Trial · NCT00388505
Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis
NCT00388505, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2012-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis. Trials, record NCT00388505. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00388505
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis
- NCT number
- NCT00388505
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 517 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Cystic Fibrosis
- Interventions
- Tobramycin Inhalation Powder, Tobramycin Solution for Inhalation
- First posted
- 2006-10-17
- Last updated
- 2012-07-24
- Results first posted
- 2012-07-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events | 25 weeks | An adverse event (AE) is any untoward medical occurrence, including any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication that does not necessarily have a causal relationship with study medication. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability, is a congenital anomaly or defect, or is a significant medical event that may jeopardize the patient or require intervention to prevent one of the outcomes listed above. |
| Secondary | Serum Tobramycin Concentrations | Weeks 1, 5, 17 and 21 | Serum tobramycin concentrations were measured in a subset of participants at Week 1 (start of cycle 1), Week 5 (End of Cycle 1), Week 17 (start of cycle 3) and Week 21 (end of cycle 3). Serum samples were collected at pre-dose and post-dose at specified intervals; one specimen between 0 to 2 hours; two additional specimens between 2 and 5 hours (sample times must have been a minimum of 2 hours apart). |
| Secondary | Percentage of Participants With a Decrease From Baseline in Auditory Acuity | Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) | Audiology testing was performed only at selected centers. Auditory acuity was measured from 250 to 8000 Hertz using a standard dual-channel audiometer. |
| Secondary | Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1) | Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25) | Forced expiratory volume in one second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 is then converted to a percentage of normal (percent predicted) based on height, weight, and race. FEV1 was measured at Baseline (prior to beginning study treatment) and predose on Day 28 of Cycles 1, 2 and 3 and at the follow-up visit. Relative change = 100 \* ((Day 28 of Cycle 3 value - Baseline value)/ Baseline value). |
| Secondary | Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication | Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21). | Patient's self-reported treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM, a validated instrument) which was modified by adding four study-specific questions; the standard fourteen questions of the TSQM were not altered. Responses to nearly all items are rated on a five-point or seven-point rating scale and the items are factored into 4 domains. The TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that domain. |
| Secondary | Change From Baseline in Pseudomonas Aeruginosa Sputum Density | Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25). | Three Pseudomonas aeruginosa biotypes were assessed in patient's sputum; mucoid, dry and small colony variant. Overall density is defined as the sum of all bio-types in Pseudomonas aeruginosa density. |
| Secondary | Change From Baseline in Tobramycin Minimum Inhibitory Concentration | Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25) | The minimum inhibitory concentration (MIC) is the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism after overnight incubation. The MIC of tobramycin against total Pseudomonas aeruginosa colonization was assessed over the course of the study. |
| Secondary | Antipseudomonal Antibiotic Usage During the Study | 25 Weeks | The average number of days patients required antipseudomonal antibiotics during the course of the study. |
| Secondary | Hospitalization Due to Respiratory Events During the Study | 25 Weeks | The average number of days patients were hospitalized due to respiratory events during the course of the study. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events | 25 weeks | All Randomized Safety population. | participants | NUMBER |
| SECONDARY | Serum Tobramycin Concentrations | Weeks 1, 5, 17 and 21 | Pharmacokinetic subpopulation | μg/mL | MEAN |
| SECONDARY | Percentage of Participants With a Decrease From Baseline in Auditory Acuity | Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) | Audiology subpopulation | percentage of participants | NUMBER |
| SECONDARY | Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1) | Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25) | Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported. | percent of predicted | MEAN |
