Old Drug Holds New Promise
UVM's Asthma Clinical Research Center will be
the lead site in a national trial to study theophylline,
an inexpensive asthma medication prescribed since
the 1970s but considered by researchers to have
new potential. Called LODO for Effectiveness of
Low Dose Theophylline, the new trial is sponsored
by the 19 American Lung Association (ALA) Asthma
Clinical Research Centers (ACRC) across the country
and seeks to enroll more than 600 people, age
15 and over, who suffer from persistent asthma
symptoms despite treatment. The ALA ACRC at UVM,
headed by Charles Irvin, professor of medicine
and director of the Vermont Lung Center, is the
only ACRC in New England.
When theophylline, a pill-form treatment classified
as a bronchodilator, was developed, clinicians
believed it was necessary to prescribe high doses
in order to open narrow, inflamed airway passages.
"Back then, clinicians followed the strong coffee
model of prescription," Irvin said. "They felt
that, in order to get the maximum effect, they
needed to prescribe the maximum strength." The
medication, which became associated with side
effects and drug interactions, fell out of favor
when newer treatment options became available.
Scientists have decided to give theophylline another
chance. Recent studies in such scientific journals
as The Lancet and the American Journal of Respiratory
Critical Care Medicine suggest that theophylline
may have the capacity to reduce airway inflammation
and clear away mucus in reduced doses one-quarter
to one-third of those needed to open asthmatic
The LODO study seeks to identify whether or not
theophylline can be an effective add-on therapy
that will produce better overall results for asthmatics.
In order to compare the effects and safety of
low doses of theophylline, the study also is looking
at the effects of Montelukast (sold as Singulair),
as well as a placebo, on asthma patients. During
the study, the patient, the investigator and the
staff will not know which treatment each participant
receives. Over the course of six months, study
participants will take one capsule with dinner
each evening. They also will record their peak
expiratory flow daily, measured by how fast they
can blow out.
Then they will take their regular
daily medication, usually an inhaled steroid.
"About a third of all asthma sufferers are unable
to manage their asthma well," Irvin said. Secondary
benefits to this drug, he said, are "the convenience
of a pill versus an inhaler, and the fact that
Theophylline is very inexpensive. The days activities
will include free, two-minute breathing tests;
asthma treatment mini-seminars; "Faces of Asthma,"
a slideshow featuring celebrities with asthma;
access to asthma experts; and educational displays
and literature. Information about the LODO trial:
Mary Lynn, 847-2193.