Montelukast Group Research Articles

Montelukast as an effective adjuvant in the treatment of moderate acne vulgaris.

Although antibiotics are among the most commonly used treatments of acne, there are refractory cases, or they can cause some complications. Recently, leukotriene B4 has been found to play a major role in inflammatory acne lesions. This double blind, randomized clinical trial was conducted on 108 patients with acne who needed systemic therapy and referred to dermatology clinics affiliated to Shiraz University of Medical Sciences. One group (53 patients) received 100 mg doxycycline daily plus placebo and the other group (55 patients) received 100 mg daily doxycycline plus 10mg daily montelukast. Both groups also received topical benzoyl peroxide 5% every other night. The study period was 3 months and the patients were investigated by lesion count, investigator global assessment (IGA), global acne grading system (GAGS), and Cardiff acne disability index (CADI) scoring systems. Total lesion count, inflammatory lesion count, and non-inflammatory lesion count as well as IGA and GAGS decreased in both treatment groups. At the end of the study, however, the inflammatory lesion count and IGA score reduced more significantly in the montelukast group (p=0.018 and 0.045, respectively). In addition, the two groups were significantly different with regard to the percentage of decrease in the total lesion count, inflammatory lesions, and IGA (p=0.033, 0.003, and 0.044, respectively). Thus, montelukast can be used as an adjuvant therapy besides other treatments of acne, especially for inflammatory lesions.

Comparison of Cromolyn Sodium, Montelukast, and Zafirlukast Prophylaxis for Capsular Contracture.

Capsular contracture is the most common complication following breast augmentation. Recently, prophylaxis studies aiming to inhibit the release of profibrotic substances to prevent capsular contracture have gained in importance. This study investigated the effects of cromolyn sodium, montelukast, and zafirlukast on capsular contracture in a rat model. Thirty female Wistar albino rats were randomly divided into five groups: control, sham, cromolyn sodium, montelukast, and zafirlukast. Intraperitoneal injections were administered daily to the sham (1 ml per day), cromolyn sodium (10 mg/kg per day), montelukast (10 mg/kg per day), and zafirlukast (1.25 mg/kg per day) groups 1 month before surgery. Miniature breast implants were then placed on the backs of the rats in each group. Injections were continued for the next 3 months. The rats were subsequently killed, and the capsules were harvested and assessed histopathologically. The histopathologic outcomes were acute inflammation status, inflammation severity, synovial metaplasia, foreign body reaction, mast cell count, and capsular thickness. The cromolyn sodium, montelukast, and zafirlukast groups had less acute inflammation and lower mean inflammation severity scores, foreign body reaction occurrence, mast cell counts, and capsular thickness than the control and sham groups ( p < 0.05). These parameters were better in the cromolyn sodium group than in the montelukast and zafirlukast groups ( p < 0.05). Cromolyn sodium appears to inhibit capsular contracture more efficiently than montelukast and zafirlukast. This report may be a pioneer study for the prophylactic use of cromolyn sodium in capsular contracture. The prophylactic administration of cromolyn sodium appears to reduce capsular contracture more efficiently than that of montelukast and zafirlukast. This report might constitute a pioneer study for the prophylactic use of cromolyn sodium in capsular contracture.

Combined anti-mediator therapy for severe destructive forms of acute necrotizing pancreatitis in rats

