Cystic Fibrosis MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0 Level: LLT Classification code 10021860 Term: Infection Pseudomonas aeruginosa System Organ Class: 100000004862
Conditions
Interventions
Trade Name: TOBI Podhaler
Pharmaceutical Form: Capsule
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
Novartis Pharmaceuticals Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Provide written informed consent, HIPPA (Health Insurance Portability and Accountability Act) authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure. Confirmed diagnosis of CF 3.FEV1 at screening (Visit 1) =25% and = 80% of normal predicted values for age, sex, and height 4.P. aeruginosa must be present within 6 months prior to screening and at screening 5.Able to comply with all protocol requirements 6.Clinically stable in the opinion of the investigator Are the trial subjects under 18? yes Number of subjects for this age range: 3 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: History of Burkholderia cenocepacia (Bcc) complex within 2 years prior to screening and/or Bcc complex at screening 2.Hemoptysis more than 60 cc at any time within 30 days prior to study drug administration 3.History of hearing loss or chronic tinnitus deemed clinically significant by the investigator 4.Serum creatinine 2 mg/dL or greater, BUN 40 mg/dL or greater, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening 5.Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics 6.Patients who are unable to discontinue previously received inhaled antibiotic regimen(s) (inhaled antibiotics are not allowed other than study drug) 7.Use of inhaled aminoglycosides within 28 days prior to study drug administration (Visit 2) 8.Use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration 9.Use of loop diuretics within 7 days prior to study drug administration 10.Administration of any investigational drug within 30 days prior to enrollment or 5 half-lives, whichever is longer 11.Signs and symptoms of acute pulmonary disease, e.g , pneumonia, pneumothorax 12.Hospitalization during the baseline visit 13.History of malignancy 14.Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening 15.Patients with other clinically significant conditions (not associated with the study indication) which might interfere with the assessment of this study 16.Patients or caregivers with a history of noncompliance to medical regimens and patients or caregivers who are considered potentially unreliable 17.Pregnant or nursing (lactating) women 18.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide efficacy and safety data comparing two dosing schedules of Tobramycin Inhalation Powder (TIP) for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis.;Secondary Objective: To provide efficacy and safety data comparing two dosing schedules of Tobramycin Inhalation Powder (TIP) for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis.;Primary end point(s): Change from baseline in Forced Expiratory Volume in 1 second ( FEV1) percent predicted [ Time Frame: Baseline and Day 168 ] The Forced Expiratory Volume in 1 second (FEV1) percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 percent predicted indicates improvement in lung function.;Timepoint(s) of evaluation of this end point: Time Frame: Baseline and Day 168 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percent change from baseline in Forced Expiratory Volume in 1 second (FEV1) percent predicted [ Time Frame: Baseline and Day 168 ] The Forced Expiratory Volume in 1 second (FEV1) percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 percent predicted indicates improvement in lung function. •Percent change from baseline in Forced Vital Capacity (FVC) percent predicted [ Time Frame: Baseline and Day 168 ] Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function. •Percent change from baseline in forced expiratory flow (FEF) 25%-75% predicted [ Time Frame: Baseline and day 168 ] The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function. The predicted percent will be assessed. •Change from baseline in Pseudomonas aeruginosa sputum density [ Time Frame: Baseline and day 168 ] Change from baseline in Pseudomonas aeruginosa sputum density will be measured by log10 colony forming units per gram of sputum. •Time to first hospitalization due to respiratory-related events [ Time Frame: Day 1 to day 168 ] Time to the first hospitalization due to respiratory-related events (number of days) per patient. •Percentage of patients with hospitalizations due to respiratory-related events [ Time Frame: Day 1 to day 168 ] Percentage of patients with hospitalization due to respiratory-related events •Length of hospital stay due to respiratory-related events [ Time Frame: Day 1 to d | — |
Countries
United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed