Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles

Exclusion Criteria

• •1. History of Burkholderia cenocepacia (Bcc) complex within 2 years prior to screening and/or Bcc complex at screening
• •2. Hemoptysis more than 60 cc at any time within 30 days prior to study drug administration
• •3. History of hearing loss or chronic tinnitus deemed clinically significant by the investigator
• •4. Serum creatinine 2 mg/dL or greater, BUN 40 mg/dL or greater, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening
• •5. Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
• •6. Patients who are unable to discontinue previously received inhaled antibiotic regimen(s) (inhaled antibiotics are not allowed other than study drug)
• •7. Use of inhaled aminoglycosides within 28 days prior to study drug administration (Visit 2)
• •8. Use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration
• •9. Use of loop diuretics within 7 days prior to study drug administration
• •10. Administration of any investigational drug within 30 days prior to enrollment or 5 half-lives, whichever is longer
• •11. Signs and symptoms of acute pulmonary disease, e.g , pneumonia, pneumothorax
• •12. Hospitalization during the baseline visit
• •13. History of malignancy
• •14. Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening
• •15. Patients with other clinically significant conditions (not associated with the study indication) which might interfere with the assessment of this study
• •16. Patients or caregivers with a history of noncompliance to medical regimens and patients or caregivers who are considered potentially unreliable
• •17. Pregnant or nursing (lactating) women
• •18. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods.