Abstract | BACKGROUND: METHODS: This randomised, parallel-group, double-blind, double-dummy study was done at 187 sites across 17 countries. Eligible patients had symptomatic COPD, severe or very severe airflow limitation, at least one moderate or severe exacerbation in the previous year, and were receiving inhaled maintenance medication. After a 2 week run-in period with one inhalation per day of IND/GLY (85 μg/43 μg), patients were randomly assigned (1:1), via an interactive response technology system, to receive 52 weeks of treatment with two inhalations of extrafine BDP/FF/G (87 μg/5 μg/9 μg) twice per day or one inhalation of IND/GLY (85 μg/43 μg) per day. Randomisation was stratified by country and severity of airflow limitation. The primary endpoint was the rate of moderate-to-severe COPD exacerbations across 52 weeks of treatment in all randomised patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment. Safety was assessed in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT02579850. FINDINGS: Between May, 29 2015, and July 10, 2017, 1532 patients received BDP/FF/G (n=764) or IND/GLY (n=768). Moderate-to-severe exacerbation rates were 0·50 per patient per year (95% CI 0·45-0·57) for BDP/FF/G and 0·59 per patient per year (0·53-0·67) for IND/GLY, giving a rate ratio of 0·848 (0·723-0·995, p=0·043) in favour of BDP/FF/G. Adverse events were reported by 490 (64%) of 764 patients receiving BDP/FF/G and 516 (67%) of 768 patients receiving IND/GLY. Pneumonia occurred in 28 (4%) patients receiving BDP/FF/G versus 27 (4%) patients receiving IND/GLY. One treatment-related serious adverse event occurred in each group: dysuria in a patient receiving BDP/FF/G and atrial fibrillation in a patient receiving IND/GLY. INTERPRETATION: In patients with symptomatic COPD, severe or very severe airflow limitation, and an exacerbation history despite maintenance therapy, extrafine BDP/FF/G significantly reduced the rate of moderate-to-severe exacerbations compared with IND/GLY, without increasing the risk of pneumonia. FUNDING: Chiesi Farmaceutici.
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Authors | Alberto Papi, Jørgen Vestbo, Leonardo Fabbri, Massimo Corradi, Hélène Prunier, Géraldine Cohuet, Alessandro Guasconi, Isabella Montagna, Stefano Vezzoli, Stefano Petruzzelli, Mario Scuri, Nicolas Roche, Dave Singh |
Journal | Lancet (London, England)
(Lancet)
Vol. 391
Issue 10125
Pg. 1076-1084
(03 17 2018)
ISSN: 1474-547X [Electronic] England |
PMID | 29429593
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2018 Elsevier Ltd. All rights reserved. |
Chemical References |
- Adrenergic beta-2 Receptor Agonists
- Bronchodilator Agents
- Glucocorticoids
- Indans
- Muscarinic Antagonists
- Quinolones
- indacaterol
- Beclomethasone
- Glycopyrrolate
- Formoterol Fumarate
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Topics |
- Administration, Inhalation
- Adrenergic beta-2 Receptor Agonists
(administration & dosage)
- Aged
- Beclomethasone
(administration & dosage)
- Bronchodilator Agents
(administration & dosage)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Formoterol Fumarate
(administration & dosage)
- Glucocorticoids
(administration & dosage)
- Glycopyrrolate
(administration & dosage)
- Humans
- Indans
(administration & dosage)
- Male
- Middle Aged
- Muscarinic Antagonists
(administration & dosage)
- Pulmonary Disease, Chronic Obstructive
(drug therapy)
- Quinolones
(administration & dosage)
|