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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: Tobramycin Inhalation Powder (Drug); Tobramycin Solution for Inhalation (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Michael Konstan, MD, Principal Investigator, Affiliation: University Hospital Case Medical Center

Summary

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

Clinical Details

Official title: A Randomized, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Treatment-emergent Adverse Events

Secondary outcome:

Serum Tobramycin Concentrations

Percentage of Participants With a Decrease From Baseline in Auditory Acuity

Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1)

Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication

Change From Baseline in Pseudomonas Aeruginosa Sputum Density

Change From Baseline in Tobramycin Minimum Inhibitory Concentration

Antipseudomonal Antibiotic Usage During the Study

Hospitalization Due to Respiratory Events During the Study

Eligibility

Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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. Exclusion Criteria:

- 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

Locations and Contacts

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, Bogota, Colombia

Novartis Investigative Site, Cali, Colombia

Novartis Investigative Site, Medellin, 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, Essen, Germany

Klinikum der Johann-Wolfgang-Goethe-Universitaet, Frankfurt 60596, Germany

Novartis Investigative Site, Frankfurt, Germany

Novartis Investigative Site, Hamburg, Germany

Novartis Investigative Site, Hannover, Germany

Novartis Investigative Site, Koeln, Germany

Novartis Investigative Site, Muenchen, Germany

Ludwig-Maximilians-Universitaet, Munich 80337, Germany

Novartis Investigative Site, Hungary, Hungary

Novartis Investigative Site, Kaposvar, Hungary

Novartis Investigative Site, Haifa, Israel

Novartis Investigative Site, Jerusalem, Israel

Novartis Investigative Site, Petach-Tikva, Israel

Novartis Investigator Site, Genoa, Italy

Novartis Investigative Site, Palermo, Italy

Novartis Investigative Site, 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, Baracaldo, Spain

Novartis Investigative Site, Barcelona, Spain

Novartis Investigative Site, Madrid, Spain

Novartis Investigative Site, Malaga, Spain

Novartis Investigative Site, Sevilla, 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

Novartis Investigative Site, Hartford, Connecticut 06102, United States

Emory University CF Center, Atlanta, Georgia 30322, United States

Rush University Center, Chicago, Illinois 60612, United States

University of Louisville, Louisville, Kentucky 40202, United States

Novartis Investigative Site, Boston, Massachusetts 02115, United States

Novartis Investigative Site, Lebanon, New Hampshire 03756, United States

Novartis Investigative Site, Livingston, New Jersey 07039, United States

Novartis Investigative Site, Long Branch, New Jersey 07740, United States

Novartis Investigative Site, Morristown, New Jersey 07967, United States

Novartis Investigative Site, Somerset, New Jersey 08873, United States

Novartis Investigative Site, Albany, New York 12208, United States

Novartis Investigative Site, Buffalo, New York 14222, United States

Novartis Investigative Site, New Hyde Park, New York 11040, United States

Novartis Investigative Site, New York City, New York 10011, United States

University of Rochester, Rochester, New York 14642, United States

Novartis Investigative Site, Stony Brook, New York 11794, United States

Novartis Investigative Site, Syracuse, New York 13210, United States

Novartis Investigative Site, Valhalla, New York 10595, United States

Penn State College of Medicine, Hershey, Pennsylvania 17033, United States

Drexel University College of Medicine, Philadelphia, Pennsylvania 19102, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Novartis Investigative Site, Burlington, Vermont 05401, United States

University of Virginia Health System, Charlottesville, Virginia 22903, United States

West Virginia University Health Sciences Center, Morgantown, West Virginia 26506, United States

Additional Information

Starting date: February 2006
Last updated: June 19, 2012

Page last updated: August 23, 2015

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