Seasonal Allergic Rhinoconjunctivitis Research Articles

Was wissen Erzieherinnen über Allergien? Wissensstand zu Ursachen und Manifestationsformen atopischer Erkrankungen

Given the increasing prevalence of atopic diseases, we aimed to determine the level of knowledge about the pathogenesis and symptoms of these diseases among teachers in nursery schools. This occupational group has regularcontact with affected children and is ought to give appropriate advice and educate their charges. Nevertheless, we are not aware of comparative investigations regarding this occupational group. The existing surveys mostly dealt with schoolteachers and their knowledge about asthma. In the course of two professional meetings at the end of 2002, a standardized questionnaire was distributed to teachers attending from all nursery schools in Schleswig-Holstein. The instrument covers information on basic socio-demographic characteristics and the personal and family history of atopic diseases. The knowledge about frequency, symptoms, causes, therapeutic and preventive measures was assessed separately for the three major atopic diseases (allergic rhinoconjunctivitis, asthma, atopic eczema). The data were analyzed descriptively and the influence of age, professional experience, education and personal, i.e. family history of atopic diseases on the overall result was investigated. A total of 177 completed questionnaires were received from female (95.2%) and another 9 questionnaires from male teachers, who had a mean age of 40 years (range 21-64 years). On average the teachers took care of 31 children. Initially, 25% believed to have sufficient knowledge on allergies. At the end of the questionnaire 85% felt not to be sufficiently informed about the subject (p < 0.001). The prevalence of atopic diseases in the general population was generally estimated too high. Only 7.5% of the participants recalled the established fact of a higher frequency of allergies in higher social classes. 91 % believed that environmental influences causally contribute to the manifestation of allergies and 84.4% reported that chemical compounds or food additives are reasons for the development of allergies. Little was known about the pathomechanisms of allergies or typical allergens. 54% supposed wood preservatives and 37% believed asbestos to be among the most common allergens in Germany. Amajority of 76% agreed with the statement that allergies are congenital and 54% believed that an underrather than an overreaction (61%) of the immune system describes the pathomechanism. Almost all subjects (96%) shared the conviction that allergies can be life threatening. Only 7% estimated the significance of a diagnostic allergy test correctly. The crossreactivity between pollen and food allergens as well as the clinical shift from allergic rhinitis to asthma was known to about 60% of the subjects. The typical allergens responsible for a seasonal allergic rhinoconjunctivitis were known to most of the teachers (87% - 98%). The knowledge about the pathogenesis of asthma was limited. 54% considered the impairment of inspiration as a typical symptom of an asthma attack. Characteristics of an atopic eczema such as pruritus (93%) and a familial predisposition (62%) were known to most of the teachers. Another 66%, however, believed that atopic eczema often occurs together with psoriasis. Fortunately, only 2.2% would not follow the current recommendations for vaccination in children with atopic eczema. Teachers, who were affected by an atopic eczema themselves, showed better overall results (100% vs. 49.1% with a result above average, p = 0.002). Furthermore, the educational level significantly influenced to the overall result: 17.6% of the participants who graduated after 8 years of school achieved a result above average compared with 55.8% of the participants with a higher graduation (p = 0.004). The level of knowledge of the teachers is limited and they seem to realize this fact. Particularly, with respect to the great willingness of further education (87.1%) and the educational key position of the teachers training on atopic diseases should be enhan

Comparison of ketotifen fumarate ophthalmic solution alone, desloratadine alone, and their combination for inhibition of the signs and symptoms of seasonal allergic rhinoconjunctivitis in the conjunctival allergen challenge model: a double-masked, placebo- and active-controlled trial

