Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies.
Administration, Inhalation
Adult
Aged
Aged, 80 and over
Bronchodilator Agents
/ administration & dosage
Clinical Trials, Phase III as Topic
/ methods
Double-Blind Method
Drug Therapy, Combination
Female
Formoterol Fumarate
/ administration & dosage
Glycopyrrolate
/ administration & dosage
Humans
Lung
/ drug effects
Male
Metered Dose Inhalers
/ trends
Middle Aged
Multicenter Studies as Topic
/ methods
Pulmonary Disease, Chronic Obstructive
/ diagnosis
Randomized Controlled Trials as Topic
/ methods
Respiratory Function Tests
/ methods
Severity of Illness Index
Chronic obstructive pulmonary disease
Clinically important deterioration
Exacerbations
Fixed-dose combination
Formoterol fumarate dihydrate
GFF MDI
Glycopyrronium
LAMA/LABA
Metered dose inhaler
Symptomatic
Journal
Respiratory research
ISSN: 1465-993X
Titre abrégé: Respir Res
Pays: England
ID NLM: 101090633
Informations de publication
Date de publication:
25 May 2020
25 May 2020
Historique:
received:
18
12
2019
accepted:
05
05
2020
entrez:
27
5
2020
pubmed:
27
5
2020
medline:
16
3
2021
Statut:
epublish
Résumé
The Phase III PINNACLE studies assessed the efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI), a dual long-acting bronchodilator for chronic obstructive pulmonary disease (COPD). Here we present a pre-specified pooled analysis of PINNACLE-1, PINNACLE-2, and PINNACLE-4. PINNACLE-1, -2, and -4 were multicenter, double-blind, randomized controlled trials that enrolled patients with moderate-to-very severe COPD, with no requirement for exacerbation history or a high symptom burden. Patients received GFF MDI 18/9.6 μg, glycopyrrolate (GP) MDI 18 μg, formoterol fumarate (FF) MDI 9.6 μg, or placebo MDI, twice-daily for 24 weeks. The primary endpoint of the pooled analysis was the change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV The pooled intent-to-treat population included 4983 patients; of these, 61.9% had a COPD assessment test (CAT) score ≥15, and 25.0% had experienced ≥1 moderate/severe exacerbation in the past year. At week 24, GFF MDI improved morning pre-dose trough FEV This pooled analysis of the PINNACLE studies demonstrated that GFF MDI improved lung function and reduced the risk of exacerbations compared with monocomponents and placebo in patients with COPD. Exacerbation reductions with GFF MDI versus comparators were generally greater in patients with higher symptom burden and those with exacerbation history. ClinicalTrials.gov NCT01854645, NCT01854658, and NCT02343458. Registered 13 May 2013 (NCT01854645, NCT01854658) and 6 January 2015 (NCT02343458).
Sections du résumé
BACKGROUND
BACKGROUND
The Phase III PINNACLE studies assessed the efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI), a dual long-acting bronchodilator for chronic obstructive pulmonary disease (COPD). Here we present a pre-specified pooled analysis of PINNACLE-1, PINNACLE-2, and PINNACLE-4.
METHODS
METHODS
PINNACLE-1, -2, and -4 were multicenter, double-blind, randomized controlled trials that enrolled patients with moderate-to-very severe COPD, with no requirement for exacerbation history or a high symptom burden. Patients received GFF MDI 18/9.6 μg, glycopyrrolate (GP) MDI 18 μg, formoterol fumarate (FF) MDI 9.6 μg, or placebo MDI, twice-daily for 24 weeks. The primary endpoint of the pooled analysis was the change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV
RESULTS
RESULTS
The pooled intent-to-treat population included 4983 patients; of these, 61.9% had a COPD assessment test (CAT) score ≥15, and 25.0% had experienced ≥1 moderate/severe exacerbation in the past year. At week 24, GFF MDI improved morning pre-dose trough FEV
CONCLUSIONS
CONCLUSIONS
This pooled analysis of the PINNACLE studies demonstrated that GFF MDI improved lung function and reduced the risk of exacerbations compared with monocomponents and placebo in patients with COPD. Exacerbation reductions with GFF MDI versus comparators were generally greater in patients with higher symptom burden and those with exacerbation history.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT01854645, NCT01854658, and NCT02343458. Registered 13 May 2013 (NCT01854645, NCT01854658) and 6 January 2015 (NCT02343458).
Identifiants
pubmed: 32450869
doi: 10.1186/s12931-020-01388-y
pii: 10.1186/s12931-020-01388-y
pmc: PMC7249639
doi:
Substances chimiques
Bronchodilator Agents
0
Glycopyrrolate
V92SO9WP2I
Formoterol Fumarate
W34SHF8J2K
Banques de données
ClinicalTrials.gov
['NCT01854645', 'NCT01854658', 'NCT02343458']
Types de publication
Journal Article
Meta-Analysis
Langues
eng
Sous-ensembles de citation
IM
Pagination
128Subventions
Organisme : AstraZeneca
ID : NA
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