Nighttime Nasal Symptom Research Articles

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.

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.

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).

A randomized, double-blind placebo-controlled study of intranasal standardized cinnamon bark extract for seasonal allergic rhinitis

ObjectivesThe aim of the study was to assess the safety and efficacy of a nasal spray containing a polyphenol-rich standardized extract of cinnamon bark (Cinnamomum zeylanicum) (IND02) for the treatment of seasonal allergic rhinitis (SAR). MethodsThis study was a randomized, double-blind, placebo-controlled study conducted in otherwise healthy men and women, aged between 18 and 75 years old, who were experiencing acute SAR symptoms. Participants were randomized in a 1:1 ratio to a nasal spray containing either IND02 (100 μg/100 μL) or matching placebo in each nostril, twice a day, for seven days. ResultsThe outcome measures were the rhinoconjunctivitis quality of life questionnaire (RQLQ), the total daily symptom score comprising of day-time nasal, day-time eye, and night-time nasal symptom scores, the Work Productivity and Activities Impairment (WPAI:SHP), the Pittsburgh Sleep Quality Index (PSQI), the Perceived Stress Scale (PSS) and laboratory clinical parameters. ResultsThe IND02 group showed a statistically and clinically significant reduction in total RQLQ and the sub-domains; activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function. There was a significant reduction in the total daily symptom score and sub-domains of total day-time nasal, total day-time eye and total night-time nasal symptoms scores, and total work impairment and regular activity impairment in the IND02 group compared with the placebo group after treatment. The laboratory clinical parameters remained within healthy normal reference range. ConclusionThe use of a nasal spray of a standardized extract of cinnamon bark (IND02) over seven days reduced symptom severity and improved quality of life, work productivity and regular daily activities in participants experiencing SAR.

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.

Oral Antihistamines Alone vs in Combination with Leukotriene Receptor Antagonists for Allergic Rhinitis: A Meta-analysis.

Objective To evaluate whether an adjuvant therapy of leukotriene receptor antagonists (LTRAs) based on oral H1-antihistamines (H1) can increase efficacy of allergic rhinitis (AR) treatment. Data Sources The search involved databases of PubMed, EMBASE, and Cochrane Central Register of Controlled Trials, from inception up to September 23, 2017. Randomized controlled trials (RCTs) that compared efficacy of LTRAs + H1 vs H1 alone were eligible. Review Methods Pooled comparative effects were measured using weighted mean difference (WMD) and 95% confidence interval (CI). Subgroup analysis comparing seasonal vs perennial AR was prespecified to explore the source of heterogeneity. The evidence quality of each outcome was assessed by the GRADE approach. Results A total of 8 RCTs were included (n = 1886), and all measured outcomes used scaled scores. Compared with H1 alone, H1 + LTRAs were superior to improve overall daytime (WMD, -0.11; 95% CI, -0.19 to -0.03, high quality) and composite (WMD, -0.12; 95% CI, -0.23 to -0.01; low quality) nasal symptoms. Specifically, H1 + LTRAs had better efficacy against composite nasal rhinorrhea, sneezing, and daytime itching but not congestion. The effects were more pronounced in patients with perennial AR compared to those with seasonal AR. There were no significant differences in nighttime nasal symptoms and eye symptoms between the 2 groups. Conclusion The current evidence suggests that LTRAs + H1 can increase the therapeutic efficacy against daytime and composite nasal symptoms, including rhinorrhea, sneezing, and itching; however, it does not affect nighttime nasal symptoms and eye symptoms. The patients with perennial AR may benefit more from the combination therapy.

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

Efficacy of 2 months of allergen-specific immunotherapy with Bet v 1–derived contiguous overlapping peptides in patients with allergic rhinoconjunctivitis: Results of a phase IIb study

An immunotherapy formulation consisting of 3 contiguous overlapping peptides (COPs) derived from Bet v 1, the major birch pollen allergen, showed good clinical tolerability in a previous phase I/IIa clinical trial. We sought to evaluate the efficacy and safety of allergen-specific immunotherapy using 2 dose regimens of Bet v 1 COPs versus placebo in subjects with birch pollen-induced allergic rhinoconjunctivitis. A randomized, double-blind, placebo-controlled phase IIb clinical trial was performed to assess the efficacy of Bet v 1 COP immunotherapy during the 2013 birch pollen season. Before the season, Bet v 1 COPs (50 and 100μg in aluminum hydroxide) or placebo (saline and aluminum hydroxide) were administered as 5 subcutaneous injections to 239 adults with allergic rhinoconjunctivitis to birch pollen. Bet v 1 COPs at 25 or 50μg were administered on day 1, and 50 or 100μg was administered on days 8, 15, 29, and 57, respectively. Patients were monitored for adverse events during the treatment period and assessed for combined rhinoconjunctivitis symptom and medication scores, as well as quality of life. Rhinoconjunctivitis symptom and medication scores improved in both Bet v 1 COP-treated groups, reaching statistical significance over placebo in the 50-μg group (least squares mean, -0.23; 26% improvement; P=.015). Both active groups showed significant improvement in quality of life and nighttime nasal symptom scores, supporting the primary end point findings. Bet v 1 COP injections were well tolerated, with a higher frequency of systemic adverse events in the 100-μg group. Two months of preseasonal immunotherapy with 3 COPs derived from Bet v 1 at a 50-μg dose showed promising efficacy, small risk for systemic reactions, and immunomodulatory changes in this single-season, dose-finding, phase IIb trial in patients allergic to birch pollen.