Introduction: Inflammatory mediators play a major role in pathogenesis of acute pancreatitis with TNF (tumor necro­sis factor) as the most important one. Development of effective combined therapy could help to decrease tissue damage, improve results and, finally, diminish the mortality rate in this severe pathology.&#x0D; Materials and methods: All the studies were performed on 120 female white Wistar rats, weighing 250±25g. Acute pancreatitis reproduced by an intracanalicular injection of bile salts compound.&#x0D; Results and discussion: The data obtained in the course of the study on the pronounced pancreatoprotective effect of infliximab are explained by its key role in the onset of the systemic inflammatory response, and, therefore, with the blockade of tumor necrosis factor alpha in the early stages, there is no pronounced secondary damage to the pancreas, which is reflected in a significant decrease in edema from 4.87±0.03 in the model up to 2.75±0.04, and as a conse­quence, an improvement in the blood supply of the acinar tissue from 182.38±15.92 PU up to 287.92±14.64 PU, which is expressed in a decrease in the zones of necrosis and in a decrease in mortality and, finally, efficiency coefficient from 13480.000 to 4283.348. A selective blocker of cysteinyl leukotrienes has a less pronounced protective reaction against damage to pancreatocytes, but to a much greater extent than octreotide. That is expressed by changes in the efficiency coefficient to the level of 8621.18 in montelukast group and 12767.30 in octreotide group, respectively. On the other hand, the effect of the use of infliximab does not surpass that of montelukast, and their combined use has a pronounced additive effect, which is proved by the efficiency coefficient at the level of 2390.33. This reaction is explained by the fact that TNF alpha-mediated pathway of activation of leukotriene biosynthesis is the main, but not the only one.&#x0D; Conclusion: The combined anti-mediator therapy provides a great opportunity to improve the standard therapy of acute pancreatitis.

A Comparative Study of Montelukast and Azelastine add on Therapy in Moderate to Severe Allergic Rhinitis Treatment: A Double-Blind Randomized Clinical Trial.

Allergic Rhinitis (AR) is a prevalent chronic inflammatory nasal condition with significant negative effects on the patients' quality of life. This study aimed to investigate the efficacy of Montelukast and intranasal antihistamine in combination with intranasal corticosteroid (INCS) in moderate to severe allergic rhinitis on the patients' quality of life and AR control. This double-blind randomized clinical trial study was carried out on 66 moderate to severe AR patients referred to Namazi Hospital, Shiraz, Iran from 2020 to 2021, who were randomly divided into 3 groups. Group one received Montelukast add-on therapy and Budesonide nasal spray. The second group received intranasal antihistamine (Azelastine) add-on therapy and Budesonide nasal spray and the third group as the control group received intranasal Budesonide spray with a placebo tablet.To measure the impact of each medication on the patient's quality of life and AR control, we employed the Sino-Nasal Outcome Test-22 questionnaire (SNOT 22). We evaluated the symptoms and compared them at baseline, one and three months after the start of treatments. Spirometry was performed to investigate the possibility of co-morbid asthma at baseline and end of the study. The patients' mean age was 30.13 ± 12.7 years. Most patients experienced perennial AR (65.2%). Reduction of mean scores SNOT22 was statistically different between groups (P-value < 0.001). Three months after treatment, the mean decrease of SNOT-22 in the Azelastine group was statistically significant compared to both Montelukast (P-value < 0.001) and control groups (P-value < 0.001). No significant difference was observed between the Montelukast and control groups (P-value = 0.142). 23 of 66 patients were diagnosed with asthma and asthma treatment was initiated. The amount of FEV1 change after AR treatment was not statistically significant between the groups in asthmatic patients (P-value = 0.351). Based on our findings, we recommend Azelastine in conjunction with an intranasal corticosteroid for the treatment of moderate to severe allergic rhinitis. In moderate to severe AR or even asthma management, Montelukast has no greater impact than INCS.

Comparison of C-reactive protein and Vitamin D3 level among Patients of Allergic Rhinitis while on treatment with either Nasal Fluticasone or Combination Therapy of Montelukast and Levocetirizine: A Randomized Control Study

