SAN DIEGO — An oral extract of the speedwell (also known as veronica) plant appeared to reduce some symptoms of chronic obstructive pulmonary disease (COPD), researchers reported here.
The peak expiratory flow increased in patients on YPL-001 by about 10%, while the increase in the placebo patients was less than 3%, according to Nathaniel Marchetti, DO, of the Lewis Katz School of Medicine at Temple University in Philadelphia, and colleagues.
“YPL-001 is an oral formulation of an extract from the aerial part of the plant speedwell used in traditional Asian medicine to treat respiratory inflammatory diseases including … COPD,” they explained in a presentation at the American Thoracic Society (ATS) annual meeting.
The phase IIa study was initiated to determine the safety and tolerability of YPL-001, so the trend toward efficacy was encouraging, Marchetti said.
“We found that the treatment with the drug was very well tolerated,” he noted. “There were very few side effects other than those commonly seen among COPD patients including exacerbations.”
“This is a medication, a herbal product, that has been used for millennia in Asia to treat inflammatory respiratory diseases,” he added. “What Yungjin Pharm of Korea is trying to do is to take this herbal, and make it more standardized, so that everyone gets the same dose, and also to figure how not only whether it works, but how it works, so we can use it to treat people in a more systematic way.”
Speedwell/Veronica is commonly found in the U.S. as well. Plants are sold in garden shops and are also a frequent lawn weed problem.
The researchers enrolled 60 patients diagnosed with COPD who were assigned to 80 mg or 160 mg of YPL-001 or placebo, twice daily for 8 weeks. They underwent bronchoscopy and were sent home with a device that allowed them to record daily symptoms, Marchetti said.
During the study, patients received a daily inhaled dose of tiotropium (18 μg) and inhaled albuterol as needed. Following a 2-week run-in period, eligible patients were randomized to receive either 80 mg YPL-001, 160 mg YPL-001, or matching placebo.
Safety assessments included physical examinations, vital signs, pulse oximetry, electrocardiograms, laboratory tests, and adverse events. Assessment of respiratory symptoms was performed daily through patient self-report of peak expiratory flow, major and minor symptoms of COPD exacerbation, dyspnea, and activity using an electronic diary.
The incidence of adverse events occurred more often among the placebo patients, with 70% reporting adverse events versus those who took YPL-001. About half the patients on the novel agent reported some adverse events on the low-dose YPL-001, and 38% of patients on the high dose of YPL-001 reported adverse events, usually COPD-associated cough, Marchetti said.
Linda Nici, MD, of the University of Texas Health Science Center in San Antonio, expressed caution about the se of the herbal agents.
“We have had a whole host of historical case of bad outcomes with some herbal agents,” noted Nici, who was not involved in the study.
But these patients are very challenging, and I would not discount any therapy,” she stressed to MedPage Today. “We use a lot of supplemental medicine in the palliative care world for patients who are on maximal pharmaceutical agents to make these patients feel better. I would think that this drug could be a substitute for standard care, if you can achieve an improvement in quality of life.”
ATS session moderator Antonio Anzueta, MD, also of the San Antonio institution, pointed out that the study was “early,” with a “low numbers of patients. We certainly need additional studies before we can determine how this drug may be used in the clinic.”
Credit:Â medpagetoday.com
