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An extrafine ICS/LABA combination decreases COPD exacerbations more than

Date: 17/05/2016

Parma (Italy), May 17 2016 – In the treatment of chronic obstructive pulmonary disease (COPD) the combination of inhaled corticosteroids (ICS) and long acting bronchodilators LABA (Long Acting Beta2-agonists) reduces moderate and severe exacerbations, and it is recommended for this purpose in the in-force clinical guidelines. A comparative analysis of published data presented at the American Thoracic Society annual congress in San Francisco (May 13-18) shows that in patients with COPD the fixed combination of the ICS/LABA Beclomethasone/Formoterol (BDP/FF) in an extrafine formulation reduces the frequency of moderate/severe exacerbations more effectively than the combination of LABA/Long-Acting Muscarinic Antagonist (LAMA) in comparison to the corresponding monotherapies. Indeed, the ICS containing extrafine combination consistently results in a significant reduction of exacerbations over LABA (25-30% on average) which is considered clinically-relevant being anchored to an improvement in patients’ quality of life. Conversely, currently available data indicate that LABA/LAMAs provide a smaller reduction over LABA (10-12%) that does not reach the threshold of clinical relevance. This supports the importance of ICS-containing combinations in the prevention of COPD exacerbations.


COPD is a progressive disease obstructing both large and small airways, causing patients to have a considerably impaired pulmonary function, poor quality of life and risk to exacerbate. Patients with moderate and severe COPD are prone to exacerbations, the frequency of these exacerbations increases with the severity of the disease and negatively impacts on disease progression.  Fixed combinations of ICS/LABA are recommended as first choice treatment in patients at risk of exacerbations. Extrafine BDP/FF is approved for COPD in the EU as both a pressurized metered dose inhaler and a dry powder inhaler, targeting both large and small airways.


A separate analysis, based on published data, on the effect of extrafine BDP/FF compared to IND/GLY (indacaterol/glycopyrrolate) on reduction of moderate/severe exacerbations will be presented at the ATS Congress in San Francisco on May 18. This analysis shows that, in comparison to the corresponding monotherapies:


  • The reduction of annual moderate/severe exacerbation rate observed with BDP/FF over the LABA monocomponent alone is above the suggested threshold of 20% for minimal clinically important difference (MCID), either in the overall population or in patients stratified by eosinophil count,;
  • The reduction of moderate/severe exacerbations observed with IND/GLY over the LAMA monocomponent alone is smaller than that of BDP/FF and below the proposed MCID.


“Based on this analysis, there is evidence that the addition of an ICS to a LABA in a fixed dose combination does provide a relevant benefit to a patient’s risk to exacerbate and potentially be hospitalised for an acute exacerbation of COPD compared with the bronchodilator therapy alone” commented Stefano Petruzzelli, Chief Medical Officer at Chiesi Farmaceutici, “whereas LABA-LAMA do not confer that advantage to the corresponding LAMA monotherapy.”


“The interpretation of these results on the efficacy of extrafine BDP/FF” added Alberto Papi, Professor of Respiratory Medicine at the University of Ferrara (Italy), “should take into account both the inflammatory nature of most exacerbations and the added value of the extrafine formulation that allows a greater penetration of the drugs in the peripheral region of the respiratory tract”.



Chiesi Farmaceutici

Chiesi Farmaceutici is a research-focused international group, with more than 80 years of experience headquartered in Parma (Italy). Chiesi researches, develops and commercializes innovative pharmaceutical solutions in the respiratory therapeutics, specialist medicine and rare diseases areas.

In 2015, Chiesi achieved sales of over 1.4 billion Euros, constituting a 9.4 % growth over 2014. Its R&D centers in Parma (Italy), Paris (France), Cary (USA), Chippenham (UK) and the R&D team of the controlled Danish company Zymenex, integrate their efforts to advance Chiesi's pre-clinical, clinical and registration programs. The Chiesi Group employs approximately 4500 people, 560 of which are dedicated to R&D activities