We conducted the present study to compare the vitamin D3 status and C-reactive protein (CRP) among allergic rhinitis patients who were on treatment with either intranasal Fluticasone or oral Levocetrizine and Montelukast therapy. Material and Methods: The study was a prospective randomized, single blinded, comparative, parallel group study, with two intervention groups conducted at Civil Hospital Jogindernagar of Himachal Pradesh, India. A total of Fifty patients diagnosed with allergic rhinitis was randomly allocated to either Group A receiving oral Montelukast and Levocetrizine or Group B receiving Fluticasone propionate aqueous nasal spray and followed up for 6 weeks. Vitamin D status and C-reactive protein (CRP) after 6 weeks was taken as primary outcome variables. Results: Among Group A , Recovery at 6 weeks was occurred in 9 (36%) patients while in Group B Recovery at 6 weeks was occurred in 17(68 %) patients.(p value 0.046). There was statistically significant lower mean CRP level was found in group B as compared to Group A (p value 0.003). Although, lower mean Vit D3 level was found in group B as compared to Group A but this difference was not found to be statistically significant. (p value 0.218). Although, lower mean CRP and higher mean Vit D3 level was found in recovered patients in group A as compared to who were not recovered but this difference was not found to be statistically significant(p value 0.198 and 0.324 respectively). Similarly,higher mean CRP and Vit D3 level was found in recovered patients in group B as compared to who were not recovered but this difference was not found to be statistically significant.( p value 0.804 andp value 0.418). Similarly ,in recovered patients there was no statistical significant difference in mean CRP and Vit D3 level(P value 0.9536 and 0.2486 respectively) in both groups, although the mean CRP and Vit D3 level were higher in Group A as compared to group B. But in non recovered patients, the mean CRP level was statistically higher in Group A as compared to group B(P value0.0029) while there was no statistical significant difference in Vit D3 level in both groups.(p value-0.8919). Conclusion: Study concluded that there was no statistical significant difference in mean Vitamin D3 and CRP levels in both groups as well as there was no significant association between Vitamin D3 and CRP levels and recovery status of patients in both groups.

Montelukast suppresses the development of irritable bowel syndrome phenotype possibly through modulating NF-κB signaling in an experimental model.

Irritable bowel syndrome (IBS) is a functionalgut disorder with multi-factorial pathophysiology that causes recurring pain or discomfort in the abdomen, as well as altered bowel habits. Montelukast, a well-known cysteinyl leukotriene receptor 1 (CysLT1R) antagonist, is widely used for the anti-inflammatory management of asthma. The present study aimed to evaluate the effects of pharmacological inhibition of CysLT1R on acetic acid-induced diarrhea-predominant IBS (D-IBS) in rats. Behavioral pain responses to noxious mechanical stimulation were decreased in the montelukast-treated rats as compared to the model animals following colorectal distension (CRD)-induced visceral hypersensitivity. Stool frequency decreased dose-dependently by montelukast in IBS rats exposed to restraint stress. A significantly shorter immobility time was also observed in IBS rats who received montelukast vs IBS group in the forced swimming test (depression-like behavior). Furthermore, there were significant decreases in the NF-κB protein expression, inflammatory cytokine (TNF-α, and IL-1ß) levels, and histopathological inflammatory injuries concomitant with increased anti-inflammatory cytokine, IL-10, in montelukast-treated rats compared with the IBS group. Cysteinyl leukotriene production and CysLT1R mRNA expression showed no remarkable differences among the experimental groups. The present results suggest the possible beneficial effects of montelukast in the management of D-IBS symptoms. The molecular mechanismunderlying such effects, at least to some extent, might be through modulating CysLT1R-mediated NF-κB signaling. Yet, more studies are required to demonstrate the clinical potential of this drug for IBS therapy.

Effect of montelukast therapy on clinical course, pulmonary function, and mortality in patients with COVID-19.

The inflammatory/anti‐inflammatory balance has an important role in the clinical course of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) (coronavirus disease [COVID‐19]) infection, which has affected over 200 million people since it first appeared in China in December 2019. This study aimed to determine the effectiveness of montelukast, which has known anti‐inflammatory and bronchodilatory effects, in these patients. The prospective randomized controlled study included 180 patients who were hospitalized in the infectious diseases department of our hospital between May and July 2021 and were diagnosed with the delta variant of SARS‐CoV‐2 by real‐time polymerase chain reaction of nasopharyngeal swabs. The patients were divided into three groups and received only standard treatment according to national guidelines (Group 1) or standard treatment plus 10 mg/day montelukast (Group 2) or 20 mg/day montelukast (Group 3). Laboratory parameters and pulmonary function tests (PFTs) at admission and on Day 5 of treatment were compared. Comparison of laboratory parameters on Day 5 showed that Groups 2 and 3 had significantly lower levels of lactate dehydrogenase, fibrinogen, D‐dimer, C‐reactive protein, and procalcitonin compared with Group 1 (p = 0.04, 0.002, 0.05, 0.03, and 0.04, respectively). In the comparison between Groups 2 and 3, only fibrinogen was significantly lower in Group 3 (p = 0.02). PFT results did not differ between the groups at admission, while on Day 5, only Group 3 showed significant improvements in forced expiratory volume in 1 s, forced vital capacity, and peak expiratory flow 25–75 compared with admission (p = 0.001 for all). Montelukast may be beneficial in COVID‐19 patients to maintain the inflammatory/anti‐inflammatory balance, prevent respiratory failure through its bronchodilator activity, and reduce mortality.

