CClinicalTrials.gg
Sign In
CompletedNCT01519661Updated Feb 10, 2015Results posted

Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis

A Phase 4 interventional study of TBM100 in Pulmonary Infections and Pseudomonas Aeruginosa in Cystic Fibrosis, sponsored by Novartis Pharmaceuticals. Completed at 49 sites in 10 countries. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2015-02-10.

Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
157
Allocation
Non-randomized
Ages
6 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Infections
  • Pseudomonas Aeruginosa in Cystic Fibrosis

Keywords

  • Tobramycin Inhalation powder
  • Cystic fibrosis
  • Lung disease
  • Anti-bacterial agents
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 157 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
157 participants (actual)

Study arms

  • 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.

    Drug: TBM100

Interventions

  • DrugTBM100

    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.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths

    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.

    Time frame: 337 days

Secondary outcomes

  1. Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted

    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.

    Time frame: 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.

  2. Relative Change From Baseline in FVC Percent Predicted

    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.

    Time frame: 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.

  3. Relative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted

    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.

    Time frame: 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.

  4. Change From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum

    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.

    Time frame: Baseline, day 1, day 29, day 85, day 141, day 197, day 253, day 309, day 337

  5. 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

    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.

    Time frame: Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337

  6. Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events

    Time frame: Day 337

  7. Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events

    The total number of hospitalization days due to serious respiratory-related adverse events was analyzed.

    Time frame: Day 337

  8. Time to First Hospitalization Due to Serious Respiratory-related Adverse Events

    The day of first hospitalization due to serious respiratory-related adverse events was analyzed.

    Time frame: Day 337

  9. Percentage of Participants Who Used New Anti-pseudomonal Antibiotics

    Time frame: Day 337

  10. Number of Days of New Anti-pseudomonal Antibiotic Use

    The total number of days of new anti-pseudomonal antibiotic use was analyzed.

    Time frame: Day 337

  11. Time to Use of New Anti-pseudomonal Antibiotic

    Time to first use of new anti-pseudomonal antibiotic was analyzed.

    Time frame: Day 337

07

Results

Posted Feb 10, 2015

Participant flow

Participant flow — Overall Study
MilestoneTobramycin Inhalation Powder (TIP)
Started157
Completed96
Not completed61
Withdrew: Protocol deviation6
Withdrew: Lost to follow-up3
Withdrew: Withdrawal by subject17
Withdrew: Lack of efficacy6
Withdrew: Adverse event29

Outcome measures

PrimaryPercentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths

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.

Time frame:
337 days
Reported as:
Number · Percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths
Percentage of participantsTobramycin Inhalation Powder (TIP)
Adverse events (serious and non-serious)85.4
Serious adverse events31.2
Deaths0.0
SecondaryRelative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted

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.

Time frame:
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.
Reported as:
Mean · Percent change
Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted
Percent changeTobramycin Inhalation Powder (TIP)
Day 29, Cycle 1 (n=149)0.8 ± 17.17
Day 85, Cycle 2 (n=146)0.0 ± 17.09
Day 141, Cycle 3 (n=128)0.2 ± 15.13
Day 197, Cycle 4 (n=116)-0.2 ± 15.36
Day 253, Cycle 5 (n=105)-1.5 ± 17.19
Day 309, Cycle 6 (n=100)-1.9 ± 14.55
Day 337, Completion (n=93)-3.5 ± 16.81
SecondaryRelative Change From Baseline in FVC Percent Predicted

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.

Time frame:
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.
Reported as:
Mean · Percent change
Relative Change From Baseline in FVC Percent Predicted
Percent changeTobramycin Inhalation Powder (TIP)
Day 29, Cycle 1 (n=149)-2.5 ± 12.95
Day 85, Cycle 2 (n=146)-2.8 ± 12.81
Day 141, Cycle 3 (n=128)-2.1 ± 12.25
Day 197, Cycle 4 (n=116)-1.8 ± 12.64
Day 253, Cycle 5 (n=105)-3.5 ± 13.11
Day 309, Cycle 6 (n=100)-3.1 ± 12.17
Day 337, Completion (n=93)-2.8 ± 13.50
SecondaryRelative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted

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.

