New drug gives longer-lasting relief to emphysema sufferers
Clinical Research Coordinator Elizabeth Milan (left) test patient Judy Parsley at the ASAP clinic. (Photo by Donna Jones Bailey).
A clinical trial under way at Vanderbilt University Medical Center's Asthma, Sinus, and Allergy Program (ASAP) aims to ease the suffering of people with emphysema.
The trial is testing a new inhaled drug, formoterol fumarate, which is designed to be effective for 12 hours with fewer side effects than existing emphysema medications.
Emphysema, also called Chronic Obstructive Pulmonary Disease (COPD), strikes about 15 million Americans every year and is one of the most difficult diseases to treat with medications, said Dr. John J. Murray, associate professor of Medicine and chief operating officer of ASAP.
"One common myth about emphysema is that it is an end-stage disease that no one recovers from. Even though there is permanent damage to the lung tissue, about 40 percent of people improve somewhat after we start them on this medication."
To qualify for the trial patients must be between the ages of 40 and 60, have COPD, have smoked for at least ten years, but may not be dependent on oxygen.
Once a patient has qualified, they are randomized to receive formoterol fumarate, the standard drug therapy of theophylline, or placebo tablets.
"The patients who are admitted in the study will come in for six scheduled visits in a 12-month period," said Elizabeth A. Millan, clinical research coordinator.
Participants in the study are eligible for a $600 stipend upon completion of the year-long trial.
"Our hope is that these patients will not only improve therapeutically, but that the method of dosing will also become easier to manage," said Millan.
Unlike the current standard medications requiring patients to use an inhaler every four hours, formoterol fumarate lasts for 12 hours, allowing patients to sleep and pursue other tasks without interruption, an option that was unavailable with most other emphysema medications.
Formoterol fumarate works by stimulating receptor sites on the lining of the lungs. Once stimulated, the asthma-like symptoms of emphysema patients are calmed.
Formoterol fumarate is more biologically active then previous medicines that aimed to stimulate the same site, making it effective for a much longer period of time, Murray said.
To assess the impact of airway obstruction, patients are given a pulmonary function test to measure their lung capacity. This test, given periodically throughout the clinical trial, will provide an accurate evaluation as to the effectiveness of the study medication.
"We typically observe an improvement in pulmonary function fairly quickly after the patient begins taking the new medication," said Millan.
Anyone interested in participating in the study may contact Elizabeth Millan at 936-5764.