Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis
NCT ID: NCT00388505
Last Updated: 2012-07-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
517 participants
INTERVENTIONAL
2006-02-28
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tobramycin inhalation powder (TIP)
Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
Tobramycin Inhalation Powder
Tobramycin Inhalation Powder (TIP) capsules for inhalation.
Tobramycin solution for inhalation (TOBI)
Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
Tobramycin Solution for Inhalation
Tobramycin solution for inhalation (TOBI), supplied as 300 mg/5mL ampoules administered with a nebulizer
Interventions
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Tobramycin Inhalation Powder
Tobramycin Inhalation Powder (TIP) capsules for inhalation.
Tobramycin Solution for Inhalation
Tobramycin solution for inhalation (TOBI), supplied as 300 mg/5mL ampoules administered with a nebulizer
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
6 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Konstan, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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Novartis Investigative Site
Hartford, Connecticut, United States
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
Calgary, , Canada
Novartis Investigative Site
Hamilton, , Canada
Novartis Investigative Site
Ste-Foy, , Canada
Novartis Investigative Site
Vancouver, , Canada
Novartis Investigative Site
Santiago, , Chile
Novartis Investigative Site
Baranquilla, , Colombia
Novartis Investigative Site
Bogotá, , Colombia
Novartis Investigative Site
Cali, , Colombia
Novartis Investigative Site
Medellín, , Colombia
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Rouen, , France
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Bochum, , Germany
Novartis Investigative Site
Bonn, , Germany
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Essen, , Germany
Klinikum der Johann-Wolfgang-Goethe-Universitaet
Frankfurt, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Hanover, , Germany
Ludwig-Maximilians-Universitaet
Munich, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Hungary, , Hungary
Novartis Investigative Site
Kaposvár, , Hungary
Novartis Investigative Site
Haifa, , Israel
Novartis Investigative Site
Jerusalem, , Israel
Novartis Investigative Site
Petah Tikva, , Israel
Novartis Investigator Site
Genoa, , Italy
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Palermo, , Italy
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Potenza, , Italy
Novartis Investigative Site
Roma, , Italy
Novartis Investigative Site
Monterrey Nuevo Leon, , Mexico
Novartis Investigative Site
Groesbeek, , Netherlands
Novartis Investigative Site
Rotterdam, , Netherlands
Novartis Investigative Site
Barakaldo, , Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Málaga, , Spain
Novartis Investigative Site
Seville, , Spain
Novartis Investigative Site
Valencia, , Spain
Novartis Investigative Site
Belfast, , United Kingdom
Novartis Investigative Site
Birmingham, , United Kingdom
Novartis Investigative Site
Cambridge, , United Kingdom
Novartis Investigative Site
Leeds, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Sheffield, , United Kingdom
Countries
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Related Links
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Other Identifiers
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CTBM100C2302
Identifier Type: -
Identifier Source: org_study_id