Mean Total Nasal Symptom Score Research Articles

Efficacy and Safety of Bojungikgi-Tang for Persistent Allergic Rhinitis: A Randomized, Double-Blinded, Placebo-Controlled, Phase II Trial.

Conventional treatments for allergic rhinitis (AR) exhibit insufficiency and long-term use-related side effects. Considering the reported anti-inflammatory and immunoregulatory effects of Bojungikgi-tang (BJIGT), we aimed to assess its efficacy on persistent AR (PAR). Patients with PAR were randomly assigned in a 1:1:1 ratio into high-dose BJIGT, standard-dose BJIGT, and placebo groups, followed by 1-week run-in and 4-week treatment periods. The primary outcome included the mean change in Total Nasal Symptom Score (TNSS), with secondary outcomes encompassing the Korean Allergic Rhinitis-Specific Quality of Life Questionnaire, biomarkers, overall assessment, TNSS by AR pattern identification, and the Sasang constitution. The mean TNSS change was more improved in the BJIGT group than in the placebo group; however, no statistically significant differences were observed. Additional interaction effect analysis revealed a statistically significant improvement in the high-dose BJIGT group compared with the placebo group from weeks 1-2 to weeks 3-4. Regarding secondary outcomes, the BJIGT group exhibited similar or improved results compared with the placebo group, showing no statistically significant differences. No serious adverse effects or clinically significant changes in safety assessments were observed. Given that this study validated clinical improvement and safety, it serves as potential groundwork for pertinent future studies.

The effectiveness of subcutaneous immunotherapy in allergic diseases of children and adults

ObjectivesImmunotherapy is the gradual administration of increasing doses of allergens to reduce or eliminate the patient's adverse clinical response following exposure to these allergens. The goal of the current study was to evaluate the effectiveness of subcutaneous immunotherapy in patients with allergic diseases referred to the Bushehr Asthma and Allergy Clinic, Iran. Materials and methodsPatients with respiratory allergic diseases, who had positive skin prick test, randomly enrolled in this observational study and underwent immunotherapy for one year. To evaluate the efficacy of immunotherapy, two questionnaires were completed for all the patients before and one year after the start of immunotherapy, including the Total Nasal Symptom Score (TNSS) and Asthma Control Test (ACT). ResultsA total of 878 patients with asthma or allergic rhinitis disorder [53.6% (n=471) male and 46.4% (n=407) female] with a median (IQR) age of 28.0 (12.0–35.0) years were randomly enrolled in this observational study. Five hundred forty-nine patients (64.8%) were over 18 years old and 298 patients (33.9%) were under 18 years old, the age of the other patients was not known. The median (IQR) duration of disease was 84.0 (36.0–138.0) months. Rinithis allergy had most frequent than asthma [39.9% (n=350) vs. 22.2% (n=195), respectively] and 218 patients (24.8%) have both of them. After the treatment, 234 patients (54.5%) completely stop and 26.3% patient (n=113) used less than half of the drugs. The mean TNSS (n=259) and ACT (n=186) scores for patients had significant difference before and after immunotherapy [13.64 vs. 5.68, P<0.001; 7.91 vs. 17.43, P<0.001, respectively]. ConclusionThe mean TNSS and ACT score before and after the treatment significantly improved the patients’ symptoms. To conclude, standard immunotherapy can be effective in patients with moderate to severe allergic rhinitis and mild to moderate persistent allergic asthma to reduce clinical symptoms.

A pediatric randomized, controlled trial of German cockroach subcutaneous immunotherapy

