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Montelukast for Children with Obstructive Sleep Apnea: Results of a Double-Blind, Randomized, Placebo-Controlled Trial.
Kheirandish-Gozal, L, Bandla, HP, Gozal, D
Annals of the American Thoracic Society. 2016;(10):1736-1741
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Abstract
RATIONALE Obstructive sleep apnea (OSA) is highly prevalent in children and is usually treated by adenotonsillectomy. Nonsurgical therapies for OSA consist primarily of antiinflammatory approaches and have gained popularity, but their efficacy remains to be critically examined. OBJECTIVES To determine the effect of montelukast on pediatric OSA. METHODS A prospective randomized double-blind controlled trial of polysomnographically diagnosed OSA in children ages 2-10 years who were treated with either oral montelukast (4 or 5 mg daily) or placebo for 16 weeks. Adherence to the medication was ascertained using automated timed pill dispensers along with weekly telephonic reminders. MEASUREMENTS AND MAIN RESULTS Ninety-two children diagnosed with OSA were approached, and 64 (69.6%) agreed to participate. Of these, 57 (89.0%) completed the 16-week trial, 28 in the montelukast group and 29 in the placebo group. Age, sex, and percentage of obesity were similar in the two groups, as were initial apnea-hypopnea index (AHI) scores. Overall, intention-to-treat analyses revealed that beneficial effects occurred in 20 children receiving montelukast (71.4%), whereas only 2 (6.9%) of the children receiving placebo showed reductions in AHI score (P < 0.001). Indeed, AHI decreased from 9.2 ± 4.1/hour total sleep time (TST) to 4.2 ± 2.8/hour TST (P < 0.0001) in montelukast-treated children, whereas in children receiving placebo, the AHI did not change (from 8.2 ± 5.0/h TST before to 8.7 ± 4.9/h TST at completion of the trial). CONCLUSIONS When compared with placebo, montelukast for 16 weeks effectively reduced the severity of obstructive sleep apnea in children 2-10 years of age. These results support a therapeutic role for leukotriene modifiers in pediatric OSA provided that long-term trials confirm current findings. Clinical trial registered with www.clinicaltrials.gov (NCT 00599534).
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Leukotriene D4 inhalation challenge for predicting short-term efficacy of montelukast: a pilot study.
Guan, WJ, Shi, X, Zheng, JP, Gao, Y, Jiang, CY, Xie, YQ, Liu, QX, Zhu, Z, Guo, E, An, JY, et al
The clinical respiratory journal. 2015;(1):111-20
Abstract
INTRODUCTION The convenient measure to predict efficacy of leukotriene receptor antagonist is lacking. OBJECTIVES To determine if leukotriene D4 inhalation challenge predicts short-term efficacy of montelukast in asthma. METHODS In this open-labelled 28-day trial, 45 patients with asthma were allocated to leukotriene-sensitive and leukotriene-insensitive group to receive montelukast monotherapy (10 mg, once daily) based on the positive threshold of leukotriene D4 inhalation challenge test (4.800 nmol). Miscellaneous measurements comprised fractional exhaled nitric oxide, methacholine inhalation challenge, Asthma Control Test and Asthma Quality of Life Questionnaire. Peak expiratory flow was self-monitored throughout the treatment. End point assessments were performed 3 to 5 days after montelukast withdrawal. RESULTS Twenty-three patients in leukotriene-sensitive group and 10 leukotriene-insensitive group completed the study. Both groups differed neither in 28-day peak expiratory flow rate nor in maximal weekly peak expiratory flow (both P > 0.05). However, minimal weekly peak expiratory flow was significantly higher in leukotriene-insensitive group throughout the treatment course (all P < 0.05) except for week 1 (P > 0.05). Both groups did not differ statistically in the post-treatment improvement in forced expiratory volume in 1 s (FEV1 ) predicted% prior to inhalation challenge, fractional exhaled nitric oxide or the airway responsiveness to leukotriene D4 or methacholine (all P > 0.05). There was a marked increase in Asthma Control Test score and the symptom score of Asthma Quality of Life Questionnaire in both groups (both P < 0.05). The overall significance of Logistic regression model was unremarkable (P = 0.467). CONCLUSION Responsiveness to inhaled leukotriene D4 alone might not be sufficient to predict the short-term efficacy of montelukast monotherapy in patients with asthma.
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Desloratadine-montelukast combination improves quality of life and decreases nasal obstruction in patients with perennial allergic rhinitis.
