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Background: It is unclear what constitutes a clinically meaningful response for allergic rhinitis (AR) outcomes. The objectives of these post hoc analyses were (1) to define a clinically meaningful response using novel efficacy analyses (including a responder analysis), and (2) to compare the efficacy of MP29-02 [a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP)] with commercially available FP, AZE and placebo in seasonal AR (SAR) patients, using these novel analyses. Methods: 610 moderate-to-severe SAR patients (≥12 years old) were randomized into a double-blind, placebo-controlled, 14-day, parallel-group trial. Change from baseline in the reflective total nasal symptom score (rTNSS) over 14 days was the primary outcome. Post hoc endpoints included the sum of nasal and ocular symptoms (rT7SS), efficacy by disease severity and by predominant nasal symptom, and a set of responder analyses. Results: MP29-02 most effectively reduced rT7SS (relative greater improvement: 52% to FP; 56% to AZE) and both nasal and ocular symptoms irrespective of severity. More MP29-02 patients achieved a ≥30, ≥50, ≥60, ≥75 and ≥90% rTNSS reduction, which occurred days faster than with either active comparator; MP29-02 alone was superior to placebo at the ≥60% (or higher) threshold. One in 2 MP29-02 patients achieved a ≥50% rTNSS reduction and 1 in 6 achieved complete/near-to-complete response. Only MP29-02 was consistently superior to placebo for all patients, whatever their predominant symptom. Conclusions: MP29-02 provided faster and more complete symptom control than first-line therapies. It was consistently superior irrespective of severity, response criteria or patient-type, and may be considered the drug of choice for moderate-to-severe AR. These measures define a new standard for assessing relevance in AR.

Background: Japanese cedar (JC) pollinosis is the most common seasonal allergic rhinitis in Japan. Standardized JC pollen extract is available for subcutaneous immunotherapy, but this treatment is limited by potentially serious side effects. The aim of this double-blind, randomized comparative study was to evaluate the efficacy and safety of standardized JC pollen extract in a new oral formulation (CEDARTOLEN®, Torii Pharmaceutical Co., Ltd., Tokyo, Japan) for sublingual immunotherapy (SLIT) for JC pollinosis. Methods: A total of 531 subjects with JC pollinosis were randomized into 2 groups at a ratio of 1:1 to receive daily sublingual administration of standardized JC pollen extract with a maintenance dose of 2,000 Japanese allergy units (JAU) or placebo for 2 consecutive pollen seasons. The efficacy was evaluated using the total nasal symptom and medication score (TNSMS) as the primary end point. Secondary end points included the total ocular symptom and medication score (TOSMS) and scores for individual symptoms and medication. Results: The TNSMS was significantly lower (p < 0.0001) in the SLIT group than in the placebo group in the peak symptom period by 18 and 30% in the first and second seasons, respectively. All secondary end points were also significantly lower in the SLIT group in both seasons. No systemic anaphylaxis occurred. Conclusions: SLIT with daily administration of standardized JC pollen extract was effective for improving nasal and ocular symptoms of JC pollinosis and reducing the use of relief medication. The JC pollen extract was well tolerated with only local adverse events.

This study aimed to explore the therapeutic effects of the combined use of omalizumab with conventional anti-allergy treatment for IgE-mediated allergic diseases and to provide new treatment options for the clinical management of IgE-mediated allergic diseases. Patients with IgE-mediated allergic diseases who visited the Allergy Department of the First Hospital of Hebei Medical University between June 2020 and June 2022 were randomly divided into two groups: the conventional anti-allergy treatment group (control) and the experimental group receiving conventional treatment combined with omalizumab. The treatment lasted for 24 weeks, with patient follow-up and evaluation of treatment effects for seasonal allergic rhinitis, allergic asthma, and urticaria. The evaluation of treatment effects for seasonal allergic rhinitis, urticaria, and allergic rhinitis showed that the experimental group had significantly better outcomes than the control group. The combined use of omalizumab with conventional anti-allergy treatment was effective in treating IgE-mediated seasonal allergic rhinitis, urticaria, and allergic asthma, providing a new therapeutic option for the clinical management of IgE-mediated allergic diseases.

