Management Of Seasonal Allergic Rhinitis Research Articles

AM-301, a barrier-forming nasal spray, versus saline spray in seasonal allergic rhinitis: A randomized clinical trial.

Saline nasal sprays are frequently used in the management of seasonal allergic rhinitis (SAR) for the cleansing and clearing of aeroallergens from the nasal cavity. Also using a drug-free approach, AM-301 nasal spray is forming a thin film barrier on the nasal mucosa to prevent contact with allergens, trap them, and facilitate their discharge. A clinical trial compared the efficacy, safety, and tolerability of AM-301 and saline spray in SAR. A total of 100 patients were randomized 1:1 to self-administer AM-301 or saline 3 × daily for 2 weeks. Primary efficacy endpoint: reduction in mean daily reflective Total Nasal Symptom Score (rTNSS). Secondary efficacy endpoints: reduction in mean instantaneous TNSS and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), global impression of efficacy. Safety and tolerability: adverse events, relief medication use, symptom-free days, global impression of tolerability. AM-301-treated patients achieved a significantly lower rTNSS than the saline group (LS square means difference -1.1, 95% CI -1.959 to -0.241, p = .013) with improvement observed across all individual nasal symptoms. Likewise, all secondary endpoints showed statistical significance in favor of AM-301; for example, quality of life was significantly improved overall (p < .001) as well as for each individual RQLQ domain. Both treatments showed similarly good safety and tolerability. With AM-301, fewer patients used relief medication and more enjoyed symptom-free days compared to saline treatment. AM-301 was more effective than saline in improving SAR nasal symptoms and related quality of life while offering similar tolerability, demonstrating the benefits of a barrier approach.

The clinical efficacy of desloratadine, a non-sedating antihistamine, in the management of allergic conditions: A review of the evidence

Desloratadine is a relatively new, second-generation, tricyclic antihistamine which came into medical use in 2001. This study aimed to review the available evidence in the literature around the clinical efficacy of desloratadine on a range of allergic conditions. A database search in Medline, PubMed, Embase, and Google Scholar was conducted for the research articles published until July 2020, using the keyword desloratadine. An additional reference lists search and citation tracking were also performed. Research articles in English pertaining to desloratadine and its efficacy were considered for inclusion. Study designs, including randomized controlled trials (RCT), observational/case-control studies, and case series were considered. The collective evidence from the current literature shows superior efficacy of desloratadine compared to placebo and some of the other treatment options in the management of seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), chronic idiopathic urticaria (CIU), and asthmatic symptoms. There is also evidence for potential new roles introduced for desloratadine such as acne treatment, chronic otitis media, and chronic rhinosinusitis, which warrants further investigation. In most studies, desloratadine’s safety and tolerability were comparable with placebo. Current evidence suggest that desloratadine is an ideal option for most of the allergic conditions due to its efficacy as well as favourable safety and tolerability profile. Further large-scale studies are needed to establish the efficacy and safety profile of desloratadine and to compare its effectiveness against other treatments in the management of allergic conditions.

Coincidence of pollen season and coronavirus disease 2019 pandemic: less time outdoors - lesser allergy symptoms in 2020.

BackgroundThis year, pollen season coincided with the first wave of the coronavirus disease 2019 pandemic. Strict preventive measures have been implemented during April and May and then a normalization phase started in our country in June. Our aim is to evaluate the effect of preventive measures during the pandemic process on allergic airway disease symptoms.MethodsA prospective questionnaire-based study was planned and a questionnaire form was sent to the cell-phones of the subjects with pollen allergy followed in our clinic. Number of airborne grass pollens was determined by Burkard volumetric 7-day spore trap.ResultsA total of 222 pollen allergic patients were included in the study. At the beginning of the pandemic, majority of the subjects were spending time mostly indoors. The rate of home-office workers gradually decreased and the rate of office workers and the number of days at work increased from April to June, significantly. Nasal and ocular symptoms of the patients, also increased in June compared to April and May and, approximately one-third of the patients had less symptoms when compared to the same period of the previous year. The rates of using a face mask and taking a shower on return home were high among the subjects during all season.ConclusionOur study showed that spending less time outside during the pollen season and wearing a mask outdoors reduces exposure to pollens and causes a reduction in symptoms. Thus, strict application of measures that cannot be applied in daily practice can make a significant contribution to the management of seasonal allergic rhinitis.

