We're sorry, but this trial is no longer enrolling volunteers.
A 24-week, Open-label, Parallel-group, Interventional Phase IV Study Comparing Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles for the Treatment of Pulmonary Pseudomonas Aeruginosa in Patients With Cystic Fibrosis
Description
Phase
Phase 4 - refines the treatment to become part of standard care.
Inclusion and Exclusion Criteria
- 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.
- Confirmed diagnosis of CF
- FEV1 at screening (Visit 1) ≥25% and ≤ 80% of normal predicted values for age, sex, and height
- P. aeruginosa must be present within 6 months prior to screening and at screening
- Able to comply with all protocol requirements
- Clinically stable in the opinion of the investigator
- History of Burkholderia cenocepacia (Bcc) complex within 2 years prior to screening and/or Bcc complex at screening
- Hemoptysis more than 60 cc at any time within 30 days prior to study drug administration
- History of hearing loss or chronic tinnitus deemed clinically significant by the investigator
- 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
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
- Patients who are unable to discontinue previously received inhaled antibiotic regimen(s) (inhaled antibiotics are not allowed other than study drug)
- Use of inhaled aminoglycosides within 28 days prior to study drug administration (Visit 2)
- Use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration
- Use of loop diuretics within 7 days prior to study drug administration
- Administration of any investigational drug within 30 days prior to enrollment or 5 half-lives, whichever is longer
- Signs and symptoms of acute pulmonary disease, e.g , pneumonia, pneumothorax
- Hospitalization during the baseline visit
- History of malignancy
- Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening
- Patients with other clinically significant conditions (not associated with the study indication) which might interfere with the assessment of this study
- Patients or caregivers with a history of noncompliance to medical regimens and patients or caregivers who are considered potentially unreliable
- Pregnant or nursing (lactating) women
- 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.
Sites
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California
- Novartis Investigative Site, Los Angeles, California, 90027
- Novartis Investigative Site, Long Beach, California, 90801
- Novartis Investigative Site, Orange, California, 92868
- Novartis Investigative Site, Ventura, California, 93003
- Novartis Investigative Site, La Jolla, California, 92037
- Novartis Investigative Site, Sacramento, California, 95817
- Novartis Investigative Site, Sacramento, California, 95819
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Arizona
- Novartis Investigative Site, Phoenix, Arizona, 85016
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Utah
- Novartis Investigative Site, Salt Lake City, Utah, 84132
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Oregon
- Novartis Investigative Site, Portland, Oregon, 97239
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Washington
- Novartis Investigative Site, Tacoma, Washington, 98405
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Oklahoma
- Novartis Investigative Site, Oklahoma City, Oklahoma, 73112
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Texas
- Novartis Investigative Site, Austin, Texas, 78723
- Novartis Investigative Site, Tyler, Texas, 75708
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Missouri
- Novartis Investigative Site, St. Louis, Missouri, 63104
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Illinois
- Novartis Investigative Site, Glenview, Illinois, 60025
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Indiana
- Novartis Investigative Site, Indianapolis, Indiana, 46202
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Florida
- Novartis Investigative Site, Pensacola, Florida, 32504
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