Dexamethasone to Treat Acute Chest Syndrome in People With Sickle Cell Disease

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Anemia, Sickle Cell

In brief

People with sickle cell disease (SCD) may develop acute chest syndrome (ACS), which is a common and serious lung condition that usually requires hospitalization. Dexamethasone is a medication that may decrease hospitalization time for people with ACS, but it may also bring about new sickle cell pain. This study will evaluate the effectiveness of a dexamethasone regimen that includes a gradual dose reduction at decreasing hospitalization and recovery time in people with SCD and ACS.

Key facts

Study ID

NCT00530270

Run by

Children's Hospital Medical Center, Cincinnati

People needed

12

Starts

2006-12-01

Expected to finish

2008-11-01

Last updated by the study team

2013-04-09

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of sickle cell anemia (Hgb SS) or sickle-β0-thalassemia (Hgb Sβ0)
• Current episode of ACS, defined as a new lobar or segmental pulmonary infiltrate seen on a chest radiograph and two or more of the following findings:
• Temperature of 38.5°C or higher
• Tachypnea (i.e., rapid breathing)
• Dyspnea or increased work of breathing
• Chest wall pain
• Oxygen saturation of less than 90% in room air by pulse oximetry
• Current episode of ACS diagnosed in the 24 hours prior to study entry
• Ability to take medication in capsule form

You may not qualify if…

• Prior participation in this study
• Diagnosed with any medical condition that will likely be worsened by corticosteroid therapy, including any of the following conditions:
• Diabetes mellitus
• High blood pressure
• Esophageal or gastrointestinal ulceration or bleeding
• Known avascular necrosis
• Diagnosis of ACS in the 6 months prior to study entry
• Treatment with oral or parenteral corticosteroid therapy for any reason in the 14 days prior to study entry
• Use of inhaled corticosteroids or systemic corticosteroids for respiratory illness in the 3 months prior to study entry
• Long-term lung condition that requires treatment with corticosteroids
• Participation in a program of chronic transfusions that ended fewer than 4 months ago. A program of chronic transfusions includes a regimen of serial simple or exchange transfusions given at least every 6 weeks for at least three consecutive transfusions for the prevention of SCD-related complications.
• Pregnant
• Treatment with any investigational drug in the 90 days prior to study entry
• History of either tuberculosis or a positive skin test for tuberculosis
• Known HIV infection or a current systemic fungal infection

Where it is running

• University of California - Davis — Sacramento, California, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• St. Christopher's Hospital — Philadelphia, Pennsylvania, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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