Isotonic nasal spray versus fluticasone nasal spray in treatment of allergic rhinitis

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; &lt;span lang="EN-IN"&gt;Allergic rhinitis (AR) is a prevalent disease with great morbidity and causing significant societal and economic burden. Aims and objectives: To compare efficacy of fluticasone nasal spray and isotonic saline nasal spray in allergic rhinitis.&lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; &lt;span lang="EN-IN"&gt;This was a prospective randomized study conducted on patients of allergic rhinitis coming to ENT OPD a tertiary care teaching hospital. Sixty patients diagnosed with concomitant diagnosis of allergic rhinitis was randomly allocated to either Fluticasone propionate nasal spray (n= 30) and isotonic saline spray (n= 30). &lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; &lt;span lang="EN-IN"&gt;The most common age group in fluticasone group was 21 to 30 years while in isotonic saline group 31 to 40 years was the most common age group. There was 52.8% of female and 47.2% in fluticasone group while in isotonic saline group, 52.5% of study population were female and 47.5% were male. There was significant improvement in VAS on day 15 and day 30 as compared to day 1 in fluticasone treated subjects as compared to isotonic saline group. After one month, Nasal blockage, nasal discharge, sneezing, nasal itching was improved to 71%, 69%, 81% and 78% in fluticasone treated subjects as compared to isotonic saline group in which improvement was up to 11%, 17%, 09% and 12% respectively and this difference was statistically significant. &lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; &lt;span lang="EN-IN"&gt;Fluticasone nasal spray has the potential to enhance patient satisfaction and compliance and reduce the need for polypharmacy in the management of seasonal allergic rhinitis.&lt;/span&gt;&lt;/p&gt;

Patient education in the effective management of hay fever.

Hay fever, or seasonal allergic rhinitis, is a common condition that affects one in four people in the UK. It is characterised by cold-like symptoms that may include a runny nose, itchy eyes, sneezing and nasal congestion or blockage. Patient education is important in improving patient concordance with treatment regimens and effectively managing hay fever symptoms, and may include advice on ways to avoid pollen. Encouraging patients to start treatment in advance of pollen dispersal, before they experience symptoms, enables optimum management of seasonal allergic rhinitis. Adjunctive treatment, using a nasal douche before applying a nasal corticosteroid spray, is recommended as an aid to nasal hygiene, to improve the efficacy of medication and to reduce allergic inflammation. Often a nasal corticosteroid spray is applied using an incorrect technique, rendering it ineffective. It is important for patients to understand how a nasal corticosteroid spray works and the need for continuous daily treatment using a correct application technique for maximum efficacy of the medication delivered. Standard operating procedures have been developed to demonstrate the effective technique for applying a nasal spray and to improve patients' understanding of the recommended nasal douching treatment.

Adolescent seasonal allergic rhinitis and the impact of health-care professional training: cluster randomised controlled trial of a complex intervention in primary care.

Background:Seasonal allergic rhinitis is typically poorly managed, particularly in adolescents, in whom it is responsible for considerable morbidity. Our previous work has demonstrated that if poorly controlled this can impair educational performance.Aim:The primary aim of this trial was to assess the impact of a primary care–based professional training intervention on clinical outcomes in adolescents with seasonal allergic rhinitis. Methods:Cluster trial in which UK general practice staff were randomised to a short, intensive workshop on the evidence-based management of seasonal allergic rhinitis. The primary outcome measure was the change in the validated Rhinoconjunctivitis Quality of Life Questionnaire with Standardized Activities (RQLQ(S)) score between baseline and 6 weeks post intervention (minimal clinically important difference=0.5). Secondary outcome measures of interest included health-care professionals’ knowledge and confidence in managing seasonal allergic rhinitis, number of seasonal allergic rhinitis-related consultations, relevant treatments prescribed and symptom scores.Results:Thirty-eight general practices were randomised (20 in the intervention arm) and 246 patients (50.2% males, mean age 15 years) were included in the primary outcome analysis. Health-care professionals’ knowledge and confidence of the clinical management of seasonal allergic rhinitis improved. This did not, however, result in clinically or statistically significant improvements in RQLQ(S): −0.15, (95% confidence interval, −0.5 to +0.2). There were no differences in consultation frequency, treatments issued for seasonal allergic rhinitis or symptom scores.Conclusions:Although associated with increases in professionals’ self-assessed confidence and understanding of seasonal allergic rhinitis management, this intensive training workshop did not translate into improvements in adolescents’ disease-specific quality of life or a reduction in rhinitis symptoms.

