Innovative threatment for COPD has its first data published

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Date: 03/01/2017

The prestigious publication "The Lancet" released the results of Chiesi Pharmaceuticals' TRILOGY¹ study, which demonstrated the superiority of the efficacy of the fixed TRIPLA combination of extra fine particles in the same inhaler compared to the standard treatment for COPD (Chronic Obstructive Pulmonary Disease).


  • The results of this study convincingly provide scientific support for the development of the first Triple Inhaler in COPD. This inhaler is specifically developed to produce extra fine particles of this combination, which efficiently reach the lung, resulting in significant improvements to patients.
  • This is another achievement that puts Chiesi and its Research Centers at the forefront of developing innovative therapies for the treatment of COPD.


Chiesi's TRILOGY study was published in the special issue of The Lancet - one of the world's most prestigious medical journals, and presented at the European Society of Respiratory Diseases (ERS) Congress in London last month. The study provided, for the first time, evidence on the efficacy of the extrafine triple fixed combination of ICS (inhaled corticosteroid) particles + LABA (Long-Acting Beta-2 Agonist) + LAMA (Long-Acting Muscarinic Antagonist) evaluated for a period of one year.


This combination showed higher results than the current standard treatment for this condition (fixed combination of ICS + LABA). The clinical efficacy parameters of the combination demonstrated high safety and demonstrated that it:


  • reduces the annual incidence of exacerbations of COPD, which is the greatest threat to patients and the main cause of hospitalization and death, and a higher cost for the health system;
  • improves lung function significantly;
  • reduces shortness of breath (dyspnea) and improves the patient's symptoms profile


 In addition, the results of a second pivotal clinical study called TRINITY² were also presented during the congress. This study confirmed the superiority of the extra fine fixed combination of ICS + LABA + LAMA also in comparison with tiotropium (a LAMA) and the current standard treatment for COPD (ICS + LABA).




 A New Standard of Care for COPD


COPD affects the respiratory system and, in particular, small airways (bronchioles)³ which tend to be reached inadequately by the usual medications. In addition, the disease has two distinct characteristics: an obstructive component that limits the airflow, especially during expiration, and an inflammatory component in both the proximal and inner airways of the lungs3. The triple combination tested in the TRILOGY study is the first containing three different active ingredients that improve airflow and treat inflammation. They are:


  • beclomethasone, an inhaled corticosteroid (ICS) anti-inflammatory agent;
  • formoterol, a long-acting beta-2 agonist (LABA) bronchodilator;
  • and glycopyrronium, a long-acting muscarinic antagonist (LAMA) bronchodilator.


This way, the triple combination achieves its beneficial effect (including a reduction in the risk of exacerbations) by acting simultaneously on the two main characteristics of the disease.


At the same time, the unique formulation of the extra fine particles (Modulite® technology) developed by Chiesi in its Research Center ensures that the inhaled drug effectively reaches and treats the small airways even in the deepest regions of the lungs4, 5.






Chiesi commitment to unmet medical needs:


Patients with COPD still have unmet medical needs, such as reducing the risk of exacerbations, which impairs the quality of life and can lead to hospitalization and even be fatal.6,7,8,9. Quality of life10 worsens when symptoms, such as shortness of breath and cough, get out of control, taking the patient to the hospital. In addition, COPD is a progressively progressive disease, 3 which requires that therapy be continuously intensified. This intensification presupposes that patients are treated with multiple medications that, up to the moment, are inhaled through different devices. The possibility, therefore, of taking all the necessary drugs reaching central and peripheral airways using only an inhaler greatly simplifies the treatment of patients with the disease.


"Based on these unmet medical needs, Chiesi has developed an extensive research and development program for the first extra fine triple combination of ICS + LABA + LAMA and, for the first time, long-term clinical data clearly demonstrate its superiority compared to two standard therapies: ICS + LABA at a fixed dose and a LAMA monotherapy, which are currently recommended as first-line therapy in patients with symptomatic COPD," commented Stefano Petruzzelli, Director of Global Clinical Development for Chiesi Farmacêutica.





¹The TRILOGY study


The TRILOGY study, published in The Lancet and featured in this year's European Society of Respiratory Diseases (ERS) Congress in London, is a 52-week multicenter, randomized, double blind, controlled phase III trial. The study, which was previously approved by the European Medicines Agency (EMA), involved 1,368 patients from 159 study centers in 14 countries in Europe and South America.


The patients - aged over 40 years with a diagnosis of severe or very severe COPD and a recent history of at least one exacerbation - were initially treated with a fixed combination of ICS + LABA for two weeks and then randomized into two groups: half of the patients continued the ICS + LABA treatment while the other half was treated with the fixed triple combination ICS + LABA + LAMA. Patients were evaluated after 4, 12, 26, 40 and 52 weeks.


