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Pakistan Journal of Medical Sciences 2021Generally, the blockage of upper respiratory tract in children is seen with the hypertrophy of adenoids and tonsils. Normally for patients with adenoid hypertrophy (AH),...
BACKGROUND & OBJECTIVES
Generally, the blockage of upper respiratory tract in children is seen with the hypertrophy of adenoids and tonsils. Normally for patients with adenoid hypertrophy (AH), Adenoidectomy with or without Tonsillectomy is carried out, however it has its own complications like haemorrhage and recurrence of adenoid tissue. Consequently, therapeutic approach has increased extraordinary consideration rather than surgical procedure. The inflammatory process proposed for AH has prompted the utilization of anti-inflammatory drugs to treat this issue. The objective of this study was to assess the impacts of Montelukast sodium in children with enlarged adenoids.
METHODS
A randomized controlled trail was performed from April 2018 to March 2019 in the Otorhinolaryngology clinic of Dr. Akbar Niazi Teaching Hospital, Islamabad. In this randomized, placebo treatment-controlled trial, 60 children aged 4-12 years meeting inclusion criteria were isolated into two groups. The study group was treated with Montelukast sodium 5mg consistently for three months while the control group got placebo treatment for a similar timeframe. A questionnaire was filled by parents/ guardians of every child before and after the intervention to evaluate the severity of sleep discomfort, snoring and mouth breathing.
RESULTS
Following 3 months of treatment, significant reduction in size of the adenoids was seen in 76% of study group compared with just 3% of control group getting placebo treatment.
CONCLUSION
Montelukast sodium seems to be effective in the reduction of the size of adenoids and improvement in clinical manifestations. It can be viewed as a viable option in contrast to surgical treatment in children with hypertrophy of adenoids.
PubMed: 33679914
DOI: 10.12669/pjms.37.2.2670 -
Annals of Translational Medicine Jan 2023The oral soluble film (OSF) is a new drug delivery system. Whether montelukast sodium OSF has similar pharmacokinetic (PK) properties and bioequivalence to chewable...
Pharmacokinetics and bioequivalence study of montelukast sodium oral soluble film and chewable tablet in healthy Chinese volunteers: randomized trials under fasting and fed conditions.
BACKGROUND
The oral soluble film (OSF) is a new drug delivery system. Whether montelukast sodium OSF has similar pharmacokinetic (PK) properties and bioequivalence to chewable tablet (CT) should be investigated.
METHODS
This study, conducted at Haikou People's Hospital, consisted of two trials: a randomized, open-label, single-dose, 3-sequence, 3-period crossover trial under fasting conditions and a randomized, open-label, single-dose, 2-sequence, 2-period crossover trial under fed conditions. Healthy volunteers were randomized 1:1:1 to receive single-dose oral montelukast sodium OSF without water, OSF, or CT with water in the fasting trial, and 1:1 to receive OSF or CT with water in the fed trial in each period, with a 7-day washout period. Randomization was performed according to random number tables generated using computer. Blood samples were collected over a 24-h period. Plasma drug concentrations were tested using high-performance liquid chromatography-tandem mass spectrometry. The primary PK parameters were maximum plasma drug concentration (C), area under the plasma drug concentration-time curve (AUC) from t=0 to the last quantifiable concentration (AUC), and AUC from t=0 to infinity (AUC). The other PK parameters included time to C (T), terminal elimination rate constant (λ), and half-life (t). Safety was also assessed. Analysis of variance on log-transformed primary PK parameters was applied to analyze the bioequivalence between the OSF and CT. The bioequivalence margin was 80-125%.
RESULTS
From November 2018 to January 2019, 30 subjects were included in each trial. The PK parameters between OSF and CT were numerically similar. All 90% confidence intervals (CIs) of the geometric mean ratio (GMR) for the primary PK parameters fell within 80-125%, confirming the bioequivalence of montelukast sodium OSF and CT under fasting and fed conditions. In the fasting trial, 6 (20%) adverse events (AEs) were reported, including 3 (10%) cases after OSF administration without water and 3 (10%) after OSF administration with water, with no serious AEs. No AEs were recorded in the fed trial.
CONCLUSIONS
Montelukast sodium OSF is bioequivalent to CT, with acceptable safety. The OSF is an alternative option of CT.
