pulmicort and montelukast

This meta-analysis aimed to compare the efficacy of montelukast (MKST) combined with budesonide (BUD) and BUD alone in the treatment of pulmonary inflammation and pulmonary function in children with cough variant asthma (CVA). Five electronic databases were searched for studies about MKST+BUD therapy and BUD alone therapy on inflammation and pulmonary function in CVA children from inception to November 23, 2021. Twenty-two articles were included. The results showed that, compared with BUD alone, the combination treatment could achieve better improvement of pulmonary function and lower levels of inflammation (MKST+BUD group: FEV1: SMD = 2.77, 95% CI: 2.07, 3.46; FVC: SMD = 2.54, 95% CI: 1.82, 3.27; PEF: SMD = 2.27, 95% CI: 1.79, 2.75; IgE: SMD = -7.95, 95% CI: -9.66, -6.25; TNF-α: SMD = -4.67, 95% CI: -6.04, -3.31; IL-8: SMD = -8.18, 95% CI: -11.46, -4.90; BUD alone group: FEV1: SMD = 1.83, 95% CI: 1.34, 2.31; FVC: SMD = 1.39, 95% CI: 0.93, 1.84; PEF: SMD = 1.51, 95% CI: 1.13, 1.89; IgE: SMD = -4.93, 95% CI: -6.14, -3.72; TNF-α: SMD = -2.78, 95% CI: -3.76, -1.80; IL-8: SMD = -4.94, 95% CI: -7.10, -2.79). To conclude, compared with BUD alone, MKST+BUD therapy was found to be more effective in improving pulmonary function and reducing inflammation in CVA children. Key Words: Montelukast, Budesonide, Cough variant asthma, Children, Pulmonary function, Inflammatory markers, Meta-analysis.

Topics: Asthma; Budesonide; Child; Cough; Humans; Immunoglobulin E; Inflammation; Interleukin-8; Tumor Necrosis Factor-alpha

This study aimed to compare the therapeutic effects of different drugs on obstructive sleep apnea/hypopnea syndrome (OSAHS) in children by using a network meta-analysis approach.. PubMed, Embase and Cochrane Library were searched from the inception of each database to November 2015. Randomized controlled trials (RCTs) concerning the comparisons in the therapeutic effects of eight placebo-controlled drugs on OSAHS in children were included in this study. Network meta-analysis combined direct evidence and indirect evidence to evaluate the weighted mean difference (WMD) and surface under the cumulative ranking curves (SUCRA) of therapeutic effects of eight drugs on OSAHS in children.. A total of seven RCTs were finally incorporated into our network meta-analysis. Pairwise meta-analysis results revealed that therapeutic effect of placebo was significantly poorer than that of intranasal mometasone furoate, montelukast, budesonide and fluticasone concerning apnea hypopnea index (AHI) value [WMD=1.40, 95% confidence interval (CI)=1.17-1.63; WMD=2.80, 95% CI=1.01-4.59; WMD=3.50, 95% CI=3.34-3.66; WMD=7.20, 95% CI=5.26-9.14, respectively], and fluticasone is better than placebo concerning sleep efficiency (WMD=3.50, 95% CI=2.42-4.58); regarding visual analogue scale, the therapeutic effect of placebo was poorer compared with sucralfate and clindamycin (WMD=1.94, 95% CI=1.13-2.75; WMD=1.06, 95% CI=0.22-1.90), and sucralfate is better than clindamycin (WMD=-0.88, 95% CI=-1.65 to -0.11). However, network meta-analysis results showed no obvious difference in the therapeutic effects of different drugs on OSAHS regarding AHI and sleep efficiency. Furthermore, the best SUCRA value was very high for fluticasone concerning AHI (86.6%) and budesonide concerning sleep efficiency (94.0%) for OSAHS treatment.. Fluticasone and budesonide have relatively good effects in the treatment of OSAHS in children, thus providing an important guiding significance for the treatment of OSAHS in children.

Topics: Acetates; Bayes Theorem; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Cyclopropanes; Female; Fluticasone; Humans; Male; Prognosis; Quinolines; Randomized Controlled Trials as Topic; Risk Assessment; Severity of Illness Index; Sleep Apnea, Obstructive; Sulfides; Treatment Outcome

To evaluate the therapeutic effect and safety of montelukast sodium combined with budesonide in children with cough variant asthma.. The databases CNKI, Wanfang Data, VIP, PubMed, EMbase, and BioMed Central were searched for randomized controlled trials (RCTs) of montelukast sodium combined with budesonide in the treatment of children with cough variant asthma. Data extraction and quality assessment were performed for RCTs which met the inclusion criteria, and RevMan 5.3 software was used to perform quality assessment of the articles included and Meta analysis.. A total of 11 RCTs involving 1 097 patients were included. The results of the Meta analysis showed that compared with the control group (inhalation of budesonide alone), the observation group (inhalation of montelukast sodium combined with budesonide) had significantly higher overall response rate and more improved pulmonary function parameters including forced expiratory volume in the first second, percentage of forced expiratory volume in the first second, and peak expiratory flow, as well as significantly lower recurrence rate (P<0.01). The incidence of adverse events showed no significant difference between the two groups.. Inhalation of montelukast sodium combined with budesonide has a significant effect in children with cough variant asthma and does not increase the incidence of adverse events.

Topics: Acetates; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Child; Cough; Cyclopropanes; Drug Therapy, Combination; Humans; Quinolines; Sulfides

Eosinophilic oesophagitis (EO) is an immune/antigen mediated, chronic, relapsing disease characterised by dysphagia, food bolus impaction and a dense oesophageal eosinophilic infiltrate. Characteristic endoscopic features include corrugated rings, linear furrows and white exudates, but none are diagnostic. Despite its increasing prevalence, EO remains underdiagnosed. There is a strong association with other atopic conditions. Symptoms, histology and endoscopic findings can overlap with gastro-oesophageal reflux disease. Currently endoscopy and oesophageal biopsies are the investigation of choice. Oesophageal physiology studies, endoscopic ultrasound, impedance planimetry and serology may have a role in the diagnosis and monitoring of response to therapy. Acid reducing medication is advocated as first line or adjuvant therapy. Dietary therapy is comprised of elimination diets or can be guided by allergen assessment. In adults, topical corticosteroids are the mainstay of therapy. Endoscopic dilatation is safe and effective for the treatment of non-responsive strictures. Other therapeutic options (immunomodulators, biological agents, leukotriene receptor antagonists) are under investigation.

Topics: Acetates; Administration, Inhalation; Anti-Inflammatory Agents; Biopsy; Budesonide; Cyclopropanes; Deglutition Disorders; Eosinophilic Esophagitis; Esophagoscopy; Feeding Behavior; Female; Glucocorticoids; Humans; Immunologic Factors; Male; Quinolines; Sulfides

Obstructive sleep apnea (OSA) is characterized by partial or complete upper airway obstruction during sleep. Approximately 1% to 4% of children are affected by OSA, with adenotonsillar hypertrophy the most common underlying risk factor. Surgical removal of enlarged tonsils and adenoids is the most commonly used treatment for OSA. Given the perioperative risk of the intervention and an estimated recurrence rate of up to 20%, there has recently been an increased interest in non-surgical treatment modalities. As the enlarged adenoids and tonsils consist of hypertrophied lymphoid tissue, anti-inflammatory agents have been proposed as a useful non-invasive treatment option in children with OSA.. To assess the efficacy of anti-inflammatory drugs for the treatment of OSA in children.. We identified trials using searches of the Cochrane Airways Group Specialized Register, MEDLINE (1950 to 2010), EMBASE (1988 to 2010), CINAHL (1982 to 2010), CENTRAL (1964 to 2010), Web of Science (1900 to 2010), LILACS (1982 to 2010) and International Pharmaceutical Abstracts (IPA) (1970 to 2010).. Randomized controlled trials (RCTs) comparing anti-inflammatory drugs against placebo, other anti-inflammatory drugs, or other treatment in children between one and 16 years with objectively diagnosed OSA (Apnea Hypopnea Index (AHI) ≥ 1/hour (h)).. Both authors independently performed data extraction and quality assessment. It was not possible to combine data from the included studies; we summarized data in a narrative fashion.. We included three RCTs. The first study was a six-week parallel-group trial (25 participants, mean age 3.8 years, mean AHI 10.8/h) of intranasal fluticasone versus placebo showed a statistically significant effect of the drug on improving the AHI. The second study compared intranasal budesonide with placebo in a six-week cross-over trial (62 participants, mean age 8.2 years, mean AHI 3.7/h). The authors reported an advantage of the drug over placebo in reducing the AHI. However, the patients were not analyzed as randomized so the result must be interpreted with caution. No valid group comparisons were reported for the third trial (30 participants, oral montelukast versus placebo in a 12-week parallel-group trial), which has so far only been published as an abstract.. A single small study has found a short-term beneficial effect on the AHI in children with mild to moderate OSA. However, long-term safety and efficacy data are not available yet. Further RCTs are needed to evaluate anti-inflammatory drugs for OSA in children.

Topics: Acetates; Administration, Intranasal; Administration, Oral; Androstadienes; Anti-Inflammatory Agents; Budesonide; Child; Child, Preschool; Cyclopropanes; Fluticasone; Humans; Quinolines; Randomized Controlled Trials as Topic; Sleep Apnea, Obstructive; Sulfides

The objective of this study was to analyse inter-and intra-country quantitative and qualitative differences in anti-asthmatic prescriptions to children and adolescents.. A literature search was performed in EMBASE and MEDLINE to identify pharmaco-epidemiological studies published from January 1, 2000 to December 31, 2008 in which anti-asthmatic prescription prevalence in out-hospital children was measured. A meta-analytic weighted average and 95% confidence intervals of prescription prevalences were calculated using a random-effect(s) model. Inter- and intra-country quantitative and, where possible, qualitative prescribing patterns were compared and assessed.. Twelve studies were identified (ten from Europe, one from Canada and one from the USA), but epidemiological indicators varied widely, and only eight were suitable for meta-analysis. The data from these studies revealed inter-country quantitative differences in prescription prevalences in the overall population

Topics: Acetates; Adolescent; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Canada; Child; Cromolyn Sodium; Cyclopropanes; Drug Prescriptions; Ethanolamines; Europe; Fluocinolone Acetonide; Fluticasone; Humans; Italy; Prevalence; Quinolines; Salmeterol Xinafoate; Sulfides; United States

Clinical studies have shown that the combination of an inhaled corticosteroid (ICS) and a long-acting beta(2)-adrenoceptor agonist (LABA) for patients with asthma is more effective than the use of ICS alone in equivalent or higher doses, as well as the use of other combinations. However, the relatively higher acquisition costs for the combination therapy require assessment of the value of the incremental costs, especially from a societal perspective. This review provides an overall assessment of the cost effectiveness of ICS plus LABA combination therapy for asthma. A systematic literature research was conducted in MEDLINE to identify studies published between January 1994 and September 2005. Cost-effectiveness studies derived from 11 clinical studies were identified. The ICS plus LABA combination was compared with ICS alone in eight studies, ICS plus a leukotriene antagonist in two studies, and a leukotriene antagonist alone in one study. All studies focused on measuring direct medical costs in a total of six different healthcare systems, and three studies conducted sensitivity analyses, including productivity costs. Outcomes were measured in treatment success (changes in lung function), episode-free days, and symptom-free days by evaluating short-term follow-up. The combination of ICS and LABA was found to be more efficacious and cost effective compared with ICS alone or alternative combinations of controller medications. Further considerations for measuring long-term outcomes and dose-response relationships might be required to provide further evidence on the cost effectiveness of combination therapy with ICS plus LABA.

Topics: Acetates; Androstadienes; Anti-Asthmatic Agents; Asthma; Budesonide; Clinical Trials as Topic; Cost-Benefit Analysis; Cyclopropanes; Dose-Response Relationship, Drug; Drug Therapy, Combination; Ethanolamines; Fluticasone; Formoterol Fumarate; Humans; Nebulizers and Vaporizers; Quinolines; Sulfides

Salmeterol/fluticasone propionate, administered twice daily via a multidose dry powder inhaler (Seretide/Advair Diskus), Seretide Accuhaler or metered-dose hydrofluoroalkane (chlorofluorocarbon-free) inhaler (Seretide Evohaler), is a combination of the long-acting beta(2)-adrenoceptor agonist (beta(2)-agonist) [LABA] salmeterol and the corticosteroid fluticasone propionate. Maintenance therapy with combined salmeterol/fluticasone propionate is at least as effective in improving lung function and symptoms and is as well tolerated in patients with asthma as concurrent salmeterol plus fluticasone propionate. In patients previously receiving as-required short-acting beta(2)-agonists (SABAs) or inhaled corticosteroids, salmeterol/fluticasone propionate was significantly more effective in providing asthma control than fluticasone propionate and in improving lung function and asthma symptoms than inhaled corticosteroids (at equivalent or higher dosages), salmeterol or montelukast (as monotherapy or in combination with fluticasone propionate). Salmeterol/fluticasone propionate was more effective in improving asthma symptoms than adjusted-dose budesonide/formoterol in patients with uncontrolled asthma despite treatment with inhaled corticosteroids with or without a LABA in a well designed 1-year study. In pharmacoeconomic analyses, salmeterol/fluticasone propionate compared favourably with inhaled corticosteroids and mono- or combination therapy with oral montelukast. Salmeterol/fluticasone propionate is, therefore, an effective, well tolerated and cost-effective option for the maintenance treatment of patients with asthma.

Topics: Acetates; Administration, Inhalation; Albuterol; Androstadienes; Asthma; Asthma, Exercise-Induced; Bronchodilator Agents; Budesonide; Clinical Trials as Topic; Cyclopropanes; Drug Combinations; Economics, Pharmaceutical; Ethanolamines; Fluticasone; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Humans; Quinolines; Salmeterol Xinafoate; Sulfides; Therapeutic Equivalency

Bronchial asthma is a prevalent type of respiratory disease that affects a large proportion of pediatric patients. The purpose of this study is to further investigate the clinical effects of budesonide combined with montelukast sodium in treating bronchial asthma.. Eighty six children with bronchial asthma were equally divided into study and control groups via randomized double-blind controlled trial. The control group was treated with aerosol inhalation of budesonide combined with placebo, while the study group was treated with budesonide combined with montelukast sodium. Pulmonary function parameters, immunoglobulin, and recovery of related symptoms, along with the adverse reaction rate, were observed and compared between both groups.. Before treatment, there was no marked difference in pulmonary function parameters and immunoglobulin indexes between both groups (. Budesonide combined with montelukast sodium in the treatment of bronchial asthma has the value of clinical application and promotion.

Topics: Acetates; Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Budesonide; Child; Humans; Quinolines

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.

Topics: Acetates; Administration, Intranasal; Adolescent; Adrenal Cortex Hormones; Adult; Asthma; Budesonide; Cyclopropanes; Double-Blind Method; Histamine Antagonists; Histamine H1 Antagonists; Humans; Nasal Sprays; Phthalazines; Quality of Life; Quinolines; Rhinitis, Allergic; Sulfides; Treatment Outcome; Young Adult

Whether cysteinyl-leukotriene receptor antagonists (LTRAs) have a similar antitussive effect to inhaled corticosteroids and long-acting β2-agonist (ICS/LABA), and that LTRA plus ICS/LABA is superior to LTRAs alone or ICS/LABA alone in treating cough variant asthma (CVA) remain unclear. This study aimed to investigate and compare the efficacy of montelukast alone, budesonide/formoterol alone and the combination of both in the treatment of CVA.. Ninety-nine CVA patients were assigned randomly in a 1:1:1 ratio to receive montelukast (M group: 10 mg, once daily), budesonide/formoterol (BF group: 160/4.5 μg, one puff, twice daily), or montelukast plus budesonide/formoterol (MBF group) for 8 weeks. The primary outcomes were changes in the cough visual analogue scale (VAS) score, daytime cough symptom score (CSS) and night-time CSS, and the secondary outcomes comprised changes in cough reflex sensitivity (CRS), the percentage of sputum eosinophils (sputum Eos%) and fractional exhaled nitric oxide (FeNO). CRS was presented with the lowest concentration of capsaicin that induced at least 5 coughs (C5). The repeated measure was used in data analysis.. Montelukast alone, budesonide/formoterol alone and a combination of both were effective in improving cough symptom, decreasing cough reflex sensitivity and alleviating eosinophilic airway inflammation in patients with CVA, and the antitussive effect and anti-eosinophilic airway inflammation were similar. Trial registration ClinicalTrials.gov, number NCT01404013.