Time frame:
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.
Reported as:
Mean · Percent change
Relative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted
Percent changeTobramycin Inhalation Powder (TIP)
Day 29, Cycle 1 (n=149)10.3 ± 36.05
Day 85, Cycle 2 (n=146)9.4 ± 55.35
Day 141, Cycle 3 (n=128)5.5 ± 31.82
Day 197, Cycle 4 (n=116)6.0 ± 30.96
Day 253, Cycle 5 (n=105)2.9 ± 33.23
Day 309, Cycle 6 (n=100)4.3 ± 32.44
Day 337, Completion (n=93)0.7 ± 33.78
SecondaryChange From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum

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.

Time frame:
Baseline, day 1, day 29, day 85, day 141, day 197, day 253, day 309, day 337
Reported as:
Mean · log10 Colony Forming Unit (CFU)
Change From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum
log10 Colony Forming Unit (CFU)Tobramycin Inhalation Powder (TIP)
Sum of all biotypes, Day 29, Cycle 1 (n=141)-1.6 ± 2.28
Sum of all biotypes, Day 85, Cycle 2 (n=135)-1.1 ± 1.80
Sum of all biotypes, Day 141, Cycle 3 (n=119)-1.2 ± 1.98
Sum of all biotypes, Day 197, Cycle 4(n=107)-1.1 ± 2.11
Sum of all biotypes. Day 253, Cycle 5 (n=98)-1.3 ± 2.23
Sum of all biotypes, Day 309, Cycle 6 (n=89)-1.2 ± 2.09
Sum of all biotypes, Day 337, Completion (n=85)-0.4 ± 2.08
SecondaryTobramycin MIC 50 and MIC 90 Values Over All Isolates for the Sum of All Biotypes (Mucoid, Dry and Small Colony Variant) of Pseudomonas Aeruginosa

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.

Time frame:
Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337
Reported as:
Number · ug/mL
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
ug/mLTobramycin Inhalation Powder (TIP)
Baseline - MIC 50 (n=156)2
Cycle 1, day 29 - MIC 50 (n=144)2
Cycle 2, day 85 - MIC 50 (n=137)2
Cycle 3, day 141 - MIC 50 (n=124)2
Cycle 4, day 197 - MIC 50 (n=108)2
Cycle 5, day 253 - MIC 50 (n=98)2
Cycle 6, day 309 - MIC 50 (n=90)4
Completion, day 337 - MIC 50 (n=89)2
Baseline - MIC 90 (n=156)128
Cycle 1, day 29 - MIC 90 (n=144)256
Cycle 2, day 85 - MIC 90 (n=137)256
Cycle 3, day 141 - MIC 90 (n=124)256
Cycle 4, day 197 - MIC 90 (n=108)128
Cycle 5, day 253 - MIC 90 (n=98)256
Cycle 6, day 309 - MIC 90 (n=90)256
Completion, day 337 - MIC 90 (n=89)512
SecondaryPercentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events
Time frame:
Day 337
Reported as:
Number · Percentage of participants
Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events
Percentage of participantsTobramycin Inhalation Powder (TIP)
Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events26.8
SecondaryNumber of Hospitalization Days Due to Serious Respiratory-related Adverse Events

The total number of hospitalization days due to serious respiratory-related adverse events was analyzed.

Time frame:
Day 337
Reported as:
Mean · Days
Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events
DaysTobramycin Inhalation Powder (TIP)
Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events18.1 ± 17.14
SecondaryTime to First Hospitalization Due to Serious Respiratory-related Adverse Events

The day of first hospitalization due to serious respiratory-related adverse events was analyzed.

Time frame:
Day 337
Reported as:
Median · Days
Time to First Hospitalization Due to Serious Respiratory-related Adverse Events
DaysTobramycin Inhalation Powder (TIP)
Time to First Hospitalization Due to Serious Respiratory-related Adverse EventsNA (NA to NA)
SecondaryPercentage of Participants Who Used New Anti-pseudomonal Antibiotics
Time frame:
Day 337
Reported as:
Number · Percentage of participants
Percentage of Participants Who Used New Anti-pseudomonal Antibiotics
Percentage of participantsTobramycin Inhalation Powder (TIP)
Percentage of Participants Who Used New Anti-pseudomonal Antibiotics65.6
SecondaryNumber of Days of New Anti-pseudomonal Antibiotic Use

The total number of days of new anti-pseudomonal antibiotic use was analyzed.