Background: Ketotifen fumarate is a topical antiallergic combination mast-cell stabilizer and antihistamine indicated for the temporary prevention of ocular itching due to allergic conjunctivitis. Desloratadine is a systemic antihistamine indicated for the treatment of seasonal and perennial allergic rhinitis. Objective: The purpose of this study was to compare the efficacy of ketotifen 0.025% ophthalmic solution instilled in the eye, desloratadine 5-mg tablets taken orally, and their combination for prevention of the signs and symptoms of allergic rhinoconjunctivitis, as induced by the conjunctival allergen challenge (CAC) model. Methods: This was a randomized, double-masked, placebo- and active-controlled, single-center clinical trial. At visit l, the dose of allergen necessary to elicit a qualifying allergic reaction was determined for subjects meeting the entry criteria. At visit 2, the allergen dose determined at visit 1 was confirmed, and all subjects who had a qualifying ocular and nasal allergic reaction were randomized to 1 of 3 treatment groups: ketotifen ophthalmic solution and placebo tablet, desloratadine tablet and placebo eyedrop, or ketotifen and desloratadine. Subjects were instructed to instill 1 drop into each eye twice daily and take 1 tablet with water once daily at the same time as the morning eyedrop for ∼4 weeks. At visit 3, subjects brought in their medication and were given 1 drop of the eyedrop bilaterally and 1 tablet with water. Bilateral CAC was performed 2 hours after administration of medication. Using standardized scales, subjects rated ocular itching at 3, 5, and 7 minutes after CAC; ocular tearing and eyelid swelling at 10, 15, and 20 minutes after CAC; and nasal signs and symptoms (sneezing, rhinorrhea and postnasal drip, pruritus, and nasal congestion) at 10, 20, 30, 40, and 50 minutes after CAC. The investigator graded ocular redness and chemosis at 10, 15, and 20 minutes after CAC. At all visits, subjects were offered an anti-allergy eyedrop to relieve any immediate ocular discomfort caused by CAC. Results: One hundred two subjects were screened—82 (55 women, 27 men; mean age, 42.8 years [range, 21–70 years]) were randomized to treatment, and 80 completed the study. Subjects in the group that received ketotifen (n = 27) and the group that received ketotifen with desloratadine (n = 26) had significantly lower mean itching scores compared with those in the group that received desloratadine alone (n = 27) at all time points ( P ≤ 0.05). Total ocular redness, calculated by summing the mean redness scores for each of the 3 vessel beds, was significantly lower in the ketotifen group than in the other treatment groups at most time points ( P ≤ 0.05). All treatments attenuated nasal symptoms; no statistically significant differences were noted between treatment groups, with the exception of the 50-minute time point, at which combination treatment was significantly more effective than ketotifen alone ( P ≤ 0.05). The proportion of subjects who requested relief drops after CAC was significantly lower in both the ketotifen alone and combination treatment groups compared with the desloratadine alone group ( P = 0.004). Conclusions: Ketotifen ophthalmic solution significantly decreased the signs and symptoms of ocular and nasal allergic rhinoconjunctivitis. The addition of ketotifen to the oral desloratadine regimen improved the overall antiallergic efficacy of both medications.

A randomized, double-blind, parallel-group comparison of olopatadine 0.1% ophthalmic solution versus placebo for controlling the signs and symptoms of seasonal allergic conjuctivitis and rhinoconjunctivitis

Background: The most common form of allergic ocular disease is seasonal allergic conjunctivities, coinciding with the pollen season and generally associated with rhinitis. Symptoms of allergic conjunctivitis include ocular itching, hyperemia, tearing, mucus production, foreign body sensation, chemosis, and lid edema. Similarly, the primary symptoms of allergic rhinoconjunctivitis are nasal itching, irritation, sneezing, watery rhinorrhea, and congestion combined with ocular itching, tearing, and swelling. Objective: This study compared olopatadine 0.1% ophthalmic solution with placebo eyedrops (over-the-counter artificial tear product), instilled in the eye, with regard to the prevention and relief of the ocular and nasal symptoms of seasonal allergic conjunctivitis and rhinoconjunctivitis. Methods: This was a randomized, double-blind, parallel-group study, conducted at 7 US centers, to instill either olopatadine 0.1% ophthalmic solution or placebo eyedrops (artificial tears) in both eyes twice daily for 10 weeks. Patients were evaluated for efficacy (intent-to-treat) and safety. Only patients with proven grass pollen allergy (dermal and conjunctival allergen challenge tests) were selected; all patients were studied during the same period, historically shown to be grass season; and grass pollen counts were obtained. Results: A total of 131 patients (64 olopatadine; 67 placebo) were assessed for efficacy (intent-to-treat); 132 patients were assessed for safety. The mean (SD) age of participants was 38.53 (11.61) years (range, 18 to 87 years), and 58.0% were women ( 76 131 ), with no significant differences between groups for age or sex. In the olopatadine group, 1.6% of patients were black ( 1 64 ), compared with 14.9% of the placebo group ( 10 67 ) ( P = 0.005). Mean scores of ocular itching and hyperemia were lower at all assessment times with olopatadine than placebo. The difference was statistically significant ( P < 0.05) for itching on days 7, 14, 35, 63, and 70, and for hyperemia on days 14, 28, 42, and 63, after correction for multiplicity. Linear regression slopes predicting ocular itching and hyperemia from the pollen count were significantly lower ( P < 0.003 and P < 0.035, respectively) with olopatadine than with placebo. Similar results were obtained for rhinorrhea, sneezing, and nasal itching ( P < 0.006, P < 0.012, and P < 0.034, respectively). With placebo, the proportion of patients with frequent ocular itching and hyperemia increased as a function of pollen level; however, with olopatadine, the proportions remained low and virtually constant. Conclusion: In the population studied, olopatadine 0.1% ophthalmic solution controlled ocular and nasal symptoms of allergic conjunctivitis and rhinoconjunctivitis and was well tolerated when administered twice daily for 10 weeks.

