Parma (Italy), 7-9-17- Chiesi announces today the completion of the clinical study TRIBUTE with its extrafin formulation of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA)triple combination (Trimbow®) for Chronic Obstructive Pulmonary Disease (COPD). The primary objective of the 52-week study was to investigate whether Trimbow® would be superior to fixed LABA/LAMA combination (Ultibro®) in reducing moderate and severe exacerbations in COPD patients. TRIBUTE randomized 1,532 patients to either Trimbow® or Ultibro®. The primary endpoint was met with a significant reduction of moderate/severe exacerbation compared to Ultibro® along with a comparable safety profile.
Chiesi’s extrafine fixed triple combination (Trimbow®) has recently received a marketing authorization from the European Commission following EMA Committee for Human Medicinal Products (CHMP) positive opinion. Trimbow® contains three active ingredients, the anti-inflammatory inhaled corticosteroid (ICS) beclomethasone dipropionate, and two bronchodilators, the long-acting beta2 agonist (LABA) formoterol fumarate and the long-acting muscarinic antagonist (LAMA) glycopyrronium, delivered as an extrafine formulation in a single pressurized metered dose inhaler (pMDI).
Trimbow® is licensed for Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (for effects on symptoms control and prevention of exacerbations section 5.1 of the SPC should be referenced).
Stefano Petruzzelli, Head of Global Clinical Development of Chiesi, commented: “The TRIBUTE study showed for the first time the superiority of a triple ICS/LABA/LAMA fixed combination on exacerbations when compared to a fixed LABA/LAMA combination, finally providing the missing piece of evidence of the benefit of the triple therapy over single and double combination therapies in the target COPD patients. Even more importantly, TRIBUTE showed that such clinical improvements are associated with a comparable safety profile providing further reassurance of the positive benefit-risk profile of the Chiesi extrafine ICS/LABA/LAMA combination in the management of COPD.”
Paolo Chiesi, Vice President and Head of Research and Development of Chiesi added: “In two previous long-term studies, TRILOGY3 and TRINITY4 Trimbow® consistently showed superior clinical efficacy compared to standard of care therapies with ICS/LABA and LAMA respectively on a range of clinically-relevant outcomes including exacerbations, lung function and quality of life. Along with TRILOGY and TRINITY, TRIBUTE provides evidence for Trimbow® as a valid therapeutic option for those COPD patients in whom current standard of treatments are not adequate to control their symptoms and prevent exacerbations”.
1Clinicaltrial.gov available at: https://clinicaltrials.gov - NCT02579850
2Trimbow SmPC available at: http://www.ema.europa.eu
3 Singh et al. (Lancet 2016; 388: 963-73)
4 Vestbo et al. (Lancet 2017; 389-10082: 1919–29)