sodium or placebo nasal spray and followed through the weed pollen season. There was no difference between the two groups in either symptom scores or use of antihistamines for asymptomatic relief.     

Double-blind, placebo-controlled study with a modified therapeutic vaccine of Salsola kali (Russian thistle) administered through use of a cluster schedule

BACKGROUND: The inhalation of Salsola kali pollen is a common cause of respiratory diseases in Europe and North America. OBJECTIVE: To evaluate the efficacy and safety of a depigmented and glutaraldehyde-polymerized therapeutic vaccine of S kali. METHODS: The trial was randomized, double-blind, and placebo-controlled using a rush protocol in the build-up phase. Sixty patients with rhinoconjunctivitis (19 also had mild asthma) were randomly allocated to receive either active treatment (polymerized extract) or placebo. The final distribution was 41 patients in the active and 19 in the placebo group. Side effects were registered. Symptom and medication scores and the number of days free of symptoms during the pollen season were assessed to evaluate the clinical efficacy. A Rhinoconjunctivitis Quality of Life Questionnaire was completed in the previous pollen season (before treatment) and during the pollen season 1 year later (in the trial). Dose-response skin tests were performed at baseline and at the end of the trial. RESULTS: There was a significant difference (P < .05) in symptom and medication scores between both groups during the pollen season, with the active group the one that had fewer symptoms and lower intake of medication. The number of days without symptoms was higher in the active group (P < .05). This group also had a significant improvement in the Rhinoconjunctivitis Quality of Life Questionnaire and a reduction in skin sensitivity. No moderate or severe systemic reactions were registered. CONCLUSION: Immunotherapy with this modified vaccine of S kali pollen is safe and efficacious to treat patients clinically sensitive to this pollen. CLINICAL IMPLICATIONS: Patients allergic to S kali (Russian thistle) can be successfully treated with immunotherapy to improve symptoms of allergic rhinitis and asthma, reduce medication use, and improve quality of life parameters.     

Comparison of the Clinical Effect of Ketotifen and DSCG in Pollen-Induced Childhood Asthma

Thirty-six children with a mean age of 8.9 years were studied with respect to the prophylactic effect and tolerance of ketotifen in comparison with disodium cromoglycate. All had a verified deciduous tree pollen-induced asthma. The children were stratified into two matched groups and the double-blind technique was used. The study was performed during the whole deciduous tree pollen season. Daily pollen counts were performed during the whole observation period as well as daily registrations of allergic symptoms, additional medication and pulmonary expiratory flow. No significant differences were found between the two substances tested. No adverse reactions or side effects were noted.     

Sublingual-swallow immunotherapy with standardized 3-grass pollen extract: a double-blind, placebo-controlled study.

BACKGROUND: Sublingual immunotherapy (SLIT) is accepted as a safe and effective route for the treatment of grass pollen allergy, but clarification of its clinical and biological efficacy requires more study. OBJECTIVE: To evaluate the efficacy, safety, and compliance of SLIT with a standardized 3-grass pollen extract in patients with grass pollen seasonal allergic rhinoconjunctivitis, with or without mild asthma. METHODS: This multicenter, randomized, double-blind study included 127 patients (aged 12-41 years; mean age, 24.9 years) with grass pollen seasonal allergic rhinoconjunctivitis, with or without mild asthma. They received either SLIT with a high-dose, standardized, 3-grass pollen extract or placebo for 10 months before and during the grass pollen season. The efficacy evaluation compared weekly clinical scores (defined as the sum of the symptom score and rescue medication score) to measure rhinoconjunctivitis and asthma for the first 8 weeks of the pollen season. We also evaluated safety and compliance and measured changes in anti-Dactylis specific IgG4 antibody levels. RESULTS: There was a trend in favor of the study group in the mean adjusted clinical score. The groups were not comparable on inclusion (P = .02): the SLIT group included more subjects with asthma and had a higher mean IgG4 serum level. Additional exploration according to subgroups with and without asthma found that among the patients without asthma, the SLIT group had a significantly better clinical score (P = .045). Anti-Dactylis specific IgG4 levels increased significantly in the SLIT group. CONCLUSION: SLIT with a standardized, high-dose, 3-grass pollen extract is safe and significantly improves the clinical score in patients with hay fever and without asthma during the pollen season.     

