-
1.
Comparison of the efficacy and mechanisms of intranasal budesonide, montelukast, and their combination in treatment of patients with seasonal allergic rhinitis.
Chen, H, Lou, H, Wang, Y, Cao, F, Zhang, L, Wang, C
International forum of allergy & rhinology. 2018;(11):1242-1252
Abstract
BACKGROUND Although intranasal steroids and anti-cysteinyl-leukotriene-receptor antagonists are efficacious in the treatment of seasonal allergic rhinitis (SAR), combinations of these agents have not unequivocally been demonstrated to be superior to the individual drugs. We aimed to compare the efficacy and potential mechanisms of budesonide nasal spray (BD), oral montelukast (MNT), and combination therapy comprising a half-dose of budesonide plus montelukast (hBD+MNT) in SAR patients. METHODS We performed a single-center, randomized, open-label study in SAR subjects (n = 100). Participants were randomized to receive BD (256 μg), MNT (10 mg), or hBD (128 μg)+MNT for 14 days. Symptom severity scores, nasal cavity volume (NCV), fraction of exhaled nitric oxide (FeNO), eosinophil cationic protein (ECP), histamine and cysteinyl-leukotrienes (CysLTs), and T-cell subsets were assessed before and after treatment. RESULTS All treatments significantly improved symptoms from baseline; however, hBD+MNT produced significantly greater improvements in nasal congestion compared with BD or MNT alone. The BD and hBD+MNT groups had fewer patients with uncontrolled symptoms and improved NCV to a greater level than the MNT group. FeNO was decreased to a significantly greater extent from baseline after hBD+MNT treatment than after BD and MNT treatments. ECP, histamine, and CysLTs showed significantly greater decreases after BD and hBD+MNT treatments than after MNT treatment. BD decreased T-helper 1 (Th1) and Th2 cells and increased T-regulatory (Treg) cells in nasal mucosa and MNT decreased Th1 cells and increased Treg cells in peripheral blood, and this trend was reflected with hBD+MNT. CONCLUSION The hBD+MNT combination may have an overall better efficacy profile than BD and MNT monotherapy for treatment of SAR.
-
2.
Add-on therapy with montelukast in the treatment of Henoch-Schönlein purpura.
Wu, SH, Liao, PY, Chen, XQ, Yin, PL, Dong, L
Pediatrics international : official journal of the Japan Pediatric Society. 2014;(3):315-22
Abstract
BACKGROUND Previous studies suggested that leukotrienes (LT) were involved in the pathogenesis of Henoch-Schönlein purpura (HSP). This study investigated the efficacy of an add-on therapy with montelukast in the treatment of HSP. METHODS In this four-center, double-blind, placebo-controlled, parallel paired comparative study, 130 children with HSP were divided into two large groups: 84 patients without nephritis and 46 patients with nephritis. For each pair of patients with the same severity of disease, one subject was randomly allocated to one subgroup and the other allocated to the other subbroup; one subgroup received routine treatment plus placebo treatment, while the other subgroup received routine treatment plus montelukast treatment for 3 months. The efficacy was determined using Severity Scale Score (SSS). Blood eosinophil count, eosinophil cationic protein (ECP), IgE, interleukin (IL)-4, IL-5, IL-6, IL-8, IL-17, LTB4 , and urinary LTE4 were measured. RESULTS Add-on therapy with montelukast alleviated the symptoms of HSP including purpura, abdominal pain, stool occult blood, arthritis, proteinuria and hematuria, and, accordingly, shortened the length of hospital stay, and lowered blood eosinophil count, ECP, IgE, IL-4, IL-5, IL-6, IL-8, IL-17, LTB4 , and urinary LTE4 production, and also lowered the HSP relapse rate during the 3 months of treatment, but did not alter the outcome of nephritis at the end of follow up. CONCLUSIONS Add-on therapy with montelukast alleviated the symptoms of HSP. HSP may be improved by add-on therapy with a leukotriene receptor antagonist.
-
3.
Add-on montelukast vs double-dose budesonide in nonasthmatic eosinophilic bronchitis: a pilot study.