Development of a quality-of-life assessment for the allergic child or teenager with multisystem allergic disease

Background: Health-related quality of life (HRQOL) questionnaires currently being used to evaluate allergic disease are organ-specific. They therefore fail to take account of the systemic aspects of allergic disease. Objective: To develop and validate a pediatric HRQOL questionnaire for allergic disease (Pediatric Allergic Disease Quality of Life Questionnaire, PADQLQ) that encapsulates problems related to the eyes, ears, nose, lungs, skin, emotions, and everyday activities. Methods: In the development phase, 77 subjects (6 to 16 years of age), with seasonal or perennial allergic problems, were asked how much they were bothered by each different area of HRQOL impairment. The highest scoring areas were used to construct the PADQLQ. In the validation phase of the study, 36 subjects (8 to 16 years of age) with seasonal allergic rhinoconjunctivitis, seasonal allergic asthma, and/or cutaneous manifestations of grass pollen allergy were assessed before and during the pollen season. Results: The PADQLQ contains 26 questions. In addition to standard symptoms (eg, rhinitis), it incorporates multiorgan symptoms that are usually overlooked (eg, hearing problems). The PADQLQ demonstrated good cross-sectional and longitudinal validity, showing a high degree of correlation with symptom scores and quality of life as measured by a visual analogue scale and two-organ specific questionnaires. The PADQLQ showed good within-subject reliability and a small minimal important difference (0.33; 95% CI, 0.11 to 0.54 on a 7-point scale). Conclusions: The PADQLQ has good cross-sectional and longitudinal validity, making it a potentially useful outcome measure in the evaluation of systemic treatments such as antihistamine medications and immunotherapy in children with multisystem allergic disease. (J Allergy Clin Immunol 2003;111:491-7.)

Efficacy and safety of ketotifen fumarate eye drops as adjunctive therapy to mometasone furoate nasal spray in subjects with seasonal allergic rhinoconjunctivitis

Efficacy and safety of ketotifen fumarate eye drops as adjunctive therapy to mometasone furoate nasal spray in subjects with seasonal allergic rhinoconjunctivitis

Efficacy and Safety of Ketotifen Eye???Drops as Adjunctive Therapy to???Mometasone Nasal Spray in Subjects???with Seasonal Allergic Rhinoconjunctivitis

To compare the efficacy and safety of ketotifen 0.025% ophthalmic solution (one drop/eye) with placebo as adjunctive therapy to mometasone nasal spray (50 microg/spray, two puffs/nostril) in subjects with seasonal allergic rhinoconjunctivitis (SARC). Single-centre, randomised, double-masked, two-treatment, two-period crossover study. 8-hour allergen challenge in the Vienna Challenge Chamber. Subjects were >/=18 years old, had a >/=2-year history of SARC, and were sufficiently responsive to allergen challenge. During each challenge, subjects received a single dose of mometasone + ketotifen or mometasone + placebo. 47 subjects were randomised, and 44 completed both treatment sequences. Efficacy was based on mean area under the curve (AUC) values for symptom relief scores over time, with the primary variable being the AUC 4-6 hours postdose (AUC(4-6)) for relief of ocular itching. Between-treatment differences were assessed using analysis of variance. While improvement in ocular itching (AUC(4-6)) was observed with both treatments, improvement was significantly (p = 0.014) better with mometasone + ketotifen versus mometasone + placebo, as was improvement based on AUC(0-6) (p = 0.009) and AUC(0-2) (p = 0.006). Similar trends (in favour of mometasone + ketotifen) were observed for improvements in ocular redness, running nose, sneezing and ocular/nasal composite scores (p </= 0.05). None of the safety findings (slit-lamp biomicroscopy, vital signs, adverse events) were clinically significant. One subject discontinued treatment due to mild pharyngitis. Ketotifen eye drops adjunctive to mometasone nasal spray provided greater relief of both ocular and nasal signs and symptoms than mometasone alone in subjects with SARC.

