Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis

Completed · Phase 3

Conditions studied: Cystic Fibrosis

In brief

This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

Key facts

Study ID

NCT00388505

Run by

Novartis Pharmaceuticals

People needed

517

Starts

2006-02-01

Expected to finish

2009-03-01

Last updated by the study team

2012-07-24

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of cystic fibrosis
• Male and female patients at least 6 years of age at the time of screening.
• Forced expiratory volume in one second (FEV1) at screening must be at least 25% and less than or equal to 75% of normal predicted values for age, sex, and height based on Knudson criteria.
• Pseudomonas aeruginosa, a type of bacteria, must be present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/ deep-throat cough swab culture at the screening visit.
• Able to comply with all protocol requirements.
• Clinically stable in the opinion of the investigator.
• Use of an effective means of contraception in females of childbearing potential.
• Provide written informed consent, Health Authority Portability and Accountability Act (HIPAA) authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure.

You may not qualify if…

• History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B cepacia), a type of bacteria, within 2 years prior to screening and/or sputum culture yielding B cepacia at screening.
• Coughing up more than 60 cc of blood from the respiratory tract at any time within 30 days prior to study drug administration.
• Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
• Females who are pregnant (positive pregnancy test), lactating, or are planning to become pregnant during the study.
• History of hearing loss or chronic ringing in the ears deemed clinically significant by the investigator.
• Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study drug administration.
• Use of loop diuretics within 7 days prior to study drug administration.
• Use of any investigational treatment within 28 days prior to study drug administration.
• Initiation of treatment with chronic macrolide therapy, dornase alpha treatment or inhaled corticosteroids within 28 days prior to study drug administration (patients may be taking these therapies at the time of enrollment, but they must have initiated treatment more than 28 days prior to study drug administration).
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Emory University CF Center — Atlanta, Georgia, United States
• Rush University Center — Chicago, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Lebanon, New Hampshire, United States
• Novartis Investigative Site — Livingston, New Jersey, United States
• Novartis Investigative Site — Long Branch, New Jersey, United States
• Novartis Investigative Site — Morristown, New Jersey, United States
• Novartis Investigative Site — Somerset, New Jersey, United States
• Novartis Investigative Site — Albany, New York, United States
• Novartis Investigative Site — Buffalo, New York, United States
• Novartis Investigative Site — New Hyde Park, New York, United States
• Novartis Investigative Site — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Novartis Investigative Site — Stony Brook, New York, United States
• Novartis Investigative Site — Syracuse, New York, United States
• Novartis Investigative Site — Valhalla, New York, United States
• Penn State College of Medicine — Hershey, Pennsylvania, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Burlington, Vermont, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• West Virginia University Health Sciences Center — Morgantown, West Virginia, United States
• Novartis Investigative Site — South Brisbane, Australia
• Novartis Investigative Site — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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