Cai, C, He, MZ, Zhong, SQ, Tang, Y, Sun, BQ, Chen, QL, Zhong, NS
Respiratory medicine. 2012;(10):1369-75
Abstract
BACKGROUND Budesonide at 800 μg/d is generally suggested for treatment of nonasthmatic eosinophilic bronchitis (NAEB). In asthma, adjunctive therapy with montelukast has been shown to confer addictive anti-inflammatory effects to inhaled corticosteroid (ICS). However, whether such effects could be extrapolated to NAEB is not known. OBJECTIVES To study the efficacy and tolerability of add-on therapy with montelukast as compared to double-dose ICS in suppressing airway eosinophilia and decreasing cough severity in NAEB. METHODS In a randomized controlled trial, 26 nonsmoking, steroid-naïve NAEB patients presenting with chronic cough were treated with 800 μg/d budesonide or 400 μg/d budesonide plus montelukast 10 mg/d for 4 weeks. Cough visual analogue scale (CVAS) and eosinophil differential ratio in induced sputum (Eos) were monitored at baseline, Week 1, 2 and 4. Adverse events during treatment were recorded. RESULTS The two groups were comparable in age, gender distribution, cough duration, FEV(1)% predicted, FEV(1)/FEV ratio, baseline CVAS and geometric mean of Eos. Both regimens significantly reduced Eos and CVAS throughout the treatment course, with abrogation of sputum eosinophilia at end of therapy. There was no significant difference between the two groups in reduction of Eos and CVAS at all time points. Both regimens were well tolerated. CONCLUSIONS This preliminary study demonstrated that add-on montelukast might be an effective and well tolerated alternative to the generally suggested dose of ICS in treating steroid-naive NAEB, with suppression of eosinophilic inflammation, reduction of cough severity and sparing of ICS doses. (NCT01121016).
-
4.
A comparison of intranasal corticosteroid, leukotriene receptor antagonist, and topical antihistamine in reducing symptoms of perennial allergic rhinitis as assessed through the Rhinitis Severity Score.
Sardana, N, Santos, C, Lehman, E, Craig, T
Allergy and asthma proceedings. 2010;(1):5-9
Abstract
Rhinitis symptom complex consists of rhinorrhea, congestion, itchy mucosa, itchy eyes, and sneezing. Available medications vary in their benefit for each of these symptoms. It was the purpose of this article to compare symptom reduction with three different classes of medications. Montelukast, azelastine, and budesonide were compared to determine the effect on individual, as well as total, symptom scores using the Rhinitis Severity Score (RSS). All three medications were compared with placebo and showed efficacy in prior studies using Balaam's crossover design. The inclusion and exclusion criteria and all procedures were identical for all three studies. In analyzing the data from the RSS questionnaire, we used the procedure PROC MIXED in SAS specific for Balaam's crossover design (SAS Institute, Inc., Cary, NC). Although all three medications were effective compared with placebo, montelukast had the greatest effect of the three medications on reduction of ocular itching and throat and palate itching. Azelastine's effect was greater than budesonide and montelukast for reduction of rhinorrhea. Systemic medication, montelukast, as expected, provided better relief for symptoms distant from the nasal cavity, and the antihistamine, azelastine, reduced rhinorrhea, more than either montelukast or budesonide.
-
5.
Efficacy of leukotriene antagonists as concomitant therapy in allergic rhinitis.
Cingi, C, Gunhan, K, Gage-White, L, Unlu, H
The Laryngoscope. 2010;(9):1718-23
Abstract
OBJECTIVES/HYPOTHESIS The symptoms of allergic rhinitis result from an immunoglobulin E-dependent mast cell activation cascade, marked by the release of inflammatory mediators, including histamine. Patients with perennial allergic rhinitis also have elevated levels of cysteinyl leukotrienes (CysLTs) in nasal lavage fluid. Histamine and CysLTs produce different responses in the pathogenesis of allergic rhinitis, and this study tested the hypothesis that the effects of combined antihistamine and leukotriene antagonist therapy would be more effective than antihistamine alone. STUDY DESIGN Multicentered, prospective, randomized, placebo-controlled, parallel-group. METHODS Three groups totaling 275 patients using: 1) fexofenadine alone, 2) fexofenadine with montelukast, or 3) fexofenadine with placebo, participated in a 21-day trial conducted during the spring pollen season. Objective analysis included pre- and poststudy physical examination findings and nasal resistance measurements. Subjective data gathered included a daily patient diary and pre- and poststudy patient satisfaction measurements. RESULTS The group using both fexofenadine and montelukast showed significantly better control of nasal congestion both subjectively, using patient diary and visual analog scale evaluations, and objectively, using rhinomanometry and physical examination, compared to groups using antihistamine alone or with placebo. CONCLUSIONS Our data provided both objective and subjective evidence that leukotriene receptor antagonist-antihistamine combination therapy is more effective than antihistamine alone in the control of allergic rhinitis symptoms.