Topics: Acetates; Administration, Inhalation; Adrenal Cortex Hormones; Antitussive Agents; Asthma; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Capsaicin; Cough; Cyclopropanes; Formoterol Fumarate; Humans; Inflammation; Leukotriene Antagonists; Quinolines; Sulfides

It is not unequivocally proven whether a combination of an intranasal corticosteroids (INSs) and a cysteinyl leukotriene receptor antagonist has greater efficacy than INSs in the treatment of seasonal allergic rhinitis (SAR).. Single-center, randomized, open-label study.. Study subjects included 46 participants with SAR. Participants were randomized to receive budesonide (BD; 256 μg) plus montelukast (MNT; 10 mg) (BD + MNT) or BD alone (256 μg) for 2 weeks. Visual analog scale scores for five major symptoms of SAR, nasal cavity volume (NCV), nasal airway resistance (NAR), and fractional exhaled nitric oxide (FeNO) were assessed before and at the end of treatments.. Both treatments significantly improved the five main SAR symptoms from baseline; however, BD + MNT produced significantly greater improvements in nasal blockage and nasal itching compared to BD alone. At baseline, the nasal blockage score was significantly correlated with NCV and NAR (r = -0.473, P = .002 and r = -0.383, P = .013, respectively). After 2 weeks of treatment, BD + MNT significantly improved NCV, but not NAR, to a greater level than BD. The number of patients with FeNO concentration ≥ 30 ppb at baseline was significantly decreased after BD + MNT treatment, but not after BD treatment. Similarly, BD + MNT treatment led to a significantly greater decrease in FeNO concentration than BD treatment.. BD + MNT treatment may have an overall superior efficacy than BD monotherapy for patients with SAR, especially in improvement of nasal blockage, itching, and subclinical lower airway inflammation. Also, NCV and NAR could be used to assess nasal blockage more accurately.. 1b Laryngoscope, 131:E1054-E1061, 2021.

Topics: Acetates; Administration, Intranasal; Adult; Bronchodilator Agents; Budesonide; China; Cyclopropanes; Drug Therapy, Combination; Female; Humans; Leukotriene Antagonists; Male; Nasal Obstruction; Quinolines; Rhinitis, Allergic; Sulfides

The aim of this study was to explore the clinical effect of montelukast sodium chewable tablets combined with inhaled budesonide in the treatment of pediatric asthma and its influence on inflammatory factors. One hundred and thirty-five asthmatic children were randomly divided into montelukast sodium group, budesonide group and combined group. Clinical symptoms, lung function, inflammatory factors and immune related indices of patients in each group were observed and recorded. After treatment, the times to disappearance of wheezes, dyspnea, asthma and hospital stay in the combined group were significantly shorter than those in the single-drug group (all p < 0.001). Forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), peak expiratory flow (PEF) were significantly higher than those before treatment, and in the combined group value were significantly higher than in the single-drug group in the same period (all p < 0.001). Tumor necrosis factor-α (TNF-α), interleukin-4 (IL-4), IL-8 and hypersensitive C-reactive protein (hs-CRP) were significantly lower than before treatment, and the combined group was significantly lower than the single-drug group in the same period (all p < 0.05). The number of CD4

Topics: Acetates; Administration, Inhalation; Administration, Oral; Anti-Asthmatic Agents; Asthma; Budesonide; Child; Child, Preschool; Cyclopropanes; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Inflammation; Male; Quinolines; Respiratory Function Tests; Sulfides; Tablets; Treatment Outcome

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.. 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.. 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.. The hBD+MNT combination may have an overall better efficacy profile than BD and MNT monotherapy for treatment of SAR.

Topics: Acetates; Administration, Intranasal; Adolescent; Adult; Anti-Inflammatory Agents; Budesonide; Cyclopropanes; Drug Therapy, Combination; Female; Humans; Leukotriene Antagonists; Male; Middle Aged; Quinolines; Rhinitis, Allergic, Seasonal; Sulfides; Treatment Outcome; Young Adult

Topics: Acetates; Adult; Airway Management; Anti-Asthmatic Agents; Asthma; Budesonide; Cyclopropanes; Dose-Response Relationship, Drug; Drug Administration Routes; Drug Monitoring; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Indoleacetic Acids; Male; Middle Aged; Pyridines; Quinolines; Receptors, Immunologic; Receptors, Prostaglandin; Severity of Illness Index; Sulfides; Treatment Outcome

Cysteinyl leukotriene (LT) has been proposed in the pathogenesis of chronic rhinosinusitis with nasal polyps (CRSwNP). This study sought to examine the expression of the LT receptor (LTR) in CRSwNP patients and evaluate the potential role of LTR antagonist (LTRA) in the management of eosinophilic CRSwNP (ECRS) patients.. Nasal polyps and uncinate process tissues were collected from 18 ECRS patients, 13 non-eosinophilic CRSwNP (non-ECRS) patients, and 16 control subjects. The messenger RNA (mRNA) and protein expression of LTR (cysteinyl leukotriene receptor 1 [CysLT1R] and cysteinyl leukotriene receptor 2 [CysLT2R]) was examined using quantitative reverse-transcription polymerase chain reaction (qRT-PCR), immunohistochemistry, and Western blot analysis. Moreover, the effects of LTRA and steroids on total nasal symptom scores (TNSS) of uncontrolled ECRS patients were evaluated.. The mRNA and protein expression of CysLT1R and CysLT2R was significantly increased in polyp tissues compared with healthy controls (p < 0.05). Compared with the non-ECRS subset, the ECRS subset showed significantly increased expression of CysLT1R and CysLT2R, as well as leukotriene C4 (LTC4) and leukotriene D4 (LTC4) levels (p < 0.05). Moreover, combined LTRA and steroids significantly decreased TNSS more than steroids alone in uncontrolled ECRS patients (p < 0.01).. Our findings indicate that LTR was differentially expressed between ECRS and non-ECRS patients, and that LTRA may be used as an additional therapy for ECRS patients.

Topics: Acetates; Adult; Anti-Inflammatory Agents; Biomarkers; Blotting, Western; Budesonide; Case-Control Studies; Chronic Disease; Cyclopropanes; Drug Therapy, Combination; Eosinophils; Female; Humans; Leukotriene Antagonists; Leukotrienes; Male; Middle Aged; Nasal Polyps; Prospective Studies; Quinolines; Receptors, Leukotriene; Reverse Transcriptase Polymerase Chain Reaction; Rhinitis; Sinusitis; Sulfides; Treatment Outcome

The efficacy of montelukast (MONT), a cysteinyl leukotriene receptor antagonist, in nonasthmatic eosinophilic bronchitis (NAEB), especially its influence on cough associated life quality is still indefinite. We evaluated the efficacy of MONT combined with budesonide (BUD) as compared to BUD monotherapy in improving life quality, suppressing airway eosinophilia and cough remission in NAEB.. A prospective, open-labeled, multicenter, randomized controlled trial was conducted. Patients with NAEB (aged 18-75 years) were randomized to inhaled BUD (200 μg, bid) or BUD plus oral MONT (10 μg, qn) for 4 weeks. Leicester cough questionnaire (LCQ) life quality scores, cough visual analog scale (CVAS) scores, eosinophil differential ratio (Eos), and eosinophil cationic protein (ECP) in induced sputum were monitored and compared.. The control and MONT groups contained 33 and 32 patients, respectively, with similar baseline characteristics. Significant with-in group improvement in CVAS, LCQ scores, Eos, and ECP was observed in both groups during treatment. After 2-week treatment, add-on treatment of MONT was significantly more effective than BUD monotherapy for CVAS decrease and LCQ scores improvement (both P < 0.05). Similar results were seen at 4-week assessment (both P < 0.05). 4-week add-on therapy of MONT also resulted in a higher percentage of patients with normal sputum Eos (<2.5%) and greater decrease of ECP (both P < 0.05).. MONT combined with BUD was demonstrated cooperative effects in improvement of life quality, suppression of eosinophilic inflammation, and cough remission in patients with NAEB.

Topics: Acetates; Adolescent; Adult; Aged; Aged, 80 and over; Bronchitis; Budesonide; Cough; Cyclopropanes; Female; Humans; Inflammation; Male; Middle Aged; Quality of Life; Quinolines; Sulfides; Young Adult

Data comparing various second-line treatments for asthma with subjective and objective assessment are lacking. This study aimed to compare the efficacy and safety of montelukast, doxofylline, and tiotropium with a low-dose budesonide in patients with mild to moderate persistent asthma.. Patients, all of whom were concurrently using inhaled budesonide (400 µg), were treated for 6 months with formoterol (12 µg), montelukast (10 mg), doxofylline (400 mg), or tiotropium (18 µg). Outcomes included forced expiratory volume in 1 second (FEV1), Saint George Respiratory Questionnaire (SGRQ) scores, asthma symptom scores (daytime and nighttime), and assessment of tolerability and rescue medication use.. A total of 297 patients completed the study. In all 4 groups, significant improvements were observed in all the outcome measures, with formoterol treatment having greater and earlier improvements than the other 3 second-line controller medications with budesonide. Among the second-line treatments, monteradlukast improved the FEV1 from day 45 (P < 0.01), SGRQ scores from day 30 (P < 0.0001), daytime scores from day 30 (P < 0.05), nighttime scores from day 30 (P < 0.0001), and rescue medication use from day 15 (P < .0001) at a faster rate than doxofylline or tiotropium with budesonide. No patients discontinued the treatment because of adverse reactions.. Among the tested second-line treatment regimens, the budesonide/montelukast combination was found to be superior to either the budesonide/doxofylline or budesonide/tiotropium combination in all the outcome measures without adversely affecting the tolerability of the patients. Further clinical studies with blinding techniques are likely to be useful.

Topics: Acetates; Adolescent; Adult; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Male; Quinolines; Respiratory Function Tests; Sulfides; Theophylline; Tiotropium Bromide

To investigate the clinical efficacy of montelukast plus budesonide nasal spray and desloratadine citrate disodium tablets on moderate and severe persistent allergic rhinitis.. Senenty patients with moderate and severe persistent allergic rhinitis were devided randomly study group (n = 35) and control group (n = 35). The study group were treated with montelukast sodium tablets combined with budesonide nasal spray and desloratadine citrate disodium tablets for 4 weeks, the control group received budesonide nasal spray and desloratadine citrate disodium tablets for 4 weeks. Comparing visual analogue scale (VAS) scores of nasal symptoms, rhino conjunctivitis quality of life questionnaire (RQLQ) scores and total effective rate in two groups at baseline and after treatment.. (1) VAS scores of nasal symptoms: the difference of total nasal symptoms VAS scores or single nasal symptom VAS scores from both groups at 2 weeks and 4 weeks after treatment were statistically significant (P < 0.05); (2) RQLQ scores: the difference of RQLQ scores of 2 group's at baseline and 4 weeks after treatment were statistically significant, the difference of RQLQ scores about nasal symptoms in two groups at 4 weeks after treatment were statistically significant (P < 0.05); (3) The total effective rate was 94.29% in study group but 80.00% in control group, the differences were statistically significant (P < 0.05).. Montelukast plus budesonide nasal spray and desloratadine citrate disodium tablets can work together better on relieving clinical syptoms quickly and promoting the life quality of patients with moderate and severe persistent allergic rhinitis.

Topics: Acetates; Budesonide; Cyclopropanes; Humans; Loratadine; Nasal Sprays; Quinolines; Rhinitis, Allergic, Perennial; Sulfides; Surveys and Questionnaires

To compare the efficacy of oral Montelukast and inhaled Budesonide as a first line preventive therapy in mild persistent asthma in age group 2-18 y.. This prospective randomized controlled clinical study was conducted for 12 wk. Sixty patients of mild persistent asthma aged 2 to 18 y were randomly allocated to either oral Montelukast (n = 60) or inhaled Budesonide (n = 60) group. Outcomes measured were improvement in peak expiratory flow rate (PEFR), forced expiratory volume 1 s/forced vital capacity (FEV1/FVC), day time and night time symptoms and frequency of exacerbations and need to change medications.. There was significant improvement in PEFR, FEV1/FVC, day time and night time symptoms and frequency of exacerbations in both groups. However, more significant improvement in FEV1/FVC (CI 95 %, p = 0.029) and day time symptoms (CI 95 %, p = 0.002) was seen in Budesonide group compared to Montelukast group.. The present study suggests that oral Montelukast is not inferior to Budesonide in treatment of mild persistent asthma in 2 to 18 y children in terms of control of symptoms and improvement in pulmonary function tests over a 12 wk period. However, there was more significant improvement in day time symptoms, more significant increase in FEV1/FVC ratio and less exacerbation in patients receiving Budesonide compared to those receiving Montelukast. However, side effects due to long term use of steroids such as growth stunting and bone osteopenia should also be considered before recommending. Trial registered at CTRI no. REF/2012/09/004035.

Topics: Acetates; Adolescent; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Cyclopropanes; Female; Humans; Male; Prospective Studies; Quinolines; Severity of Illness Index; Sulfides

There is no comparative study among asthma patients receiving first-line versus various second-line treatment regimens for mild to moderate persistent asthma.. We assessed the pulmonary function in asthma patients receiving montelukast, doxofylline, and tiotropium with budesonide in a pilot group.. Patients were recruited as per the study criteria and randomly allocated to 4 groups to receive budesonide (400 µg) with formoterol (12 µg), doxofylline (400 mg), montelukast (10 mg), or tiotropium (18 µg) for a period of 3 months. Outcomes included forced expiratory volume in 1 second (FEV1) and rescue medication use.. A total of 167 patients were recruited; among them, 123 patients completed the study. At baseline, no significant difference (P > 0.05) was observed in any of the outcome measures. Significant within-group improvement in FEV1 was observed in all the groups. At day 90, between-group difference revealed that improvement in FEV1 was significantly (P < 0.05) high for budesonide plus formoterol followed by budesonide plus doxofylline, budesonide plus montelukast, and, lastly, budesonide plus tiotropium. Similarly, within-group comparison revealed a significant (P < 0.05) reduction in rescue medication use in all the groups. The intensity in decrease was more in budesonide plus formoterol group followed by budesonide plus doxofylline, budesonide plus montelukast, and budesonide plus tiotropium groups.. On the basis of our findings, among the second-line treatment regimens, budesonide plus doxofylline and budesonide plus montelukast was found to be better than budesonide plus tiotropium in patients with mild to moderate persistent asthma. Further studies with a larger sample size are likely to be useful.

Topics: Acetates; Adult; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Drug Therapy, Combination; Female; Forced Expiratory Volume; Formoterol Fumarate; Humans; Male; Middle Aged; Quinolines; Respiratory Function Tests; Sulfides; Theophylline; Tiotropium Bromide

Budesonide inhalation suspension (BIS) and montelukast provide acceptable asthma control, whereas overall measures favored BIS in children aged 2 to 8 years with mild persistent asthma.. We compared BIS and montelukast over a 1-year period in children aged 2 to 4 years with asthma.. Data were derived from a 52-week, open-label, randomized, active-controlled, multicenter study (NCT00641472). Children with mild asthma received either BIS 0.5 mg or montelukast 4 to 5 mg once daily. Patients were stepped up to twice-daily BIS or oral corticosteroids for mild or severe asthma worsening, respectively. Primary efficacy assessment was time to first additional asthma medication for exacerbation over 52 weeks.. Two hundred two patients, age 2 to 4 years, received BIS (n = 105) or montelukast (n = 97). No difference was observed between the BIS and montelukast groups in median time to first additional asthma medication over 52 weeks (183 vs 86 days). Statistically significant differences were observed in favor of BIS over montelukast in the percentage of patients requiring oral steroids at 52 weeks (21.9% vs 37.1%; P = .022), the rate (number/patient/year) of additional courses of medication (1.35 vs 2.30; P = .003), the rate of additional oral steroid therapy (0.44 vs 0.88; P = .008), and caregivers' ability to manage the patient's symptoms (P = .026). Both treatments were well tolerated.. BIS and montelukast provided acceptable asthma control in children aged 2 to 4 years with mild persistent asthma with no significant difference between treatments in the primary end point; however, several secondary outcomes showed statistically significant differences (and many had numerical differences) in favor of BIS over montelukast.

Topics: Acetates; Administration, Inhalation; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Budesonide; Child, Preschool; Cyclopropanes; Drug Administration Schedule; Female; Humans; Male; Quinolines; Sulfides; Suspensions; Treatment Outcome

Topics: Acetates; Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma, Exercise-Induced; Budesonide; Child; Cyclopropanes; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Leukotriene Antagonists; Male; Placebos; Quinolines; Receptors, Leukotriene; Signal Transduction; Sulfides

Severe asthma remains a worldwide medical problem. However, this disease has not been adequately explored in the elderly. This study was performed to determine how the addition of montelukast to antiasthmatic therapy improves the control of severe asthma in elderly patients.. Elderly patients (>60 years old) with diagnoses of severe asthma were observed over 24 months of therapy: the first 12 months using inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) and the second 12 months with oral montelukast added in two-thirds of the patients, with the remaining third representing the control group. The primary efficacy endpoint of the study was the percentage of days without asthma symptoms in the first 12 months of treatment compared with the percentage after adding montelukast therapy.. A total of 512 elderly, asthmatic patients were included in the study: seventy-one (13.9%) patients had well-controlled asthma, 211 (41.2%) had partly controlled asthma, and 230 (44.9%) had uncontrolled asthma. During the first year of treatment using ICS and LABA, an increase in the median percentage of days without asthma was observed from 50.1% to 62.1%, as well as a decrease in the percentage of days with short beta-receptor agonist use, from 52.2% to 46.8%. These differences were significantly greater after 12 months, when montelukast was added to the therapy (78.4% and 39.5%, respectively). This improvement was not observed in the control group. After 2 years of observation, the median number of asthma exacerbation incidents per patient decreased from 1.6 per year to 1.2 per year when montelukast was added.. Severe asthma in elderly patients is very poorly treated, with this population exhibiting very low compliance with antiasthmatic therapy. Adding montelukast provides benefits and improved control; however, it does not resolve severe asthma control problems.

