Interviewees: Tom Casale, Creighton University School of Medicine; Beth Corn, Mount Sinai School of Medicine
Why isn’t there a treatment for allergies like hay fever that actually works and doesn’t have annoying side effects?
“I don’t have allergies, but my wife has allergies, and she keeps asking me to find something that works,” says Tom Casale, chief of Allergy and Immunology at Creighton University School of Medicine. “So it’s sort of a mixed feeling, because I want to make her feel better, but I don’t want to put myself out of business,” he quips.
“But despite our best efforts, about 40 to 50 percent of patients, for example, in the middle of ragweed season, will not have improvement in their symptoms to the point where they can go outside and do what they want without having runny nose, sneezing, itchiness, etcetera,” Casale says. “Even to our best efforts with intranasal steroids and antihistamines or allergy shots, they still can’t get out in the peak of the pollen season and enjoy life like they’d like to.”
Now he is leading clinical trials to test an unusual new treatment, flowing carbon dioxide gas through the nostrils. “It is a little bit of a strange idea when you think about it,” he says. “It’s in a higher concentration than you would normally exhale. And it’s in a more rapid flow.”
In an early study, Casale and his team recruited people with allergies, confirmed by a positive skin test. Volunteers also had to have symptoms of allergic rhinitis, or hay fever, at the time of being dosed. Then they were randomly dosed with either the CO2 treatment or plain air.
The researchers wrote in the “Journal of Allergy and Clinical Immunology” that the results with CO2 were promising and had fewer side effects than current treatments.
“The duration of treatment is unclear at this point from the studies, but the initial one we did, we used one minute in each nostril, separated by a couple of minutes,” Casale explains. “What we found is that with the introduction of the nasal carbon dioxide, patients got significant relief of all of their symptoms of allergic rhinitis or hay fever within 10 minutes. And it actually lasted for up to 24 hours. So they had relief of nasal congestion, sneezing, running nose, itchiness, all the principle symptoms of hay fever.”
Casale says so far, they have only discovered one minor side effect; some patients experienced a brief burning sensation during the active treatment.
He acknowledges that that could make further clinical trials difficult to “blind.”
Beth Corn, chief of the Allergy Clinic at New York’s Mount Sinai Medical Center, thinks that may not be a big problem because further studies could also compare CO2 against other treatments. “As an initial study, it’s a very exciting idea and it’s a novel concept,” Corn says. “I think that more research needs to go into it, but I think that once that’s done and if the facts bear out and patients actually do derive improvement, then it will be a very exciting and innovative way of treating allergy.”
Corn, who has allergies herself, has no connection to the research. “When I read this article in the journal, I said, ‘Wow this is so exciting.’ I hadn’t even heard about it, so it was all news to me.”
“It’s not a medication, so that’s totally different,” she says. “I myself think that less is more, and if you can get by on treating patients with fewer medications, which will ultimately have fewer side effects, I think that’s definitely beneficial for patients.”
While Casale says more research is also needed into how the treatment might work, Corn finds early evidence persuasive. “A certain protein is reduced, and this protein is known to cause nasal congestion, stuffiness, and the thought is that if this protein is hindered, if its not produced, then nasal congestion will be reduced,” she explains.
Casale says the company funding the clinical trials is further investigating how CO2 affects proteins that dilate blood vessels. In fact, he explains, the company, called Capnia, first began studying CO2 for treating migraines, which are also thought to be caused by dilated blood vessels.
“The blood vessels get bigger, and when that happens in the brain, you get a headache. If it happens in the nose, you get nasal congestion. So if we could treat those, then we could have improvement maybe in both disorders,” Casale says.
Casale says the company has developed a pocket-sized prototype that it hopes will gain Food and Drug Administration approval.
Even though carbon dioxide is ubiquitous, Casale explains that “it needs approval for a couple of reasons. One is the device. And any time you use a device to administer any type of treatment, that has to be looked at by the FDA.”
“In addition…the amount of carbon dioxide that we’re giving is higher than what you expire, and the flow rate is different, so that makes it different. And because of that, you have to demonstrate that not only it’s effective, but it’s safe in individuals as well.”
Casale’s team has now begun a new trial that objectively monitors peoples’ congestion by measuring the area of their nasal cavities. “If you have something that decreases the congestion, the area in the nose should be increased,” Casale explains. They are also using scratch and sniff tests to see if the treatment helps with allergies, effects on sufferers’ senses of smell.
This research was published in the Journal of Allergy and Clinical Immunology and was funded by Capnia, Inc.
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