Cockroach allergy contributes to morbidity among urban children with asthma. Few trials address the effect of subcutaneous immunotherapy (SCIT) with cockroach allergen among these at-risk children. We sought to determine whether nasal allergen challenge (NAC) responses to cockroach allergen would improve following 1 year of SCIT. Urban children with asthma, who were cockroach-sensitized and reactive on NAC, participated in a year-long randomized double-blind placebo-controlled SCIT trial using German cockroach extract. The primary endpoint was the change in mean Total Nasal Symptom Score (TNSS) during NAC after 12 months of SCIT. Changes in nasal transcriptomic responses during NAC, skin prick test wheal size, serum allergen-specific antibody production, and T-cell responses to cockroach allergen were assessed. Changes in mean NAC TNSS did not differ between SCIT-assigned (n= 28) versus placebo-assigned (n= 29) participants (P= .63). Nasal transcriptomic responses correlated with TNSS, but a treatment effect was not observed. Cockroach serum-specific IgE decreased to a similar extent in both groups, while decreased cockroach skin prick test wheal size was greater among SCIT participants (P= .04). A200-fold increase in cockroach serum-specific IgG4 was observed among subjects receiving SCIT (P< .001) but was unchanged in the placebo group. T-cell IL-4 responses following cockroach allergen stimulation decreased to a greater extent among SCIT versus placebo (P= .002), while no effect was observed for IL-10 or IFN-γ. A year of SCIT failed to alter NAC TNSS and nasal transcriptome responses to cockroach allergen challenge despite systemic effects on allergen-specific skin tests, induction of serum-specific IgG4 serum production and down-modulation of allergen-stimulated T-cell responses.

Using Intranasal Corticosteroids and Oral Antihistamines to Treat Allergic Rhinitis: A Comparison of The Mean Total Nasal Symptom Score

Background: Allergic rhinitis (AR) is a global public health issue. The disease is a leading cause of death and disabilities globally. Objective: To compare the mean total nasal symptom score using intranasal corticosteroids with oral anti-histamine in management of allergic rhinitis. Study Design: Randomized controlled trial. Settings: Department of ENT, Shalamar Medical and Dental College/ Shalamar Hospital, Lahore Pakistan. Duration: 1st January 2023 to 30 June 2023. Methods: 100 cases equally divided in two groups A&amp;B, Intranasal corticosteroids were administered in Group A and oral anti-histamine in Group B cases, The final evaluation was done after 4 weeks of treatment. Results: Comparison of mean total nasal symptom score using intranasal corticosteroids with oral anti-histamine in management of allergic rhinitis shows that 1.51 ± 0.37 score in Group-A and 1.27 ± 0.11 score in Group-B, (p-value &lt; 0.05). Conclusion: We found that the use of intranasal corticosteroids resulted in a substantially reduced mean total nasal symptom score compared to the use of oral anti-histamine in the treatment of allergic rhinitis.

Sodium Chloride versus Lactose as a Carrier for House Dust Mite Allergen in Allergen Chamber Studies: A Clinical Study to Assess Noninferiority

Introduction: In the Fraunhofer allergen challenge chamber (ACC), a standardized, universal, good manufacturing practice-conforming technology using a spray dried solution of lactose (L) and allergen extract has been established. In this study, we investigated the noninferiority of hypertonic sodium chloride (S) versus L as a carrier for house dust mite (HDM) allergen to simplify manufacturing, reduce costs, and allow for wider use. Methods: Using a participant-blinded, sham exposure-controlled, single-arm, sequential intervention study, we challenged adults with HDM allergic rhinitis five times in the ACC. Participants were first exposed to S, L, and clean air (block 1), followed by S + HDM and L + HDM (block 2). Primary endpoints were mean total nasal symptom score (TNSS) and mean nasal secretion weight. Results: 19 participants were enrolled in the study (10 females; mean age 32 years [22–49], 4 with mild allergic asthma). The safety profile of S + HDM and L + HDM was similar; eight participants experienced mild procedure-related adverse events including tiredness, cough, and dyspnea. Due to dropouts, 13 participants completed the study and were evaluated. Mean TNSS and nasal secretion were as follows: S 0.98, 0.28 g; L 1.1, 0.20 g; clean air 1.1, 0.23 g; S + HDM 5.7, 4.8 g; L + HDM 5.1, 5.1 g. Separate block 1/block 2 MANOVAs with TNSS and nasal secretion as dependent variables revealed no significant differences between the carriers, neither alone and compared with clean air (p = 0.2059, Wilk’s λ = 0.78) nor combined with HDM (p = 0.3474, Wilk’s λ = 0.89). Noninferiority of S was established using a meta-analysis-based minimal clinical important difference of −0.55: mean TNSS difference between S + HDM and L + HDM was 0.62 (90% CI: −0.51 to 1.74). Conclusion: S as an HDM carrier was safe and well tolerated. It was noninferior to L which makes it an adequate and easy-to-use carrier substitute.

Efficacy of Japanese cedar pollen sublingual immunotherapy tablets for Japanese cypress pollinosis.

