Back to resultsSafety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis.
Primary Purpose
Bronchiectasis, Lower Respiratory Infection
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
POL7080
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiectasis focused on measuring POL7080, Pseudomonas aeruginosa, Non cystic fibrosis bronchiectasis, Exacerbation
Eligibility Criteria
Inclusion Criteria:
- Male and female aged ≥18 to <80 years and suffering from exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection
- Sputum sample collected for culture before starting treatment
Exclusion Criteria:
- Female patients who are pregnant or breast feeding or unwilling to follow reliable method of contraception
- 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
- Current exacerbation of bronchiectasis is associated with lung abscess or empyema
- Current exacerbation episode is suspected or documented to be due to pathogens other than Pseudomonas aeruginosa
- Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count < 200/mm3
- 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
Sites / Locations
- Hospital Bellvitge
- Hospital Clinic
- Hospital La Fe
- Royal Infirmary
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
POL7080
Arm Description
POL7080 administered daily
Outcomes
Primary Outcome Measures
Sputum bacterial clearance
Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa
Secondary Outcome Measures
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.
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.
Volume of sputum in 24 hours
Reduction in 24 hours sputum volume as compared to baseline will be computed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02096315
Brief Title
Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis.
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 Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Study Start Date
December 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polyphor Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis, Lower Respiratory Infection
Keywords
POL7080, Pseudomonas aeruginosa, Non cystic fibrosis bronchiectasis, Exacerbation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
POL7080
Arm Type
Experimental
Arm Description
POL7080 administered daily
Intervention Type
Drug
Intervention Name(s)
POL7080
Intervention Description
Intravenous infusion
Primary Outcome Measure Information:
Title
Sputum bacterial clearance
Description
Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa
Time Frame
Day 4, Day 5, Day 10, Day 15 and Day 20
Secondary Outcome Measure Information:
Title
Adverse events
Description
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.
Time Frame
Daily assessment up to 20 days from informed consent.
Title
Laboratory abnormalities.
Description
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.
Time Frame
Day 4, Day 10, Day 15 and Day 20
Title
Volume of sputum in 24 hours
Description
Reduction in 24 hours sputum volume as compared to baseline will be computed
Time Frame
Day 4, Day 10, Day 15 and Day 20
Other Pre-specified Outcome Measures:
Title
To measure the plasma concentrations of POL7080
Description
Blood samples to measure POL7080 concentrations before, during and after administration of POL7080
Time Frame
Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female aged ≥18 to <80 years and suffering from exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection
Sputum sample collected for culture before starting treatment
Exclusion Criteria:
Female patients who are pregnant or breast feeding or unwilling to follow reliable method of contraception
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
Current exacerbation of bronchiectasis is associated with lung abscess or empyema
Current exacerbation episode is suspected or documented to be due to pathogens other than Pseudomonas aeruginosa
Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count < 200/mm3
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Polverino, MD
Organizational Affiliation
Hospital Clinic, Barcelona, SPAIN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Hill, MD PhD
Organizational Affiliation
Royal Infirmary, Edinburgh, U.K.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Facility Name
Royal Infirmary
City
City of Edinburgh
Country
United Kingdom
12. IPD Sharing Statement
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Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis.
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