Comparison of the efficacy and tolerability of topically administered azelastine, sodium cromoglycate and placebo in the treatment of seasonal allergic conjunctivitis and rhino-conjunctivitis

SUMMARYObjective and setting: Azelastine (AZE) in a novel, eye drop, formulation, was compared with topically applied sodium cromoglycate (SCG) and placebo (PLA) in the treatment of seasonal allergic conjunctivitis or rhino-conjunctivitis in a multicentre, parallel group study.Research design: 144 subjects ranging in age from 16 to 65 years participated. All had at least a 2-year history of seasonal allergic conjunctivitis and were symptomatic at the time of inclusion.Medications were administered topically either twice daily (AZE/PLA) or four times daily (SCG) over a 2-week treatment period.Method and outcome measures: Azelastine and placebo were compared double-blind; the comparison versus SCG was carried out in an open manner. Itching, redness, flow of tears, eyelid swelling, foreign-body sensation, photophobia, soreness and discharge were scored on a 4-point severity scale.Results: Results for the decrease of main conjunctivitis symptoms (itching, tearing and conjunctival redness) showed a marked effect for both active treatments on day 3 with a sustained improvement on days 7 and 14. A clear response to treatment (an improvement of sum scores for day 3 of >3 points compared to baseline) occurred in 85.4% of azelastine-treated patients, 83.0% of sodium cromoglycate patients and 56.3% of placebo patients. Response rates for both active treatments were statistically superior to those for placebo (azelastine p = 0.005; sodium cromoglycate p = 0.007). Global assessment of efficacy was at least 'satisfactory' for 90.0% of azelastine patients, 81.3% of sodium cromoglycate patients and 66.3% of placebo-treated patients. The most frequent adverse effects were transient application site reactions which tended to disappear with increasing duration of treatment, and, less frequently, taste perversion.Conclusion: The results of this study indicate that the therapeutic use of azelastine eye drops in patients with seasonal allergic conjunctivitis or rhino-conjunctivitis can be recommended.

Pollen immunotherapy reduces the development of asthma in children with seasonal rhinoconjunctivitis (the PAT-study)

Background: Children with allergic rhinitis are likely to develop asthma. Objective: The purpose of this investigation was to determine whether specific immunotherapy can prevent the development of asthma and reduce bronchial hyperresponsiveness in children with seasonal allergic rhinoconjunctivitis. Methods: From 6 pediatric allergy centers, 205 children aged 6 to 14 years (mean age, 10.7 years) with grass and/or birch pollen allergy but without any other clinically important allergy were randomized either to receive specific immunotherapy for 3 years or to an open control group. All subjects had moderate to severe hay fever symptoms, but at inclusion none reported asthma with need of daily treatment. Symptomatic treatment was limited to loratadine, levocabastine, sodium cromoglycate, and nasal budesonide. Asthma was evaluated clinically and by peak flow. Methacholine bronchial provocation tests were carried out during the season(s) and during the winter. Results: Before the start of immunotherapy, 20% of the children had mild asthma symptoms during the pollen season(s). Among those without asthma, the actively treated children had significantly fewer asthma symptoms after 3 years as evaluated by clinical diagnosis (odds ratio, 2.52; P < .05). Methacholine bronchial provocation test results improved significant in the active group (P < .05). Conclusion: Immunotherapy can reduce the development of asthma in children with seasonal rhinoconjunctivitis. (J Allergy Clin Immunol 2002;109:251-6.)

Mizolastine in the treatment of seasonal allergic rhinoconjunctivitis: a European clinical experience with 5408 patients managed in daily practice (PANEOS SAR Study).

Mizolastine, a potent H1 antihistamine with additional antiallergic properties, is marketed for the treatment of allergic rhinoconjunctivitis and urticaria. The objective was to investigate the safety and effectiveness of mizolastine under conditions of daily practice in patients with seasonal allergic rhinoconjunctivitis (SAR). In an open multicenter study, mizolastine 10 mg daily was administered for 14 days during the pollen season. Nasal and ocular symptoms, time to onset of symptom relief, and effect of the drug on diurnal alertness were evaluated. Safety was evaluated on the basis of self-reported adverse events (AE). A total of 5408 patients (36+/-14 years of age, females=57%) with a history of SAR for 8+/-9 years were treated for a mean of 17.1+/-5.0 days. SAR symptoms improved in 93% and decreased by at least 50% in 86% of patients; 78% reported improvement after the first drug intake and 51% from the first hour. Sixty-nine percent considered mizolastine more effective than other antihistamines taken previously. The incidence of AE was low (3.8%). The high responder rate, the rapid onset of action, and the low incidence of AE observed in this large multicenter study confirm the previously reported beneficial efficacy and safety of mizolastine in the management of SAR.