Relationship between montelukast and behavioral problems in preschool children with asthma.

There is insufficient clarity regarding whether or not drugs used in asthma cause behavioral problems in children. A total of 155 individuals, categorized into an asthma group (n = 95) and a control group (n = 60), were enrolled in the current prospective controlled study. The asthma group consisted of patients receiving treatment (inhaled corticosteroids [ICS] or montelukast) for at least 1 month. Check Behavior Checklist (CBCL) for ages 1.5-5 scores for the asthma and controls were compared. The asthma group was divided into two subgroups based on prophylactic therapy received, ICS and montelukast, and these groups' CBCL scores were also compared. The asthma group consisted of 95 children (ICS subgroup 45, montelukast subgroup 50) and the healthy control group of 60 cases. The mean total CBCL score was higher in the asthma group than in the control group (42 vs 32, respectively, P = 0.001). Internalization and externalization scores were also higher in the asthma group compared to the control group (P = 0.004 and P = 0.005, respectively). No significant difference was determined in terms of CBCL scores between the ICS and montelukast groups (P = 0.3). Montelukast was discontinued in one asthmatic child due to hallucination. This study determined a higher rate of behavioral problems in preschool children with asthma compared to healthy children. In contrast to other studies in the literature, we determined no difference in terms of total CBCL, and internalization and externalization scores of children with asthma who received ICS and montelukast. Nevertheless, it should be kept in mind that montelukast may cause serious neuropsychiatric events such as hallucination.

Deprescribing montelukast in children with asthma: a systematic review

BackgroundNational and international asthma guidelines recommend adjusting asthma treatment based on levels of control, yet no guidance is given regarding the stepping-down of montelukast in children and young people (CYP).ObjectiveTo...

D-Pinitol Attenuated Ovalbumin-induced Allergic Rhinitis in Experimental Mice via Balancing Th1/Th2 Response.

Allergic rhinitis (AR) is a complex, chronic immunoinflammatory disorder of the membrane lining of the nasal mucosa. D-Pinitol is considered a cyclic polyol with a potential effect against various allergies. In the present study, we evaluated the anti-allergic effect of pinitol on ovalbumin (OVA)-induced AR model in mice. BALB/c mice were initially sensitized with an intraperitoneal injection of OVA and divided into 5 groups (n=18, in each group) for a treating schedule of distilled water (DW), montelukast (10 mg/kg), and pinitol (5, 10, and 20 mg/kg) through the mouth. Two saline-injected groups were considered as controls by orally administrating DW and pinitol 20. Thereafter, test and control groups were intranasally challenged by OVA and saline, respectively. Our results showed that the OVA challenge caused a marked elevation in AR symptoms like nasal rubbing, sneezing, and discharge which were remarkably diminished using pinitol (10 and 20 mg/kg) and the results were comparable with montelukast. Additionally, increased levels of total and OVA-specific serum Immunoglobulin (Ig) E and IgG1 were significantly attenuated by pinitol as compared to the control group but not the montelukast group. In AR-induced mice, pinitol had significant modulatory effects on representative markers of Th2 (GATA binding protein 3), signal transducer and activator of transcription-6, Interleukins (IL)-4, IL-5, IL-13, suppressors of cytokine signaling 1, Toll-like receptor 4, and myeloid differentiation factor 88), and Type 1 T helper (Th1) immune responses (T-box protein expressed in T cells and Interferon-gamma) as well as the histopathological aberrations induced in the nasal mucosa. In conclusion, Pinitol had potential effects on OVA-induced AR mice through amelioration of nasal symptoms and balancing the Th1/Th2 immune responses during the allergic rhinitis condition.

