Daytime Nasal Symptoms Research Articles

Efficacy and Safety of Montelukast+Levocetirizine Combination Therapy Compared to Montelukast Monotherapy for Allergic Rhinitis in Children.

The combination therapy of leukotriene receptor antagonists and antihistamines may alleviate allergic rhinitis (AR) symptoms better than monotherapy. This study aimed to investigate the safety and efficacy of Monterizine®, a fixed-dose combination of montelukast and levocetirizine, compared to montelukast monotherapy in pediatric patients with AR. One hundred seventy-six children aged 6 to 14 years with perennial AR symptoms were recruited. One hundred forty-seven subjects were randomized into 1 of 2 groups: the mont+levo group (fixed-dose combination of montelukast [5 mg] + levocetirizine [5 mg]) or the mont group (montelukast single agent [5 mg]). Study subjects took the treatment every evening for 4 weeks and recorded their daytime nasal symptom score (DNSS) and nighttime nasal symptom score (NNSS) in a diary every day. Adverse events (AEs) were also recorded, and patients were surveyed as to their overall satisfaction with the therapeutic product they received. When DNSS and NNSS were assessed individually, daytime nasal congestion symptom scores decreased more in the mont+levo group during the 4-week treatment period than in the mont group (P = 0.0341). The daytime rhinorrhea symptom scores also decreased more in the mont+levo group (P = 0.0469). The nighttime nasal congestion score (severity when awake) decreased more in the mont+levo group than in the mont group (P = 0.0381). Study subjects in the mont+levo group experienced a greater improvement in quality of life than subjects in the mont group (P < 0.0001). The combination therapy of montelukast and levocetirizine was more effective in reducing both daytime nasal symptoms (nasal congestion and rhinorrhea) and nighttime nasal symptoms (severity of nasal congestion when awake). With fewer AEs and higher overall satisfaction, combination therapy is recommended for pediatric patients with perennial AR.

Expert perspectives on the prescription pattern of levocetirizine₊montelukast and fexofenadine₊montelukast for the management of allergic rhinitis in the Indian settings

Background: Studies have shown that oral antihistamines are considered as the gold-standard therapy for allergic rhinitis. However, there is dearth of studies among clinicians, so this study aimed to gather expert opinion on the prescribing pattern of levocetirizine₊montelukast and fexofenadine₊montelukast for managing AR in India. Methods: This cross-sectional study, conducted through a multi-response questionnaire comprising 24 questions, gathered insights from experts across diverse Indian settings. It explored perspectives on clinical observations, experiences, demographic profiles, treatment characteristics in AR, and the utilization of fexofenadine₊montelukast and levocetirizine₊montelukast for AR management in clinical practice. The data were analyzed through descriptive analysis. Results: Majority of clinicians (52%) preferred levocetirizine₊montelukast for AR, with half of them recommending a 2-week course. Additionally, 38% of clinicians noted its effectiveness in addressing all AR symptoms. Most clinicians agreed that levocetirizine and montelukast combination therapy was effective in improving nighttime nasal symptoms (74%) and nasal congestion (69%). Furthermore, majority of clinicians acknowledged that the combination offers both immediate (74%) and long-term (56%) relief from AR symptoms. Approximately 58% of the healthcare providers reported overall improvement across categories with fexofenadine₊montelukast, encompassing daytime nasal symptoms, nighttime nasal symptoms, and daytime eye symptoms. Conclusion: Clinicians recommended the combination of levocetirizine₊montelukast and fexofenadine₊montelukast to manage AR. Levocetirizine₊montelukast combination was preferred by clinicians for its efficacy in alleviating nighttime nasal symptoms and congestion. Fexofenadine₊montelukast combination was also endorsed for overall improvement across various symptoms.

Montelukast treatment response according to eosinophil-derived neurotoxin level in children with allergic rhinitis