Topics: Acetates; Administration, Inhalation; Age Factors; Aged; Aged, 80 and over; Albuterol; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Chi-Square Distribution; Cyclopropanes; Drug Therapy, Combination; Female; Humans; Leukotriene Antagonists; Male; Middle Aged; Quinolines; Salmeterol Xinafoate; Spirometry; Sulfides; Surveys and Questionnaires

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.. 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.. 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.. 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.. 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).

Topics: Acetates; Adult; Aged; Bronchitis; Bronchodilator Agents; Budesonide; Chronic Disease; Cough; Cyclopropanes; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Leukotriene Antagonists; Male; Middle Aged; Pilot Projects; Pulmonary Eosinophilia; Quinolines; Sulfides; Treatment Outcome; Young Adult

The adverse effect of inhaled corticosteroids (ICS) treatment on bone metabolism in children with asthma is still controversial, and a possible beneficial effect of vitamin D added to ICS on bone turnover is uncertain.. We conducted a randomized, double-blind, parallel-group, 6-month trial to assess the effects of a medium and high dose of ICS and a high-dose ICS with vitamin D on bone metabolism in children with newly diagnosed atopic asthma.. 96 children were equally randomized to 4 groups receiving the following doses of inhaled budesonide [μg/day]: 400 (ICS 400 group), 800 (ICS 800 group), 800 with oral vitamin D (ICS 800 with vit D group), and montelukast as a control (control group). Markers of bone production (osteocalcin, alkaline phosphatase) and bone degradation (amino-terminal cross-linked telopeptide of type I collagen--NTx, carboxy-terminal telopeptides of type I collage), and also concentration of 25-hydroxycholecalciferol (25OH D) and calcium-phosphorus balance (calcium, phosphorus, parathormon-PTH) in serum and/or urine were assessed twice: before and after 6 months of treatment.. We obtained a significant decrease in phosphorus and PTH serum levels in ICS 400 and ICS 800 with vit D groups compared to control group, and a significant decrease of NTx urine level in ICS 800 with vit D group.. Medium doses of inhaled corticosteroids exert an advantageous effect on bone metabolism in newly diagnosed asthmatic children. Vitamin D together with a high dose of inhaled corticosteroids has a beneficial effect on both calcium-phosphorus balance and collagen turnover.

Topics: Acetates; Administration, Inhalation; Adolescent; Asthma; Bone and Bones; Budesonide; Child; Child, Preschool; Cyclopropanes; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Parathyroid Hormone; Phosphorus; Quinolines; Sulfides

Eosinophil is considered to be a main protagonist in asthma; however, often discordances between clinical manifestations and response to treatment are observed. We aimed to determine the occurrence of neutrophil predominance in asthma and to identify its characteristics on the basis of clinical-functional features, induced sputum cellular pattern and soluble molecules, to guide the appropriated anti-inflammatory therapy. A total of 41 patients were included in randomized groups: 21-40 year-old, with stable mild-to-severe asthma, steroid-naïve and non-smokers. An induced sputum sample was obtained under basal conditions, a second one after treatment with budesonide (400 ug b.i.d.) or montelukast (10 mg/d) for six weeks, and a final one after a 4-week washout period. By cytospin we evaluated eosinophil (EP) or neutrophil predominance (NP), and in supernatant we determined LTE4, and CC16. Peak expiratory flow variability (PEFV) was measured. A total of 23/41 patients corresponded to EP and 18/41 patients to NP. The PEFV was higher in EP than in NP. LTE4 was higher with NP than with EP. No difference was found for CC16. Montelukast reduced the predominant cell in both subsets, whereas budesonide only reduced eosinophils in EP. Budesonide and montelukast reduced PEFV in EP but not in NP. Considering the total treated-samples in each subset, CC16 level increased significantly in EP.. a NP subset of asthmatic patients was identified. These patients show a lower bronchial lability; the leukotriene pathway is involved which responds to anti-leukotriene treatment. This phenotype shows a poor recovery of CC16 level after treatment.

Topics: Acetates; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Budesonide; Cell Count; Cyclopropanes; Drug Therapy, Combination; Eosinophils; Female; Humans; Male; Neutrophils; Quinolines; Severity of Illness Index; Single-Blind Method; Sputum; Sulfides; Uteroglobin; Young Adult

There is a lack of evidence for treatment of newly diagnosed asthma, and they are based mainly on expert opinion. This pilot study was aimed at evaluating the effects of inhaled corticosteroid (ICS) in two different doses and montelukast sodium on clinical symptoms and lung function in children with newly diagnosed asthma. This was a randomized, double-blind, parallel-group, 12-month pilot trial, studying the effects of budesonide 800 mcg/day and 400 mcg/day and montelukast 5 or 10 mg tablet according to age on clinical symptoms and lung function in 60 children with newly diagnosed asthma. After 6 months of treatment with different doses of inhaled budesonide and montelukast sodium, asthma control and lung function significantly improved in all three groups of treatment; there were no differences between groups. We found significant correlation between time of enrollment and individual answer to the treatment in montelukast group only; children enrolled later (at the end of heating season) responded better to treatment. The answer to both ICS doses was independent from time of enrollment. The results of the present pilot study suggest that natural exposure, even to perennial allergens, should be considered in choosing the initial asthma treatment. We showed that montelukast may be used as initial asthma therapy in children allergic to house-dust mites preferably at the end of the heating season. Therefore, ICS could be a better choice as initial asthma therapy during maximum allergen exposure.

Topics: Acetates; Administration, Inhalation; Adolescent; Animals; Antigens, Dermatophagoides; Asthma; Budesonide; Child; Child, Preschool; Cyclopropanes; Evidence-Based Medicine; Female; Humans; Male; Pilot Projects; Pyroglyphidae; Quinolines; Respiratory Function Tests; Sulfides

Allergen-specific immunotherapy (SIT) is the only available potentially curative approach in the management of allergic diseases. Therapies that boost regulatory T cell induction during SIT might further enhance its effectiveness.. The purpose of this study was to assess the effect of montelukast treatment on early clinical and immunologic effects of allergen-specific immunotherapy in children with asthma.. It was a randomized, double-blind, placebo-controlled trial conducted in 36 children with asthma and allergy to house dust mites who required from 400 to 800 microg of inhaled budesonide per day during the 7-month run-in period. Patients were randomly allocated to receive 5 mg montelukast daily (n = 18) or placebo (n = 18) as an addition to inhaled corticosteroid (ICS) treatment during the 3-month build-up phase of SIT, when modification of ICS doses was not allowed. During the 7 months of the maintenance phase of SIT, ICS doses were adjusted to control the asthma symptoms.. After 12 months of SIT, a reduction of the median daily ICS dose, necessary to control asthma symptoms, was 16.7% grater in patients from the placebo group than in patients from the montelukast group. Intervention with montelukast significantly impaired the induction of regulatory T lymphocytes. During the build-up phase of SIT, patients in the placebo group frequently experienced an increase in asthma symptoms leading to exclusions from the per protocol population.. Our study failed to show a beneficial effect of montelukast on SIT. In fact, quite the opposite occurred: compared with placebo, montelukast intervention led to less effectiveness of SIT.

Topics: Acetates; Administration, Inhalation; Animals; Anti-Asthmatic Agents; Antigens, Dermatophagoides; Asthma; Budesonide; Chemotherapy, Adjuvant; Child; Cyclopropanes; Desensitization, Immunologic; Double-Blind Method; Follow-Up Studies; Humans; Lymphocyte Activation; Pyroglyphidae; Quinolines; Sulfides; T-Lymphocytes, Regulatory; Time Factors

To evaluate the efficacy of add-on montelukast on asthma control and allergic rhinitis symptoms in asthmatic patients still symptomatic with chronic treatment with inhaled corticosteroid and long-acting beta(2) agonist (ICS/LABA), irrespective of the dose.. This 2-month, open-label, real-life, multicentre, observational study was undertaken by 499 general practitioners in Belgium. Patients (>or= 4 years old) with uncontrolled asthma despite fluticasone/salmeterol or budesonide/formoterol therapy had oral montelukast 4, 5, or 10 mg daily added to their therapy, depending on the registered dose for their age. Asthma control, assessed by the 6-item Juniper Asthma Control Questionnaire (ACQ) was recorded at baseline and after 2 months of treatment with montelukast and the patients' global evaluation of asthma was also recorded at the end of the study. Concomitant allergic rhinitis symptoms were evaluated according to the patients' perception.. A total of 5769 patients were eligible for analysis. Addition of montelukast was associated with significant decrease in mean (SD) ACQ score (from 1.97 [0.77] at baseline to 1.05 [0.69] after add-on treatment, p < 0.001). There was also a significant improvement in all individual symptoms of the ACQ score (p < 0.001). After 2 months, 89% of the patients reported global improvement of their asthma, with a good correlation between patients' global evaluation and change in ACQ scores. Of the 2442 patients who reported allergic rhinitis symptoms at baseline, 91% showed a global improvement of their asthma symptoms and 82% in their rhinitis symptoms after adding montelukast.. This open-label observational study showed an improvement, after 2 months of add-on therapy with montelukast, in both asthma and allergic rhinitis symptoms in patients not adequately controlled on a fixed association of ICS/LABA.

Topics: Acetates; Adult; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Belgium; Budesonide; Cyclopropanes; Drug Therapy, Combination; Ethanolamines; Female; Fluticasone; Formoterol Fumarate; Humans; Male; Middle Aged; Quinolines; Salmeterol Xinafoate; Sulfides; Surveys and Questionnaires

To examine parent-reported signs and symptoms as antecedents of wheezing in preschool children with previous moderate to severe wheezing episodes, and to determine the predictive capacity of these symptom patterns for wheezing events.. Parents (n = 238) of children age 12 to 59 months with moderate-to-severe intermittent wheezing enrolled in a year-long clinical trial completed surveys that captured signs and symptoms at the start of a respiratory tract illness (RTI). Sensitivity, specificity, negative predictive value, and positive predictive value (PPV) for each symptom leading to wheezing during that RTI were calculated.. The most commonly reported first symptom categories during the first RTI were "nose symptoms" (41%), "significant cough" (29%), and "insignificant cough" (13%). The most reliable predictor of subsequent wheezing was significant cough, which had a specificity of 78% and a PPV of 74% for predicting wheezing.. Significant cough is the most reliable antecedent of wheezing during an RTI. It may be useful to consider individualized symptom patterns as a component of management plans intended to minimize wheezing episodes.

Topics: Acetates; Adult; Albuterol; Anti-Asthmatic Agents; Asthenia; Bronchodilator Agents; Budesonide; Causality; Child, Preschool; Cough; Cyclopropanes; Double-Blind Method; Female; Glucocorticoids; Humans; Infant; Male; Quinolines; Respiratory Sounds; Respiratory Tract Infections; Sensitivity and Specificity; Socioeconomic Factors; Sulfides; Surveys and Questionnaires

Clinical trials in children with moderate-to-severe persistent asthma are limited.. We sought to determine whether azithromycin or montelukast are inhaled corticosteroid sparing.. The budesonide dose (with salmeterol [50 microg] twice daily) necessary to achieve control was determined in children 6 to 17 years of age with moderate-to-severe persistent asthma. After a budesonide-stable period of 6 weeks, children were randomized in a double-masked, parallel, multicenter study to receive once-nightly azithromycin, montelukast, or matching placebos plus the established controlling dose of budesonide (minimum, 400 microg twice daily) and salmeterol twice daily. Primary outcome was time from randomization to inadequate asthma control after sequential budesonide dose reduction.. Of 292 children screened, only 55 were randomized. Inadequate adherence to study medication (n = 80) and improved asthma control under close medical supervision (n = 49) were the major reasons for randomization failure. A futility analysis was requested by the Data Safety Monitoring Board. In data available for analyses, no differences were noted for either treatment compared with placebo in time to inadequate control status (median: azithromycin, 8.4 weeks [95% confidence limit, 4.3-17.3]; montelukast, 13.9 weeks [95% confidence limit, 4.7-20.6]; placebo, 19.1 weeks [95% confidence limit, 11.7-infinity]), with no difference between the groups (log-rank test, P = .49). The futility analysis indicated that even if the planned sample size was reached, the results of this negative study were unlikely to be different, and the trial was prematurely terminated.. Based on these results, neither azithromycin nor montelukast is likely to be an effective inhaled corticosteroid-sparing alternative in children with moderate-to-severe persistent asthma.

Topics: Acetates; Adolescent; Albuterol; Anti-Bacterial Agents; Asthma; Azithromycin; Bronchodilator Agents; Budesonide; Child; Cyclopropanes; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Medication Adherence; Quinolines; Salmeterol Xinafoate; Severity of Illness Index; Sulfides; Time Factors

Acute wheezing illnesses in preschoolers require better management strategies to reduce morbidity.. We sought to examine the effectiveness of episodic use of an inhaled corticosteroid and a leukotriene receptor antagonist in preschoolers with intermittent wheezing.. In a randomized, double-blind, placebo-controlled 12-month trial, 238 children aged 12 to 59 months with moderate-to-severe intermittent wheezing received 7 days of either budesonide inhalation suspension (1 mg twice daily), montelukast (4 mg daily), or placebo in addition to albuterol with each identified respiratory tract illness (RTI). Proportion of episode-free days (EFDs) during the 12-month trial was the primary outcome.. The 3 treatment groups did not differ in proportions of EFDs, with adjusted mean EFDs of 76% (95% CI, 70% to 81%) for budesonide, 73% (95% CI, 66% to 79%) for montelukast, and 74% (95% CI, 65% to 81%) for conventional therapy (P = .66). The 3 groups did not differ in oral corticosteroid use, health care use, quality of life, or linear growth. However, during RTIs, budesonide and montelukast therapy led to modest reductions in trouble breathing (38% [P = .003] and 37% [P = .003], respectively) and interference with activity scores (32% [P = .01] and 40% [P = .001], respectively) that were most evident in those with positive asthma predictive indices.. In preschool children with moderate-to-severe intermittent wheezing, episodic use of either budesonide or montelukast early in RTIs, when added to albuterol, did not increase the proportion of EFDs or decrease oral corticosteroid use over a 12-month period. However, indicators of severity of acute illnesses were reduced, particularly in children with positive asthma predictive indices.

Topics: Acetates; Administration, Inhalation; Albuterol; Bronchodilator Agents; Budesonide; Child, Preschool; Cyclopropanes; Double-Blind Method; Female; Glucocorticoids; Humans; Infant; Leukotriene Antagonists; Male; Quinolines; Respiratory Sounds; Respiratory Tract Diseases; Sulfides

To examine the potential of montelukast, a leukotriene receptor antagonist, as an adjunct to oral and inhaled steroid in subjects with chronic nasal polyps.. Prospective, randomized controlled trial.. Thirty-eight consecutive adult patients with bilateral nasal polyps were randomized into two groups. Eighteen subjects were treated with oral prednisolone for 14 days and budenoside nasal spray for 8 weeks. Twenty subjects received similar treatment with additional oral montelukast for 8 weeks. Subjects completed a modified nasal ICSD symptom score at 8 and 12 weeks after beginning treatment and the SF-36 quality of life questionnaire at 12 weeks.. Symptom scores improved in both groups after treatment. Subjects treated with montelukast reported significantly less headache (P = 0.013), facial pain (P = 0.048) and sneezing (P = 0.03) than controls. Four weeks after completing treatment, no significant differences were recorded.. Montelukast therapy may have clinical benefit as an adjunct to oral and inhaled steroid in chronic nasal polyposis, but effects are not maintained after cessation of treatment.

Topics: Acetates; Administration, Inhalation; Administration, Oral; Adult; Aged; Aged, 80 and over; Budesonide; Cohort Studies; Cyclopropanes; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Leukotriene Antagonists; Male; Middle Aged; Nasal Polyps; Prednisolone; Quinolines; Sulfides; Treatment Outcome

Exercise-induced bronchoconstriction occurs in a large proportion of children with asthma, limiting everyday activities important for their physical and social development.. The purpose of this randomized, double-blind, placebo-controlled study was to compare the ability of different patterns of antiasthmatic treatment, recommended in childhood asthma, to protect patients from exercise-induced bronchoconstriction.. Children 6 to 18 years of age with atopic asthma were randomized to a 4-week, placebo-controlled, double-blind trial. Patients were randomly allocated to receive daily 200 microg budesonide (twice daily, 100 microg per dose) + 9 microg formoterol (twice daily, 4.5 microg per dose; n = 20); 200 microg budesonide + 5 or 10 mg montelukast (once daily at bedtime; n = 20); 5 or 10 mg montelukast (n = 20); 200 microg budesonide (n = 20); or placebo (n = 20). A standardized treadmill exercise challenge was performed before and after treatment.. Exercise-induced bronchoconstriction, reflected by area under the curve for the FEV1 values from exercise over the 20-minute period and by maximum percent fall in FEV1 after exercise, was significantly diminished after 4 weeks in all active treatment groups, and compared with placebo. Exercise-induced bronchoconstriction protection improved more significantly in the budesonide + montelukast and montelukast groups compared with other therapeutic options.. These data indicate differences in effects on exercise-induced bronchoconstriction between therapeutic options recommended in childhood asthma. Control of childhood asthma with exercise-induced bronchoconstriction can be obtained by using regular controller treatment.

