
Nobody ever told Kimberly Andrews or Dave Alchier whether they received a placebo or the real thing in a 2007 double-blind study of a new oral treatment for an allergy to grass at Allegheny General Hospital.
Nobody had to.
From the virtually symptom-free "grass season" they had enjoyed, it seems fairly obvious that there was nothing fake about the liquid drops they placed under their tongues every morning for several months. Rather, those drops had to have comprised grass allergens that helped them build up a resistance to the substance, the same way allergy shots do. How else to explain their lack of sneezing, itchy eyes and runny noses?
"It was very helpful to me," said Mr. Alchier, 52, an electrical engineer from Bakerstown.
"I had a real allergy substitution -- I could tell right away from the results. I didn't have near the problems I had years before."
Ms. Andrews, 39, of the North Shore, who manages patient access services at AGH, had a similar experience. "I just know I had a fabulous spring. ... My symptoms were very mild to nonexistent."
This method, long in use in Europe, is called sublingual immunotherapy, or SLIT. Ms. Andrews and Mr. Alchier were part of an AGH study, which in turn was part of a nationwide study undertaken by Greer, a developer and provider of allergy immunotherapy products and services.
The grass test was Phase II in a long-term study to get SLIT approved by the U.S. Food and Drug Administration. Phase I, held in 2006, centered on the ragweed allergen. Now, AGH -- and Ms. Andrews -- are taking part in Greer's Phase III, a more comprehensive study of using SLIT as a weapon against ragweed. To his disappointment, Mr. Alchier no longer falls within the age requirements for volunteers of between 18 and 50.
The study is still in the recruitment stage. Greer wants 458 people nationwide and AGH is looking for a minimum of 16 and could take as many as 40. As of April 11, it had 10. Since ragweed season starts Aug. 15, the group must be complete by mid-May to get the slow buildup of ragweed allergen started.
"We hope the FDA will approve of this someday," said Dr. David Skoner, director of AGH's Division of Allergy, Asthma and Immunology. Also lead investigator for the SLIT study, he is quite enthusiastic about using sublingual immunotherapy as an alternative to allergy shots.
"The reason why is that the injections we give frighten people. They're afraid of needles," he said. "That would be the treatment of choice for most, but a lot of people, especially children, turn away. They don't want to get a shot every week, or every month. Or they're not able. ...
"Also, people get on the shots and it's inconvenient, and they can't make it weekly, monthly or every two weeks. They fall away," Dr. Skoner added.
"And then there are people who have reactions to the shots. They can give you a swollen arm or sometimes they can give you anaphylaxis, which can be fatal in very rare cases.
"SLIT so far has been safe, there's no needles and the adherent rate should be better [because] a lot of it's done at home. Those are major reasons why it's a good thing: They're easy, safe, there's no pain, and I think longterm adherence will be better."
Mr. Alchier, who says he has "tried it all" to combat multiple allergies to seasonal things like trees and ragweed and general all-year things like cat dander, called SLIT "a big plus" because of its convenience. "With sublingual immunotherapy, you just put it under your tongue, don't eat or drink for a time period and then you're set to go."
To find out if you may be eligible for the study, call 412-359-4079.