TRIAL REGISTRATION
ClinicalTrials.gov identifiers: NCT05528198 (the fasting trial) and NCT05531994 (the fed trial).
PubMed: 36819512
DOI: 10.21037/atm-22-6485 -
Medicine Jun 2021Cough 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...
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/).
Topics: Acetates; Administration, Inhalation; Asthma; Budesonide; Child; Chronic Disease; Cough; Cyclopropanes; Drug Therapy, Combination; Glucocorticoids; Humans; Leukotriene Antagonists; Meta-Analysis as Topic; Quinolines; Randomized Controlled Trials as Topic; Sulfides; Systematic Reviews as Topic; Treatment Outcome
PubMed: 34160429
DOI: 10.1097/MD.0000000000026416 -
Heliyon Mar 2023Montelukast Sodium (MK) is a leukotriene receptor antagonist, an oral drug generally prescribed to control chronic asthma symptoms. This research aims to provide the...
Montelukast Sodium (MK) is a leukotriene receptor antagonist, an oral drug generally prescribed to control chronic asthma symptoms. This research aims to provide the transdermal delivery of this drug in a controlled release profile as a better mode of drug delivery, specifically for the pediatric and elderly population. Transdermal delivery of the drug not only improves the drug's bioavailability but also maintains the concentration of the drug in the plasma without increasing the frequency of the drug dosage. Transdermal film formulations were developed using sodium alginate (SA) and lignosulphonic acid (LS) as the matrix and PEG-400 or Glycerine (Gly) as the plasticizers. Various physiochemical characteristic evaluations of the formulated films were conducted, revealing that the formulation with Glycerine as the plasticizer had a smooth surface and was flexible. It was observed that this formulation had the highest moisture uptake capacity and the lowest moisture loss capacity when compared with the other two formulations. It was also observed that the barium chloride cross-linked formulation had a higher swelling index when compared with calcium chloride cross-linked films. The surface pH of all the formulations was monitored to be around 7.5. In the release studies, the cross-linked films showed a controlled release over 36 h compared with the non-cross-linked films. Based on the observations and results, the cross-linked film formulation showed a better-controlled release of the drug and could potentially increase its bioavailability. TGA analysis of the polymeric mixture demonstrated the thermal stability of the SA blends, which enhanced the flexibility of the SALS blend with Glycerine. XRD of samples confirmed the amorphous nature of SALS blends with Gly, which influences the flexibility of the blend. The blends are further investigated for morphology using SEM to test their compatibility with the drug.
PubMed: 36950594
DOI: 10.1016/j.heliyon.2023.e14469 -
Eye (London, England) May 2022Vernal keratoconjunctivitis is a chronic, seasonally exacerbated, allergic inflammation of the eye. The study aims to evaluate the efficacy and safety of oral... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
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.
METHODS
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.
RESULTS
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.
CONCLUSIONS
Montelukast was found to be safe and effective as a long-term therapy to prevent relapse in moderate to severe vernal keratoconjunctivitis.
Topics: Acetates; Child; Conjunctivitis, Allergic; Cyclopropanes; Humans; Ophthalmic Solutions; Prospective Studies; Pruritus; Quinolines; Seasons; Sulfides; Treatment Outcome
PubMed: 33947979
DOI: 10.1038/s41433-021-01484-3 -
International Journal of Cancer Oct 2020Rituximab-associated infusion reactions (IRs) are significant burdens on oncology patients, caregivers and healthcare providers. We evaluated whether montelukast and... (Comparative Study)
Comparative Study
Rituximab-associated infusion reactions (IRs) are significant burdens on oncology patients, caregivers and healthcare providers. We evaluated whether montelukast and rupatadine improve rituximab delivery, decrease frequency/severity of IRs and the number of medications used to control IRs. Using a nonrandomized clinical study design, we assessed adult rituximab naïve patients with B-cell lymphoid malignancies from January 2017 to July 2019. Prior to the first rituximab infusion patients received one of the premedication regimens: (i) standard premedications, diphenhydramine hydrochloride and acetaminophen ("SP" group); (ii) SP + montelukast ("M" group); (iii) SP + rupatadine ("R" group); (iv) SP + rupatadine + montelukast Schedule 1 ("M + R Schedule 1" group); (v) SP + rupatadine + montelukast Schedule 2 ("M + R Schedule 2" group). A total of 223 patients with a median age of 69 years were assessed. Demographics and treatment groups were comparable among all five groups. Mean rituximab infusion time was 290 min in the SP group versus 273, 261, 243 and 236 min in the M, R, M + R Schedule 1 and M + R Schedule 2 groups, respectively. The incidence of rituximab IRs was 75% in the SP group versus 44, 41, 22 and 22% in the M, R, M + R Schedule 1 and M + R Schedule 2 groups, respectively. The median reaction grade was 2 in the SP group and 0 in all other groups. The median number of rescue medications was 3 in the SP group and 0 in all other groups. In conclusion, montelukast and rupatadine significantly improved rituximab delivery, decreased the rate and severity of IRs and reduced the need for rescue medications.
