The study showed that benefits from treatment lasted for at least one year, but an Asthmatx spokeswoman told DOTmed News that they have data which show five years after the procedure patients are still benefiting from it.

SIDE EFFECTS


Although Alair makes the patients better, at first they might get worse. According to the company's research, treatment can trigger asthma attacks.

"In the period immediately following bronchial thermoplasty, there was an expected transient increase in the frequency and worsening of respiratory-related symptoms, which were the type expected following bronchosocopy in patients with asthma," Asthmatx said on their website.

The company said these events occurred within a day of the procedure and usually resolved within the first week.

Other possible side effects during treatment listed by the FDA include partially collapsed lung, coughing up blood, wheezing, anxiety, nausea and headaches. However, an FDA spokesman told DOTmed News that these events "are not unexpected" in patients with severe chronic asthma. As with Asthmatx, their review team believed some of the side effects might be related to the actual bronchoscopic procedure, rather than the Alair treatment.

Currently, the device can only be used on adults, and can't be used on patients with pacemakers, defibrillators or other implanted electrical devices, for fear the treatment would interfere with their functioning. And for now, patients who have already undergone the Alair treatment also can't have the same section of lung re-treated.

The FDA will continue to monitor the device. The agency is requiring Asthmatx to run a 5-year post-approval study that will follow some of the patients from the original AIR 2 trial, as well as an additional 300 patients at medical centers throughout the U.S.

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