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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01519661
Registration number
NCT01519661
Ethics application status
Date submitted
24/01/2012
Date registered
27/01/2012
Date last updated
10/02/2015
Titles & IDs
Public title
Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis
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Scientific title
A Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis
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Secondary ID [1]
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2011-002000-32
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Secondary ID [2]
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CTBM100C2401
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Infections
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Pseudomonas Aeruginosa in Cystic Fibrosis
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Cystic fibrosis
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Respiratory
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TBM100
Experimental: Tobramycin Inhalation Powder (TIP) - Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
Treatment: Drugs: TBM100
Tobramycin inhalation powder was assigned as four capsules at 28mg dosage strength. It was inhaled b.i.d in the morning and in the evening via the T-326 Inhaler.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths
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Assessment method [1]
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Adverse events were deemed treatment-emergent if the onset date/time was on or after the date and time of first study drug. All adverse events were included after this time during both on and off-treatment periods.
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Timepoint [1]
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337 days
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Secondary outcome [1]
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Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted
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Assessment method [1]
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Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day X FEV1 % predicted - baseline FEV1 % predicted) / baseline FEV1 % predicted) • 100.
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Timepoint [1]
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Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.
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Secondary outcome [2]
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Relative Change From Baseline in FVC Percent Predicted
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Assessment method [2]
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Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FVC % predicted from baseline to pre-dose day X = ((pre-dose day X FVC % predicted - baseline FVC % predicted) / baseline FVC % predicted) • 100.
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Timepoint [2]
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Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.
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Secondary outcome [3]
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Relative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted
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Assessment method [3]
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Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recored at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEEF25-75 from baseline to pre-dose day X = ((pre-dose day X FEF25-75 - baseline FEF25-75) / baseline FEF25-75) • 100.
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Timepoint [3]
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Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.
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Secondary outcome [4]
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Change From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum
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Assessment method [4]
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Sputum was collected in sterile containers and cultured for Pseudomonas aeruginosa (Pa.) (quantitative test) and other typical Cystic Fibrosis respiratory pathogens. The Pa. biotypes measured were mucoid, dry and small colony variant. Results are presented for the sum of all biotypes of Pa, with data transformed using a base 10 logarithm.
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Timepoint [4]
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Baseline, day 1, day 29, day 85, day 141, day 197, day 253, day 309, day 337
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Secondary outcome [5]
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Tobramycin MIC 50 and MIC 90 Values Over All Isolates for the Sum of All Biotypes (Mucoid, Dry and Small Colony Variant) of Pseudomonas Aeruginosa
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Assessment method [5]
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Tobramycin MIC 50 and MIC 90 values were defined as the lowest concentration of tobramycin required to inhibit 50% and 90%, respectively, of the P. aeruginosa strains tested.
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Timepoint [5]
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Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337
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Secondary outcome [6]
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Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events
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Assessment method [6]
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Timepoint [6]
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Day 337
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Secondary outcome [7]
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Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events
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Assessment method [7]
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The total number of hospitalization days due to serious respiratory-related adverse events was analyzed.
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Timepoint [7]
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Day 337
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Secondary outcome [8]
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Time to First Hospitalization Due to Serious Respiratory-related Adverse Events
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Assessment method [8]
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The day of first hospitalization due to serious respiratory-related adverse events was analyzed.
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Timepoint [8]
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Day 337
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Secondary outcome [9]
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Percentage of Participants Who Used New Anti-pseudomonal Antibiotics
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Assessment method [9]
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Timepoint [9]
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Day 337
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Secondary outcome [10]
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Number of Days of New Anti-pseudomonal Antibiotic Use
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Assessment method [10]
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The total number of days of new anti-pseudomonal antibiotic use was analyzed.
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Timepoint [10]
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Day 337
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Secondary outcome [11]
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Time to Use of New Anti-pseudomonal Antibiotic
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Assessment method [11]
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Time to first use of new anti-pseudomonal antibiotic was analyzed.
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Timepoint [11]
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Day 337
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Eligibility
Key inclusion criteria
- Confirmed diagnosis of Cystic Fibrosis
- FEV1 at screening must be between 25 and 75 percent of normal predicted values for
age, sex and height based on the Knudson equation
- Pseudomonas aeruginosa must be present in a sputum / deep cough throat swab culture or
bronchoalveolar lavage within 6 months prior to screening and in the
sputum/deep-throat cough swab culture at screening
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Minimum age
6
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of sputum culture or deep cough throat swab culture yielding Burkholderia
cenocepacia complex within 2 years prior to screening and /or sputum culture yielding
Burkholderia cenocepacia at screening
- Hemoptysis more than 60mL at any time within 30 days prior to study drug
administration
- History of hearing loss or chronic tinnitus deemed clinically significant
- Serum creatinine 2mg/dl or more, BUN 40mg/dl or more, or an abnormal urinalysis
defined as 2+ or greater proteinuria at screening
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
- Patients who are regularly receiving more than 1 class of inhaled anti-pseudomonal
antibiotic
- Any use of inhaled or systemic anti-pseudomonal antibiotic within 28 days prior to
study drug administration
- Use of loop diuretics within 7 days prior to study drug administration
Other protocol-defined inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2014
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Sample size
Target
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Accrual to date
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Final
157
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - New Lambton Heights
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Recruitment hospital [2]
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Novartis Investigative Site - Clayton
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Recruitment hospital [3]
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Novartis Investigative Site - Parkville
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Recruitment postcode(s) [1]
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2305 - New Lambton Heights
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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Colorado
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Florida
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Georgia
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United States of America
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Missouri
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Nebraska
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United States of America
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Nevada
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New Jersey
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Ohio
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Oklahoma
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United States of America
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South Carolina
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Texas
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Canada
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France
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Giens Cedex
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France
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Montpellier
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France
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Paris
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France
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Reims
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France
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Roscoff
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Germany
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Essen
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Germany
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Frankfurt
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Hungary
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Budapest
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FI
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Italy
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GE
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Italy
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ME
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Italy
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VR
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Italy
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Napoli
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Italy
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Palermo
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Italy
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Roma
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Mexico
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Distrito Federal
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Mexico
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Nuevo León
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Spain
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Cataluña
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Spain
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Comunidad Valenciana
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study assessed the long term safety data for the use of tobramycin inhalation powder in
patients suffering from cystic fibrosis who have a chronic pulmonary infection with
Pseudomonas aeruginosa.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01519661
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01519661
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