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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

NCT02712983 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2020-08-25

Study results available
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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.

Conditions

  • Non-cystic Fibrosis Bronchiectasis

Interventions

DRUG

TIP

TIP dose regimen

DRUG

TIP and placebo

TIP and inhaled placebo dose regimen

DRUG

Placebo

Inhaled placebo dose regimen

Sponsors & Collaborators

  • Queen's University, Belfast

    collaborator OTHER

  • University Hospital, Antwerp

    collaborator OTHER

  • University of Milan

    collaborator OTHER

  • Fundacion Clinic per a la Recerca Biomédica

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Papworth Hospital NHS Foundation Trust

    collaborator OTHER_GOV

  • Royal Brompton & Harefield NHS Foundation Trust

    collaborator OTHER

  • University of Dundee

    collaborator OTHER

  • University of Edinburgh

    collaborator OTHER

  • Novartis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Novartis Pharma · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2019-03-20
Completion
2019-03-20

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02712983 on ClinicalTrials.gov