Background Eosinophil-derived neurotoxin (EDN) is an important biomarker of eosinophilic inflammation. Methods This study evaluated Montelukast treatment response according to EDN concentration in children with perennial allergic rhinitis (PAR). Fifty-two children with PAR were recruited and took a combination of Montelukast (5mg) and Levocetirizine (5mg) “Mont/Levo Group” or only Montelukast (5mg) “Mont Group” for 4 weeks. All caregivers were instructed to record rhinitis symptoms for 4 weeks. EDN was measured before and after treatment. Results Daytime nasal symptom scores (DNSS) significantly decreased in both the Mont/Levo (p = 0.0001; n = 20) and Mont Group (p < 0.0001; n = 20), but there were no significant differences between the two groups. EDN concentration also significantly decreased after treatment in both groups (p < 0.0001 and p < 0.001, respectively). For secondary analysis, children with a high initial EDN concentration (EDN ≥ 53 ng/mL) were placed in the “High EDN Group”, while those with a lower initial EDN concentration (EDN < 53 ng/mL) were put in the “Low EDN Group”. Both groups experienced significant reductions in DNSS after either treatment regimen (p < 0.0001 and p = 0.0027, respectively) but the High EDN Group had greater reductions. EDN concentrations in the High EDN Group decreased significantly from either treatment (p < 0.0001). Conclusion We found that children with AR and a high serum EDN concentration may respond well to Montelukast treatment. A therapeutic strategy using EDN concentrations in patients with AR to evaluate therapeutic response may help improve quality of care.

Expert opinion on the prescription practice of antihistamines for the management of allergic rhinitis in Indian settings

Several clinical studies corroborate the synergistic effects of montelukast in conjunction with antihistamine for reducing the symptoms and quality of life of AR patients. Some studies also highlighted a significant quantitative differences in the prescribing patterns of antihistamines across different countries. So, this study aimed to gather expert opinions on the management of allergic rhinitis (AR) using antihistamines alone or in various combinations in Indian settings.The cross-sectional, multiple-response, 23-item survey was primarily focused on current practices, clinical observations, and experiences related to AR and the utilization of oral histamines for disease management. The study involved otorhinolaryngologist from diverse settings in India.Out of 435 participants, 29% reported sneezing as the common AR symptoms. The majority (84.83%) favoured antihistamine and leukotriene receptor antagonist combinations for AR treatment. Specifically, 52% preferred levocetirizine, while 43% favoured fexofenadine. About 63% opted for polytherapy with oral antihistamines and anti-leukotrienes for AR management. Of these, 48% chose levocetirizine and montelukast for various AR symptoms. According to 60% of participants, fexofenadine + montelukast effectively improved nasal and eye symptoms. Around 64% preferred levocetirizine + montelukast for nighttime nasal symptoms, while 55% chose fexofenadine + montelukast for daytime nasal symptoms. Around 64% of the respondents favoured levocetirizine + montelukast for improving all AR symptoms, and 69% favoured antihistamine + montelukast for its cost-effectiveness.Experts recommend antihistamine and leukotriene receptor antagonist combinations for managing AR symptoms, with levocetirizine and fexofenadine being popular choices. Polytherapy with these combinations was favoured, especially for managing nighttime and daytime nasal symptoms.

Role of Montelukast on Vitamin D Levels in Asthma and Seasonal Allergic Rhinitis in Eastern India

Background: Allergic rhinitis and asthma are both chronic heterogeneous disorders, with an overlappingepidemiology of prevalence, health care and social costs in quality of life. Both are inflammatory disorders with asimilar pathophysiology and vitamin D has a significant role in the pathogenesis of the disease.Aims and Objective: The objective of this study was to evaluate the role of serum vitamin D in patients withsymptomatic allergic rhinitis and active asthma during the allergy season and observe the effect of montelukast10 mg daily as treatment.Materials and methods: This study included 130 asthmatic and seasonal allergic rhinitis patients following asingle-blind, placebo run-in period of 3 days–5 days, patients were randomized to oral montelukast 10 mg (n = 68)or placebo (n = 62) daily during the 2-week, double-blind, active-treatment period. The serum vitamin D was alsoevaluated in both the groups.Results: The serum vitamin D levels were found to be higher in patients taking monteleukast compared to placeboafter 2 weeks (p&lt; 0.001). Montelukast reduced the Total Nasal symptoms score which includes Daytime nasalsymptoms and Nighttime symptoms compared to placebo after 2 weeks (p &lt; 0.001). Conclusion: Montelukastprovides significant relief from symptoms of seasonal allergic rhinitis, while also conferring a benefit for asthma,in patients with both allergic rhinitis and asthma. Further, it has a beneficial role in improving vitamin D levels.

