Functional respiratory imaging assessment of glycopyrrolate and formoterol fumarate metered dose inhalers formulated using co-suspension delivery technology in patients with COPD.
Administration, Inhalation
Adrenergic beta-2 Receptor Agonists
/ administration & dosage
Aged
Airway Resistance
/ drug effects
Bronchodilator Agents
/ administration & dosage
Cross-Over Studies
Double-Blind Method
Drug Compounding
Female
Forced Expiratory Volume
Formoterol Fumarate
/ administration & dosage
Glycopyrrolate
/ administration & dosage
Humans
Lung
/ diagnostic imaging
Male
Metered Dose Inhalers
Middle Aged
Muscarinic Antagonists
/ administration & dosage
Plethysmography, Whole Body
Pulmonary Disease, Chronic Obstructive
/ diagnostic imaging
Severity of Illness Index
Spirometry
Time Factors
Tomography, X-Ray Computed
Treatment Outcome
Vital Capacity
formoterol fumarate dihydrate
functional respiratory imaging
glycopyrronium
long-acting muscarinic antagonist
long-acting β2-agonist
Journal
Therapeutic advances in respiratory disease
ISSN: 1753-4666
Titre abrégé: Ther Adv Respir Dis
Pays: England
ID NLM: 101316317
Informations de publication
Date de publication:
Historique:
entrez:
9
5
2020
pubmed:
10
5
2020
medline:
2
6
2021
Statut:
ppublish
Résumé
Functional respiratory imaging (FRI) is a quantitative postprocessing imaging technique used to assess changes in the respiratory system. Using FRI, we characterized the effects of the long-acting muscarinic antagonist (LAMA), glycopyrrolate metered dose inhaler (GP MDI), and the long-acting β Patients in this phase IIIb, randomized, double-blind crossover study received twice-daily GP MDI (18 μg) and FF MDI (9.6 μg). Primary endpoints were specific (i.e. corrected for lobar volume) image-based airway volume (siVaw) and specific image-based airway resistance (siRaw), measured using FRI. Secondary and other endpoints included additional FRI, spirometry, and body plethysmography parameters. Postdose efficacy assessments were performed within 60-150 min of dosing on day 15. A total of 23 patients were randomized and 19 completed both treatment periods. GP MDI and FF MDI both achieved significant improvements from baseline to day 15 in siVaw [11% ( Both GP MDI and FF MDI significantly improved siRaw and siVaw at day 15 NCT02937584
Sections du résumé
BACKGROUND
Functional respiratory imaging (FRI) is a quantitative postprocessing imaging technique used to assess changes in the respiratory system. Using FRI, we characterized the effects of the long-acting muscarinic antagonist (LAMA), glycopyrrolate metered dose inhaler (GP MDI), and the long-acting β
METHODS
Patients in this phase IIIb, randomized, double-blind crossover study received twice-daily GP MDI (18 μg) and FF MDI (9.6 μg). Primary endpoints were specific (i.e. corrected for lobar volume) image-based airway volume (siVaw) and specific image-based airway resistance (siRaw), measured using FRI. Secondary and other endpoints included additional FRI, spirometry, and body plethysmography parameters. Postdose efficacy assessments were performed within 60-150 min of dosing on day 15.
RESULTS
A total of 23 patients were randomized and 19 completed both treatment periods. GP MDI and FF MDI both achieved significant improvements from baseline to day 15 in siVaw [11% (
CONCLUSION
Both GP MDI and FF MDI significantly improved siRaw and siVaw at day 15
CLINICALTRIALS.GOV REGISTRATION NUMBER
NCT02937584
Identifiants
pubmed: 32380894
doi: 10.1177/1753466620916990
pmc: PMC7225799
doi:
Substances chimiques
Adrenergic beta-2 Receptor Agonists
0
Bronchodilator Agents
0
Muscarinic Antagonists
0
Glycopyrrolate
V92SO9WP2I
Formoterol Fumarate
W34SHF8J2K
Types de publication
Clinical Trial, Phase II
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1753466620916990Références
Eur J Pharm Sci. 2018 Jan 1;111:450-457
pubmed: 29055732
Int J Chron Obstruct Pulmon Dis. 2018 Sep 26;13:2969-2984
pubmed: 30310273
Eur J Pharmacol. 2014 Dec 15;745:135-43
pubmed: 25446566
Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55
pubmed: 17507545
Arch Bronconeumol. 2020 Feb;56(2):65-67
pubmed: 31320191
Respir Med. 2016 Nov;120:16-24
pubmed: 27817811
Proc Am Thorac Soc. 2008 May 1;5(4):549-55
pubmed: 18453370
Respir Med. 2018 Jan;134:16-23
pubmed: 29413503
Thorax. 2019 Aug;74(8):797-805
pubmed: 31036773
Radiology. 2010 Dec;257(3):854-62
pubmed: 21084417
Int J Chron Obstruct Pulmon Dis. 2018 Jun 12;13:1873-1888
pubmed: 29928118
Respir Med. 2017 May;126:105-115
pubmed: 28427541
J Aerosol Med Pulm Drug Deliv. 2015 Apr;28(2):88-99
pubmed: 25004168
Int J Chron Obstruct Pulmon Dis. 2011;6:637-46
pubmed: 22162649
Expert Rev Respir Med. 2018 Apr;12(4):261-264
pubmed: 29451042
Eur Respir J. 2012 Aug;40(2):298-305
pubmed: 22183484
Eur Respir J. 2004 Jun;23(6):932-46
pubmed: 15219010
Int J Chron Obstruct Pulmon Dis. 2018 Aug 30;13:2673-2684
pubmed: 30214185
Ann Intern Med. 2015 Sep 15;163(6):461-4
pubmed: 26259067
Respir Med. 2005 Dec;99(12):1511-20
pubmed: 16199148
Chest. 2017 Feb;151(2):340-357
pubmed: 27916620
Expert Rev Respir Med. 2016 Feb;10(2):193-206
pubmed: 26731531
Int J Chron Obstruct Pulmon Dis. 2018 Jun 19;13:1965-1977
pubmed: 29950826
AAPS PharmSciTech. 2018 Feb;19(2):837-844
pubmed: 29019170
Respir Res. 2010 Sep 10;11:122
pubmed: 20831787
Respir Med. 2015 Oct;109(10):1305-11
pubmed: 26303336