Topics: Acetates; Adolescent; Anti-Asthmatic Agents; Antigens, Dermatophagoides; Asthma; Bronchoconstriction; Bronchodilator Agents; Budesonide; Child; Cyclopropanes; Double-Blind Method; Drug Therapy, Combination; Ethanolamines; Exercise; Female; Forced Expiratory Volume; Formoterol Fumarate; Glucocorticoids; Humans; Hypersensitivity; Male; Quinolines; Sulfides; Treatment Outcome

Pulmonary function tests (PFTs) and especially spirometry measures are useful tools in evaluating early response to treatment of asthma in children mainly due to their worldwide availability. The aim of our study was to determine the effects of anti-asthma treatment in children, equally on FEV(1), FEF25-75%, R(int) and SR(aw) values.. Children 6-18 years of age with moderate atopic asthma were randomized to 4-week, placebo-controlled, double-blind trial. Patients were randomly allocated to receive 200 microg budesonide (B) (n=29), 5 or 10 mg (according to age) montelukast (M) (n=29), 200 microg B + 5 or 10 mg M (n=29), 200 microg B + 9 microg formoterol (F) (n=29) or placebo (n=27). FEV(1,) FEF25-75%, R(int), SR(aw) were measured before and after treatment.. R(int), SR(aw), FEV(1) improved significantly in all active treatment groups while FEF25-75% improved significantly only in BM group and M group. Combination therapy, showed significantly greater effects on R(int) than monotherapy: BM group compared to B group (P=0.01) and M group (P=0.03) and BF group compared to B group (P=0.01) and M group (P=0.04).. This study shows that using single parameter for monitoring asthma can be misleading. Using combination of lung function techniques provides better assessment of treatment. Results of our study confirm this hypothesis. The best effect on large and small airways was achieved with combined anti-inflammatory therapy.

Topics: Acetates; Adolescent; Airway Resistance; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Child; Cyclopropanes; Double-Blind Method; Drug Therapy, Combination; Ethanolamines; Female; Forced Expiratory Volume; Formoterol Fumarate; Humans; Male; Maximal Midexpiratory Flow Rate; Plethysmography, Whole Body; Quinolines; Respiratory Function Tests; Sulfides

Montelukast and ketotifen are oral anti-allergy medications in asthmatic children. This study investigates the modulation effect of montelukast and ketotifen on children with intermittent to mild persistent asthma as demonstrated by the levels of peak expiratory flow (PEF), asthma scores (AS), exhaled nitric oxide (eNO) and plasma stromal cell-derived factor-1 (SDF-1) concentration in a randomized, prospective study.. Fifty asthmatic children were enrolled and received 8 weeks of treatment with oral montelukast sodium 5mg chewable tablet administered once daily, or 1mg ketotifen, and were followed for a 4-week post-treatment washout period. ENO concentration, AS and PEF were measured before, 2, 4, 6 and 8 weeks after initial treatment, and 4 weeks after cessation of treatment.. Montelukast therapy was showed to improve AS, PEF and eNO within 2 weeks and remained the improvement during the treatment period. Montelukast also significantly decreased plasma SDF-1 levels after 8 weeks of treatment. In contrast, the ketotifen treatment revealed no significant effects in these clinical parameters until 4 and 6 weeks of the therapy, and did not suppress plasma SDF-1 levels after 8 weeks of treatment. To prove whether montelukast directly suppressed SDF-1 induction, we studied effects of montelukast on the LPS-induced SDF-1 expression and SDF-1-induced chemotaxis of monocytic (THP-1) cells. Montelukast, but not ketotifen, could suppress SDF-1 expression and its related chemotaxis on THP-1 monocytic cells.. Leukotriene receptor antagonist, such as montelukast, may be a better non-steroid anti-inflammatory drug for mild childhood asthma in preventing airway inflammation.

Topics: Acetates; Administration, Oral; Adolescent; Anti-Allergic Agents; Anti-Asthmatic Agents; Asthma; Budesonide; Calcium; Cell Line; Cell Movement; Chemokine CXCL12; Chemokines, CXC; Chemotaxis; Child; Cyclopropanes; Dose-Response Relationship, Drug; Double-Blind Method; Exhalation; Female; Flavonoids; Humans; Ketotifen; Male; Monocytes; Nitric Oxide; Peak Expiratory Flow Rate; Prospective Studies; Quinolines; Sulfides

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

Topics: Acetates; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Breath Tests; Bronchodilator Agents; Budesonide; Child; Cyclopropanes; Double-Blind Method; Drug Therapy, Combination; Ethanolamines; Female; Formoterol Fumarate; Humans; Male; Nitric Oxide; Quinolines; Sulfides

Many patients with asthma remain symptomatic with impaired airway function on inhaled steroids. This study investigates the relationship between the clinical effect seen in response to additional treatment and the effect on airway inflammatory indices. Seventy-five adult asthmatic patients, incompletely controlled on 800 mcg budesonide/day, were randomised following a 4 week run-in period, to a double-blind, multi-centre controlled clinical trial of doubling inhaled corticosteroid (budesonide 1600 mcg/day) or adding 10mg montelukast for 12 weeks. Induced sputum was collected at baseline and end of treatment and analysed for eosinophil and neutrophil percentages, leukotrienes C4, D4 and E4, IL-8, Eosinophil Cationic Protein (ECP) and histamine. Sputum evidence of inflammation (2.0% eosinophils) was seen in only 29% of these patients and the percentage of eosinophils and other markers of airway inflammation did not change over the study period in either treatment group. There were significant improvements in am PEF (montelukast: 31.7 L/min, budesonide: 32.3 L/min) and quality of life with both treatments. We conclude that while both treatments showed similar improvements in lung function and quality of life, there was no evidence from these sputum markers measured that the effects were mediated via a reduction in airway inflammation or that the level of pre-treatment markers was associated with outcome.

Topics: Acetates; Administration, Inhalation; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Double-Blind Method; Female; Humans; Male; Middle Aged; Quinolines; Sputum; Sulfides; Treatment Outcome

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.. 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 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.. 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.

Topics: Acetates; Administration, Intranasal; Administration, Oral; Adolescent; Anti-Allergic Agents; Anti-Asthmatic Agents; Breath Tests; Budesonide; Child; Child, Preschool; Cromolyn Sodium; Cyclopropanes; Drug Therapy, Combination; Female; Follow-Up Studies; Glucocorticoids; Humans; Leukotriene Antagonists; Loratadine; Male; Nitric Oxide; Peak Expiratory Flow Rate; Quinolines; Rhinitis, Allergic, Perennial; Single-Blind Method; Sulfides; Treatment Outcome

Guidelines recommend daily controller therapy for mild persistent asthma. Montelukast has demonstrated consistent benefit in controlling symptoms of asthma and may be an alternative, orally administered, nonsteroidal agent for treating mild asthma.. To determine whether montelukast is as effective as budesonide in controlling mild persistent asthma as determined by FEV(1).. Between November 2003 to October 2005, participants aged 5-15 years with recently diagnosed mild persistent asthma (n = 62) were randomized to oral montelukast (5 mg daily) [N(1) = 30] or inhaled budesonide (400 microg per day in two doses) [N(2) = 32] in a single center, double-blind study.. Baseline demographic and spirometric parameters were comparable. The median (95% confidence interval) percentage predicted FEV(1) was similar in the two groups after 12 weeks of treatment (budesonide: 76.70 (67.96-90.53%), montelukast: 75 (67.40-88.47)%; p = 0.44). There was similar improvement in spirometric parameters and clinical symptom scores in both the groups. There was no statistically significant difference between the groups in the need for rescue drugs as well as side effects reported by parents.. Montelukast is as effective as inhaled budesonide in the treatment of mild persistent asthma in children aged 5-15 years. Montelukast may be used as an alternative to low dose inhaled corticosteroids for management of mild persistent asthma.

Topics: Acetates; Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Budesonide; Child; Child, Preschool; Chronic Disease; Cyclopropanes; Double-Blind Method; Female; Forced Expiratory Volume; Humans; India; Male; Quinolines; Sulfides

Inhaled corticosteroids and anti-leukotriene agents are widely used in the treatment of pediatric asthma. Although data on the effect of corticosteroids on growth are available, there are few such data on anti-leukotriene agents. The aim of this study was to assess the influence of montelukast on short-term lower leg growth rate (LLGR) in prepubertal children with asthma.. Forty-two boys (6- to 12-year old) and 29 girls (6- to 11-year old) with mild asthma were randomized to 1 of 2 crossover arms, with two treatment sequences per arm: montelukast 5 mg once daily/placebo or inhaled dry powder budesonide 200 microg twice daily/placebo. Budesonide was used as a positive control to ensure that the method was sensitive enough to detect a suppression of LLGR. The 3-week double-blind treatment period was followed by a 3-week washout. Primary outcome was LLGR over the 3-week treatment, measured by knemometry.. Ninety-four percent of patients completed the study. Mean LLGR was similar between patients receiving montelukast and placebo treatments: mean difference, -0.02 mm/week [95% confidence interval -0.14, 0.11]. Mean LLGR in patients receiving budesonide was significantly less than for those receiving placebo (difference of -0.16 mm/week [-0.25, -0.06], P = 0.002). Mean LLGR was similar for patients taking placebo in the two arms (0.43 and 0.44 mm/week).. Montelukast 5 mg did not significantly affect short-term LLGR in prepubertal children.

Topics: Acetates; Anti-Asthmatic Agents; Asthma; Body Height; Budesonide; Child; Cyclopropanes; Double-Blind Method; Female; Humans; Leg; Male; Quinolines; Sulfides; Treatment Outcome

Budesonide inhalation suspension and the leukotriene receptor antagonist montelukast have demonstrated efficacy in children with mild persistent asthma, but comparative long-term studies in young children are needed.. To compare the long-term efficacy and safety of budesonide inhalation suspension and montelukast.. After a run-in period, children 2 to 8 years old with mild asthma or recurrent wheezing were randomized to once-daily budesonide inhalation suspension 0.5 mg or once-daily oral montelukast 4 or 5 mg for 52 weeks. Subjects were stepped up to twice-daily budesonide inhalation suspension or oral corticosteroids for mild or severe asthma worsening, respectively. The primary outcome was time to first additional medication for asthma worsening at 52 weeks. Secondary variables included times to the first additional asthma medication measured at 12 and 26 weeks; times to the first asthma exacerbation (mild and severe) measured at 12, 26, and 52 weeks; exacerbation rates (mild and severe) over a period of 52 weeks; diary variables (eg, peak expiratory flow [PEF]); patient-reported outcomes; and Global Physician and Caregiver Assessments.. No significant between-group differences were observed for time to first additional asthma medication at 52 weeks; however, time to first additional asthma medication was longer (unadjusted P = .050) at 12 weeks and exacerbation rates were lower over a period of 52 weeks (unadjusted P = .034) for budesonide versus montelukast. Time to first severe exacerbation (requiring oral corticosteroids) was similar in both groups, but the percentage of subjects requiring oral corticosteroids over a period of 52 weeks was lower with budesonide (25.5% vs 32.0%). Peak flow and Caregiver and Physician Global Assessments favored budesonide.. Both treatments provided acceptable asthma control; however, overall measures favored budesonide inhalation suspension over montelukast.. These findings are consistent with studies in older children demonstrating better outcomes with inhaled corticosteroids versus montelukast.

Topics: Acetates; Administration, Inhalation; Age Factors; Anti-Asthmatic Agents; Asthma; Budesonide; Child; Child, Preschool; Cyclopropanes; Female; Humans; Infant; Infant, Newborn; Male; Quinolines; Sulfides; Treatment Outcome

The motive behind conducting this study was to determine if better control of asthma can be achieved by adding a second controller medication and to assess its use to reduce the dose of inhaled steroids.. The study aimed to determine whether either oral sustained-release theophylline or montelukast added to inhaled steroids improved clinical symptoms and pulmonary function test parameters when compared to high-dose steroids alone.. Ninety patients with incompletely controlled asthma were allocated, in a randomised, double-blind fashion, to one of three treatment groups: group A: double dose of inhaled budesonide (400 microg b.i.d.), group B: 400 mg oral sustained-release theophylline plus budesonide (200 microg b.i.d.) and group C: 10 mg montelukast plus budesonide (200 microg b.i.d.). The primary endpoints were forced expiratory volume in 1 s (FEV(1)) and mean morning peak expiratory flow rate (PEFR).. All three groups had improved FEV(1) and PEFR at 8 weeks (p < 0.001). Group C increased their PEFR by 18.7 l/min (95% confidence interval, CI, 12.4-25.1) more than group A and by 19.8 l/min (95% CI 13.4-26.1) more than group B (both p = 0.001). Similarly, group C had a 114 ml (95% CI 45-183 ml) greater improvement in FEV(1) than group A and a 95 ml (95% CI 26-164 ml) greater improvement than group B (both p = 0.01).. Addition of montelukast to budesonide is safe and results in greater improvement in pulmonary function test parameters than high-dose budesonide treatment or addition of theophylline.

Topics: Acetates; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Delayed-Action Preparations; Double-Blind Method; Forced Expiratory Volume; Humans; Middle Aged; Patient Selection; Quinolines; Sulfides; Theophylline

There is increasing evidence that the assessment of eosinophilic airway inflammation using induced sputum and measurement of airway hyperresponsiveness provides additional, clinically important information concerning asthma control. The aim of this study was to directly compare the effects of different treatments on these markers in patients with asthma and persistent symptoms, despite the use of low-dose inhaled corticosteroids. A double-blind four-way crossover study was performed, which compared a 1-month treatment with budesonide 400 mug b.i.d., additional formoterol, additional montelukast and placebo in 49 patients with uncontrolled asthma despite budesonide 100 mug b.i.d., with each treatment separated by a 4-week washout period. The change in sputum eosinophil count with formoterol (2.4 to 3.8% change, 0.6-fold reduction, 95% confidence interval (CI) 0.5-0.9) differed significantly from placebo (2.8 to 2.5% change, 1.1-fold reduction, 95% CI 0.7-1.6) and high-dose budesonide (2.7 to 1.6% change, 1.6-fold reduction, 95% CI 1.2-2.2). The effects of montelukast did not differ from placebo. The changes in methacholine airway responsiveness were small and did not differ between treatments. High-dose budesonide had the broadest range of beneficial effects on other outcomes, including symptom scores, morning peak expiratory flow and forced expiratory volume in one second. In conclusion, treatment given in addition to low-dose inhaled corticosteroids results in modest benefits. Formoterol and high-dose budesonide have contrasting effects on eosinophilic airway inflammation.

Topics: Acetates; Administration, Inhalation; Adult; Aged; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Bronchial Hyperreactivity; Bronchial Provocation Tests; Budesonide; Cross-Over Studies; Cyclopropanes; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Eosinophils; Ethanolamines; Formoterol Fumarate; Glucocorticoids; Humans; Leukocyte Count; Lung Volume Measurements; Male; Methacholine Chloride; Middle Aged; Quinolines; Sputum; Sulfides

Montelukast is reported to be beneficial in asthma as add-on therapy to inhaled corticosteroids and may reduce the need for the latter.. To evaluate whether a combination of oral montelukast and 200 microg of inhaled budesonide has comparable efficacy to 400 microg of inhaled budesonide alone in children with moderate persistent asthma.. In this prospective, blinded, hospital-based randomized controlled trial, 71 children with moderate persistent asthma were randomized to receive either montelukast, 5-mg chewable tablet, with 200 microg of inhaled budesonide or only 400 microg of inhaled budesonide daily for 12 weeks. Baseline and serial measurements of forced expiratory volume in 1 second, peak expiratory flow rate, and Asthma Symptom Score were performed; the frequency and severity of exacerbations were also recorded.. Measurements of forced expiratory volume in 1 second, peak expiratory flow rate, and Asthma Symptom Score showed no significant differences between the 2 groups at baseline, during the serial follow-up visits, and at the end of the study. However, children who received montelukast had a greater frequency of exacerbations vs those who did not (33.3% vs 9.1%; P < .01).. The overall control of asthma with 5 mg of oral montelukast and 200 microg of inhaled budesonide is inferior to that with 400 microg of inhaled budesonide in children with moderate persistent asthma.

