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

Condition(s) targeted: Cystic Fibrosis

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

Phase: Phase 3

Status: Recruiting

Sponsored by: Novartis

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

Overall contact:
Novartis, Phone: 862-778-8300

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

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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Primary outcome: Safety assessed by incidence of treatment-emergent adverse events and clinical laboratory results

Secondary outcome:

Serum tobramycin concentrations

Audiology test results (at select CF centers)

Change in forced expiratory volume in one second (FEV1) at baseline and after Week 24

Patient satisfaction, assessed using the Treatment Satisfaction Questionnaire for Medication

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

Criteria:

Inclusion Criteria:

- Confirmed diagnosis of cystic fibrosis

- Male and female subjects at least 6 years of age at the time of screening.

- 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.

- P 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, 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 60cc 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 costicosteroids within 28 days prior to study drug administration (subjects 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

Novartis, Phone: 862-778-8300

Ludwig-Maximilians-Universitaet, Munich 80337, Germany; Recruiting

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

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

Rush University Center, Chicago, Illinois 60612, United States; Recruiting

University of Louisville, Louisville, Kentucky 40202, United States; Recruiting

Starting date: February 2006
Ending date: July 2009
Last updated: July 29, 2008