Effectiveness of, Adherence to and Satisfaction with Montelukast Treatment in Allergic Rhinitis Patients with Uncontrolled Asthma Symptoms while on Treatment with Low Dose Inhaled Corticosteroids

2007 ◽  
Vol 119 (1) ◽  
pp. S244-S245
Author(s):  
C. Koch ◽  
A. Kaplan ◽  
J. Sampalis ◽  
E. Psaradellis ◽  
A. McIvor
BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e040528
Author(s):  
Sofia Cividini ◽  
Ian Sinha ◽  
Sarah Donegan ◽  
Michelle Maden ◽  
Giovanna Culeddu ◽  
...  

IntroductionAsthma affects millions of children worldwide—1.1 million children in the UK. Asthma symptoms cannot be cured but can be controlled with low-dose inhaled corticosteroids (ICSs) in the majority of individuals. Treatment with a low-dose ICS, however, fails to control asthma symptoms in around 10%–15% of children and this places the individual at increased risk for an asthma attack. At present, there is no clear preferred treatment option for a child whose asthma is not controlled by low-dose ICS and international guidelines currently recommend at least three treatment options. Herein, we propose a systematic review and individual participant data network meta-analysis (IPD-NMA) aiming to synthesise all available published and unpublished evidence from randomised controlled trials (RCTs) to establish the clinical effectiveness of pharmacological treatments in children and adolescents with uncontrolled asthma on ICS and help to make evidence-informed treatment choices. This will be used to parameterise a Markov-based economic model to assess the cost-effectiveness of alternative treatment options in order to inform decisions in the context of drug formularies and clinical guidelines.Methods and analysisWe will search in MEDLINE, the Cochrane Library, the Cochrane Central Register of Controlled Trials (CENTRAL), Embase, NICE Technology Appraisals and the National Institute for Health Research (NIHR) Health Technology Assessment series for RCTs of interventions in patients with uncontrolled asthma on ICS. All studies where children and adolescents were eligible for inclusion will be considered, and authors or sponsors will be contacted to request IPD on patients aged <18. The reference lists of existing clinical guidelines, along with included studies and relevant reviews, will be checked to identify further relevant studies. Unpublished studies will be located by searching across a range of clinical trial registries, including internal trial registers for pharmaceutical companies. All studies will be appraised for inclusion against predefined inclusion and exclusion criteria by two independent reviewers with disagreements resolved through discussion with a third reviewer. We will perform an IPD-NMA—eventually supplemented with aggregate data for the RCTs without IPD—to establish both the probability that a treatment is best and the probability that a particular treatment is most likely to be effective for a specific profile of the patient. The IPD-NMA will be performed for each outcome variable within a Bayesian framework, using the WinBUGS software. Also, potential patient-level characteristics that may modify treatment effects will be explored, which represents one of the strengths of this study.Ethics and disseminationThe Committee on Research Ethics, University of Liverpool, has confirmed that ethics review is not required. The dissemination plan consists of publishing the results in an open-access medical journal, a plain-language summary available for parents and children, dissemination via local, national and international meetings and conferences and the press offices of our Higher Education Institutions (HEIs). A synopsis of results will be disseminated to NICE and British Thoracic Society/Scottish Intercollegiate Guidelines Network (SIGN) as highly relevant to future clinical guideline updates.PROSPERO registration numberCRD42019127599.


2009 ◽  
Vol 16 (suppl a) ◽  
pp. 17A-24A ◽  
Author(s):  
Paul K Keith ◽  
Caroline Koch ◽  
Michel Djandji ◽  
Jacques Bouchard ◽  
Eliofotisti Psaradellis ◽  
...  

