A study from a Phase 3 trial on an inhaled antibiotic therapy for non-cystic fibrosis bronchiectasis entitled “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” was recently published in The Lancet Respiratory Medicine by Prof. Alan F Barker from the Department of Medicine at Oregon Health and Science University and colleagues. The findings outline new insights into effectively treating the disease.
Bronchiectasis is characterized by dilated airways caused by chronic bronchial inflammation due to inadequate elimination of pathogens and constant infections in the airways. Besides infections, other conditions may lead to bronchiectasis such as immunodeficiency, aspiration, and primary ciliary dyskinesia. The therapy for this condition is based on airway clearance with strong antibiotic schedules and physiotherapy.
In these clinical trials, the research team evaluated the clinical advantage of the administration by inhalation of the antibiotic aztreonam in non-cystic fibrosis bronchiectasis. They assessed the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with non-cystic fibrosis bronchiectasis and Gram-negative bacterial infection. The AIR-BX1 and AIR-BX2 were two double-blind, multi-center, randomized, placebo-controlled phase 3 trials, composed of patients 18 years or older that had bronchiectasis and a history of positive sputum or bronchoscopic culture for target Gram-negative organisms. The patients were distributed randomly to be treated with AZLI or placebo (1:1). In the trials, the patients were treated during two 4-week courses with AZLI 75 mg or placebo (eFlow nebulizer) 3 times a day and followed for 4 weeks without therapy. The researchers assessed the alteration from baseline Quality of Life-Bronchiectasis Respiratory Symptoms scores (QOL-B-RSS) after 4 weeks as the primary end-point.
The research team found that the treatment with AZLI treatment did not improve significantly the non-cystic fibrosis bronchiectasis condition based on the Quality of Life-Bronchiectasis Respiratory Symptoms scores. Therefore, there is a need for continuous development of inhaled antibiotics for patients with non-cystic fibrosis bronchiectasis and the used of placebo-controlled studies to assess their clinical potential.
For more information concerning these trials visit the ClinicalTrials.gov website.