Multi-strain Symbiotic Preparations as a Novel Adjuvant Approach to Allergic Rhinitis

Objective. To investigate the effects of Lactobacillus acidophilus NCFM / Bifidobacterium lactis BL-04 / fructooligosaccharide and Lactobacillus plantarum LP01/ Lactobacillus paracasei LPC00 / fructo-oligosaccharide preparations in the routine clinical management of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR), respectively. Materials and Methods. Seventy-six and fifty-one outpatients attending 36 Allergy Clinics in Italy with clinically documented allergic rhinitis consumed a symbiotic combination of Lactobacillus acidophilus NCFM / Bifidobacterium lactis BL-04/ fructo-oligosaccharide and Lactobacillus plantarum LP01/ Lactobacillus paracasei LPC00 / fructo-oligosaccharide over a period of 4 months. Data on Allergic Rhinitis and Impact on Asthma (ARIA) classification, nasal symptoms severity by Visual Analogical Scale (VAS), and concomitant use of corticosteroids and antihistamines drugs were collected after 2 and 4 months of treatment (T1 and T2 respectively). Results. After the treatment with two multi-strain symbiotic preparations a significant reduction between baseline evaluation (T0) and T1/T2 on total nasal symptoms and ARIA classification of rhinitis were observed. A significant decrease on VAS index at all time points of the treatment vs pre-treatment was detected for Lactobacillus plantarum / Lactobacillus paracasei symbiotic combination; significant decrease was observed for Lactobacillus acidophilus / Bifidobacterium lactis symbiotic combination between T0 and T1, while a further reduction at T2 did not reach statistical significance. In addition a decrease in consumption of orally-administered corticosteroids and antihistamines drugs was found. Conclusion. These data on the effect of Lactobacillus acidophilus NCFM/ Bifidobacterium lactis BL-04 / fructooligosaccharide and Lactobacillus plantarum LP01/ Lactobacillus paracasei LPC00 / fructo-oligosaccharide preparations support their potential positive effect in the routine clinical management of subjects with SAR and PAR, respectively. Future studies are warranted to confirm this potential beneficial effect.

Clinical Study of the Therapeutic Efficacy and Safety of Emedastine Difumarate versus Cetirizine in the Treatment of Seasonal Allergic Rhinitis

The therapeutic efficacy and tolerability of emedastine difumarate (CAS 87233-62-3) in male and female Caucasian patients with seasonal allergic rhinitis as compared to cetirizine (CAS 83881-51-0) was evaluated. The study was designed as a double-blind, randomised, parallel groups comparison of two antihistamines administered by oral route (emedastine 4 mg o.d. versus cetirizine 10 mg o.d.) in a population of 120 patients suffering from grass pollen allergic rhinitis. The duration of the treatment period was 14 days. Primary efficacy variable was a total symptoms score (including among symptoms nasal congestion, sneezing, rhinorrhea, nasal/throat/palate itching, eye itching and lacrimation) evaluated after 14 days of treatment vs. baseline value. Safety was assessed on routine laboratory assays and recording vital signs and adverse events (AEs). The between-group difference in primary efficacy variable averaged over the 2-week treatment period was not statistically significant. Results clearly showed that no significant difference exists between the two treatments as far as total symptoms score evaluated after 14 days of treatment vs. baseline values are concerned. Therefore, the efficacy profiles of the study medications are overlapping. The pattern and incidence of AEs was similar in both treatment groups. The most frequent AEs with both compounds were related to the CNS, headache being the most reported one. In particular, this study seems to disclose a slighter tendency to drowsiness with emedastine than with cetirizine. Both drugs under investigation in this trial appear to be effective for relieving the symptoms of seasonal allergic rhinitis in Caucasian adult patients. The results demonstrate that emedastine 4 mg o.d. is comparable in efficacy to cetirizine 10 mg once daily in the symptomatic management of seasonal allergic rhinitis. Moreover, based on the results of this study, emedastine can be considered a safe and well-tolerated drug and its safety profile seems to resemble that of cetirizine.

