Combination Montelukast Research Articles

Therapeutic effect of acupuncture combined montelukast sodium on cough variant asthma in children: A protocol for systematic review and meta-analysis.

Background:Cough variant asthma in children is a special type of asthma. Although there are many effective cases of combined acupuncture and western medicine in the clinical treatment of this kind of children, there is no standardized acupuncture combined with western medicine to evaluate the curative effect. Therefore, combined with existing reports, a systematic review and meta-analysis of acupuncture combined with montelukast sodium in the treatment of cough variant asthma in children were carried out to obtain conclusive results.Methods:The following electronic databases will be searched: PubMed, the Cochrane Library, Embase, Web of Science, Medline, CNKI, Chinese Biomedical Literature Database, VIP, and Wan Fang databases. We will consider articles published between database initiation and October 2021. We will use Review Manager 5.4, provided by the Cochrane Collaborative Network for statistical analysis. Clinical randomized controlled trials related to acupuncture combined with montelukast sodium on cough variant asthma in children were included in this study. Language is limited to both Chinese and English. Research selection, data extraction, and research quality assessments were independently completed by two researchers. We then assessed the quality and risk of the included studies and observed the outcome measures.Results:This study provides a high-quality synthesis to assess the effectiveness and safety of acupuncture combined with montelukast sodium on cough variant asthma in children.Conclusion:This systematic review will provide evidence to determine whether acupuncture combined with montelukast sodium is an effective and safe intervention for patients with cough variant asthma in children.INPLASY Registration number:INPLASY2021110006.

Evaluation of efficiency and safety of combined montelukast sodium and budesonide in children with cough variant asthma: A protocol for systematic review and meta-analysis.

Background:Cough variant asthma (CVA) is classified as a distinct form of asthma. As the primary or only symptom, cough is the leading cause for the most prevalent chronic cough among kids. The American College of Clinical Pharmacy, British Thoracic Society, and Chinese guidelines established for diagnosing and treating chronic cough in kids recommend inhaled corticosteroids, combined with leukotriene receptor antagonists when necessary.Methods:We will conduct a comprehensive search in major databases using keywords to find studies related to the analysis of montelukast sodium and budesonide for treating CVA in kids. Two reviewers will independently assess the quality of the selected research articles and perform data extraction. Next, we will use the RevMan software (version: 5.3) to conduct the statistical analysis of the present study.Results:This study will assess the efficacy and safeness of using montelukast sodium and budesonide to treat kids with CVA by pooling the results of individual studies.Conclusion:Our findings will provide vigorous evidence to judge whether montelukast sodium and budesonide therapy is an efficient form of therapy for CVA patients.Ethics and dissemination:Ethics approval is not needed for the present meta-analysis.OSF registration number:May 17, 2021.osf.io/cuvjz (https://osf.io/cuvjz/).

The therapeutic role of lactobacillus and montelukast in combination with metformin in diabetes mellitus complications through modulation of gut microbiota and suppression of oxidative stress

Male reproductive dysfunction is one of the overlooked findings of diabetes mellitus (DM) that deserves greater scientific attention. This study is designed to explore the therapeutic potential of metformin and montelukast, in combination with Lactobacillus, for modulation of intestinal flora and suppression of oxidative stress in testicular and liver damage in diabetic male rats. A DM model was induced by streptozotocin (STZ)which caused functional, biochemical, and inflammatory injuries to the testicular and liver tissues. The experimental panel included nine rat groups: normal control, normal control plus metformin, normal control plus montelukast, DM control, DM plus montelukast, DM plus a combination of metformin and Lactobacillus, DM plus a combination of montelukast and Lactobacillus, and DM plus a combination of metformin and montelukast. In parallel, clinical evaluation of microscopic examination scoring, and hepatic and testicular injuries, were evaluated. Biochemical markers including glucose level, lipid profile, inflammatory markers (tumor necrosis factor- (TNF-α) and interleukin-17 (IL-17), Caspase-3, and Bax proteins expressions were measured. The change in the microbiota abundance was investigated using conventional and real-time PCR. The current study revealed a significant difference in the relative abundance of microbiota, where DM is associated with an enormous increase of Bacteroides spp., Clostridium spp., E. coli, and Fusobacterium spp., and a significant decrease in Bifidobacteria spp., and Lactobacillus spp., in contrast with normal control. Metformin and montelukast, in combination with Lactobacillus, significantly reversed the testicular and liver damage caused by STZ. Moreover, the drugs significantly reduced the oxidative, inflammatory, and apoptotic activities induced by STZ.

