NCT02181257 - 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)

Burton CM, Carlsen J, Mortensen J, Andersen CB, Milman N, Iversen M
Long-term survival after lung transplantation depends on development and severity of bronchiolitis obliterans syndrome. J Heart Lung Transplant. 2007 Jul;26(7):681-6. doi: 10.1016/j.healun.2007.04.004.
Hadjiliadis D, Steele MP, Govert JA, Davis RD, Palmer SM
Outcome of lung transplant patients admitted to the medical ICU. Chest. 2004 Mar;125(3):1040-5. doi: 10.1378/chest.125.3.1040.
Morrell MR, Despotis GJ, Lublin DM, Patterson GA, Trulock EP, Hachem RR
The efficacy of photopheresis for bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2010 Apr;29(4):424-31. doi: 10.1016/j.healun.2009.08.029. Epub 2009 Oct 22.
Reviewed in: Centers for Medicare and Medicaid Services
Final Decision Memorandum for Extracorporeal Photophresis (CAG-00324R), April 2012

Extracorporeal Photopheresis for the Management of Progressive Bronchiolitis Obliterans Syndrome in Medicare-Eligible Recipients of Lung Allografts

Clinical trial NCT02181257 - References