DIFFERENCES OF DAYTIME NASAL SYMPTOMS SCORE AND NIGHTTIME SYMPTOMS SCORE BETWEEN THE COMBINATION OF MONTELUKAST WITH LORATADINE AND SINGLE LORATADINE IN ALLERGIC RHINITIS (Meta-Analisis)

Background: The success of allergic rhinitis (AR) therapy has not yet been achieved because 76% of patients with AR still experience symptoms of nasal obstruction despite receiving oral AH. The symptom of a blocked nose at night is the most disturbing in 80% of patients with AR. Complaints of nasal congestion that persist after administration of AH are associated with swelling of the nasal mucosa caused by cysteine leukotrienes (CystLTs). The severity of AR symptoms can be assessed by the daytime nasal symptoms score (DNSS) and nighttime symptoms score (NSS). Objective: To know the difference between DNSS and NSS between the combination of montelukast and loratadine and single loratadine in patients with AR. Methods: Meta-analytical study, with Science Direct database, PubMed central and publisher website, Cochrane library, ResearchGate, and SAGE journals, year of publication limited to the last twenty-five years, randomized controlled trial, comparison single loratadine. DNSS and NSS differences assessment is based on the mean difference (MD). Test for heterogeneity using RevMan 5.4. Results: The search for articles found 777, with 3 articles meeting the eligibility criteria, 3 assessment articles based on DNSS and two articles based on NSS. The use of the combination of montelukast and loratadine did not show a significant reduction in DNSS (MD -0.11; 95% CI -0.25 to 0.03; p=0.13; I2=73%) and show a significant reduction in NSS (MD -0.05; 95% CI -0.10 to -0.00; p=0.004; I2=37%). Conclusion: There was no difference in DNSS between montelukast and loratadine combined with single loratadine in AR patients. There was no difference in NSS between montelukast and montelukast loratadine combined with single loratadine in AR.

Evaluation of efficacy and safety of montelukast and levocetirizine FDC tablet compared to montelukast and levocetirizine tablet in patients with seasonal allergic rhinitis: a randomized, double blind, multicentre, phase III trial

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; To evaluate efficacy, safety and tolerability of Montelukast 10 mg+levocetirizine 5 mg FDC compared to either montelukast 10 mg or levocetirizine 5 mg given alone in seasonal allergic rhinitis (SAR) patients.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; Phase III, multicentre, randomized, double blind, parallel group, active controlled study was conducted in 279 SAR patients at 16 sites across India. Efficacy was assessed using daytime nasal symptoms score (Primary efficacy outcome), night-time symptoms score, daytime eye symptom score, patient's global evaluation, physician's global evaluation, rhino-conjunctivitis quality-of-life score. &lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; At end of treatment there was statistically significant evidence from the per protocol analysis that patients on FDC had a greater improvement in change from baseline in daytime nasal symptoms score than patients who received Montelukast (p=0.0266) or Levocetirizine (p=0.0409). These results were consistent with the Intent to treat analysis. Analysis of the secondary efficacy endpoints provided numerically greater improvement in the nighttime symptoms score, daytime eye symptoms score, and rhinoconjunctivitis quality-of-life scores in the FDC group as compared to the Montelukast group or Levocetirizine group. The FDC of Montelukast and Levocetirizine was found to be safe and generally well tolerated. The majority of adverse events were mild in severity, resolved without treatment and were unrelated to study medication.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Fixed dose combination of Montelukast and Levocetirizine was safe, generally well tolerated and superior on efficacy compared to Montelukast or Levocetirizine in patients of seasonal allergic rhinitis.&lt;/p&gt;

Efficacy of Montelukast in Allergic Rhinitis Treatment: A Systematic Review and Meta-Analysis.

