Clinical trial offers hope to emphysema sufferers
There was a time when severe emphysema kept Joyce Bragano from circling the office building during walking work breaks with colleagues.
“I couldn’t even walk a quarter of the way around,” the retired FedEx Corp. customer service specialist from Crafton said. “I’d be wheezing, coughing and my leg muscles would cramp up due to lack of oxygen.”
The condition greatly minimized Bragano’s quality of life until two years ago, when she learned about an international study led by the University of Pittsburgh in which doctors placed small metal coils into the lung. The coils, inserted through a scope in the mouth, tighten diseased tissue and open healthy airways, said Dr. Frank Sciurba, director of the UPMC Pulmonary Function and Exercise Physiology Laboratory. Sciurba inserted 20 coils into Bragano’s lungs as part of the clinical trial at UPMC Montefiore in May 2014.
Sciurba said the coils are designed to treat people with severe emphysema, a chronic obstructive pulmonary disease that causes long-term disability and early death. Symptoms include thick and inflamed airways, diseased lung tissue and loss of elasticity in airways and air sacs.
More than 11 million Americans have the disease, according to the American Lung Association, and as many has 24 million people might unknowingly have it.
Now that the study is over, the Food and Drug Administration will determine whether doctors can use the coils for widespread treatment.
Bragano’s breathing improved on a weekly basis, and she is doing things she considered impossible several years ago. Last week, she spent a half-day traversing the Pittsburgh Zoo & PPG Aquarium with her 3-year-old granddaughter, Ava. On Saturday, she spent the day with friends walking around Ross Park Mall and Station Square. She plans to visit Kennywood with two of her grandchildren Friday for school picnics.
“This has been amazing for me, just amazing,” she said. “I am happy that I took this chance. Things were going downhill for me, and I had nothing to lose, all to gain. It came down to life quality.”
Sciurba was the lead author of the three-year study, which involved 315 patients with severe emphysema at 26 sites in the United States and Europe. He presented the findings Sunday and Monday during the American Thoracic Society International Meeting in San Francisco.
The study was published online Sunday in the Journal of the American Medical Association. The company that made the coils, PneumRx Inc. of Mountainview, Calif., sponsored and funded the trial.
Study participants were picked at random to receive standard care — which included optimal inhaler medications and pulmonary rehabilitation — or coil insertion, in which the metal devices were placed in the most severely affected lobe of each lung. Those receiving coils showed modest improvement in walking distance after a year, while the other group declined.
Patients who received coils reported a dramatic improvement in their quality of life and breathing functions.
“I have many patients just looking for a chance to improve,” Sciurba said. “In some cases when symptoms are so severe, the patients are willing to try anything.”
Standard treatment for chronic obstructive pulmonary disease ranges from inhaler medications and oxygen treatments to pulmonary rehabilitation. In severe cases, a lung transplant might be necessary.
Some patients in the study reported pneumonia, inflammation and collapsed lungs. Sciurba said the conditions were short-lived, and investigators learned during the study that some suspected pneumonia cases resulted from X-rays being misread because of the expansion of the coils, which are 4 to 6 inches long when straightened.
Bragano said she did not experience any side effects.
“I don’t know where I’d be without this — probably lugging around a tank of oxygen everywhere I went,” she said.
A PneumRx representative said cost information about the product is not available.
“As a clinician who takes care of a lot of patients with emphysema, I hope I can offer this to patients,” Sciurba said. “I’m encouraged that Joyce says she’s doing so well. That’s wonderful.”
Ben Schmitt is a Tribune-Review staff writer.