Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Respiratory Aspiration; Fibrosis
Intervention: Tobramycin Inhalation Powder; Tobramycin Solution for Inhalation
Intervention description: Tobramycin Inhalation Powder (TIP) capsules for inhalation.; Tobramycin solution for inhalation (TOBI), supplied as 300 mg/5mL ampoules administered with a nebulizer
Intervention MeSH terms: Tobramycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 517.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: tobramycin

Summary:

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

Eligibility 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