OBJECTIVE: To evaluate the effectiveness of montelukast as add-on therapy for patients diagnosed with asthma and concurrent allergic rhinitis who remain uncontrolled while receiving inhaled corticosteroid (ICS) monotherapy or ICS/long-acting beta-2-agonist (LABA) therapy in a community practice setting.DESIGN: An eight-week, multicentre, open-label, observational study. Patients were 15 years of age or older and, while treated with an ICS or ICS/LABA, had allergic rhinitis and uncontrolled asthma symptoms by at least two criteria as per the Canadian Asthma Consensus Guidelines. The primary outcome measure was the percentage of patients with controlled asthma symptoms after eight weeks of treatment with montelukast 10 mg once daily added to ICS or ICS/LABA therapy.RESULTS: In total, 1004 patients participated in the survey phase of the study. Of these patients, 319 continued in the treatment phase and 301 (94.4%) completed the eight-week assessment. At baseline, all patients had uncontrolled asthma symptoms based on the Canadian Asthma Consensus Guidelines; at the eight-week assessment, 229 patients (76.1%) achieved asthma control. According to the Asthma Control Questionnaire (as determined by scores of 0.75 or less), 164 patients (54.7%) achieved well-controlled asthma at week 8. The mean (± SD) Asthma Control Questionnaire score decreased from 2.03±0.80 to 0.92±0.80 (P<0.001) for all patients, representing a clinically significant improvement. A statistically and clinically significant reduction in the overall Mini Rhinitis Quality of Life Questionnaire score was achieved with a decrease from 2.57±1.20 to 1.12±1.00 (–1.45±1.35; P<0.001). Patient and physician satisfaction rates with montelukast add-on therapy were also significantly increased when compared with baseline treatment.CONCLUSION: Montelukast add-on therapy is effective for managing asthma and allergic rhinitis symptoms in patients who were previously uncontrolled with ICS or ICS/LABA treatment.


2009 ◽  
Vol 16 (suppl a) ◽  
pp. 17A-24A ◽  
Author(s):  
Paul K Keith ◽  
Caroline Koch ◽  
Michel Djandji ◽  
Jacques Bouchard ◽  
Eliofotisti Psaradellis ◽  
...  

OBJECTIVE: To evaluate the effectiveness of montelukast as add-on therapy for patients diagnosed with asthma and concurrent allergic rhinitis who remain uncontrolled while receiving inhaled corticosteroid (ICS) monotherapy or ICS/long-acting beta-2-agonist (LABA) therapy in a community practice setting.DESIGN: An eight-week, multicentre, open-label, observational study. Patients were 15 years of age or older and, while treated with an ICS or ICS/LABA, had allergic rhinitis and uncontrolled asthma symptoms by at least two criteria as per the Canadian Asthma Consensus Guidelines. The primary outcome measure was the percentage of patients with controlled asthma symptoms after eight weeks of treatment with montelukast 10 mg once daily added to ICS or ICS/LABA therapy.RESULTS: In total, 1004 patients participated in the survey phase of the study. Of these patients, 319 continued in the treatment phase and 301 (94.4%) completed the eight-week assessment. At baseline, all patients had uncontrolled asthma symptoms based on the Canadian Asthma Consensus Guidelines; at the eight-week assessment, 229 patients (76.1%) achieved asthma control. According to the Asthma Control Questionnaire (as determined by scores of 0.75 or less), 164 patients (54.7%) achieved well-controlled asthma at week 8. The mean (± SD) Asthma Control Questionnaire score decreased from 2.03±0.80 to 0.92±0.80 (P<0.001) for all patients, representing a clinically significant improvement. A statistically and clinically significant reduction in the overall Mini Rhinitis Quality of Life Questionnaire score was achieved with a decrease from 2.57±1.20 to 1.12±1.00 (–1.45±1.35; P<0.001). Patient and physician satisfaction rates with montelukast add-on therapy were also significantly increased when compared with baseline treatment.CONCLUSION: Montelukast add-on therapy is effective for managing asthma and allergic rhinitis symptoms in patients who were previously uncontrolled with ICS or ICS/LABA treatment.