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.

Comparison of therapeutic efficacy of antihistaminics and combinations of montelukast with allergic rhinitis

Allergic Rhinitis is basically a chronic disease that decreases quality of life. Antihistaminics have been used for the first time in allergic rhinitis. In the search for an alternative treatment in resistant allergic rhinitis, Montelukasts and their combinations have been used. Randomized double-blind controlled study. In our study, the effect on the quality of life of the compounds used recently be compared after 3 months of treatment. In this study, 7 groups of 40 patients, 18-65 years old were planned for each group. The number of females and males was equal in each group (20). The patients in group A and group B will be called for checks after 3 months of medical treatment in the C-D-E-F-G-H group without treatment for 3 months. The patients in Group C received 10 mg Rupatadin Fumarate tablets orally (1 * 1 single dose) before bedtime, 5 mg Levosetirizine Dihydrochloride tablets in the patients in Group D orally (1 * 1 single dose) before bedtime, 10 mg Montelukast Sodium tablets in patients in Group E Before oral (1 * 1 single dose), patients in Group F 5 mg Desloratadin + 10 mg Montelukast Sodium tablets orally (1 * 1 single dose) before bedtime, and patients in Group G Levocetirizine Dihydrochloride + 10 mg Montelukast Sodium tablet orally before bedtime (1 * 1 single dose) will be given. These treatments will continue for 3 months without interruption. The Rinokonjucivations Quality of Life Questionnaire (RQLQ) will be completed with a total of 28 questions. No significant superiority of the Rupatadine molecule to levocetirizine was detected. The score of the Montelukast areas was significantly low when compared to the Rupatadine and Levosetirizine groups. Combined Montelukastes were found to be much more effective than single antihistaminics and single montelukast. There was no difference in quality of life between the combined Montelukast. Antihistaminics are the first treatment option in patients with allergic rhinitis,In resistant cases, combinations with montelukast should be used.

Magnesium Sulfate Combined Montelukast Sodium Clinical Observationon Treatment of Infantile Asthma

Objective: To observe the application of magnesium sulfate combined Montelukast pediatric asthma clinical curative effect of sodium. Methods: Select zhenan county maternity and child care in November 2014 to November 2015 treated 66 cases of children asthma, randomly divided into control group and research group, 33 cases in each group, control group given conventional treatment, treatment group on the basis of this combined with magnesium sulfate and montelukast sodium, adjuvant therapy, observe the therapeutic effect of two groups. Results: The treatment group effective rate was 96%, better than the control group 81%, comparing the two groups have significant difference (P < 0.05), and the symptoms disappear time significantly less than the control group. Conclusion: The application of combined montelukast sodium and magnesium sulfate on infantile asthma with obvious therapeutic effect, less adverse reaction, worth clinical promotion.

Effect of combination of montelukast and levocetirizine on otitis media with effusion: a prospective, placebo-controlled trial

Conclusion: This study demonstrated that treatment with montelukast in combination with levocetirizine may have a beneficial effect on clinical improvement of middle ear fluid in children with otitis media with effusion (OME). Objective: To evaluate the effect of the combination of montelukast and levocetirizine on shortening the duration of effusion in successfully treated OME in children. Methods: This was a randomized, prospective, double-blind, placebo-controlled trial. The study group consisted of 120 children (age range 2–6 years), who were diagnosed with OME of at least 2 months duration. The children were randomized into one of four groups. The treatment packs containing montelukast 4 mg (tablet) and/or levocetirizine 2.5 mg/5 ml as the active drug or placebo were prepared, numbered, and distributed by the second author. Results: The amelioration of bilateral otoscopic sign scores in the combination therapy group was statistically significantly greater than in all the other groups (p < 0.05). Improvement in bilateral tympanometric findings in the combination therapy group and montelukast group was greater than in the other groups. However, this difference was not statistically significant (p > 0.05). When we compared the difference between otoscopic sign scores before and after treatment we found that it was statistically significant in every group (p > 0.05). However, the significant improvement in tympanometric findings occurred in all groups except the levocetirizine group (p > 0.05).

