Unusual device may aid cystic fibrosis patients

UPDATE: The story below was written in October 2011. At the time it was written, it was correct to the best of our knowledge.

Since the original article was published, several things have changed.

The Vibralung® was approved by the U.S. Food and Drug Administration for use in humans in May 2014.

The approved device is simple to use, light weight, portable, requires no effort other than to breathe in and out and is more affordable than the alternatives. It will be for sale to the public beginning in September 2014.

An article about how Westmed Inc. was cleared to market the device appeared in the Aug. 29, 2014 issue of the Phoenix Business Journal.

For information about how to purchase a Vibralung®, contact Westmed president Jon McKinnon.


Pharmacy students Courtney Wheatley and Steve Karpen (back) help cystic fibrosis patient Mindy Siler test the VibraLung®.

What do cystic fibrosis patients and racehorses have in common? They both need to have optimal lung function.

“Many racehorse owners clear congestion from their animals’ lungs before a race,” says Eric Snyder, assistant professor in the Department of Pharmacy Practice and Science. “Clearing mucus from a horse’s lungs allows the horse to better transfer oxygen from its lungs into its blood so it can perform better during a race. Cystic fibrosis patients need to clear mucus from their lungs just to live and maintain a high quality of life.”

Clearing the lungs is critical
The sad fact of life for the approximately 30,000 Americans who suffer from cystic fibrosis (CF) is that they must get their chests pounded at least twice a day.

Chest pounding, also known as chest percussion, loosens the thick mucus that forms in the lungs of CF patients, allowing them to cough or sneeze up mucus and consequently breathe more easily. Chest pounding is a primary therapy for treating the disease.

To achieve chest percussion, CF patients today have two main choices: they can have a respiratory therapist perform the chest-pounding or they can purchase a CF “vest.” The vest, once the patient puts it on, uses air waves to shake the whole upper body, helping to loosen mucus in the lungs.

Although the vest can be used in a patient’s home (which allows the patient to avoid a trip to the respiratory therapist), the device is large, making it unwieldy for travel, and it can be expensive. That’s where racehorse know-how comes in.

To clear mucus from the lungs of a racehorse (and other animals with lung congestion and airway diseases), some owners use a device called the Vibralung®, also known as VibraVM®. It fits over one of the horse’s nostrils (the other nostril is taped shut), and blasts sound waves into the horse’s lungs to break up mucus. The horse sneezes to eject the mucus, clearing its lungs. VibraLung is available locally through Westmed, Inc.

From humans to horses – and back again
“About two years ago, Westmed’s president, Jon McKinnon, and the inventors of the VibraVM came up with the idea that perhaps the Vibralung could help a large population of people who had lung disease,” says Snyder. “Jon contacted Wayne Morgan, professor of pediatrics in the UA College of Medicine, and asked if he’d study the VibraLung. It had never been scientifically tested in humans before. Of course, Dr. Morgan said ‘yes.’ He brought me into the study because our lab has very sensitive equipment that can assess both the safety and effectiveness of a lung device in humans.”

Vibralung reached Snyder’s lab via a circuitous route. The product evolved from a device invented years ago by Art Hughes, the owner of Vibralung, to treat his first wife, Linda, who had been deemed terminally ill with bronchiectasis and given a month to live. Art and Linda were both musicians and Art was a self-taught engineer, so together they came up with the idea of using sound waves to break up the congestion in Linda’s lungs.

The prototype worked so well, Linda’s doctor saw in improvement in her condition within three weeks and seven months later, she was off oxygen. Linda lived an additional six and a half years, finally passing away from cancer.

After Art remarried, his new wife, Lucille, had a brother-in-law who was a large animal veterinarian. He saw the Vibralung in 2005 and thought it might help horses with heaves (COPD or RAO). They successfully treated the first horse in August 2005 and started selling the product in the equine market in 2006. Vibralung went on to become an aid to racehorse owners.

COP is conducting the first scientific study of Vibralung on humans
Collaborating with Snyder and Morgan on the first clinical study of Vibralung in humans are Mark Brown and Cori Daines, both of the College of Medicine; Hanna Phan of the College of Pharmacy; and Courtney Wheatley, PhD student in the pharmaceutical sciences clinical research graduate track at COP. Wheatley is coordinating the study, which includes scheduling other pharmacy students to help with the testing.

According to Snyder, in addition to the named collaborators, the hospital staff – from respiratory therapists to nurses – has been very supportive, which is a necessity in a clinical study performed in a hospital.

“The team completed Phase I of the research last year,” says Snyder, who is principal investigator on the study. “In humans, we put the Vibralung over the patient’s mouth and plug his or her nose. To test the safety of this process, we did every cardiovascular and lung function measurement possible in our laboratory to see if any damage was being done. We tested 10 patients who had at least 75 percent lung function and found no evidence of damage.

"So now the device is in Phase II trials, with sicker patients. We will test 30 patients who have been admitted to the hospital anyway due to CF symptoms. While they’re there, if they’re willing, we test the VibraLung on them. We are comparing outcomes of using the Vibralung directly to results achieved with a CF vest.”

See the Vibralung and the vest in action
Click on the “play” button below to see Paul Wojcik, pharmacy student, explain and demonstrate the Vibralung.


To see a demonstration of the percussive vest, click this link to a YouTube video of "the vest."

Study design and potential outcomes
Each patient in the Vibralung Phase II study will be tested for 12 days. Ten patients will use the vest for the first six days, and the Vibralung for the second six days. A second group of 10 patients will use the Vibralung for the first six days, then switch to the vest for the second six days. A third group of 10 patients will use only the vest for 12 days. For safety purposes, the patients testing the Vibralung will use the new therapy twice a day and the vest twice a day, to make sure their lungs stay as healthy as possible.

“Even if the Vibralung proves to be only as good as the vest, it would be a big deal,” says Snyder. “The Vibralung is much cheaper – only about $1,000 – and much smaller – only about the size of a football. The vest, because it requires an air compressor, is quite a bit larger. The Vibralung is much more portable.”

Mindy Siler, a CF patient who has participated in many of Snyder’s studies, volunteered to test the Vibralung.

“I couldn’t tell a lot of difference between the Vibralung and the vest,” says Siler. “But I was more than willing to test it. Anything I can do to potentially help CF patients, I’m there.”

Snyder expects the study, which was funded with $113,000 for one year by WestMed, to be finished in early 2012.

“We are hopeful that the outcomes achieved with the Vibralung will compare favorably to the results of using the vest, but we will not know for sure for several more months.” says Snyder. “That would make the Vibralung valuable not only to CF patients, but possibly to people with other lung diseases, too.”
 

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