NCT01960413

Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia

Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia (Also Known as the Montelukast Trial in Sickle Cell Anemia)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)

Interventions

Type	Name	Description
DRUG	Montelukast added to Hydroxyurea
DRUG	Placebo added to Hydroxyurea

Timeline

• Start date: 2013-11-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2013-10-10
• Last updated: 2019-03-26
• Results posted: 2019-03-26

Locations

2 sites across 1 country: United States