Clinical Study of the Therapeutic Efficacy and Safety of Emedastine Difumarate versus Terfenadine in the Treatment of Seasonal Allergic Rhinitis

Emedastine is a new H1-receptor antagonist endowed with potent and selective antihistamine activity. The aim of this study was to evaluate the therapeutic efficacy and tolerability of emedastine difumarate (CAS 87233-62-3) in Caucasian patients in the treatment of seasonal allergic rhinitis as compared to terfenadine (CAS 50679-08-8). A total of 130 patients suffering from grass pollen allergic rhinitis were randomly assigned to 14 days treatment with either emedastine difumarate (2 mg b.i.d.) or terfenadine (60 mg b.i.d.) in a double-blind, randomised, crossover design. Primary efficacy parameter was a Total Severity Symptom Score, including among symptoms nasal congestion, sneezing, rhinorrhea, nasal/throat/palate itching, eye itching and lacrimation. Safety was assessed on routine laboratory tests and recording vital signs and adverse events (AEs). Emedastine 2 mg b.i.d. was significantly more effective than terfenadine 60 mg b.i.d. in reducing Total Symptom Severity Score (p = 0.0258). This statistical significant difference was also obtained in controlling sneezing and rhinorrhea (p = 0.003). Moreover, both the physician and patients indicated emedastine as the preferred therapy (p < 0.01). Forty-seven drug related AEs were reported for emedastine (= 51.07 %) and 53 for terfenadine (64.15 %), most of them involving the CNS. The results of study show that emedastine difumarate is more effective than terfenadine in the symptomatic management of seasonal allergic rhinitis and is particularly active in controlling the main nasal symptoms, such as sneezing and rhinorrhea; it is safe and well tolerated in this therapeutic indication, while related AEs are less if compared to those displayed by terfenadine.

Ciclesonide for the treatment of seasonal allergic rhinitis

Allergic rhinitis is considered one of the most common afflictions of humans, affecting up to 30% of the world’s population, and is increasing in incidence. Primary symptoms, comorbid conditions and complications of this disorder exact a significant toll, resulting in an enormous physical, social and economic impact on society. Single-season allergic rhinitis accounts for approximately 20% of cases of allergic rhinitis with another 40% having mixed seasonal-perennial presentations. Management of this disorder encompasses several treatment options, with intranasal corticosteroids recommended as first-line treatment in moderate-to-severe seasonal allergic rhinitis in current practice parameters. Ciclesonide is the most recently approved product in this category for the management of seasonal allergic rhinitis and is the subject of this article.

Development and pilot evaluation of a novel probiotic mixture for the management of seasonal allergic rhinitis

Microbial exposure may direct the immune system away from allergic-type responses, but until now probiotic interventions have had limited success in the prevention and treatment of allergic diseases. In this study, a novel probiotic mixture was specifically created based on preliminary in vitro investigations on pollen-induced immune responses. A mixture with Lactobacillus rhamnosus GR-1 and a novel fecal Bifidobacterium adolescentis isolate was formulated into a yogurt and tested for its effects in 36 subjects with allergic rhinitis over 2 pollen seasons in a double-blind, placebo-controlled trial. The new formulation was well tolerated, but did not have significant effects on the quality of life scores, use of antihistamines, or eosinophil cationic protein concentration in nasal lavage. However, at the end of the grass pollen season, serum IL-10 and IL-12 levels were increased in the probiotic group compared to the controls. During the ragweed season, the serum TGF-&beta; levels were significantly higher in the probiotic group than in the controls. In conclusion, the novel probiotic formulation had potentially desirable effects on the cytokine profile of patients with allergic rhinitis, but provided few clinical benefits. The study highlights the challenges in designing efficient immunomodulatory probiotic therapies based upon in vitro findings.

Fluticasone furoate nasal spray: Profile of an enhanced-affinity corticosteroid in treatment of seasonal allergic rhinitis.

Of the classes of pharmacotherapy for seasonal allergic rhinitis, intranasal corticosteroids are the preferred treatment and are recommended in practice guidelines as first-line pharmacotherapy for rhinitis with prominent nasal congestion. The enhanced-affinity intranasal corticosteroid fluticasone furoate nasal spray (GW685698X), is one of the newest additions to the armamentarium for allergic rhinitis. This review summarizes the preclinical and clinical data on fluticasone furoate nasal spray and discusses its place in pharmacotherapy for seasonal allergic rhinitis. Important attributes of fluticasone furoate in seasonal allergic rhinitis include low systemic bioavailability (<0.5%), onset of symptom relief as early as eight hours after initiation of treatment, 24-hour symptom relief with once-daily dosing, comprehensive coverage of both nasal and ocular symptoms, safety and tolerability with daily use, and availability in a side-actuated device that makes medication delivery simple and consistent. With these attributes, fluticasone furoate nasal spray has the potential to enhance patient satisfaction and compliance and reduce the need for polypharmacy in the management of seasonal allergic rhinitis.