After 26 weeks of treatment, the use of Chiesi's fixed triple therapy showed the following:


  • a statistically significant increase in lung function in the morning prior to inhalation of the first daily dose: FEV1 (forced expiratory volume in 1 second) was, on average, 81 mL higher compared to the double combination of ICS + LABA;
  • a statistically significant increase in lung function two hours after the first daily dose: two hours after the dose, FEV1 was on average 117 mL higher compared to the double combination of ICS + LABA, which means that the drug has a very short effect, an important factor that can improve patient adherence to treatment;
  • a significant improvement in patients' quality of life. The St. George’s Respiratory Questionnaire, which is administered to assess the quality of life of people with respiratory disorders, has shown that patients treated with the fixed triple combination improved their score by an average of more than 4 units, which Is considered a clinically significant limit.


These results were confirmed at the end of the 52-week treatment period and also showed that the annual rate of moderate and severe exacerbation was reduced by 23%. This is extremely important since exacerbations, more than any other factor, worsen the quality of life of patients with COPD, who often need hospitalization - besides being the main cause of death among these patients.


"The study provided evidence of the importance of treating severe COPD with all three active ingredients - ICS, LABA and LAMA - and that they can be administered simultaneously using only one inhaler." The efficacy of the extra fine triple combination has been proven in terms of improvements in both the pulmonary function and in important clinical parameters, such as a reduction in the incidence of exacerbations of the disease," said Alberto Papi, Professor and Coordinator of Respiratory Medicine and Vice President of the School of Medicine of the University of Ferrara.






2The TRINITY study


The TRINITY study, presented at the ERS Congress, is a 52-week multicenter, randomized, double blind, controlled study. It involved 2,580 patients over 40 years of age with severe or very severe COPD, who were divided into three groups: one group was treated with tiotropium (LAMA), another group with fixed triple combination (ICS + LABA + LAMA) and a third group with an extemporaneous triple therapy (ICS / LABA plus LAMA, taken separately). The results demonstrate that Chiesi's fixed triple combination achieved the following:


  • A 20% reduction in moderate and severe exacerbations compared to tiotropium (LAMA);
  • A statistically significant increase in lung function in the morning before the intake of the first daily dose: FEV1 (forced expiratory volume in 1 second) was, on average, 61 mL higher than tiotropium (LAMA).


In addition, the efficacy and safety of Chiesi's fixed triple combination were comparable to those of the extemporaneous triple therapy, with the added benefit that the patient was able to use only one inhaler.


 "We are proud of the results achieved by our research and development program and, over the next year, the release of new data confirming the efficacy and superiority of the ICS + LABA + LAMA fixed dose combination, which we deem appropriate for the treatment of a disease such as COPD. This option, developed by Chiesi in its Research Centers, guarantees a double benefit: on the one hand, it marks a real progress in the management of patients by reducing the impact of their pathological condition on their health and quality of life. On the other hand - and more importantly - its clinical impact can lead to an economic benefit in the health system, since it can avoid the direct and indirect costs associated with patient hospitalization," says Paolo Chiesi, Vice President and Director of Research and Development for Chiesi Farmacêutica.






About Chiesi


Chiesi, an ethical pharmaceutical company with more than 80 years of dedication to the research and development of medicines and new technologies, is currently one of the main pharmaceutical industries in Europe, with an extensive line of products in several therapeutic segments. With headquarters in Parma, Italy, the group operates in all continents, with 26 direct subsidiaries, three production plants (Italy, France and Brazil) and four research and development centers for new products and technologies (Italy, France, United States and England).


Chiesi Farmacêutica, Chiesi’s Brazilian subsidiary, has been responsible for all operations in Brazil since 1976, offering healthcare professionals and patients medicines of recognized quality and reliability all over the world.


Currently the Chiesi Group has more than 3,000 employees worldwide, 360 of them in Brazil, 140 of which are dedicated exclusively to the scientific dissemination to more than 30 thousand doctors in the country.


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About COPD


COPD is a respiratory disease characterized by persistent bronchial obstruction associated with an increase in the chronic inflammatory response of the airways to harmful particles or gas. Classic symptoms associated with COPD are dyspnea (shortness of breath), chronic cough and chronic productive expectoration. In some cases, an acute exacerbation of the abovementioned symptoms may occur, causing an exacerbation. A dual mechanism at work in bronchial obstruction in patients with COPD: on the one hand, inflammation of the small airways may occur, along with thickening of the airway walls and increased resistance to airflow. On the other hand, a progressive destruction of the lung parenchyma (emphysema) associated with loss of elastic retraction of the lung may occur. It is important to note that both mechanisms can coexist, leading to a significant reduction of airflow in the lungs.






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