GlaxoSmithKline and Theravance, Inc. announced yesterday that the US Food and Drug Administration (FDA) has approved the BREO™ ELLIPTA™ as once-daily maintenance treatment for COPD, including chronic bronchitis and emphysema. It's also supposed to help reduce COPD exacerbations in patients who are prone to them.
The BREO ELLIPTA is a combination of fluticasone furoate (FF), an inhaled corticosteroid and vilanterol (VI), a long-acting beta2 agonist (LABA).
"This approval means that we can now realize our plan to bring BREO ELLIPTA to appropriate COPD patients in the US. We know that one of the main issues for patients who have experienced a COPD exacerbation is about possible future episodes. BREO ELLIPTA will help patients breathe better day-to-day and reduce the risk of future exacerbations, with a once-daily inhalation."
The BREO ELLIPTA will market as Relvar outside the US and is reportedly seen, at least initially, as a complimentary product to GSK's top-selling Advair. There is some indication that it may eventually replace Advair. BREO ELLIPTA should be available by prescription in the US during the third quarter of 2013.
COPD is often not recognized until later in the course of the disease, which ultimately delays treatment. Early diagnosis is important because delaying treatment can have a negative impact on your prognosis. A new study tells us that if we ask questions during the screening process about prior respiratory events, we may be able to identify COPD in its earlier stages, leading to earlier treatment and better patient outcomes.
The study, conducted by the Mayo Clinic in Scottsdale, Arizona, looked at the medical records of 702 patients. Of these, 356 were women with a mean age of 67.5 years, and 346 were men with a mean age of 66.6. Each patient had an initial diagnosis of COPD during the study period.
The following summarizes the results:
- Respiratory events that were identified as probabe COPD exacerbations were common in the 2 years prior to a COPD diagnosis with a range of 0 to 16 events per individual patient.
- Pre-diagnostic respiratory events were predictive of similar events in the period following the diagnosis.
What this means is that there are a lot of people experiencing COPD exacerbations who are unaware that they have COPD. If you, or someone you know, has a history of smoking or exposure to other types of airway irritants, and you are experiencing frequent respiratory infections, talk to your doctor about getting a spirometry test.
Yawn B.P., Wollan P., Rank M. Exacerbations in the pre- and post- COPD diagnosis period. Published Date May 2013 Volume 2013:4 Pages 1 - 6. DOI: http://dx.doi.org/10.2147/POR.S41778.
Medical oxygen is covered by Medicare for patients who meet very specific qualifications. Breathlessness alone, is not one of them. If Medicare has denied payment for your home or portable oxygen treatment, take a look at the following to make sure you meet the criteria:
If you use supplemental oxygen, how compliant are you with your treatment? If you say not very, you're not alone. Studies suggest that many people who are prescribed oxygen therapy don't use it like they're supposed to. But, what if you could view oxygen as a friend, rather than a foe? Wouldn't that help you recognize how important it is to your health and well being?
To learn more about oxygen therapy and how it benefits you, read:
I received an email from a reader with COPD asking the following question about his experience with a collapsed lung:
I am a 56 year old Asian American from Hawaii. I was diagnosed with COPD back in 2011 and have since been on oxygen therapy 24/7, although I don't use it on a 24-hour basis. Back in 2010, I suffered a collapsed lung, got a chest tube and was sent home. All was well, but in December 2010 I had another collapsed lung and this time I got the chest tube and also received surgery to put a talc on my chest wall to prevent a collapsed lung again. At one point I had three chest tubes in my side at one time for a few days. It all cleared but this time I was sent home with having to use oxygen therapy. I still don't know why this happened. Any information or comments from you will be greatly appreciated.
A collapsed lung in COPD is often the result of having a pneumothorax, a common complication of COPD. A pneumothorax occurs when a hole develops in the lung that causes an accumulation of air or gas in the space between the lung and the chest wall. People with COPD are at greater risk for pneumothorax because their lung structure is weak making it more vulnerable to the development of these holes.
I hope this answers the question posed by the reader. For more information about pneumothorax, including causes, treatment and prevention, read:
Research tells us that one in five COPD patients, in the severe or very severe stages of the disease who are hospitalized for acute exacerbation, get readmitted to the hospital within 30 days of discharge due to poor home management. According to ResMed, a leading product development company that specializes in products designed for people with sleep and respiratory disorders, these re-admissions could be avoided with proper in-home treatment.
In a press release last week, ResMed announced government clearance of their variable positive airway pressure (VPAP) device for the in-home treatment of COPD and other types of respiratory disorders. ResMed believes the device will help keep patients suffering from the more severe stages of the disease out of the hospital.
The device will be sold in the United States and, because it's been cleared by the FDA, the treatment will be more accessible to homebound patients through Medicare's Respiratory Assist Device qualifying guidelines.
According to ResMed:
The ResMed VPAP COPD is used at night, which helps ensure that COPD patients maintain their ventilation when they are most vulnerable. It customizes the breath delivered to the patient with a rapid inhalation phase and allows an extended exhalation. This can help overcome air trapping that is common in COPD patients, enabling better gas exchange in their lungs.
Built on the popular ResMed S9™ Series platform, the VPAP COPD device is compact and easy for a patient to integrate into a sleep setting. Combined with the companion H5i™ heated humidification device, the VPAP COPD creates a comfortable patient experience, increasing the likelihood of patients continuing their therapy.
For more information about this device, visit www.resmed.com.
An FDA advisory panel recommended approval last Wednesday of BREO ELLIPTA, a once daily maintenance medication for the treatment of COPD.
BREO ELLIPTA is the proposed name for FF/VI 100/25 mcg, a drug combo containing fluticasone furoate (FF), an inhaled corticosteroid and vilanterol (VI), a long-acting beta agonist. The recommendation is a critical first step in getting FDA approval for the drug.
The use of BREO, administered by the ELLIPTA inhaler, is being proposed in the United States and the European Union for long-term, once daily maintenance treatment of airflow obstruction in patients with emphysema and chronic bronchitis and also to reduce exacerbations in patients who have a history of them. In the European Union, the drug is also being considered for the treatment of asthma. A final decision from the FDA is expected to be released later this year.
Studies suggest that COPD and heart failure frequently co-exist. Is this because having one places you at greater risk for the other? Or, is it simply because they share a common risk factor?
Discover why heart failure is so prevalent in COPD and learn how to recognize signs and symptoms of heart disease so you can report them sooner to your doctor.
The COPD Foundation has posted an action alert on their website urging all interested parties to contact members of Congress to tell them to increase funding for COPD research. This request comes after startling results were released from the Behavioral Risk Factor Surveillance System (BRFSS) data which highlights, most importantly, the critical need to address the many challenges and hardships faced by the COPD community.
Let's rally together so that Congress hears our message loud and clear, that COPD is an urgent public health concern and needs to be addressed aggressively. Join me today in sending an urgent email or printed letter to members of Congress by following the link below:
Have you ever wondered how you can have shortness of breath, yet a completely normal pulse oximetry reading? If so, you're not alone; in COPD, this is not uncommon. Find out the answer to this frequently asked question by reading the following: