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Severe Persistent Asthma

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181. Influenza Vaccine Feasibility Study in Children With Persistent Asthma

protocol and associated documents and procedures, CISA is proposing to carry out a study at the three sites to assess the feasibility of recruiting, enrolling, retaining, and collecting clinical data on children 5-11 years with persistent asthma of varied levels of severity in an influenza vaccine safety study. Findings from this proposed feasibility study will facilitate improving the LAIV4 study in the future if it goes forward through the CISA Project or in another venue. In 2016-2017 season, FDA (...) children. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 40 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other Official Title: Feasibility Study to Assess the Safety of Quadrivalent, Live Attenuated Influenza Vaccine (LAIV4) Versus Quadrivalent Inactivated Influenza Vaccine (IIV4) in Children Aged 5-11 Years With Persistent Asthma of Varied Severity (Cell

2016 Clinical Trials

182. To Determine the Measurement Properties of the ACT in an African American Adolescent Population With Persistent Asthma

medication use for asthma requiring at least low-dose inhaled corticosteroids (ICS). Asthma may range from mild persistent through severe persistent asthma, to include subjects that may require daily or every other day oral corticosteroids for control of asthma symptoms Exclusion Criteria: Children younger than age 12 and older than 18 Children unable to perform spirometry Medical history or underlying health problems that may preclude participation in the protocol per the study physician (including (...) To Determine the Measurement Properties of the ACT in an African American Adolescent Population With Persistent Asthma To Determine the Measurement Properties of the ACT in an African American Adolescent Population With Persistent Asthma - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum

2016 Clinical Trials

183. Fevipiprant, a prostaglandin D2 receptor 2 antagonist, in patients with persistent eosinophilic asthma: a single-centre, randomised, double-blind, parallel-group, placebo-controlled trial. Full Text available with Trip Pro

Fevipiprant, a prostaglandin D2 receptor 2 antagonist, in patients with persistent eosinophilic asthma: a single-centre, randomised, double-blind, parallel-group, placebo-controlled trial. Eosinophilic airway inflammation is often present in asthma, and reduction of such inflammation results in improved clinical outcomes. We hypothesised that fevipiprant (QAW039), an antagonist of prostaglandin D2 receptor 2, might reduce eosinophilic airway inflammation in patients with moderate-to-severe (...) eosinophilic asthma.We performed a single-centre, randomised, double-blind, parallel-group, placebo-controlled trial at Glenfield Hospital (Leicester, UK). We recruited patients with persistent, moderate-to-severe asthma and an elevated sputum eosinophil count (≥2%). After a 2-week single-blind placebo run-in period, patients were randomly assigned (1:1) by the trial pharmacist, using previously generated treatment allocation cards, to receive fevipiprant (225 mg twice per day orally) or placebo

2016 The lancet. Respiratory medicine Controlled trial quality: predicted high

184. Allergy testing in children with persistent asthma: Comparison of four diagnostic methods. (Abstract)

microarray platforms applied on a well-characterized pediatric asthma cohort.Seventy-one children were recruited from a nationwide Swedish study on severe childhood asthma. Severe (n = 40) and controlled (n = 31) asthmatics were assessed for allergic sensitization by two microarray systems (Microtest and ISAC) and by two standard diagnostic methods (ImmunoCAP and skin prick test). Data on clinical history, physical examination, spirometry, asthma control test, and doctor's diagnosis were collected (...) Allergy testing in children with persistent asthma: Comparison of four diagnostic methods. Multiple allergic sensitizations are common in persistent childhood asthma, and thorough assessment of allergy is crucial for optimal care of these children. Microarray testing offers opportunities for improved sIgE characterization, which has been projected to be useful in the management of multisensitized patients.The aim of this study was to investigate the accuracy and information obtained by two

2016 Allergy

185. Efficacy and safety of a CXCR2 antagonist, AZD5069, in patients with uncontrolled persistent asthma: a randomised, double-blind, placebo-controlled trial. (Abstract)

Efficacy and safety of a CXCR2 antagonist, AZD5069, in patients with uncontrolled persistent asthma: a randomised, double-blind, placebo-controlled trial. Airway neutrophilic inflammation is a pathological feature in some patients with severe asthma. Stimulation of the chemokine receptor CXCR2 mediates neutrophil migration into the airways. We investigated the safety and efficacy of AZD5069, a CXCR2 antagonist, as an add-on therapy in patients with uncontrolled severe asthma.In this multicentre (...) , randomised, double-blind, placebo-controlled, dose-finding trial, we enrolled patients aged 18 years or older with uncontrolled asthma despite combination therapy with long-acting β2 agonists and medium-dose or high-dose inhaled corticosteroids. Patients were randomised in a 1:1:1:1 ratio via an interactive voice-response or web-response system to receive 5, 15, or 45 mg oral AZD5069 twice daily or matched placebo. The primary endpoint was the number of severe asthma exacerbations in 6 months. Safety