-
6.
Efficacy of levocetirizine compared with montelukast in subjects with ragweed-induced seasonal allergic rhinitis in the Environmental Exposure Unit.
Day, JH, Briscoe, MP, Ratz, JD
Allergy and asthma proceedings. 2008;(3):304-12
Abstract
Levocetirizine dihydrochloride, a potent H1-receptor antagonist, and montelukast sodium, a selective leukotriene receptor antagonist, have been approved for the treatment of seasonal allergic rhinitis (SAR), but target two different pathways that cause SAR symptoms. The study objective was to compare the efficacy of levocetirizine (LCTZ), 5 mg, and montelukast (MLKT), 10 mg, in reducing SAR symptoms in ragweed-sensitive adults exposed to ragweed pollen in the Environmental Exposure Unit (EEU). This randomized, double-blind, placebo-controlled, parallel-group study of 418 adult subjects with SAR to ragweed compared the efficacy of LCTZ, MLKT, and placebo administered once daily (11:00 A.M.) for 2 consecutive days in the EEU. There were three evaluation periods: period I, 0-5 hours after first dose; period II, 22.5-24 hours after first dose; and period III, 0-4.5 hours after second dose. The primary efficacy variable was the Major Symptom Complex (MSC) score (six symptoms) over period I. Both active drugs significantly improved the MSC score compared with placebo in all periods. The adjusted mean MSC score difference between LCTZ and MLKT was -0.93 (p = 0.100) in period I, -3.11 (p < 0.001) in period II, -2.42 (p < 0.001) in period III, and -1.88 (p < 0.001) over the total treatment period. The same trends were observed for the Total Symptom Complex score (10 symptoms) and most individual symptoms. Subject-reported global satisfaction was greater for LCTZ compared with MLKT and placebo. All treatments had a favorable safety profile. LCTZ, 5 mg, was more effective than MLKT, 10 mg, in subjects with SAR and had better subject-reported global satisfaction.
-
7.
Montelukast decreased exhaled nitric oxide in children with perennial allergic rhinitis.
Hung, CH, Hua, YM, Hsu, WT, Lai, YS, Yang, KD, Jong, YJ, Chu, YT
Pediatrics international : official journal of the Japan Pediatric Society. 2007;(3):322-7
Abstract
BACKGROUND Measurement of exhaled nitric oxide (eNO) is a simple and noninvasive method for assessment of inflammatory airway diseases. eNO is elevated in adolescent patients with perennial allergic rhinitis and related to bronchial hyperresponsiveness. The aim of this study was to investigate whether oral loratadine, montelukast, nasal budesonide or nasal sodium cromoglycate could reduce airway inflammation as indicated by decrease of eNO in children with perennial allergic rhinitis as demonstrated by eNO levels. METHODS A randomized and investigator-blinded study was conducted in a hospital-based outpatient clinic. Children with perennial allergic rhinitis were divided into four groups and treated by loratadine, loratadine with nasal sodium cromoglycate, loratadine with oral montelukast, and loratadine with nasal budesonide, respectively. Allergic rhinitis scores, eNO and peak expiratory flow were measured before and 2, 4, 6 and 8 weeks after treatment. RESULTS Results showed that eNO in children with perennial allergic rhinitis was reduced by nasal budesonide and oral montelukast within 2 weeks (24.56 +/- 14.42 vs 18.42 +/- 12.48, P < 0.001, in budesonide group; 27.81 +/- 13.4 vs 19.09 +/- 10.45, P < 0.001, in montelukast group), but not in the loratadine and cromoglycate groups. In contrast, loratadine or sodium cromoglycate also did not decrease eNO levels although they could decrease the symptom scores. CONCLUSIONS It was concluded that four common treatment modalities could effectively release symptom scores, but decrease of airway inflammation as determined by decrease of eNO might be only achieved by nasal budesonide and montelukast, but not nasal sodium cromoglycate and loratadine. Children with perennial allergic rhinitis with high eNO levels may require oral montelukast or nasal budesonide treatment to prevent airway hyperresponsiveness.