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.

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.

Fluticasone furoate nasal spray is more effective than fexofenadine for nighttime symptoms of seasonal allergy

Nasal symptoms of allergic rhinitis are an important cause of sleep disturbance. Reduction of nasal symptoms, particularly nasal obstruction, has been linked to improvements in self-reported sleep quality. The enhanced-affinity intranasal corticosteroid fluticasone furoate and the oral antihistamine fexofenadine were compared with respect to nighttime symptoms of seasonal allergic rhinitis. In two randomized, double-blind, double-dummy, parallel-group studies, patients received fluticasone furoate nasal spray (FFNS),110 microg (study 1, n = 312; study 2, n = 224); fexofenadine, 180 mg (study 1, n = 311; study 2, n = 227); or placebo (study 1, n = 313; study 2, n = 229) once daily for 2 weeks. Fluticasone furoate was more effective (p < 0.001) than fexofenadine and placebo in both studies with respect to the mean changes from baseline over the treatment period in the nighttime symptoms score, nighttime reflective total nasal symptom score, predose instantaneous nasal symptom score, and morning peak nasal inspiratory flow. Fluticasone furoate was more effective than placebo (p <or= 0.001) in study 1 and more effective than both placebo and fexofenadine (p <or= 0.034) in study 2 with respect to the mean changes from baseline in the nighttime reflective total ocular symptom score and predose instantaneous total ocular symptom score. In these double-dummy studies, fexofenadine did not separate from placebo in comparisons of the nighttime symptoms score or the nighttime nasal or ocular symptom measures. The incidence of adverse events was similar among groups. FFNS once daily was more effective than fexofenadine and placebo with respect to nighttime sleep disturbance caused by seasonal allergy symptoms.

Once-Daily Fluticasone Furoate Nasal Spray Showed Greater Improvements in Relieving Nighttime Nasal Symptoms and Increasing Peak Nasal Inspiratory Flow Versus Oral Fexofenadine in Subjects With Seasonal Allergic Rhinitis (SAR)

Once-Daily Fluticasone Furoate Nasal Spray Showed Greater Improvements in Relieving Nighttime Nasal Symptoms and Increasing Peak Nasal Inspiratory Flow Versus Oral Fexofenadine in Subjects With Seasonal Allergic Rhinitis (SAR)

A Double-Blind Non-inferiority Clinical Study of Montelukast, a Cysteinyl Leukotriene Receptor 1 Antagonist, Compared with Pranlukast in Patients with Seasonal Allergic Rhinitis

During the course of development of montelukast, a cysteinyl leukotriene receptor 1 antagonist, for treatment of seasonal allergic rhinitis, a double-blind, non-inferiority study was carried out to evaluate the efficacy and safety of montelukast 5mg and 10mg compared with pranlukast 450mg, which has a similar mechanism of action. Montelukast 5mg, 10mg or pranlukast 450mg and the corresponding placebo were orally administered to patients with seasonal allergic rhinitis three times a day for 2 weeks. Non-inferior efficacy of montelukast 5mg and 10mg to pranlukast 450mg was investigated by the change from the baseline in the composite nasal symptoms scores over the 2-week treatment period. Montelukast 5mg, 10mg once daily and the pranlukast 450mg/day showed significant improvements in the change from the baseline in the composite, daytime and nighttime nasal symptom scores, and the improvement lasted for 2 weeks. Montelukast 5mg and 10mg were non-inferior to pranlukast 450mg in the change from the baseline in the composite nasal symptoms scores. The incidence rates of adverse experiences and drug-related adverse experiences were not significantly different among the three treatment groups. The results indicate that administration of montelukast 5mg and 10mg once daily are potent alternatives for the treatment of seasonal allergic rhinitis and demonstrated that the efficacy and the safety profiles are comparable with pranlukast 450mg/day.

