Respiration Day 2017

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Date: 28/05/2017

 The present and future of chronic obstructive pulmonary disease is the focus of the Respiration Day 2017: from the new GOLD report to the first extrafine triple combination in a single inhaler, just recommended for approval by CHMP

 

  • The Respiration Day is an International Conference on "Breakthroughs in Basic and Clinical Research in Chronic Respiratory Disease”, with the participation of more than 700 researchers and clinicians from all over the world.

 

  • COPD and some important developments on its treatment are one of the area of focus for the conference, such as the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) positive opinion on Chiesi's new triple therapy (ICS/LABA/LAMA), which precedes marketing authorization in the European Union.

 

Parma (Italy), May 26, 2017 – Today Parma hosts the 13th edition of the Respiration Day, an international conference dedicated to respiratory diseases and organised by the University of Parma with the support of Chiesi Foundation. This year topic is: "Breakthroughs in Basic and Clinical Research in Chronic Respiratory Disease”. More than 700 clinicians and researchers from all over the world are attending and prominent representatives of the international scientific community are gathered to discuss new scenarios in the field of respiratory diseases. The main focus of the conference is chronic obstructive pulmonary disease (COPD), a progressive disease estimated to affect more than 380 million people worldwide,[1] and a major cause of mortality and disability.

 

"COPD is a respiratory disease characterized by airway inflammation that results in structural changes that cause airway obstruction and difficult breathing", explains Leonardo M. Fabbri, former Professor of Respiratory and Internal Medicine at the University of Modena and Reggio Emilia and Visiting Professor of Respiratory and Internal Medicine at the Universities of Ferrara and Gothenburg, and one of the Conference Chairs. “It makes breathing difficult – continues Fabbri – and it is an invalidating disease with an enormous impact on daily activities, such as taking a leisurely walk to the bakery for bread or even personal hygiene.  The clinical picture of a patient with COPD may worsen suddenly due to the onset of acute episodes called exacerbations: a 'step down' in health status, after which the recovery of symptoms and lung function becomes more prolonged and difficult, sometimes impossible. The phenomenon of co-morbidity is also emerging: COPD is increasingly regarded as a systemic disease and we now know that it rarely strikes alone. A diagnosis of COPD should alert the clinician, because it is often a red flag for other chronic conditions that need to be treated properly".

 

One of the main research goals is to slow and modify the course of COPD. "The clinical course of COPD is much more about the development of disabling breathlessness and fatigue, loss of daily functions and progressive loss of quality of life, not least in those experiencing exacerbations of their disease", commented Jørgen Vestbo, Professor of Respiratory Medicine at the University of Manchester during his presentation. "Progressive loss of health status - explained Vestbo - is a characteristic of COPD that may be amenable to therapy. Progressive loss of function can also be reduced and in some cases reverted by combining pulmonary rehabilitation and optimal bronchodilator treatment. Patients with frequent exacerbations which have a marked impact on health status can also be assisted by appropriate medical interventions, increasingly guided by exacerbation phenotyping and biomarkers. Further improvements in characterisation of COPD and COPD exacerbations will enable us to even better tailor therapies that can impact on the clinical course of COPD and truly benefit patients”.

 

In this context, a major novelty from a therapeutic point of view is Chiesi's triple extrafine fixed-dose therapy, the first to combine three active principles - an inhaled corticosteroid (ICS) anti-inflammatory, a long-acting β2 agonist (LABA) bronchodilator, and a long-acting muscarinic antagonist (LAMA) bronchodilator - in a single inhaler. The benefits with this therapy are its ability to relieve and prevent symptoms such as shortness of breath, wheezing and cough and to reduce exacerbations of COPD symptoms[2]. On May 19th, the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on Chiesi's new triple therapy, which precedes authorization for marketing in the European Union.

 

Additional benefits of Chiesi's fixed-dose triple therapy is the administration mode and the extrafine formulation. The three active ingredients ICS/LABA/LAMA are administered simultaneously through a single inhaler, facilitating proper drug intake and potentially increasing adherence to therapy; at the same time, the extrafine formulation is able to reach both the large and he small airways of the respiratory tree.

 

"In patients affected by COPD, the dysfunction of small airways disease is crucial for the progression and clinical presentation of the disease," says Alfredo Chetta, Professor of Respiratory Medicine at the University of Parma, speaker and one of the Conference Chairs. "In these patients, the degree of airflow obstruction correlates with the wall remodelling of small airways, which is considered as a repair response to airway wall injury. Studies based on micro-computed tomography have also suggested that in COPD patients, narrowing and loss of terminal bronchioles may occur prior the development of emphysematous destruction of alveoli. Importantly, direct measurement of airway resistance has shown that small airways resistance increases from four to 40 times in COPD patients. This finding indicates that small airways are the main site of airflow limitation in patients with the disease. COPD patients might benefit from respiratory drugs delivered via extra-fine particles, which have a deeper penetration into the lungs, thereby targeting the small airway”.

 

Another novelty in the area of COPD is the recent revision of GOLD report. A revised classification of disease severity was introduced in the 2017 update, with four categories - ABCD - based on symptoms and exacerbation history, whereas the assessment of pulmonary function is now mainly reserved for confirming the diagnosis. "For the first time it is also specified that therapies should aim not only to improve respiratory function, but also to treat symptoms and prevent exacerbations", says Fabbri.

 

World No Tobacco Day

The World Health Organization (WHO) has declared this May 31 as World No Tobacco Day: an occasion to remember that smoking is among the main risk factors for COPD. “The data on the number of smokers in the world today are striking”, concludes Fabbri: "It is true that pollution is another important risk factor, but smoking cigarettes is like breathing from a car's exhaust pipe, and quitting smoking is considered among the few actions that can change the course of the disease and increase survival".

Today, Sir Richard Peto of Oxford University is among the Respiration Day International Conference participants, giving an honorary lecture on the pulmonary and extrapulmonary effects of smoking.

 

About COPD

COPD is a respiratory disease characterized by a persistent bronchial obstruction, associated with an increased chronic inflammatory response of the airways to noxious particles or gas. The classic symptoms associated with COPD are dyspnoea, chronic cough and chronic productive sputum. In some cases, an acute worsening of the above-mentioned symptoms may occur, triggering an exacerbation. A double mechanism is at work in the bronchial obstruction in COPD patients: on one hand, an inflammation of the small airways together with the thickening of the airways walls and increased airflow resistance may occur. On the other, a progressive destruction of lung parenchyma (emphysema) associated with the loss of elastic retraction of the lung may take place. It is important to underline that both mechanisms may coexist, leading to a significant airflow reduction throughout the lungs.

 

About Trimbow

Trimbow is the first extrafine fixed triple 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). Trimbow will be available as twice a day pMDI (pressurized metered dose inhaler) to be licensed for COPD indication, with an approved indication for maintenance treatment of COPD patients.

 

[1]Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017. Available from www.goldcopd.org.

[2] http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004257/WC500228080.pdf