For some patients, even inhaled steroids can't control their asthma. A new medication called Xolair, or omalizumab, was approved in summer 2003 for those people. Omalizumab blocks immunoglobulin E (IgE), a part of your immune system. People with allergic asthma make more IgE in response to allergies, but omalizumab should stop the molecule before it can tell your airways to tighten and swell. British researchers looked at how well omalizumab worked.

What the researchers wanted to know: Does the drug omalizumab help patients with poorly controlled asthma?

What they did: The study was carried out at 49 centers in France, Germany, Spain, Switzerland, and the United Kingdom. Patients were eligible to join if they had moderate to severe allergic asthma and their disease was poorly controlled, which meant they had visited the emergency room or hospital and had to go on oral steroids in the past year. All of them were already inhaling steroids daily. All 312 patients got care for their asthma, and two thirds were randomly chosen to get omalizumab injections. Since omalizumab treatment involves getting stuck with a needle every two to four weeks, the trial wasn't blinded—everyone knew who was being treated and who wasn't. For one year, patients filled out daily diary cards and went in for tests every three months. The researchers analyzed the number of "asthma deterioration-related incidents"—times when asthma messed with the patients' life by making them take oral steroids or antibiotics for two or more days, miss two or more days of school or work, pay an unplanned visit to the doctor, or go to the hospital or emergency room.

What they found: People getting omalizumab treatment had half as many of those asthma deterioration-related incidents as people who didn't get omalizumab. Significantly more omalizumab patients (one third, compared with one fifth of non-omalizumab patients) went the whole year without their asthma causing any of those incidents. Over three quarters of the patients in both groups had adverse events during the study—perhaps not surprisingly, aggravated asthma was the most frequent. Five patients getting omalizumab had to drop out because of serious adverse events, and 10 more dropped out because of less serious problems, most related to getting injections.

What the study means to you: It appears that omalizumab (marketed as Xolair) could help people who have moderate to severe allergic asthma that can't be controlled with other asthma drugs.

Caveats: There was no placebo arm of the study, so patients getting omalizumab knew it and probably got a boost just from knowing they were being treated.

Find out more: The National Heart, Lung, and Blood Institute sponsors research on asthmahttp.

Read the article: Ayres, J.G., Higgins, B., Chilvers, E.R., Ayre, G., Blogg, M., and H. Fox. "Efficacy and Tolerability of Anti-Immunoglobulin E Therapy With Omalizumab in Patients With Poorly Controlled (Moderate-to-Severe) Allergic Asthma." Allergy. July 2004, Vol. 59, pp. 701–708.

Abstract online: http://www.blackwell-synergy.com