Time frame:
Day 337
Reported as:
Mean · Days
Number of Days of New Anti-pseudomonal Antibiotic Use
DaysTobramycin Inhalation Powder (TIP)
Number of Days of New Anti-pseudomonal Antibiotic Use33.1 ± 25.17
SecondaryTime to Use of New Anti-pseudomonal Antibiotic

Time to first use of new anti-pseudomonal antibiotic was analyzed.

Time frame:
Day 337
Reported as:
Median · Days
Time to Use of New Anti-pseudomonal Antibiotic
DaysTobramycin Inhalation Powder (TIP)
Time to Use of New Anti-pseudomonal Antibiotic136 (97 to 170)

Adverse events

Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tobramycin Inhalation Powder (TIP)—49/157 (31.2%)121/157 (77.1%)
Most frequent serious events
Showing 10 of 19
Most frequent serious events
EventTobramycin Inhalation Powder (TIP)
Infective pulmonary exacerbation of cystic fibrosisInfections and infestations39/157
HaemoptysisRespiratory, thoracic and mediastinal disorders5/157
PneumoniaInfections and infestations3/157
InfluenzaInfections and infestations2/157
Supraventricular tachycardiaCardiac disorders1/157
TachyarrhythmiaCardiac disorders1/157
Deafness unilateralEar and labyrinth disorders1/157
TinnitusEar and labyrinth disorders1/157
GastritisGastrointestinal disorders1/157
Gastrooesophageal reflux diseaseGastrointestinal disorders1/157
Most frequent other events
Showing 10 of 22
Most frequent other events
EventTobramycin Inhalation Powder (TIP)
Infective pulmonary exacerbation of cystic fibrosisInfections and infestations66/157
CoughRespiratory, thoracic and mediastinal disorders37/157
HaemoptysisRespiratory, thoracic and mediastinal disorders33/157
NasopharyngitisInfections and infestations20/157
Sputum increasedRespiratory, thoracic and mediastinal disorders16/157
Upper respiratory tract infectionInfections and infestations15/157
PyrexiaGeneral disorders12/157
Oropharyngeal painRespiratory, thoracic and mediastinal disorders12/157
DiarrhoeaGastrointestinal disorders11/157
HeadacheNervous system disorders11/157

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Tobramycin Inhalation Powder (TIP)
Mean27.8 ± 10.82
Sex: Female, Male
Sex: Female, Male(Participants)Tobramycin Inhalation Powder (TIP)
Female60
Male97
Weight
Weight(kilograms (kg))Tobramycin Inhalation Powder (TIP)
Mean57.4 ± 13.52
Body Mass Index
Body Mass Index(kg/m^2)Tobramycin Inhalation Powder (TIP)
Mean20.5 ± 3.35
FEV1 % predicted
FEV1 % predicted(percent)Tobramycin Inhalation Powder (TIP)
Mean50.2 ± 13.95
FVC % predicted
FVC % predicted(percent)Tobramycin Inhalation Powder (TIP)
Mean73.9 ± 15.88
FEF25-75 % predicted
FEF25-75 % predicted(percent)Tobramycin Inhalation Powder (TIP)
Mean21.8 ± 12.75
Sputum density of P. aeruginosa - sum of all biotypes
Sputum density of P. aeruginosa - sum of all biotypes(log10 Colony Forming Units (CFU))Tobramycin Inhalation Powder (TIP)
Mean7.6 ± 1.65

1 further baseline measures are reported on the registry.