247 Health-Related Quality of Life and Prognostic Value of Acoustic Rhinometry in Patients With Perennial Allergic Rhinitis Treated with Fix Combination of Montelukast Plus Desloratadine

ObjectiveTo determine prognostic value of acoustic rhinometry in patients with perennial allergic rhinitis (PAR) treated with montelukast in fix combination with desloratidine and to assess effectiveness of this medication on health-related quality of life (HRQL).Study designA randomized, double-blind, prospective and multicentric clinical study.SettingTertiary university hospitals.MethodsPatients 20 years of age and older with PAR were assessed over 3 months of treatment with fix combination of montelukast 10 mg plus desloratidine 5 mg once daily (n = 40). Comparative acoustic rhinometric evaluation was used to compare nasal changes in before and after treatments. For evaluation of HRQL between before and after treatments at the first and third months, the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was used.ResultsNasal symptoms and findings including itching, sneezing, discharge, congestion and edema and color change of turbinates have been decreased after treatment. In acoustic rhinometry, minimum cross-sectional area (MCA) measurements and volume results were statistically higher than in before treatment (P < 0.001). Correlation was found that between the volume results and nasal discharged and/or congestion in right nasal passages. In left nasal passages, statistical relation was described between the MCA measurements and itching and/or change of turbinate color (P < 0.05). There was a larger decrease in the overall RQLQ score for the group using montelukast plus desloratidine compared with the pre-treatment scores (P < 0.001). The difference between scores at baseline versus the end of the first and third months for all domains was statically significant (P < 0.001). The treatment difference in change from first month to the end of the third month was statically significant, in favor of the third month, for eye, nose, and non- nose/eye symptoms, sleep, practical problems, emotions and activities that have been limited by nose or eye symptoms, and for overall score.ConclusionsSignificant reductions in signs and symptoms of PAR with montelukast plus desloratadine treatment were accompanied by improved disease-specific QOL measures. Montelukast in combination with desloratidine provides improvements in acoustic rhinometric values including volume and MCA in patients with PAR. Acoustic rhinometry should be use in diagnostic and prognostic process in patients with PAR.

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.

Formoterol, montelukast, and budesonide in asthmatic children: Effect on lung function and exhaled nitric oxide

It has been proposed that asthma control may be achieved in part by minimizing airway inflammation. The simultaneous effects of inhaled steroids associated with long-acting beta-agonists and leukotriene antagonists on pulmonary function and airway inflammation are still largely unexplored in children with moderate persistent asthma. The aim of this study was to investigate the effects of add-on therapy with long-acting beta-agonists and leukotriene antagonists on FEV1 and exhaled nitric oxide levels (FENO) in children. Forty-eight steroid-naïve atopic asthmatic children, 7-11 years of age, were randomly treated in four groups for two consecutive one-month periods, as follows: (1) first month: budesonide 200 microg twice daily; second month: budesonide 400 microg twice daily; (2) first month: budesonide 200 microg twice daily+formoterol 9 microg twice daily; second month: budesonide 200 microg twice daily+montelukast 5mg once daily; (3) first month: budesonide 200 microg twice daily+montelukast 5mg once daily; second month budesonide 200 microg+formoterol 9 microg twice daily; (4) first and second month: budesonide 400 microg twice daily. All treatments resulted in a significant increase in lung function and a decrease in FENO compared with values at baseline. Budesonide+montelukast in combination was the most effective treatment for reducing FENO levels. This study demonstrates that add-on therapy with montelukast plus low-dose budesonide is more effective than the addition of long-acting beta-agonists or doubling the dose of budesonide for controlling FENO in asthmatic children.

