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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Tobramycin Inhalation Powder 112 mg (four 28-mg capsules) taken via inhaler once or twice a day, depending on study arm
Novartis Investigative Site
Mobile, Alabama, United States
Change From Baseline in Forced Expiratory Volume in 1 Second ( FEV1) Percent Predicted
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.
Time frame: Baseline and Day 168
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted
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.
Time frame: Baseline and Day 168
Percent Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted
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.
Time frame: Baseline and Day 168
Percent Change From Baseline in Forced Expiratory Flow (FEF) 25%-75% Predicted
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.
Time frame: Baseline and day 168
Change From Baseline in Pseudomonas Aeruginosa Sputum Density
Change from baseline in Pseudomonas aeruginosa sputum density will be measured by log10 colony forming units per gram of sputum.
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Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Sacramento, California, United States
Novartis Investigative Site
Ventura, California, United States
Novartis Investigative Site
Altamonte Springs, Florida, United States
Novartis Investigative Site
Jacksonville, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Pensacola, Florida, United States
Novartis Investigative Site
Glenview, Illinois, United States
...and 11 more locations
Time frame: Baseline and day 168
Time to First Hospitalization Due to Respiratory-related Events
Time to the first hospitalization due to respiratory-related events (number of days) per patient.
Time frame: Day 1 to day 168
Percentage of Patients With Hospitalizations Due to Respiratory-related Events
Percentage of patients with hospitalization due to respiratory-related events
Time frame: Day 1 to day 168
Length of Hospital Stay Due to Respiratory-related Events
The number of days in length of hospital stay per patient due to respiratory-related events will be measured.
Time frame: Day 1 to day 168
Time to First Usage of Anti-pseudomonal Antibiotic
Time to first usage of anti-pseudomonal antibiotic per patient will be assessed by number of days
Time frame: Day 1 to day 168
Percentage of Patients Who Use Anti-pseudomonal Antibiotic
Percentage of patients who use anti-pseudomonal antibiotic will be assessed.
Time frame: Day 1 to day 168
Duration of Use of Anti-pseudomonal Antibiotic
Number of days of use of anti-pseudomonal antibiotic per patient will be assessed.
Time frame: Day 1 to day 168
Change From Baseline in Tobramycin Minimal Inhibitory Concentration for Pseudomonas Aeruginosa
Change from baseline in tobramycin minimal inhibitory concentration for Pseudomonas aeruginosa will be measured by laboratory testing.
Time frame: Baseline and day 168