Health Condition 1: null- Cystic Fibrosis
Conditions
Interventions
Intervention1: TIP new: Experimental: Tobramycin Inhalation Powder
Tobramycin Inhalation Powder as produced by a modified manufacturing process (TIP new)
Control Intervention1: Placebo Comparator:
Sponsors
Novartis HealthCare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: . Written informed consent given by adult subjects or by the parents/legal guardian on behalf of the subject in combination with the subjectâ?? s assent, if capable of assenting, before any assessment is performed. • Confirmed diagnosis of CF by the presence of one or more clinical features of CF in addition to o a quantitative pilocarpine iontophoresis sweat chloride test of > 60 mEq/L; or o identification of well-characterized disease-causing mutations in each CFTR gene; or o an abnormal nasal transepithelial potential difference characteristic of CF. • Male and female subjects aged 6 years to 21 years of age at the time of screening. • FEV1 at screening must be >= 25% and based on Knudson criteria. • P. aeruginosa 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 expectorate a sputum sample or to provide a deep-throat cough swab at screening. • Able to comply with all protocol requirements. • Use of an effective means of contraception in females of childbearing potential. • Clinically stable in the opinion of the investigator to be treated according to this protocol.
Exclusion criteria
Exclusion criteria: * Any use of inhaled anti-pseudomonal antibiotics within 4 months prior to screening. * Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics. Other protocol-defined inclusion/exclusion criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change from baseline FEV1 percent predicted compared to placeboTimepoint: Day 29 of on-treatment period of cycle 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Density of microorganisms in sputum samplesTimepoint: Day 1, 29, 57;Pharmacokinetic properties of tobramycin from TIPnewTimepoint: Days 1 and 29;Safety profile of TIPnewTimepoint: As reported until 4 weeks post study | — |
Countries
Egypt, Estonia, India, Latvia, Russian Federation
Contacts
Public ContactMurugananthan K
Outcome results
None listed