Montelukast in the Treatment of Allergic Rhinitis

Cysteinyl-leukotrienes (CysLTs) are endogenous mediators of inflammation and play an important role in allergic airway disease by stimulating bronchoconstriction, mucus production, mucosal oedema and inflammation, airway infiltration by eosinophils, and dendritic cell maturation that prepares for future allergic response. Montelukast inhibits these actions by blocking type 1 CysLT receptors found on immunocytes, smooth muscle and endothelium in the respiratory mucosa. Initially developed as a treatment for asthma, montelukast has more recently found use in the treatment of allergic rhinitis (AR). We conducted a systematic review of studies that have evaluated montelukast in the treatment of seasonal AR (SAR) and perennial AR (PAR), with and without concomitant asthma. Primary consideration was given to large, randomised, placebo-controlled, double-blind clinical trials in which AR endpoints were assessed and the use of concurrent treatments for AR was excluded. Eight such studies were found in the literature. The primary endpoint in these was daytime nasal symptom severity represented by a composite score derived from individual self-ratings of nasal congestion, rhinorrhoea, nasal pruritus and sneezing. Secondary endpoints have included these individual nasal symptom scores, additional scores for eye, ear and throat symptoms, the impact of rhinitis on quality of sleep, global evaluations of outcome by patients and physicians, and measures of the severity of concomitant asthma. A general outcome was that patients treated with montelukast had significantly greater improvements in their symptoms of SAR and PAR than did patients who were given a placebo. As monotherapy, montelukast exhibited efficacy similar to that of loratadine, but less than that of the intranasally administered corticosteroid fluticasone propionate. The use of montelukast in combination with antihistamines such as loratadine or cetirizine has generally resulted in greater efficacy than when these agents were used alone, and in some studies has produced results comparable with intranasally applied corticosteroids. In patients with AR comorbid with asthma, montelukast treatment has resulted in significant improvements in both, compared with placebo. Montelukast is well tolerated and has a favourable safety profile; adverse events have occurred at similar frequencies in patients taking either montelukast or placebo. Montelukast provides an effective and well tolerated oral treatment for allergic airway inflammation in patients with SAR or PAR without asthma, and in patients in whom AR is comorbid with asthma.

Reversal of Allergen-induced Airway Remodeling by CysLT1 Receptor Blockade

Airway inflammation in asthma is accompanied by structural changes, including goblet cell metaplasia, smooth muscle cell layer thickening, and subepithelial fibrosis. This allergen-induced airway remodeling can be replicated in a mouse asthma model. The study goal was to determine whether established airway remodeling in a mouse asthma model is reversible by administration of the cysteinyl leukotriene (CysLT)1 receptor antagonist montelukast, the corticosteroid dexamethasone, or the combination montelukast + dexamethasone. BALB/c mice, sensitized by intraperitoneal ovalbumin (OVA) as allergen, received intranasal OVA periodically Days 14-73 and montelukast or dexamethasone or placebo from Days 73-163. Allergen-induced trafficking of eosinophils into the bronchoalveolar lavage fluid and lung interstitium and airway goblet cell metaplasia, smooth muscle cell layer thickening, and subepithelial fibrosis present on Day 73 persisted at Day 163, 3 mo after the last allergen challenge. Airway hyperreactivity to methacholine observed on Day 73 in OVA-treated mice was absent on Day 163. In OVA-treated mice, airway eosinophil infiltration and goblet cell metaplasia were reduced by either montelukast or dexamethasone alone. Montelukast, but not dexamethasone, reversed the established increase in airway smooth muscle mass and subepithelial collagen deposition. By immunocytochemistry, CysLT1 receptor expression was significantly increased in airway smooth muscle cells in allergen-treated mice compared with saline-treated controls and was reduced by montelukast, but not dexamethasone, administration. These data indicate that established airway smooth muscle cell layer thickening and subepithelial fibrosis, key allergen-induced airway structural changes not modulated by corticosteroids, are reversible by CysLT1 receptor blockade therapy.

Effect of combined montelukast and desloratadine on the early asthmatic response to inhaled allergen

The early asthmatic response (EAR) to inhaled allergen results from IgE-mediated release of multiple mast-cell mediators, including leukotrienes and histamine, both of which cause bronchoconstriction. Combination therapy directed at blocking the effects of both mediators might protect against the EAR better than either therapy alone. We sought to evaluate the effect of desloratadine and montelukast, administered alone and in combination, on the EAR to inhaled allergen. Ten adults with mild-to-moderate atopic asthma participated in a randomized, 4-way crossover study design comparing placebo, 5 mg of desloratadine, 10 mg of montelukast, and the combination administered at 26 hours and 2 hours before each allergen challenge conducted at least 7 days apart. The primary end point was the concentration of allergen that resulted in a 20% decrease in FEV1 (PC20). The geometric mean allergen PC20 (mean log +/- SEM) for combination therapy, montelukast, desloratadine, and placebo was 697 U/mL (2.8433 +/- 0.3253), 338 U/mL (2.5295 +/- 0.2979), 123 U/mL (2.0883 +/- 0.2102), and 104 U/mL (2.0166 +/- 0.2553), respectively (n = 9; P < .00001, ANOVA). Montelukast increased the allergen PC20 4.8-fold, and combination therapy increased the allergen PC20 8.9-fold. The effect of the combination was greater than that with montelukast alone (P < .02). Desloratadine treatment was no different than placebo. The early response to inhaled allergen was unchanged after desloratadine therapy and partially inhibited with montelukast therapy. The combination of desloratadine and montelukast provided superior efficacy to either blocker administered alone. Investigations into the possible mechanisms of the enhanced inhibition are necessary.

