Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
The FORWARD study is a randomised, double-blind trial that compares the efficacy and safety of 48 weeks treatment with extrafine beclomethasone dipropionate/formoterol fumarate (BDP/FOR), 100/6 μg pMDI, 2 inhalations BID, vs. FOR 12 μg pMDI, 1 inhalation BID, in severe COPD patients with a history of exacerbations. Co-primary endpoints were exacerbation rate over 48 weeks and pre-dose morning FEV1 at 12 weeks.
The ITT population included 1186 patients (69% males, mean age 64 years) with severe airflow limitation (mean post-bronchodilator FEV1 42% predicted). Salbutamol as rescue therapy, theophylline and tiotropium (if stable regimen prior to screening) were allowed.
Compared to FOR, BDP/FOR: (1) reduced the exacerbation rate (rate ratio: 0.72 [95% confidence interval 0.62–0.84], p < 0.001); (2) improved pre-dose morning FEV1 (mean difference: 0.069 L [0.043–0.095] p < 0.001); (3) prolonged the time to first exacerbation; (4) improved the SGRQ total score. The percentage of patients with adverse events was similar (52.1% with BDP/FOR and 49.2% with FOR). Pneumonia incidence was low, slightly higher with BDP/FOR (3.8%) than with FOR (1.8%). No difference for laboratory values, ECG or vital signs.
Extrafine BDP/FOR significantly reduces the exacerbation rate and improves lung function of patients with severe COPD and history of exacerbations as compared to FOR alone.
The ITT population included 1186 patients (69% males, mean age 64 years) with severe airflow limitation (mean post-bronchodilator FEV1 42% predicted). Salbutamol as rescue therapy, theophylline and tiotropium (if stable regimen prior to screening) were allowed.
Compared to FOR, BDP/FOR: (1) reduced the exacerbation rate (rate ratio: 0.72 [95% confidence interval 0.62–0.84], p < 0.001); (2) improved pre-dose morning FEV1 (mean difference: 0.069 L [0.043–0.095] p < 0.001); (3) prolonged the time to first exacerbation; (4) improved the SGRQ total score. The percentage of patients with adverse events was similar (52.1% with BDP/FOR and 49.2% with FOR). Pneumonia incidence was low, slightly higher with BDP/FOR (3.8%) than with FOR (1.8%). No difference for laboratory values, ECG or vital signs.
Extrafine BDP/FOR significantly reduces the exacerbation rate and improves lung function of patients with severe COPD and history of exacerbations as compared to FOR alone.
Date Issued
2014-06-06
Date Acceptance
2014-05-24
Citation
Respiratory Medicine, 2014, 108 (8), pp.1153-1162
ISSN
1532-3064
Publisher
Elsevier
Start Page
1153
End Page
1162
Journal / Book Title
Respiratory Medicine
Volume
108
Issue
8
Copyright Statement
© 2014 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://
creativecommons.org/licenses/by-nc-nd/3.0/).
creativecommons.org/licenses/by-nc-nd/3.0/).
Subjects
Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Respiratory System
Cardiovascular System & Cardiology
COPD
Extrafine
Exacerbation
Inhaled steroids
Long acting bronchodilators
Patient reported outcomes
OBSTRUCTIVE PULMONARY-DISEASE
FLUTICASONE PROPIONATE/SALMETEROL 250/50
RANDOMIZED CONTROLLED-TRIAL
SALMETEROL/FLUTICASONE PROPIONATE
SALMETEROL
IMPACT
BUDESONIDE/FORMOTEROL
PREVENTION
OUTCOMES
PMDI
Beclomethasone
Bronchodilator Agents
Double-Blind Method
Ethanolamines
Female
Forced Expiratory Volume
Formoterol Fumarate
Glucocorticoids
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Pulmonary Disease, Chronic Obstructive
Seasons
Treatment Outcome
Vital Capacity
FORWARD Investigators
1102 Cardiovascular Medicine And Haematology
1103 Clinical Sciences
Publication Status
Published