We previously demonstrated the efficacy of Japanese cedar (JC) pollen sublingual immunotherapy (SLIT) tablets for treating seasonal allergic rhinitis in a clinical trial (trial no. 206-2-1) that covered 5 pollen dispersal seasons from 2015 to 2019. Our aim was to perform post hoc analysis of the 206-2-1 trial data to evaluate the efficacy of JC pollen SLIT tablets for patients with rhinitis induced by pollen from Japanese cypress (JCY), a related Cupressaceae species that has a pollen dispersal season overlapping with that of JC. Data were analyzed for 240 patients who received placebo during the first pollen dispersal season in 2015, were then rerandomized to receive JC SLIT tablets (the PA group) or placebo (the PP group) for 18 months (the 2016 and 2017 dispersal seasons), and were observed untreated for 2 years (the 2018 and 2019 dispersal seasons). The PA and PP groups were assigned to "high" and "low" subgroups if their rhinitis symptoms were exacerbated/did not change or decreased, respectively, during the peak JCY pollen dispersal period in 2015. The mean total nasal symptom and medication scores and other outcomes were compared for the high-PP, high-PA, low-PP, and low-PA groups during the 2016 to 2019 peak JCY pollen dispersal periods. The mean total nasal symptom and medication scores were significantly lower for the high-PA and low-PA groups than for the corresponding PP groups over the 4 years of treatment and observation. JCY pollen-specific IgE levels increased in both PA groups. JC pollen SLIT tablets effectively suppressed JCY pollinosis symptoms, supporting the clinical relevance of immunologic cross-reactivity between JC and JCY allergens.

Efficacy and Safety of a Drug-Free, Barrier-Forming Nasal Spray for Allergic Rhinitis: Randomized, Open-Label, Crossover Noninferiority Trial

Introduction: Symptoms of allergic rhinitis can be reduced by nonpharmacological nasal sprays that create a barrier between allergens and the nasal mucosa. A new nasal spray (AM-301) containing the clay mineral bentonite was tested for its ability to reduce symptoms of grass pollen. Methods: This open-label, crossover, noninferiority trial compared the efficacy and safety of AM-301 to that of hydroxypropyl methylcellulose (HPMC; Nasaleze® Allergy Blocker), an established barrier method. Adults with seasonal allergic rhinitis were exposed to Dactylis glomerata pollen, in a controlled setting, the Fraunhofer allergen challenge chamber, first without protection and then protected by HPMC or AM-301 (7 days apart). Efficacy was assessed from total nasal symptom score (TNSS), nasal secretion weight, and subjective rating. The primary endpoint was the difference, between AM-301 and HPMC, in least square mean change in TNSS over a 4-h exposure to allergen. Results: The study enrolled 36 persons, and 35 completed all study visits. The mean TNSS was 5.91 (SD = 1.45) during unprotected exposure, 5.20 (SD = 1.70) during protection with HPMC, and 4.82 (SD = 1.74) during protection with AM-301. The difference in least square means between the two treatments was −0.39 (95% CI: −0.89 to 0.10), establishing the noninferiority of AM-301. No difference in mean weight of nasal secretions was observed between the treatments. Efficacy was rated as good or very good for AM-301 by 31% and for HPMC by 14% of subjects. Sixteen subjects reported adverse events with a relationship to AM-301 or HPMC; most adverse events were mild, and none was serious. Discussion/Conclusion: AM-301 demonstrated noninferiority toward HPMC in the primary endpoint and was perceived better in subjective secondary endpoints. Both barrier-forming products had a persisting protective effect over 4 h and were safe.

Effectiveness of bilastine and fexofenadine among allergic Rhinitis patients in Ranchi, Jharkhand, India.

Allergic rhinitis is a worldwide health problem which impairs quality of life and interferes with daily activities. Untreated allergic rhinitis also carries a significant financial burden for the society. Bilastine, a novel second-generation antihistaminic drug that is highly selective for the H1 histamine receptor, has a rapid onset and prolonged duration of action. Thus, the aim of our study was to compare the effectiveness of bilastine and fexofenadine in treatment of allergic Rhinitis patients. 104 patients were enrolled who have fulfilled the inclusion criteria for the study from the OPD of Ear, Nose and Throat Department. Patients were divided randomly in two groups A and B. Patients of group A were allowed to take tab Bilastine 20 mg OD whereas, patients of group B were allowed to take tab. Fexofenadine Hydrochloride 120 mg OD orally for two weeks. The baseline Total Nasal Symptom Score (TNSS) were compared between two groups. The study findings showed that the mean TNSS was significantly reduced in our study group. Baseline TNSS was 13.55 and 13.45 in Group A and Group B respectively. Reduction in this parameter first become apparent in the 24 hours and maintained till 2nd week. Bilastine showed significant improvement in quality of life of Allergic rhinitis patients and proved to be more effective than fexofenadine in reducing the TNSS score, when used alone in allergic rhinitis patient.