Cingi, C, Oghan, F, Eskiizmir, G, Yaz, A, Ural, A, Erdogmus, N
International forum of allergy & rhinology. 2013;(10):801-6
Abstract
BACKGROUND The effects of desloratadine-montelukast combination on quality of life (QoL) and nasal airflow of patients with perennial allergic rhinitis (PAR) has not been reported. The objective of this work was investigate the efficacy of desloratadine-montelukast combination on nasal obstruction and health-related quality of life (HRQL) of patients with PAR. METHODS The patients with PAR (n = 40) were assessed using acoustic rhinometry (AcR) and Rhinoconjunctivitis QoL Questionnaire (RQLQ) before therapy. Desloratadine-montelukast fixed-dose combination treatment was applied to every patient once daily. The AcR and RQLQ score were reevaluated at the first and third months; and statistical comparison of pretreatment and posttreatment results was performed. RESULTS Nasal symptoms and signs such as itching, sneezing, discharge, congestion, and edema, and color change of turbinates have been decreased after treatment. In AcR, minimum cross-sectional area (MCA) measurements and volume results were increased after the treatment. Correlation was found between the volume results and nasal discharge and/or congestion in right nasal passages. In left nasal passages, statistical relation was observed between the MCA and itching and/or change of turbinate color (p < 0.05). A significant decrease in the overall RQLQ score was determined at the first and third months of therapy. The difference between scores at baseline and end of the first and third months for all domains was statically significant (p < 0.001). The treatment difference in change from the first month to the end of the third month was statistically significant (p < 0.05). CONCLUSION Desloratadine-montelukast combination therapy causes subjective and objective decrease in nasal obstruction, reduces the other symptoms of PAR and improves the disease-specific QoL.
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Urinary leukotriene E4/exhaled nitric oxide ratio and montelukast response in childhood asthma.
Rabinovitch, N, Graber, NJ, Chinchilli, VM, Sorkness, CA, Zeiger, RS, Strunk, RC, Bacharier, LB, Martinez, FD, Szefler, SJ, ,
The Journal of allergy and clinical immunology. 2010;(3):545-51.e1-4
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Abstract
BACKGROUND A subset of children with asthma respond better to leukotriene receptor antagonists than to inhaled corticosteroids. Information is needed to identify children with these preferential responses. OBJECTIVE We sought to determine whether the ratio of urinary leukotriene E(4) (LTE(4)) to fractional exhaled nitric oxide (FE(NO)) delineates children with preferential responsiveness to montelukast compared with fluticasone propionate (FP) therapy. METHODS Data from 318 children with mild-to-moderate asthma enrolled in 2 National Heart, Lung, and Blood Institute Childhood Asthma Research and Education Network studies (Characterizing the Response to a Leukotriene Receptor Antagonist and an Inhaled Corticosteroid [CLIC] and the Pediatric Asthma Controller Trial [PACT]) were analyzed. The association between LTE(4)/FE(NO) ratios at baseline and improved lung function or asthma control days (ACDs) with montelukast and FP therapy was determined, and phenotypic characteristics related to high ratios were assessed. RESULTS LTE(4)/FE(NO) ratios were associated with a greater response to montelukast than FP therapy for FEV(1) measurements (2.1% increase per doubling of ratio, P = .001) and for ACDs per week (0.3-ACD increase, P = .009) in the CLIC study. In PACT the ratio was associated with greater ACD responsiveness to MT than FP therapy (0.6 ACD increase, P=.03) [corrected]. In a combined study analysis, LTE(4): FE(NO) ratios were associated with greater response to MT than FP therapy for FEV(1) (1.8% increase, P =.0005) and ACDs (0.4 increase, P =.001)[corrected].Children with LTE(4)/FE(NO) ratios at or above the 75th percentile were likely (P < .05) to be younger and female and exhibit lower levels of atopic markers and methacholine reactivity. CONCLUSION LTE(4)/FE(NO) ratios predict a better response to montelukast than FP therapy in children with mild-to-moderate asthma.
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Quality of life in patients with persistent allergic rhinitis treated with montelukast alone or in combination with levocetirizine or desloratadine.