Background: As an anti-inflammatory and antioxidant, sodium pyruvate significantly reduces inflammatory cytokines and oxygen radicals such as interleukin (IL) IL-6, IL-8, Monocyte Chemoattractant Protein-1, and hydrogen peroxide. Thus, sodium pyruvate holds promise as a treatment for many respiratory diseases, including allergic rhinitis (AR). Novel treatments for AR are needed as current medications, including steroids, often fail to treat severe symptoms. Methods: The data from five human clinical studies were analyzed to determine the effect of 20 mM sodium pyruvate nasal spray (N115) in patients with AR. Nasal inflammation scores were compared to a placebo control or a no-treatment baseline control. Three studies were open-labeled and two were appropriately blinded to both patients and clinicians using computer randomization of subjects. Results: The intranasal administration of sodium pyruvate significantly improved nasal inflammation scores in all five clinical trials of patients with AR (p < 0.0001 in all trials). Conclusions: These results give credence to the overall ability of sodium pyruvate, administered by nasal spray, to treat inflammation of the nasal airways.

Since Agaricus blazei Murill (AbM) extract reduced specific IgE and ameliorated a skewed Th1/Th2 balance in a mouse allergy model, it was tested in blood donors with self-reported, IgE-positive, birch pollen allergy and/or asthma. Sixty recruited donors were randomized in a placebo-controlled, double-blinded study with pre-seasonal, 7-week, oral supplementation with the AbM-based extract AndosanTM. Before and after the pollen season, questionnaires were answered for allergic rhino-conjunctivitis, asthma, and medication; serum IgE was measured, and Bet v 1-induced basophil activation was determined by CD63 expression. The reported general allergy and asthma symptoms and medication were significantly reduced in the AbM compared to the placebo group during pollen season. During the season, there was significant reduction in specific IgE anti-Bet v 1 and anti-t3 (birch pollen extract) levels in the AbM compared with the placebo group. While the maximal allergen concentrations needed for eliciting basophil activation before the season, changed significantly in the placebo group to lower concentrations (i.e., enhanced sensitization) after the season, these concentrations remained similar in the AndosanTM AbM extract group. Hence, the prophylactic effect of oral supplementation before the season with the AbM-based AndosanTM extract on aeroallergen-induced allergy was associated with reduced specific IgE levels during the season and basophils becoming less sensitive to allergen activation.

Background Allergic rhinitis (AR) and allergic asthma are caused by an IgE-mediated inflammatory reaction. Probiotics may exert anti-inflammatory and immune-modulatory activity. Thus, this study aimed at investigating whether a Bifidobacteria mixture could be able to relieve nasal symptoms, and affect quality of life (QoL) in children with AR and intermittent asthma due to Parietaria allergy. Materials and methods The present study was conducted as placebo-controlled, double-blinded, and randomized. Globally, 40 children (18 males; mean age 9 ± 2.2 years) were enrolled. They were treated with probiotics or placebo: 1 sachet/day for 4 weeks. AR symptoms, and QoL were assessed at baseline and after treatment. Use of rescue medications, such as cetirizine syrup and salbutamol spray, was also permitted and recorded. Results Children treated with probiotic mixture achieved a significant improvement of symptoms ( p  < 0.005), and QoL (( p  < 0.001). Placebo group had worsening of symptoms ( p  < 0.005) and QoL ( p  < 0.001). The use of rescue medications was overlapping in the two groups. The intergroup analysis showed that probiotic mixture was significantly superior than placebo for all parameters. Conclusions The current study demonstrated that a Bifidobacteria mixture was able of significantly improving AR symptoms and QoL in children with pollen-induced AR and intermittent asthma. Clinical trial registration ClinicalTrials.gov ID NCT02807064 .

Background/objectives: An imbalance between Th1 and Th2 cells is involved in allergic rhinitis (AR) that may be improved by probiotics. To test the efficacy of the probiotic Lactobacillus paracasei subsp. paracasei LP-33, a double-blind, placebo-controlled, randomized trial was carried out in patients with AR to grass pollen treated with loratadine and presenting altered quality of life. Subjects/methods: Subjects with persistent AR, symptomatic during the grass pollen season, and a positive skin test or specific immunoglobulin E to grass pollens were included by general practitioners (GPs). All received loratadine for 5 weeks. The primary end point was the improvement in Rhinitis Quality of Life (RQLQ) global score at the fifth week of LP-33 consumption compared with placebo (in addition to loratadine). Secondary end points included nasal and ocular symptoms (individual and total symptom scores), visual analogue scale and time of first exacerbation of the symptoms when loratadine was stopped. Results: A total of 425 subjects were included. Using intent-to-treat analysis, the RQLQ global score decreased significantly more in the LP-33 group than in the placebo group ( P =0.0255, difference=−0.286 (95% confidence interval (CI): −0.536; −0.035)). No significant differences were noted for the change of the rhinitis total symptom score 5 global score between groups ( P =0.1288, difference=−0.452 (95% CI: −1.036; 0.132)). Significant differences in ocular symptoms (RQLQ) were observed between groups ( P =0.0029, difference=−0.4087 (95% CI: −0.6768; −0.1407)). Conclusions: This study performed by GPs shows that LP-33 improves the quality of life of subjects with persistent AR who are currently being treated with an oral H 1 -antihistamine. Whereas nasal symptoms had not changed, ocular symptoms had consistently improved.