Fluticasone propionate aqueous nasal spray provided significantly greater improvement in daytime and nighttime nasal symptoms of seasonal allergic rhinitis compared with montelukast

The safety and efficacy of intranasal corticosteroids for the treatment of allergic rhinitis is well documented in the literature. Additionally, an expert panel has concluded that intranasal corticosteroids are the first line of therapy when obstruction is a major component of rhinitis. Montelukast is a leukotriene receptor antagonist recently approved for the treatment of seasonal allergic rhinitis (SAR). This randomized, double-blind, double-dummy, parallel-group study was conducted to compare the effectiveness of a 15-day course of intranasal fluticasone propionate 200 microg, once daily (FP200QD), to oral montelukast 10 mg, once daily (MON10QD), in relieving daytime and nighttime nasal symptoms associated with SAR. The intent-to-treat (ITT) analysis population consisted of 705 eligible males and females (> or = 15 years) with SAR randomized to either FP200QD (N = 353) or MON10QD (N = 352). The primary efficacy endpoint was the mean change from baseline in subject-rated daytime total nasal symptom scores (the sum of four individual scores: nasal congestion, itching, rhinorrhea, and sneezing), evaluated via visual analog scales, and averaged over weeks 1 to 2. Secondary endpoints included the four daytime individual nasal symptom scores, the nighttime total, and individual nasal symptom scores (each evaluated on a four-point scale from 0 to 3). Statistically significant differences favoring FP200QD over MON10QD were observed for the mean change from baseline in daytime total nasal symptom scores (P < 0.001), daytime individual nasal symptom scores (P < 0.001), nighttime total (P < 0.001), and all individual nasal symptom scores (P < or = 0.002) over the 15-day treatment period. FP200QD and MON10QD were both well tolerated. The results of this well controlled study demonstrated that FP200QD was consistently superior to MON10QD with regard to every efficacy endpoint evaluated, including daytime and nighttime nasal congestion, in subjects with SAR.

Anti-inflammatory activity of an extract of Petasites hybridus in allergic rhinitis

Previous studies have suggested that histamine and leukotrienes (LTs) play an important pathobiological role in IgE-mediated allergic diseases. In vitro studies suggested that an extract of Petasites hybridus (Ze339) blocks LT synthesis in monocytes and granulocytes. Petasins are considered to be the pharmacologically active fraction within Ze339. Patients suffering from allergic rhinitis received three times a day two tablets of Ze339 standardized to 8 mg petasins within a time period of 1 week. After 5 days of treatment, Ze339 significantly improved primary end points, which were day- and nighttime nasal symptoms. Nasal resistance, which was measured by rhinomanometry, gradually decreased as a consequence of Ze339 treatment reaching normal levels after 5 days (rhinomanometry: from 403.5±62.0 to 844.8±38.8 ml). Levels of inflammatory mediators in nasal fluids and serum were measured 90 min after drug administration every day in the morning. After 5 days of treatment, a significant reduction of histamine (from 153.7±32.1 to 53.0±8.4 pg/ml) and LT levels (LTB 4: from 313.1±46.5 to 180.6±32.2 pg/ml; cysteinyl-LT: from 137.0±42.2 to 70.1±16.5 pg/ml) could be observed. Moreover, quality-of-life scores significantly improved. The drug had no effect on the distribution of lymphocyte subpopulations in the blood as well as on the capacity of blood leukocytes to generate cytokines and lipid mediators. These results suggest that Ze339 is effective in treating allergic rhinitis patients by decreasing levels of nasal inflammatory mediators.