Efficacy and Safety of Bojungikgi-Tang for Persistent Allergic Rhinitis: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Phase II Trial.

Background Allergic rhinitis (AR) is a common disease, and conventional medications are often insufficient for treatment. Bojungikgi-tang (BJIGT) is an herbal medicine widely used in traditional medicine and has anti-inflammatory and immunoregulatory effects. We hypothesize that BJIGT would improve nasal symptoms in patients with persistent AR (PAR). Methods This is a randomized, double-blind, placebo-controlled, phase II trial. A total of 105 patients, identified with perennial allergens, with a history of PAR and a mean total nasal symptom score (TNSS) ≥ 5 during the run-in period will be recruited from Daejeon Korean Medicine Hospital. Participants will be randomly assigned to a high-dose BJIGT group, standard-dose BJIGT group, or control group (placebo) in a 1 : 1 : 1 allocation ratio after a week run-in period. The treatment medication will be taken three times per day for 4 weeks. The primary outcome measure is the mean change in the TNSS before and after medication. The secondary outcome measures include the Korean Allergic Rhinitis-Specific Quality of Life Questionnaire, total IgE and eosinophil count, overall assessment of AR, pattern identification questionnaire for AR, and Sasang constitution. Discussion. The aim of this study is to investigate the efficacy and safety of BJIGT in the treatment of PAR and to determine the suitable dosage of BJIGT. Therefore, we planned a randomized, controlled, phase II trial of two different doses of BJIGT compared with placebo, and the results of this study are expected to provide evidence for the use of BJIGT as a treatment of PAR. Trial Registration. The National Clinical Trial Registry Clinical Research Information Service, CRIS, KCT0006616, https://cris.nih.go.kr/cris/search/detailSearch.do/20706.

Effectiveness and safety of electric heating moxibustion for perennial allergic rhinitis: A pilot, randomized, assessor-blind trial

BackgroundThe prevalence of allergic rhinitis (AR), an inflammatory disease, is gradually increasing. Studies have reported that moxibustion is effective for treating AR. Electric heating moxibustion (EM) was developed to offer adaptable heat stimulation without the generation of smoke. ObjectivesThe objective of this study was to examine the possibility of EM in treating perennial allergic rhinitis (PAR) and to assess the feasibility of using this technique on a larger scale by comparing EM with acupuncture (AC). DesignA randomized pilot study was conducted on 40 patients with PAR. Patients were randomly assigned to one of two treatment groups: EM or AC. The primary outcome measure was the change in the total nasal symptom score (TNSS) between before and after treatment. The secondary outcome measures were the changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ), nasal endoscopy index for pattern identification, pattern identification questionnaire for AR, total serum immunoglobulin E (IgE), eosinophil count, and adverse effects (AEs). ResultsThe results showed a statistically significant improvement in mean TNSS and RQLQ scores in both groups (p < 0.05), but no significant difference between the two groups. However, mean changes in itching and sneezing TNSS were significantly higher in the AC group. There was no significant difference in total serum IgE or eosinophil count before versus after treatment, nor was there any significant difference of three pattern subgroups between the two groups in the mean TNSS change. While the AC group reported two treatment-related AEs, there were no treatment-related AEs in the EM group. ConclusionThis trial provides evidence that EM isa safe alternative treatment for patients with PAR. Trial registrationClinicalTrials.gov, NCT03342105. Registered on 14 November 2017.

The effectiveness of forest honey toward symptoms of atrophy patients: Study of ear nose and throat-head neck and dermatology venereology.

