دورية أكاديمية
أعرض في EDS

STOP: an open label crossover trial to study ICS withdrawal in patients with a combination of obesity and low-inflammatory asthma and evaluate its effect on asthma control and quality of life.

التفاصيل البيبلوغرافية
العنوان: STOP: an open label crossover trial to study ICS withdrawal in patients with a combination of obesity and low-inflammatory asthma and evaluate its effect on asthma control and quality of life.
المؤلفون: Witte JA; Department of Pulmonology, STZ Centre of Excellence for Asthma and COPD, Franciscus Group, Rotterdam, The Netherlands. a.witte2@franciscus.nl.; Department of Pulmonology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands. a.witte2@franciscus.nl., Braunstahl GJ; Department of Pulmonology, STZ Centre of Excellence for Asthma and COPD, Franciscus Group, Rotterdam, The Netherlands.; Department of Pulmonology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands., Blox WJB; Department of Pulmonology, Albert Schweitzer Ziekenhuis, Dordrecht, The Netherlands., van 't Westeinde SC; Department of Pulmonology, Maasstad Ziekenhuis, Rotterdam, The Netherlands., In 't Veen JCCM; Department of Pulmonology, STZ Centre of Excellence for Asthma and COPD, Franciscus Group, Rotterdam, The Netherlands.; Department of Pulmonology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands., Kappen JH; Department of Pulmonology, STZ Centre of Excellence for Asthma and COPD, Franciscus Group, Rotterdam, The Netherlands.; Allergy and Clinical Immunology, Immunomodulation and Tolerance Group, Inflammation Repair and Development, Imperial College, National Heart and Lung Institute, London, UK., van Rossum EFC; Department of Internal Medicine, Division of Endocrinology, and Obesity Center CGG (Centrum Gezond Gewicht), Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
المصدر: BMC pulmonary medicine [BMC Pulm Med] 2022 Feb 05; Vol. 22 (1), pp. 53. Date of Electronic Publication: 2022 Feb 05.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 100968563 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2466 (Electronic) Linking ISSN: 14712466 NLM ISO Abbreviation: BMC Pulm Med Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : BioMed Central, [2001]-
مواضيع طبية MeSH: Quality of Life* , Withholding Treatment*, Adrenal Cortex Hormones/*therapeutic use , Anti-Asthmatic Agents/*therapeutic use , Asthma/*drug therapy , Randomized Controlled Trials as Topic/*methods, Administration, Inhalation ; Adolescent ; Adult ; Aged ; Asthma/complications ; Asthma/psychology ; Cross-Over Studies ; Drug Therapy, Combination ; Female ; Health Status Indicators ; Humans ; Male ; Middle Aged ; Netherlands ; Obesity/complications ; Program Development ; Young Adult
مستخلص: Background: Asthma patients with obesity often have a high disease burden, despite the use of high-dose inhaled corticosteroids (ICS). In contrast to asthmatics with normal weight, the efficacy of ICS in patients with obesity and asthma is often relatively low. Meanwhile, patients do suffer from side effects, such as weight gain, development of diabetes, cataract, or high blood pressure. The relatively poor response to ICS might be explained by the low prevalence of type 2 inflammatory patterns (T2-low) in patients with asthma and obesity. T2-low inflammation is characterized by low eosinophilic count, low Fractional exhaled NO (FeNO), no clinically allergy-driven asthma, and no need for maintenance oral corticosteroids (OCS). We aim to study whether ICS can be safely withdrawn in patients with T2-low asthma and obesity while maintaining an equal level of asthma control. Secondary outcomes focus on the prevalence of 'false-negative' T2-low phenotypes (i.e. T2-hidden) and the effect of ICS withdrawal on parameters of the metabolic syndrome. This study will lead to a better understanding of this poorly understood subgroup and might find new treatable traits.
Methods: The STOP trial is an investigator-initiated, multicenter, non-inferiority, open-label, crossover study aiming to assess whether ICS can be safely withdrawn in adults aged 17-75 years with T2-low asthma and obesity (body mass index (BMI) ≥ 30 kg/m 2 ). Patients will be randomly divided into two arms (both n = 60). One arm will start with fixed-dose ICS (control group) and one arm will taper and subsequently stop ICS (intervention group). Patients in the intervention group will remain ICS naïve for ten weeks. After a washout of 4 weeks, patients will crossover to the other study arm. The crossover study takes 36 weeks to complete. Patients will be asked to participate in the extension study, to investigate the long-term metabolic benefits of ICS withdrawal.
Discussion: This study yields valuable data on ICS tapering in patients with T2-low asthma and obesity. It informs future guidelines and committees on corticosteroid-sparing algorithms in these patients. Trial registration Netherlands Trial Register, NL8759, registered 2020-07-06, https://www.trialregister.nl/trial/8759 . Protocol version and date: version 2.1, 20 November 2020.
(© 2022. The Author(s).)
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فهرسة مساهمة: Keywords: Asthma; Corticosteroids; ICS tapering; Obesity; RCT; T2-low
المشرفين على المادة: 0 (Adrenal Cortex Hormones)
0 (Anti-Asthmatic Agents)
تواريخ الأحداث: Date Created: 20220206 Date Completed: 20220314 Latest Revision: 20220314
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC8818143
DOI: 10.1186/s12890-022-01843-0
PMID: 35123457
قاعدة البيانات: MEDLINE
الوصف
تدمد:1471-2466
DOI:10.1186/s12890-022-01843-0