Relationship between airborne pollen count and treatment outcome in Japanese cedar pollinosis patients

In Japan, information on daily Japanese cedar pollen counts is made public during pollen season. If symptom severity and treatment outcome are predictable according to these pollen counts, management of seasonal allergic rhinitis may become more precise. The aims of the study were to evaluate the relationship between airborne pollen counts, symptom severity and treatment outcome in Japanese cedar pollinosis patients. In the randomized study, patients with moderate to most severe Japanese pollinosis were treated with fexofenadine (60 mg BD) or fexofenadine and nasal corticosteroids for 2 weeks. During the same period daily airborne pollen counts were measured. A total of 105 adult patients were enrolled. No difference of treatment efficacy was seen among groups. Detailed results of efficacy and safety were previously described elsewhere. In univariate analysis, the mean cumulative amount of airborne pollen exposure for 4 days prior to the study tended to affect symptom severity (P = 0.053) and the mean cumulative amount of airborne pollen during the treatment period tended to show difference among five treatment outcome categories (P = 0.066). In multivariate analysis, the mean cumulative amount of airborne pollen exposure for 4 days prior to the study was identified as the only significant factor of symptom severity (P = 0.0327) and cumulative amount of airborne pollen during the treatment period (P = 0.027) and allergic history (P = 0.027) were significant factors of treatment outcomes. No serious adverse effect was reported during the study. The amount of airborne pollen may be predictive of both symptom severity and treatment outcome.

PAA4 ADVERSE DRUG REACTIONS IN ECONOMIC EVALUATIONS

Rationale: Economic evaluations of pharmaceuticals require that health outcomes include adverse as well as beneficial effects of therapy. When the incidence and/or severity of adverse drug reactions (ADRs) result in an unfavourable risk/benefit profile, regulatory authorities such as the EMEA and FDA, contain risks by imposing restrictions (for instance on dose, to specific patient sub-groups, or use of concomitant medications) or withdrawing the drug from the market. Decisions made by regulatory authorities are not based upon the expected utility theory, and as a result, drugs that are deemed harmful appear to be cost-effective in economic evaluations. Objectives: To review the health economic literature for drugs that have since been withdrawn for safety reasons. To assess the cost-effectiveness of the non-sedating anti-histamine, terfenadine (withdrawn in 1998 for its cardiotoxicity) compared with chlorpheniramine, a sedating anti-histamine which is still available. Methods: Literature searches of economic evaluations of drug that have been withdrawn since 1980 were conducted using PubMed. A decision analysis comparing terfenadine with chlorpheniramine for the management of seasonal allergic rhinitis was developed. Data on clinical effectiveness were obtained from an RCT that compared both drugs. Observational data were obtained for estimates of the incidence of ventricular dysrythmias, the incidence of serious injuries as a consequence of sedation with chlorpheniramine, and the risk of death resulting from arrhythmias or serious injuries. Health state utilities were obtained from published sources. A 12-month time horizon was adopted, with probabilistic sensitivity analysis and threshold analyses conduced to assess the impact of uncertainty in parameter estimates. Results: Examples of published cost-effectiveness analyses included troglitazone (PPAR activator, withdrawn in 2000 for hepatotoxicity), and rofecoxib (COX-2 inhibitor, voluntarily withdrawn in 2004 for cardiotoxicity). Despite including ADRs in the analyses, both drugs were deemed cost-effective. For troglitazone, the authors stated inclusion of liver failure in the model leads to a decrease of 0.01% in LYG. The analysis of treatments for allergic rhinitis revealed that, in fact, chlorpheniramine had a less favourable risk/benefit ratio than terfenadine, with a mean difference of 3.6 QALYs per 1000 patients (95% credible interval, -0.4, 8.3). Threshold analysis suggested that it would require the relative risk of serious injury with terfenadine, compared with chlorpheniramine, to increase from 45% to 85%, or for the efficacy of terfenadine to reduce from 60% to 34% for the decision to be reversed. Conclusions: The inclusion in economic evaluations of ADRs that are deemed too hazardous to warrant market authorisation by regulators, may lead to counter-intuitive estimates of cost-effectiveness. This may be the fault of regulators for not adopting decision analytic models, or reflect a lack of risk aversion in economic evaluations. Alternative explanations are explored, including: Imprecision in the analyses (including the assumption of 'class effect' for sedating anti-histamines), the strength of causality (the link between terfenadine and cardiotoxicity is better established than accidents resulting from sedation with chlorpheniramine) and regulatory risk aversiveness (regulatory authorities consider avoidable risks differently from unavoidable risks).

