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

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 FEV(1) at 12 weeks. The ITT population included 1186 patients (69% males, mean age 64 years) with severe airflow limitation (mean post-bronchodilator FEV(1) 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 FEV(1) (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.

• Authors: J A Wedzicha, D Singh, J Vestbo, P L Paggiaro, P W Jones, F Bonnet-Gonod, G Cohuet, M Corradi, S Vezzoli, S Petruzzelli, A Agusti, FORWARD Investigators
• Journal: Respiratory medicine (Respir Med) Vol. 108 Issue 8 Pg. 1153-62 (Aug 2014) ISSN: 1532-3064 [Electronic] England
• PMID: 24953015 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Bronchodilator Agents
• Ethanolamines
• Glucocorticoids
• Beclomethasone
• Formoterol Fumarate

Topics

• Beclomethasone (administration & dosage, adverse effects)
• Bronchodilator Agents (administration & dosage, adverse effects)
• Double-Blind Method
• Ethanolamines (administration & dosage, adverse effects)
• Female
• Forced Expiratory Volume (drug effects)
• Formoterol Fumarate
• Glucocorticoids (administration & dosage, adverse effects)
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Pulmonary Disease, Chronic Obstructive (drug therapy)
• Seasons
• Treatment Outcome
• Vital Capacity (drug effects)