The primary hypothesis for this trial is that montelukast adds efficacy to hydroxyurea therapy for improving vaso-occlusion when compared to hydroxyurea alone. In this feasibility trial, we will compare participants treated with montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8 weeks.

The following specific aims will be tested in adolescents and adults with sickle cell disease:

• Aim 1: To determine whether montelukast versus placebo added to hydroxyurea will improve markers of vaso-occlusion-associated tissue injury in adolescents and adults with sickle cell disease
• Aim 2: To evaluate physiologic effects of montelukast versus placebo added to hydroxyurea in adolescents and adults with sickle cell disease
  • Subaim 2A: To determine if montelukast versus placebo added to hydroxyurea will improve lung function in adolescents and adults with sickle cell disease
  • Subaim 2B: To determine if montelukast versus placebo added to hydroxyurea will improve forearm microvascular blood flow in adolescents and adults with sickle cell disease, respectively

More information: clinicaltrials.gov, ITHANET Clinical Trials