Efficacy, tolerability, and safety of montelukast versus finasteride for the treatment of moderate acne in women: A prospective, randomized, single-blinded, active-controlled trial.

Acne is a chronic inflammatory skin disease which involves the pilosebaceous unit. Tissue inflammation isone of the crucial mechanisms, amongst others. Of the various cytokines, leukotriene B4 (LT-B4) is the most potentleucocyte chemotactic mediator. Montelukast is an antagonist of the LT-B4 receptor. Finasteride is an antiandrogen whichspecifically inhibits the 5α-reductase enzyme. This study aimed at comparing the efficacy, tolerability and safety of montelukast versus finasteride in the treatmentof moderate acne in women. This randomized, single-blinded, prospective trial over 12weeks recruited 65 female subjects with moderate acne vulgaris (Global Acne Grading System Scale) for evaluation. One group (n=30) received oral montelukast (10mg PO daily), while the second group (n=25) received oral finasteride (2.5mg PO daily) in combination with topical clindamycin 2% solution. Lesion count and acne severity were evaluated at time intervals of 0 (baseline), 4, 8, and 12weeks. Adverse effects of the drugs were noted. Both lesion count and severity of acne decreased significantly after treatment in both the groups as compared to the baseline. The acne severity score reached from 33.93 in time zero to 20.6 in the 12th week and 35.71 at baseline to 16.43 at the end of treatment in the Montelukast and Finasteride groups, respectively. Side effects were noted in 3 patients and 2 patients in the monteleukast and finasteride group, respectively, which were transient and non-serious in nature proving the satisfactory tolerability and safety of these two drugs. The results of this study show that both montelukast and finasteride have good efficacy in the treatment of acne. Finasteride has more efficacy than montelukast for treating moderate acne in normo-androgenic women.

Treatment of pediatric mild persistent asthma with low-dose budesonide inhalation suspension vs. montelukast in China.

There are limited studies comparing budesonide inhalation suspension (BIS) withmontelukast in real-world settings where treatment adherence and persistency may be suboptimal. This real-world study aims to investigate the control effectiveness of montelukast or BIS as amonotherapy in Chinese children with mild asthma. Data were derived from a retrospective questionnaire-based analysis of 2‒14-year-old children with mild persistent asthma, who received either 500 µg of BIS (n = 153) or 4‒5mg of montelukast (n = 240) once daily. The indicators of asthma control, the Asthma Control Test (ACT)/Childhood ACT (C-ACT) score, and the asthma-related medical costs were assessed. The differences between the two groups were compared using an unpaired t-test (normally distributed), Mann-Whitney U test (non-normally distributed) or chi-squared test (categorical variables). Medication compliance in the past 3-month period was better in the montelukast group than in the BIS group (P = 0.042). The montelukast group exhibited better asthma control in the past 4-week period, including lower percentages of asthmatic children with symptoms more than twice a week (P = 0.021), had night waking or night coughing (P = 0.022), or required reliever medication more than twice a week (P < 0.001). The montelukast group had a lower percentage of children with an ACT/C-ACT score ≤ 19 (P = 0.015). Caregivers reported a significantly better exercise tolerance in the children who received montelukast vs. BIS in the past 12months (P < 0.001). Significantly higher medical expenditures attributable to asthma in the past 12months were observed in the BIS group vs. montelukast group (P < 0.001). Both treatments provided acceptable overall asthma control in children with mild persistent asthma; however, more reliever medication and more medical expenditures attributable to asthma were needed for BIS vs. montelukast in real-world settings, where factors such as compliance were also taken into account.

