Safety of tiotropium Respimat
Administration, Inhalation
Adolescent
Adrenal Cortex Hormones
/ administration & dosage
Adult
Black or African American
/ ethnology
Aged
Asthma
/ diagnosis
Child
Child, Preschool
Cholinergic Antagonists
/ administration & dosage
Drug Therapy, Combination
Humans
Infant
Middle Aged
Placebos
/ administration & dosage
Safety
Tiotropium Bromide
/ administration & dosage
Treatment Outcome
Young Adult
Adult
Asthma
Black or african american
Pediatric
Safety
Tiotropium
Journal
Respiratory medicine
ISSN: 1532-3064
Titre abrégé: Respir Med
Pays: England
ID NLM: 8908438
Informations de publication
Date de publication:
08 2019
08 2019
Historique:
received:
31
01
2019
revised:
10
05
2019
accepted:
01
07
2019
pubmed:
16
7
2019
medline:
15
4
2020
entrez:
15
7
2019
Statut:
ppublish
Résumé
Black patients with asthma have a higher disease burden and greater morbidity compared with other racial/ethnic groups. Tiotropium Respimat 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 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. Tiotropium Respimat NCT01634113, NCT01634139, NCT01634152, NCT01257230, NCT01277523, NCT01316380, NCT00350207, NCT01172808, NCT01172821, NCT01340209, NCT00772538, NCT00776984.
Sections du résumé
BACKGROUND
Black patients with asthma have a higher disease burden and greater morbidity compared with other racial/ethnic groups. Tiotropium Respimat
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
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
CLINICAL TRIAL IDENTIFIERS
NCT01634113, NCT01634139, NCT01634152, NCT01257230, NCT01277523, NCT01316380, NCT00350207, NCT01172808, NCT01172821, NCT01340209, NCT00772538, NCT00776984.
Identifiants
pubmed: 31302579
pii: S0954-6111(19)30226-4
doi: 10.1016/j.rmed.2019.07.002
pii:
doi:
Substances chimiques
Adrenal Cortex Hormones
0
Cholinergic Antagonists
0
Placebos
0
Tiotropium Bromide
XX112XZP0J
Types de publication
Clinical Trial, Phase II
Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
58-60Informations de copyright
Copyright © 2019. Published by Elsevier Ltd.