دورية أكاديمية
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.
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).) |
References: | Front Pharmacol. 2018 Apr 17;9:258. (PMID: 29719507) Indian Pediatr. 2009 Apr;46(4):300-3. (PMID: 19179741) Clin Exp Allergy. 2017 Feb;47(2):161-175. (PMID: 28036144) J Allergy Clin Immunol. 2007 May;119(5):1043-52; quiz 1053-4. (PMID: 17472810) Am J Respir Crit Care Med. 2000 Jan;161(1):64-72. (PMID: 10619799) J Clin Epidemiol. 1994 Jan;47(1):81-7. (PMID: 8283197) J Allergy Clin Immunol. 2019 May;143(5):1811-1820.e7. (PMID: 30529449) Front Immunol. 2020 Aug 04;11:1724. (PMID: 32849611) J Allergy Clin Immunol Pract. 2020 Feb;8(2):452-463. (PMID: 32037109) J Clin Endocrinol Metab. 2015 Jun;100(6):2171-80. (PMID: 25844620) Eur Respir J. 2006 Mar;27(3):495-503. (PMID: 16507848) Chest. 2007 Jul;132(1):98-105. (PMID: 17550933) J Allergy Clin Immunol. 2019 Jan;143(1):305-315. (PMID: 29857009) Allergy. 2020 Feb;75(2):302-310. (PMID: 31267562) Drug Saf. 2008;31(9):769-74. (PMID: 18707191) Monaldi Arch Chest Dis. 2010 Sep;73(3):116-23. (PMID: 21214041) J Clin Med. 2021 Jan 06;10(2):. (PMID: 33418879) Curr Pharm Biotechnol. 2018;19(15):1210-1220. (PMID: 30605054) Arch Intern Med. 2007 Oct 22;167(19):2047-53. (PMID: 17954797) Thorax. 1992 Feb;47(2):76-83. (PMID: 1549827) Rev Med Liege. 2017 May;72(5):241-245. (PMID: 28520323) Thorax. 1999 Jul;54(7):581-6. (PMID: 10377201) Chest. 2008 Sep;134(3):546-551. (PMID: 18641096) Psychoneuroendocrinology. 2017 Jun;80:1-6. (PMID: 28288364) Neuroendocrinology. 2020;110(3-4):282-291. (PMID: 31220843) Can Respir J. 2006 Apr;13(3):129-33. (PMID: 16642226) J Asthma. 2008 Aug;45(6):445-51. (PMID: 18612895) Arch Neurol. 1989 Oct;46(10):1121-3. (PMID: 2803071) Clin Exp Allergy. 1992 May;22(5):525-32. (PMID: 1628250) Eur Respir J. 1999 Oct;14(4):902-7. (PMID: 10573240) Am J Respir Crit Care Med. 2001 Feb;163(2):406-12. (PMID: 11179114) Eur Respir J. 2021 Apr 1;57(4):. (PMID: 33033149) Respir Med. 2007 Nov;101(11):2240-7. (PMID: 17686624) Ann Oncol. 2019 Oct 1;30(10):1660-1666. (PMID: 31529107) Am J Respir Crit Care Med. 2019 Feb 15;199(4):465-477. (PMID: 30371106) Lancet Respir Med. 2017 Sep;5(9):691-706. (PMID: 28822787) Eur Respir J. 2020 Feb 27;55(2):. (PMID: 31515400) J Allergy Clin Immunol. 2018 Apr;141(4):1169-1179. (PMID: 29627041) Chest. 2020 Jan;157(1):16-25. (PMID: 31622588) Clin Rev Allergy Immunol. 2019 Apr;56(2):219-233. (PMID: 30206782) Biochem Pharmacol. 2020 Sep;179:113994. (PMID: 32335139) J Allergy Clin Immunol. 2005 Apr;115(4):720-7. (PMID: 15805990) Am J Respir Crit Care Med. 1999 Jul;160(1):93-9. (PMID: 10390385) Am Rev Respir Dis. 1993 Apr;147(4):832-8. (PMID: 8466117) J Clin Endocrinol Metab. 2017 Oct 1;102(10):3765-3774. (PMID: 28973553) Open Respir Med J. 2014 Dec 31;8:59-65. (PMID: 25674175) Clin Med Res. 2009 Jun;7(1-2):14-20. (PMID: 19251584) Thorax. 2008 Nov;63(11):1018-23. (PMID: 18984817) Respir Res. 2021 Jul 8;22(1):201. (PMID: 34238280) Clin Exp Allergy. 2018 May;48(5):525-535. (PMID: 29383782) Lancet Respir Med. 2021 Jan;9(1):57-68. (PMID: 32916135) |
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 |
تدمد: | 1471-2466 |
---|---|
DOI: | 10.1186/s12890-022-01843-0 |