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

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

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

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