Magazine article Drug Topics

Drug Study Is a Walk in the Park for Allergy Sufferers

Magazine article Drug Topics

Drug Study Is a Walk in the Park for Allergy Sufferers

Article excerpt

Well over 100 people were invited to the big bash at Iowa City Park. Two full days of food and frolic awaited those with the credentials to get in. Of course, the event was held at the height of the season--the hay fever season, that is.

The hosts, researchers at the University of Iowa, were studying an oral investigational agent called Accolate (ICI 204,219, Zeneca Pharmaceuticals Group) in the treatment of ragweed allergic rhinitis. The guests, all highly sensitive to ragweed, were participating in a double blind, randomized clinical trial,

"We know when the peak ragweed season is around here," Thomas Casale, director of the division of allergy and immunology, and associate professor of medicine at the University of Iowa College of Medicine, told Drug Topics. "We can sort of predict that in advance." So, on a day expected to be a trial for any allergy sufferer, the investigators assembled potential subjects in the park.

On the first day, study candidates arrived at about 7:30 A.M., Casale explained. Despite a history of ragweed-induced hay fever and positive skin tests for ragweed allergy, all were monitored for three hours to ensure that their symptoms were significant before they were enrolled into the trial. Then, the 160 patients who were to be included received either placebo or one of four different doses of Accolate: 10 mg, 20 mg, 40 mg, or 100 mg. After that, they "stayed in the park for the rest of the day and filled out symptom score cards every hour," the physician said. Plasma concentrations of drug were evaluated twice a day.

"It's a happening," Casale chuck-led. As the pollen counts soared above 1,000, patients were kept well-fed. "They eat a lot. I had 100 pizzas," he said. When they weren't eating, the subjects played baseball or horseshoes. Some read or lounged about. The researchers, who throw these shindigs on a "fairly frequent" basis, haul out a television, VCR, and a stack of movies when the weather is poor. The only activity that's always off limits is swimming, since it can affect nasal symptoms, thus confounding study results.

At about 4:30 P.M., everybody went home, returning early the next morning for another nine hours in the great outdoors. The patients received the same compound they'd had the day before and continued to document their allergy symptoms every hour. During each of the two evenings following the outings, participants completed another three-symptom score cards at predetermined intervals. …

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