2021 ◽  
Vol 15 (1) ◽  
Author(s):  
David N. Pham

Abstract Background T cell-mediated eosinophilia is associated with numerous conditions—including atopic dermatitis, food allergies, and asthma—collectively known as the “atopic march.” Benralizumab is a recombinant, humanized, afucosylated monoclonal antibody directed against the ⍺ chain of the eosinophil cell surface receptor IL-5R. Benralizumab treatment causes near-complete depletion of circulating eosinophils and was approved in 2017 for add-on, maintenance treatment of severe asthma with an eosinophilic phenotype, based on the results of the CALIMA and SIROCCO pivotal trials. Benralizumab is not currently approved for the treatment of eosinophilic conditions besides asthma; however, during the CALIMA trial, spontaneous resolution of atopic dermatitis was observed in a patient, concurrent with reduction in her asthma symptoms. Case presentation In January 2015, a 14-year-old Asian girl with severe, uncontrolled asthma was enrolled in CALIMA. The patient’s baseline eosinophil blood count was 1200 cells/μL, her pre-bronchodilator forced expiratory volume in 1 second (FEV1) was 1.9 L and FEV1/forced vital capacity (FVC) ratio was 71.4%, and her post-bronchodilator FEV1 was 3.2 L (FEV1/FVC of 115.9%). Her overall baseline asthma symptom score was 3.9 and her asthma exacerbation rate in the prior year was 4. She also displayed a pronounced, pruritic, chronic, inflammatory rash consistent with atopic dermatitis across her face. The investigator was blinded to the patient’s treatment group during treatment; however, her asthma symptoms diminished over the course of the study (FEV1 at 56 weeks, 3.01 L/110.5% (pre) and 3.25 L/119.3% (post); overall asthma symptom score 2.1; one influenza-associated exacerbation). Furthermore, her atopic dermatitis symptoms resolved spontaneously within the first 5 months of the study. After unblinding, the patient was confirmed to have been randomized to an active treatment arm, and her blood eosinophil count had dropped below the limit of detection after the first study dose. Conclusions Given the potential shared mechanisms between eosinophilic asthma and atopic dermatitis, it is plausible that benralizumab-induced eosinopenia factored into the resolution of the patient’s atopic dermatitis. Further clinical studies are warranted to determine whether benralizumab or other drugs targeted against IL-5/IL-5R may be useful in managing multiple conditions associated with eosinophilia.


2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Abdullah Alnajem ◽  
Abdullah Redha ◽  
Dalal Alroumi ◽  
Ahmed Alshammasi ◽  
Mohamad Ali ◽  
...  

Abstract Background Globally, a surge in electronic cigarette (e-cigarette) use has been observed in recent years, with youth being the most susceptible group. Given their recent emergence, studies assessing the health consequences of using e-cigarettes and exposure to their secondhand aerosols (SHA) are limited. Hence, this study sought to assess associations between e-cigarette use and household exposure to SHA from e-cigarettes with asthma symptoms among adolescents. Methods A school-based cross-sectional study was conducted by enrolling high school students (n = 1565; aged 16–19 years) in Kuwait. Participants self-completed a questionnaire on tobacco products use (e-cigarettes and cigarettes) and asthma symptoms. Current e-cigarette use and cigarette smoking were defined as any use in the past 30 days. Household exposure to SHA from e-cigarettes in the past 7 days was reported as none (0 days), infrequent (1–2 days), and frequent (≥ 3 days). Asthma symptoms included current (past 12 months) wheeze, current asthma (history of clinical diagnosis and current wheeze and/or medication use), and current symptoms of uncontrolled asthma (≥ 4 attacks of wheeze, ≥ 1 night per week sleep disturbance from wheeze, and/or wheeze affecting speech). Associations were assessed using Poisson regression with robust variance estimation, and adjusted prevalence ratios (aPRs) and 95% confidence intervals (CIs) were estimated. Results Among the analytical study sample (n = 1345), current e-cigarette use and cigarette smoking was reported by 369 (27.4%) and 358 (26.6%) participants, respectively. Compared to never e-cigarette users and never cigarette smokers, current e-cigarette users with no history of cigarette smoking had increased prevalence of current wheeze (aPR = 1.54, 95% CI 1.01–2.45) and current asthma (aPR = 1.85, 95% CI 1.03–3.41). Moreover, the frequency of exposure to household SHA from e-cigarettes was associated with asthma symptoms. For example, compared to those with no exposure to household SHA, frequent exposure to household SHA was associated with current wheeze (aPR = 1.30, 95% CI 1.04–1.59), current asthma (aPR = 1.56, 95% CI 1.13–2.16), and current uncontrolled asthma symptoms (aPR = 1.88, 95% CI 1.35–2.62). Conclusions E-cigarette use and their household SHA exposure were independently associated with asthma symptoms among adolescents. Hence, such observations indicate that e-cigarette use and passive exposure to their aerosols negatively impact respiratory health among adolescents.


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