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Severe Persistent Asthma

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4941. Exhaled nitric oxide identifies the persistent eosinophilic phenotype in severe refractory asthma. (Abstract)

Exhaled nitric oxide identifies the persistent eosinophilic phenotype in severe refractory asthma. The fractional concentration of exhaled nitric oxide (FENO) is increased in asthma, correlates with eosinophilic inflammation, and decreases after steroid therapy.We sought to examine whether persistent eosinophilia would be accompanied by an increased FENO level despite steroid therapy in patients with severe refractory asthma (SRA) as manifestations of steroid resistance.Subjects with SRA (...) , subjects with mild-moderate asthma, and healthy control subjects had FENO measured, followed by endobronchial biopsy and bronchoalveolar lavage. Tissue and bronchoalveolar lavage inflammatory cells were assessed for all subjects, and eosinophil status (EOS+/EOS-) was determined for subjects with SRA.Twenty-four subjects with SRA, 15 subjects with moderate-mild asthma, and 17 healthy control subjects were studied. Subjects with EOS+ SRA had significantly higher median FENO levels compared with levels

2005 Journal of Allergy and Clinical Immunology

4942. Association between neutrophilic and eosinophilic inflammation in patients with severe persistent asthma. (Abstract)

Association between neutrophilic and eosinophilic inflammation in patients with severe persistent asthma. Eosinophils are generally recognized as effector cells in asthma. Recently, neutrophils have been suggested to contribute to the development of chronic severe asthma. The mechanisms by which neutrophils contribute to the pathophysiology of asthma remain to be elucidated; however, neutrophils may affect either accumulation or functional status of eosinophils via the generation (...) of inflammatory mediators. The objective of this study was to evaluate whether neutrophilic inflammation is associated with eosinophilic inflammation in severe asthma.Following the inhalation of hypertonic saline, induced sputum was obtained from 12 healthy controls, 10 mild persistent asthmatics who were treated with low-dose inhaled corticosteroids, and 8 severe persistent asthmatics who were treated with combinations of drugs including high-dose inhaled corticosteroids and oral prednisolone. Subsequently

2005 International Archives of Allergy and Immunology

4943. Parameters associated with persistent airflow obstruction in chronic severe asthma. (Abstract)

Parameters associated with persistent airflow obstruction in chronic severe asthma. The significance of severe airflow obstruction in severe asthma is unclear. The current study determined whether severe airflow obstruction is related to inflammatory or structural changes in the airways. Patients with severe asthma from a tertiary referral clinic were divided into two groups according to their postbronchodilator forced expiratory volume in one second (FEV1): severe persistent airflow limitation (...) obstruction. Patients with severe asthma and irreversible airflow obstruction had longer disease duration, a greater inflammatory process and more high resolution computed tomography airway abnormalities suggestive of airway remodelling, despite being on similar treatments and experiencing equivalent impairment in quality of life.

2004 European Respiratory Journal

4944. Relationships between duration of asthma and asthma severity among children in the Childhood Asthma Management Program (CAMP) (Abstract)

was also found to be significantly associated with physician/nurse assessment of asthma severity and other historical measures of medication use.These data demonstrate that asthma duration is associated with lower lung function, greater methacholine responsiveness, more asthma symptomatology, and greater use of as-needed albuterol, which are all measures of asthma severity. As such, early diagnosis and intervention may be necessary to ameliorate these adverse effects of persistent asthma. (...) Relationships between duration of asthma and asthma severity among children in the Childhood Asthma Management Program (CAMP) Many factors, including heredity, atopic status, and environment, have been implicated in the determination of asthma severity. Relatively little is known about the degree to which asthma duration influences asthma severity.The Childhood Asthma Management Program (CAMP), consisting of 1041 children (age 8. 9 +/- 2.1 years at enrollment) with mild-to-moderate asthma

1999 The Journal of allergy and clinical immunology Controlled trial quality: uncertain

4945. The relationship of frequency of follow-up visits to asthma outcomes in patients with moderate persistent asthma. (Abstract)