Topics: Acetates; Administration, Inhalation; Administration, Oral; Anti-Asthmatic Agents; Asthma; Budesonide; Child; Cyclopropanes; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Humans; Male; Quinolines; Respiratory Function Tests; Sulfides

Montelukast has been shown to be effective in controlling the increase in exhaled NO in asthmatic children re-exposed to house dust mite (HDM). This study compared the effect of low dose inhaled budesonide and oral montelukast in preventing the expected relapse of airway inflammation and reactivity in a group of 24 mild asthmatic children allergic to HDM after a brief period of exposure to relevant allergens.. Lung function, bronchial hyperresponsiveness (BHR) to methacholine (PC(20)), fractional exhaled nitric oxide (FeNO) levels and sputum eosinophilia were evaluated.. Pulmonary function remained stable. The BHR was unchanged after exposure in the group treated with budesonide, whereas a significant increase (P = 0.028) was observed in the patients receiving montelukast. No significant difference was observed in FeNO levels after exposure to mite antigen in the two groups. In both the groups of asthmatic children we observed a significant increase in sputum eosinophil % after the exposure to mite antigen.. The significant increase in BHR level observed in the group of children receiving montelukast suggests a more comprehensive effect as disease controller by inhaled steroids than by leukotriene antagonist in allergic asthmatic children re-exposed to relevant allergens.

Topics: Acetates; Allergens; Anti-Asthmatic Agents; Antigens, Dermatophagoides; Asthma; Bronchial Hyperreactivity; Bronchoconstrictor Agents; Bronchodilator Agents; Budesonide; Child; Cyclopropanes; Eosinophils; Exhalation; Female; Humans; Lung; Male; Methacholine Chloride; Nitric Oxide; Quinolines; Respiratory Function Tests; Sputum; Sulfides

Since IgE is considered to play a crucial role in allergic immune responses, the reduction of free IgE level has been an attractive target in the treatment of allergic diseases. The present study was conducted to determine the effects of a 6-month treatment with different doses of inhaled budesonide and montelukast sodium in children with newly diagnosed atopic asthma.. In this randomized, double-blind, double-dummy trial, 51 children with newly diagnosed asthma and sensitivity to house-dust mites were randomly allocated to receive budesonide (in two different doses 400 or 800 mcg) or montelukast for 6 months. The primary end point was the level of serum total and specific IgE before and after treatment. The secondary end points were clinical parameters and forced expiratory volume in 1s (FEV1).. After 6 months of treatment, a high dose of inhaled corticosteroid and montelukast, significantly decreased levels of total and specific IgE. Medium dose of inhaled corticosteroid had no effect on total and specific IgE serum level. Clinical score and FEV1 significantly improved after 6 months of treatment with medium (P = 0.002) and high dose (P = 0.001) of inhaled budesonide and montelukast (P = 0.002). There were no differences between groups in changes of all clinical parameters after treatment.. Only high doses of inhaled corticosteroids and montelukast decreased the serum IgE levels. Perhaps long-term treatment with montelukast will be beneficial to asthma patients by decreasing IgE levels.

Topics: Acetates; Administration, Inhalation; Administration, Oral; Adolescent; Anti-Asthmatic Agents; Antigens, Dermatophagoides; Asthma; Budesonide; Child; Child, Preschool; Cyclopropanes; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Immunoglobulin E; Male; Quinolines; Severity of Illness Index; Sulfides; Treatment Outcome

Pharmacological therapy with inhaled steroids (IS) is currently considered the gold-standard of treatment for mild-persistent asthma. Leukotriene receptor antagonist drugs (LTRAs) play an important role associated with IS, allowing dose tapering and maintaining control of asthma symptoms. The aim of this study was to determine the effectiveness of montelukast (MON) to allow tapering of the inhaled dose of budesonide (BUD) in patients with mild-moderate persistent asthma. This 16-wk single-blind randomized study included 40 asthmatic patients divided in 2 treatment groups. After a run-in period (4 wk), in which all patients inhaled 400 microg of BUD twice daily (bid), group A (20 patients) received MON (oral, 10 mg/day) combined with inhaled BUD (400 microg/bid), while group B (20 patients) was treated with BUD for the whole period of the study. In both groups, at every 4 wk the dose of BUD was halved. After 12 wk of treatment the mean value of forced expiratory volume during the first sec (FEV1, as % of predicted value) was significantly greater in group A compared with group B (94 +/- 7.5 vs 83.1 +/- 6.9; p<0.005). The mean values of peak expiratory flow (PEF), the percentages of asthmatic exacerbations, and the use of beta2-short-acting agonist (SABA) were similar in the 2 groups at 4, 8, and 12 wk. In conclusion, in patients with mild-moderate persistent asthma, MON therapy is useful in tapering the dose of IS in order to reduce its side effects and to maintain the clinical stability of the disease.

Topics: Acetates; Administration, Inhalation; Adolescent; Adult; Aged; Asthma; Budesonide; Cyclopropanes; Female; Humans; Male; Middle Aged; Quinolines; Respiratory Function Tests; Single-Blind Method; Sulfides; Time Factors

Otitis media with effusion (OME) is a common pediatric disease and there is great controversy concerning its management. Mechanical, medical and surgical treatments have not proven adequate in resolving the disease and serve mainly to manage complications. Leukotriene inhibitors are new drugs that have been approved recently for the treatment of asthma in children. The aim of this study was to evaluate the impact of leukotriene inhibitor therapy for asthma on the clinical course of OME in children with co-existing disease. Fifty children with bilateral OME and asthma, divided equally into two groups, were studied. The children in the first group were treated with budesonide and terbutaline inhalers together with the leukotriene inhibitor montelukast, whereas the children in the second group were treated with the inhalers alone. Duration of treatment was 30 days. Pneumatic otoscopy, tympanometry and pure-tone audiometry were performed at the beginning and at the end of treatment. Fifteen (60%) of the children receiving inhalers and montelukast and nine (36%) of those receiving only inhalers were found free of OME after 30 days of therapy. Thus, it may be concluded that a statistically significant beneficial effect on the clinical course of OME resulted from the addition of montelukast to the treatment of children with co-existing asthma and OME. Given that no medication has been shown to be effective in OME therapy, further investigation of the possible effects of leukotriene inhibitors is warranted.

Topics: Acetates; Administration, Inhalation; Adolescent; Asthma; Bronchodilator Agents; Budesonide; Child; Cyclopropanes; Drug Therapy, Combination; Humans; Leukotriene Antagonists; Otitis Media with Effusion; Quinolines; Sulfides; Terbutaline

Although current guidelines suggest the use of inhaled corticosteroids as the first line therapy in persistent asthma, the concerns about high-dose corticosteroids may limit their usage. We aimed to investigate the efficacy of inhaled budesonide plus oral montelukast versus a double dose of inhaled budesonide.. Thirty patients with moderate asthma took part in the study. Following a 2-week run in period, the patients were randomized into two groups to receive 400 microg/day of inhaled budesonide plus 10 mg/day of montelukast (BUD + M group) or 800 microg/day of inhaled budesonide (high BUD group). The patients were evaluated at 2-week intervals (during a total treatment period of 6 weeks) for symptom scores, asthma exacerbations, lung function, use of short-acting beta2 agonist, blood eosinophil counts and adverse events.. At the end of the study, morning and daytime symptom scores were significantly reduced within the groups. Although there was a significant decrease in the frequency of short-acting beta2 agonist use in the BUD + M group, the decrease in the high BUD group was not significant. During the study period, no patient in either group experienced an asthma exacerbation. Blood eosinophil levels significantly declined in both the BUD + M (0.87 +/- 0.31%) and high BUD groups (0.67 +/- 0.29%) as compared with baseline levels (BUD + M = 2.60 +/- 0.65%, high BUD group = 2.60 +/- 0.47%; P < 0.05).. Our results suggest that the addition of montelukast to low-dose inhaled budesonide is as effective as a double dose of inhaled budesonide in asthma control.

Topics: Acetates; Adult; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Drug Therapy, Combination; Female; Humans; Leukotriene Antagonists; Male; Quinolines; Spirometry; Sulfides

Proinflammatory leukotrienes, which are not completely inhibited by inhaled corticosteroids, may contribute to asthmatic problems [corrected]. A 16 week multicentre, randomised, double blind, controlled study was undertaken to study the efficacy of adding oral montelukast, a leukotriene receptor antagonist, to a constant dose of inhaled budesonide.. A total of 639 patients aged 18-70 years with forced expiratory volume in 1 second (FEV(1)) > or =55% predicted and a minimum predefined level of asthma symptoms during a 2 week placebo run in period were randomised to receive montelukast 10 mg (n=326) or placebo (n=313) once daily for 16 weeks. All patients received a constant dose of budesonide (400-1600 microg/day) by Turbuhaler throughout the study.. Mean FEV(1) at baseline was 81% predicted. The median percentage of asthma exacerbation days was 35% lower (3.1% v 4.8%; p=0.03) and the median percentage of asthma free days was 56% higher (66.1% v 42.3%; p=0.001) in the montelukast group than in the placebo group. Patients receiving concomitant treatment with montelukast had significantly (p<0.05) fewer nocturnal awakenings and significantly (p<0.05) greater improvements in beta agonist use and morning peak expiratory flow rate (PEFR).. For patients with mild airway obstruction and persistent asthma symptoms despite budesonide treatment, concomitant treatment with montelukast significantly improves asthma control.

Topics: Acetates; Administration, Inhalation; Adult; Aged; Analysis of Variance; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Quality of Life; Quinolines; Sulfides; Treatment Outcome

Inhaled corticosteroids (ICS) affect many inflammatory pathways in asthma but have little impact on cysteinyl leukotrienes. This may partly explain persistent airway inflammation during chronic ICS treatment and failure to achieve adequate asthma control in some patients. This double blind, randomised, parallel group, non-inferiority, multicentre 16 week study compared the clinical benefits of adding montelukast to budesonide with doubling the budesonide dose in adults with asthma.. After a 1 month single blind run in period, patients inadequately controlled on inhaled budesonide (800 microg/day) were randomised to receive montelukast 10 mg + inhaled budesonide 800 microg/day (n=448) or budesonide 1600 microg/day (n=441) for 12 weeks.. Both groups showed progressive improvement in several measures of asthma control compared with baseline. Mean morning peak expiratory flow (AM PEF) improved similarly in the last 10 weeks of treatment compared with baseline in both the montelukast + budesonide group and in the double dose budesonide group (33.5 v 30.1 l/min). During days 1-3 after start of treatment, the change in AM PEF from baseline was significantly greater in the montelukast + budesonide group than in the double dose budesonide group (20.1 v 9.6 l/min, p<0.001), indicating faster onset of action in the montelukast group. Both groups showed similar improvements with respect to "as needed" beta agonist use, mean daytime symptom score, nocturnal awakenings, exacerbations, asthma free days, peripheral eosinophil counts, and asthma specific quality of life. Both montelukast + budesonide and double dose budesonide were generally well tolerated.. The addition of montelukast to inhaled budesonide is an effective and well tolerated alternative to doubling the dose of inhaled budesonide in adult asthma patients experiencing symptoms and inadequate control on budesonide alone.

Topics: Acetates; Administration, Inhalation; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Quinolines; Single-Blind Method; Sulfides; Treatment Outcome

We studied 51 atopic non-smoking subjects who were divided to four treatments groups: (A) montelukast 10mg daily, (B) budesonide 400 microg twice a day (bid), (C) montelukast 10 mg daily plus budesonide 400 microg bid and (D) budesonide 800 microg bid. Bronchial responsiveness was assessed before and after 12 weeks of treatment. The bronchial responsiveness, evaluated by means of PC(20) values, showed a strong significant increase in groups B, C and D, and a weak but significant rise in group A, when compared to basal data. Regarding other pulmonary parameters (FEV(1), PEF) there were no significant differences among the groups after 12 weeks of therapy. A statistical significance was founded after therapy between group A and C (p < 0.05), but not between the group B and D treated with only budesonide at different doses. No significant differences was observed in the side effect pattern among the various treatments. The study data demonstrated that administration of montelukast provided an important and additional effect on bronchial hyperresponsiveness. Oral administration represents a significant advantage over the majority of other anti-asthmatic drugs. Our results confirm the anti-inflammatory properties of both the inhaled corticosteroid (ICS) and montelukast and the possible role of these drugs can have on airway remodelling. While currently low dose ICS remains the reference drug as a controller in mild-moderate persistent asthma, montelukast may be viewed as a possible option, either in monotherapy or in association.

Topics: Acetates; Adult; Analysis of Variance; Anti-Asthmatic Agents; Asthma; Bronchi; Bronchial Provocation Tests; Budesonide; Cyclopropanes; Female; Humans; Male; Quinolines; Sulfides; Treatment Outcome

Previous adult studies demonstrated the clinical efficacy of an additional treatment with leukotriene receptor antagonists on steroid-dependent asthma, but there is little knowledge about anti-inflammatory add-on effects within the lung. In this study, we hypothesized that steroid-treated children exhibit a decrease in bronchial inflammation in induced sputum under additional treatment with montelukast. Twenty-five asthmatic children aged 6 to 14 y, who had been taking inhaled corticosteroids (400-800 microg/d budesonide) regularly for at least 12 wk, were randomized to receive additional treatment with either montelukast (5 mg orally, once daily) or placebo over a 4-wk period. As primary efficacy variable, eosinophil cationic protein (ECP) in induced sputum as direct measurement of bronchial inflammation was assessed before and after treatment. To assure a baseline level of inflammation, an ECP concentration above 100 microg/L was required. Sputum eosinophil count, concentration of exhaled nitric oxide, urinary excretion of eosinophil protein X, and quality-of-life items were considered as secondary outcome variables. After treatment with montelukast, ECP in sputum was significantly reduced (montelukast: median -975 microg/L [5 to 95% confidence interval: -4295 to 583 microg/L]; placebo: 561 microg/L [-1335 to 3320 microg/L]; p < 0.01) and the quality-of-life score had significantly improved (p < 0.05) compared with placebo. Partly explained by low baseline levels, no statistically significant change in concentration of exhaled nitric oxide (p > 0.05), urinary excretion of eosinophil protein X (p > 0.05), or eosinophil count (p > 0.05) was found. In conclusion, add-on treatment with montelukast can suppress sputum ECP in children with steroid-dependent asthma, while at the same time an improvement in quality of life items occurs.

Topics: Acetates; Adolescent; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Blood Proteins; Budesonide; Child; Cyclopropanes; Drug Therapy, Combination; Eosinophil Granule Proteins; Eosinophils; Female; Humans; Male; Quinolines; Ribonucleases; Sputum; Sulfides; Treatment Outcome

Inhaled, long-acting beta2-agonists or antileukotrienes are alternatives as add-on therapy for asthmatic children taking regular inhaled steroids. Any complementary effects would be relevant to the choice between these alternatives. Exhaled nitric oxide (FeNO) may reflect these effects.. To compare the control of FeNO provided by salmeterol or montelukast add-on therapy in asthmatic children undergoing regular maintenance treatment with a daily dose of 400 microg of budesonide.. The study included children with increased FeNO despite regular treatment with budesonide, 400 microg/d, and normal lung function. Montelukast, 5 mg/d, salmeterol, 50 microg twice daily, or placebo was compared as add-on therapy to budesonide, 400 microg, in a randomized, double-blind, double-dummy, crossover study.. Twenty-two children completed the trial. The geometric mean FeNO level was 20 ppb (95% confidence interval [CI], 15-27 ppb) after salmeterol, which was significantly higher than after montelukast (mean, 15 ppb; 95% CI, 11-18 ppb; P = 0.002) and placebo (mean, 15 ppb; 95% CI, 10-21 ppb; P = 0.03). There was no difference in FeNO between the montelukast and placebo groups. Mean forced expiratory volume in 1 second (FEV1) was significantly increased after salmeterol (mean, 2.63 L; 95% CI, 2.34-2.91 L) compared with placebo (mean, 2.48 L; 95% CI, 2.19-2.77 L). Montelukast (mean, 2.57 L; 95% CI, 2.33-2.80 L) was no different than placebo.. The FeNO levels were significantly higher after salmeterol add-on treatment compared with both placebo and montelukast add-on treatment. Salmeterol significantly improved lung function (FEV1) compared with placebo and nonsignificantly compared with montelukast. Montelukast failed to reduce FeNO and improve lung function compared with placebo in this group of children taking regular budesonide, 400 microg.

Topics: Acetates; Administration, Inhalation; Adolescent; Albuterol; Asthma; Breath Tests; Bronchodilator Agents; Budesonide; Child; Cross-Over Studies; Cyclopropanes; Double-Blind Method; Humans; Nitric Oxide; Quinolines; Salmeterol Xinafoate; Sulfides

The purpose of this study was to compare the efficacy and safety of the inhaled budesonide, sustained-release theophylline and montelukast, a leukotriene receptor antagonist, in patients with mild persistent asthma. In this single-center, randomized, parallel-group study that not designed blindly and placebo-controlled manner, 74 patients with mild persistent asthma were treated with either inhaled budesonide 400 microg once daily, oral montelukast 10 mg once daily, or sustained-release theophylline 400 mg once daily for 3 months. In all three treatment groups, improvements were attained in overall asthma control. Asthma symptom scores and supplemental beta2-agonist use were quite the same in all three treatment groups (P>0.05). Although inhaled budesonide group resulted in significantly greater improvements compared with the other two groups in the lung functions (P<0.05), the changes in FEV1 and PEF are within the baseline variability and there was no statistically significant difference among the groups when analyzed by treatment month (P>0.05). Exacerbations of asthma were experienced by 16% of the patients in the montekulast group, by 12.5% of the patients in the theophylline group, and by none of the patients in the budesonide group. The adverse event in each of the three groups was 12%, 16% and 16.7%, respectively. It is concluded that the most important clinical parameters do not point that one of the treatments is more effective than others. Treatment with inhaled corticosteroid is preferred, but sustained-release theophylline and leukotriene antagonists are alternative controller medications in mild persistent asthma.

