Asthma Study Shows Patients Have More Options to Control Disease

May 16, 2007

WINSTON-SALEM, N.C. – People with mild asthma that is well-controlled with twice-daily use of inhaled steroids may be able to reduce inhaler use to once a day – or switch to a daily pill – according to new research conducted at Wake Forest University Baptist Medical Center and 20 other centers.

“This is good news for patients with mild, persistent asthma because it gives them more choices about how to manage their disease,” said Stephen P. Peters, M.D., Ph.D., lead author and a professor of pediatrics, internal medicine-pulmonary and associate director of the Center for Human Genomics.

The study, involving 500 children and adults with mild asthma, was conducted by the American Lung Association’s Asthma Clinical Research Centers. Its goal was to determine if patients whose symptoms are well controlled on twice daily inhaled corticosteroid can “step down” their medication use. The results are reported in the May 17 issue of the New England Journal of Medicine.

Asthma is considered mild, but persistent, when symptoms occur more than two times a week or cause the patient to awaken during the night more than twice a month. The standard treatment for mild-persistent asthma is twice-daily use of an inhaled steroid to prevent symptoms. Patients may also take additional drugs such as the inhaler albuterol, known as “rescue” therapy, to treat symptoms. A majority of people with asthma have mild disease, according to Peters.

The study involved patients whose asthma was treated with twice-daily inhaled fluticasone propionate (Flovent® Discus), a commonly prescribed synthetic steroid. This drug is designed to suppress inflammation within the airways that can cause narrowing.

Study participants were randomly divided into three groups. One group continued to take fluticasone twice a day for 16 weeks. Two other groups took alternative therapies: either a combination of fluticasone propionate and salmeterol in a single inhaler (Advair® Discus) once daily or the oral medication montelukast (Singulair®) that blocks chemicals produced by the body that cause inflammation, also taken once daily. Salmeterol, used in the combination therapy, is a long-acting bronchodilator, or a drug that relaxes and opens the airways.

The study measured rates of treatment failure among the three groups. Treatment failure included hospitalization or urgent medical care, the need for additional medications for asthma, a decline in lung function, or the need to take more than 10 puffs a day of a “rescue” inhaler for two consecutive days.

The groups taking twice-daily fluticasone and once-daily fluticasone/salmeterol both had a treatment failure rate of 20 percent. In the group taking montelukast, the rate was 30 percent.

“This study suggests that patients whose asthma is well controlled on twice-daily fluticasone can be switched to once-daily flucitasone/salmeterol without increased rates of treatment failure,” said Peters.

He said that even though montelukast had a higher rate of treatment failure than the inhaled medications, it can also be considered an option for some patients, since a majority of patients also did well on this treatment.

“While the group on the combination inhaler therapy clearly did better than those on the oral montelukast therapy, it is important to note that 70 percent of patients on this oral therapy did well according to the treatment failure criteria, and were symptom-free on 79 percent of days,” said Peters. “Patients should find a therapy that that works for them and fits their desires, preferences and lifestyle.”

Patients on fluticasone/salmeterol once daily were symptom-free 83 percent of days and those on fluticasone/salmeterol were symptom-free for 86 percent of days.

Peters said two factors determine a medication’s effectiveness: how well it works when it is taken as prescribed and how well patients adhere to the therapy. He said patients may adhere better to therapy that is required once a day – or that involves taking a pill rather than using an inhaler. In addition, while the risks of low-dose steroids are low, some patients may perceive a risk and be more willing to take the drugs if they are only required once a day.

“Patients who are doing well with the gold standard which is twice a day inhaled corticosteroid, but want to try other options, should talk to their doctors,” Peters said.

He said it should be noted that a limitation of the study is that it was conducted for only 16 weeks and that flutcasone/salmeterol is currently approved by the U.S. Food and Drug Administration for twice-daily use.

Other members of the writing committee were Nicholas Anthonisen, M.D., Mario Castro, M.D., Janet T. Holbrook, M.P.H., Ph.D., Charles G. Irvin, Ph.D., Lewis Smith, M.D., and Robert A. Wise, M.D.



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