The relationship of frequency of follow-up visits to asthma outcomes in patients with moderate persistent asthma. Although regular follow-up is recommended for patients with asthma, the optimal frequency of such follow-up has not been defined. The purpose of this study was to evaluate the relationship of the interval between routine physician visits to asthma outcomes in patients with moderate persistent asthma.The study population was a volunteer sample of subjects aged 18 years or older (...) with moderate persistent asthma requiring at least moderate doses of inhaled corticosteroids who were followed for at least 6 months by one of two allergists in a large staff model HMO. Subjects were randomized to one of three groups: 1) monthly physician visits, 2) semi-annual physician visits, and 3) semiannual physician visits and monthly nurse phone calls. All subjects were advised to call their physician for questions or increased symptoms. The primary outcome variable was total asthma quality of life

2003 Journal of Asthma Controlled trial quality: uncertain

4946. Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma

Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic 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. Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic 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 our for details. ClinicalTrials.gov Identifier: NCT00567476 Recruitment Status : Completed First Posted : December 5, 2007 Results First Posted : May 23

2007 Clinical Trials

4947. Daclizumab Improves Asthma Control in Patients with Moderate to Severe Persistent Asthma. Full Text available with Trip Pro

Daclizumab Improves Asthma Control in Patients with Moderate to Severe Persistent Asthma. Airway inflammation in asthma is associated with increased activated CD25(+) T cells, IL-2, and soluble IL-2 receptors (IL-2Rs).A randomized, double-blinded, placebo-controlled study was used to evaluate the safety and efficacy of daclizumab, a humanized IgG1 monoclonal antibody against the IL-2R alpha chain (CD25) of activated lymphocytes, in adults with moderate to severe persistent asthma.Patients (...) in the patients treated with daclizumab.Daclizumab improved pulmonary function and asthma control in patients with moderate to severe chronic asthma inadequately controlled on ICS. The mechanism of action likely involves inhibition of proinflammatory cytokine generation by IL-2R blockade in activated T cells. Clinical trial registered with www.clinicaltrials.gov (NCT00028288).

2008 American Journal of Respiratory and Critical Care Medicine Controlled trial quality: predicted high

4948. Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma

Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma Efficacy and Safety of Omalizumab in Patients With Severe 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 (...) . Efficacy and Safety of Omalizumab in Patients With Severe 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 our for details. ClinicalTrials.gov Identifier: NCT00046748 Recruitment Status : Completed First Posted : October 4, 2002 Last Update Posted : August 2, 2017 Sponsor: Novartis Pharmaceuticals Information provided by: Novartis Study

2002 Clinical Trials

4949. Increased peak expiratory flow variation in asthma: severe persistent increase but not nocturnal worsening of airway inflammation. (Abstract)

Increased peak expiratory flow variation in asthma: severe persistent increase but not nocturnal worsening of airway inflammation. Asthma at night is characterized by a nocturnal increase in airway obstruction. It has been hypothesized that nocturnal asthma results from an increase in airway wall inflammation at night. However, studies on inflammatory cells in bronchoalveolar lavage (BAL) fluid and bronchial biopsies have produced conflicting data. This study assessed inflammatory cell numbers (...) in the bronchial submucosa at night. Apparently, asthmatic patients with a peak expiratory flow variation >15% suffer from a higher overall severity of bronchial inflammation at night and during the day.

1998 The European respiratory journal : official journal of the European Society for Clinical Respiratory Physiology Controlled trial quality: uncertain

4950. Dose-related efficacy of budesonide administered via a dry powder inhaler in the treatment of children with moderate to severe persistent asthma. (Abstract)

Dose-related efficacy of budesonide administered via a dry powder inhaler in the treatment of children with moderate to severe persistent asthma. To determine the efficacy and safety of budesonide delivered by an inhalation-driven dry powder inhaler (Turbuhaler) in children with moderate to severe persistent asthma.In our randomized, double-blind, placebo-controlled, parallel-group, multicenter study, a total of 404 children with asthma, who were aged 6 to 18 years and who had been receiving (...) ) with moderate to severe persistent asthma.

