FDA Requires Postsafety Trials for Long-Acting Beta-Agonists


Manufacturers of long-acting beta-agonists will be required to conduct five randomized, double-blind, controlled clinical trials that will compare LABAs and inhaled corticosteroids to inhaled corticosteroids alone, the Food and Drug Administration announced in an April 15 press release.

The clinical trials will begin in 2011, and the FDA expects to receive results in 2017, according to the FDA statement.

Individual clinical trials will address each of the four approved LABAs in patients 12 years of age and older. One trial will evaluate Symbicort (budesonide and formoterol), a second trial will address Advair Diskus (fluticasone and salmeterol), and a third will evaluate Dulera (mometasone and formoterol). The fourth trial will involve Foradil (formoterol) and will also include treatment with fluticasone, which will be provided in a separate inhaler. The adult and adolescent trials will include 11,700 patients in each trial for a total of 46,800 patients.

The fifth clinical trial will involve Advair Diskus and will be conducted in pediatric patients aged 4-11 years. The pediatric trial will include 6,200 patients. Patients in all trials will be treated for 6 months, and the primary end point will be a composite of serious asthma outcomes, including asthma-related death, intubation, or hospitalization. The pediatric trial will also assess other relevant quality of life end points such as days of school missed and emergency department visits because of asthma-related illness.

Last year, the FDA announced it was requiring manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma.

LABAs should not be started in patients with acutely deteriorating asthma, the FDA advised. Patients and their families should be told that LABAs do not relieve sudden-onset asthma symptoms. A rescue inhaler, such as an albuterol inhaler, should be prescribed to treat sudden asthma symptoms, and patients should be told to seek immediate medical attention for deteriorating asthma.

For pediatric and adolescent patients who need the addition of a LABA to an inhaled corticosteroid, the FDA recommended prescribing a combination inhaled corticosteroid–LABA product to assure adherence to both medications.

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