This week, findings from an important study in the field of Cystic Fibrosis (CF) research showed that AffloVest, a second generation air bladder vest, manufactured by International Biophysics Corporation, headquartered in Austin, Texas, improved lung function in a sample of adolescent patients. The study, entitled, “An evidence-based study of adolescents with cystic fibrosis demonstrated that AffloVest by International Biophysics contributed to improved lung function scores,” was independently conducted by Michael Cooper, a respiratory therapist specializing in pediatric respiratory diseases.
- Forced expiratory volume (FEV): measures how much air a person can exhale during a forced breath. The amount of air exhaled may be measured during the first (FEV1), second (FEV2), and/or third seconds (FEV3) of the forced breath.
- Forced vital capacity (FVC): is the total amount of air exhaled during the FEV test.
- Air bladder: is a chest compression apparatus that aids in loosening and eliminating mucus from the lungs of a CF patient. The apparatus includes a mechanism for applying pressurized air to a bladder vest covering the chest of a person.
About Cystic Fibrosis:
CF is a chronically progressive life-threatening disease caused by a genetic mutation that disrupts the body’s ability to hydrate and effectively clear mucus in the lungs and/or digestive tract. The genetic mutation that causes CF affects the normal functioning of the lungs and digestive system by creating abnormal amounts of very sticky mucus that covers the lungs, pancreas, and other important organs of the respiratory and digestive systems. This sticky mucus attracts foreign pathogens, such as viruses and bacteria, making patients more susceptible to infectious diseases (i.e. pneumonia). The high microbial burden causes inflammation of the lung tissue and a high likelihood of tissue destruction due to the frequency of infections. Decreasing the amount of mucus build-up in CF patients is an important component of the clinical management of the disease.
About This Study:
In this study, Mr. Cooper documented both the lung function values and device compliance in 5 of his adolescent patients using the AffloVest over a 3-5 month period. These values were compared with those prior to using the AffloVest device in each patient. The results showed improvement in both lung function and device compliance for each patient studied.
In a company press-release, Mr. Cooper explained the importance of his findings. “When I saw something good, I started gathering data and that lead to my clinical study. I saw my patient’s numbers improving, and I believed we had something that could help my patients live longer, better lives. 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. In addition, I also noted positive changes on the FVC, FVC to FEV1 ratio.”
Mr. Cooper continued, “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. Compliance can be tough, especially with adolescents and college-aged patients. With the freedom and mobility the AffloVest provided, I knew my patients were doing their treatments. The improved numbers confirmed what they were telling me.”
In a company response, David Shockley, CEO of International Biophysics Corporation, stated, “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. 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.”