Chiesi has unveiled results of a late-stage study showing the superior efficacy of its triple combination inhaler for chronic obstructive pulmonary disease (COPD) compared with standard dual therapy.
In the Phase III Trilogy study patients - aged over 40 years with a diagnosis of severe or very severe COPD and a recent history of at least one exacerbation - were first all 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 an fixed extrafine formulation of an ICS/LABA/long-acting muscarinic antagonist (LAMA) in a single inhaler.
The data, published in the special the European Respiratory Society edition of The Lancet, provide for the first time one-year evidence that the triple combination is superior to the fixed dose ICS/LABA combined therapy on a number of clinical efficacy parameters.
After 26 weeks of treatment, the fixed dose triple therapy showed a statistically significant increase in morning pulmonary function prior to the intake of the first daily dose; FEV1 (Forced Expiratory Volume in 1 second) was 81 mL higher, on average, compared with the ICS/LABA double combination.
There was also a statistically significant increase in pulmonary function two hours after the first daily dose; two-hour post-dose FEV1 was 117 mL higher, on average, which means 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, as assessed by The Saint George's Respiratory Questionnaire, which showed patients treated with the fixed triple combination improved their score, on average, by more than 4 units, which is deemed the clinically significant threshold.
After 52 weeks' treatment, the annual rate of moderate and severe COPD exacerbations was reduced by 23 percent, the firm said, noting that this is extremely important since exacerbations worsen the quality of life of a COPD patient more than any factor, often leading to hospital admission and representing the main cause of death in patients.
According to Chiesi, its triple therapy ensures a dual benefit. "Indeed, on one hand it marks genuine progress in the management of patients, to reduce the impact of their pathological condition, on their quality of life. On the other hand, importantly its clinical impact may leverage a health economic benefit because it may avoid the direct and indirect costs associated with patient hospitalisation," said Paolo Chiesi, R&D the firm's director.