NCT00290602 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Annane D, Sébille V, Bellissant E; Ger-Inf-05 Study Group
Effect of low doses of corticosteroids in septic shock patients with or without early acute respiratory distress syndrome. Crit Care Med. 2006 Jan;34(1):22-30.
Lee HS, Lee JM, Kim MS, Kim HY, Hwangbo B, Zo JI
Low-dose steroid therapy at an early phase of postoperative acute respiratory distress syndrome. Ann Thorac Surg. 2005 Feb;79(2):405-10.

Prospective Phase II Study of Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome (ARDS) After Thoracic Surgery (E-START)

Clinical trial NCT00290602 - References