Topics: Acetaminophen; Acetates; Adult; Aged; Aged, 80 and over; Cyclopropanes; Cyproheptadine; Diphenhydramine; Drug Administration Schedule; Female; Humans; Infusions, Intravenous; Lymphoproliferative Disorders; Male; Middle Aged; Premedication; Quinolines; Rituximab; Standard of Care; Sulfides; Treatment Outcome
PubMed: 32189328
DOI: 10.1002/ijc.32985 -
International Journal of Molecular... Oct 2022Vitamin D is commonly known for its properties of airway remodeling inhibition. Due to this, we decided to analyze the action of calcitriol with anti-asthmatic drugs in...
Vitamin D is commonly known for its properties of airway remodeling inhibition. Due to this, we decided to analyze the action of calcitriol with anti-asthmatic drugs in airway remodeling. The HFL1 cell line was treated with calcitriol, beclomethasone 17-propionate, montelukast sodium, LTD4 and TGF-β in different combinations. Real-time PCR was used to analyzed the expression of ACTA2, CDH-1, Vimentin, ADAM33, MMP-9 and CysLTR1 on the mRNA level, whereas Western blot was used to analyze gene expression on the protein level. One-way analysis variants, the Kruskal-Wallis test, Student's -test or Welch's -test were used for statistical analysis. Concerning the results, pre-treatment with calcitriol increased the inhibitory effect of beclomethasone 17-propionate and montelukast sodium on the expression of ( = 0.0072), ( = 0.0002) and ( = 0.0204), and 1,25(OH)D had an influence on the effects of beclomethasone 17-propionate and montelukast sodium and of expression ( = 0.0076). On the protein level, pre-treatment with calcitriol with beclomethasone 17-propionate and montelukast sodium treatment decreased ACTA2 expression in comparison to the LT (LTD4 and TGF-β) control group ( = 0.0191). Hence, our study not only confirms that vitamin D may inhibit airway remodeling, but also shows that vitamin D has a synergistic effect with anti-asthmatic drugs.
Topics: Humans; Airway Remodeling; Calcitriol; Vimentin; Anti-Asthmatic Agents; Vitamin D; Leukotriene D4; Vitamins; Transforming Growth Factor beta; ADAM Proteins
PubMed: 36361588
DOI: 10.3390/ijms232112798 -
Molecules (Basel, Switzerland) Feb 2022Copper oxide nanoparticles (CuO NPs) were synthesized through the coprecipitation method and used as nanocarriers for etoricoxib (selective COX-2 inhibitor drug) and...
Synthesis of Copper Oxide-Based Nanoformulations of Etoricoxib and Montelukast and Their Evaluation through Analgesic, Anti-Inflammatory, Anti-Pyretic, and Acute Toxicity Activities.
Copper oxide nanoparticles (CuO NPs) were synthesized through the coprecipitation method and used as nanocarriers for etoricoxib (selective COX-2 inhibitor drug) and montelukast (leukotriene product inhibitor drug) in combination therapy. The CuO NPs, free drugs, and nanoformulations were investigated through UV/Vis spectroscopy, FTIR spectroscopy, XRD, SEM, and DLS. SEM imaging showed agglomerated nanorods of CuO NPs of about 87 nm size. The CE1, CE2, and CE6 nanoformulations were investigated through DLS, and their particle sizes were 271, 258, and 254 nm, respectively. The nanoformulations were evaluated through in vitro anti-inflammatory activity, in vivo anti-inflammatory activity, in vivo analgesic activity, in vivo anti-pyretic activity, and in vivo acute toxicity activity. In vivo activities were performed on albino mice. BSA denaturation was highly inhibited by CE1, CE2, and CE6 as compared to other nanoformulations in the in vitro anti-inflammatory activity. The in vivo bioactivities showed that low doses (5 mg/kg) of nanoformulations were more potent than high doses (10 and 20 mg/kg) of free drugs in the inhibition of pain, fever, and inflammation. Lastly, CE2 was more potent than that of other nanoformulations.
