Phase 3
Completed N=55
Open Label Extension to Bridging Study CTBM100C2303
Pseudomonas Aeruginosa · Cystic fibrosis
Source: ClinicalTrials.gov NCT00982930 ↗
Enrolled (actual)
55
Serious AEs
5.5%
Results posted
Jun 2021
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs) — 47.3 percentage of participants
◆ Published Evidence
Emerging
19citations · ~2 / year
One-year safety and efficacy of tobramycin powder for inhalation in patients with cystic fibrosis.
Summary
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who had completed their study participation in CTBM100C2303 (all visits) and who were proven infected with Pseudomonas aeruginosa (P. aeruginosa) at enrollment into CTBM100C2303.
Linked Publications
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One-year safety and efficacy of tobramycin powder for inhalation in patients with cystic fibrosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
47.3 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) |
5.5 | — |
| PRIMARY Percentage of Death Cases |
— | — |
| PRIMARY Percentage of Participants With Adverse Events and Serious Adverse Events Leading to Permanent Study Discontinuation |
1.8; 0 | — |
| PRIMARY Shift From Baseline in Laboratory Parameters to Above Upper/Lower Limit of Normal |
0.0; 16.0; 0.0; 33.3; 10.6; 32.4 | — |
| PRIMARY Acute Relative Change in Airways Reactivity [Forced Expiratory Value in One Second (FEV1) Percent (%) Predicted] From Pre-dose to 30 Minutes After Completion of First Dose of Study Drug |
0.0; -3.0; -1.4; -1.8; -3.0; -0.6 | — |
| PRIMARY Percentage of Participants With Frequency Decrease From Baseline in the Post-baseline Audiology Tests |
5.6; 0.0; 0.0; 5.0; 0.0; 0.0 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) Associated With the Use of New Antipseudomonal Antibiotic |
1; 13; 3; 9; 0; 0 | — |
| SECONDARY Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing at Each Cycle and Study Completion |
13.5; 14.8; 17.3; 13.5; 13.9 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) Percent (%) Predicted to End of Dosing at Each Cycle and Study Completion |
7.0; 7.2; 9.6; 7.4; 7.9 | — |
| SECONDARY Change From Baseline in Forced Expiratory Flow Rate Over 25 Percent and 75 Percent (FEF25-75%) Predicted to End of Dosing at Each Cycle and Study Completion |
35.2; 44.7; 40.5; 35.9; 34.7 | — |
| SECONDARY Absolute Change From Baseline in Sputum Pseudomonas Aeruginosa Density [log10 Colony Forming Units (CFU) Per Gram Sputum] to End of Dosing at Each Cycle and Study Completion |
-3.7; -3.5; -3.9; -1.1; -2.9 | — |
| SECONDARY Change From Baseline in Pseudomonas Aeruginosa Minimum Inhibitory Concentration (MIC) to End of Dosing at Each Cycle and Study Completion |
15.1; 30.7; 24.0; 28.6; 22.3 | — |
| SECONDARY Percentage of Participants With Anti-Pseudomonal Antibiotic Use During The Treatment Period |
9.1 | — |
| SECONDARY Number of Days of Hospitalization Due to Respiratory Serious Adverse Events |
13.0 | — |
Eligibility Criteria
Inclusion Criteria
- Completed all visits in study CTBM100C2303, and visit 4 took place not more than 5 days before enrollment into this study.
- Confirmed diagnosis of cystic fibrosis participants with P. aeruginosa infection.
- Forced Expiratory Volume in One Second (FEV1) at screening (study CTBM100C2303) must be between 25% and 80% of normal predicted values.
Exclusion Criteria
- Any use of inhaled anti-pseudomonal antibiotics between the termination of the core trial CTMB100C2303 and the enrollment into this study.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Data sourced from ClinicalTrials.gov (NCT00982930) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.