The effectiveness of forest honey in Total Nasal Symptom Score (TNSS) improvement in allergic rhinitis patients and index Scoring Atopic Dermatitis (SCORAD) in Atopic Dermatitis (AD) patients were discovered. It was an experimental study with a pretest-posttest design. A total of 20 people with atopy (15 people with allergic rhinitis and five people with AD) were given forest honey in the morning (1 ml × 10 ml dose) for 8 weeks and 20 atopy patients without forest honey. TNSS and SCORAD index were evaluated before the intervention, week 2, week 4, and after the intervention (week 8). The mean TNSS before treatment was higher in the honey group, namely 7.73, and a significant decrease after 8 weeks of intervention, namely 2.73 with P = 0.000. The nonhoney group showed that there was no significant difference after 8 weeks with P = 0.888. The SCORAD values of the honey and nonhoney groups had significantly different values from week 0 to week 4 (P = 0.003) and week 0 to week 8 (P = 0.003). Forest honey can give as an additional therapy for patients with allergic rhinitis and AD.

A Clinical Study to Evaluate the Role of Vitamin D3 in Allergic Rhinitis.

Allergic rhinitis is a common and chronic immunoglobulin E-mediated inflammation of nasal mucosa induced after allergen exposure. Allergic rhinitis is a global health problem that causes major illness and affects patient's social life, sleep, school and work performance. Various studies have implicated the association between low serum vitamin D levels and allergic diseases. Active form of Vitamin D3 has been shown to have immunoregulatory effect on both innate and adaptive immunity, which can significantly affect the outcome of allergic responses in allergic rhinitis. The study aims to evaluate effectiveness of Oral Vitamin D3 supplementation as an adjunct to standard therapy, in the management of allergic rhinitis. The present study is a prospective study in which 80 subjects were recruited and were randomly divided into two groups. The study group received oral vitamin D3 (60,000IU) along with intranasal steroid spray while control group received only intranasal steroid spray for 4weeks. The response in both the groups was compared by evaluating total nasal symptom score (TNSS). Subjects of allergic rhinitis showed deficiency in vitamin D indicated by mean serumvitamin D levels of 15 ± 2.42ng/ml inthe study group and 14.72 ± 2.64ng/ml in thecontrol group. The pre treatment mean TNSS score was 10.45 ± 3.1 in thestudy group and 11.43 ± 2.35 in thecontrol group. The post treatment mean TNSS score was 2.1 ± 0.21 in thestudy group and 3.85 ± 0.76 in the control group. A significant reduction in symptoms score was observed after 4weeks of oral vitamin D3 supplementation. The difference between twogroups wasfound to be statistically significant (p value < 0.05).

An Instant, Safe, Antihistamine, Anti-Inflammatory and Decongestant Polymeric Nasal Barrier to Prevent and To Treat Allergic Rhinitis in Children

Introduction: Allergic rhinitis (AR) in children is a common chronic pathology with a strong impact on patient quality of life. The main physiopathology affects the nasal cavity as a multi-factorial disease involving nasal mucosa damage, nasal inflammation with high concentrations of histamine, pro-inflammatory cytokines such as histamine, TNF-α, IL-4, IL-5, IL-6, IL-10, IL-13, and IgE antibodies on the nasal mucosa. Systemic entry of these proteins through damaged nasal mucosa maintains continued inflammatory and allergen cascades. Therefore, an ideal treatment should be multitarget in order to stop allergen exposure, inflammation, and nasal mucosa barrier degradation, but such treatments are nearly impossible to conceive. We envisaged an osmotic and protective nasal barrier film, not only capable of protecting the nasal mucosa from allergen exposure but also of trapping and neutralizing selected cytokines and cleaning the nasal surface continuously without using any harmful substance for children. Materials and Methods: We associated highly osmotic glycerol solution with specific plant polymers to conceive an osmotic but stable film. As plant polymers (tannins) can bind with selective proteins, a range of glycerol binding non-cytotoxic polymers were screened using the sandwich ELISA method to select those having binding affinity for allergen induced nasal proinflammatory cytokines. After verifying cytotoxicity and irritant potential, a 15-day observational clinical study was performed with approval from the ethics committee on 30 children aged between 4-13, suffering from allergic rhinitis. The test product (TP) was supplied in 15-ml nasal sprays and applied 2-3 times per day for a period of 15 days. Saline solution served as control (CP). The scores of nasal and ocular symptoms, effect on quality of life, eosinophil count in nasal smears, and need for antihistamine treatment was evaluated at the start, at 30 minutes and on days 2, 3 and 15 of treatment. Results: A few specific polymers were able to bind with selected cytokines and histamine at adequate filmogen concentrations. The osmotic film was stable, non-irritant and was able to clean the nasal mucosa continuously for 4-6h after each application. Clinical observations of Total Nasal Symptom Score (TNSS) grouping the scores of nasal congestion, runny nose, sneezing, and itching, revealed a strong decrease right after the 1st treatment in both groups but the reduction was much stronger and faster with the TP. The mean TNSS score reduction was 44.74% in CP vs 83.53% in the TP group after 7 days of treatment (p&lt;0.001). Total Ocular Symptom Score (TOSS) was decreased by 21.13% and 51.41% in CP v/s 35.12 and 99.59% in TP group on days 2 and 7, respectively. Nasal smear eosinophil count was equally strongly reduced in the TP v/s CP group. No treatment-related side effects were recorded in any of the groups. Conclusion: Protecting the nasal mucosa against allergens, neutralizing inflammatory cytokines, and keeping the nasal surface clean with an osmotic polymeric film, constitute a major breakthrough for the treatment of allergic rhinitis in children. This simple but scientific and logical approach should avoid exposing children to chemicals and to their long-term side effects.

