Researchers and clinicians at Queensland Children’s Medical Research Institute are recruiting patients for the COMBATCF clinical trial, which aims to combat cystic fibrosis (CF) and reduce bronchiectasis onset in the disease. The trial, titled “Prevention of Bronchiectasis in Infants with Cystic Fibrosis,” is a phase 3 study involving the drug azithromycin in children in 6 weeks to 6 months of age who have CF.
The authors write, “The general aim of this project is to conduct a randomized, double-blind, placebo-controlled clinical trial of azithromycin to determine whether treatment from infancy is safe and will prevent the onset of bronchiectasis.” To meet this goal, 150 children are expected to enroll and be treated with either a placebo or azithromycin. A Lung Disease News report indicates that of primary interest in the study is the proportion of patients who have radiologically-defined bronchiectasis at the age of 3 years.
Children will begin treatment at 3 months old and continue with the treatment until the age of 3 years. In addition to the bronchiectasis onset metric, other safety and mechanistic evaluations will be obtained, and the additional metrics include the extent and severity of bronchiectasis, CF-related quality of life, body mass index, infection with Pseudomonas aeruginosa (a commonly associated bacterium with CF), and time to first pulmonary exacerbation.
The Lung Disease News report notes that due to the long treatment window, the study is not expected to be complete until December 2017. Treatment will consist of liquid azithromycin 3 times per week or liquid placebo, depending on the assigned group of the patient.
Source: Lung Disease News