Study Results

• What We Learned:

  This study found that IV gallium nitrate did not have a significant impact on lung function (defined as a 5% or greater increase in relative change in FEV1) when compared to placebo at Day 28. For those participants who were culture positive for Pseudomonas aeruginosa at baseline, participants treated with IV gallium nitrate had a significant reduction in the amount of Pseudomonas aeruginosa from sputum when compared to those participants who received placebo. Overall, IV gallium nitrate was well-tolerated when compared to placebo.

• Primary Findings:

  Effectiveness:

  This study was conducted between March 2016 and February 2018. Of the 119 participants enrolled, 60 were randomized to receive IV gallium nitrate and 59 to receive placebo.

   

  The primary objective of the study was to evaluate the difference between the number of participants receiving IV gallium nitrate versus placebo who were defined as a “responder.” To be defined as a “responder” a participant needed to have a 5% or greater increase in lung function by Day 28 (defined by relative change in FEV1).

   

  This study did not meet its primary endpoint. There was not a statistically significant difference between the number of responders in the IV gallium nitrate group (N=22/60, 37%) versus placebo (N= 17/56, 30%) (difference= 6.3%, p=0.602).

   

  There was an increase in lung function (relative change in FEV1) for participants treated with IV gallium nitrate on Day 6 and Day 14 (3.5%, p=0.049 and 4.9%, p=0.023 respectively) when compared to placebo. However, this increase in lung function was gone at the end of the study.

   

  The study also assessed the effect of IV gallium nitrate on Pseudomonas aeruginosa. When evaluating the entire study population, the reduction of Pseudomonas aeruginosa in sputum was greater in the IV gallium treated group but this difference was not statistically significant (-0.52 log10 (CFU/gram), p=0.115).  

   

  However, for those participants who were culture positive for Pseudomonas aeruginosa at baseline (N = 51 in the IV gallium group and 54 in the placebo group), the reduction in the amount of Pseudomonas aeruginosa from sputum at Day 28 was significantly greater for the IV gallium participants than for those participants who received placebo (-.63 log10 (CFU/gram), p=0.037).

   

  Additionally, more participants on placebo received treatment with IV antibiotics prior to Day 28 (N=8/11, 73%) versus those on IV gallium nitrate (N=6/16, 38%). This could have impacted both lung function and quantity of Pseudomonas aeruginosa in sputum culture prior to the end of the study.

  Safety:

  Overall, IV gallium nitrate was safe and well-tolerated. Fewer serious adverse events (SAEs) were seen in the IV gallium nitrate group compared to the placebo group over the 56 days (p=0.001).

• Citation:

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