What Is the Effect of Pre-Emptive Oral Montelukast on Postoperative Pain Following Bimaxillary Orthognathic Surgery? A Triple-Blind Randomized Clinical Trial

The aim of this study was to assess the effect of preoperative administration of oral montelukast on the amount of postoperative pain following bimaxillary orthognathic surgery. All healthy skeletal class III deformity candidates for bimaxillary orthognathic surgery were included in this triple-blind randomized clinical trial. The subjects were randomly divided into placebo and montelukast groups. One hour before the surgery, a 10 mL of apple juice was given to each and every patient; however, a 10 mg tablet of montelukast was dissolved in the juice for the intervention group. All operations were performed by the same surgical team, under the same general anesthesia protocols. The outcome variable was the amount of postoperative pain (1-, 3-, 6-, 12-, 18-, and 24-hour intervals) which was measured during the first 24 hours using a Visual Analog Scale. For statistical analysis, the significance level was set at 0.05 using SPSS 23. A total of 60 consecutive patients, comprising 31 females (51.7%) and 29 males (48.3%) with an average age of 25.2 ± 2.2 were recruited. The average surgical duration was 193 ± 28.0 minutes. In general, pain intensity exhibited an increasing trend from the first hour postoperatively, reaching its peak in the 12th hour and decreasing thereafter. Nevertheless, the average amount of pain was significantly higher in the placebo group compared with the montelukast group, in all the studied time intervals (P < .05). The number of patients who required postoperative opioid analgesics was significantly higher in the placebo group compared to the montelukast group (P=.024). Moreover, the duration of surgery had a direct and significant effect on the postoperative pain intensity (P < .001). It might be concluded that preoperative administration of montelukast is effective in reducing postoperative pain following bimaxillary orthognathic surgery. Further studies are necessary for more relevancy.

Anti-Allergic Drug Suppressed Pancreatic Carcinogenesis via Down-Regulation of Cellular Proliferation.

Pancreatic cancer is a fatal disease, and thus its chemoprevention is an important issue. Based on the recent report that patients with allergic diseases have a low risk for pancreatic cancer, we examined the potential chemopreventive effect of anti-allergic agents using a hamster pancreatic carcinogenesis model. Among the three anti-allergic drugs administered, montelukast showed a tendency to suppress the incidence of pancreatic cancer. Further animal study revealed a significantly decreased incidence of pancreatic cancer in the high-dose montelukast group compared with controls. The development of the pancreatic intraepithelial neoplasia lesions was also significantly suppressed. The Ki-67 labeling index was significantly lower in pancreatic carcinomas in the high-dose montelukast group than in controls. In vitro experiments revealed that montelukast suppressed proliferation of pancreatic cancer cells in a dose-dependent manner with decreased expression of phospho-ERK1/2. Montelukast induced G1 phase arrest. Conversely, leukotriene D4 (LTD4), an agonist of CYSLTR1, increased cellular proliferation of pancreatic cancer cells with an accumulation of phospho-ERK1/2. In our cohort, pancreatic ductal adenocarcinoma patients with high CYSLTR1 expression showed a significantly unfavorable clinical outcome compared with those with low expression. Our results indicate that montelukast exerts a chemopreventive effect on pancreatic cancer via the LTD4–CYSLTR1 axis and has potential for treatment of pancreatic carcinogenesis.

Efficacy of montelukast in preventing seasonal recurrence of vernal keratoconjunctivitis in children.

Vernal keratoconjunctivitis is a chronic, seasonally exacerbated, allergic inflammation of the eye. The study aims to evaluate the efficacy and safety of oral montelukast in treating vernal keratoconjunctivitis in pediatric patients. This is a 26-week, prospective, randomized, open-label study. Fifty-eight patients were randomly assigned to two groups-the treatment (montelukast) and control groups. At the beginning of the study, both the groups received topical loteprednol etabonate (0.1%) in tapering doses for a month, and topical olopatadine (0.1%) for the first 3 months. Symptoms and signs observed before and after treatment and assigned scores were studied. The primary efficacy endpoint was change in the mean score on the visual analog scale (VAS) for each subjective symptom. The secondary efficacy endpoint was change in the total score of objective signs. The montelukast group showed clinically relevant improvements in the signs and symptoms of vernal keratoconjunctivitis, compared to the control group. There was considerable improvement in clinical signs. Individual symptoms such as redness, itching, foreign body sensation, and tearing showed significant improvement at 6 months follow-up. The gradual improvement in symptoms until the last visit was statistically more significant within montelukast group. Mean VAS score showed statistically significant improvement in itching (p < 0.001) and redness (p < 0.008) in montelukast group even at 3 months. No adverse events were reported in either group. Montelukast was found to be safe and effective as a long-term therapy to prevent relapse in moderate to severe vernal keratoconjunctivitis.