| SECONDARY | Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication | Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21). | Intent-to-treat population for whom data were available. | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Pseudomonas Aeruginosa Sputum Density | Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25). | Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported. | log10 Colony forming units/g | MEAN |
| SECONDARY | Change From Baseline in Tobramycin Minimum Inhibitory Concentration | Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25) | Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported. | μg/mL | MEAN |
| SECONDARY | Antipseudomonal Antibiotic Usage During the Study | 25 Weeks | Patients in the intent-to-treat population who required antipseudomonal antibiotics. | days | MEAN |
| SECONDARY | Hospitalization Due to Respiratory Events During the Study | 25 Weeks | Patients in the intent-to-treat population who were hospitalized due to respiratory events. | days | MEAN |
Source ClinicalTrials.gov
Results by group106
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | Tobramycin Inhalation Powder (TIP) | Any adverse event | 278 | participants | |
| Number of Participants With Treatment-emergent Adverse Events | Tobramycin Solution for Inhalation (TOBI) | Any adverse event | 176 | participants | |
| Number of Participants With Treatment-emergent Adverse Events | Tobramycin Inhalation Powder (TIP) | Serious adverse event | 85 | participants | |
| Number of Participants With Treatment-emergent Adverse Events | Tobramycin Solution for Inhalation (TOBI) | Serious adverse event | 61 | participants | |
| Number of Participants With Treatment-emergent Adverse Events | Tobramycin Inhalation Powder (TIP) | Death | 3 | participants | |
| Number of Participants With Treatment-emergent Adverse Events | Tobramycin Solution for Inhalation (TOBI) | Death | 0 | participants | |
| Number of Participants With Treatment-emergent Adverse Events | Tobramycin Inhalation Powder (TIP) | Discontinued due to AE(s) | 46 | participants | |
| Number of Participants With Treatment-emergent Adverse Events | Tobramycin Solution for Inhalation (TOBI) | Discontinued due to AE(s) | 17 | participants | |
| Number of Participants With Treatment-emergent Adverse Events | Tobramycin Inhalation Powder (TIP) | Discontinued due to SAE(s) | 14 | participants | |
| Number of Participants With Treatment-emergent Adverse Events | Tobramycin Solution for Inhalation (TOBI) | Discontinued due to SAE(s) | 6 | participants |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tobramycin Inhalation Powder (TIP) | 308 | |
| Overall Study | STARTED | Tobramycin Solution for Inhalation (TOBI) | 209 | |
| Overall Study | COMPLETED | Tobramycin Inhalation Powder (TIP) | 225 | |
| Overall Study | COMPLETED | Tobramycin Solution for Inhalation (TOBI) | 171 | |
| Overall Study | NOT COMPLETED | Tobramycin Inhalation Powder (TIP) | 83 | |
| Overall Study | NOT COMPLETED | Tobramycin Solution for Inhalation (TOBI) | 38 |
Source ClinicalTrials.gov
Adverse events190
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Tobramycin Inhalation Powder (TIP) | 12 | 308 | |
| other | Abdominal pain | Gastrointestinal disorders | Tobramycin Solution for Inhalation (TOBI) | 17 | 209 | |
| other | Nausea | Gastrointestinal disorders | Tobramycin Inhalation Powder (TIP) | 23 | 308 | |
| other | Nausea | Gastrointestinal disorders | Tobramycin Solution for Inhalation (TOBI) | 19 | 209 | |
| other | Vomiting | Gastrointestinal disorders | Tobramycin Inhalation Powder (TIP) | 19 | 308 | |
| other | Vomiting | Gastrointestinal disorders | Tobramycin Solution for Inhalation (TOBI) | 11 | 209 | |
| other | Chest discomfort | General disorders | Tobramycin Inhalation Powder (TIP) | 20 | 308 | |
| other | Chest discomfort | General disorders | Tobramycin Solution for Inhalation (TOBI) | 6 | 209 | |
| other | Fatigue | General disorders | Tobramycin Inhalation Powder (TIP) | 18 | 308 | |
| other | Fatigue | General disorders | Tobramycin Solution for Inhalation (TOBI) | 10 | 209 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tobramycin Inhalation Powder (TIP) | ||
| Total, all-cause mortality | Tobramycin Solution for Inhalation (TOBI) | ||
| Total, other adverse events | Tobramycin Inhalation Powder (TIP) | 241 | 308 |
| Total, other adverse events | Tobramycin Solution for Inhalation (TOBI) | 148 | 209 |
| Total, serious adverse events | Tobramycin Inhalation Powder (TIP) | 85 | 308 |
| Total, serious adverse events | Tobramycin Solution for Inhalation (TOBI) | 61 | 209 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation (TOBI): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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