The significance of hypersensitivity to nuts in patients with birch pollen allergy

This study was performed in patients with allergic rhinitis/conjunctivitis to birch pollen to determine whether patients with additional hypersensitivity to nuts and apples differed from patients without such hypersensitivity; the determination was in terms of results of skin prick test (SPT), specific IgE antibodies (RAST), and symptoms during the pollen season. Forty-seven patients with birch pollen allergy were investigated by RAST against birch and hazel pollen and by SPT. They were treated in a randomized, double-blind, placebo-controlled study with fluticasone propionate aqueous nasal spray or placebo. The area of the SPTs was larger and the specific IgE values higher in patients with hypersensitivity to nuts and apples. These patients also had more symptoms during the pollen season. We conclude that hypersensitivity to nuts is an indication of a more severe allergy in patients with birch pollen allergic rhinitis.     

Eosinophils, secretory responsiveness and glucocorticoid-induced effects on the nasal mucosa during a weak pollen season

This study examined the seasonal effects on eosinophils and secretory responsiveness of the nasal mucosa in 22 patients with allergic rhinitis due to birch pollen (11 patients received placebo and 11 budesonide, 200 micrograms once daily in each nostril). The pollen counts during the study season were too low to produce a significant symptomatology. Hence, our findings demonstrate threshold alterations of the airway mucosa in allergic rhinitis and their inhibition by anti-inflammatory drug intervention. The patients were monitored for 8 weeks with daily recordings of pollen counts and symptom scores. Once every week a series of laboratory tests was carried out: the local eosinophil influx was determined using a Rhinobrush technique; the levels of eosinophil cationic protein (ECP) were analysed in nasal lavage fluids; and the secretory response to intranasal methacholine was measured. Treatments started after a 2-week run-in period. The proportion of eosinophils increased markedly in the placebo group and was elevated also during the last two study weeks when the pollen counts were practically nil. The secretory responsiveness to methacholine increased during the pollen season and returned to baseline towards the end of the study period. The topical glucocorticoid treatment reduced the proportion of eosinophils, the ECP levels, and the secretory response to methacholine compared to placebo. We conclude that the increased traffic and activity of eosinophils and less conspicuously the increased secretory responsiveness are expressions of the mucosal inflammation that precede the development of symptoms in seasonal allergic rhinitis.     

Effect of natural seasonal pollen exposure and repeated nasal allergen provocations on elevation of exhaled nitric oxide

Background:  Exhaled nitric oxide (FENO) is a marker for allergic airway inflammation. We wondered whether in patients with intermittent allergic rhinitis only (i) natural pollen exposure and (ii) artificial pollen exposure by repeated nasal allergen provocations may lead to an elevation of FENO.
Methods:  In two prospective studies, we compared the FENO of nonatopic controls with the FENO of nonasthmatic individuals with mild intermittent rhinitis to tree and/or grass pollen. Study I: 13 atopic individuals and seven controls had measurements of FENO, blood eosinophils and eosinophilic cationic protein (ECP) before, during and after pollen season. Study II: 16 atopic individuals and 12 controls had nasal allergen provocations on four following days out of pollen season, with daily measurements of FENO before, 2 and 6 h after provocation, and determination of blood eosinophils, ECP and FEV1 at baseline, on days 5 and 10–12.
Results:  Natural pollen exposure (study I) caused a significant elevation of FENO in allergic individuals. Nasal allergen provocations (study II) did not elicit a statistically significant rise neither of FENO nor of blood eosinophils between baseline and day 5. However, a subgroup of four individuals with a rise of blood eosinophils during nasal allergen provocations showed also a rise of FENO.
Conclusions:  We suppose that in allergic rhinitis a concomitant reaction of the bronchial system is dependent on a strong local inflammation leading to a generalized immune stimulation.     

