The U.S. Food and Drug Administration has just announced the approval of a form of new long-term treatment for patients suffering from chronic obstructive pulmonary disease (COPD). The new treatment is an inhaler drug called Breo Ellipta (fluticasone furoate and vilanterol inhalation powder). It is also approved for the treatment of exacerbations in COPD patients.

COPD is a form of lung disease that progressively gets worse, it is characterized by the occurrence of chronic bronchitis or emphysema (a pair of co-existing diseases that narrow the airways). Symptoms include shortness of breath, chronic cough, chest tightness and excessive phlegm. COPD is one of the leading causes of death worldwide. The National Heart, Lung, and Blood Institute reported that it is the third leading cause of death in the U.S.

According to a previous study published in PLoS Med, by 2030 COPD is predicted to become the fourth leading cause of death.

Current and former long-term smokers are at the highest risk of developing COPD. A study published in the journal Thorax revealed that smokers have a 25% chance of developing COPD.

Management strategies of the disease include: quitting smoking (among smokers), vaccination and drug therapies (usually involving the use of inhalers). Two years ago the FDA approved a similar form of treatment to Breo Ellipta called Arcapta Neohaler (indacaterol inhalation powder) for the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with COPD.

According to Curtis Rosebraugh, M.D., M.P.H., director, Office of Drug Evaluation II, Center for Drug Evaluation and Research, FDA:

“COPD is a serious disease that makes breathing difficult. The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD.”

The new inhaler, developed by GlaxoSmithKline, works by reducing inflammation in the lungs as well as relaxing the muscles around the airways, which improves airflow and prevents wheezing and breathlessness.

Breo Ellipta is a combination of two different drugs: fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA).

Researchers evaluated the effectiveness of the inhaler in 7,700 people who were diagnosed with COPD.

The results of the study indicated that, compared to placebo, Breo Ellipta was very effective at improving lung function and reducing exacerbations.

Breo Ellipta is not approved for the treatment of asthma. In fact, as a LABA, the drug’s box label will include a warning that it can increase the risk of asthma-related death. In addition, the medication is not recommended for people under the age of 18 and should not be used as a rescue therapy to treat sudden breathing complications.

Side effects linked to Breo Ellipta therapy include:

Recently, researchers from the Boston University School of Medicine identified a genetic signature for COPD from harvested airway cells. The finding has huge potential for new treatment options and provides a novel way to study the condition. One of the senior authors of the study, Avrum Spira, MD, MSc, Alexander said: “Our data shows that there are consistent gene-expression changes that occur in both airway and lung tissue cells in individuals with COPD.”

She added:

“Part of the COPD ‘signature’ reverses with therapy, suggesting that examining airway cells might be a minimally invasive tool for monitoring the disease and evaluating the response to therapy more quickly in order to determine the best course of treatment for each individual patient.”

Another study, published in the April 2013 issue of The Journal of Nuclear Medicine, revealed that earlier diagnosis of COPD could be achieved using a novel technique known as in vivo ventilation/perfusion (V/Q) imaging.

Written by Joseph Nordqvist