Fluticasone furoate nasal spray: A single treatment option for the symptoms of seasonal allergic rhinitis

Fluticasone furoate (USAN-approved name) is a novel, enhanced-affinity glucocorticoid administered in a unique side-actuated device for the management of seasonal allergic rhinitis (SAR). We sought to evaluate the efficacy and safety of once-daily fluticasone furoate nasal spray, 110 microg, in patients aged 12 years or older with fall SAR. Patients (n = 299) received fluticasone furoate or placebo for 2 weeks in this double-blind, parallel-group randomized study. Patients evaluated nasal and ocular symptoms using a 4-point categoric scale. Efficacy was assessed on the basis of the mean change from baseline in reflective and instantaneous total nasal symptom scores and reflective total ocular symptom scores. Fluticasone furoate produced significantly greater improvements than placebo in daily reflective total nasal symptom score (-1.473, P < .001; primary end point), morning predose instantaneous total nasal symptom score (-1.375, P < .001), daily reflective total ocular symptom score (-0.600, P = .004), and patient-rated overall response to therapy (P < .001). The onset of therapeutic effect occurred at 8 hours after initial administration. Fluticasone furoate was well tolerated. Fluticasone furoate, 110 microg once daily, was effective and well tolerated for the treatment of nasal symptoms of SAR in patients aged 12 years and older. Treatment also produced significant improvements in ocular symptoms. Fluticasone furoate was fast acting, as indicated by an 8-hour onset of action, and provided 24-hour symptom control. New treatments for the bothersome symptoms of SAR are needed. One such treatment, fluticasone furoate nasal spray, provides effective relief of the symptom profile of SAR.

Standard treatment: the role of antihistamines.

Histamine-1 (H1) antihistamines are the first-line drug for the treatment of urticaria. Major progress has been achieved in recent years both in the understanding of their ligands, the H1-histamine receptors, and therefore in the mechanisms of their pharmacologic effects, as well as in the development of safer antihistamines with low or no sedating effects and no interactions on the level of potassium channels leading to QT-prolongations and interactions on the level of cytochrome P450 isoenzymes. This development has brought antihistamines very close to the ideal antihistamines that are desired by clinicians to treat most types of urticaria in patients who have to take these drugs for a long time.

As-needed use of fluticasone propionate nasal spray reduces symptoms of seasonal allergic rhinitis

Background: The daily use of intranasal corticosteroids is approved for the treatment of seasonal allergic rhinitis. Objective: Our objective was to test the effectiveness of as-needed use of intranasal corticosteroids in the treatment of seasonal allergic rhinitis. Methods: A double-blind, placebo-controlled, randomized, parallel-group study of the as-needed usage of fluticasone propionate nasal spray in the management of seasonal allergic rhinitis was performed. Outcome measures were symptom score, Rhinitis Quality of Life Questionnaire (RQLQ), and the number of eosinophils and the level of eosinophilic cationic protein (ECP) in nasal lavage. Results: Twenty-six subjects in each group completed the 4-week study. The median symptom score over the duration of the study in the placebo group was 8.5 versus 4.5 in the active group. The active group had significant improvement on the interim visit in the sleep, non-nose/eye, activities, nasal, practical, and overall domains (P < .05) of the RQLQ and on the final visit in the nasal symptom domain. The number of eosinophils was significantly lower in the active than in the placebo group at the final visit. Changes in ECP were not significant. Conclusion: As-needed fluticasone propionate nasal spray is efficacious in the treatment of seasonal allergic rhinitis. (J Allergy Clin Immunol 2000;105:732-8.)

