Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) Patients

Exclusion Criteria

• •1. Initiation of any new chronic therapy (e.g., ibuprofen, Pulmozyme®, hypertonic saline, azithromycin, TOBI®, Cayston®) within 4 weeks prior to screening.
• •2. Use of antibiotics \[oral, intravenous (iv), and/or inhaled\] for acute respiratory symptoms within 2 weeks prior to baseline.
• •3. Significant hemoptysis within 30 days prior to screening (≥5 mL of blood in one coughing episode or \>30 mL of blood in a 24 hour period)
• •4. History of colonization with nontuberculosis mycobacterium in sputum culture. The investigator can be guided by the following suggested criteria for a subject to be considered free of colonization:
• •* Two respiratory tract cultures negative for NTM in the last year, with no subsequent positive cultures; and
• •* these 2 respiratory cultures must be separated by at least 3 months; and
• •* one of these two cultures has to have been obtained within the last 6 months
• •5. Cardiac (left heart) insufficiency (defined as LVEF \<35%) at screening
• •6. Use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine or dapsone at screening
• •7. Any of the following abnormal lab values at Screening:
• •* Hemoglobin \< 10 g/dl
• •* Methemoglobn \>3%
• •* Platelet count \<100,000/mm3
• •* Prothrombin time international ratio (INR) \> 1.5
• •* Abnormal liver function defined as any two of the following:
• •* ALT \>3 x ULN
• •* AST \>3 x ULN
• •* ALP \> 3 x ULN
• •* GGT \> 3 x ULN
• •* Abnormal liver function defined as:
• •* ALT \>5 x ULN
• •* AST \>5 x ULN
• •* Abnormal renal function defined as:
• •* Calculated Creatinine Clearance \< 50 mL (as calculated by Cockcroft/Gault)
• •8. For women of child bearing potential:
• •* positive pregnancy test at screening or
• •* lactating or
• •* unwilling to practice a medically acceptable form of contraception from screening to Day 36 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent)
• •9. Use of an investigational drug within 30 days prior to screening
• •10. Intravenous or oral steroids in the 14 days prior to screening
• •11. Current use of inhaled steroids \>500 micrograms twice daily of Fluticasone or equivalent in the 30 days prior to screening
• •12. Use of supplemental oxygen (daytime or nocturnal) in the 7 days prior to screening
• •13. Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the subject