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Severe asthma controller withdrawal

David I Bernstein, Michael Gillespie, Sharon Song, Jonathan Steinfeld
OBJECTIVE: Evaluate fluticasone propionate (Fp) using a novel, inhalation-driven, multidose dry powder inhaler (MDPI) in patients with severe persistent asthma, versus placebo MDPI and Fp dry powder inhaler (DPI). METHODS: Patients with persistent asthma despite use of high-dose inhaled corticosteroids were randomized to Fp MDPI 50, 100, 200, or 400 mcg; Fp DPI 250 mcg; or placebo MDPI twice daily for 12 weeks. The primary outcome measure was change from baseline in trough forced expiratory volume in 1 second (FEV1) over the 12-week period, compared with placebo; secondary measures included change from baseline in peak expiratory flow (PEF), rescue inhaler use, and time to withdrawal due to meeting stopping criteria...
October 24, 2016: Journal of Asthma: Official Journal of the Association for the Care of Asthma
Dennis Ledford, William Busse, Benjamin Trzaskoma, Theodore A Omachi, Karin Rosén, Bradley E Chipps, Allan T Luskin, Paul G Solari
BACKGROUND: Few data are available to assist clinicians with decisions regarding long-term use of asthma therapies, including omalizumab. OBJECTIVE: To evaluate the benefit and persistency of response in subjects continuing or withdrawing from long-term omalizumab treatment. METHODS: Evaluating the Xolair® Persistency Of Response After Long-Term Therapy (XPORT) was a randomized, double-blind, placebo-controlled withdrawal study that included subjects with moderate-to-severe persistent asthma receiving long-term omalizumab...
November 5, 2016: Journal of Allergy and Clinical Immunology
M Caminati, G Senna, G Stefanizzi, R Bellamoli, S Longhi, F Chieco-Bianchi, G Guarnieri, S Tognella, M Olivieri, C Micheletto, G Festi, E Bertocco, M Mazza, A Rossi, A Vianello
BACKGROUND: In patients with asthma, particularly severe asthma, poor adherence to inhaled drugs negatively affects the achievement of disease control. A better adherence rate is expected in the case of injected drugs, such as omalizumab, as they are administered only in a hospital setting. However, adherence to omalizumab has never been systematically investigated. The aim of this study was to review the omalizumab drop-out rate in randomized controlled trials (RCTs) and real-life studies...
August 25, 2016: BMC Pulmonary Medicine
Sherif Gonem, Rachid Berair, Amisha Singapuri, Ruth Hartley, Marie F M Laurencin, Gerald Bacher, Björn Holzhauer, Michelle Bourne, Vijay Mistry, Ian D Pavord, Adel H Mansur, Andrew J Wardlaw, Salman H Siddiqui, Richard A Kay, Christopher E Brightling
BACKGROUND: 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. METHODS: We performed a single-centre, randomised, double-blind, parallel-group, placebo-controlled trial at Glenfield Hospital (Leicester, UK)...
September 2016: Lancet Respiratory Medicine
Ruwanthi Kolamunnage-Dona, Colin Powell, Paula Ruth Williamson
BACKGROUND: Clinical trials with longitudinally measured outcomes are often plagued by missing data due to patients withdrawing or dropping out from the trial before completing the measurement schedule. The reasons for dropout are sometimes clearly known and recorded during the trial, but in many instances these reasons are unknown or unclear. Often such reasons for dropout are non-ignorable. However, the standard methods for analysing longitudinal outcome data assume that missingness is non-informative and ignore the reasons for dropout, which could result in a biased comparison between the treatment groups...
April 28, 2016: Trials
Marjorie Slankard, Mary Ann Michelis, Mahesh Mansukhani, Barbara McGoey, Amy Paige, Howard Andrews, David Lederer, Stephen Canfield, Emily DiMango
INTRODUCTION: Long-acting beta agonists (LABAs) are effective for controlling asthma, however questions about their safety have led to concerns over use. Genetic polymorphisms at the 16 amino acid position of the beta-2 adrenergic receptor gene (B2AR) may be associated with increased risk. METHODS: A randomized, double blind study was conducted in patients with moderate to severe asthma being treated with combined inhaled corticosteroids/LABA (ICS/LABA), comparing the effect of LABA continuation versus withdrawal on asthma outcomes among patients stratified by B2AR genotype (Arg/Arg vs...