1998 The Journal of pediatrics Controlled trial quality: predicted high

4951. Effects of high doses of inhaled corticosteroids on adrenal function in children with severe persistent asthma. Full Text available with Trip Pro

Effects of high doses of inhaled corticosteroids on adrenal function in children with severe persistent asthma. Childhood asthma generally responds well to inhaled corticosteroids within the dosage range recommended by the manufacturers, but it is sometimes necessary to use higher doses--that is, above 400 micrograms/day--a practice which has become more widespread recently. Whereas the lack of adrenal suppression in children given inhaled corticosteroids in normal doses is well documented (...) , little is known about the effects of higher doses.The effects on adrenal function of high dose (above 400 micrograms/day) inhaled corticosteroids were evaluated by measuring cortisol concentration in the morning and performing a short tetracosactrin test in 49 children taking budesonide (mean age 9.2 years (range 4 to 16 years) and 28 children taking beclomethasone dipropionate (10.2 years (5 to 13 years)). Twenty three non-asthmatic children (8.9 years (4.9 to 13 years)) who were under investigation

1993 Thorax

4952. Therapeutic effect of zafirlukast as monotherapy in steroid-naive patients with severe persistent asthma. (Abstract)

Therapeutic effect of zafirlukast as monotherapy in steroid-naive patients with severe persistent asthma. We evaluated the efficacy of the leukotriene receptor antagonist zafirlukast (Accolate), 20 mg twice daily, as monotherapy in patients with severe persistent asthma (defined by an FEV1 < 60% of predicted before treatment and frequent night-time symptoms).Data were analyzed from a subgroup of 261 steroid-naive patients (zafirlukast, n = 149; placebo, n = 112) from four randomized, double (...) in the morning and evening PEF of approximately 40 and 11 L/min, respectively. For patients who take zafirlukast and who have a PEF variability of < 20%, the morning and evening PEF increased by 25 and 30 L/min, respectively. Regardless of the degree of PEF variability, zafirlukast significantly (p < 0.05) increased morning and evening PEF compared with placebo.Patients with severe persistent asthma who received zafirlukast as monotherapy had clinically significant improvements across all efficacy measures

1999 Chest Controlled trial quality: predicted high

4953. Reduction in oral corticosteroid use with mometasone furoate dry powder inhaler improves health-related quality of life in patients with severe persistent asthma. (Abstract)

Reduction in oral corticosteroid use with mometasone furoate dry powder inhaler improves health-related quality of life in patients with severe persistent asthma. Severe persistent asthma can have a substantial impact on a patient's health-related quality of life (HRQL), both as a result of symptoms and from side effects of treatment. The HRQL impact of two doses (400 and 800 microg twice daily) of mometasone furoate dry powder inhaler (MF DPI) was compared with placebo in patients with severe (...) component summary score and the physical function subscale) at EODBP. MF-DPI-treated patients also showed significant improvements at EODBP in each of the four subscales of the AQLQ-M (p<0.05). From EODBP to the OLE 3-month endpoint, patients treated with MF DPI twice daily maintained, or improved, SF-36 scores in most domains. Symptomatic improvement and reduction in OCS use with MF DPI were accompanied by significant improvement in HRQL in patients with severe persistent asthma. These improvements

2003 Journal of Asthma Controlled trial quality: uncertain

4954. Effect of SCH55700, a humanized anti-human interleukin-5 antibody, in severe persistent asthma: a pilot study. (Abstract)

Effect of SCH55700, a humanized anti-human interleukin-5 antibody, in severe persistent asthma: a pilot study. Antagonizing the effect of interleukin (IL)-5 is a potential new treatment strategy in allergic disorders. We evaluated the safety, biological activity, and pharmacokinetics of SCH55700, a humanized anti-human IL-5 antibody, in subjects with severe persistent asthma treated with oral or high doses of inhaled steroids. In a double-blind, randomized, multicenter trial, a rising single (...) , which reached significance 24 hours after the 0.3-mg/kg dose (p = 0.019 versus placebo). No significant changes occurred in other clinical indices of disease activity. Adverse events were not different between active treatment and placebo. We conclude that SCH55700 is a biologically active anti-human IL-5 antibody that can be safely used in severe steroid-treated asthma. Its therapeutic potential needs to be addressed in specifically designed efficacy trials.

