CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 107 enrolled
Drug / intervention
TIP +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02712983
NCT02712983Phase 2Completed
CompareCT.gov

A Randomized, Blinded, Parallel Group, Multi-center Dose-finding Study, to Assess the Efficacy, Safety and Tolerability of Different Doses of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection

Novartis Pharmaceuticals·interventional·Posted Mar 18, 2016·Updated Aug 25, 2020

In Brief

A Phase 2 clinical trial evaluating TIP, TIP and placebo, and 1 other intervention for Non-cystic Fibrosis Bronchiectasis. Completed, enrolled 107 participants across 34 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-cystic Fibrosis Bronchiectasis
CountriesBelgium, France, Germany, Italy, Spain, United Kingdom
CollaboratorsQueen's University, Belfast, University Hospital, Antwerp, University of Milan, Fundacion Clinic per a la Recerca Biomédica, Erasmus Medical Center, Papworth Hospital NHS Foundation Trust, Royal Brompton & Harefield NHS Foundation Trust, University of Dundee, University of Edinburgh

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 18, 2016
Enrollment StartFeb 8, 2017
Primary CompletionMar 20, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.3 years ago

Interventions

TIPdrug

TIP dose regimen

TIP and placebodrug

TIP and inhaled placebo dose regimen

Placebodrug

Inhaled placebo dose regimen