Beclomethasone/formoterol in the management of COPD: A randomised controlled trial

Abstract

Beclomethasone/formoterol (400/24 μg) treatment for 48 weeks improved pulmonary function, reduced symptoms compared to formoterol, was safe and well-tolerated in patients with severe stable COPD. Neither of the long-acting β2-agonist/inhaled corticosteroid combinations affected the low exacerbation rate seen in this population.

A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations

“…We have allowed patients who are taking tiotropium to continue with this medication during the FORWARD study, as it allows the comparison of extrafine BDP/F to extrafine formoterol to be performed with the patients taking their normal and recommended COPD medications. This is different to previous ICS/ LABA studies in COPD [14,21] and, arguably, is a more ''reallife'' study design. Furthermore, there are ethical issues in asking severe COPD patients to withhold an effective medication over a year for research purposes and to be treated with formoterol only.…”

“…Exacerbation rate and lung function were investigated in the previous study comparing the effects of extrafine BDP/F, BUD/F and formoterol alone in COPD patients [21]. It was observed that both combination therapies were superior to formoterol in terms of FEV1 improvement, and a similar result is expected in the FORWARD study.…”

“…With 530 evaluable patients at week 12 in each group, the study will have 80% power to detect a mean difference of 50 mL in change in predose morning FEV1, assuming a standard deviation of 290 mL, using an unpaired t-test with two-sided significance level of 0.05. The difference of 50 mL was chosen based on previous long-term clinical trials showing that ICS/LABA combinations show this level of superiority over LABA alone, and this is associated with differences in health status and exacerbation rates [14,15,16,21].…”

“…This lower daily dose is possible because of the optimised lung deposition characteristics of the extrafine formulation. A study in COPD patients has shown that the extrafine BDP/F and the BUD/F combinations cause similar improvements in forced expiratory volume in 1 s (FEV1) with both combinations being superior to formoterol alone [21]. However, neither of the combinations showed superiority compared to formoterol alone for the reduction of COPD exacerbations.…”

“…The BDP/F extrafine combination has the potential to minimise long-term corticosteroid-related side-effects in COPD patients, as the corticosteroid dose used is lower than other fixed-dose ICS/LABA combinations [21]. However, it is necessary to demonstrate that this lower corticosteroid dose reduces exacerbation rates.…”