Asthma researchers tap older, cheaper drug

Dr. Charles Irvin suspects that a 50-year-old drug with an expiring patent may prove a cheaper and more effective alternative to some newer, heavily marketed drugs used for asthma.

The drug, theophylline, may have useful anti-inflammatory effects similar to steroids when used at dosages of about one-third those prescribed in the 1950s, said Irvin, director of the American Lung Association’s clinical research center for Maine, New Hampshire and Vermont – the only one in New England. If the thesis proves true, someone paying $100 for a month’s worth of Merck’s well-publicized Singulair could substitute a low dose of theophylline for $20 a month, he estimated.

Irvin said drug company researchers in private will laugh at the notion of paying for a study involving existing drugs that don’t offer the potential of big profits. He had proposed studying theophylline to several pharmaceutical researchers. Now the study, which will have more than 600 participants, is moving forward at the American Lung Association’s 19 research centers.

“As Charlie says, [the center] is really able to focus on research that matters to patients,” said Edward Miller, executive director of the Maine chapter of the American Lung Association.

Irvin said the National Institutes of Health, which also fund pharmaceutical studies, are conducting much more complicated studies related to asthma but none is related to theophylline, he said.

Irvin, who is also a professor at the University of Vermont, was in Augusta on Wednesday to speak with the Maine Asthma Council and a medical advisory group to the American Lung Association. It is estimated that 64,000 Mainers have asthma. Irvin wants to see studies be completed that might not lead to anyone realizing major profits but that might help those with asthma.

Among the projects the research centers are tackling is whether there is a connection between gastrointestinal reflux disease and asthma and whether starting treatments for upper respiratory tract infections earlier would reduce asthma flare-ups.

Another study will look at the placebo effect on asthma sufferers. Even naysayers say if there is a placebo effect, it occurs in patients with asthma and patients in pain, Irvin said. He explained that the placebo effect reached 50 percent in one asthma study.

Irvin was a lead investigator on a study published in the New England Journal of Medicine last fall. Its findings suggest that children and adults with asthma have nothing to fear from flu vaccinations and should get them before flu season.

Irvin first became interested in theophylline’s potential when he was asked more than 10 years ago to conduct a peer review of a study conducted in Iran that had been submitted to a U.S. academic journal for publication.

“The study was flawed, but the efficacy of low-dose theophylline [reflected in the study] was very high,” he said. He thought the portion of the study related to the “dead and dying theophylline” deserved a better look, he recounted.

New work has been done on the subject recently, including an article in the respected British journal The Lancet.

The new publications suggest that theophylline, which comes in a pill, may have the capacity to reduce airway inflammation and clear away mucus in lower dosages.

“I decided there was something to this,” he said.

In the double-blind study, the patient, doctor and research staff won’t know which treatment each participant is getting. Treatments will compare the side effects and effectiveness of theophylline, Singulair and placebo sugar pills.

The research center for Maine, New Hampshire and Vermont has enrolled about 35 participants of whom five are from Maine, he said. Once the enrollment is complete, the study will run for about six months. Results may be complete in about a year, Irvin said.