Because most available treatments for managing seasonal allergic rhinitis show some side effects without reducing recurrence, natural anti-allergic products could represent an interesting treatment addition. This study aimed to analyse the efficacy and tolerance of quail egg as adjunctive therapy in seasonal allergic rhinitis. In a Consolidated Standards of Reporting Trials compliant framework, patients with seasonal allergic rhinitis were prospectively randomised to receive mometasone nasal spray for four weeks or the same topical corticosteroid therapy plus commercially available oral quail egg and zinc tablets. Forty patients were enrolled. The mometasone + quail egg and zinc tablets group showed a greater reduction in nasal itching, sneezing and total nasal symptom scores than the mometasone nasal spray only group. A higher proportion of participants in the mometasone + quail egg and zinc tablets group had good rhinitis control than in the mometasone nasal spray only group, with no need for rescue medications. Despite the need for a further larger study, quail egg preliminarily appears to be an effective adjunct to topical steroid therapy in seasonal allergic rhinitis.

Specific immunotherapy is a well-established treatment for allergic rhinoconjunctivitis; conventional regimens are lengthy, however, reducing convenience and cost-effectiveness. This study evaluated the efficacy and safety of an ultrashort course (four doses) of the immunotherapy Grass Modified Allergen Tyrosine Adsorbate (Allergy Therapeutics, Worthing, U.K.) monophosphoryl lipid A (MATA MPL). Subjects were randomized to receive four injections of either Grass MATA MPL (n = 514; 300-2000 standardized units/injection) or placebo (n = 514) before the grass pollen season. They used electronic diaries to record allergy symptoms and medication use during the pollen season. The primary end point was the difference between the mean combined symptom and medication scores in the Grass MATA MPL and placebo groups during the 4 local peak pollen weeks. The injection course was completed by 95.3 and 97.7% of the Grass MATA MPL and placebo groups, respectively, and was well tolerated. Grass MATA MPL treatment afforded a 13.6% benefit over placebo in the 4 peak pollen weeks (p = 0.0038). The benefit in subjects with 28 complete diary entries during the 4 peak pollen weeks was 24.3% (p = 0.0031). Significant benefits over placebo were observed in subjects with severe symptoms (16.6%; p = 0.0023), in those who had a history of allergic rhinoconjunctivitis for up to 35 years (up to 31%; p = 0.0059) and at sites with a higher burden of disease (31%; p < 0.0001). The ultrashort course of Grass MATA MPL was well tolerated and provided a significant benefit over placebo in relieving allergy symptoms.Corrected Version posted November 2011

Although both nasal steroids and macrolide antibiotics have been recommended for the treatment of chronic rhinosinusitis without nasal polyps (CRSsNPs), whether there is any difference in their clinical efficacy remains unexplored. In addition, few studies have investigated their clinical efficacy in a Chinese population living in China, who present distinct inflammatory patterns compared with white patients in western countries. This study compares the efficacy of mometasone furoate and clarithromycin treatment in CRSsNP in Chinese adults in a preliminary prospective, open-label, randomized trial. Forty-three CRSsNP patients were randomized to receive mometasone furoate nasal spray at 200 μg (n = 21) or clarithromycin tablet at 250 mg (n = 22) once daily for 12 weeks. Patients were assessed before the treatment and after 4, 8, and 12 weeks after treatment. Subjective symptoms were scored on a visual analog scale. Endoscopy physical findings were scored according to Lanza-Kennedy scoring system. Moreover, smoking and atopic status and coexistence of allergic rhinitis (AR) and asthma were recorded. Before the treatment, no significant difference in symptoms and nasal endoscopic physical findings were found between mometasone furoate and clarithromycin group. As early as 4 weeks after dosing, a significant reduction of total symptom scores, nasal obstruction, headache, rhinorrhea and overall burden scores, and mucosal swelling and nasal discharge scores were observed in both groups. No significant difference in symptom or endoscopic scores was observed between these two groups at any posttreatment observation time point. The coexistence of AR was correlated with lower scores of mucosal edema and nasal secretion in the mometasone furoate group after 12-week treatment. Mometasone furoate and clarithromycin show a comparable clinical effect for CRSsNPs in Chinese adults. Mometasone furoate is more effective in improving edema and secretion for CRSsNP patients with concomitant AR.