In treating allergic rhinitis, montelukast has the potential to be used as an alternative or addition to an oral antihistamine or intranasal corticosteroid. The objective of this systematic review was to assess the effectiveness of montelukast in treating allergic rhinitis. An electronic literature search was performed using the Cochrane Central Register of Controlled Trials, EMBASE, and MEDLINE from 1966 to 21 January 2019. The eligibility criteria were randomized controlled trials comparing montelukast with placebo or other standard treatments. The primary outcomes assessed were daytime nasal symptom score (DNS) and night-time nasal symptom score (NNS). The secondary outcomes assessed were composite nasal symptom score (CSS), daytime eyes symptom score (DES), and rhinoconjunctivitis quality-of-life questionnaires (RQLQ). The meta-analysis was conducted using Review Manager 5.3 software based on the random-effects model. Fifteen studies of 10387 participants met the inclusion criteria. Montelukast was more effective than placebo in improving DNS (mean difference [MD] - 0.12, 95% confidence interval [CI] - 0.15 to - 0.08; p < 0.001), NNS (MD - 0.09, 95% CI - 0.13 to - 0.05; p < 0.001), CSS (MD - 0.08, 95% CI - 0.11 to - 0.06; p < 0.001), DES (MD - 0.17, 95% CI - 0.33 to - 0.02; p < 0.030), and RQLQ (MD - 0.34, 95% CI - 0.49 to - 0.20; p < 0.001). Oral antihistamine was superior to montelukast in improving DNS (MD 0.08, 95% CI 0.03-0.13; p = 0.002), CSS (MD 0.03, 95% CI - 0.02 to 0.07; p = 0.27), DES (MD 0.06, 95% CI 0-0.12; p = 0.040), and RQLQ (MD 0.03, 95% CI - 0.05 to 0.12; p = 0.430). Montelukast was superior to oral antihistamine in improving NNS (MD -0.03, 95% CI - 0.08 to 0.03; p = 0.330). Intranasal fluticasone spray was superior to montelukast in improving DNS (MD 0.71, 95% CI 0.44-0.99; p < 0.001) and NNS (MD 0.63, 95% CI 0.29-0.97; p < 0.001). Combined montelukast and oral antihistamine was superior to oral antihistamine in improving DNS (MD - 0.15, 95% CI - 0.27 to - 0.03; p = 0.010), NNS (MD - 0.16, 95% CI - 0.28 to - 0.05; p = 0.006), CSS (MD - 0.12, 95% CI - 0.25 to - 0.01; p = 0.070), DES (MD - 0.12, 95% CI - 0.30 to 0.06; p = 0.180), and RQLQ (MD - 0.10, 95% CI - 0.28 to 0.08; p = 0.290). Combined montelukast and OAH was superior to montelukast in improving DNS (MD 0.15, 95% CI 0.08-0.21; p < 0.001), NNS (MD 0.05, 95% CI - 0.09 to 0.19; p = 0.510), CSS (MD 0.1, 95% CI 0.03-0.17; p = 0.007), DES (MD 0.18, 95% CI 0-0.36; p = 0.050), and RQLQ (MD 0.07 95% CI - 0.15 to 0.29; p = 0.530). Montelukast is more effective than placebo in treating the overall symptoms of allergic rhinitis while the combined therapy of montelukast and an oral antihistamine is superior to either montelukast or an oral antihistaminealone.

Efficacy and safety of two Ayurvedic dosage forms for allergic rhinitis: Study protocol for an open-label randomized controlled trial

BackgroundAllergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose, and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment, and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system practiced in Sri Lanka. The aim of this study is to examine the efficacy and safety of a decoction used in traditional Ayurveda for allergic rhinitis and its ready- to-use freeze dried formulation in comparison to an antihistamine over a period of 4 weeks on relief of symptoms in allergic rhinitis.Study designThis is a three-arm, open-label, non-inferiority, randomized controlled clinical trial enrolling patients with AR. Tamalakyadi decoction containing 12 ingredients (TMD12), used in traditional Ayurveda and its freeze-dried formulation are the test products. The efficacy and safety of the two Ayurvedic dosage forms will be tested against the antihistamine loratadine. Patients with symptoms of AR will be allocated randomly into the three arms after a 1-week run-in period and the medications will be given orally for 28 days. Total Nasal symptom Score (TNSS) of the patients will be used as the primary efficacy endpoint. TNSS will be recorded and compared between the three arms prior to visit 1, at the end of 28 days, and end of the first and second months of follow-up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and health-related quality of life questionnaire are used as secondary end points.DiscussionThis clinical trial will be able to provide evidence-based scientific data on Ayurvedic dosage form, TMD12, and the freeze-dried formulation in the treatment of allergic rhinitis. This trial is expected to develop capacity to scientifically evaluate various Ayurvedic treatments that are claimed to have efficacy in treatment of various disease conditions.Trial registrationISRCTN18149439 (6 May 2019).

Efficacy and safety of monotherapy versus combination therapy in treatment of allergic rhinitis : a Meta-analysis

Objective:To evaluate efficacy and safety of monotherapy versus combination therapy on allergic rhinitis（AR） in order to provide evidencebased reference for clinic drug treatment of AR.Method:The randomized controlled trials（RCT） about drug treatment of AR were searched in PubMed, Embase, Cochrane library, CNKI, WanFang Data. After screening the literatures, extracting the data and evaluating the quality, to compare total nasal symptom scores（TNSS）,composite symptom scores（CSS）,daytime nasal symptom scores（DNSS）,individual nasal symptom scores, total ocular symptom scores（TOSS）, daytime eye symptom scores（DESS）and incidence of adverse events（AE）between monotherapy group and combination therapy group. Meta-analysis was performed by RevMan 5.3 software.Result:A total of 12 RCTs were enrolled, 7 675 AR patients involved. The results of Metaanalysis showed that the efficacy of combination therapy group was superior to the monotherapy group in TNSS with significant difference（WMD=0.74,95%CI 0.31-1.17,P<0.05;WMD=1.40,95%CI0.98-1.82,P<0.05）.Compared with monotherapy group, individual nasal symptom scores in combination group were significantly decreased. There were no significant difference in incidence of AE（headache, dysgeusia, epistaxis） between two groups（RR=1.20,95%CI 0.87-1.65, P=0.28;RR=0.63,95%CI 0.31-1.24,P=0.18;RR=0.96,95%CI 0.63-1.64, P=0.85.Conclusion:Combination therapy can remarkably improve nasal symptom in AR patients compared with monotherapy, moreover, the incidence of AE between two groups were similar. We recommend combination therapy for allergic rhinitis.