October 2016: Journal of Asthma: Official Journal of the Association for the Care of Asthma
Donald P Tashkin, Gary E Moore, Frank Trudo, Michael DePietro, Bradley E Chipps
BACKGROUND: The consistency of fixed airflow limitation status during treatment in patients with asthma is unknown. OBJECTIVE: The objective of this study was to determine the consistency of fixed airflow obstruction (FAO) status during treatment and effects on treatment response. METHODS: This post hoc analysis from a 12-week study (NCT00652002) assessed patients aged 12 years or more with moderate-to-severe asthma randomized to twice-daily budesonide/formoterol (BUD/FM) via pressurized metered-dose inhaler (pMDI) 320/9 μg, BUD pMDI 320 μg, FM 9 μg via dry-powder inhaler, or placebo...
July 2016: Journal of Allergy and Clinical Immunology in Practice
Bhupendrasinh F Chauhan, Caroline Chartrand, Muireann Ni Chroinin, Stephen J Milan, Francine M Ducharme
BACKGROUND: Long-acting beta2-agonists (LABA) in combination with inhaled corticosteroids (ICS) are increasingly prescribed for children with asthma. OBJECTIVES: To assess the safety and efficacy of adding a LABA to an ICS in children and adolescents with asthma. To determine whether the benefit of LABA was influenced by baseline severity of airway obstruction, the dose of ICS to which it was added or with which it was compared, the type of LABA used, the number of devices used to deliver combination therapy and trial duration...
2015: Cochrane Database of Systematic Reviews
M M S Sneeboer, N Fens, M A van de Pol, C J Majoor, J C M Meijers, P W Kamphuisen, R Lutter, P J Sterk, E H D Bel
BACKGROUND: Epidemiologic studies have shown that patients with severe asthma have increased risk of pulmonary embolism, in particular patients with frequent asthma exacerbations. Therefore, we hypothesized that asthma exacerbations are associated with increased haemostatic activity. OBJECTIVE: To investigate whether induced loss of asthma control is associated with changes in coagulation and fibrinolytic parameters in peripheral blood. METHODS: We performed a prospective, inhaled steroid withdrawal study in 23 patients with moderate to moderately severe asthma, consisting of a baseline visit and a visit after loss of asthma control...
March 2016: Clinical and Experimental Allergy: Journal of the British Society for Allergy and Clinical Immunology
Gustavo J Rodrigo, José A Castro-Rodríguez
BACKGROUND: The role of tiotropium for the treatment of adolescents with asthma has not yet been clearly defined. OBJECTIVE: To assess the efficacy and safety of inhaled tiotropium in adolescents with moderate to severe symptomatic asthma. METHODS: Randomized, placebo-controlled trials were included in this systematic review. Primary outcomes were peak and trough forced expiratory volume in 1 second (FEV1). RESULTS: Three studies (approximately 1,000 patients) were included...
September 2015: Annals of Allergy, Asthma & Immunology
Jimmy Chong, Cheyaanthan Haran, Bhupendrasinh F Chauhan, Innes Asher
BACKGROUND: 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 for reducing the severity of an asthma exacerbation. OBJECTIVES: 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...
2015: Cochrane Database of Systematic Reviews
Cristoforo Incorvaia, Philippe Moingeon, Serena Buttafava, Franco Frati
The treatment of respiratory allergy is based on several drugs with different mechanisms of action, which encompass an effect only on symptoms, limited factors of inflammation or the whole process of inflammation. Dissecting the different treatments by their mechanism of action is relevant for the management of allergic patients. Corticosteroids, administered as nasal sprays in rhinitis or by inhalation devices in asthma, and allergen immunotherapy (AIT) are the most effective treatments for respiratory allergy, achieving the control on inflammation by a number of cellular and molecular mechanisms...
2015: Expert Review of Clinical Immunology
Tianwen Lai, Shaobin Wang, Zhiwei Xu, Chao Zhang, Yun Zhao, Yue Hu, Chao Cao, Songmin Ying, Zhihua Chen, Wen Li, Bin Wu, Huahao Shen
Currently, limited information is available to clinicians regarding the long-term efficacy of omalizumab treatment for allergic asthma. In this report, we aimed to (i) systematically review the evidence regarding the long-term efficacy of omalizumab in patients with persistent uncontrolled allergic asthma, and to (ii) discuss the cost-effectiveness evidence published for omalizumab in this patient population. A comprehensive search for randomized controlled trials (RCTs; ≥52 weeks) was performed, and six studies met our final inclusion criteria (n = 2,749)...
