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.

Blood Eosinophils: A Biomarker of Response to Extrafine Beclomethasone/Formoterol in Chronic Obstructive Pulmonary Disease

“…The results of the study have been reported (6) and showed a significant reduction in exacerbation rate (28%) and improvement in lung function with BDP/FF compared with FF treatment.…”

Differences in the efficacy and safety among inhaled corticosteroids (ICS)/long-acting beta2-agonists (LABA) combinations in the treatment of chronic obstructive pulmonary disease (COPD): Role of ICS

“…In particular, in the two replicate 1-year studies, a pooled analysis demonstrated fewer moderate and severe exacerbations in all fluticasone/vilanterol groups (0.93e0.81 exac/pt/yr) in comparison with vilanterol alone (1.11 exac/pt/yr) [26]. The other new combination, beclometasone/formoterol combination in the extrafine formulation, has been demonstrated more effective that formoterol alone in reducing the rate of moderate and severe exacerbations (OR: 0.72, CI: 0.62e0.84) [27]. Because data on these new combinations are limited, they were not included in the overall evaluation of efficacy and safety of ICS/LABA combinations in COPD.…”

Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease

“…В исследовании FORWARD при терапии экстрамелкодисперсной комбинацией бекломета зона дипропионат / формотерол в течение 48 нед. риск обострений ХОБЛ снизился на 28 % по сравне нию с формотеролом (ОР -0,72; 95% ный ДИ -0,62-0,84) [111]. По результатам объединенного ана лиза 2 рандомизированных исследований также по казано, что при лечении комбинацией флутиказона фуроат / вилантерол по сравнению с монотерапией вилантеролом достоверно снижается риск среднетя желых и тяжелых обострений ХОБЛ [112].…”