2016 The lancet. Respiratory medicine Controlled trial quality: predicted high

186. Dupilumab in Persistent Asthma with Elevated Eosinophil Levels. Full Text available with Trip Pro

Dupilumab in Persistent Asthma with Elevated Eosinophil Levels. Moderate-to-severe asthma remains poorly treated. We evaluated the efficacy and safety of dupilumab (SAR231893/REGN668), a fully human monoclonal antibody to the alpha subunit of the interleukin-4 receptor, in patients with persistent, moderate-to-severe asthma and elevated eosinophil levels.We enrolled patients with persistent, moderate-to-severe asthma and a blood eosinophil count of at least 300 cells per microliter or a sputum (...) , 0.08; 95% confidence interval, 0.02 to 0.28; P<0.001). Significant improvements were observed for most measures of lung function and asthma control. Dupilumab reduced biomarkers associated with Th2-driven inflammation. Injection-site reactions, nasopharyngitis, nausea, and headache occurred more frequently with dupilumab than with placebo.In patients with persistent, moderate-to-severe asthma and elevated eosinophil levels who used inhaled glucocorticoids and LABAs, dupilumab therapy, as compared

2013 NEJM Controlled trial quality: predicted high

187. Cognitive behavioural therapy (CBT) for adults and adolescents with asthma. Full Text available with Trip Pro

to 53. Study populations generally had persistent asthma, but severity and diagnostic measures varied. Three studies recruited participants with psychological symptomatology, although with different criteria. Interventions ranged from 4 to 15 sessions, and primary measurements were taken at a mean of 3 months (range 1.2 to 12 months).Participants given CBT had improved scores on the Asthma Quality of Life Questionnaire (AQLQ) (MD 0.55, 95% confidence interval (CI) 0.17 to 0.93; participants = 214 (...) adults with persistent asthma, CBT may improve quality of life, asthma control, and anxiety levels compared with usual care. Risks of bias, imprecision of effects, and inconsistency between results reduced our confidence in the results to low, and evidence was lacking regarding the effect of CBT on asthma exacerbations, unscheduled contacts, depression, and medication adherence. There was much variation between studies in how CBT was delivered and what constituted usual care, meaning the most optimal

2016 Cochrane

188. Serum eosinophil-derived neurotoxin: Correlation with persistent airflow limitation in adults with house-dust mite allergic asthma. (Abstract)

Serum eosinophil-derived neurotoxin: Correlation with persistent airflow limitation in adults with house-dust mite allergic asthma. The serum level of eosinophil-derived neurotoxin (EDN), a protein present in eosinophil granules, correlates with the severity of childhood asthma. However, the relationship between the serum EDN level and the severity of adult asthma has not been sufficiently investigated.This study aimed to elucidate the correlation between the serum EDN level and markers (...) of severity in adult asthma.The subjects comprised 83 adult patients who had asthma and who were undergoing treatment. Of these patients, 40 were positive for house-dust-specific immunoglobulin E (IgE) antibodies; 9 patients with severe adult asthma who were treated with omalizumab were included in the study. We measured the blood eosinophil count, serum EDN, and eosinophil cationic protein levels before investigating the correlations of these parameters with lung function and symptom score.There were

2015 Allergy and Asthma Proceedings

189. Chronic Comorbidities Contribute to the Burden and Costs of Persistent Asthma Full Text available with Trip Pro

Chronic Comorbidities Contribute to the Burden and Costs of Persistent Asthma We aimed to study the prevalence of chronic comorbidities in asthma patients and the costs of health care use associated with asthma with comorbidities.We analysed the prevalence of the four most common chronic diseases in asthma patients in 2008-2014 in Finland. Prevalence of coronary artery disease, diabetes and dyslipidaemia, hypertension, epilepsy, inflammatory bowel disease, rheumatic diseases, and severe (...) psychiatric disease was studied by register of the Social Insurance Institution of Finland. The costs of health care services were collected from the registries maintained by the National Institute for Health and Welfare (THL).Prevalence of asthma was 4.6% in 2014. Diabetes was among the four most common comorbidities in all the age groups. The other common comorbidities were hypertension (≥46 years; 12.9-37.6%), severe psychiatric disorders (age groups of 16-59 years; 1.4-3.5%), and ischaemic heart

