Results from two randomized, placebo-controlled phase 3 trials on the efficacy of inhaled Aztreonam for patients with non-cystic fibrosis bronchiectasis showed that the drug does not offer significant clinical benefit. The study published in The Lancet Respiratory Medicine.
Bronchiectasis is a chronic condition characterized by dilated airways due to chronic bronchial inflammation because of insufficient elimination of pathogens and persistent inflammation in the airways. The clinical benefit of inhaled antibiotics in non-cystic fibrosis bronchiectasis has not been previously evaluated in randomized controlled studies.
To address this unmet issue, in their research study titled “Aztreonam for inhalation solution in patients with non-cystic fibrosis bronchiectasis (AIR-BX1 and AIR-BX2): two randomized double-blind, placebo-controlled phase 3 trials,” Alan Barker from the Department of Medicine at Oregon Health and Science University and colleagues report their findings on the clinical efficacy of an inhaled solution of Azthreonam (AZLI) in AIR-BX1 and AIR-BX2, two double-blind, multi-center, randomized, placebo-controlled phase 3 trials.
In the AIR-BX trial, of the 348 patients with non-cystic fibrosis bronchiectasis and gram-negative bacterial colonization screened, 134 patients received AZLI while 132 received the placebo. In the AIR-BX2 trial, of the 404 patients with non-cystic fibrosis bronchiectasis and gram-negative bacterial colonization screened, 136 received AZLI and 138 received the placebo.
Patients were treated during two 4-week courses with 75 mg of AZLI or placebo 3 times a day and then were followed for 4 weeks without receiving therapy. Potential clinical changes were assessed with the Quality of Life-Bronchiectasis Respiratory Symptoms scores (QOL-B-RSS). Results showed that at 4 weeks the group differences were non significant in the AIR-BX1 trial, however, they were significant in AIR-BX2 trial. Adverse effects were more common in the group that received the AZLI group compared to the placebo group, and the most common adverse effects observed were dyspnea, cough, and increased sputum.
Based on these results, the researchers concluded that treatment with inhaled Aztreonam does not improve function in patients with non-cystic fibrosis bronchiectasis, as measured by QOL-B-RSS. In the study, the researchers suggest that other trials should test the benefit of inhaled antibiotics in patients suffering from this condition.