Phase III Trilogy study of Extrafine Fixed Triple Combination (formoterol + glycopyrronium + beclomethasone) shows superior efficacy for chronic obstructive pulmonary disease- Chiesi

Chiesi has announced results from the late-stage Phase III Trilogy study of Extrafine Fixed Triple Combination (formoterol + glycopyrronium + beclomethasone) showing the superior efficacy of this combination inhaler for chronic obstructive pulmonary disease (COPD) versus standard dual therapy. Patients in the Trilogy Study (with severe or very severe COPD and a recent history of at least one exacerbation) were treated with a fixed inhaled corticosteroid (ICS)/long-acting beta agonist (LABA) for two weeks and then randomised into two groups: half continuing on this regimen and the other half given the fixed extrafine triple formulation in a single inhaler.

After 26 weeks, patients on the triple therapy showed a statistically significant increase in pulmonary function prior to the intake of the first dose; FEV1 (Forced Expiratory Volume in 1 second) was 81 mL higher, on average, versus the double combination. There was also a statistically significant increase in pulmonary function two hours after the first daily dose, meaning that the drug effect is very rapid, a crucial factor that can improve patient compliance with treatment. A marked improvement of the quality of life of patients was also recorded. The data was published in a special European Respiratory Society edition of The Lancet.

Comment: The superior efficacy in improving lung function, symptoms and quality of life, and in reducing COPD exacerbations, as compared to monotherapy or a fixed double combination therapy, shows that the extrafine fixed triple combination represents an improvement for COPD patients. It is also expected that the use of a single inhaler will lead to a greater adherence to treatment. Chiesi is on track for filing by IV quarter of 2016.