2003 American journal of respiratory and critical care medicine Controlled trial quality: predicted high

4955. Comparison of the efficacy and safety of nebulized beclometasone dipropionate and budesonide in severe persistent childhood asthma. (Abstract)

Comparison of the efficacy and safety of nebulized beclometasone dipropionate and budesonide in severe persistent childhood asthma. Inhaled steroids are recommended for long-term control of asthma, but their use may be limited in young children because of difficulties in using the associated inhaler device. The use of nebulizers may help to overcome this issue, without compromising therapeutic efficacy or safety. This 14-week, multicentre, randomized, controlled, open-label, parallel-group (...) study compared the efficacy and safety of nebulized corticosteroids in paediatric patients (aged 6 months to 6 years) with severe persistent asthma. Beclometasone dipropionate (BDP) 800 microgday(-1) suspension for nebulization and budesonide (BUD) 750 microg day(-1) given by nebulization in a twice-daily regimen, and when used in addition to the usual maintenance therapy, resulted in comparable clinical efficacy across all parameters. The primary efficacy endpoint was the number of patients who did

2003 Respiratory medicine Controlled trial quality: uncertain

4956. Inhaled mometasone furoate reduces oral prednisone requirements while improving respiratory function and health-related quality of life in patients with severe persistent asthma. (Abstract)

Inhaled mometasone furoate reduces oral prednisone requirements while improving respiratory function and health-related quality of life in patients with severe persistent asthma. Inhaled corticosteroid therapy in severe persistent asthma has been shown to reduce or eliminate oral corticosteroid (OCS) use while retaining effective asthma control.We sought to evaluate the ability of mometasone furoate (MF) delivered by means of dry powder inhaler to reduce daily oral prednisone requirements (...) by 164.4% (P <.01). Oral steroids were eliminated in 40%, 37%, and 0% of patients in the MF 400 and 800 mg twice daily and placebo groups, respectively. Pulmonary function and quality of life significantly increased for MF-treated patients. Further reductions in OCS requirements were achieved with long-term MF treatment in the open-label phase.MF inhaled orally as a dry powder is an effective alternative to systemic corticosteroids in patients with severe persistent asthma.

2000 The Journal of allergy and clinical immunology Controlled trial quality: uncertain

4957. Persistent activation of nuclear factor-kappaB signaling pathway in severe uncontrolled asthma. Full Text available with Trip Pro

that these mediators are markedly decreased by pyrrolidinedithiocarbamate, an inhibitor of NF-kappaB activation. To further characterize the persistent NF-kappaB activation in severe asthma, we analyzed the expression of various components of this activation pathway in healthy subjects and in asthmatics with mild controlled, and moderate and severe uncontrolled disease. We found high amounts of phosphorylated IkappaBalpha characterizing the three asthmatic groups. Western blot analyses indicated that in peripheral (...) Persistent activation of nuclear factor-kappaB signaling pathway in severe uncontrolled asthma. The transcription factor nuclear factor-kappaB (NF-kappaB) is inactive when bound to its inhibitory protein IkappaBalpha. On cell stimulation with inflammatory signals, IkappaBalpha is phosphorylated by IkappaB kinases and subsequently degraded. Freed NF-kappaB then induces expression of cytokines such as granulocyte-macrophage colony-stimulating factor, interleukin-8, and regulated upon activation

2003 American Journal of Respiratory and Critical Care Medicine

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