Improved refill persistence with fluticasone propionate and salmeterol in a single inhaler compared with other controller therapies

Background Improved adherence to inhaled corticosteroids (ICSs) has also been associated with decreased asthma-associated morbidity and mortality. Objective The purpose of this study was to assess patient medication refill persistence with fluticasone propionate (FP) and salmeterol combination in a single inhaler (FSC), FP and salmeterol in combination from 2 separate inhalers, FP and montelukast in combination, FP as monotherapy, and montelukast as monotherapy. Methods We performed a retrospective, observational, 24-month (12-month baseline and 12-month follow-up) database study using medical and pharmacy claims from a large managed care organization. We identified 2511 subjects 12 years of age or older with a claim for asthma (International Classification of Diseases, Ninth Revision: 493.XX): 563 patients receiving FSC, 224 receiving FP plus salmeterol, 75 receiving FP plus montelukast, 798 receiving FP only, and 776 receiving montelukast only. Refill rates of FP, as a measure of adherence, were compared for each FP-containing cohort during the 12-month follow-up period. In addition, refill rates were compared between FSC, an inhaler, and montelukast, an oral medication. Results Twelve-month baseline asthma medication use and patient demographics were comparable among cohorts. Patients in the FSC cohort obtained significantly more refills compared with the number of FP refills in the other FP-containing cohorts (4.06 for FSC vs 2.35 for FP plus salmeterol, 1.83 for FP plus montelukast, and 2.27 for FP alone) over the 12-month follow-up period. In addition, patients taking FSC had similar refill persistence compared with patients taking the oral leukotriene modifier montelukast (4.51). Conclusion FSC might increase ICS refill persistence compared with FP alone in a single inhaler, FP in combination with salmeterol from 2 separate inhalers, and FP in combination with montelukast. In addition, FSC in a dry powdered inhaler had similar refill rates compared with an oral asthma agent, montelukast. Use of a single inhaler containing both an ICS (FP) and a long-acting bronchodilator (salmeterol) might increase the likelihood that patients are getting more optimal ICS therapy, as well as the benefits from the long-acting bronchodilator, with patient adherence comparable to an oral agent.

Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall

Histamine and cysteinyl leukotrienes seem to be important mediators of allergic rhinitis. This multicenter, randomized, double-blind, parallel-group, placebo-controlled trial evaluated the effectiveness and tolerability of montelukast, loratadine, and combination therapy with montelukast and loratadine for treating patients with fall seasonal allergic rhinitis. After a 1-week, single-blind, placebo run-in period, 907 male and female patients aged 15 to 82 years were randomized to 1 of 4 treatments: montelukast 10 mg (n = 155), loratadine 10 mg (n = 301), combination montelukast 10 mg and loratadine 10 mg (n = 302), or placebo (n = 149), administered once daily at bedtime for 2 weeks. The primary endpoint was the daytime nasal symptoms score (mean of congestion, rhinorrhea, pruritus, and sneezing). Mean symptom scores at baseline were similar for the four treatment groups. For each of the three active treatments, the difference was significant for the mean change from baseline compared with placebo (P < or = 0.001). However, the effect of montelukast/loratadine compared with loratadine alone, the primary comparison, was not significantly different. Differences for each therapy alone compared with placebo were also significant for most secondary endpoints, including nighttime symptom scores, eye symptoms scores, and rhinitis-specific quality of life. Differences for montelukast/loratadine compared with each therapy alone generally showed numerical superiority, and a few endpoints showed differences that were statistically significant. All active treatments showed a safety profile generally similar to placebo. Montelukast alone or in combination with loratadine is well tolerated and provides clinical and quality-of-life benefits for patients with seasonal allergic rhinitis.