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

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• 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:

1. Temperature of 38.5°C or higher

2. Tachypnea (i.e., rapid breathing)

3. Dyspnea or increased work of breathing

4. Chest wall pain

5. 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

Exclusion Criteria:

• Prior participation in this study

• Diagnosed with any medical condition that will likely be worsened by corticosteroid therapy, including any of the following conditions:

1. Diabetes mellitus

2. High blood pressure

3. Esophageal or gastrointestinal ulceration or bleeding

4. 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