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Inhaled Budesonide/Formoterol Improves Asthma Control and Lung Function: Presented at ACAAI

By Corinna S. Bowser, MD

PHILADELPHIA, PA -- November 13, 2006 -- The combination of budesonide and formoterol in a pressurized, metered-dose inhaler (Symbicort) improves both lung function and asthma control in patients with mild to moderate persistent asthma, according to randomized trial data presented here at the 2006 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI).

The combination of budesonide and formoterol was approved by the U.S. Food and Drug Administration for maintenance treatment of asthma but is not yet available to clinicians and patients in the United States. The drug also was found to reduce the risk of asthma exacerbations compared with either formoterol alone or placebo.

The formulation combines the inhaled corticosteroid budesonide with the fast-onset long-acting beta agonist (LABA) formoterol. Previous studies showed that these 2 agents were are and well tolerated when combined in a dry powder inhaler. Data presented here at ACAAI further showed the combination to be safe when delivered via a pressurized, metered-dose inhaler.

Jonathan Corren, MD, associate clinical professor of medicine, University of California, Los Angeles, California, presented the 12-week randomized trial on November 11^th.

The study included 480 asthma patients at least 12 years of age who had mild to moderate asthma that was previously treated with an inhaled corticosteroid.

Over 12 weeks, improvements in morning predose lung function (FEV₁), a primary endpoint of the trial, were greater in the budesonide/formoterol group compared with what was observed in patients receiving budesonide alone, formoterol alone, or placebo (P less than or equal to .005). Likewise, improvements in postdose FEV₁ for patients receiving the combination were greater (P < .001) versus placebo and either agent alone.

In addition, significantly fewer patients receiving budesonide/formoterol had asthma exacerbations (P less than or equal to .001) or worsening (P less than or equal to .01).

There were no asthma-related adverse events among patients treated with the budesonide/formoterol combination, and the safety profile of the combination was similar to that of its individual components and placebo. Most adverse events were mild or moderate.

Combining an inhaled corticosteroid and a LABA is similar in approach to what has been done with fluticasone and salmeterol, which are available together in an inhalation powder formulation (Advair Diskus), also used to treat asthma. The fluticasone/ salmeterol product now carries a warning that salmeterol may increase the risk asthma-related death, based on data from a large placebo-controlled study of salmeterol or placebo added to usual asthma therapy (Salmeterol Multicenter Asthma Research Trial).

However, Dr. Corren said that the "LABA controversy" should not overshadow the magnitude of clinical benefit that asthma patients can receive from the combination of an inhaled corticosteroid and LABA.

"I think this combination, whether it be fluticasone/ salmeterol, or budesonide/ formoterol, are both highly efficacious," said Dr. Corren.

He added that the "rational place" for budesonide/ formoterol treatment, when it becomes available, will be in patients with asthma that is not adequately controlled on an inhaled steroid alone.

"We don't have many other choices for a secondary adjunct," he explained. "We have these [LABAs], leukotriene modifiers, and theophylline, and I think probably the best choice is still the long-acting beta agonist, in terms of better pulmonary function, better symptom control, and better reduction in asthma attacks."


[Presentation title: Budesonide (BUD) and Formoterol (FM) in One Pressurized Metered-Dose Inhaler (BUD/FM PMDI): Effects on Lung Function and Measures of Asthma Control in Adults and Adolescents With Mild to Moderate Persistent Asthma. Abstract P82. Presentation title: Safety of Budesonide (BUD) and Formoterol (FM) in One Pressurized Metered-Dose Inhaler (BUD/FM PMDI) in Adults and Adolescents With Mild to Moderate Persistent Asthma. Abstract P83]

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