Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis.
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|ClinicalTrials.gov Identifier: NCT02096315|
Recruitment Status : Terminated
First Posted : March 26, 2014
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bronchiectasis Lower Respiratory Infection||Drug: POL7080||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
POL7080 administered daily
- Sputum bacterial clearance [ Time Frame: Day 4, Day 5, Day 10, Day 15 and Day 20 ]Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa
- Adverse events [ Time Frame: Daily assessment up to 20 days from informed consent. ]Number of adverse events reported by the patients or observed by the investigator will be recorded. Onset, end date, severity, causal relationship, outcome and measures taken will be summarized. Death, discontinuations and serious adverse events will be listed and narrative summaries will be provided.
- Laboratory abnormalities. [ Time Frame: Day 4, Day 10, Day 15 and Day 20 ]The number and severity of abnormal blood chemistry and hematology findings will be summarized descriptively and compared to baseline. Clinically significant values/outliers will be listed and commented.
- Volume of sputum in 24 hours [ Time Frame: Day 4, Day 10, Day 15 and Day 20 ]Reduction in 24 hours sputum volume as compared to baseline will be computed
- To measure the plasma concentrations of POL7080 [ Time Frame: Day 3 ]Blood samples to measure POL7080 concentrations before, during and after administration of POL7080
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096315
|Hospital La Fe|
|City of Edinburgh, United Kingdom|
|Principal Investigator:||Eva Polverino, MD||Hospital Clinic, Barcelona, SPAIN|
|Principal Investigator:||Adam Hill, MD PhD||Royal Infirmary, Edinburgh, U.K.|