A Randomized, Multicenter, Double-blind, Phase III Study to Evaluate the Efficacy on Allergic Rhinitis and Safety of a Combination Therapy of Montelukast and Levocetirizine in Patients With Asthma and Allergic Rhinitis

PurposeThe aim of this study was to evaluate the efficacy and safety of a fixed-dose combination of montelukast and levocetirizine in patients with perennial allergic rhinitis with mild to moderate asthma compared with the efficacy and safety of montelukast alone. MethodsThis study was a 4-week, randomized, multicenter, double-blind, Phase III trial. After a 1-week placebo run-in period, the subjects were randomized to receive montelukast (10 mg/day, n = 112) or montelukast (10 mg/day)/levocetirizine (5 mg/day) (n = 116) treatment for 4 weeks. The primary efficacy end point was mean daytime nasal symptom score. Other efficacy end points included mean nighttime nasal symptom score, mean composite symptom score, overall assessment of allergic rhinitis by both subjects and physicians, forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC, asthma control test score, and the frequency of rescue medication used during the treatment period. FindingsOf 333 patients screened for this study, 228 eligible patients were randomized to treatment. The mean (SD) age of patients was 43.32 (15.02) years, and two thirds of subjects were female (66.67%). The demographic characteristics were similar between the treatment groups. Compared with the montelukast group, the montelukast/levocetirizine group reported significant reductions in mean daytime nasal symptom score (least squares mean [SE] of combination vs montelukast, –0.98 [0.06] vs –0.81 [0.06]; P = 0.045). For all other allergic rhinitis efficacy end points, the montelukast/levocetirizine group showed greater improvement than the montelukast group. Similar results were observed in overall assessment scores and in FEV1, FVC, FEV1/FVC, and asthma control test score changes from baseline for the 2 treatment groups. Montelukast/levocetirizine was well tolerated, and the safety profile was similar to that observed in the montelukast group. ImplicationsThe fixed-dose combination of montelukast and levocetirizine was effective and safe in treating perennial allergic rhinitis in patients with asthma compared with montelukast alone. ClinicalTrials.gov identifier: NCT02552667.

Evaluation of efficacy of fixed dose combination of montelukast and levocetirizine compared to monotherapy of montelukast and levocetirizine in patients with seasonal 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 global health problem. Almost 10%–25% of population worldwide is affected by AR. Seasonal allergic rhinitis (SAR) is caused by an IgE-mediated reaction to seasonal aeroallergens and is fairly easy to identify because of the rapid and reproducible onset and offset of symptoms in association with pollen exposure. SAR can result in hyperresponsiveness to allergens. Treatment of allergic rhinitis is aimed to achieve optimal symptom control and reduce nasal congestion, sneezing and rhinorrhea over the course of the entire day and night. &lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; &lt;span lang="EN-IN"&gt;Out of total 274 subjects, 92 subjects in the FDC of montelukast 10 mg and levocetrizine 5 mg group, 92 subjects in montelukast 10 mg group and 90 subjects in levocetrizine 5 mg group were enrolled in the study. The total study duration was 16 days. Criteria for evaluation of primary efficacy were mean change in daytime nasal symptoms score from baseline to end of treatment. Mean change in night time symptoms score from baseline to end of treatment. Mean change in daytime eye symptoms score from baseline to end of treatment. Patient's and physician's global evaluation of allergic rhinitis at the end of treatment. Mean change in rhinoconjunctivitis quality-of life score from baseline to end of treatment. &lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; &lt;span lang="EN-IN"&gt;Primary efficacy endpoint that fixed dose combination (FDC) of montelukast 10 mg and levocetirizine 5 mg was superior to montelukast 10 mg monotherapy or levocetirizine 5mg monotherapy in the treatment of patients with seasonal allergic rhinitis. Other secondary endpoints and global impression results are also supporting the therapeutic benefit of fixed dose combination over monotherapy. &lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; &lt;span lang="EN-IN"&gt;FDC of montelukast 10 mg and levocetirizine 5 mg was superior to montelukast 10 mg monotherapy or levocetirizine 5 mg monotherapy in the treatment of patients with seasonal allergic rhinitis.&lt;/span&gt;&lt;/p&gt;