Ciebiada, M, Ciebiada, MG, Kmiecik, T, DuBuske, LM, Gorski, P
Journal of investigational allergology & clinical immunology. 2008;(5):343-9
Abstract
BACKGROUND Persistent allergic rhinitis often impairs quality of life. OBJECTIVE We assessed the extent to which treating persistent allergic rhinitis with montelukast, desloratadine, and levocetirizine alone or in combination improved quality of life. METHODS A 32-week randomized, double-blind, placebo-controlled, crossover study was performed in 2 arms: 20 patients received montelukast 10 mg/d and/or desloratadine 5 mg/d or placebo; 20 patients received montelukast 10 mg/d and/or levocetirizine 5 mg/d or placebo. The treatment periods were separated by 2-week washout periods. Quality of life was assessed on the day before starting treatment and on the last day of each treatment period using the Rhinoconjunctivitis Quality of Life Questionnaire. Sleep problems were also assessed. RESULTS In the desloratadine plus montelukast arm, the mean (SEM) quality of life score before treatment was 3.1 (0.41). After placebo, this score was 2.16 (0.43), after desloratadine it was 1.79 (0.38), after montelukast it was 1.48 (0.37), and after montelukast plus desloratadine it was 1.59 (0.37). In the montelukast plus levocetirizine arm, the mean quality of life score before treatment was 2.58 (0.49). After placebo it was 1.78 (0.46), after levocetirizine it was 1.38 (0.42), after montelukast it was 1.36 (0.37), and after montelukast plus levocetirizine it was 1.26 (0.39). CONCLUSIONS Placebo, montelukast, desloratadine and levocetirizine significantly improved quality of life. Combining montelukast with either levocetirizine or desloratadine gave additional benefits in comparison to each agent alone and could be considered for patients whose quality of life is impaired by persistent allergic rhinitis.
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Efficacy of montelukast and loratadine as treatment for allergic rhinitis in children.
Watanasomsiri, A, Poachanukoon, O, Vichyanond, P
Asian Pacific journal of allergy and immunology. 2008;(2-3):89-95
Abstract
The objective of this study was to compare the effectiveness of montelukast combined with loratadine once daily to loratadine alone for a 2-week treatment course of allergic rhinitis in a randomized, double-blind placebo controlled trial which enrolled 115 children, 6- 15-years-old. The patients were randomly assigned to receive montelukast and loratadine (treatment group) or placebo and loratadine (control group). The primary outcome was the mean percent change of the total daytime nasal symptom scores (PDTS) and secondary outcomes were the mean percent changes of the nighttime nasal, daytime eye and composite symptom scores (PNTS, PES, PCS), as well as the nasal secretion, turbinate swelling and nasal congestion scores (PNSS, PTSS, PNCS). There were no significant differences in the PDTS of the 2 groups. The change in the night time nasal congestion score (PNTS-congestion) was higher in the treatment group, but not statistically significant (p = 0.077). Only the mean percent change in decreased turbinate swelling was significantly greater in the montelukast and loratadine group than the loratadine alone group (-22 +/- 7 vs. -1 +/- 5, p < 0.05).
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Urticaria unresponsive to antihistaminic treatment: an open study of therapeutic options based on histopathologic features.
Criado, RF, Criado, PR, Martins, JE, Valente, NY, Michalany, NS, Vasconcellos, C
The Journal of dermatological treatment. 2008;(2):92-6
Abstract
BACKGROUND The non- or low-sedating H1 receptor antagonists represent the basic therapy for urticaria. OBJECTIVE To test an alternative approach to patients unresponsive to conventional treatment. MATERIALS AND METHODS A total of 22 patients with chronic urticaria unresponsive to conventional antihistamine treatment were enrolled for this study. They had uncontrolled urticaria even using multiple combinations of antihistamines on maximum doses and corticosteroids in short cycles (prednisone 20-40 mg, per os once a day, 3-7 days per month). Cutaneous biopsies of the urticaria lesions were taken. These findings were classified as: (I) a mixture of perivascular dermal inflammatory infiltrate composed of lymphocytes, monocytes and neutrophils and/or eosinophils; (II) inflammatory infiltrate composed chiefly of neutrophils; and (III) inflammatory infiltrate composed mainly of eosinophils. According to histology, the patients were submitted to one of the following therapeutic schemes: class A - antihistamine treatment plus dapsone; class B - colchicine or dapsone; class C - montelukast. RESULTS Four patients in class A, 08 in class B and seven in class C displayed complete control of urticaria after 12 weeks of treatment; one patient in class B and two in class C did not respond to treatment. Two years after discontinuation, 16 patients are still free of urticaria. CONCLUSIONS This study suggests an alternative approach for treating unresponsive chronic urticaria.
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Leukotriene receptor antagonists: a good choice in the treatment of premenstrual asthma?