Seasonal Allergic Rhinoconjunctivitis and Fatty Acid Intake: A Cross-Sectional Study in Japan

PURPOSE: To investigate the associations of fatty acid intake with seasonal allergic rhinoconjunctivitis. METHODS: The study subjects consisted of 1012 women aged 22 to 57 years (mean age ± SD: 36.5 ± 7.7 years), who had graduated from the Aichi Prefectural Junior College of Nursing, Nagoya, Japan. They completed a self-administered questionnaire on symptoms of the disease in August 1998. Symptoms of seasonal allergic rhinoconjunctivitis in spring were determined by response to the questionnaire, and fatty acid intake was estimated using a food frequency questionnaire. Odds ratios (ORs) were computed using unconditional logistic models to assess the strength of associations between the symptoms and fatty acid intake. RESULTS: An increasing trend in the ORs was observed with increasing dietary intake of n-6 polyunsaturated fatty acids. After adjustment for potential confounders, the ORs for the second, third, and highest quartiles of intake relative to the lowest were 1.28 [95% confidence interval (CI), 0.78–2.10], 1.55 (0.96–2.50), and 1.74 (1.09–2.77), respectively (trend p = 0.015). Consumption of saturated, monounsaturated, and n-3 polyunsaturated fatty acids was not significantly related to the symptoms. CONCLUSIONS: Dietary intake of n-6 polyunsaturated fatty acids was positively associated with seasonal allergic rhinoconjunctivitis in spring.

A springtime Olympics demands special consideration for allergic athletes

Background: The Sydney Olympic and Paralympic Games will be held in September-October 2000, which is early to mid-spring in the southern hemisphere. Pollen-sensitive athletes may encounter problems with allergic symptoms triggered by pollen exposure, thus compromising their ability to attain peak performance. Objective: We sought to monitor pollen levels at the major Olympic venues to provide information for allergic athletes and their team doctors in order to adequately prepare them for Olympic competition. Methods: We performed aerobiologic monitoring of the major Olympic venues to provide a profile of the most prevalent pollen species appearing during the spring. In the second part of this study, we surveyed a population of elite Australian athletes from Olympic sports to ascertain the prevalence of allergic rhinoconjunctivitis, to investigate the major allergens involved in sensitization, and to conduct a pilot study to assess the effect of allergic rhinoconjunctivitis on quality of life. Results: The pollen counts obtained at the 3 major sites were high over the period of Olympic competition. Tree pollens appeared from July, and grasses appeared from early September and peaked in the second week of October, the beginning of Paralympic competition. A relatively small number of pollen varieties comprise the majority of the total pollen count. Two hundred fourteen athletes (61% male; mean age, 21 ± 16 years) representing 12 Olympic sports participated in the study. Fifty-six percent gave a symptom history consistent with allergic rhinoconjunctivitis, 41% had symptoms of allergic rhinoconjunctivitis and a positive test response to any one allergen, and 29% had seasonal allergic rhinoconjunctivitis (a positive history and at least one positive skin prick test response to a seasonal allergen). Athletes from aquatic sports were more likely to have symptoms than those from other sports. Symptom scores were higher and quality of life ratings were poorer in allergic compared with nonallergic athletes over the spring period. Conclusion: Olympic team managers and medical officers need to adequately prepare Olympic athletes for the possibility of exposure to high pollen levels in the weeks leading up to this most important sporting event. Symptoms of pollen sensitivity, such as rhinoconjunctivitis and exacerbation of asthma, could be devastating to athletes expecting peak performance. Potential Olympic athletes should be screened for the possibility of pollen allergy and have medical programs with permitted medication tailored to meet their needs. This may involve preventative therapy with medication, such as intranasal corticosteroid sprays or immunotherapy programs, if symptoms are particularly severe. The newer nonsedating antihistamines are the treatment of choice for acute intermittent symptoms. Appropriate management will ensure that the allergic athlete will safely perform to maximum ability with permitted medication during the Spring 2000 Olympic Games in Sydney. (J Allergy Clin Immunol 2000;106:260-6.)

