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Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations

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Title: Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations
Author(s): Wedzicha, JA
Singh, D
Vestbo, J
Paggiaro, PL
Jones, PW
Bonnet-Gonod, F
Cohuet, G
Corradi, M
Vezzoli, S
Petruzzelli, S
Agusti, A
Item 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.
Publication Date: 6-Jun-2014
Date of Acceptance: 24-May-2014
URI: http://hdl.handle.net/10044/1/40597
DOI: http://dx.doi.org/10.1016/j.rmed.2014.05.013
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/).
Keywords: 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
COPD
Exacerbation
Extrafine
Inhaled steroids
Long acting bronchodilators
Patient reported outcomes
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
Humans
Pulmonary Disease, Chronic Obstructive
Ethanolamines
Beclomethasone
Bronchodilator Agents
Glucocorticoids
Vital Capacity
Forced Expiratory Volume
Treatment Outcome
Double-Blind Method
Seasons
Middle Aged
Female
Male
Kaplan-Meier Estimate
Respiratory System
1102 Cardiovascular Medicine And Haematology
1103 Clinical Sciences
Publication Status: Published
Appears in Collections:National Heart and Lung Institute
Airway Disease
Faculty of Medicine



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