Abstract
Introduction: It is not known if inhaled antibiotics improve respiratory symptoms in bronchiectasis. In the recent phase-3 ORBIT trials, 48-weeks treatment with ARD-3150 did not improve respiratory symptoms. The pre-specified method of analysis did not take account of possible improvements in symptoms while on active treatment.
Methods: ARD-3150 was administered 28-days on and 28 days off in patients with bronchiectasis and chronic P.aeruginosa infection. The quality-of-life bronchiectasis respiratory symptom scale (QOL-B RSS), which has a 1-week recall period, was administered at baseline and every 28-days. We examined whether respiratory symptoms improved during on-treatment periods and the relationship of changes in QOL-B RSS to changes in bacterial load using mixed model repeated measures (MMRM).
Results: Using MMRM, ARD-3150 treatment resulted in a significant improvement in respiratory symptoms during the on-treatment periods with concordant results between ORBIT-3 (estimate 1.4 points, standard error (SE) 0.49,p=0.004) and ORBIT-4 (estimate 1.1 point, SE 0.41,p=0.006). Changes in respiratory symptoms were correlated with changes in bacterial load in the treatment group (r=-0.89,p<0.0001) with improvements on-treatment and worsening symptoms during off-treatment periods. Individual estimates for decrements in the QOL-B RSS during exacerbation were -9.4 points (SE 0.91) in ORBIT-3 and -10.8 points (0.74) in ORBIT-4 (both p<0.0001).
Conclusion: Inhaled ARD-3150 resulted in significant improvements in respiratory symptoms during the on-treatment periods which were lost during off-treatment periods.
Footnotes
Cite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 4136.
This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2020