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

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ClinicalTrials.gov Identifier: NCT01519661
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : February 10, 2015
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pulmonary Infections
Pseudomonas Aeruginosa in Cystic Fibrosis
Intervention Drug: TBM100
Enrollment 157
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 157
Completed 96
Not Completed 61
Reason Not Completed
Protocol deviation             6
Lost to Follow-up             3
Withdrawal by Subject             17
Lack of Efficacy             6
Adverse Event             29
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 157
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 157 participants
27.8  (10.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants
Female
60
  38.2%
Male
97
  61.8%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 157 participants
57.4  (13.52)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 157 participants
20.5  (3.35)
FEV1 % predicted  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 157 participants
50.2  (13.95)
FVC % predicted  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 157 participants
73.9  (15.88)
FEF25-75 % predicted  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 157 participants
21.8  (12.75)
Sputum density of P. aeruginosa - sum of all biotypes  
Mean (Standard Deviation)
Unit of measure:  Log10 Colony Forming Units (CFU)
Number Analyzed 157 participants
7.6  (1.65)
P. aeruginosa tobramycin minimal inhibitory concentration (MIC)  
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 157 participants
> 8 ug/mL 26.1
<= 8 ug/mL 73.2
Missing 0.6
1.Primary Outcome
Title Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set: The safety set included all participants who received at least one dose of study drug.
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Measure Type: Number
Unit of Measure: Percentage of participants
Adverse events (serious and non-serious) 85.4
Serious adverse events 31.2
Deaths 0.0
2.Secondary Outcome
Title Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety set who had FEV1 percent predicted values at both baseline and the post baseline time points were analyzed at each given time point. The safety set included all participants who received at least one dose of study drug.
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Mean (Standard Deviation)
Unit of Measure: Percent change
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)
3.Secondary Outcome
Title Relative Change From Baseline in FVC Percent Predicted
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety set who had values at both baseline and the given assessment day were included in the analysis for that assessment day. Therefore, the 'n' for each assessment day is different. The safety set included all participants who received at least one dose of study drug.
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Mean (Standard Deviation)
Unit of Measure: Percent change
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)
4.Secondary Outcome
Title Relative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety set who had values at both baseline and the given assessment day were included in the analysis for that assessment day. Therefore, the 'n' for each assessment day is different. The safety set included all participants who received at least one dose of study drug.
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Mean (Standard Deviation)
Unit of Measure: Percent change
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)
5.Secondary Outcome
Title Change From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety set who had Pa sputum density values at both baseline and the given time point were included in the analysis. The safety set included all participants who received at least one dose of study drug.
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Mean (Standard Deviation)
Unit of Measure: log10 Colony Forming Unit (CFU)
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)
6.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety set who had data at each time point/cycle were analyzed at each time point. The safety set included all participants who received at least one dose of study drug.
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description:
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. Total number of isolates at each cycle/day: baseline = 279; cycle 1, day 29 = 252; cycle 2, day 85 = 238; cycle 3, day 141 = 210; cycle 4, day 197 = 184; cycle 5, day 253 = 178; cycle 6, day 309 = 164; and completion, day 337 = 158
Overall Number of Participants Analyzed 157
Measure Type: Number
Unit of Measure: ug/mL
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
7.Secondary Outcome
Title Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events
Hide Description [Not Specified]
Time Frame Day 337
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set: The safety set included all participants who received at least one dose of study drug.
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Measure Type: Number
Unit of Measure: Percentage of participants
26.8
8.Secondary Outcome
Title Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events
Hide Description The total number of hospitalization days due to serious respiratory-related adverse events was analyzed.
Time Frame Day 337
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set: The safety set included all participants who received at least one dose of study drug.
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Mean (Standard Deviation)
Unit of Measure: Days
18.1  (17.14)
9.Secondary Outcome
Title Time to First Hospitalization Due to Serious Respiratory-related Adverse Events
Hide Description The day of first hospitalization due to serious respiratory-related adverse events was analyzed.
Time Frame Day 337
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set The safety set included all participants who received at least one dose of study drug.
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
[1]
The median was not estimable due to an insufficient number of events.
10.Secondary Outcome
Title Percentage of Participants Who Used New Anti-pseudomonal Antibiotics
Hide Description [Not Specified]
Time Frame Day 337
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set: The safety set included all participants who received at least one dose of study drug.
