emphysema prevention :: Article CreatorCOPD Stages And The GOLD Criteria
SOURCES:
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How A New Emphysema Device Won FDA Approval In Six Months
FDA has approved a new device intended to treat breathing difficulty associated with severe emphysema. The approval comes just two weeks after an FDA advisory panel shot down a competing technology targeting the same patient population.
The agency approved Pulmonx Inc.'s Zephyr endobronchial valve through the breakthrough device designation, a pathway reserved for devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. Devices also must meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives, or the availability of the device is in the best interest of patients.
"I can really only sing the praises of FDA in this case," Beran Rose, vice president of marketing and business development at Pulmonx, told MD+DI.
Not only did the agency grant the company a breakthrough device designation for the Zephyr, but the product was approved in less than six months, Rose said. One of the advantages of qualifying for the breakthrough device designation is that FDA provides intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency's review of the product.
FDA also did not require an advisory panel prior to making its decision. BTG wasn't so lucky. In June, an FDA advisory panel voted against BTG's Elevair endobronchial coil system for the treatment of people with severe emphysema. The panel determined that the Elevair system is safe, but raised concerns about its effectiveness and whether or not the benefits of the system outweigh the risks.
That's not to say that the agency wasn't as thorough with its review of the Zephyr valve.
"FDA asked a lot of hard questions and I think we had a really well-executed series of studies, not just one but multiple clinical trials, and we were able to quickly answer whatever questions FDA had," Rose said. "This wasn't just the phenomenon of one trial."
It probably didn't hurt that the device is also already included in most of the major international treatment recommendations for chronic obstructive lung disease (COPD), which emphysema falls under the umbrella of, Rose said.
"Treatment options are limited for people with emphysema who have severe symptoms that have not improved from taking medicines. These have included lung surgery, such as lung volume reduction or lung transplants, which may not be suitable or appropriate for all patients," said Tina Kiang, PhD, acting director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices, in FDA's Center for Devices and Radiological Health. "This novel device is a less invasive treatment that expands the options available to patients."
The Centers for Disease Control and Prevention estimates that 3.5 million American adults have been diagnosed with emphysema, which is a type of COPD, due to damage to the air sacs (alveoli) in the lungs. Lung damage from emphysema is irreversible. The damaged alveoli can cause used air to become trapped in the lungs during exhalation, which can cause the diseased parts of the lung to get larger and put pressure on the healthy part of the lung, making it difficult to breathe.
"People think of it as a problem of not being able to breathe enough air in, but really it's a problem of not being able to breathe enough air out," Rose said.
Lungs are similar to balloons, he explained, in that when you blow air into a balloon the pressure builds inside of it and naturally wants to push the air back out. In a person with healthy lungs, when we breathe air in our lungs open and draw in that air. In people who suffer from COPD or emphysema, their lungs have lost that natural elastic quality so it is more like breathing air into a paper bag.
How the Zephyr Valve Works
During a bronchoscopic procedure requiring no cutting or incisions, Zephyr Valves are placed in the airways to occlude a diseased part of the lungs and reduce hyperinflation. This helps the healthier parts of the lungs to expand and lifts pressure off the diaphragm, thereby decreasing shortness of breath and making breathing easier.
FDA reviewed data from a multi-center study of 190 patients with severe emphysema. In the study, which MD+DI wrote about in May, 128 patients were treated with Zephyr Valves and medical management according to current clinical guidelines, including medications (bronchodilators, corticosteroids, antibiotics or anti-inflammatory maintenance medications) and pulmonary rehabilitation, while 62 patients received medical management only. Results of treatment were measured by how many patients in each arm of the study had at least a 15% improvement in pulmonary function scores (the volume of air that can forcibly be blown out in one second after full inhalation). At one year, 47.7% of patients treated with Zephyr Valves experienced at least a 15% improvement in their pulmonary function scores, compared with 16.8% of patients in the control group. Adverse events observed in the study include death, air leak (pneumothorax), pneumonia, worsening of emphysema, coughing up blood, shortness of breath, and chest pain.
Patient selection is key to the success of the procedure, and Pulmonx also has a diagnostic test called the Chartis Pulmonary Assessment System that is designed to help doctors assess whether or not the Zephyr technology will be effective for a given patient.
COPD And Allergies: Avoiding Pollutants And Allergens
This article originally appeared on Healthline.Com. It was medically reviewed by the University Of Illinois.
