Sickle Cell Anemia (HbSS, or HbSß-thalassemia0) Clinical Trial
Official title:
Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia (Also Known as the Montelukast Trial in Sickle Cell Anemia)
In this feasibility trial, the investigators will compare participants treated with montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8 weeks.
The primary hypothesis for this trial is that montelukast adds efficacy to hydroxyurea
therapy for improving vaso-occlusion when compared to hydroxyurea alone. The following
specific aims will be tested in adolescents and adults with sickle cell disease (SCD):
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.
Funding Source - FDA OOPD
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