Comparative efficacy and safety of a once-daily loratadine-pseudoephedrine combination versus its components alone and placebo in the management of seasonal allergic rhinitis

Background: The treatment of symptoms of seasonal allergic rhinitis often requires the use of a decongestant to improve nasal congestion, along with an antihistamine to adequately control other nasal, as well as nonnasal symptoms. Methods: In this double-blind, placebo-controlled, multicenter study, 874 patients with moderate to severe symptoms of seasonal allergic rhinitis were treated with one of the following: SCH 434 QD (a combination of 10 mg of loratadine in the coating and 240 mg of pseudoephedrine sulfate in an extended-release core) once daily, 10 mg of loratadine once daily, 120 mg of pseudoephedrine sulfate every 12 hours, or placebo for 2 weeks. Results: SCH 434 QD was consistently superior to placebo in controlling the symptoms of seasonal allergic rhinitis. Composite symptom scores (total, total nasal, and total nonnasal) were reduced significantly in patients treated with SCH 434 QD as compared with placebo ( p < 0.01). When compared with its individual components, reductions in mean symptom scores were consistently greater, numerically, in patients treated with SCH 434 QD than in patients who were treated with either loratadine or pseudoephedrine alone. SCH 434 QD was superior to pseudoephedrine in reducing nonnasal symptoms at all time points ( p < 0.01), and superior to loratadine in relieving nasal stuffiness at end point ( p < 0.01). In the physicians' evaluation of therapeutic response, the SCH 434 QD group had the greatest number of patients with a good or excellent response at end point (58%). All treatments were generally well tolerated with no serious or unusual adverse events. Insomnia and nervousness, adverse events commonly associated with pseudoephedrine, were noted in a significantly greater number of patients treated with SCH 434 QD or pseudoephedrine (p ≤ 0.04) as compared with those treated with loratadine or placebo. Conclusions: The results of the study demonstrate that SCH 434 QD is more effective than placebo or either of its components alone in the treatment of seasonal allergic rhinitis. (J A LLERGY C LIN I MMUNOL 1995;96:139-47.)

Clinical evaluation of the efficacy and safety of noberastine, a new H 1 antagonist, in seasonal allergic rhinitis: A placebo-controlled, dose-response study

Noberastine (NOB), a new histamine H 1 antagonist, has potent and specific peripheral antihistaminic activity. To evaluate the efficacy and safety of NOB in ragweed seasonal allergic rhinitis, 250 eligible patients were randomized to one of four parallel, double-blind treatment groups: NOB, 10, 20, and 30 mg, or placebo, each administered once daily for 3 weeks. Rescue medication was prohibited. Efficacy parameters included global response rate (percentage of responders), physician visit, patient-diary symptom scores, and onset of action. Efficacy analyses used α = 0.0167 (adjusted for multiple comparisons). Efficacy parameters demonstrated universal superiority of NOB therapy over placebo therapy with statistical significance achieved frequently; no statistically or clinically significant separation was demonstrated among NOB-treated groups. Global-response rates for all active-treatment groups (range, 62.7% to 71.1%) were statistically significantly greater than rates for the placebo-treated group (39.6%). Median time to first relief of symptoms was within 2 to 4 hours for NOB-treated groups versus 72 hours for the placebo-treated group. No significant abnormalities in safety parameters were ascribed to NOB treatment. Incidence and severity of adverse experiences of NOB-treated groups were comparable in incidence and severity to placebo treatment. NOB treatment did not appear to cause weight gain or sedation. Once-daily NOB, 10, 20, and 30 mg, is equally and highly effective and safe in the symptomatic management of seasonal allergic rhinitis compared to placebo.

Vidian nerve section for vasomotor rhinitis.

THE OTOLARYNGOLOGIST needs an adequate method of treatment for those patients who suffer with vasomotor rhinitis so severe that it defies conventional forms of therapy. It is frequently impossible to differentiate in a patient with a perennial problem, whether he suffers from true allergic vasomotor rhinitis. The diagnosis and management of seasonal allergic rhinitis is fairly satisfactory. The cause of perennial rhinitis is frequently elusive. If the physician and patient cooperatively discover the offending allergens or irritants, control of the disorder is possible. All too often, however, despite extensive allergic testing and food elimination tests no cause is found. In such instances one has to resort to less rational forms of therapy, such as the administration of drugs and performance of various intranasal procedures to produce a larger nasal airway. In this discussion we are concerned, then, with the patient who has chronic or frequently recurring nasal obstruction, watery rhinorrhea,