A comparative study to assess the efficacy of fluticasone and mometasone in allergic rhinitis

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Allergic rhinitis is the most prevalent of allergic diseases in the world. Pharmacotherapy remains the mainstay of treatment. Nasal corticosteroids being the most applicable drugs for its treatment. The objective of this study was to compare the efficacy of fluticasone propionate (FP) and mometasone furoate (MF) nasal sprays in the treatment of allergic rhinitis based on total nasal symptom score (TNSS) questionnaire.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; A prospective, randomized, open-label, parallel-group, comparative study was conducted among 80 allergic rhinitis patients fulfilling the inclusion and exclusion criteria. They were randomly assigned to two groups: FP and MF groups. FP group received 200 µg dose of FP nasal spray (1 spray/nostril) daily and the MF group received 100 µg dose of MF nasal spray (1 spray/nostril) daily for 8 weeks. The effects of the two agents were compared based on TNSS questionnaire in 0, 4 and 8 weeks after the beginning of the treatment. &lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; At the end of eight weeks of treatment, both groups showed statistically significant (p&amp;lt;0.005) improvements from their baseline TNSS. Mean TNSS was reduced from to 9.46 to 2.716 in FP group and from 10.18 to 2.504 in MF group.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Both the groups showed a significant therapeutic benefit in patients with allergic rhinitis. Even though, the difference between the two is not significant for 8 weeks therapy. &lt;/p&gt;

Efficacy of Desloratadine and Levocetirizine in Patients with Cedar Pollen-Induced Allergic Rhinitis: A Randomized, Double-Blind Study

Background: No comparative study of antihistamines that differ in structural system has been conducted in allergic rhinitis. Objective: This was a randomized, double-blind, crossover comparative study to verify the efficacy of antihistamines that differ in structural system. Methods: A total of 50 patients with moderate or more severe Japanese cedar pollen-induced allergic rhinitis were randomized to receive either placebo, desloratadine 5 mg (a tricyclic), or levocetirizine 5 mg (a piperazine). One dose of the study drug was orally administered at 9 pm on the day before a pollen exposure test, which was performed for 3 h (9 a.m. to 12 p.m.) to assess symptoms in an environmental challenge chamber (ECC). Nasal and ocular symptoms were compared at an airborne pollen level of 8,000 grains/m³. The primary endpoint was mean total nasal symptom score (TNSS) from 120 to 180 min in the ECC. Subjects with a difference of ≥1 in TNSS between 2 drugs were extracted to the relevant drug-responsive group. Results: The difference in TNSS from placebo was –2.42 (p < 0.0001) with levocetirizine and –1.66 (p < 0.01) with desloratadine, showing that both drugs were significantly more effective than placebo in controlling symptoms, but with no statistically significant difference between the 2 drugs. There were 12 subjects in the desloratadine-responsive group and 24 subjects in the levocetirizine-responsive group, with no contributor to response was detected. Conclusion: Levocetirizine tended to control nasal symptoms more effectively than desloratadine. However, the response to each antihistamine varied among individuals and the predictors to the response are unknown. Clinical Trial Registration number: UMIN ID: UMIN000029653.

