Phase 3
Completed N=49
Second Open Label Extension to Bridging Study CTBM100C2303
Chronic Obstructive Pulmonary Disease · Pseudomonas Aeruginosa
Source: ClinicalTrials.gov NCT01069705 ↗
Enrolled (actual)
49
Serious AEs
4.1%
Results posted
Jun 2021
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 23 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 have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.
Linked Publications
-
One-year safety and efficacy of tobramycin powder for inhalation in patients with cystic fibrosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
23 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
2 | — |
| PRIMARY Percentage of Participants With a Decrease of ≥20% in Forced Expiratory Value in One Second (FEV1) Percent (%) Predicted From Pre-dose to 30-minute Post-dose |
2.3; 0.0; 2.5; 4.3; 6.7; 0.0 | — |
| PRIMARY Percentage of Participants With Frequency Decrease From Baseline in the Post-baseline Audiology Tests |
0.0; 0.0; 0.0; 0.0; 5.3; 0.0 | — |
| SECONDARY Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to Each Post-baseline Visit |
59.5; 11.4; 12.6; 8.6; 11.9; 9.0 | — |
| SECONDARY Relative Change From Baseline of Forced Vital Capacity (FVC) Percent Predicted to Each Post-baseline Visit |
75.0; 5.1; 5.2; 2.6; 6.2; 2.3 | — |
| SECONDARY Relative Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent (FEF25-75%) Predicted to Each Post-baseline Visit |
36.8; 37.7; 43.2; 35.1; 34.3; 44.4 | — |
| SECONDARY Change From Baseline in Pseudomonas Aeruginosa Sputum Density to Each Post-baseline Visit |
7.4; -1.1; -3.7; -1.6; -3.6; -1.5 | — |
| SECONDARY Change From Baseline in Tobramycin Minimum Inhibitory Concentration (MIC) Values for Pseudomonas Aeruginosa to Each Post-baseline Visit |
2.2; 31.4; 21.6; 39.3; 25.5; 3.7 | — |
| SECONDARY Number of Participants Who Used New Antipseudomonal Antibiotic During Treatment Period |
7 | — |
| SECONDARY Percentage of Participants With Hospitalization Due to Respiratory Serious Adverse Events (SAEs) |
4.1 | — |
| SECONDARY Number of Days of Hospitalization Due to Respiratory Serious Adverse Events (SAEs) |
16.5 | — |
Eligibility Criteria
Inclusion Criteria
- Completed all visits in study CTBM100C2303 and CTBM100C2303E1, and visit 11 of study CTBM100C2303E1 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 (at start of 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 trial CTMB100C2303E1 and the enrollment into this study.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Data sourced from ClinicalTrials.gov (NCT01069705) 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.