Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Tobramycin Inhalation Powder
Intervention description: Tobramycin Inhalation Powder 112 mg (four 28-mg capsules) taken via inhaler once or twice a day, depending on study arm
Intervention MeSH terms: Tobramycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; CF

Summary:

      To provide efficacy and safety data comparing two dosing schedules of Tobramycin Inhalation
      Powder (TIP) for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic
      fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written informed consent, HIPPA (Health Insurance Portability and
             Accountability Act) authorization (where applicable), and assent (as appropriate)
             prior to the performance of any study-related procedure.

          2. Confirmed diagnosis of CF

          3. FEV1 at screening (Visit 1) ≥25% and ≤ 80% of normal predicted values for age, sex,
             and height

          4. P. aeruginosa must be present within 6 months prior to screening and at screening

          5. Able to comply with all protocol requirements

          6. Clinically stable in the opinion of the investigator

        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.

        Other protocol-defined inclusion/exclusion criteria may apply.