PulminiqTM (cyclosporine, USP) Inhalation Solution (CyIS)

Food and Drug Administration


Division of Special Pathogen and Immunologic Drug Products

Briefing Document for the Pulmonary Advisory Committee Meeting June 6, 2005





1.) Trulock EP et al. The Registry of the International Society for Heart Lung Transplantation: Twenty-first Official Adult Lung and Heart-Lung Transplant Report 2004, J Heart Lung Transplant 2004;23:804-15.


2.) Neuringer IP et al. Obliterative Bronchiolitis or Chronic Lung Allograft Rejection: A Basic Science Review. J Heart Lung Transplant 2005;24:3-19.


3.) Sharples LD et al. Risk Factors for Bronchiolitis Obliterans: A Systematic Review of Recent Publications. J Heart Lung Transplant 2002;21:271-81.


4.) Estenne M et al. Bronchiolitis Obliterans Syndrome 2001: An Update of the Diagnostic Criteria. J Heart Lung Transplant 2002;21:297-310.


5.) Bowdish ME et al. Surrogate Markers and Risk Factors for Chronic Lung Allograft Dysfunction. American Journal of Transplantation 2004;4:1171-78.


6.) Hsu LM Random Sampling, Randomization, and Equivalence of Contrasted Groups in Psychotherapy Outcome Research. Journal of Consulting and Clinical Psychology 1989; 57: 131-137.


7.) Pocock, S.J. and Simon, R. Sequential Treatment Assignment with Balancing for Prognostic Factors in the Controlled Clinical Trial. Biometrics 1975; 31: 103-115