Abstract | PURPOSE: PATIENTS AND METHODS: RESULTS: Overall, 74% (1411/1896) of the modified-intent-to-treat (mITT) population had no moderate/severe exacerbations in the 12 months prior to the study. BGF MDI reduced exacerbation rates versus GFF MDI in the prior (58%; unadjusted p=0.0003) and no prior (48%; unadjusted p=0.0001) exacerbations subgroups. The magnitude of reduction in exacerbation rates was generally similar within subgroups for BGF MDI versus BFF MDI and BUD/FORM DPI. In the prior exacerbations subgroup, risk during treatment for time to first exacerbation was lower with BGF MDI versus GFF MDI (p=0.0022) and BFF MDI (p=0.0110); excluding the first 30 days of data yielded similar results. The magnitude of reduction in exacerbation rates for BGF MDI compared with GFF MDI increased with eosinophil count. CONCLUSION: In patients with or without a history of exacerbations in the 12 months prior to the study, BGF MDI reduced exacerbation rates versus GFF MDI, suggesting results observed in the overall population were not driven by the small subgroup with a prior history of exacerbations.
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Authors | Fernando J Martinez, Gary T Ferguson, Eric Bourne, Shaila Ballal, Patrick Darken, Magnus Aurivillius, Paul Dorinsky, Colin Reisner |
Journal | International journal of chronic obstructive pulmonary disease
(Int J Chron Obstruct Pulmon Dis)
2021
Vol. 16
Pg. 179-189
ISSN: 1178-2005 [Electronic] New Zealand |
PMID | 33542624
(Publication Type: Clinical Trial, Journal Article)
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Copyright | © 2021 Martinez et al. |
Chemical References |
- Bronchodilator Agents
- Drug Combinations
- Fumarates
- Budesonide
- Glycopyrrolate
- Formoterol Fumarate
|
Topics |
- Administration, Inhalation
- Bronchodilator Agents
(adverse effects)
- Budesonide
(adverse effects)
- Double-Blind Method
- Drug Combinations
- Formoterol Fumarate
(adverse effects)
- Fumarates
(therapeutic use)
- Glycopyrrolate
(adverse effects)
- Humans
- Metered Dose Inhalers
- Pulmonary Disease, Chronic Obstructive
(diagnosis, drug therapy)
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