Efficacy and safety of setipiprant in seasonal allergic rhinitis: results from Phase 2 and Phase 3 randomized, double-blind, placebo- and active-referenced studies

BackgroundAntagonism of chemoattractant receptor-homologous molecule on T-helper type-2 cells (CRTH2), a G-protein coupled receptor for prostaglandin D2, could be beneficial for treating allergic disorders. We present findings on the efficacy and safety/tolerability of a CRTH2 antagonist (setipiprant) in participants with seasonal allergic rhinitis (AR) in a real-life setting over 2 weeks.MethodsA Phase 2 trial and a Phase 3 trial were conducted at seven centers in Texas, USA during the Mountain Cedar pollen season. Both were prospective, randomized, double-blind, placebo- and active-referenced (cetirizine) studies. The Phase 2 trial assessed setipiprant 100–1000 mg b.i.d. and 1000 mg o.d. versus placebo in adult and elderly participants. The Phase 3 trial assessed setipiprant 1000 mg b.i.d. in adolescent, adult, and elderly participants. Efficacy was assessed using daytime nasal symptom scores (DNSS), night-time nasal symptom scores (NNSS) and daytime eye symptom scores (DESS).Results579 participants were randomized in the Phase 2 trial (mean age 41.6–43.4 years); 630 were randomized in the Phase 3 trial (mean age 37.5–40.7 years). A statistically significant, dose-related improvement in mean change from baseline DNSS was observed over 2 weeks with setipiprant 1000 mg b.i.d. versus placebo in the Phase 2 trial (−0.15 [95% CI −0.29, −0.01]; p = 0.030). Setipiprant 1000 mg b.i.d. had no significant effect on this endpoint in the Phase 3 trial (−0.02 [95% CI −0.12, 0.07]; p = 0.652). Total and individual NNSS and DESS symptom scores were significantly improved with setipiprant 1000 mg b.i.d. versus placebo in the Phase 2 but not the Phase 3 trial. Setipiprant showed a favorable safety/tolerability profile.ConclusionsThe Phase 2 trial was the first large clinical study to assess a CRTH2 antagonist in seasonal AR in a real-life setting. Setipiprant dose-related efficacy in the Phase 2 trial was not confirmed during Phase 3. Setipiprant was well tolerated in both studies.Trial registration NCT01241214 and NCT01484119

Effectiveness of air purifier on health outcomes and indoor particles in homes of children with allergic diseases in Fresno, California: A pilot study

ABSTRACTObjective: Epidemiologic studies indicate that indoor air pollution is correlated with morbidity caused by allergic diseases. We evaluated the effectiveness of reducing the levels of indoor fine particulate matter <2.5 micrometer diameter (PM2.5) in Fresno, California using air purifiers on health outcomes in children with asthma and/or allergic rhinitis. Methods: The active group (with air purifiers) and the control group consisted of eight houses each. Air purifiers were installed in the living rooms and bedrooms of the subjects in the active group during the entire 12-week study duration. Childhood asthma control test, peak flow rate monitoring, and nasal symptom scores were evaluated at weeks 0, 6, and 12. Results: At 12 weeks, the active group showed a trend toward an improvement of childhood asthma control test scores and mean evening peak flow rates, whereas the control group showed deterioration in the same measures. Total and daytime nasal symptoms scores significantly reduced in the active group (p = 0.001 and p = 0.011, respectively). The average indoor PM2.5 concentrations reduced by 43% (7.42 to 4.28 μg/m3) in the active group (p = 0.001). Conclusions: Intervention with air purifiers reduces indoor PM2.5 levels with significant improvements in nasal symptoms in children with allergic rhinitis in Fresno.

Nasal Surgeries in Allergic Rhinitis- How far they are useful in improving Symptoms?

Allergic rhinitis is a common condition affecting 20% of population and causes significant morbidity. It is managed conservatively. But, allergy can be associated with co-morbidities like deviated nasal septum and hypertrophy of inferior turbinate. It's sequelae include chronic sinusitis and recurrent sinonasal polyposis.. This prospective clinical study was carried out in a tertiary hospital from September 2013-2015(24 months) to see whether surgery would significantly improve their symptoms. Patients were selected (n=50) with moderate to severe allergic rhinitis who were refractory to medical management alone and with significant complications. Though essential, surgery would not relieve of the patient from inherent allergy. So, standardization of indications for surgery in these conditions has been attempted. Results: Majority of patients belonged to age group11-30 with mean age of 27.84 with slightly male preponderance of 1.6:1. The daytime nasal symptom score(DTNSS) was 7.5 in pre-treatment group and was 0.24 after surgery at 3 months follow up. The 'p' value was less than 0.0001 which was statistically significant. It can be concluded that medical management alone is not sufficient in moderate to severe allergic rhinitis patients with complications and the symptoms of these patients significantly improve when combined with surgical management.