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Measure Type: Number
Unit of Measure: Percentage of participants
65.6
11.Secondary Outcome
Title Number of Days of New Anti-pseudomonal Antibiotic Use
Hide Description The total number of days of new anti-pseudomonal antibiotic use was analyzed.
Time Frame Day 337
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set: The safety set included all participants who received at least one dose of study drug.
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Mean (Standard Deviation)
Unit of Measure: Days
33.1  (25.17)
12.Secondary Outcome
Title Time to Use of New Anti-pseudomonal Antibiotic
Hide Description Time to first use of new anti-pseudomonal antibiotic was analyzed.
Time Frame Day 337
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set The safety set included all participants who received at least one dose of study drug.
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Median (95% Confidence Interval)
Unit of Measure: Days
136
(97 to 170)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tobramycin Inhalation Powder (TIP)
Hide Arm/Group Description 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.
All-Cause Mortality
Tobramycin Inhalation Powder (TIP)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tobramycin Inhalation Powder (TIP)
Affected / at Risk (%)
Total   49/157 (31.21%) 
Cardiac disorders   
Supraventricular tachycardia  1  1/157 (0.64%) 
Tachyarrhythmia  1  1/157 (0.64%) 
Ear and labyrinth disorders   
Deafness unilateral  1  1/157 (0.64%) 
Tinnitus  1  1/157 (0.64%) 
Gastrointestinal disorders   
Gastritis  1  1/157 (0.64%) 
Gastrooesophageal reflux disease  1  1/157 (0.64%) 
Pancreatitis  1  1/157 (0.64%) 
Subileus  1  1/157 (0.64%) 
Infections and infestations   
Bronchopneumonia  1  1/157 (0.64%) 
Infective pulmonary exacerbation of cystic fibrosis  1  39/157 (24.84%) 
Influenza  1  2/157 (1.27%) 
Pneumonia  1  3/157 (1.91%) 
Injury, poisoning and procedural complications   
Rib fracture  1  1/157 (0.64%) 
Metabolism and nutrition disorders   
Hyperamylasaemia  1  1/157 (0.64%) 
Reproductive system and breast disorders   
Ovarian cyst  1  1/157 (0.64%) 
Respiratory, thoracic and mediastinal disorders   
Bronchospasm  1  1/157 (0.64%) 
Haemoptysis  1  5/157 (3.18%) 
Pneumothorax  1  1/157 (0.64%) 
Pulmonary embolism  1  1/157 (0.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Tobramycin Inhalation Powder (TIP)
Affected / at Risk (%)
Total   121/157 (77.07%) 
Gastrointestinal disorders   
Abdominal pain  1  6/157 (3.82%) 
Diarrhoea  1  11/157 (7.01%) 
Nausea  1  8/157 (5.10%) 
Vomiting  1  7/157 (4.46%) 
General disorders   
Chest discomfort  1  9/157 (5.73%) 
Fatigue  1  9/157 (5.73%) 
Pyrexia  1  12/157 (7.64%) 
Infections and infestations   
Infective pulmonary exacerbation of cystic fibrosis  1  66/157 (42.04%) 
Nasopharyngitis  1  20/157 (12.74%) 
Pharyngitis  1  5/157 (3.18%) 
Rhinitis  1  6/157 (3.82%) 
Upper respiratory tract infection  1  15/157 (9.55%) 
Investigations   
Forced expiratory volume decreased  1  8/157 (5.10%) 
Nervous system disorders   
Headache  1  11/157 (7.01%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  37/157 (23.57%) 
Dysphonia  1  7/157 (4.46%) 
Dyspnoea  1  11/157 (7.01%) 
Haemoptysis  1  33/157 (21.02%) 
Oropharyngeal pain  1  12/157 (7.64%) 
Respiratory tract congestion  1  5/157 (3.18%) 
Sputum increased  1  16/157 (10.19%) 
Wheezing  1  8/157 (5.10%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01519661     History of Changes
Other Study ID Numbers: CTBM100C2401
2011-002000-32 ( EudraCT Number )
First Submitted: January 24, 2012
First Posted: January 27, 2012
Results First Submitted: December 17, 2014
Results First Posted: February 10, 2015
Last Update Posted: February 10, 2015