Topics: Acetates; Administration, Inhalation; Adrenergic beta-2 Receptor Antagonists; Adult; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Delayed-Action Preparations; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Leukotriene Antagonists; Male; Middle Aged; Peak Expiratory Flow Rate; Quinolines; Sulfides; Theophylline; Treatment Outcome

The aim of this prospective, self-controlled, single-blind study was to assess the effect of montelukast added to maintenance therapy with inhaled corticosteroids (ICS) on fractional exhaled nitric oxide (FENO) in asthmatic children. Thirty-five children (age 11.2+/-0.4 yrs (mean+/-SEM)) with mild-to-moderate persistent asthma treated with low to medium doses of ICS and FENO > 20 parts per billion (ppb) were included. The patients were randomly assigned to two groups: 17 patients continued ICS (group C) and 18 had montelukast added to ICS for 3 weeks (group M). FENO measurements were performed in both groups at baseline (T1) and after 3 weeks (T2), and in group M also after 2 weeks of washout. FENO was measured by a chemiluminescence analyser using an on-line method (50 mL x s(-1)) with nitric oxide-free air. The overall mean daily dose of ICS was equivalent to 530+/-58 microg x day(-1) of beclomethasone in group M and to 564+/-55 microg x day(-1) of beclomethasone in group C. There were no significant differences in baseline FENO and forced expiratory volume in one second (FEV1) between the two groups. After 3 weeks there was a significant reduction of FENO values in patients of group M (T1 52.2+/-7.8 ppb, T2 36.1+/-4.6 ppb) but no significant changes in group C (T1 43.5+/-6.0 ppb, T2 47.8+/-9.4 ppb). In group M after 2 weeks of montelukast withdrawal, FENO rose to baseline values (55.6+/-8.7 ppb). In conclusion, after montelukast treatment there is a fractional exhaled nitric oxide reduction in asthmatic children receiving maintenance therapy with inhaled corticosteroids. This suggests an anti-inflammatory effect of montelukast additive to that of inhaled corticosteroids.

Topics: Acetates; Administration, Inhalation; Administration, Oral; Adolescent; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Breath Tests; Budesonide; Child; Cyclopropanes; Drug Therapy, Combination; Female; Fluticasone; Forced Expiratory Volume; Humans; Male; Maximal Midexpiratory Flow Rate; Nitric Oxide; Prospective Studies; Quinolines; Single-Blind Method; Sulfides

Inhaled corticosteroids are effective antiinflammatory therapy for asthma; however, they do not completely abolish allergen-induced airway inflammation. Leukotriene modifiers attenuate both early and late allergen responses and have antiinflammatory properties. We reasoned that treatment with budesonide and montelukast in combination might provide greater antiinflammatory effects than either drug alone, and the purpose of this study was to compare the effects of treatment with budesonide and montelukast, alone or in combination, on outcome variables after allergen inhalation. Ten subjects with asthma with dual responses after allergen inhalation were included in this randomized, double-blind, crossover study. Outcomes included early and late asthmatic responses, and changes in airway responsiveness and sputum eosinophilia, measured before and after challenge. Treatment with montelukast attenuated the maximal early asthmatic response compared with placebo (p < 0.001) and budesonide (p = 0.002). Both budesonide and montelukast, alone and in combination, attenuated the maximal late asthmatic response compared with placebo (p < 0.01). Budesonide and montelukast, alone and in combination, afforded protection against allergen-induced airway hyperresponsiveness (p < 0.05), although the treatment effect of budesonide was greater than that of montelukast (p < 0.05). Treatment with budesonide and montelukast, alone and in combination, also attenuated allergen-induced sputum eosinophilia. Thus, montelukast and budesonide attenuated allergen-induced asthmatic responses, airway hyperresponsiveness, and sputum eosinophilia, although combination treatment did not provide greater antiinflammatory effects than either drug alone.

Topics: Acetates; Administration, Inhalation; Administration, Oral; Anti-Inflammatory Agents; Asthma; Budesonide; Cross-Over Studies; Cyclopropanes; Double-Blind Method; Drug Therapy, Combination; Humans; Inflammation; Leukotriene Antagonists; Prospective Studies; Quinolines; Respiratory Hypersensitivity; Respiratory System; Sulfides

We tested the hypothesis that adding montelukast to budesonide would improve asthma control in children with inhaled glucocorticoid-dependent persistent asthma.. In a multicenter, randomized, double-blind, crossover study, we compared the benefit of adding montelukast, 5 mg, or placebo once daily to budesonide, 200 microg, twice daily.. After a 1-month run-in with budesonide, 200 microg, twice daily, 279 children were randomized to montelukast or placebo. The mean +/- SD age was 10.4 +/- 2.2 years, the mean forced expiratory volume in 1 second (FEV(1)) was 77.7% +/- 10.6% predicted, and reversibility was 18.1% +/- 12.9%. Compared with adding placebo to budesonide, adding montelukast produced significant improvements in mean percent change from baseline FEV(1) (P =.062 [P =.010 for per-protocol analysis]), mean absolute change from baseline FEV(1) (P =.040), mean increase from baseline in morning (P =.023) and evening (P =.012) peak expiratory flows, decrease in exacerbation days by approximately 23% (P <.001), decreased beta2-agonist use (P =.013), and reduced blood eosinophil counts (P <.001). The treatments did not differ significantly with regard to safety.. Montelukast, 5 mg, added to budesonide improved asthma control significantly, indicated by a small additive effect on lung function and a clinically relevant decrease in asthma exacerbation days.

Topics: Acetates; Anti-Asthmatic Agents; Asthma; Budesonide; Cyclopropanes; Double-Blind Method; Drug Therapy, Combination; Forced Expiratory Volume; Humans; Predictive Value of Tests; Quality of Life; Quinolines; Sulfides; Treatment Outcome

Allergic rhinitis and asthma commonly coexist and are both mediated by similar inflammatory mechanisms. Leukotriene antagonists may therefore be an alternative to corticosteroid therapy.. To compare oral montelukast with inhaled plus intranasal budesonide in patients with seasonal allergic rhinitis and asthma.. A single-blind double-dummy placebo-controlled crossover study was performed comparing once daily 10 mg oral montelukast with 400 microg inhaled plus 200 microg intranasal budesonide in 12 patients with allergic rhinitis and asthma: mean (S.E.) age 34.0 years (2.7), forced expiratory volume in 1 s (FEV1) 91.2 (3.8)% predicted. Each treatment was for 2 weeks with a 1-week placebo run-in and washout. Measurements were made after each active treatment and placebo for: adenosine monophosphate bronchial challenge, exhaled and nasal nitric oxide. Patients also recorded their domiciliary peak expiratory flow, nasal peak inspiratory flow, asthma and seasonal allergic rhinitis symptoms.. There were no significant differences between the placebos for any measurement. For adenosine monophosphate PC20, geometric mean fold differences (95% confidence interval (CI) for difference) were 6.4 (2.2-18.6) for placebo vs. budesonide, 2.9 (1.0-8.4) for placebo vs. montelukast, and 2.1 (1.1-4.5) for budesonide vs. montelukast. For exhaled nitric oxide (p.p.b.) there was significant (P < 0.05) suppression with both montelukast (10.9) and budesonide (10.1) compared with placebo (18.8). For nasal nitric oxide and nasal peak flow there were only significant differences with budesonide compared with placebo. Both treatments reduced total seasonal allergic rhinitis symptoms but only budesonide had a significant effect on nasal symptoms.. Once-daily inhaled plus intranasal budesonide and once daily montelukast showed comparable efficacy on lower airway, but only the budesonide had significant efficacy on upper airway inflammatory markers. Both treatments significantly reduced allergic rhinitis symptoms.

Topics: Acetates; Administration, Oral; Administration, Topical; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Biomarkers; Budesonide; Confidence Intervals; Cross-Over Studies; Cyclopropanes; Humans; Quinolines; Rhinitis, Allergic, Seasonal; Single-Blind Method; Sulfides

Both domiciliary and laboratory measures of nasal function have been used to evaluate treatment response in allergic airways disease; however, these measures have not been compared.. To determine the relationship of domiciliary measures (daily symptoms, peak inspiratory nasal flow, and nasal oral index) and laboratory measures (rhinomanometry, acoustic rhinometry) in assessing treatment response with topical steroids and specific inflammatory mediator blockage.. Twenty-one patients with seasonal allergic rhinitis and asthma were enrolled into a single-blind, placebo-controlled, crossover study comparing 2 weeks of 1) 400 microg inhaled plus 200 microg intranasal budesonide once daily and 2) 10 mg montelukast plus 10 mg cetirizine once daily. Before each treatment, patients received 7 to 10 days of placebo period. Laboratory measurements were made of nasal resistance by posterior rhinomanometry, and nasal volume between 0 and 5 cm by acoustic rhinometry after both placebo and active treatment periods. Daily domiciliary recordings were made of allergic rhinitis nasal symptoms scores and peak nasal and oral inspiratory flow rate (enabling the calculation of a nasal/oral index) throughout the study.. There were significant (P < 0.05) improvements for all allergic rhinitis symptoms with both therapies, after factoring for pollen count. Spearman's rank correlation for comparison among nasal symptoms and the objective responses were: nasal inspiratory flow rate (R = -0.50, P = 0.02); nasal/oral index (R = -0.55 P = 0.01); rhinomanometry (R = 0.24, P = 0.30); and acoustic rhinometry (R = -0.21, P = 0.36).. Both treatments were effective in managing allergic rhinitis symptoms, and patients' symptoms were more closely associated with domiciliary measurements of nasal flow than laboratory measurements of nasal function.

Topics: Acetates; Administration, Inhalation; Administration, Intranasal; Adult; Airway Resistance; Anti-Allergic Agents; Anti-Inflammatory Agents; Asthma; Budesonide; Cetirizine; Cross-Over Studies; Cyclopropanes; Female; Glucocorticoids; Histamine H1 Antagonists; Humans; Leukotriene Antagonists; Male; Nasal Obstruction; Quinolines; Rhinitis, Allergic, Seasonal; Rhinomanometry; Rhinometry, Acoustic; Sulfides

To compare the antiasthmatic efficacy of inflammatory mediator blockade versus topical corticosteroid therapy in patients with seasonal allergic rhinitis (SAR) and asthma, 14 patients were enrolled into a single-blind, double-dummy, placebo-controlled crossover study comparing 2 wk therapy of (1) 400 microgram orally inhaled budesonide plus 200 microgram intranasal budesonide (BUD) or (2) 10 mg oral montelukast plus 10 mg oral cetirizine (ML + CZ). Before each treatment period, patients received 7 to 10 d placebo washout. All treatments were given once daily in the morning. Throughout the study, patients recorded the following domiciliary measures: peak expiratory flow (PEF), rescue inhaler requirement, asthma symptoms, and daily activity score. Laboratory measurements were made at trough of adenosine monophosphate (AMP) bronchial challenge and exhaled nitric oxide (NO). Compared with pooled placebo (PL), there were significant (p < 0.05) improvements in all domiciliary measures with both treatments (mean PEF [L/min] PL: 463; BUD: 478; ML + CZ: 483). For geometric mean AMP PC(20) (mg/ml), there was an improvement (p < 0.05), compared with PL (47), for ML + CZ (133) but not for BUD (51); whereas for NO (ppb) there was significant suppression with BUD (7.6) but not ML + CZ (11.5) compared with PL (13.6). In conclusion, both combined mediator blockade and combined topical corticosteroids are equally effective antiasthma therapy in patients with asthma and SAR.

Topics: Acetates; Administration, Inhalation; Administration, Oral; Anti-Asthmatic Agents; Asthma; Bronchial Provocation Tests; Budesonide; Cetirizine; Cross-Over Studies; Cyclopropanes; Double-Blind Method; Drug Therapy, Combination; Forced Expiratory Volume; Humans; Inflammation Mediators; Leukotriene Antagonists; Quinolines; Rhinitis, Allergic, Seasonal; Sulfides

Allergic rhinitis as common airway disease has high prevalence in all peoples worldwide. In allergic diseases, Th2 cells release type 2 cytokines that support the inflammation in airways. All the drugs used for allergic rhinitis do not cure completely, and the choice of drugs according to cost and efficacy is very important in all groups of atopic patients. Therefore, in this study, the effect of commercial drugs on cytokine gene expression has been studied. Male Balb/c mice were divided into six groups. Allergic rhinitis was induced in five of the six groups with ovalbumin, and four of these five groups were treated with salbutamol, budesonide, theophylline, and montelukast. The fifth group was used as positive control group and the sixth group as negative control group. For the survey, RNA was extracted, cDNA was synthesized, and quantitative real-time PCR was done for 21 genes. The four drugs had different effects on mRNA expression of cytokines (IL-1b, 2, 4, 5, 7, 8, 9, 11, 12, 13, 17, 18, 22, 25, 31, 33, 37, IFN-γ, TNF-α, TGF-β1, and eotaxin) in the allergic rhinitis groups. Salbutamol can be used during pregnancy and breastfeeding, but it has some side effects. Budesonide in the inhaled form is generally safe in pregnancy. Theophylline cannot control allergic attack in the long run. Montelukast is not useful in the treatment of acute allergic attacks. Immunomodulatory and anti-inflammatory effects of drugs in control of allergic rhinitis via Th2 cytokines can be new approaches in molecular medicine.

Topics: Albuterol; Animals; Budesonide; Cytokines; Disease Models, Animal; Gene Expression; Male; Mice; Mice, Inbred BALB C; Ovalbumin; Rhinitis, Allergic; Theophylline

There are limited studies comparing budesonide inhalation suspension (BIS) with montelukast 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 a monotherapy 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 4‒5 mg 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 12 months (P < 0.001). Significantly higher medical expenditures attributable to asthma in the past 12 months 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.

Topics: Acetates; Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Asthma; Budesonide; Child; Child, Preschool; China; Cyclopropanes; Humans; Quinolines; Retrospective Studies; Sulfides

Airway epithelial barrier dysfunction is increasingly recognized as a key feature of asthma and other lung diseases. Respiratory viruses are responsible for a large fraction of asthma exacerbations, and are particularly potent at disrupting epithelial barrier function through pattern recognition receptor engagement leading to tight junction dysfunction. Although different mechanisms of barrier dysfunction have been described, relatively little is known about whether barrier integrity can be promoted to limit disease. Here, we tested three classes of drugs commonly prescribed to treat asthma for their ability to promote barrier function using a cell culture model of virus-induced airway epithelial barrier disruption. Specifically, we studied the corticosteroid budesonide, the long acting beta-agonist formoterol, and the leukotriene receptor antagonist montelukast for their ability to promote barrier integrity of a monolayer of human bronchial epithelial cells (16HBE) before exposure to the viral mimetic double-stranded RNA. Of the three, only budesonide treatment limited transepithelial electrical resistance and small molecule permeability (4 kDa FITC-dextran flux). Next, we used a mouse model of acute dsRNA challenge that induces transient epithelial barrier disruption in vivo, and studied the effects budesonide when administered prophylactically or therapeutically. We found that budesonide similarly protected against dsRNA-induced airway barrier disruption in the lung, independently of its effects on airway inflammation. Taken together, these data suggest that an under-appreciated effect of inhaled budesonide is to maintain or promote airway epithelial barrier integrity during respiratory viral infections.

Topics: Acetates; Administration, Inhalation; Animals; Asthma; Bronchi; Bronchodilator Agents; Budesonide; Cell Line; Cell Membrane Permeability; Cyclopropanes; Dextrans; Electric Impedance; Epithelial Cells; Female; Fluorescein-5-isothiocyanate; Formoterol Fumarate; Humans; Male; Mice; Mice, Inbred C57BL; Models, Biological; Molecular Mimicry; Poly I-C; Quinolines; RNA, Double-Stranded; RNA, Viral; Sulfides; Tight Junctions

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.. 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.. 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.. Our findings will provide vigorous evidence to judge whether montelukast sodium and budesonide therapy is an efficient form of therapy for CVA patients.. Ethics approval is not needed for the present meta-analysis.. 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

Asthma in elderly patients causes excessive suffering and inconvenience. Regimens with better efficacy and less adverse events are still in need of researches.. To investigate the effect of montelukast sodium plus budesonide on lung function, inflammatory factors, and immune levels in elderly asthma patients.. A total of 180 patients with asthma were assigned into the control group and the observation group. The control group was given aerosol inhalation of budesonide suspension, while the observation group was given budesonide inhalation and oral montelukast sodium. The treatment effect, lung function (forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF)%), inflammatory factors (interleukin (IL)-4, IL-6, and tumor necrosis factor-α (TNF-α)), and immune level (immunoglobulin (Ig) A, and IgE) were analyzed and compared between the two groups.. After treatment, the effective rate was significantly higher in the observation group. The lung function and serum inflammatory factors were improved in both groups. The FEV1, FVC, and PEF% in the observation group were better, and the inflammatory factors IL-4, IL-6, and TNF-α were lower. Patients in both groups showed elevated IgA level and reduced IgE level, and the improvements were more significant in the observation group. There was no significant difference between the two groups in terms of adverse reaction.. Montelukast sodium plus budesonide has a promising clinical effect on asthma in elderly patients, effectively improves lung function and immunocompetence, and controls inflammatory response, without increasing the adverse reaction.

