Data from Pharmawand - Curated by EPG Health - Date added 20 April 2017

The Lancet has published the results of TRINITY study, which 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 Chronic Obstructive Pulmonary Disease (COPD). The study led by Jørgen Vestbo, former President of the European Respiratory Society (ERS) and Professor of Respiratory Medicine at the University of Manchester (UK) and the University of Southern Denmark, was conducted on 2,580 patients over the age of 40 with severe or very severe COPD. Patients were randomly assigned to one of three arms: one treated with the triple fixed dose combination (ICS/LABA/LAMA), another with an extemporary triple therapy (a fixed dose combination of ICS/LABA plus a LAMA, taken in two different inhalers) and a third with the LAMA tiotropium.

Chiesi’s fixed triple combination is superior to the LAMA tiotropium over 52 weeks of treatment based on the following statistically -and clinically - significant effects: • Annual rate of moderate and severe exacerbations reduced by 20% after 52 weeks of treatment. • Lung function, expressed as trough FEV1 (Forced Expiratory Volume in 1 second), increased by 61 mL after 52 weeks of treatment. Another important finding is the absence of an increased risk of pneumonia associated with the use of ICS. Moreover, the efficacy and safety of the triple fixed dose combination were not inferior to those of the extemporary triple combination, with the added advantage of using only one device to deliver all three active drugs: namely: •an inhaled corticosteroid (ICS) anti-inflammatory beclomethasone. •a long-acting ?2 agonist (LABA) bronchodilator formoterol. •a long-acting muscarinic antagonist (LAMA) bronchodilator glycopyrronium.

A further advantage is provided by the extra fine particle formulation which allows the active principles to reach not only the central airways, but also the small airways. COPD is characterized by chronic inflammation causing structural changes, narrowing of the small airways and destruction of the lung parenchyma. It is estimated that small airways impairment is present in up to 90% of COPD symptomatic patients

In the TRILOGY4 study published last September 2016 in The Lancet, the same triple fixed dose combination from Chiesi had already demonstrated superior efficacy compared to a fixed dose combination therapy with ICS/LABA (a standard of care in COPD) for a large number of clinical parameters, reducing the annual exacerbation rate by 23%, while improving pulmonary function and reducing dyspnea.

See- "Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial- Jørgen Vestbo, Alberto Papi, Massimo Corradi, Viktor Blazhko, Isabella Montagna, Catherine Francisco, and others.The Lancet - Published: April 3, 2017.

Comment: extrafine ICS/LABA/LAMA triple fixed dose combination therapy was filed at EMA in September 2016.


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