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| |  ACAAI: Single-unit Combination Therapy Might Not Decrease Health-Care Use for Severe Asthmatics By Paula Moyer NEW ORLEANS, LA -- November 18, 2003 -- People with severe or difficult-to-control asthma fare no better with single-unit combination-therapy delivery systems than with multiple delivery systems, according to findings presented here November 8th at the Annual Meeting of the American College of Allergy, Asthma, and Immunology. Single-unit combination therapy for asthma consists of a long-term beta-agonist and a corticosteroid combined in one inhalation device. The device approved in the United States consists of the corticosteroid fluticasone propionate (Flovent) and the long-term beta-agonist salmeterol xinafoate (Serevent). "These findings mean that the therapies available are not adequate for severe asthma," said co-investigator Bob Lanier, MD. "If [severe asthmatics] aren't doing well despite new medications and new delivery systems, they might need something else [that addresses the allergic component of asthma]." Dr. Lanier noted that nearly 90% of people with asthma also have allergies. Dr. Lanier, an allergist in private practice, Fort Worth, Texas, United States, is also a clinical professor of paediatrics, University North Texas Health Science Center, Denton. Dr. Lanier pointed out that as many as one-third to one-half of people with asthma have severe or difficult-to-treat disease. The investigators recruited 4,756 patients from 283 sites. The participants had asthma and were at least 6 years old. Among these, the investigators identified a subset of 386 patients who were at least 13 years old and who used single-unit combination therapy. The team created a control group comprised of 1,310 patients who had never used such therapy. The investigators then compared the outcomes of those who used a single-unit combination asthma-therapy modality with those who had never used such treatment. These patients were compared at baseline and at 12-month visits. These patients were compared demographically. They were also compared by asthma severity; difficulty in controlling their asthma; serum levels of immunoglobulin E (IgE), and lung function. The investigators also compared the 2 groups' rates of health-care utilisation, their current medications, their asthma-related impairment regarding work productivity and activity, and their asthma-related quality of life. At the beginning of the study, 2 groups had similar rates of health-care utilisation, except that, surprisingly, the single-unit combination asthma-therapy group had had significantly more short-term courses of oral corticosteroids (P = .01). At Month 12, both groups' rates of health-care utilisation had declined by equivalent amounts. In all other parameters, the 2 groups were similar, the investigators reported. These findings show that, among patients with severe or difficult-to-treat asthma, those taking single-unit combination asthma therapy have similar outcomes to those using multiple asthma medications in terms of asthma-related health-care utilisation, the investigators stated. The study, known as The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR), was funded by Genentech and Novartis, which together manufacture Xolair (omalizumab), a medication that suppresses immunoglobulin E (IgE), a key component of allergic disease. Dr. Lanier is not financially involved with the companies.
[Study Title: Combination Asthma Medication and Healthcare Use in Severe or Difficult-to-Treat Asthma. Abstract P42]
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