Role of antioxidants on the clinical outcome of patients with perennial allergic rhinitis.

Background:Antioxidants have a preventive or therapeutic role in oxygen free radical–mediated cell and tissue damage. The study aimed to investigate the therapeutic effects of antioxidants and intranasal steroid fluticasone furoate (FF) on the clinical outcome of patients with perennial allergic rhinitis.Methods:Subjects with perennial allergic rhinitis (n = 61) were randomly divided into two groups, group A (n = 30) received FF and group B (n = 31) received FF with antioxidants for 6 weeks. Nasal and ocular symptoms were evaluated weekly by using a four-point categoric scale. The efficacy of the study drug was assessed based on the mean change from baseline of the total daytime nasal symptom scores, total nighttime nasal symptom scores, and the composite symptom scores.Results:The combined therapy (FF with antioxidants) resulted in marked improvements (p ≤ 0.05) in the mean total daytime nasal symptom scores, total nighttime nasal symptom scores, and composite symptom scores of subjects compared with ones treated with intranasal steroid (FF) alone, which highlighted the therapeutic effect of antioxidants in allergic rhinitis.Conclusion:Significant improvement in clinical outcome was observed in subjects who received antioxidants along with FF. However, because this was an open-label study, the results must be interpreted with caution, and further double-blind, placebo-controlled, dose-ranging trials supplemented with different antioxidants together with intranasal steroids are suggested.

Meta-analysis of leukotriene receptor antagonist montelukast in the treatment of allergic rhinitis

To evaluate the treatment outcomes of leukotriene receptor antagonists (LTRA) as monotherapy or combined with the second-generation oral H1-histamines in the treatment of allergic rhinitis (AR), and to provide a basis for optimizing clinical therapeutic strategies. PubMed,EMBASE, CBMdisc and CJFD databases, retrieving randomized controlled trials (RCTs) of AR therapy literatures were searched. Based on the literature inclusion and exclusion criteria, the related literatures were selected and the quality was evaluated by using the Jadad scale. Meta-analysis was performed by Stata 12.1 software.For continuous outcomes, the weighted mean difference (WMD) and its 95% confidence intervals (CI) were calculated. The forest plots were drawn. The treatment outcomes included daytime nasal symptom scores (DNSS), nighttime symptom scores (NSS), composite symptom scores (CSS), daytime eye symptom scores (DESS), and the rhinoconjunctivitis quality of life questionnaire (RQLQ) were used to evaluate the therapeutic effects of LTRA on seasonal and perennial AR. Eleven of clinical RCTs including 14 809 cases of AR patients, aged 15 to 85 years old, were available for Meta-analysis. Montelukast, a drug of LTRA, was primarily evaluated in the study. The results of Meta-analysis showed: (1) Compared with the placebo, montelukast statistically significantly reduced the DNSS,NSS, CSS, and RQLQ scores in patients with seasonal and perennial AR, as well as the DESS in patients with seasonal AR.(2) There were no statistical differences in the improvement of the CSS,DESS, and RQLQ scores in patients with seasonal AR after the treatment by montelukast compared with loratadine, a second-generation oral H1-histamine.(3) Montelukast statistically significantly reduced the NSS, but not DNSS, in patients with seasonal AR compared with loratadine.(4) The combination therapy of montelukast and loratadine statistically significantly improved the CSS compared with either montelukast or loratadine monotherapy. Montelukast, a representative drug of LTRA, can be used as first-line therapy for AR, with comprehensive improvement of the nasal and ocular symptoms and the quality of life in AR patients. Montelukast combined with loratadine can significantly improve the diurnal and nocturnal symptoms for patients with seasonal AR, and the curative effect is better than the single use of montelukast or loratadine.