08

Study locations

49 sites
  • Novartis Investigative Site
    Little Rock, Arkansas 72205, United States
  • Novartis Investigative Site
    Denver, Colorado 80206, United States
  • Novartis Investigative Site
    Jacksonville, Florida 32207, United States
  • Novartis Investigative Site
    Atlanta, Georgia 30322, United States
  • Novartis Investigative Site
    St. Louis, Missouri 63110, United States
  • Novartis Investigative Site
    Omaha, Nebraska 68198, United States
  • Novartis Investigative Site
    Las Vegas, Nevada 89107, United States
  • Novartis Investigative Site
    Morristown, New Jersey 07962, United States
  • Novartis Investigative Site
    Akron, Ohio 44308, United States
  • Novartis Investigative Site
    Cleveland, Ohio 44106, United States
  • Novartis Investigative Site
    Oklahoma City, Oklahoma 73104, United States
  • Novartis Investigative Site
    Oklahoma City, Oklahoma 73112, United States
  • Novartis Investigative Site
    Charleston, South Carolina 29425, United States
  • Novartis Investigative Site
    Dallas, Texas 75230, United States
  • Novartis Investigative Site
    Fort Worth, Texas 76104, United States
  • Novartis Investigative Site
    Houston, Texas 77030, United States
  • Novartis Investigative Site
    San Antonio, Texas 78212, United States
  • Novartis Investigative Site
    Tacoma, Washington 98405, United States
  • Novartis Investigative Site
    Madison, Wisconsin 53792-1615, United States
  • Novartis Investigative Site
    Milwaukee, Wisconsin 53226, United States
  • Novartis Investigative Site
    Caba, Buenos Aires C1425DTG, Argentina
  • Novartis Investigative Site
    Capital Federal, Buenos Aires C1425EFD, Argentina
  • Novartis Investigative Site
    Córdoba, Cordoba X5014AKN, Argentina
  • Novartis Investigative Site
    Paraná, Entre Rios E3100FKA, Argentina
  • Novartis Investigative Site
    New Lambton Heights, New South Wales 2305, Australia
  • Novartis Investigative Site
    Clayton, Victoria 3168, Australia
  • Novartis Investigative Site
    Parkville, Victoria 3052, Australia
  • Novartis Investigative Site
    Calgary, Alberta T2N 4n1, Canada
  • Novartis Investigative Site
    Edmonton, Alberta T6G 2B7, Canada
  • Novartis Investigative Site
    Montreal, Quebec H3T1C5, Canada
  • Novartis Investigative Site
    Giens Cedex, 83406, France
  • Novartis Investigative Site
    Montpellier, 34059, France
  • Novartis Investigative Site
    Paris, 75006, France
  • Novartis Investigative Site
    Reims, 51092, France
  • Novartis Investigative Site
    Roscoff, 29684, France
  • Novartis Investigative Site
    Essen, 45147, Germany
  • Novartis Investigative Site
    Frankfurt, 60590, Germany
  • Novartis Investigative Site
    Budapest, 1121, Hungary
  • Novartis Investigative Site
    Firenze, FI 50139, Italy
  • Novartis Investigative Site
    Genova, GE 16147, Italy
  • Novartis Investigative Site
    Messina, ME 98125, Italy
  • Novartis Investigative Site
    Verona, VR 37126, Italy
  • Novartis Investigative Site
    Napoli, 80131, Italy
  • Novartis Investigative Site
    Palermo, 90100, Italy
  • Novartis Investigative Site
    Roma, 00161, Italy
  • Novartis Investigative Site
    Mexico, Distrito Federal 06720, Mexico
  • Novartis Investigative Site
    Monterrey, Nuevo León 64460, Mexico
  • Novartis Investigative Site
    Barcelona, Cataluña, Spain
  • Novartis Investigative Site
    Valencia, Comunidad Valenciana 46026, Spain
09

References and documents

Publications

  • Sommerwerck U, Virella-Lowell I, Angyalosi G, Viegas A, Cao W, Debonnett L. Long-term safety of tobramycin inhalation powder in patients with cystic fibrosis: phase IV (ETOILES) study. Curr Med Res Opin. 2016 Nov;32(11):1789-1795. doi: 10.1080/03007995.2016.1211516. Epub 2016 Sep 9. PubMed 27435882 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01519661
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 27, 2012
Start date
Jan 2012
Primary completion
Jan 2014
Completion
Jan 2014
Results posted
Feb 10, 2015
Last update
Feb 10, 2015

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cystic Fibrosis→

Other studies from this sponsor

Novartis Pharmaceuticals

Start the discussion