New effective treatment for COPD patients

People suffering from chronic obstructive pulmonary disease (COPD) have something to hope for with the availability of first-in-class once-daily dual bronchodilator in the country.

COPD affects 210 million people all over the world. Around half of these COPD sufferers are below 65 years old.

In the country, the disease affects up to one in five Filipinos (or 14 to 20 percent). Of these individuals, 3 percent do not consult a doctor and about half are not aware they have this debilitating disease.

The new product, which Novartis recently launched at the Seda Hotel, Bonifacio Global City, Taguig, relieves symptoms and reduces their sudden worsening in adult patients with COPD.

Valuable role

A guest speaker during recent launch is Dr. Napoleon Apolinario, a COPD patient. Apolinario, who is a former director of the University of the Philippines-Philippine General Hospital, recounted that he read about the launch of the Novartis COPD product, Seebri, in Inquirer Science/Health.

Apolinario acknowledged the role of Seebri in improving his COPD symptoms and enhancing his quality of life. He also recognized the valuable role of media in informing the public about the availability of new, effective treatments for chronic debilitating diseases.

Manufactured by innovative healthcare solutions provider Novartis based in Switzerland, indacaterol/glycopyrronium combines the proven efficacy and safety profiles of two established Novartis treatments: beta2-adrenergic agonist indacaterul and muscarinic antagonist glycopyrronium that are both long-acting.

New treatment option

Novartis Healthcare Philippines president and managing director Dr. Nikolaos Tripodis said: “The launch of indacaterol/glycopyrronium offers an effective new treatment option, including first-line therapy for COPD patients in the Philippines. The dual bronchodilation provided by indacaterol/glycopyrronium is delivered through our patented Breezhaler device, a single-dose dry powder inhaler with low-airflow resistance, making it suitable for patients with different severity of airflow limitation. The Breezhaler device allows patients to hear, feel and see that they have taken the full-dose correctly.”

Dr. Teresita de Guia, chair of the COPD Foundation and the Philippine Foundation for Lung Health, Research and Development Inc., stressed: “Achieving symptomatic control for COPD patients can be a real challenge. Many of my patients tell me that not being able to catch their breath is the most difficult symptom of COPD. The launch of indacaterol/glycopyrronium is welcome news, as COPD patients in the country now have a new treatment option that could help improve their symptoms and give them a better quality of life.”

Around 200 Filipino patients took part in the comprehensive Ignite Phase III clinical trial program of indacaterol + glycopyrronium, the Novartis once-daily dual bronchod ilator for COPD.

One of the largest international trial programs in COPD, Ignite is comprised of 11 studies with over 10,000 patients from 52 counties. It showed that the indacaterol + glycopyrronium significantly improved lung function compared to several current standard treatments. It likewise showed that patients on Navortis dual bronchodilator experienced significant symptomatic improvements in breathlessness, exercise tolerance, rescue medication use and health-related quality of life compared to placebo.

The 11 Ignite studies are Illuminate, Shine, Bright, Enlighten, Spark, Blaze, Arise, Beacon, Radiate, Lantern and Flame. The first eight studies were completed in 2012. They are designed to investigate the efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, shortness of breath and quality of life in patients treated with indacaterol and glycopyrronium.

Two studies involving Filipinos are Shine and Spark. Shine is a multicenter randomized clinical trial conducted in 26 weeks. It showed that the dual bronchodilator was superior in efficacy than the single bronchodilator, with a safety and tolerability profile similar to placebo. Of the total 2,224 patients in this study, 88 were Filipinos.

Spark differs from Shine in two ways—the length of trial and the number of Filipino participants. It lasted for 64 weeks, involving 2,224 patients, 107 of who were Filipinos.

Spark showed that indacaterol + glycopyrronium was more effective in reducing all COPD exacerbations compared to glycopyrronium and tiotropium, a treatment with established efficacy in preventing exacerbations. It also showed that the dual bronchodilator effect of indacaterol + glycopyrronium resulted in substantially improved lung function.

Communication gaps

There exist communication gaps on how physicians provide advice and support to patients, particularly in the way treatment may help control and minimize the physical effects of morning symptoms of COPD. This was one of the conclusions of a survey sponsored by Novartis Pharma AG and published recently in the journal “Current Medical Research and Opinion.” The survey involved 1,134 patients from Brazil, Canada, China, France, Germany, Japan, Spain and the United Kingdom.

“Caused primarily by cigarette smoking, COPD is a progressive life-threatening disease characterized by cough, shortness of breath and coughing up phlegm—all of which can have profound effects on patients’ quality of life,” said Dr. Philip O’Hagan, healthcare consultant at Maidenhead, Berkshire, United Kingdom. According to him, these symptoms can be more severe in the morning and compromise the patients’ ability to perform even simple tasks such as getting up, going up and down the stairs and making the bed, and may be associated with an increased frequency of exacerbations.

Clear directions

Dr. Neils H. Chavannes of the Leiden University Medical Center at Leiden, the Netherlands, said: “Joint international guidelines provide clear directions on the diagnosis and treatment of COPD, including the prevention or, at least, minimization of acute exacerbations and hospitalization. However they provide little guidance to physicians and nurses in their role as ‘educators’ and ‘encouragers’ with respect to improving and maintaining the quality of life of their patients.”

O’Hagan and Chevannes were the lead researchers of the survey.

Dr. Aileen David-Wang, Section of Pulmonary Medicine chief at Manila Doctors Hospital, said: “This important survey is a wake-up call to Filipino physicians and their patients with COPD. Patients and doctors need to work as a team and communicate clearly with each other in order to optimize the management of COPD and improve patients’ quality of life.”