Effects of using montelukast during acute wheezing attack in hospitalized preschool children on the discharge rate and the clinical asthma score.

In chronic asthma treatment, leukotriene receptor antagonists have been recommended, but it is not clear whether montelukast can be used in acute recurrent wheezing attacks in children. To investigate the safety and effectiveness of oral montelukast in addition to standard treatment in hospitalized children aged between 6 and 72 months with acute recurrent wheezing attacks. One hundred patients aged between 6 and 72 months who had wheezing attacks with clinical asthma scores (CAS) ≥3 and were hospitalized were included in this randomized, double-blind, placebo-controlled, parallel-group clinical trial. All the patients included in the study were given 0.15 mg/kg (maximum 5 mg) nebulized salbutamol (8 L/min and with 100% O2 ) with 4 hof intervals, 1 mg/kg prednisolone (maximum 5 days), nebulized ipratropium bromide (total eight doses) with 6 hof intervals. In addition to this treatment, one group received 4 mg montelukast, and the other group received a placebo. The CASof the patients were evaluated with 4-hintervals. Total hospital length of stay (LOS) was not different between the montelukast and placebo groups (p = 0.981). There was no statistically significant difference between the two treatment groups in terms of discharge time, CAS, and oxygen saturation (p ≥ 0.05). Adding montelukast to standard treatment in patients hospitalized for moderate-to-severe wheezing attacks did not affect hospital LOS and CAS.

Effects of salbutamol, montelukast and prednisone on orthodontic tooth movement in rats

Objective: To evaluate the effect of salbutamol, montelukast, and prednisone on orthodontic tooth movement in rats. Material and Methods: In vivo experimental preclinical study. The sample consisted of 48 rats randomly distributed in four study groups. Group A was given saline solution; to group B, salbutamol 4 mg/Kg; to group C, montelukast 2.5 mg/Kg and to group D, prednisone 2.5 mg/Kg. All were fitted with orthodontic devices and the medications were administered intraperitoneally every 12 hours for 5 days. The clinical evaluation (variation in the interincisal distance) was performed at one, three, five, and seven days and the histopathological analysis (cell count) at five and seven days. Results: In the clinical evaluation of the variation in the interincisal distance, a significant difference was found in all the evaluations (p &lt;0.05). It was found that the salbutamol group presented higher variation values in the interincisal distance on all the days evaluated. In the histopathological analysis at five and seven days, it was found that the osteoblast and osteocyte count was significantly higher in the salbutamol group compared to the other groups (p &gt;&lt;0.05). However, in the subgroup analysis, it was found that there was no significant difference in the osteoblast and osteocyte count between the prednisone, montelukast, and control group (p&gt;0.05). Conclusion: The administration of salbutamol increased the magnitude of orthodontic tooth movement; nonetheless, the administration of montelukast and prednisone did not modify the magnitude of orthodontic tooth movement in rats. Keywords Albuterol; Montelukast; Prednisone; Rats; Tooth movement.

