Clinical Study Reveals that AffloVest for CF, Bronchiectasis Improves Lung Function in Cystic Fibrosis Adolescent Patients

Clinical Study Reveals that AffloVest for CF, Bronchiectasis Improves Lung Function in Cystic Fibrosis Adolescent Patients

A new clinical study recently revealed that the AffloVest can improve lung function in adolescent patients with cystic fibrosis. The study was conducted by Michael Cooper, RT, from Chicago and is entitled “An evidence-based study of adolescents with cystic fibrosis demonstrated that AffloVest® by International Biophysics contributed to improved lung function scores”.

CF is a life-threatening genetic disease in which a defective gene causes the body to form unusually thick, sticky mucus that can result in serious respiratory and gastrointestinal manifestations. This thick, difficult to clear mucus can accumulate in the lungs creating an environment prone to severe bacterial infections, with the majority of the patients dying due to respiratory failure.

Maintaining proper airway function is essential not only for patients with CF but also with other respiratory disorders such as bronchiectasis, a respiratory condition characterized by airway chronic inflammation, dilatation and scarring, and also mucus accumulation that can lead to severe lung infections. International Biophysics Corporation developed the AffloVest, the first truly portable high frequency chest wall oscillation (HFCWO) vest designed for patients with respiratory conditions, to address the medical needs of people with bronchiectasis, CF, and other airway-related diseases. AffloVest technology is based on mechanical wave technology using eight individual oscillating motors inside the vest to effectively disrupt and mobilize mucus in the lungs. AffloVest was introduced in the United States in late 2013.

AffloVest caught the attention of Dr. Cooper, a clinician who is committed to improving long-term care management and quality of life for patients with chronic respiratory disorders such as CF and bronchiectasis. “When I see something good, I start gathering data and that lead to my clinical study,” said Cooper in a news release.

afflovestIn the study, Cooper assessed the overall lung function of five adolescent patients with CF aged between 14 and 18 years using the forced expiratory test (FEV1, the forced expiratory volume in 1 second), prior and after AffloVest use for 3 to 5 months in comparison to older air bladder technology HFCWO devices. He found that patients using AffloVest exhibited an improvement in lung function higher than 10% in comparison to when they used air bladder technology.

“With the AffloVest, I saw an overall 11.5% increase, with one patient achieving an 18.8% increase. I felt that I had uncovered a true clinical discovery,” said Cooper. “Many devices and variables can improve lung function scores, but they are usually less than 10%, which is considered suboptimal. But when you see 11.5% improvements, I knew we had something important here.”

In addition, the fact that AffloVest is quiet, completely portable, self-contained and battery operated offers patients freedom and mobility without compromising effectiveness, which leads to better treatment compliance, especially among teenagers. “These teens were wearing AffloVest while playing basketball and dancing, something I had never seen before,” noted Cooper.

“We are pleased to see these enhanced lung function scores in Mr. Cooper’s CF patients. When he contacted us about his clinical study, we didn’t even know that he had done this study. However, the results reinforced the positive feedback we had received from other patients and clinicians over the last year,” concluded the CEO of International Biophysics Corporation, David Shockley. “It is so rare now to see a clinical study being done without corporate funding or direction. Mr. Cooper is a true investigating clinician who deeply cares about his patient’s well-being. He told me he wants the very best for “his kids” as he refers to them. It is so gratifying to see how the AffloVest is truly impacting these lives.”

3 comments

  1. D'Aun says:

    Actually, this article does NOT show that AffloVest improves lung function. Notice how there are no p-values, no control group, and that they only show you the data from 12 of the 25 patients in the (very small) sample group. In addition, these are adolescents, and they are measuring the volumes as total amount, not compared to their predicted values which change with age. When it does use the predicted values, there is only one value, not 2. When you grow older and/or taller (as the adolescents in this study are very likely to have done, especially since the tests were done 8 months apart for some patients), your lung volumes increase. If they had a control group, this would have shown that. The author purposely left out important data that would have shown the reader that AffloVest makes no significant difference in a patient’s lung function compared to any other therapy.

    Now, I actually like AffloVest. It’s one of my favorite HFCWO devices! I am just extremely disturbed that someone allowed a paper this ethically and scientifically flawed to be published anywhere.

  2. Patricia Silva, PhD says:

    Hello D’Aun, in this particular study, Dr. Cooper only assessed the use of the AffloVest in 5 adolescents (between 14 and 18 years) during a period of 3-5 months. The study is not a clinical trial, and the results are based on Dr. Cooper’s observations when clinically assessing the 5 adolescents regarding any potential improvement in lung function.
    The following information is written on the original article: “The data described in this paper were collected independently by the clinician author and not at the direction of International Biophysics Corporation (IBC). All patients independently obtained an Afflovest by prescription from their physicians via their own insurance or private pay for their own personal use. Results were documented during routine clinical visits.”

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