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

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).