Chiesi recently completed a long-term study showing that its extra-fine, fixed-dose, triple combination inhaler Trimbow is more effective than Utibron (indacaterol and glycopyrronium) as a therapy for chronic obstructive pulmonary disease (COPD).
Trimbow contains 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. An agonist binds to a receptor prompting the receptor to produce a biological response, while an antagonist prevents a receptor from acting.
Chiesi’s Trimbow uses a single pressurized meter dose inhaler (pMDI) to deliver the triple therapy combination. It was developed as a treatment for COPD patients who fail to respond to a combination of an inhaled corticosteroid and a β2 agonist. The therapy was approved by the European Commission in July this year, meaning it can be marketed in all 28 member countries of the E.U.
The 52-week, Phase 3 TRIBUTE study (NCT02579850) randomized 1,532 patients to receive either Trimbow or Utibron (fixed-dose LABA/LAMA combination).
The primary endpoint of the study was met with Trimbow showing superior results in reducing COPD exacerbations compared to Utibron, along with a comparable safety profile.
Utibron was developed by Novartis as a maintenance bronchodilator treatment to relieve symptoms in adults with COPD. It is marketed in the U.S. as Utibron Neohaler by Sunovion.
“The TRIBUTE study showed for the first time the superiority of a triple ICS/LABA/LAMA fixed-dose combination inhaler on exacerbations when compared to a fixed-dose LABA/LAMA combination, finally providing the missing piece of evidence of the benefit of the triple therapy over single and double combination inhaler therapies in the target COPD patients,” Stefano Petruzzelli, Chiesi’s head of global clinical development, said in a press release.
“Even more importantly, TRIBUTE showed that such clinical improvements are associated with a similar safety profile, providing further reassurance of the positive benefit-risk profile of the Chiesi extra fine fixed-dose ICS/LABA/LAMA combination inhaler in the management of COPD,” Petruzzelli added.
Two previous studies assessing Trimbow, called TRILOGY and TRINITY, showed the superior clinical efficacy of the drug compared to standard of care therapies with ICS/LABA and LAMA, respectively, regarding several clinically-relevant outcomes, such as lung function, exacerbations, 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 ICS/LABA treatments are not adequate to control their symptoms and prevent exacerbations,” said Paolo Chiesi, the company’s vice president and head of research and development.