PMID- 31302579 OWN - NLM STAT- MEDLINE DCOM- 20200414 LR - 20221207 IS - 1532-3064 (Electronic) IS - 0954-6111 (Linking) VI - 155 DP - 2019 Aug TI - Safety of tiotropium Respimat((R)) in black or African-American patients with symptomatic asthma. PG - 58-60 LID - S0954-6111(19)30226-4 [pii] LID - 10.1016/j.rmed.2019.07.002 [doi] AB - BACKGROUND: Black patients with asthma have a higher disease burden and greater morbidity compared with other racial/ethnic groups. Tiotropium Respimat((R)), as add-on to at least inhaled corticosteroids (ICS), improves lung function and asthma control and reduces asthma exacerbation risk in patients, with a safety profile comparable with placebo. This study aimed to assess the safety of tiotropium Respimat((R)), compared with placebo, in black or African-American patients. METHODS: Data were pooled from 12 randomized, placebo-controlled, parallel-group, Phase II or III trials from the global Boehringer Ingelheim program with once-daily tiotropium Respimat((R)) (5 mug or 2.5 mug). Trial participants had symptomatic persistent asthma with a broad range of severities and were aged 1-75 years. The safety results of black or African-American patients were compared with the overall trial population. RESULTS: Of the 5165 patients treated with tiotropium or placebo, 3.2% were black or African American. For both doses of tiotropium, the proportion of patients reporting adverse events (AEs) was approximately 10% lower compared with placebo and was generally comparable with the proportion of patients reporting AEs in all groups of the overall population. The number of investigator-assessed drug-related AEs, AEs leading to trial drug discontinuation or serious AEs reported by patients was low and comparable between treatment groups and with the overall population. CONCLUSION: Tiotropium Respimat((R)) appears to be a generally safe add-on bronchodilator treatment option to ICS with or without other controllers in pediatric and adult black or African-American patients with asthma. CLINICAL TRIAL IDENTIFIERS: NCT01634113, NCT01634139, NCT01634152, NCT01257230, NCT01277523, NCT01316380, NCT00350207, NCT01172808, NCT01172821, NCT01340209, NCT00772538, NCT00776984. CI - Copyright (c) 2019. Published by Elsevier Ltd. FAU - Graham, LeRoy M AU - Graham LM AD - Mercy Care of Atlanta, City of Refuge Clinic, Atlanta, Georgia, USA. Electronic address: lmg254@gmail.com. FAU - Kerstjens, Huib A M AU - Kerstjens HAM AD - University of Groningen, University Medical Center Groningen, Groningen, the Netherlands. Electronic address: h.a.m.kerstjens@umcg.nl. FAU - Vogelberg, Christian AU - Vogelberg C AD - University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany. Electronic address: christian.vogelberg@uniklinikum-dresden.de. FAU - Hamelmann, Eckard AU - Hamelmann E AD - Evangelisches Klinikum Bethel gGmbH, Bielefeld, Germany. Electronic address: Eckard.Hamelmann@evkb.de. FAU - Szefler, Stanley J AU - Szefler SJ AD - The Breathing Institute, Children's Hospital Colorado, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, USA. Electronic address: Stanley.Szefler@childrenscolorado.org. FAU - Pisternick-Ruf, Wendelgard AU - Pisternick-Ruf W AD - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany. Electronic address: wendelgard.pisternick-ruf@boehringer-ingelheim.com. FAU - Engel, Michael AU - Engel M AD - Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany. Electronic address: michael.engel@boehringer-ingelheim.com. FAU - El Azzi, Georges AU - El Azzi G AD - Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany. Electronic address: georges.el_azzi@boehringer-ingelheim.com. FAU - Unseld, Anna AU - Unseld A AD - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany. Electronic address: anna.unseld@boehringer-ingelheim.com. FAU - Foggs, Michael B AU - Foggs MB AD - Advocate Health Care, Chicago, IL, USA. Electronic address: immunotype@aol.com. LA - eng PT - Clinical Trial, Phase II PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20190702 PL - England TA - Respir Med JT - Respiratory medicine JID - 8908438 RN - 0 (Adrenal Cortex Hormones) RN - 0 (Cholinergic Antagonists) RN - 0 (Placebos) RN - XX112XZP0J (Tiotropium Bromide) SB - IM MH - Administration, Inhalation MH - Adolescent MH - Adrenal Cortex Hormones/administration & dosage/therapeutic use MH - Adult MH - Black or African American/*ethnology MH - Aged MH - Asthma/diagnosis/*drug therapy/ethnology/mortality MH - Child MH - Child, Preschool MH - Cholinergic Antagonists/*administration & dosage/adverse effects/therapeutic use MH - Drug Therapy, Combination MH - Humans MH - Infant MH - Middle Aged MH - Placebos/administration & dosage MH - Safety MH - Tiotropium Bromide/*administration & dosage/adverse effects/therapeutic use MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Adult OT - Asthma OT - Black or african american OT - Pediatric OT - Safety OT - Tiotropium EDAT- 2019/07/16 06:00 MHDA- 2020/04/15 06:00 CRDT- 2019/07/15 06:00 PHST- 2019/01/31 00:00 [received] PHST- 2019/05/10 00:00 [revised] PHST- 2019/07/01 00:00 [accepted] PHST- 2019/07/16 06:00 [pubmed] PHST- 2020/04/15 06:00 [medline] PHST- 2019/07/15 06:00 [entrez] AID - S0954-6111(19)30226-4 [pii] AID - 10.1016/j.rmed.2019.07.002 [doi] PST - ppublish SO - Respir Med. 2019 Aug;155:58-60. doi: 10.1016/j.rmed.2019.07.002. Epub 2019 Jul 2.