GlaxoSmithKline (GSK) says its groundbreaking triple drug therapy for chronic obstructive pulmonary disease (COPD) has achieved its study goals. The drug has come out clear from a phase III-b multicenter, open-label randomized controlled trial (PCT) that was conducted at 80 primary care centers in Salford and South Manchester and the localities in their vicinity.
The company representatives, in a statement released today, said that GSK has achieved two primary goals. Firstly, a significant improvement of lung functioning in patients of COPD was observed. Secondly, the improved results were compared from competitor brand’s drug, AstraZeneca Plc’s Symbicort.
The study was a result of collaboration between GSK, North West e-Health (NWEH), The University of Manchester, Salford Royal NHS Foundation Trust, University Hospital of South Manchester (UHSM), NHS Salford and GPs and community pharmacists in Salford, Trafford and South Manchester.
2,802 trial participants were identified from practice database and invited to become a part of the study by their own general physicians with the drug trial being an experimental combination of three, otherwise, separately used drugs for chronic lung conditions. As a result of the successful phase III-b trial, GSK will be applying for market approval of the drug by the end of 2016.
It is worth noting that GSK is a market leader in respiratory medicine and is currently competing with drugs from its rival brands; AstraZeneca and Novartis AG. With this drug trial, GSK has pioneered the use of three drugs combined together, targeting the disease through three modes of action administered by an inhaler.
The study was collaboration between GSK and Innoviva. Innoviva, Inc. is a bio-pharmaceutical company that ventures with GSK to jointly development drugs. Innoviva, Inc. has partnered with GSK in developing respiratory drugs, Relvar/BreoEllipta and Anoro Ellipta. Innoviva, Inc. also reserves a right to 13% economic gains of GSK in future. However, previously GSK had also partnered with Theravance BioPharma, Inc. for earlier-stage programs.
According to the study, Relvar Ellipta (fluticasone furoate “FF”/vilanterol “VI” or “FF/VI”) administered as a dosage of 100/25mcg achieved better results in comparison to usual care. With Relvar Ellipta, the exacerbation, that is a sudden worsening of cough in a chronic lung condition; was significantly reduced in the trial participants. The usual care drugs included long-acting muscarinic antagonists (LAMA), long-acting beta2-agonists (LABA) and inhaled corticosteroids (ICS) which can be taken as monotherapy, dual or triple combinations.
The lead investigator, Jorgen Vestbo, Professor of Respiratory Medicine, University Hospital South Manchester NHS Foundation Trust and the University of Manchester,, said; “This is an important finding; what we are seeing today is the tip of the iceberg,”
He added that, the Salford Lung Study plays a very important role in understanding the daily basis prescription of COPD. He also said that over the period of coming months, they will be able to monitor the day-to-day effectiveness of the FF/VI drug. Additional factors such as treatment choices for COPD, patient behaviors and co-morbidities will also be monitored with time.
During the investigation, 2,802 patients, subgroups were made who were to receive FF/VI with LAMA, FF/VI without LAMA or usual care with included LAMA, LABA and/or ICS.
The FF/VI drug was administered once daily with the Ellipta inhaler. On the other hand, patients who were taking LAMA in addition to ICS/LABA therapy were taken as triple therapy, as prescribed by their general physician depending on the individual’s condition. These usual care drugs were taken as single or dual long-acting bronchodilator therapies in combination with inhaled corticosteroid.
Patients, who came from broad demographic groups had a mean age of 67 years with almost equal number of male and female participants. A significant improvement in moderate to severe COPD exacerbation was observed in 8.4% of patients.
These patients were monitored for a period of 12 months through normal clinical procedures. Moreover, single electronic medical records (EMR) were maintained carefully maintained for all the participants. Finally, the primary effectiveness of the drug was evaluated through the annual rate of moderate or severe exacerbations of the participants.
Although the drug does by its trademark name, Relvar Ellipta, in the UK, the same drugs is licensed as Breo Ellipta in the US, where it is licensed to be used for COPD including chronic bronchitis and emphysema or both. However, the drug is not recommended for patients of acute bronchospasm.
In Europe, the drug is licensed to be used by adults diagnosed with COPD with a forced expiratory volume (FEV1) of below 70% whose exacerbation showed no improvement after regular bronchodilator therapy.
Although this study has shows promising improvement in patients with COPD, the drug trial also recorded some adverse effects of the drugs. In a six-month long trial, 9% of patients experienced nasopharyngitis (inflammation of nasopharynx and pharynx), 7% of patients underwent upper respiratory tract infections, 7% of patients felt headaches while in 5% of patients, oral candidiasis (fungal infection of mouth) was observed.
in conducting studies to reach the aforementioned results. To conduct these studies, more than 2,000 healthcare professionals were given prior training. Furthermore, the company plans on analyzing the effect of the drug on asthma patients in 2017.
With the approval of this drug, the stocks of GSK lifted 0.73% to 1448.5p and shares in Innoviva also saw a 5.75% rise from US$0.63 to US$11.63.
The study leaders aim to disclose further data and analyses about the drug trials which will provide doctors and patients alike with helpful insights.