2015: Scientific Reports
Elisabeth H Bel, Sally E Wenzel, Philip J Thompson, Charlene M Prazma, Oliver N Keene, Steven W Yancey, Hector G Ortega, Ian D Pavord
BACKGROUND: Many patients with severe asthma require regular treatment with oral glucocorticoids despite the use of high-dose inhaled therapy. However, the regular use of systemic glucocorticoids can result in serious and often irreversible adverse effects. Mepolizumab, a humanized monoclonal antibody that binds to and inactivates interleukin-5, has been shown to reduce asthma exacerbations in patients with severe eosinophilic asthma. METHODS: In a randomized, double-blind trial involving 135 patients with severe eosinophilic asthma, we compared the glucocorticoid-sparing effect of mepolizumab (at a dose of 100 mg) with that of placebo administered subcutaneously every 4 weeks for 20 weeks...
September 25, 2014: New England Journal of Medicine
Izabela Kupryś-Lipińska, Damian Tworek, Piotr Kuna
The article presents case reports of 2 women who became pregnant during therapy with omalizumab. Both subjects suffered from very severe asthma and were treated chronically with all available medications including systemic steroids (first - 20 mg prednisolone/day, second - 40 mg prednisolone/day). Both were enrolled into treatment with omalizumab and started regular therapy in 2007. The course of asthma significantly improved in both cases (withdrawal of oral steroids or significant reduction of their dose, better asthma control)...
May 2014: Postȩpy Dermatologii i Alergologii
Kevin Vézina, Bhupendrasinh F Chauhan, Francine M Ducharme
BACKGROUND: Inhaled anticholinergics given in addition to β2-agonists are effective in reducing hospital admissions in children presenting to the emergency department with a moderate to severe asthma exacerbation. It seems logical to assume a similar beneficial effect in children hospitalised for an acute asthma exacerbation. OBJECTIVES: To assess the efficacy and safety of anticholinergics added to β2-agonists as inhaled or nebulised therapy in children hospitalised for an acute asthma exacerbation...
2014: Cochrane Database of Systematic Reviews
Rik J B Loymans, Armin Gemperli, Judith Cohen, Sidney M Rubinstein, Peter J Sterk, Helen K Reddel, Peter Jüni, Gerben ter Riet
OBJECTIVE: To determine the comparative effectiveness and safety of current maintenance strategies in preventing exacerbations of asthma. DESIGN: Systematic review and network meta-analysis using Bayesian statistics. DATA SOURCES: Cochrane systematic reviews on chronic asthma, complemented by an updated search when appropriate. ELIGIBILITY CRITERIA TRIALS OF Adults with asthma randomised to maintenance treatments of at least 24 weeks duration and that reported on asthma exacerbations in full text...
2014: BMJ: British Medical Journal
Izabela Kupryś-Lipińska, Piotr Kuna
INTRODUCTION: Many clinical and observational studies have demonstrated effectiveness of omalizumab (OMA) in the treatment of severe asthma, but the optimal duration of the therapy remains unknown. AIM: The article presents the authors' clinical experience on OMA cessation in routine practice. MATERIAL AND METHODS: Due to new reimbursement criteria, OMA therapy has been interrupted in 11 subjects (6 women/5 men). The mean age of patients was 50...
February 2014: Postȩpy Dermatologii i Alergologii
Daniela Pelclová, Zdenka Fenclová, Stěpánka Vlčková, Pavlína Klusáčková, Jindřiška Lebedová, Kamila Syslová, Jaromír Běláček, Marek Kuzma, Tomáš Navrátil, Sergey Zakharov, Petr Kačer
OBJECTIVES: To search for optimal markers in the exhaled breath condensate (EBC), plasma and urine that would reflect the activity/severity of occupational asthma (OA) after the withdrawal from the exposure to the allergen. MATERIAL AND METHODS: Markers of oxidative stress: 8-iso-prostaglandin F2α (8-isoprostane, 8-ISO), malondialdehyde (MDA), 4-hydroxy-trans-2-nonenale (HNE), cysteinyl leukotrienes (LT) and LTB4 were determined using liquid chromatography and mass spectrometry in 43 subjects with immunological OA (49...
April 2014: International Journal of Occupational Medicine and Environmental Health
Donald W Cockcroft, Malcolm R Sears
Possible adverse effects of adrenergic bronchodilators in asthma have been the subject of discussion for more than half a century, with recent intense debate about the safety of longacting β agonists (LABAs). In this Debate, we consider the issues of bronchodilator and bronchoprotective tolerance resulting from the frequent use of bronchodilators, which is noted particularly with shortacting drugs, but has also been shown to occur quicker and to a greater extent with LABAs. Increased allergen responsiveness and masking allowing inflammation to increase, while symptoms and lung function remain apparently controlled, have also been observed...
June 2013: Lancet Respiratory Medicine
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