Topics: Acetates; Aged; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Budesonide; Cyclopropanes; Female; Humans; Inflammation; Male; Middle Aged; Quinolines; Respiratory Function Tests; Sulfides

Topics: Acetates; Adrenergic beta-2 Receptor Antagonists; Amoxicillin-Potassium Clavulanate Combination; Anti-Asthmatic Agents; Antibodies, Monoclonal, Humanized; Asthma; Azithromycin; Betacoronavirus; Budesonide; Convalescence; Coronavirus Infections; COVID-19; Cyclopropanes; Eosinophils; Female; Humans; Hydroxychloroquine; Ipratropium; Male; Middle Aged; Pandemics; Pneumonia, Viral; Quinolines; SARS-CoV-2; Sulfides; Treatment Outcome

For children aged 1-5 years with persistent asthma, double low-dose inhaled corticosteroids (ICS) are recommended as the preferred Step 3 treatment and low-dose ICS plus leukotriene receptor antagonists (LTRA) as an alternative. Budesonide inhalation suspension (0.5 mg daily) and montelukast (4.0 mg daily) are commonly used low-dose ICS and LTRA, respectively, among children in China. This study compared the cost-effectiveness of double low-dose budesonide vs. low-dose budesonide plus montelukast from a Chinese healthcare payer's perspective.. A Markov model was constructed with four health states (i.e. no exacerbation, mild exacerbation, moderate-to-severe exacerbation, and death). Transition probabilities were estimated based on exacerbation rates, case-fatality of hospitalized patients due to exacerbation, and natural mortality. Treatment adherence was considered and assumed to impact both drug costs and exacerbation rates. Costs (in 2019 Chinese Yuan [¥]) included drug costs and exacerbation management costs. Cost inputs and utilities for each health state were obtained from a public database and the literature. In-depth interviews were conducted with a health economics expert to validate the model, and a clinical expert to verify inputs and assumptions related to clinical practice. Costs and quality-adjusted life-years (QALYs) were estimated over a year. Deterministic and probabilistic sensitivity analyses were performed.. Compared with low-dose budesonide plus montelukast, double low-dose budesonide was associated with lower costs (¥1,534 vs. ¥2,327), fewer exacerbation events (0.43 vs. 1.67) and slightly better QALYs (0.98 vs. 0.97). Sensitivity analyses supported the robustness of the results and the generalizability of findings across geographic regions in China.. The cost-effectiveness analysis suggests that double low-dose budesonide is a dominant Step 3 treatment strategy compared with low-dose budesonide plus montelukast for patients aged 1-5 years with persistent asthma in China.

Topics: Acetates; Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Budesonide; Child; China; Cost-Benefit Analysis; Cyclopropanes; Drug Therapy, Combination; Humans; Quinolines; Sulfides

In the current study electrospraying methodology was used for particle engineering of montelukast and budesonide to prepare a combined inhalable dry powder formulation applicable as a smart regimen in asthma treatment. For this, electrospraying was carried out using different solvents and drug concentrations. No carrier was added for the formulation of montelukast-budesonide combination as montelukast played the role of both active ingredient and carrier. Scanning electron microscopy, particle size analysis, gas chromatography, powder X-ray diffraction, Fourier transform infrared spectroscopy, and differential scanning calorimetry were used to evaluate the physicochemical properties of the produced drug particles. In vitro drug deposition pattern was assessed using next generation impactor, and the dissolution profile of the selected formulations was characterized via modified diffusion franz cell method. The FPF value for the co-electrosprayed carrier free formulation of montelukast-budesonide was 38% with a significantly enhanced dissolution rate for budesonide compared to the budesonide alone formulations. The pharmacological effects of hypothesized combined formulation was assessed by measuring its power to inhibit the production of reactive oxygen species in human normal lung cells. The results showed that the combination of montelukast and budesonide can exert a synergistic effect. The findings in the current study emphasize that using montelukast as a carrier for budesonide not only has greatly improved the aerosolization behavior and dissolution rate of budesonide but also has resulted in synergistic pharmacological effects, indicating the suitability of this combination as an anti-asthmatic therapeutic.

Topics: Acetates; Administration, Inhalation; Aerosols; Budesonide; Cyclopropanes; Dry Powder Inhalers; Humans; Lung; Particle Size; Powders; Quinolines; Sulfides; Technology

Topics: Acetates; Adolescent; Anti-Asthmatic Agents; Asthma; Budesonide; Child; Child, Preschool; Cyclopropanes; Drug Costs; Female; Humans; Male; Medication Adherence; Office Visits; Patient Acceptance of Health Care; Quinolines; Republic of Korea; Retrospective Studies; Sulfides; Suspensions; Symptom Flare Up; Time Factors; Treatment Outcome

To determine the effects of combined treatment of montelukast and budesonide on young children with cough variant asthma, and their serum inflammatory factors of serum hypersensitive c-reactive protein (hs-CRP), tumour necrosis factor-α (TNF-α), interleukin-6 (IL-6) and pulmonary function.. An experimental study.. The Second Affiliated Hospital of Xi'an Jiaotong University, China, from January 2016 to January 2017.. A total of 112 children with cough variant asthma were randomly divided into observation group and control group with 56 cases in each group. All children were treated with antibiotics and resolving phlegm. The control group were given budesonide, while the observation group was treated additionally with montelukast. After the course, improvement time of clinical symptoms of cough, asthma, etc., changes in levels of serum inflammatory factors of hs-CRP, TNF-α and IL-6, and pulmonary function indexes of forced vital capacity (FVC), forced expiratory volume at the end of the first 1s (FEV1), peak expiratory flow (PEF), and observe concurrence of untoward effects in the two groups of sick children were compared.. After treatment, extinction time for cough and for asthma of the observation group was less than those in the control group (all p<0.001). Levels of serum hs-CRP, TNF-α, IL-6 in the observation group were all lower than those of the control group (all p<0.001). Pulmonary function indices of FVC, FEV1 and PEF of the two groups of sick children were all higher than those of the control group (all p<0.001). During the treatment, there was no difference in the comparison of untoward effect rate of the two groups (p=0.696). After follow-up observation on the two groups of sick children for 1 year, the recurrence rate of the observation group was lower than that of the control group (p=0.026).. Curative effects on young children with cough variant asthma of montelukast combined with budesonide are significant. The therapy may improve clinical symptoms and pulmonary function and reduce serum inflammatory factor level of sick children, with high application value and worthy of application and promotion.

Topics: Acetates; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Budesonide; C-Reactive Protein; Child; Child, Preschool; Cough; Cyclopropanes; Female; Humans; Interleukin-6; Lung; Male; Quinolines; Respiratory Function Tests; Sulfides; Treatment Outcome; Tumor Necrosis Factor-alpha

The effectiveness of budesonide (BUD), a locally active steroid, on eosinophilic gastroenteritis (EGE) is not well understood. This study is to retrospectively evaluate the efficacy of BUD in children with EGE.. Forty-four children, diagnosed with EGE, were enrolled from 2013 to 2017 in our center. According to patients' preference, all the patients were treated with dietary elimination (DE) and montelukast therapy, or combined with prednisone (PRED)/BUD. Patients' clinical manifestations, treatments, and outcomes were reviewed from the medical records. Twenty-four patients (7 PRED, 7 BUD, 10 DE) received therapy for ≥8 weeks, followed by repeat endoscopy and biopsies. Histological response was defined as <20 eos/hpf (eosinophils per high-power field).. Significant number of patients in DE+PRED (6/7, 85.7%) and DE+BUD (6/7, 85.7%) groups achieved histological response than in the DE group (3/10.30%) (p = 0.024). Mean post-treatment peak eos/hpf in the DE+PRED group was 16.57 ± 6.85 vs. 10.00 ± 5.07 in the DE+BUD group vs. 36.60 ± 24.57 in the DE group (p = 0.009). Change of eos/hpf from pre- to post-treatment was -49.86 ± 45.02 vs. -34.29 ± 23.44 in the BUD group vs. -0.3 ± 23.95 in the DE group (p = 0.011). There were no significant differences between DE+PRED and DE+BUD groups (p = 0.470, p = 0.363, respectively).. BUD is effective in the treatment of EGE and has similar effectiveness with PRED.

Topics: Acetates; Adolescent; Biopsy; Budesonide; Child; Child, Preschool; Cyclopropanes; Endoscopy; Enteritis; Eosinophilia; Eosinophils; Female; Gastritis; Humans; Infant; Male; Prednisone; Quinolines; Retrospective Studies; Sulfides; Treatment Outcome

Asthma is a chronic inflammatory airway disease induced by many environmental factors. The inhalation of allergens and pollutants promotes the production of reactive oxygen species (ROS) leading to airway inflammation, hyper-responsiveness, and remodeling in allergic asthma. The effects of asthma medications on ROS production are unclear. The present study investigated the anti-ROS effects of current asthma medications including inhaled corticosteroid (ICS; budesonide and fluticasone), leukotriene receptor antagonist (LTRA; montelukast), long-acting β2 agonists (LABAs; salmeterol and formoterol), and a new extra-LABA (indacaterol).. The human monocyte cell line THP-1 cells were pre-treated with different concentrations of the asthma medications at different time points after hydrogen peroxide (H. Montelukast, fluticasone, and salmeterol suppressed H. Different asthma medications have different anti-ROS effects on monocytes. The combination therapy with LABA and ICS seemed not to be the only choice for asthma control. Montelukast may also be a good supplemental treatment for the poorly controlled asthma because of its powerful anti-ROS effects. Our findings provide a novel therapeutic view in asthma.

Topics: Acetates; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Albuterol; Anti-Asthmatic Agents; Budesonide; Cyclopropanes; Fluticasone; Formoterol Fumarate; Humans; Indans; Leukotriene Antagonists; Monocytes; Quinolines; Quinolones; Reactive Oxygen Species; Salmeterol Xinafoate; Sulfides; THP-1 Cells

This study investigated the effectiveness and safety of montelukast combined budesonide (MCB) treatment for children with chronic cough-variant asthma (CCVA).In total, 82 cases of children with CCVA, aged 4 to 11 years were included in this study. All cases received either MCB or budesonide alone between May 2015 and April 2017. The primary outcome was lung function, measured by the peak expiratory flow rates (PEFRs) and forced expiratory volume in 1 second (FEV1). The secondary outcome was measured by the clinical assessment score. Furthermore, adverse events (AEs) were also recorded in this study. All outcomes were measured after 8-week treatment.After 8-week treatment, MCB showed greater effectiveness than did budesonide alone in improving the lung function, measured by PEFR V1 (P = .02), and FEV1 (P < .01). Similarly, the clinical assessment score also demonstrated significant difference between the 2 groups (P < .05). In addition, no serious AEs occurred in both groups.The results of this study demonstrate that the effectiveness of MCB is superior to budesonide alone in the treatment of children with CCVA.

Topics: Acetates; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Cough; Cyclopropanes; Drug Monitoring; Drug Therapy, Combination; Female; Humans; Male; Quinolines; Respiratory Function Tests; Retrospective Studies; Sulfides; Symptom Assessment; Treatment Outcome

The patient presented with bloody diarrhoea, and crampy abdominal pains. She was diagnosed with eosinophilic gastroenteritis (EGE) after the finding of persistently high peripheral eosinophil counts and histology of endoscopic biopsies. She responded to steroids but became dependent on it and her symptoms recurred on steroid tapering. There was little improvement with alternative treatment such as budesonides, azathioprine and montelukast. Surprisingly her symptoms improved significantly after she was treated with clarithromycin for chest infection and she was continued on clarithromycin. Her eosinophil counts fell dramatically and follow-up CT (thorax, abdomen and pelvic) scan showed the mucosal thickening had improved. She became completely free of the symptoms since she was on clarithromycin and her eosinophils counts fell within the normal range during the follow-up.

Topics: Acetates; Adult; Anti-Bacterial Agents; Azathioprine; Biopsy; Budesonide; Clarithromycin; Cyclopropanes; Endoscopy; Enteritis; Eosinophilia; Eosinophils; Female; Gastritis; Gastroenteritis; Humans; Leukocyte Count; Macrolides; Mucous Membrane; Quinolines; Sulfides

Mannitol- and exercise bronchial provocation tests are both used to diagnose exercise-induced bronchoconstriction. The study aim was to compare the short-term treatment response to budesonide and montelukast on airway hyperresponsiveness to mannitol challenge test and to exercise challenge test in children and adolescents with exercise-induced bronchoconstriction.. Patients were recruited from a paediatric asthma rehabilitation clinic located in the Swiss Alps. Individuals with exercise-induced bronchoconstriction and a positive result in the exercise challenge test underwent mannitol challenge test on day 0. All subjects then received a treatment with 400 μg budesonide and bronchodilators as needed for 7 days, after which exercise- and mannitol-challenge tests were repeated (day 7). Montelukast was then added to the previous treatment and both tests were repeated again after 7 days (day 14).. Of 26 children and adolescents with exercise-induced bronchoconstriction, 14 had a positive exercise challenge test at baseline and were included in the intervention study. Seven of 14 (50%) also had a positive mannitol challenge test. There was a strong correlation between airway responsiveness to exercise and to mannitol at baseline (r = 0.560, p = 0.037). Treatment with budesonide and montelukast decreased airway hyperresponsiveness to exercise challenge test and to a lesser degree to mannitol challenge test. The fall in forced expiratory volume in one second during exercise challenge test was 21.7% on day 0 compared to 6.7% on day 14 (p = 0.001) and the mannitol challenge test dose response ratio was 0.036%/mg on day 0 compared to 0.013%/mg on day 14 (p = 0.067).. Short-term treatment with an inhaled corticosteroid and an additional leukotriene receptor antagonist in children and adolescents with exercise-induced bronchoconstriction decreases airway hyperresponsiveness to exercise and to mannitol.

Topics: Acetates; Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Asthma, Exercise-Induced; Bronchial Provocation Tests; Bronchoconstrictor Agents; Bronchodilator Agents; Budesonide; Child; Cyclopropanes; Drug Administration Schedule; Exercise Test; Female; Forced Expiratory Volume; Humans; Male; Mannitol; Quinolines; Sulfides; Treatment Outcome; Young Adult

Bronchiolar Clara cells play a critical role in lung homoeostasis. The main goal of this study was to evaluate the effects of chronic allergy on these cells and the efficacy of budesonide (BUD) and montelukast (MK) in restoring their typical phenotypes after ovalbumin-induced chronic allergy in mice. Chronic allergy induced extensive bronchiolar Alcian blue-periodic acid-Schiff (AB/PAS)-positive metaplasia. In addition, cells accumulated numerous big electron-lucent granules negative for Clara cell main secretory protein (CC16), and consequently, CC16 was significantly reduced in bronchoalveolar lavage. A concomitant reduction in SP-D and CYP2E1 content was observed. The phenotypic changes induced by allergy were pharmacologically reversed by both treatments; MK was more efficient than BUD in doing so. MK decreased AB/PAS reactivity to control levels whereas they remained persistently elevated after BUD. Moreover, most non-ciliated cells recovered their normal morphology after MK, whereas for BUD normal cells coexisted with 'transitional' cells that contained remnant mucous granules and stained strongly for CC16 and SP-D. Glucocorticoids were also less able to reduce inflammatory infiltration and maintained higher percentage of neutrophils, which may have contributed to prolonged mucin expression. These results show that chronic allergy-induced mucous metaplasia of Clara cells affects their defensive mechanisms. However, anti-inflammatory treatments were able to re-establish the normal phenotype of Clara cell, with MK being more efficient at restoring a normal profile than BUD. This study highlights the role of epithelial cells in lung injuries and their contribution to anti-inflammatory therapies.