Topics: Acetates; Analgesics; Anti-Infective Agents; Anti-Inflammatory Agents; Chemistry Techniques, Synthetic; Copper; Cyclopropanes; Drug Compounding; Etoricoxib; Metal Nanoparticles; Quinolines; Spectrum Analysis; Structure-Activity Relationship; Sulfides
PubMed: 35209221
DOI: 10.3390/molecules27041433 -
BMC Pulmonary Medicine Dec 2023This study aimed to evaluate the efficacy and safety of montelukast (Mon) + fluticasone propionate (Flu) versus Flu in the treatment of cough variant asthma (CVA) in... (Meta-Analysis)
Meta-Analysis
An efficacy and safety evaluation of montelukast + fluticasone propionate vs. fluticasone propionate in the treatment of cough variant asthma in children: a meta-analysis.
PURPOSE
This study aimed to evaluate the efficacy and safety of montelukast (Mon) + fluticasone propionate (Flu) versus Flu in the treatment of cough variant asthma (CVA) in children.
METHODS
Eligible documents were selected from various databases. Weighted mean difference (WMD) and 95% confidence interval (CI) were used to evaluate continuous variables, and categorical variables were evaluated using risk ratio (RR) and 95% CI. Heterogeneity analysis was performed using Cochran's Q test and I statistics, followed by sensitivity analysis and publication bias evaluation.
RESULTS
Nine studies were included, and Flu + Mon was found to significantly improve the total effective rate and reduce cough recurrence compared to Flu. The cough remission and disappearance times in the Mon + Flu group were significantly lower than those in the Flu group. FEV1% recovery in the Mon + Flu group was significantly better than that in the Flu group.
CONCLUSION
Mon + Flu is effective and safe for the treatment of CVA in children.
Topics: Child; Humans; Acetates; Anti-Asthmatic Agents; Asthma; Cough; Cyclopropanes; Fluticasone; Quinolines
PubMed: 38053076
DOI: 10.1186/s12890-023-02721-z -
Medicine Dec 2020Bronchial asthma (BA) is a chronic airway inflammatory disease with reversible airflow limitation as the main clinical manifestations, such as wheezing, cough, shortness...
BACKGROUND
Bronchial asthma (BA) is a chronic airway inflammatory disease with reversible airflow limitation as the main clinical manifestations, such as wheezing, cough, shortness of breath, chest tightness, etc, mediated by a variety of inflammatory cells, which can be recurrent. Clinical can improve symptoms, but cannot be cured; glucocorticoid is the most important first-line medication. Clinical practice has shown that montelukast sodium combined with fluticasone in the treatment of adult BA can improve clinical efficacy and reduce adverse reactions. The purpose of this study is to systematically study the efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult BA.
METHODS
The Chinese databases (CNKI, VIP, Wanfang, Chinese Biomedical Database) and English databases (PubMed, the Cochrane Library, Embase, Web of Science) were searched by computer, for the randomized controlled clinical studies of montelukast sodium combined with fluticasone in the treatment of adult BA from establishment of database to October 2020. Two researchers independently extracted the relevant data and evaluated the quality of the literatures, and used RevMan5.3 software to conduct meta-analyze of the included literatures.
RESULTS
This study assessed the efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult BA through total effective rate, pulmonary function (FEV1, FVC, PEF, FEV1/FVC), and adverse reactions.
CONCLUSION
This study will provide reliable evidence-based evidence for the clinical application of montelukast sodium combined with fluticasone in the treatment of adult BA.
OSF REGISTRATION NUMBER
DOI 10.17605/OSF.IO/CKQFM.
Topics: Acetates; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Cyclopropanes; Drug Combinations; Fluticasone; Humans; Meta-Analysis as Topic; Quinolines; Research Design; Sulfides; Systematic Reviews as Topic; Treatment Outcome
PubMed: 33350727
DOI: 10.1097/MD.0000000000023453