-
8.
Montelukast administered in the morning or evening to prevent exercise-induced bronchoconstriction in children.
Pajaron-Fernandez, M, Garcia-Rubia, S, Sanchez-Solis, M, Garcia-Marcos, L
Pediatric pulmonology. 2006;(3):222-7
Abstract
Montelukast is recommended to be taken in the evening. The effectiveness of this drug to prevent exercise-induced bronchoconstriction (EIB) in children was already evaluated. However, there is no information to determine if this effectiveness could vary depending on dosage time. Children (n = 24) with a documented history of EIB performed an exercise challenge test before starting montelukast treatment. Twelve children were randomly allocated to receive the drug in the morning for 2 weeks, and another 12 to receive it in the evening. After this treatment period and after a week of washout, the children were crossed over. An exercise test was repeated after the first and second periods of treatment. Values obtained after morning or evening dosage were compared with pretreatment values for the whole group of children. There was a significant effect of montelukast for protecting against EIB, measured both as percent of maximum fall in forced expired volume in 1 sec (FEV1) (18.9 +/- 9.7, morning, 18.7 +/- 11.3, evening, vs. 27.5 +/- 9.8, pretreatment; P < 0.05) or as area under the curve (156.4 +/- 102.0, morning, 145.4 +/- 130.6, evening, vs. 294.3 +/- 156.5, pretreatment; P < 0.005). There were no statistical differences between taking the drug in the morning or evening. In conclusion, montelukast, taken for 2 weeks, is equally effective in exercise-induced bronchoconstriction when dosing either in the morning or in the evening.
-
9.
Linear growth in prepubertal asthmatic children treated with montelukast, beclomethasone, or placebo: a 56-week randomized double-blind study.
Becker, AB, Kuznetsova, O, Vermeulen, J, Soto-Quiros, ME, Young, B, Reiss, TF, Dass, SB, Knorr, BA, ,
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology. 2006;(6):800-7
Abstract
BACKGROUND Antileukotrienes and inhaled corticosteroids are asthma controller agents widely used in the treatment of pediatric asthma. OBJECTIVE To evaluate the effects of montelukast and beclomethasone on linear growth in prepubertal asthmatic children for 1 year. METHODS This was a 30-center study of boys (6.4-9.4 years old) and girls (6.4-8.4 years old) at Tanner stage I with mild, persistent asthma. After a placebo run-in period, 360 patients were randomized in equal ratios to double-blind, double-dummy treatment with 5 mg of montelukast, 200 microg of beclomethasone twice daily (positive control), or placebo for 56 weeks; 90% of the patients completed the study. The primary end point was linear growth velocity, measured using a stadiometer. RESULTS Linear growth rates were similar between the montelukast and placebo groups; the mean difference for the year was 0.03 cm. The mean growth rate with beclomethasone was significantly less than with placebo (-0.78 cm) or montelukast (0.81 cm) (P < .001 for both). Median percentage of days with beta-agonist use was greater with placebo (14.58%) vs montelukast (10.55%) or beclomethasone (6.65%) (P < .05 for all). More patients used oral corticosteroid rescue with placebo (34.7%) than with montelukast (25.0%) or beclomethasone (23.5%). An imbalance in bone marker levels was seen with beclomethasone but not with montelukast. CONCLUSION In prepubertal asthmatic children, montelukast did not affect linear growth, whereas the growth rate with beclomethasone was significantly decreased during 1 year of treatment.
-
10.
Montelukast (Singulair) for perennial allergic rhinitis.
Obstetrics and gynecology. 2006;(4):943-4