Differences in clinical and immunologic reactivity of patients allergic to grass pollens and to multiple-pollen species. II. Efficacy of a double-blind, placebo-controlled, specific immunotherapy with standardized extracts

The IgE response of patients only allergic to grass pollens differs from response of patients allergic to multiple-pollen species. The IgE immunoblots to orchard-grass pollens confirmed that polysensitized patients had more proteins revealed than patients only allergic to grass pollens. To determine if both groups of patients present a different response toward specific immunotherapy (IT), a double-blind, placebo-controlled study was performed in 70 patients. Patients receiving the active treatment had a rush IT with either a standardized orchard grass-pollen extract or with a standardized mixed-pollen extract prepared, depending on the sensitivity of the patients. The maintenance dose was defined as that dose effective in grass-pollen IT in previous experiments. The same equipotent maintenance dose was administered for all pollen species. Symptom-medication scores during the pollen season and nasal challenge with orchard grass-pollen grains demonstrated that grass pollen-allergic patients had a significantly improved efficacy by comparison to placebo treatment, whereas polysensitized patients had a nonsignificant improvement. Serum grass-pollen IgG was significantly increased after IT in both treated groups. This study demonstrate that the response toward specific IT differs in patients only allergic to grass pollens by comparison to polysensitized patients.     

Seasonal Variation of Asthma and Allergic Rhinitis

The seasonal variation of consultations on account of asthma and allergic rhinitis, and the relationship with air concentrations of pollen, spores, and lead, cadmium, dust, soot and sulfur dioxide was investigated in Danish general practice during a 1-year period 1977-78. A population of about 500,000 was studied. Among about 3000 asthmatics there were less consultations during spring than the rest of the year, but the seasonal variation of consultations with symptoms was rather small. The highest rate of consultations was in week 24, which is close to the peak of the grass pollen period. No relationship was found between asthma symptoms and concentrations of pollution indicators. Among about 5000 patients with allergic rhinitis the rate of consultations with symptoms increased at the start of the tree pollen season, still more at the start of the birch pollen season, and was very high during weeks 21-26 in the grass pollen season. Two thirds of all consultations for symptomatic allergic rhinitis took place within 10 weeks (Nos. 18-27). During the grass pollen season there was a relative preponderance of young patients, while during the birch pollen season older patients dominated. No connection was seen between rhinitis symptoms and pollution indicators. The different seasonal variation of asthma and allergic rhinitis indicates that the two patient categories differ as regards symptom-provoking factors. Allergic rhinitis is mainly precipitated by grass and birch pollen. The precipitating factors of asthma were not disclosed in this study, with the exception perhaps of some influence from pollen, and - among 0-4-year-old children - respiratory infections.     

Effect of vitamin E supplementation on the regular treatment of seasonal allergic rhinitis.

BACKGROUND: Vitamin E supplementation is widely used in clinical practice for the prevention and treatment of different medical conditions. Evidence from basic science studies suggests that vitamin E may reduce immune allergic responses. However, only a few clinical studies of the effect of vitamin E on allergic conditions have been performed in patients with atopic dermatitis and asthma, and none have been performed in patients with allergic rhinitis. OBJECTIVE: To determine the effect of high-dose vitamin E supplementation in combination with the usual ("real-life") treatment on the symptoms of seasonal allergic rhinitis during the pollen season. METHODS: In a double-blind, placebo-controlled, randomized study, 112 patients with documented hay fever received either vitamin E (800 mg/d) or placebo in addition to their regular antiallergic treatment during the pollen season. Patients recorded their daily nasal and eye symptoms and their daily need for other medications to control allergic symptoms. RESULTS: Although no effect was observed on ocular symptoms, nasal symptom scores were lower in patients who received vitamin E supplementation during the hay fever season. However, there was no reduction in the percentage of days with serious symptoms or in the percentage of days that medications were used to control allergic symptoms during the pollen season. CONCLUSIONS: Vitamin E supplementation may be a valuable addition to the treatment of patients with seasonal allergic rhinitis. However, further clinical and basic science studies are needed to determine its real value.