Measuring Quality of Life in Children With Rhinoconjunctivitis

1. Juniper EF, 2. Howland WC, 3. Roberts NB, 4. Thompson AK, 5. King DR, 6. Math B (1998) J Allergy Clin Immunol. 101:163–170. [OpenUrl][1][CrossRef][2][PubMed][3][Web of Science][4] #### Purpose of the Study To develop, pretest, and validate a questionnaire to measure quality of life in children with seasonal allergic rhinoconjunctivitis (SAR). ##### Study Population Children, ages 6 to 12 years, with a history of SAR and troublesome symptoms during the previous month. ##### Methods Two studies in different locations were conducted to develop the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ). Study 1 was the “development” phase in which PRQLQ questions were developed and modified in 34 children with SAR. Forty-eight items in 8 initial domains were reduced to 23 questions in 5 domains (nose symptoms, eye symptoms, … [1]: {openurl}?query=rft.jtitle%253DJournal%2Bof%2BAllergy%2Band%2BClinical%2BImmunology%26rft.stitle%253DJournal%2Bof%2BAllergy%2Band%2BClinical%2BImmunology%26rft.aulast%253DJuniper%26rft.auinit1%253DE.%2BF.%26rft.volume%253D101%26rft.issue%253D2%2BPt%2B1%26rft.spage%253D163%26rft.epage%253D170%26rft.atitle%253DMeasuring%2Bquality%2Bof%2Blife%2Bin%2Bchildren%2Bwith%2Brhinoconjunctivitis.%26rft_id%253Dinfo%253Adoi%252F10.1016%252FS0091-6749%252898%252970380-X%26rft_id%253Dinfo%253Apmid%252F9500748%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/external-ref?access_num=10.1016/S0091-6749(98)70380-X&link_type=DOI [3]: /lookup/external-ref?access_num=9500748&link_type=MED&atom=%2Fpediatrics%2F104%2FSupplement_2%2F368.2.atom [4]: /lookup/external-ref?access_num=000072244800004&link_type=ISI

Rapid symptom relief in rhinitis

In some patients, symptoms of allergic rhinitis can be severe and therefore rapid relief is required. There are many treatment options for allergic rhinitis but histamine H1 blockers and topical corticosteroids represent the first-line treatment. Although the latter drugs are usually very effective on nasal symptoms, their onset of action is around 24 h. Thus drugs that are more rapidly effective are of interest. Recently 400 French specialists (in Allergy, ENT and Pneumology) met together to define the criteria for selecting a drug for the treatment of rhinitis. Twelve criteria were proposed and rapid onset of action (less than 24 h) was among the foremost designated criteria. In the first trial, a comparison of mizolastine (10 mg once daily [od]) with cetirizine (10 mg od) and placebo was carried out in the management of seasonal allergic rhino-conjunctivitis (SAR) with special focus on onset of action. A total of 375 patients were included in this European multicentric, randomized, parallel group and placebo-controlled study. By comparison to placebo, both cetirizine and mizolastine reduced significantly nasal and ocular symptoms during the 28-day follow-up trial. The percentage of responders ranged from 40% in the placebo group to 55% in the mizolastine group and 53% in the cetirizine group. Both active drugs were effective from the first intake with a rapid onset within 2 h. However, mizolastine was more rapidly and more profoundly effective than cetirizine during the first 12 h. A second trial included 257 patients suffering from perennial allergic rhino-conjunctivitis (PAR) in a 4-week double-blind placebo-controlled multicentric study. During the study, patients recorded, using a diary card, ocular and nasal symptoms, including nasal blockage. The mean values of nasal score between day 1, 14 and 28 in the mizolastine group were statistically significantly lower than those in the placebo group. The mean values of ocular score showed a statistical difference in recordings between day 1 and day 14 in favour of the mizolastine group. Mizolastine was an effective drug both in SAR and PAR with a rapid onset of action. Mizolastine relieved symptoms more effectively than cetirizine (SAR) and placebo (SAR and PAR) at the beginning of treatment.