2015 Mediators of inflammation

190. House dust mite sublingual immunotherapy is safe in patients with mild-to-moderate, persistent asthma: a clinical trial. (Abstract)

-controlled, persistent asthma [mild in 290 patients (59.9%), moderate in 183 (37.8%) and severe in 11 (2.3%)]. No treatment-related serious AEs were reported. A total of 87.0% and 75.9% of the patients in the active and placebo groups, respectively, experienced at least one AE (mostly mild), and 78.9% and 48.1% experienced an ADR (mostly mild or moderate oral reactions). The incidence of asthma exacerbations (symptoms requiring a short course of oral corticosteroids) during the study was similar (...) House dust mite sublingual immunotherapy is safe in patients with mild-to-moderate, persistent asthma: a clinical trial. The safety of allergen immunotherapy (AIT) in asthma has not always been sufficiently documented; accordingly, fear of asthma exacerbations has made physicians somewhat reluctant to prescribe AIT in this context. In a double-blind, placebo-controlled, randomized clinical trial, house dust mite (HDM) sublingual AIT was found to be efficacious in moderate, persistent asthma

2015 Allergy Controlled trial quality: predicted high

191. Persistent airflow obstruction in patients with asthma: Characteristics of a distinct clinical phenotype. Full Text available with Trip Pro

%) of the patients with persistent obstruction fulfilled the ATS criteria for severe refractory asthma (SRA), in contrast to 4.5% in the group without persistent obstruction. A cluster analysis identified three clinically relevant clusters: Cluster 1 (n = 56, not related to persistent airflow obstruction) included non-atopic patients, who did not receive high-dose ICS without SRA; Cluster 2 (n = 53, related to persistent airflow obstruction) included atopic patients, receiving high-dose ICS and/or oral CS (...) , fulfilling SRA criteria; Cluster 3 (n = 61, not related to persistent airflow obstruction) included atopic patients not receiving high-dose ICS, without SRA.Asthma patients with persistent airflow obstruction present a distinct asthma phenotype, with significant differences in clinical, functional and inflammatory characteristics compared to patients without fixed airway obstruction. These patients present more often severe refractory asthma and require more intense treatment.Copyright © 2015 Elsevier

2015 Respiratory medicine

192. Evaluation of Dupilumab in Patients With Persistent Asthma

Evaluation of Dupilumab in Patients With Persistent Asthma Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Evaluation (...) of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02414854 Recruitment Status : Completed First Posted : April 13, 2015 Results First Posted : October 23, 2018 Last Update Posted : October 23, 2018 Sponsor: Sanofi Collaborator: Regeneron

2015 Clinical Trials

193. A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma

A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results (...) information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing

2015 Clinical Trials

194. Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthma. (Abstract)

Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthma. Fluticasone furoate (FF; inhaled corticosteroid) combined with vilanterol (VI; long-acting beta(2) agonist) is a once-daily therapy for asthma and chronic obstructive pulmonary disease. This 12-week phase III study compared the efficacy and safety of once-daily (evening dosing) FF/VI 100/25 mcg versus FF 100 mcg (primary objective) and FF/VI 100/25 mcg versus FF/VI 200/25 mcg (descriptive (...) comparison only) in patients (n = 1039) ≥12 years with moderate-to-severe persistent asthma.The primary end point was weighted mean (wm) 0-24-h serial forced expiratory volume in 1 s (FEV(1)) at week 12. Secondary end points (change from baseline) were trough FEV(1) and the proportion (%) of rescue-free 24-h periods (both powered), the proportion (%) of symptom-free 24-h periods, and morning and evening peak expiratory flow (PEF). Safety data (adverse events, AEs) were collected throughout.Compared

2015 Journal of Asthma Controlled trial quality: uncertain

195. A Study to Investigate the Efficacy, Safety, and Tolerability of Repeat Doses of Inhaled GSK2269557 in Adults With Persistent, Uncontrolled Asthma

with an inhaled corticosteroid (ICS) or long acting beta 2 agonist (LABA). This study is the first administration of GSK2269557 to asthmatic subjects, and the aims of the study are to investigate the efficacy, safety, tolerability, and pharmacokinetics of four weeks of treatment with orally inhaled GSK2269557 1000 microgram (mcg) in subjects with persistent uncontrolled asthma. In a sub-study, biological mediators will be measured from induced sputum and blood. Approximately 50 subjects will be randomised (...) A Study to Investigate the Efficacy, Safety, and Tolerability of Repeat Doses of Inhaled GSK2269557 in Adults With Persistent, Uncontrolled Asthma A Study to Investigate the Efficacy, Safety, and Tolerability of Repeat Doses of Inhaled GSK2269557 in Adults With Persistent, Uncontrolled Asthma - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies

