Study Results

• What We Learned:

  This study found that participants being treated with AquADEKs-2 did not have significant reduction in respiratory inflammation when compared with the control multivitamin group. AquADEKs-2 was well-tolerated.

• Primary Findings:

  Effectiveness:

  This study was conducted between September 2013 and June 2015. Of the 73 participants enrolled in the study, 36 were randomized to the AquADEKS-2 group (antioxidant-enriched multivitamin) and 37 to the control multivitamin group. A total of 69 participants completed the study (AquADEKs-2= 34 and control multivitamin= 35).

   

  The primary efficacy endpoint of this study was to measure the change in sputum myeloperoxidase levels between the two groups. Sputum myeloperoxidase is a measure of respiratory inflammation. This study did not meet its primary endpoint as there was no difference in sputum myeloperoxidase levels between the AquADEKs-2 group and the control group at week 16.

   

  While antioxidant levels significantly increased in the AquADEKs-2 group (p<0.001), there were no significant changes in any of the blood and sputum markers of inflammation. Lung function and growth did not differ between the AquADEKs-2 and control multivitamin groups at 16 weeks. However, participants receiving AquADEKs-2 had a longer time to first pulmonary exacerbation requiring antibiotics when compared with participants receiving the control multivitamin (p=0.04).

  Safety:

  The adverse event profile was similar for both the AquADEKs-2 group and control multivitamin group.

• Citation:

  Am J Respir Crit Care Med ;DOI 10.1164/rccm.201801-0105OC [Epub ahead of print]

For current information about the overall development status of this drug, please check the Drug Development Pipeline.