drugset / Trial / 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
Phase 2
Completed
107 enrolled
Novartis Pharmaceuticals
Erasmus Medical Center · collabFundacion Clinic per a la Recerca Biomédica · collabPapworth Hospital NHS Foundation Trust · collabQueen's University, Belfast · collabRoyal Brompton & Harefield NHS Foundation Trust · collabUniversity Hospital, Antwerp · collabUniversity of Dundee · collabUniversity of Edinburgh · collabUniversity of Milan · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study was to support the selection of a safe and tolerable tobramycin inhalation powder (TIP) dose, and regimen that exhibits effective bacterial reduction of P. aeruginosa in non-cystic fibrosis bronchiectasis (BE) patients with P. aeruginosa colonization.
Timeline
- Start
- 2017-02-08
- Primary completion
- 2019-03-20
- Completion
- 2019-03-20
Outcome
Met primary endpoint
paper All three TIP doses significantly reduced the P. aeruginosa sputum density from baseline to day 29 versus placebo in a dose-dependent manner (p≤0.0001, each). PMID 32855225 ↗
registry analysis (other test); Pooled TIP vs Pooled PBO; LS Mean Diff (SE) vs pooled placebo -2.8 (95% CI -3.66 to -1.89) NCT02712983 ↗
Publications
- Loebinger MR, Polverino E, Chalmers JD, Tiddens HAWM, Goossens H, Tunney M, Ringshausen FC, Hill AT, Pathan R, Angyalosi G, Blasi F, Elborn SJ, Haworth CS; iBEST-1 Trial Team. Efficacy and safety of TOBI Podhaler in Pseudomonas aeruginosa-infected bronchiectasis patients: iBEST study. Eur Respir J. 2021 Jan 5;57(1):2001451. doi: 10.1183/13993003.01451-2020. Print 2021 Jan.
- Loebinger MR, Polverino E, Blasi F, Elborn SJ, Chalmers JD, Tiddens HA, Goossens H, Tunney M, Zhou W, Angyalosi G, Hill AT, Haworth CS; iBEST-1 Trial Team. Efficacy and safety of tobramycin inhalation powder in bronchiectasis patients with P. aeruginosa infection: Design of a dose-finding study (iBEST-1). Pulm Pharmacol Ther. 2019 Oct;58:101834. doi: 10.1016/j.pupt.2019.101834. Epub 2019 Aug 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tobramycin | Unknown | 84 mg | — |
| Subject | Tobramycin | Unknown | 140 mg | — |
| Subject | Tobramycin | Unknown | 224 mg | — |