2015 Clinical Trials

196. Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma

Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail (...) Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read

2015 Clinical Trials

197. A Non-interventional Study to Investigate the Current Situation of Asthma-COPD Overlap Syndrome in Patients Over Age 40 With Persistent Airflow Limitation in China

-BD FEV1/FVC<0.7) based on GINA and GOLD 2015 definition [ Time Frame: one day ] Secondary Outcome Measures : - The proportions of COPD and asthma, respectively, among the patients over age 40 with persistent airflow limitation (post-BD FEV1/FVC<0.7) based on GINA and GOLD 2015 definition. [ Time Frame: one day ] - The distributions of the severity of airflow limitation according to GOLD lung function grading based on post-BD FEV1 in patients with ACOS, COPD or asthma. [ Time Frame: one day (...) A Non-interventional Study to Investigate the Current Situation of Asthma-COPD Overlap Syndrome in Patients Over Age 40 With Persistent Airflow Limitation in China A Non-interventional Study to Investigate the Current Situation of Asthma-COPD Overlap Syndrome in Patients Over Age 40 With Persistent Airflow Limitation in China - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x

2015 Clinical Trials

198. Persistence of asthma requires multiple feedback circuits involving type 2 innate lymphoid cells and IL-33. Full Text available with Trip Pro

in resolution of chronic asthma. In agreement with the foregoing, IL-33 and ILC2 levels were increased in the airways of asthmatic patients. IL-33 levels correlated with disease severity.We present a critical network of feedback and feed-forward interactions between epithelial cells and ILC2s involved in maintaining chronic asthma. Although T cells contributed to the severity of chronic asthma, they were redundant in maintaining airway hyperreactivity and remodeling.Copyright © 2015 American Academy (...) Persistence of asthma requires multiple feedback circuits involving type 2 innate lymphoid cells and IL-33. Asthma in a mouse model spontaneously resolves after cessation of allergen exposure. We developed a mouse model in which asthma features persisted for 6 months after cessation of allergen exposure.We sought to elucidate factors contributing to the persistence of asthma.We used a combination of immunologic, genetic, microarray, and pharmacologic approaches to dissect the mechanism

2015 Journal of Allergy and Clinical Immunology

199. Intermittent inhaled corticosteroid therapy versus placebo for persistent asthma in children and adults. (Abstract)

for reducing the severity of an asthma exacerbation.To compare the efficacy and safety of intermittent ICS versus placebo in the management of children and adults diagnosed with, or suspected to have, symptoms of mild persistent asthma.We searched the Cochrane Airways Group Specialised Register of trials (CAGR), the ClinicalTrials.gov website and the World Health Organization (WHO) trials portal in March 2015.We included randomised controlled trials (RCTs) that compared intermittent ICS versus placebo (...) Intermittent inhaled corticosteroid therapy versus placebo for persistent asthma in children and adults. International guidelines advocate using daily inhaled corticosteroids (ICS) in the management of children and adults with persistent asthma. However, in real world clinical settings, these medicines are often used at irregular intervals by patients. Recent evidence suggests that the use of intermittent ICS, with treatment initiated at the time of early symptoms, may still have benefits

2015 The Cochrane database of systematic reviews

200. CYT003, a TLR9 Agonist, in Persistent Allergic Asthma - A Randomized Placebo-controlled Phase 2b Study. (Abstract)

CYT003, a TLR9 Agonist, in Persistent Allergic Asthma - A Randomized Placebo-controlled Phase 2b Study. New treatment options are required for patients with asthma not sufficiently controlled with inhaled therapies. In a Phase 2a trial, CYT003, a Toll-like receptor-9 agonist immunomodulator, improved asthma control during inhaled glucocorticosteroid reduction in patients with allergic asthma. This double-blind Phase 2b study assessed the efficacy and safety of CYT003 in patients with persistent (...) moderate-to-severe allergic asthma not sufficiently controlled on standard inhaled glucocorticosteroid therapy with/without long-acting beta-agonists (LABAs).Overall, 365 patients received seven doses of subcutaneous CYT003 (0.3, 1, or 2 mg) or placebo as add-on therapy to conventional controller medication. Change from baseline in Asthma Control Questionnaire (ACQ) score was the primary outcome; secondary outcomes included change in forced expiratory volume, Mini Asthma Quality of Life Questionnaire

2015 Allergy Controlled trial quality: predicted high

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