GlaxoSmithKline plc (GSK) will provide updates on emerging areas of research with data from across its comprehensive respiratory portfolio of approved medicines, investigational programmes and scientific collaborations, at the European Respiratory Society (ERS) International Congress, 3rd -7th September, London, UK. More than 30 abstracts from the company will be featured at the meeting.

Highlights include data from a number of key studies:

FULFIL, the pivotal phase III study for the investigational once-daily ‘closed’ triple combination therapy, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25mcg), a combination inhaled corticosteroid, long-acting muscarinic antagonist, long-acting beta2 agonist, compared to the inhaled corticosteroid and single bronchodilator treatment, budesonide/formoterol (400/12mcg) delivered in the Turbohaler inhaler in patients with chronic obstructive pulmonary disease (COPD). Results will report on the co-primary endpoints of lung function and health-related quality of life as measured by SGRQ, as well as a secondary endpoint assessing annual rate of moderate/severe exacerbations and safety data over 24 weeks and 52 weeks of treatment. Headline data from the study were announced in June, and regulatory submissions for the closed triple therapy in the US and Europe are anticipated by end of 2016.

The Salford Lung Study in COPD, an innovative randomised controlled trial, designed to measure the effectiveness and safety of Relvar Ellipta (fluticasone furoate/vilanterol or FF/VI 100/25mcg) when compared with patients’ usual care for COPD and undertaken in an everyday clinical practice setting. Results will report on the primary endpoint of annual rate of moderate/severe exacerbations and safety findings.

Vestri, GSK’s long-term safety study for Advair Diskus (fluticasone propionate/salmeterol) compared to fluticasone propionate monotherapy, to treat children aged 4-11 years with asthma. This was undertaken by GSK as a post-marketing requirement of the US Food and Drug Administration (FDA). Results will report on the primary safety endpoint and primary efficacy data.

Data will also be presented which provide insight into the burden of severe asthma and characterize the role of GSK’s anti-IL 5 monoclonal antibody, Nucala (mepolizumab), in the treatment of patients with severe refractory eosinophilic asthma. Exploratory data for GSK’s dual bronchodilator treatment for COPD, Anoro Ellipta (umeclidinium/vilanterol, UMEC/VI), investigates the risk of experiencing clinically important deteriorations in COPD, following an escalation of treatment from single bronchodilator tiotropium to UMEC/VI.

Professor Neil Barnes, Global Franchise Medical Head, Respiratory said, “We are delighted that this year’s ERS is taking place in our home city of London. As the largest respiratory scientific meeting in the world, the ERS provides a great forum to share and debate the ongoing research we are conducting to advance respiratory science and help patients with lung disease. Our approach to research starts with our understanding that each patient is different. That is why our discovery and development work is focused on understanding patient types and our clinical programmes on generating evidence that supports a clinician’s ability to select the right medicine for the right patients. This has resulted in GSK’s broad portfolio of respiratory medicines, with a treatment option available at each stage of disease as defined in international guidelines for asthma and COPD.”

COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing. COPD is thought to affect 329 million people worldwide.

Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.

Current estimates indicate that as many as 242 million people live with asthma worldwide. For many of these patients, existing therapies can provide adequate control of their symptoms if used appropriately. However, up to 5% of patients with asthma have difficulty in achieving symptom control with existing therapies. Severe asthma is defined as asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic corticosteroids) to prevent it from becoming ‘uncontrolled’ or which remains ‘uncontrolled’ despite this therapy. Severe asthma patients are also often categorised by long-term use of oral corticosteroids (OCS).

Breo Ellipta 100/25mcg (FF/VI) is licensed in the US for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with a history of exacerbations. Breo Ellipta 100/25mcg is the only strength indicated for the treatment of COPD.

Breo Ellipta100/25mcg is not indicated for the relief of acute bronchospasm.

Relvar Ellipta (FF/VI) is approved in Europe for the symptomatic treatment of adults with chronic obstructive pulmonary disease (COPD) with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.

For COPD, the most common adverse reactions (=3% and more common than in placebo) reported in two 6-month clinical trials with Breo Ellipta 100/25 (and placebo) were nasopharyngitis, 9% (8%); upper respiratory tract infection, 7% (3%); headache, 7% (5%); and oral candidiasis, 5% (2%).  In addition to the reactions reported in the 6-month studies, adverse reactions occurring in =3% of the subjects treated with Breo Ellipta 100/25 in two 1-year studies included back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, influenza, pharyngitis, and pyrexia.

Anoro Ellipta is a combination long-acting muscarinic antagonist (LAMA) (also known as an anticholinergic) / long-acting beta2-adrenergic agonist (LABA).

In the US, Anoro Ellipta is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma. The FDA-approved strength is umeclidinium/vilanterol 62.5/25mcg.