Overview
Chronic obstructive pulmonary disease (COPD) is a progressive lung disease that makes it hard to breathe. If you have COPD, it's important to take steps to avoid triggers that can make your symptoms worse. For example, smoke, chemical fumes, air pollution, high ozone levels, and cold air temperatures may aggravate your symptoms.
Some people with COPD also have asthma or environmental allergies. Common allergens, such as pollen and dust mites, might also make your COPD worse.
What's the link between COPD, asthma, and allergens?
In asthma, your airways are chronically inflamed. During an acute asthma attack they swell even more and produce thick mucus. This can block your airways, making it difficult to breathe. Common asthma triggers include environmental allergens, such as dust mites and animal dander.
The symptoms of asthma and COPD are sometimes hard to tell apart. Both conditions cause chronic inflammation of your airways and interfere with your ability to breathe. Some people have asthma-COPD overlap syndrome (ACOS) — a term used to describe people who have traits of both diseases.
How many people with COPD have ACOS? Estimates range from about 12 to 55 percent, report researchers in Respiratory Medicine. According to scientists in the International Journal of Tuberculosis and Lung Disease, you may be more likely to be hospitalized if you have ACOS rather than COPD alone. That isn't surprising, when you consider the ways that both diseases affect your airways. Asthma attacks are particularly dangerous when your lungs are already compromised with COPD.
How can you avoid common indoor allergens?
If you have COPD, try to limit your exposure to indoor air pollution and irritants, including smoke and aerosol sprays. You may also need to avoid common airborne allergens, especially if you've been diagnosed with asthma, environmental allergies, or ACOS. It can be hard to avoid airborne allergens entirely, but you can take steps to reduce your exposure.
Pollen
If your breathing problems become worse during certain times of year, you might be reacting to pollen from seasonal plants. If you suspect pollen is triggering your symptoms, check your local weather network for pollen forecasts. When pollen counts are high:
limit your time outdoors keep the windows closed in your car and home use an air conditioner with a HEPA filter Dust mites
Dust mites are another common allergy, asthma, and COPD trigger. To limit dust in your home:
replace carpets with tile or wood floors regularly wash all your bedding and area rugs vacuum your home on a regular basis using a vacuum cleaner with a HEPA filter install HEPA filters in your heating and cooling systems and replace them regularly Wear an N-95 particle mask while you're vacuuming or dusting. Even better, leave those tasks to someone who doesn't have allergies, asthma, or COPD.
Pet Dander
Microscopic bits of skin and hair make up animal dander, a common allergen. If you suspect your pet is contributing to your breathing problems, consider finding them another loving home. Otherwise, bathe them regularly, keep them away from your bedroom, and vacuum your home frequently.
Mold
Mold is another common cause of allergic reactions and asthma attacks. Even if you're not allergic to it, inhaling mold can lead to a fungal infection in your lungs. The risk of infection is higher among people with COPD, warns the Centers for Disease Control and Prevention.
Mold thrives in moist environments. Regularly examine your home for signs of mold, especially near faucets, showerheads, pipes, and roofs. Keep your indoor humidity levels at 40 to 60 percent using air conditioners, dehumidifiers, and fans. If you find mold, don't clean it up yourself. Hire a professional or ask someone else to clean the affected area.
Chemical fumes
Many household cleaners produce potent fumes that can aggravate your airways. Bleach, bathroom cleaners, oven cleaners, and spray polish are common culprits. Avoid using products like these indoors in areas without proper ventilation. Even better, use vinegar, baking soda, and mild solutions of soap and water to meet your cleaning needs.
Chemical fumes from dry cleaning can also be irritating. Remove the plastic from dry-cleaned garments and air them out thoroughly before you store or wear them.
Scented hygiene products
Even mild fragrances can be bothersome for some people with allergies, asthma, or COPD, especially in closed environments. Avoid using scented soaps, shampoos, perfumes, and other hygiene products. Ditch scented candles and air fresheners too.
The takeaway
When you have COPD, avoiding your triggers is key to managing your symptoms, improving your quality of life, and lowering your risk of complications. Take steps to limit your exposure to pollutants, irritants, and allergens, such as:
smoke pollen dust mites animal dander chemical fumes scented products If your doctor suspects you have asthma or allergies in addition to COPD, they may order lung function tests, blood tests, skin prick tests, or other allergy testing. If you're diagnosed with asthma or environmental allergies, take your medications as prescribed and follow your recommended management plan.
This article was reposted with permission from Healthline Media for informational purposes only. The Weather Company and Healthline Media do not provide medical advice, diagnosis, or treatment. See additional information.
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