Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02712983 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | PHASE2 | COMPLETED | 107 | — | — | Feb 8, 2017 | Mar 20, 2019 | Aug 25, 2020 | 34 | Belgium, France +4 |
Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. Change was determined using the formula = (Post-baseline value - baseline value). If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes. Only values for all morphotypes presented.
| Arm | Type | Description |
|---|---|---|
| Cohort A (3 capsules o.d.): TIP | EXPERIMENTAL | Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) |
| Cohort A (3 capsules o.d.): TIP/PBO | EXPERIMENTAL | Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical |
| Cohort A (3 capsules o.d.): PBO | PLACEBO_COMPARATOR | Cohort A (3 capsules o.d.): Inhaled placebo (PBO) |
| Cohort B (5 capsules o.d.): TIP | EXPERIMENTAL | Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) |
| Cohort B (5 capsules o.d.): TIP/PBO | EXPERIMENTAL | Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical |
| Cohort B (5 capsules o.d.): PBO | PLACEBO_COMPARATOR | Cohort B (5 capsules o.d.): inhaled placebo (PBO) |
| Cohort C (4 capsules b.i.d.): TIP | EXPERIMENTAL | Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) |
| Cohort C (4 capsules b.i.d.): TIP/PBO | EXPERIMENTAL | Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical |
| Cohort C (4 capsules b.i.d.): PBO | PLACEBO_COMPARATOR | Cohort C (4 capsules b.i.d.): inhaled placebo (PBO) |
| Name | Type | Description |
|---|---|---|
| TIP | DRUG | TIP dose regimen |
| TIP and placebo | DRUG | TIP and inhaled placebo dose regimen |
| Placebo | DRUG | Inhaled placebo dose regimen |
Key Inclusion Criteria: * Written informed consent must be obtained before any assessment is performed. * Male and female patients of ≥ 18 years of age at screening (Visit 1). * Proven diagnosis of non-CF BE as documented by computed tomography or high-resolution computed tomography * At least 2 or...