Nasal nitric oxide in the inferior turbinate surface decreases with intranasal steroids in allergic rhinitis: A prospective study

ObjectiveIt remains controversial whether nasal nitric oxide (NO) serves as a reliable parameter to evaluate treatment efficacy in patients with allergic rhinitis (AR). The measurement of local nasal NO levels has been shown to be a sensitive marker for the diagnosis of symptomatic AR patients. Here we assessed the applicability of nasal NO to evaluations of the efficacy of intranasal steroids (INS) in a prospective design. MethodsWe enrolled 25 patients with perennial AR and 10 age-matched healthy participants. The AR patients received fluticasone furoate (FF) once daily for 2 months. Fractional exhaled NO and nasal NO measurements were carried out using an electrochemical analyzer at pretreatment and at 2 weeks and 2 months after treatment. Nasal NO levels were directly measured at two different areas of the nasal cavity: the surface of the inferior turbinate (IT area) and the front of the middle meatus (MM area). Subjective nasal symptoms were also recorded at each visit. ResultsThe mean total nasal symptom score in the AR patients decreased significantly after FF treatment (p<0.0001). The mean nasal NO levels in the IT area in the AR patients were significantly higher at pretreatment than those of the healthy participants (109 vs. 62.5 ppb, respectively; p<0.001). After FF administration, the nasal NO levels in the IT area of the AR group showed a significant reduction at both 2 weeks and 2 months (79.1 and 71.9 ppb, respectively; p<0.05 and p<0.01). There was no significant difference in nasal NO levels in the MM area between the controls and the AR group at any visit timepoint. When the ratio of the MM area to the IT area (MM/IT ratio) was plotted for each subject, the untreated AR patients showed a marked decrease in the ratio, whereas after the FF treatment, the AR patients' mean MM/IT ratios showed a significant increase. No significant difference compared to the control group existed at 2 months. ConclusionNasal NO measurement around the inferior turbinate is an objective measure to evaluate allergic conditions and is useful to monitor therapeutic effects of INS.

Technical and clinical validation of the Allergen BioCube® for timothy grass.

IntroductionField studies for allergic rhinitis (AR) commonly have inconsistent allergen concentrations and subject exposure patterns due to varying environmental conditions and subject behaviors. A technical and clinical validation study was conducted for the Allergen BioCube® using timothy grass to confirm uniform allergen concentration and clinically relevant subject symptom responses.MethodsAllergen concentrations were verified by laser particle counts. Subjects (N = 14) with positive skin test reactions and no symptoms at screening received four 3‐h timothy grass exposures in the BioCube over consecutive days. Subjects evaluated nasal itching, sneezing, rhinorrhea, and nasal congestion while in the BioCube; Total Nasal Symptom Score (TNSS) was computed. Peak Nasal Inspiratory Flow (PNIF), Peak Expiratory Flow Rate (PEFR), sIgE blood tests, and Nasal Inflammation Score (NIS) were assessed. A correlation analysis was conducted for mean sIgE, skin test, and TNSS.ResultsUniform timothy grass concentrations were achieved in the BioCube, both spatially and temporally, at all subject positions. Mean TNSS increased substantially from pre‐exposure levels (0.36 ± 0.74 to 1.86 ± 2.14) to maximums of 7.07 ± 2.76 at 1.5 h and 6.71 ± 2.70 at 3 h BioCube exposure. Twelve (86%) subjects had TNSS increases ≥6 units. PNIF decreased 12–24% from baseline at 3‐h BioCube exposure. NIS increased (baseline = 0) to 3.7 (maximum score = 4). A low/moderate correlation (r = 0.485) occurred between mean sIgE blood levels and mean skin tests; neither sIgE or skin tests correlated with mean TNSS. However, subjects with high skin test scores or positive blood IgE tended to also have higher TNSS.ConclusionsThe Allergen BioCube achieved technical and clinical validation for uniform timothy grass concentration and clinically meaningful AR sign and symptom responses. The Allergen BioCube can be used to assess the efficacy of therapies for reduction of AR signs and symptoms resulting from grass exposure.

Is the Effect and Safety of Single Daily Dose of Fluticasone Nasal Spray Better than Alternate Day Regimen in Allergic Rhinitis?