Topics: Acetates; Animals; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Bronchi; Budesonide; Chronic Disease; Cyclopropanes; Cytochrome P-450 CYP2E1; Disease Models, Animal; Epithelium; Female; Mice; Mice, Inbred BALB C; Ovalbumin; Phenotype; Pulmonary Surfactant-Associated Protein D; Quinolines; Sulfides; Uteroglobin

A skewed T-helper (T(h))1/T(h)2 immune response is considered to be the major cause of allergic disorders. Overproduction of T(h)2 cytokines, which promote recruitment and activation of mast cells and eosinophils, plays a key part in the pathogenesis of allergic asthma. The mechanisms by which omalizumab is effective in asthma treatment are not yet fully understood. A 16-year-old girl who was experiencing frequent asthma attacks in spite of daily administration of budesonide (640 μg) and montelukast (10mg) was given omalizumab (375 mg) at intervals of 2 weeks, to prevent a visit to the emergency room. Plasma levels of T(h)1 cytokines [interferon (IFN)-γ and interleukin (IL)-12p70], T(h)2 cytokines (IL-4 and IL-13), other proinflammatory and regulatory cytokines [IL-6, IL-10, IL-17, tumor necrosis factor (TNF)-α, and transforming growth factor (TGF)-β], chemokines [monocyte chemotactic protein (MCP)-1, chemokine ligand (CCL)7, and CCL17], and soluble Fas ligand (sFasL) were measured before treatment and after treatment for 8 weeks. She showed a good clinical response to omalizumab: her lung function parameters improved and the use of β2-agonist decreased. No emergency room visits were required after omalizumab treatment for 8 weeks. Plasma levels of sFasL and TGF-β showed obvious increases after omalizumab therapy. IL-12p70 levels were decreased as compared to the corresponding baseline levels. These findings suggest that the effects of omalizumab in asthma treatment are not restricted to the regulation of the skewed T(h)1/T(h)2 cytokine immune response, and sFasL-mediated apoptosis and regulatory T-cell (Treg)-mediated TGF-β seem to have important roles in the therapeutic effects of omalizumab.

Topics: Acetates; Adolescent; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal, Humanized; Apoptosis; Asthma; Budesonide; Cyclopropanes; Fas Ligand Protein; Female; Humans; Immunologic Factors; Lung; Omalizumab; Quinolines; Respiratory Function Tests; Sulfides; T-Lymphocytes, Regulatory; Transforming Growth Factor beta; Treatment Outcome

Inhaled corticosteroids (ICS) are used in asthma therapy for their anti-inflammatory effects. P-glycoprotein (PGP) is a transmembrane efflux pump for many drugs, including corticosteroids. Expression of PGP is associated with therapy resistant disease.. The purpose of this study was to compare expression levels of PGP in blood lymphocytes of pediatric asthma patients either on ICS or on the leukotriene inhibitor montelukast medication.. The evaluation of lymphocyte PGP expression was performed on a sample of 99 children (66 boys and 33 girls) aged 2-18 (median 12) years with intermittent or persisting mild asthma, (as defined by GINY 2002). The asthmatic children were divided into 3 groups: (1) treated by ICS budesonide 200-400 microg per day (n = 27) more than 1 year; (2) treated by oral montelukast 4 or 5 mg at an age-based dose (n = 16); and (3) treated by inhaled corticosteroids and montelukast (n = 45). Reference PGP values were obtained from a group of 64 healthy children (23 boys and 29 girls) aged 2-15 years (median, 10 years). The expression of lymphocyte PGP was determined on fixed and permeabilized blood mononuclear cells using indirect immunofluorescence staining technique by flow cytometry modified according to Boer et al., 1997.. Based on the weighted medians for PGP expression in peripheral blood lymphocytes, we found a significant difference (p < 10(-3)) between the group of asthma patients (n = 99), (619 +/- 5.3) and healthy controls (n = 64) (446.9 +/- 4.4). Second, there was a lower level of PGP expression in the group treated by ICS (548.6 +/- 9) than the group treated by montelukast and montelukast with budesonide (643.2 +/- 6.3) (p < 10(-6)).. The anti-inflammatory activity of ICS is more effective in decreasing the production of pro-inflammatory mediators and results in reduced multidrug resistence (MDR-1) gene activity and expression of lymphocyte PGP in asthmatic children.

Topics: Acetates; Administration, Inhalation; Administration, Oral; Adolescent; Adrenal Cortex Hormones; Asthma; ATP Binding Cassette Transporter, Subfamily B, Member 1; Budesonide; Case-Control Studies; Child; Child, Preschool; Cyclopropanes; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Flow Cytometry; Fluorescent Antibody Technique, Indirect; Follow-Up Studies; Humans; Inflammation Mediators; Leukotriene Antagonists; Male; Nebulizers and Vaporizers; Probability; Quinolines; Reference Values; Sensitivity and Specificity; Severity of Illness Index; Sulfides; T-Lymphocytes; Treatment Outcome

Although current guidelines place single leukotriene receptor antagonists use as a therapeutic option in mild persistent asthma, there is still uncertainty about its place. In this study efficiency of montelukast monotherapy in children with moderate persistent asthma was evaluated. Children (age 6 to 16) with persistent moderate asthma were treated prospectively with budesonide combined with montelukast (n=20), or only montelukast (n=15) during six months. Asthma symptoms and exacerbations were obtained from diary data. This study suggests that both treatments were effective and well tolerated. It could be concluded that sole montelukast treatment in children with moderate persistent asthma is effective.

Topics: Acetates; Adolescent; Asthma; Budesonide; Child; Cyclopropanes; Drug Therapy, Combination; Humans; Leukotriene Antagonists; Prospective Studies; Quinolines; Sulfides

Topics: Abdominal Pain; Acetates; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Budesonide; Capillary Permeability; Cough; Cyclopropanes; Diarrhea; Dyspnea; Female; Humans; Lung; Mast Cells; Mastocytosis, Systemic; Middle Aged; Nedocromil; Quinolines; Sulfides

Topics: Acetates; Administration, Inhalation; Albuterol; Bronchodilator Agents; Budesonide; Child, Preschool; Cyclopropanes; Double-Blind Method; Female; Glucocorticoids; Humans; Infant; Leukotriene Antagonists; Male; Quinolines; Respiratory Sounds; Respiratory Tract Diseases; Sulfides

Topics: Acetates; Administration, Inhalation; Administration, Oral; Age Factors; Anti-Asthmatic Agents; Asthma; Budesonide; Child; Child, Preschool; Cyclopropanes; Female; Humans; Infant; Leukotriene Antagonists; Male; Quinolines; Randomized Controlled Trials as Topic; Research Design; Sulfides; Treatment Outcome

Since allergic rhinitis in asthma patients is associated with worse asthma control, the treatment of the comorbid condition may improve outcomes.. A 1-year retrospective study using the UK Mediplus database (2001-2004) included asthmatic patients aged 15-55 with allergic rhinitis. Patients starting therapy based on the Global Initiative for Asthma guidelines, defined as an increase in inhaled corticosteroids (high-dose inhaled corticosteroids, hdICS), or the addition of montelukast (ICS+MON) or long-acting beta-agonists (ICS+LABA) to ICS, were studied. Univariable and multiple logistic regressions evaluated asthma-related outcomes.. Among 2,596 asthma and allergic rhinitis patients, 83.2% initiated ICS+LABA, 12.1% hdICS and 4.7% ICS+MON. The mean age was 34 years and 60% were female. ICS+MON patients had more moderate-severe asthma (p = 0.04). Approximately 84% of the ICS+LABA patients experienced an asthma control failure compared to 50% in the other groups (p < 0.0001). The proportions of patients requiring treatment change were 73.8, 22 and 27.3% in the ICS+LABA, hdICS and ICS+MON groups, respectively (p = 0.001). Asthma-related resource use was similar among all groups. The ICS+MON group received fewer mean prescriptions for oral corticosteroids (p = 0.024) than the other groups (p = 0.026).. In asthma and allergic rhinitis, treatment with ICS+MON or hdICS was associated with lower rates of asthma control failure and fewer treatment changes than the ICS+LABA group. MON users also required fewer oral corticosteroids.

Topics: Acetates; Adolescent; Adrenergic beta-Agonists; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Cohort Studies; Comorbidity; Cyclopropanes; Drug Therapy, Combination; Female; Fluticasone; Humans; Male; Middle Aged; Quinolines; Rhinitis; Sulfides; Treatment Outcome; United Kingdom

This Society for Medicines Research symposium, sponsored by UCB, was held on September 11, 2007, at the Wellcome Trust Conference Centre, Hinxton, Cambridge, United Kingdom. The meeting, organized by Ruth Lock, Steve Collingwood and Andrew Ratcliffe, reviewed current thinking in the area of airway drug delivery and the challenges and progress made in the discovery and development of novel medicines to treat respiratory diseases, such as chronic obstructive pulmonary disease, asthma, allergic rhinitis and cystic fibrosis.

Topics: Acetates; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Cyclopropanes; Drug Combinations; Drug Therapy; Ethanolamines; Humans; Leukotriene Antagonists; Molecular Structure; Quinolines; Respiratory Tract Diseases; Sulfides

Tonsillectomy and adenoidectomy (T&A) is the primary therapeutic approach for sleep-disordered breathing (SDB) in children. However, residual mild SDB will be found in more than one third of these patients after T&A. We hypothesized that combined therapy with the leukotriene receptor antagonist montelukast and intranasal budesonide would result in normalization of residual SDB after T&A.. During the period of October 2002 to February 2005, children who underwent T&A for SDB underwent a routine postoperative (second) overnight polysomnographic evaluation (PSG) 10 to 14 weeks after T&A surgery. In children with residual apnea hypopnea index (AHI) >1 and <5/hour of total sleep time (TST), treatment with montelukast and intranasal budesonide aqueous solution was administered for a period of 12 weeks (M/B group), at which time a third PSG was performed. Children who had residual SDB and did not receive M/B therapy from their treating physicians were recruited as control subjects.. Twenty-two children received M/B, and 14 children served as control subjects. Mean age, gender distribution, ethnicity, and BMI were similar in the 2 treatment groups. The mean AHI at the second PSG was 3.9 +/- 1.2/hour of TST and 3.6 +/- 1.4/hour of TST in M/B-treated and control patients, respectively. Similar nadir arterial oxygen saturation (87.3 +/- 1.2%) and respiratory arousal index (4.6 +/- 0.7/hour of TST) were recorded for both groups. However, the M/B group demonstrated significant improvements in AHI (0.3 +/- 0.3/hour of TST), in nadir arterial oxygen saturation (92.5 +/- 3.0%), and in respiratory arousal index (0.8 +/- 0.7/hour of TST) on the third PSG, whereas no significant changes occurred over time in control subjects.. Combined anti-inflammatory therapy that consists of oral montelukast and intranasal budesonide effectively improves and/or normalizes respiratory and sleep disturbances in children with residual SDB after T&A.

Topics: Acetates; Adenoidectomy; Administration, Intranasal; Administration, Oral; Budesonide; Child; Cyclopropanes; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Leukotriene Antagonists; Male; Polysomnography; Quinolines; Sleep Apnea Syndromes; Sulfides; Tonsillectomy

Topics: Acetates; Anti-Inflammatory Agents; Budesonide; Child; Cyclopropanes; Humans; Leukotriene Antagonists; Polysomnography; Quinolines; Severity of Illness Index; Sleep Apnea Syndromes; Sulfides; Treatment Outcome

Topics: Acetates; Administration, Inhalation; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Double-Blind Method; Drug Therapy, Combination; Humans; Leukotriene Antagonists; Quinolines; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Seasonal; Sulfides; Time Factors

The Clinical Outcomes with Montelukast as a Partner Agent to Corticosteroid Therapy (COMPACT) trial demonstrated that montelukast added to budesonide (MNT + BD) was as efficacious as double the dose of budesonide (dBD) in improving morning peak expiratory flow (AM PEF) in adult asthmatics. Recent studies have demonstrated that montelukast is also effective in treating daytime and nighttime allergic rhinitis (AR) symptoms in asthmatic patients. This analysis was designed to examine whether asthmatic patients with comorbid AR respond differently than patients without comorbid AR in terms of asthma control (lung function).. There were 216 asthmatic patients in the MNT+BD group and 184 patients in the dBD group with AR. Treatment differences in the change from baseline in AM PEF were compared. Least square (LS) mean and 95% confidence interval (CI) were derived from an anova model adjusting for baseline and study site.. There was a 9.2% increase in AM PEF from baseline in the MNT+BD group compared with a 6% increase in the dBD group. The LS mean difference [(MNT+BD)-dBD] was 14.2 l/min (P=0.028). Other secondary endpoints were similar between groups.. In the subgroup of asthmatic patients with AR, a combined treatment approach that included montelukast and budesonide provided significantly greater efficacy in reducing airflow obstruction compared with doubling the dose of budesonide. These results support recommendations by the Allergic Rhinitis and its Impact on Asthma initiative that suggest a unified approach aimed at treating the airway inflammation common to both diseases is beneficial for the large proportion of asthmatics who also suffer from AR.

Topics: Acetates; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Lung; Male; Peak Expiratory Flow Rate; Quinolines; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Sulfides

Topics: Acetates; Adrenal Cortex Hormones; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Budesonide; Child; Cyclopropanes; Drug Administration Schedule; Humans; Quinolines; Sulfides

Topics: Acetates; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Drug Therapy, Combination; Germany; Glucocorticoids; Humans; Leukotriene Antagonists; Multicenter Studies as Topic; Quinolines; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Sulfides

Topics: Acetates; Adolescent; Adult; Aged; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Bronchodilator Agents; Budesonide; Cyclopropanes; Drug Therapy, Combination; Fluticasone; Glucocorticoids; Humans; Leukotriene Antagonists; Middle Aged; Multicenter Studies as Topic; Quinolines; Randomized Controlled Trials as Topic; Sulfides; Time Factors

Topics: Acetates; Albuterol; Asthma; Breath Tests; Bronchodilator Agents; Budesonide; Cyclopropanes; Exhalation; Humans; Nitric Oxide; Quinolines; Respiratory Function Tests; Salmeterol Xinafoate; Sulfides

Topics: Acetates; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Budesonide; Clinical Trials as Topic; Cyclopropanes; Dose-Response Relationship, Drug; Drug Therapy, Combination; Humans; Leukotriene Antagonists; Quinolines; Sulfides

Topics: Acetates; Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Aged; Asthma; Bronchodilator Agents; Budesonide; Chronic Disease; Cyclopropanes; Drug Therapy, Combination; Humans; Leukotriene Antagonists; Middle Aged; Quinolines; Sulfides

Previous studies in which leukotriene-receptor antagonist and corticosteroids were used have suggested a possible role for these anti-inflammatory drugs in the prevention of exercise-induced bronchoconstriction, but no direct comparisons have been made.. A crossover study was undertaken to compare the ability of both montelukast and budesonide to protect patients from exercise-induced bronchoconstriction.. A total of 20 patients (median age, 17 years; range, 8 to 36 years), who had clinical exercise-induced bronchoconstriction for 1 year and decreased FEV1 of at least 20% after exercise on two occasions, were enrolled in this study. To compare the therapies in each patient, we administered, consecutively, 10 mg of montelukast once daily at bedtime for 3 days and, later, 400 microg of budesonide twice daily for 15 days, or vice versa, with a 15-day intervening washout period during which no patient received treatment. Exercise challenges were performed at baseline (no therapy) and after each treatment. The percentage of FEV1 declines at 2, 7, and 12 minutes after exercise and the area under the curve (summarizing the extent and modification of FEV1 decreases relative to time) were measured and compared.. Both budesonide and montelukast significantly reduced the decrease in FEV1 (area under the curve) after exercise with respect to the baseline condition of no therapy (P = 0.0001). Overall, budesonide offered better protection (area under the curve) than did montelukast (P = 0.01), particularly in the short-term evaluation (2 minutes after exercise; P = 0.003); however, considerable individual variations in the responses to both budesonide and montelukast were observed. The degree of protection against decreases in FEV1 ranged from 0% to almost 100% for both treatments. In 16 of 20 patients, budesonide therapy offered better protection than did montelukast, and in the other 4 patients, montelukast showed better protection than did budesonide. No side effects of either montelukast or budesonide were detected during the study.. Treatment with budesonide or montelukast prevents exercise-induced bronchoconstriction. Because substantial variation in the response may be present among patients, both drugs should be tested in each patient before long-term therapy is chosen.

Topics: Acetates; Adolescent; Adult; Anti-Asthmatic Agents; Asthma, Exercise-Induced; Bronchoconstriction; Bronchodilator Agents; Budesonide; Child; Cyclopropanes; Female; Forced Expiratory Volume; Humans; Male; Quinolines; Spirometry; Sulfides

Topics: Abnormalities, Drug-Induced; Acetates; Administration, Inhalation; Administration, Intranasal; Administration, Oral; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Animals; Anti-Allergic Agents; Anti-Asthmatic Agents; Asthma; Budesonide; Chlorpheniramine; Cyclopropanes; Ephedrine; Female; Histamine H1 Antagonists; Humans; Hydroxyurea; Hypersensitivity; Indoles; Ipratropium; Leukotriene Antagonists; Metaproterenol; Nasal Decongestants; Nebulizers and Vaporizers; Nedocromil; Phenylcarbamates; Pregnancy; Pregnancy Complications; Quinolines; Salmeterol Xinafoate; Sulfides; Sulfonamides; Terbutaline; Tosyl Compounds; Tripelennamine