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

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

Study Overview

• Status: Terminated
• Conditions: Bronchiectasis; Lower Respiratory Infection
• Intervention / Treatment: Drug: POL7080

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Clinic
  • Barcelona, Spain
    • Hospital Bellvitge
  • Valencia, Spain
    • Hospital la Fe
• United Kingdom
  • City of Edinburgh, United Kingdom
    • Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female aged ≥18 to <80 years and suffering from exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection
2. Sputum sample collected for culture before starting treatment

Exclusion Criteria:

1. Female patients who are pregnant or breast feeding or unwilling to follow reliable method of contraception
2. Subjects suffering from cystic fibrosis, active pulmonary mycobacterial infection, end stage chronic obstructive pulmonary disease on long term oxygen therapy, severe uncontrolled asthma, active sarcoidosis and active allergic broncho-pulmonary aspergillosis
3. Current exacerbation of bronchiectasis is associated with lung abscess or empyema
4. Current exacerbation episode is suspected or documented to be due to pathogens other than Pseudomonas aeruginosa
5. Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count < 200/mm3
6. Patients who are currently enrolled in, or have not yet completed at least 30 days since ending another investigational device or drug trial or are receiving other investigational agent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: POL7080; POL7080 administered daily	Drug: POL7080; Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sputum bacterial clearance	Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa	Day 4, Day 5, Day 10, Day 15 and Day 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	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.	Daily assessment up to 20 days from informed consent.
Laboratory abnormalities.	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.	Day 4, Day 10, Day 15 and Day 20
Volume of sputum in 24 hours	Reduction in 24 hours sputum volume as compared to baseline will be computed	Day 4, Day 10, Day 15 and Day 20

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the plasma concentrations of POL7080	Blood samples to measure POL7080 concentrations before, during and after administration of POL7080	Day 3

Collaborators and Investigators

• Sponsor: Polyphor Ltd.
• Investigators: Principal Investigator: Eva Polverino, MD, Hospital CLinic, Barcelona, Spain; Principal Investigator: Adam Hill, MD PhD, Royal Infirmary, Edinburgh, U.K.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (ESTIMATE): March 26, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Exacerbation; Pseudomonas aeruginosa; Non cystic fibrosis bronchiectasis; POL7080
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Bronchial Diseases; Fibrosis; Bronchiectasis; Infections; Respiratory Tract Infections; Anti-Infective Agents; Anti-Bacterial Agents; Murepavadin
• Other Study ID Numbers: POL7080-002