![]() TRINITY 2, published on the online issue of April 3, 2017, is the study that for the first time has demonstrated the superiority of the extrafine ICS/LABA/LAMA triple fixed dose combination therapy, developed by Chiesi, compared to the LAMA tiotropium, one of the standard treatments for COPD, again on a series of efficacy parameters including exacerbations.The study provided for the first time, one year evidence that the extrafine fixed ICS/LABA/LAMA triple combination developed by Chiesi is superior to the fixed dose ICS/LABA combined therapy (one of the standard treatments for this condition) regarding a series of clinical parameters including exacerbations, and demonstrates a high safety profile. TRILOGY 1 is the study published in the special ERS edition of The Lancet and presented at the 2016 ERS Congress in London.Two of the studies were recently published by The Lancet - one of the most prestigious international medical journals: The CHMP recommendation is based on the efficacy and safety data of 12 clinical studies involving over 7000 patients. ![]() Therefore, a simplified treatment option based on ICS/LABA/LAMA able to improve lung function and reduce the risk of exacerbations in COPD patients uncontrolled by previous therapies would definitely satisfy those unmet needs. The possibility of taking all drugs needed by using only one inhaler considerably simplifies the treatment of patients, decreasing the burden on patients and may improve adherence. This requires patients to be treated with many drugs that, to date, have to be taken through two or even three inhalers. Moreover, COPD is a disease that deteriorates with time 9 and therapy often needs to be progressively intensified. Indeed, the quality of life 8 worsens when symptoms, such as dyspnoea and cough, are not controlled, and the patient needs to be hospitalised. ![]() Patients with COPD have unmet therapeutic needs, such as reducing the risk of exacerbations that impair the quality of life, may lead to hospitalisation or even be life-threatening 4, 5, 6, 7. It is also with this goal in mind that Chiesi has developed the first fixed dose ICS/LABA/LAMA Triple combination.” COPD affects millions of people across Europe and Chiesi is committed to developing new therapeutic options that could help these patients adherence to the therapy, thus reducing the risk of exacerbations and at the same time improving their quality of life. Paolo Chiesi, Chiesi Group Vice President and Head of R&D, said, “ Today’s positive opinion is an important step forward to make our extrafine Triple combination available to COPD patients. Trimbow is a combination of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP), Formoterol fumarate (FF) and Glycopyrronium bromide (GB). ![]() Parma (Italy), May 22 2017 – Chiesi Group (Chiesi), an international research-focused Healthcare company, announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for the extrafine triple combination ICS/LABA/LAMA, under the brand name Trimbow ®, for the first time in a single inhaler for the treatment of Chronic Obstructive Pulmonary Disease (COPD). CHMP positive opinion is based on data obtained in 12 clinical studies involving more than 7000 patients.Trimbow is the first fixed triple combination as extrafine formulation in a single inhaler that may improve adherence to the therapy.Chiesi is the first pharmaceutical company to have demonstrated with randomized clinical trials, two of which published in The Lancet 1,2, the efficacy of the triple extrafine combination to prevent exacerbations, improve symptoms and quality of life. ![]()
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