The FDA has approved Breztri Aerosphere as a maintenance treatment for COPD. The treatment is a combination of budesonide, glycopyrrolate, and formoterol fumarate.
The approval follows the Phase III ETHOS trial results, which showed a “significant reduction in the rate of moderate or severe exacerbations,” when compared to a dual combination of glycopyrrolate/formoterol fumarate, and PT009, according to a release from the manufacturer.
Bartolome Celli, MD, from Harvard Medical School, told Pharm/alert that the triple combination makes a difference in treating the condition, which can significantly impact a patient’s quality of life.
“It contains two substances that dilate your windpipes,” Celli said. “They’re called bronchodilators. Some of them are well known because they’re used in asthma, but these are given twice a day, and they are combined in the same canister with an inhaled corticosteroid. And an inhaled corticosteroid is like any steroid, a potent anti-inflammatory. However, it is given at a dose which produces relatively little side effects. The novelty is that the three substances are placed in one canister so the patient can use the canister twice a day, two shots, and get the dose for one day. “
While he was not involved in the trial, Celli said the large number of patients enrolled, and the positive findings that were published are encouraging for patients living with COPD.
“The triple combination beat the double combination in several outcomes, most important being exacerbations, which, our audience I’m sure knows what they are,” Celli explained. “They occur frequently, and they’re associated with very poor outcomes. It also beat the components in mortality. There was a difference in mortality in favor of the triple when all three are used together, compared with either of the two, the double or the dual bronchodilator combination. It also impacted more frequently on quality of life, making patients feel better when they used the triple when compared to the other two combinations.
Celli said the fact that patients can get the treatment they need in one canister rather than relying on keeping multiple treatments on hand can make a big difference in how they approach their own care.
He said the trial results showed that by having the triple combination, the need for patients to use a rescue inhaler was also reduced.
Celli noted there are some safety concerns to be considered before prescribing the medication.
“Individuals who take these medications are usually elderly,” Celli said. “They may have comorbidities, and we have to be careful in individuals, for example, who have cardiac arrhythmia since we use substances that may increase heart rate and arrhythmias. The second side effect that has been noted for patients who take inhaled corticosteroids, independent of whether they’re on the triple combination or the dual combination, whenever you take inhaled corticosteroids, there is an increase in the risk of pneumonia. So, it may be recommended that individuals who have purulent sputum, who have repeated infections, we either put them on the medications and watch them closely or avoid the medication altogether. What we do know is that those individuals who get pneumonia are not at an increased risk of death from that pneumonia.”