A Placebo-Controlled Trial of a HEPA Air Cleaner in the Treatmentof Cat Allergy

Wood RA, Johnson EF, Van Natta MLHua Chen P, Eggleston PAAm J Respir Crit Care Med.1581998115120Air cleaners and air filtration devices have enjoyed considerable popularity as a form of environmental control to remedy allergic problems. There are, however, many unanswered questions in regard to their efficacy. This study attempts to address the question of efficacy of the high-efficiency particulate arrestor (HEPA) cleaners in reducing allergen levels and disease activity in the homes of cat-allergic patients who continue to live with the triggering allergen (cat).This study involved adults who had asthma and/or allergic rhinitis. They all had a history of allergic symptoms with cat exposure to the extent they required daily medications. They also had at least one cat in the home.A 1-month baseline period helped to determine the minimum amount of medication needed to control asthma and/or allergic rhinitis symptoms. Daily diaries were kept regarding medication use, peak flow, nasal and chest symptom scores, and sleep difficulty. At a home visit, the number of cats and the presence of carpeting was noted. Baseline air and dust samples were collected in the patient's bedroom. Pillows and mattresses were then covered and bedding was washed weekly. Patients were instructed to keep the cat(s) out of the bedroom. A second home visit was conducted to ensure compliance with the environmental control measures. For the next 3 months, a Honeywell Environcare HEPA filter was placed in the bedroom. This unit provided 15 air changes/hour in a 12- × 15-foot room. In the control group the filter was removed. Home visits occurred every month to sample the air and dust. A timer on the air filter units monitored compliance. Cat antigen, Fel d 1, was measured by enzyme-linked immunosorbent assay (ELISA). Other variables that were evaluated included spirometry, methacholine sensitivity, and radioallergosorbent test (RAST).There were 35 patients in the study; 17 served as the control group. All study patients had cat-induced rhinitis and 28 had cat-induced asthma. Thirteen study patients had one cat and 18 had two. All but 1 patient had carpeting in the bedroom. There were no significant differences between the treatment and control groups in medication use or demographics. There was no change in the level of airborne Fel d 1 in either group during the baseline period when the cat was kept out of the bedroom and covers were in place. When the HEPA filter was added, there was a modest decrease over 3 months in the level of airborne Fel d 1 in the group with the active air filter. The geometric mean level decreased from 3.0 ng/m3 at baseline to 1.7 ng/m3 at 3 months. There was no difference in cat allergen levels in settled dust samples at any point during the study. There was a trend toward decreased nighttime nasal symptoms in the treatment group; however, this did not reach statistical significance. No significant differences were observed in chest symptoms, peak flow measures, sleep, medication use, spirometry, methacholine challenges, or RAST results.The HEPA filter did provide for a significant decrease in Fel d 1 levels in the air. However, those using a HEPA filter did not experience any significant difference in any measure of disease activity for both rhinitis and asthma.It must be noted that this paper does not deal with children at all; however, it does deal with a common problem that affects children. Parents see these forms of allergy treatment advertised and may ask their pediatricians about their efficacy. There are numerous options available for environmental control, many of which have not been studied in any rigorous way. This article points out a number of key concepts using this form of environmental control measure. Airborne levels do decrease, but the new level achieved was not associated with significant differences in disease control. The study emphasizes the importance of avoidance and the lack of efficacy of the HEPA units in this model of allergy.

Air Cleaners for Cat Allergy: Effective, but Not Useful

Source: Wood RA, Johnson EF, Van Natta ML, Chen PH, Eggleston PA. A placebo-controlled trial of a HEPA air cleaner in the treatment of cat allergy. Am J Resp Crit Care Med. 1998;158:115–120.This double-blind, placebo-controlled trial evaluated the efficacy of high-efficiency particulate air (HEPA) room-size cleaners in reducing allergic symptoms in 35 cat-allergic individuals living with one or more cats. At the beginning of a 1-month baseline period, the participants’ beds were equipped with impervious mattress and pillow covers, and they were instructed to wash bedding weekly and keep cats out of the bedroom. After baseline observation, the participants’ bedrooms were equipped with either an active or a placebo air cleaner (Honeywell Envirocare HEPA). (The cleaners were identical except that the HEPA element had been removed from the placebo.) Evaluations over 3 months included: monthly measurements of cat-allergen levels; daily morning, afternoon, and nighttime nasal- and chest-symptom scores; twice-daily peak-flow rates; daily medication scores; monthly spirometry; and methacholine challenge testing before and after the study. Compliance in using the air cleaners was monitored by hidden run-timers within each unit. Airborne allergen levels were reduced in the active-cleaner group when compared to the placebo group (p=0.045); however, no significant differences were found in any of the symptom-related outcome measures. The authors conclude that a combination of HEPA room air cleaners, mattress and pillow covers, and cat exclusion can reduce airborne cat allergen levels in bedrooms, but these efforts have no detectable effect on either rhinitis or asthma symptoms in cat allergic individuals.Cat allergy is common, and symptoms typically occur when sensitive individuals are exposed to a cat. Since cat allergen is carried on small particles that tend to remain airborne, removal by an air cleaner would appear useful. The authors took pains to select participants with adequate symptoms to allow evaluation and to study them when exposure to seasonal allergens was unlikely. This study included a reasonably large number of individuals (ages 23 to 60 years) and followed them for 3 months in a double-blind, placebo-controlled design. The investigators monitored compliance running the cleaner, keeping the cat from the bedroom and maintaining the pillow and mattress coverings, and documented changes in symptoms using multiple objective and subjective measures. This meticulous study design detected no effect on either nasal or chest symptoms. Were there enough participants to detect effects? Using the data obtained, the investigators calculated that to achieve a p-value of 0.05 or less, they would need 284 subjects to detect a difference in nighttime nasal symptoms, and 14 744 subjects to detect a difference in morning nasal symptoms. If it takes hundreds of subjects to show statistical significance, these interventions seem unlikely to offer any clinically useful benefit for patients. Did the air cleaners have adequate airflow to be effective? The air cleaners studied are designed to filter 21 000 cubic feet per hour, approximately 15 air changes per hour in a 12 x 15′ room. The bottom line would appear to be that the only effective method of reducing symptoms from cat allergen at home is to remove the cat from the home.