Pasaoglu, G, Mungan, D, Abadoglu, O, Misirligil, Z
The Journal of asthma : official journal of the Association for the Care of Asthma. 2008;(2):95-9
Abstract
The aim of this study was to investigate the effects of leukotriene receptor antagonists (LTRAs) on the premenstrual exacerbation of asthma (PMA). Twenty-four female patients with mild asthma were enrolled in the study. Patients were followed for three menstrual cycles and separated into two groups based on whether they exhibit premenstrual worsening of asthma symptoms (n = 11) or not (n = 13). During the first month all were treated with only inhaled steroids (IS) (run-in period); during the second month they received IS plus placebo; and during the third month they were given IS plus montelukast. Furthermore, they were advised to use beta(2)-agonists as needed. Peak expiratory flow rate (PEFR) and symptom scores were recorded during the 3 months. Pulmonary function tests (PFT) and the levels of oestrogen, progesterone, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) were measured a week before the beginning of the menstrual period. At the end of the 3-month period, it was observed that following therapy with montelukast, the patients with PMA showed significant improvement in PEFR variability and symptom scores when compared with the placebo group. Baseline FSH levels were higher, but FSH and other hormone levels and PFTs did not change in these groups. However, in the group without PMA there was no difference between the montelukast or placebo groups in PEFR variability, symptom scores, PFTs, and hormone levels. Based on the data in hand, it could be stated that LTRAs have ensured the control of symptoms and improved PEFR variability in patients with PMA by suppressing inflammation. We are of the view that LTRAs would be a right choice in the treatment of patients with PMA.
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Real-life effectiveness of Singulair (montelukast) in 506 children with mild to moderate asthma.
Amirav, I
The Israel Medical Association journal : IMAJ. 2008;(4):287-91
Abstract
BACKGROUND Based on the outcome of several randomized controlled trials, the orally active leukotriene receptor antagonist montelukast (Singulair, Merck) has been licensed for treatment of asthma. The drug is favored for treating childhood asthma, where a therapeutic challenge has arisen due to poor compliance with inhalation therapy. OBJECTIVES To assess the efficiency of and satisfaction with Singulair in asthmatic children under real-life conditions. METHODS Montelukast was prescribed for 6 weeks to a cohort of 506 children aged 2 to 18 years with mild to moderate persistent asthma, who were enrolled by 200 primary care pediatricians countrywide. Four clinical correlates of childhood asthma--wheeze, cough, difficulty in breathing, night awakening--were evaluated from patients' diary cards. RESULTS Due to under-treatment by their physicians, almost 60% of the children were not receiving controller therapy at baseline. By the end of the study, which consisted of montelukast treatment, a significant improvement over baseline was noted in asthma symptoms and severity, as well as in treatment compliance. The participating pediatricians and parents were highly satisfied with the treatment. CONCLUSIONS The results of this extensive study show that the use of montelukast as monotherapy in children presenting with persistent asthma resulted in a highly satisfactory outcome for themselves, their parents and their physicians.
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Effects of montelukast on subjective and objective outcome measures in preschool asthmatic children.
Moeller, A, Lehmann, A, Knauer, N, Albisetti, M, Rochat, M, Johannes, W
Pediatric pulmonology. 2008;(2):179-86
Abstract
It is well accepted that control of airway inflammation is crucial for overall asthma control. Hence, efficient anti-inflammatory therapy is important for disease control. Therefore, we studied the effect of a treatment with montelukast on subjective and objective measures in preschool asthmatic children with insufficient control of airway inflammation, illustrated by increased fractional exhaled nitric oxide (FeNO). Thirty-one preschool children (2.5-5 years) were included in this study. Children with FeNO > or = 10 ppb at the first visit received montelukast 4 mg as a first line therapy or an add-on therapy to their baseline treatment (group 1). Therapy was not changed at first visit in children with FeNO < 10 ppb (group 2). Symptom scores, FeNO, lung function (forced oscillation, Rrs8Hz) and airway responsiveness to adenosine 5'-monophosphate (AMP) were assessed at visits 1 and 2 eight weeks apart. There was a significant decrease in FeNO (median [interquartile range]; 12.9 [3.7] vs. 7.6 [6.85] ppb, P = 0.011), Rrs8Hz (mean +/- SD; 10.03 +/- 3.1 vs. 8.72 +/- 2.43 hPa.s/L; P = 0.047) and symptom scores (2[2] vs. 1.5[2], P = 0.034) and a significant increase in the provocative AMP dose (2.65 +/- 2.1 vs. 4.54 +/- 1.05; P = 0.015) in group 1 but not in group 2. First line or add-on treatment of oral montelukast in preschool children with mild to moderate asthma and elevated FeNO, decreased levels of FeNO, improved airway responsiveness to AMP, lung function and symptom scores.