Safety of tiotropium Respimat® in black or African-American patients with symptomatic asthma
Copyright © 2019. Published by Elsevier Ltd..
BACKGROUND: Black patients with asthma have a higher disease burden and greater morbidity compared with other racial/ethnic groups. Tiotropium Respimat®, 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®, 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® (5 μg or 2.5 μg). 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® 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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:155 |
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| Enthalten in: |
Respiratory medicine - 155(2019) vom: 05. Aug., Seite 58-60 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Graham, LeRoy M [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 14.04.2020 Date Revised 07.12.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.rmed.2019.07.002 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 245 | 1 | 0 | |a Safety of tiotropium Respimat® in black or African-American patients with symptomatic asthma |
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| 500 | |a Date Completed 14.04.2020 | ||
| 500 | |a Date Revised 07.12.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2019. Published by Elsevier Ltd. | ||
| 520 | |a BACKGROUND: Black patients with asthma have a higher disease burden and greater morbidity compared with other racial/ethnic groups. Tiotropium Respimat®, 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®, compared with placebo, in black or African-American patients | ||
| 520 | |a 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® (5 μg or 2.5 μg). 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 | ||
| 520 | |a 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 | ||
| 520 | |a CONCLUSION: Tiotropium Respimat® 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 | ||
| 520 | |a CLINICAL TRIAL IDENTIFIERS: NCT01634113, NCT01634139, NCT01634152, NCT01257230, NCT01277523, NCT01316380, NCT00350207, NCT01172808, NCT01172821, NCT01340209, NCT00772538, NCT00776984 | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Adult | |
| 650 | 4 | |a Asthma | |
| 650 | 4 | |a Black or african american | |
| 650 | 4 | |a Pediatric | |
| 650 | 4 | |a Safety | |
| 650 | 4 | |a Tiotropium | |
| 650 | 7 | |a Adrenal Cortex Hormones |2 NLM | |
| 650 | 7 | |a Cholinergic Antagonists |2 NLM | |
| 650 | 7 | |a Placebos |2 NLM | |
| 650 | 7 | |a Tiotropium Bromide |2 NLM | |
| 650 | 7 | |a XX112XZP0J |2 NLM | |
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| 700 | 1 | |a Vogelberg, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Hamelmann, Eckard |e verfasserin |4 aut | |
| 700 | 1 | |a Szefler, Stanley J |e verfasserin |4 aut | |
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| 700 | 1 | |a Engel, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a El Azzi, Georges |e verfasserin |4 aut | |
| 700 | 1 | |a Unseld, Anna |e verfasserin |4 aut | |
| 700 | 1 | |a Foggs, Michael B |e verfasserin |4 aut | |
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