"When you design a big trial like this, somebody has to be the central data bank," said Drazen. "Hershey was our bank and without them we would have been buried under an avalanche of data."
"Each patient's data must be kept separate," said Drazen. "All of the people involved in the study must remain uninformed of the preliminary results, so as not to bias the collection of the data. And when the huge mound of data is collected, the statisticians must distill out the results very quickly. The DCC at Hershey did an outstanding job. They cleaned up and analyzed the data very quickly."
The study speaks to the concerns of more than 7 million Americans with mild asthma -- and their physicians -- about the safety and effectiveness of inhaled beta-agonists, according to NHLBI director Claude Lenfant, M.D. Patients with only occasional asthma symptoms need not take medication regularly, he said.
"Since more than half of the asthma patients in this country have mild asthma, this study should result in a substantial decrease in the overall cost of asthma care," he added.
According to the NHLBI, asthma affects more than 13 million Americans. The frequency, severity of illness, and death rate from the disease have been increasing steadily for more than a decade. Asthma also is a major cause of lost wages and school absenteeism, resulting in estimated annual health care costs of more than $4.6 billion.
Prior to 1990 most asthma experts believed that prescribing beta-agonists
on a regularly scheduled basis improved overall control of asthma symptoms.
Several studies since then have suggested that regular beta-agonist use
might induce tolerance or even adverse effects, leading to diminished control
of asthma in some patients, and some hypothesized that this could account
for the increasing asthma severity, hospitalization and de
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Contact: Gail Brown
gxg14@psu.edu
717-531-8604
Penn State
24-Sep-1996