Montelukast in hospitalized patients diagnosed with COVID-19

Objective Several therapeutic agents have been assessed for the treatment of COVID-19, but few approaches have been proven efficacious. Because leukotriene receptor antagonists, such as montelukast have been shown to reduce both cytokine release and lung inflammation in preclinical models of viral influenza and acute respiratory distress syndrome, we hypothesized that therapy with montelukast could be used to treat COVID-19. The objective of this study was to determine if montelukast treatment would reduce the rate of clinical deterioration as measured by the COVID-19 Ordinal Scale. Methods We performed a retrospective analysis of COVID-19 confirmed hospitalized patients treated with or without montelukast. We used “clinical deterioration” as the primary endpoint, a binary outcome defined as any increase in the Ordinal Scale value from Day 1 to Day 3 of the hospital stay, as these data were uniformly available for all admitted patients before hospital discharge. Rates of clinical deterioration between the montelukast and non-montelukast groups were compared using the Fisher’s exact test. Univariate logistic regression was also used to assess the association between montelukast use and clinical deterioration. A total of 92 patients were analyzed, 30 who received montelukast at the discretion of the treating physician and 62 patients who did not receive montelukast. Results Patients receiving montelukast experienced significantly fewer events of clinical deterioration compared with patients not receiving montelukast (10% vs 32%, p = 0.022). Our findings suggest that montelukast associates with a reduction in clinical deterioration for COVID-19 confirmed patients as measured on the COVID-19 Ordinal Scale. Conclusions Hospitalized COVID-19 patients treated with montelukast had fewer events of clinical deterioration, indicating that this treatment may have clinical activity. While this retrospective study highlights a potential pathway for COVID-19 treatment, this hypothesis requires further study by prospective studies.

The Effect of Oral Montelukast Administration in Cholesteatoma Development and Inflammation: An Experimental Animal Model.

We hypothesized that oral montelukast treatment could inhibit cholesteatoma formation in an experimental animal model. Inflammation and excessive proliferation have been described in the histopathology of cholesteatoma. The aim of this study was to determine the effect of oral montelukast on cholesteatoma development. Eighteen healthy female Wistar albino rats weighing 250 g were chosen for the study. The animals were divided into two groups: group 1 received montelukast and group 2 was the control group. Intratympanic propylene glycol injection was administered into the left ears and physiologic serum was instilled into the right ears of the animals on the first, eighth, and fifteenth days. The effects of montelukast administration were evaluated by histological examination of the tympanic membrane and middle ear. Group 1 (montelukast group) showed significant differences in terms of cholesteatoma formation, granulation, epithelial invagination, and inflammation. Cholesteatoma formation in the left ear was observed in 2 (22%) and 8 (89%) rats in groups 1 and 2, respectively (p = 0.015). Development of cholesteatoma and inflammation was significantly lower in the montelukast-administered group. Thus, oral montelukast was found effective in preventing cholesteatoma formation.

A Double-blind Randomized Controlled Trial on the Effects of Montelukast on the Serum Level of Inflammatory Factors in Patients with Chronic Obstructive Pulmonary Disease

Background: Chronic obstructive pulmonary disease (COPD) is a major noncommunicable respiratory disease with diverse pulmonary and external pulmonary clinical manifestations. This disease is one of the leading causes of mortality in the world, and about 1% of the adult population suffers from COPD. Objectives: The aim of this study was to assess the effect of Montelukast on the serum level of inflammatory factors in patients with chronic obstructive pulmonary disease (COPD). Methods: In a randomized placebo-controlled trial, 74 patients with COPD with stable conditions were followed for two months after a random assignment to the placebo and montelukast (10 mg/d) groups. All patients continued their treatment protocol irrespective of their group to evaluate the effects of the addition of montelukast on serum levels of common inflammatory factors, such as Tumor Necrosis Factor alpha (TNF-α), C-reactive protein (CRP), and Interleukin 18 (IL-18) in COPD patients. SPSS 18 software was used for data analysis. Results of quantitative data were reported as mean ± standard deviation or median (interquartile range) and qualitative data as frequency (percentage). If the data distribution was normal, the paired t-test was used to compare the mean before and after and using an independent t-test to compare the mean changes between the two groups. The Mann-Whitney U test and Wilcoxon signed-rank test were also used if the data were not assumed to be normal. A P &lt; 0.05 was considered as the level of significance. Results: At baseline, there were no significant differences in laboratory studies between the two groups. After two months of intervention, there was no evidence of decreased TNF-α and CRP in the montelukast group. IL-18 levels were not significantly different at the end of the study between the two groups (P = 0.23), but it had a decreasing trend in the montelukast group (from 20.25 ± 5.98 ng/ml to 16.19 ± 4.17 ng/ml, P &lt; 0.001). Conclusions: Montelukast complementary therapy in COPD patients only improve the serum IL-18 levels and has not a reducing effect on the level of TNF-α and CRP evidenced by keeping their trend from baseline to the end of the study.