Efficacy and Safety of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler in Chinese Patients with COPD: A Subgroup Analysis of KRONOS.
Administration, Inhalation
Adult
Aged
Bronchodilator Agents
/ therapeutic use
Budesonide
/ therapeutic use
China
Dose-Response Relationship, Drug
Double-Blind Method
Drug Combinations
Female
Forced Expiratory Volume
/ drug effects
Formoterol Fumarate
/ therapeutic use
Glycopyrrolate
/ therapeutic use
Humans
Male
Metered Dose Inhalers
Middle Aged
Pulmonary Disease, Chronic Obstructive
/ drug therapy
Quality of Life
Respiratory Function Tests
/ methods
Bronchodilator agents
China
Chronic obstructive
Disease exacerbation
Pulmonary disease
Pulmonary function tests
Journal
Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
21
11
2019
pubmed:
11
3
2020
medline:
15
12
2020
entrez:
11
3
2020
Statut:
ppublish
Résumé
This pre-specified subgroup analysis evaluated the efficacy and safety of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) triple therapy versus corresponding dual therapies in the China subgroup of the phase III, double-blind KRONOS study in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Patients were randomized 2:2:1:1 to BGF MDI 320/18/9.6 μg, glycopyrrolate/formoterol fumarate (GFF) MDI 18/9.6 μg, budesonide/formoterol fumarate (BFF) MDI 320/9.6 μg, or budesonide/formoterol fumarate dry powder inhaler (BUD/FORM DPI) 400/12 μg twice daily for 24 weeks. The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV In the China subgroup (n = 432; 22.7% of the KRONOS population), BGF MDI demonstrated nominally significant improvements in the primary endpoint versus BFF MDI (least squares mean (LSM) difference 68 mL; P = 0.0035) and BUD/FORM DPI (LSM difference 78 mL; P = 0.0010) but not GFF MDI (LSM difference - 4 mL; P = 0.8316). BGF MDI demonstrated at least numerical improvements versus comparators in secondary lung function and symptom endpoints. BGF MDI reduced the rate of moderate/severe COPD exacerbations versus GFF MDI (rate ratio 0.41; P = 0.0030), with numerical benefits versus BFF MDI and BUD/FORM DPI. All treatments were well tolerated. Results demonstrated that BGF MDI showed benefits on lung function (vs inhaled corticosteroid/long-acting β ClinicalTrials.gov NCT02497001.
Identifiants
pubmed: 32152869
doi: 10.1007/s12325-020-01266-5
pii: 10.1007/s12325-020-01266-5
pmc: PMC7140742
doi:
Substances chimiques
Bronchodilator Agents
0
Drug Combinations
0
Budesonide
51333-22-3
Glycopyrrolate
V92SO9WP2I
Formoterol Fumarate
W34SHF8J2K
Banques de données
ClinicalTrials.gov
['NCT02497001']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
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