Introduction: The goal of corticosteroid therapy is to maximize efficacy, minimize potential systemic side effects, and improve patient adherence. Factors that will potentially improve adherence to treatment and differentiate the intranasal corticosteroids are dosing regimens, patient preference and cost effectiveness. Aim and objective: To study and compare the efficacy and safety of daily versus alternate day regimen of fluticasone nasal spray. Materials and methods: A prospective, randomized comparative study was done at a tertiary care hospital which included 80 patients of symptomatic allergic rhinitis with symptoms of at least one-year duration; divided into two groups; Group A patients received once daily fluticasone furoate nasal spray for 8 weeks along with levocetirizine for 7 days. Group B patients received alternate day fluticasone furoate nasal spray for 8 weeks along with levocetirizine for 7 days. Symptoms were assessed and compared using TNS (Total nasal symptom) score at 8 weeks and after 4 weeks of stopping treatment i.e., 12 weeks after initiation of the study. Results: At 8 weeks, the mean TNS score was 0.85 ± 0.86 in Group A whereas in Group B the mean TNS score was 1.40 ± 1.08. This improvement, between both groups was statistically highly significant (p=0.007) indicating lower scores i.e., better outcome in Group A. After 4 weeks of stopping treatment i.e., 12 weeks after initiation of the study, the mean TNS score was 0.3 ± 0.42 in Group A whereas in Group B the mean TNS score was 0.45 ± 0.68. This improvement, between both groups was statistically significant (p=0.039) with marginally lower scores in Group A. Conclusion: A good subjective as well as objective outcome in terms of symptom improvement can be obtained in patients with allergic rhinitis with once daily treatment as compared to those patients who received alternate day treatment with intranasal steroids spray.

Management of Intractable Nasal Hyperreactivity by Selective Resection of Posterior Nasal Nerve Branches.

The posterior nasal nerves emerge from the sphenopalatine foramen and contain sensory and autonomic nerve components. Posterior nasal neurectomy is an effective method to remove pathological neural networks surrounding the inferior turbinate that cause unregulated nasal hypersensitivity with excess secretion in patients with severe allergic rhinitis (AR). We describe the sophisticated endoscopic surgical procedure that allows feasible access to the confined area and selective resection of the nerve branches with the preservation of the sphenopalatine artery (SPA). We retrospectively analyzed the cases of 23 symptomatic severe AR patients who failed to respond to standard medical treatment and underwent surgery. There have been no major complications after surgery including nasal bleeding or transient numbness of the upper teeth. The mean total nasal symptom scores (TNSS) were decreased by 70.2% at 12 months after the procedure. Our comparison of the clinical effectiveness based on the number of severed nerve branches revealed that the improvement of the TNSS was significantly higher in patients with >2 branches. We conclude that this minimally invasive technique that preserves the SPA is clinically useful and decreases the rate of postoperative complications. This trial is registered with UMIN000029025.

Technical and clinical validation of an environmental exposure unit for ragweed.

BackgroundAllergic rhinitis is a common condition, with ragweed pollen one of the more prevalent aeroallergens. Environmental exposure units such as the Allergen BioCube® are valuable models for clinical allergy studies. A study was conducted to validate the Allergen BioCube for uniform ragweed pollen concentrations and clinically relevant sign and symptom responses to ragweed exposure.MethodsRagweed pollen concentrations were measured on 3 consecutive days in the Allergen BioCube and verified by Rotorod collection and continuous laser particle count measurements. Subjects (N=10) were exposed to ragweed pollen in the BioCube for 3 hours per day for 3 consecutive days. Subjects assessed their nasal itching, sneezing, rhinorrhea, and nasal congestion during each BioCube exposure; total nasal symptom score was computed. Peak nasal inspiratory flow was also assessed during BioCube exposure.ResultsUniform ragweed pollen concentrations were obtained throughout each of the 3-hour testing periods in the Allergen BioCube, both spatially and temporally, at all subject positions, with a low mean standard deviation of 10%. Pronounced increases in mean total nasal symptom scores (6.7±0.94 to 7.6±0.86, last 90 minutes of exposure) occurred for all three BioCube ragweed pollen exposure visits. Mean peak nasal inspiratory flow decreased 24% at 3 hours of BioCube exposure on Day 3. No safety issues of concern occurred in this study.ConclusionThe Allergen BioCube achieved technical and clinical validation for ragweed allergen. Ragweed pollen concentration was uniform both temporally and spatially. Allergic rhinitis signs and symptoms were induced in subjects during exposure to ragweed in the BioCube at clinically meaningful levels for allergy studies.