NCT02096315

Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis.

A Phase II, Open-label, Multicenter Study to Assess the Tolerance, Safety, Efficacy and Pharmacokinetics/Pharmacodynamics (PK/PD) of POL7080 in the Treatment of Patients With Acute Exacerbation of Non-cystic Fibrosis Bronchiectasis Due to Pseudomonas Aeruginosa Infection Requiring Intravenous Treatment

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Polyphor Ltd. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis bronchiectasis caused by Pseudomonas aeruginosa infection.

Detailed description

* Patients will be recruited after written informed consent. * Adverse events will be coded using Medical Dictionary for regulatory activities (MedDRA). * Descriptive statistics will be used for all the safety and efficacy variables.

Conditions

• Bronchiectasis
• Lower Respiratory Infection

Interventions

Type	Name	Description
DRUG	POL7080	Intravenous infusion

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-03-26
• Last updated: 2017-02-01

Locations

4 sites across 2 countries: Spain, United Kingdom