Efficacy of Montelukast and Levocetirizine as Treatment for Allergic Rhinitis

Antihistamines are effective in reducing majority of symptoms of allergic rhinitis, but are ineffective for nasal congestion and nighttime symptoms. Montelukast have been found to provide quick relief. Comparison of Montelukast has been done with Antihistamines but data is limited. Hence, this study was done to compare the effectiveness of montelukast combined with levocetirizine once daily to levocetirizine alone for a 6-week treatment course of allergic rhinitis. In this randomized, open, parallel study, out of 102 patients were randomly assigned to receive montelukast and levocetirizine (treatment group) or levocetirizine alone (control group), 95 patients completed the entire 6 weeks of study. The primary outcome measure was the mean change of the total daytime nasal symptom score (PDTS) and secondary outcome measures were mean change of night time nasal, daytime eye and composite symptom (PNTS, PES, PCS). The change in total daytime nasal symptom, composite symptoms and nighttime nasal symptom scores was signifi cantly (p<0.05) greater in montelukast and levocetirizine group than in levocetirizine alone group. The change in daytime eye symptom scores was comparable in both the groups but not statistically significant (p=0.94). Montelukast combined with levocetirizine was effective in reducing daytime, nighttime, composite and daytime eye symptom score as compared to levocetrizine alone.

Clinical Studies of Combination Montelukast and Loratadine in Patients with Seasonal Allergic Rhinitis

Background. Concomitant use of montelukast and loratadine may improve symptoms of seasonal allergic rhinitis (SAR) more than treatment with either drug alone. Objective. We compared the efficacy of this combination versus placebo, nasal beclomethasone, montelukast, and loratadine in study 1 and versus placebo, montelukast, and loratadine in study 2. Methods. Patients were randomly allocated to double-blind treatment with intranasal beclomethasone 200 μ g/twice daily (study 1 only), placebo, montelukast 10 mg+loratadine 10 mg, montelukast 10 mg, or loratadine 10 mg once daily. The primary endpoint was the Composite Symptom Score (CSS): average of daily diary scores for Daytime Nasal Symptoms and Nighttime Symptoms. Results. In study 1, improvements in the change from baseline in CSS were seen for montelukast+loratadine (least-squares means [95% CI] = −0.43 [−0.51, −0.35]), beclomethasone (−0.57 [−0.64, −0.49]), montelukast, and loratadine. All treatments were significantly better than placebo; montelukast+loratadine had a significantly greater effect on CSS than montelukast alone but no difference compared to loratadine was detected. Beclomethasone provided significantly greater improvement versus montelukast+loratadine on the primary and secondary endpoints except for the rhinoconjunctivitis quality-of-life score. In study 2, the combination treatment was similar to montelukast, loratadine, and placebo for the primary and secondary endpoints. Conclusion. In study 1, montelukast+loratadine had a significantly greater effect on CSS than placebo and montelukast alone; however, in all comparisons, nasal beclomethasone had a greater effect on daily symptoms. In contrast, the combination of montelukast+loratadine in study 2 did not provide greater improvement compared with placebo, montelukast, or loratadine monotherapy, perhaps due to a large placebo effect.

Clinical studies of the DP1 antagonist laropiprant in asthma and allergic rhinitis

Prostaglandin D(2) is a proinflammatory mediator believed to be important in asthma and allergic rhinitis (AR). Allelic variants in the prostaglandin D(2) receptor type 1 (DP1) gene (PTGDR) have been suggested to be associated with asthma susceptibility. We sought to investigate the efficacy of the DP1 antagonist laropiprant (alone or with montelukast) in asthma and seasonal AR and explore whether sequence variations in PTGDR are associated with asthma severity. For asthma, in a double-blind crossover study, 100 patients with persistent asthma were randomized to placebo or laropiprant, 300 mg/d for 3 weeks, followed by addition of montelukast, 10 mg/d for 2 weeks. PTGDR promoter haplotypes were categorized as high, medium, or low transcriptional efficiency. The primary efficacy end point was FEV(1). For AR, in a double-blind parallel-group study, 767 patients sensitized to a regionally prevalent fall allergen with symptomatic fall rhinitis were allocated to laropiprant, 25 mg/d or 100 mg/d; cetirizine, 10mg/d; or placebo for 2 weeks. The primary end point was the Daytime Nasal Symptoms Score. For asthma, no significant differences in FEV(1) or asthma symptoms were noted for laropiprant versus placebo or laropiprant plus montelukast vs montelukast (differences between montelukast and placebo: P <or= .001). No clear association was seen between haplotype pair (ie, diplotype) and asthma severity. For AR, although cetirizine (vs placebo) demonstrated an improvement in the Daytime Nasal Symptoms Score (P < .001), laropiprant did not. Laropiprant did not demonstrate efficacy in asthmatic patients or patients with AR. Variations in PTGDR did not appear related to baseline asthma severity or treatment response (NCT00533208; NCT00783601).