The FDA announced it was requiring the new clinical safety trials on April 15 in an FDA drug safety communication.
All of the asthma drugs belong to a class of medications known as long-acting beta-agonists (LABAs). The FDA is concerned that the side effects of the drugs may increase the risk of severe asthma problems and death.
Four of the ordered clinical trials will be for 11,700 patients 12 years of age and older and cover each of the four drugs; Advair, Dulera, Foradil and Symbicort. There will be a fifth clinical trial, again for Advair, involving patients ages 4 to 11 years old that will include 6,200 patients.
In all of the trials, the patients will be observed while undergoing treatment for six months. In the older subjects, researchers will compare the rate of serious asthma side effects, such as intubation, hospitalization and death. The pediatric trial will also look at issues that affect the children’s quality of life, such as missed days of school and emergency room visits. The FDA hopes to have results by 2017.
The trials will compare the safety of using LABAs in combination with traditional corticosteroid asthma treatments, as compared to the use of just corticosteroids alone. In February 2010, the FDA declared that LABAs should be contraindicated for use as a stand-alone asthma treatment.
That decision came after a review of previous studies that found that some LABAs can mask worsening inflammation in the airways, leading to worsening symptoms that may not be recognized in a timely manner. This could result in severe injury or death.
Asthma affects 20 million Americans, including 6.5 million children. It is a chronic disease with symptoms like wheezing, difficulty breathing and spasms, which can severely limit activities and impact quality of life.