Measuring quality of life in children with rhinoconjunctivitis

Objective: The objective of this study was to develop, pretest, and validate a questionnaire to measure quality of life in children with seasonal allergic rhinoconjunctivitis (SAR). Methods (development study): Thirty-four children with SAR were enrolled from summer camps, notices in the media, and an allergy clinic (Southern Ontario). After generating a pool of 48 potentially important quality of life items, the children identified the ones that they experienced with their SAR and scored each for bother (1 = a little bothered to 4 = extremely bothered). Items identified most frequently and with the highest bother score were included in the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ). The PRQLQ was pretested for ease completion and accuracy of understanding. Results (development study): The PRQLQ has 23 items in five domains (nose symptoms, eye symptoms, practical problems, other symptoms, and activities). Responses are given on a seven-point scale, and children are asked to score their experiences during the previous 7 days. Methods (validation study): Seventy-five children with symptomatic SAR were enrolled from notices in the media and a pediatric allergy clinic (Austin, Tex.). A single cohort design was used, with children assessed at 0, 1, and 3 weeks. The PRQLQ was administered to the children by a trained interviewer at 1 and 3 weeks. A conventional nasal symptom daily diary was completed for 1 week before each of these clinic visits. Global ratings were completed at the final visit. Results (validation study): In patients who were stable between clinic visits, the PRQLQ demonstrated good reliability (intraclass correlation coefficient = 0.93). The questionnaire was very responsive to change ( p < 0.001) and was able to differentiate between patients who were in a stable clinical state and those whose clinical state changed between visits ( p = 0.005). Correlations between the PRQLQ and diary scores were close to predicted and supported both the cross-sectional and longitudinal validity of the PRQLQ. Conclusions: The PRQLQ measures the quality of life impairments important to children with SAR. Children provide reliable and accurate responses, the measurement properties are strong, and the questionnaire can be used with confidence in clinical trials, clinical practice, and surveys. (J Allergy Clin Immunol 1998;101:163-70.)

Azelastine Eye Drops in the Treatment of Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis in Young Children

SummaryIn a randomised, multicentre study, the effect of azelastine eye drops (n = 51 patients) was compared in a double-blind manner with placebo eye drops (n = 30 patients) and in an open manner with levocabastine eye drops (n = 32 patients) during a 14-day treatment period involving 113 children (aged 4 to 12 years) suffering from seasonal allergic conjunctivitislrhinoconjunctivitis. The primary variable was the response rate defined as the number of patients showing an improvement after three days of treatment of at least three score points, from a minimum baseline score of six, in the main ocular symptoms of itching, conjunctival redness and lacrimation (each assessed on a four-point scale). Patients discontinuing due to inefficacy were regarded as non-responders.The mean response rate in the azelastine eye drops group (74%) was significantly higher (p < 0.01) than that in the placebo group (39%) and comparable with that in the levocabastine group. The response rates assessed by the patients in their diaries were very similar. Significant differences (p < 0.01) for azelastine compared with placebo were observed on days 3 and 14 in the mean sum scores for the three main symptoms and for a total of eight eye symptoms. The overall assessment of efficacy confirmed the superiority of both active treatments compared with placebo.Adverse drug reactions were reported in 23% of placebo-, 35% of azelastine- and 38% of levocabastine-treated patients. These were mainly local irritant effects. Overall tolerability was assessed as very good or good in 80%, 84% and 91% of placebo-, azelastine- and levocabastine-treated patients, respectively.Azelastine eye drops are effective and well-tolerated in children with seasonal allergic conjunctivitis.

Some alterations of the leucoeyte β2‐adrenoceptor/cAMP‐system in patients with seasonal allergic rhinoconjunctivitis are related to disease activity

Disturbances of beta2-adrenoceptors are discussed as a pathogenic factor in atopic diseases. In this study the expression and function of beta2-adrenoceptors on peripheral blood leucocytes (PBL) of seven atopic patients with seasonal rhinoconjunctivitis and their seven healthy controls was evaluated in relation to disease activity. Earlier reported data during pollen season were now compared with data obtained from the same subjects after their allergic symptoms had subsided. The variables that had indicated a beta2-adrenoceptor subsensitivity in the patients during pollen season returned to control values, i.e. the reduced beta2-adrenoceptor affinity, the reduced beta2-adrenoceptor sensitivity, the reduced increase of intracellular cyclic adenosine monophosphate (cAMP) content upon stimulation with isoproterenol, and the reduced cAMP plasma concentration (values no longer significantly different from those of controls). However, the variable that had suggested an increase in activity of the cAMP degrading enzyme phosphodiesterase (PDE), i.e. the reduced basal intracellular cAMP content of the patients, remained reduced after the pollen season (4.9 +/- 1.1 pmol/10(6) cells in patients vs 8.2 +/- 0.9 pmol/10(6) cells in controls: P<0.05). There were no significant differences in beta2-adrenoceptor density between patients and controls at both investigations. Atopic seasonal rhinoconjunctivitis is associated with various alterations in the PBL beta2-adrenoceptor/cAMP system that depend on disease activity. The reversible beta2-adrenoceptor subsensitivity is likely to be a consequence of the disease, whereas the irreversibly decreased basal intracellular cAMP content, suggested an elevated PDE activity, might be a basic trait of atopy.

Some alterations of the leucoeyte beta2-adrenoceptor/cAMP-system in patients with seasonal allergic rhinoconjunctivitis are related to disease activity

Some alterations of the leucoeyte beta2-adrenoceptor/cAMP-system in patients with seasonal allergic rhinoconjunctivitis are related to disease activity

Double-Blind, Randomised, Placebo-Controlled Study of Two Concentrations of Azelastine Eye Drops in Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis

SummaryThis double-blind, randomised, placebo-controlled study was carried out to assess the efficacy and safety of 0.025% and 0.05% azelastine eye drops twice daily administered for 14 days to patients with seasonal allergic conjunctivitis or rhinoconjunctivitis. A total of 278 patients were recruited and 226 patients were evaluable for per protocol analysis. The target parameter was the response rate. Four eye symptoms, including the main symptom (itching) were recorded by patients in diaries and eight symptoms were assessed by physicians before and after seven and 14 days of treatment. Severity of symptoms was measured on a four-point scale. The response rates for itching (improvement of at least one score point within the first three days) according to patient assessment were 43% for placebo, 52% for 0.025% and 56% for 0.05% azelastine (NS). However, a more objective assessment of the three main eye symptoms by physicians showed a concentration-dependent improvement in response rate compared with placebo (a decrease of ≥ 3 points from a baseline total score of ≥ 6), which reached statistical significance for 0.05% azelastine on Day 7 (p < 0.002). In the evaluable patient population, the scores of the three main eye symptoms as well as of all eight recorded eye symptoms, as assessed by the physician, were significantly (p <0.05) lower in the 0.05% azelastine eye drops group in comparison with the placebo group at Day 7. inefficacy was the cause of withdrawal in five and three patients on 0.025% and 0.05% azelastine, respectively, and in six patients on placebo. Adverse drug effects, mainly a mild, transient irritation and a bitter or unpleasant taste, were reported by 14% (0.025%), 20% (0.05%) and 15% (placebo) of the patients. No serious side-effects occurred. Azelastine ye drops are effective and well tolerated at a concentration of 0.05% for the treatment of seasonal allergic conjunctivitis.

Topical levocabastine—a review of therapeutic efficacy compared with topical sodium cromoglycate and oral terfenadine on days with high pollen counts

Levocabastine is a new H1-receptor antagonist specifically developed for the topical treatment of seasonal allergic rhinoconjunctivitis. Clinical experience to date clearly demonstrates that levocabastine eye drops and nasal spray are effective and well tolerated for the treatment of this allergic disorder. Analysis of data from a number of comparative trials reveals that topical levocabastine is at least as effective as sodium cromoglycate and the oral antihistamine terfenadine, even on days with high pollen counts (≥ 50 pollen particles/m3 ) when symptoms are severe. Coupled with a rapid onset of action and twice daily dosing, these findings make topical levocabastine an attractive alternative to other therapeutic approaches as a first-line therapy for the treatment, of this common condition.

Comparison of the efficacy and tolerability of topical levocabastine and sodium cromoglycate in the treatment of seasonal allergic rhinoconjunctivitis in children

Children (n = 110) with seasonal allergic rhinoconjunctivitis were randomized to receive either twice daily 0.05% levocabastine eye drops and nasal spray plus twice daily topical placebos or 2% sodium cromoglycate eye drops and nasal spray four times daily for a period of 4 weeks. Patients were required to use the nasal sprays as directed and the eye drops only when required. The results obtained suggest that topical levocabastine is at least as effective as sodium cromoglycate for the treatment of this condition. After 2 weeks treatment the effect of therapy on nasal symptoms was considered to be excellent or good in 72% of levocabastine-treated patients and 54% of patients on sodium cromoglycate (p = 0.009), with corresponding values for ocular symptoms of 81% and 57% in the two groups, respectively (p < 0.05). Investigator assessments also revealed that the severity of sneezing and lacrimation were significantly lower in the levocabastine group at this time (p < 0.05). After 4 weeks of treatment, patient diary data revealed that levocabastine was at least as effective as sodium cromoglycate with intergroup differences attaining statistical significance in favor of the topical antihistamine for nasal congestion (p < 0.05). Both agents were well-tolerated with no significant differences in the incidence or type of adverse reactions in the two treatment groups.