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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
Sponsor:
Information provided by (Responsible Party):
Polyphor Ltd.

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

Condition or disease Intervention/treatment Phase
Bronchiectasis Lower Respiratory Infection Drug: POL7080 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: POL7080
POL7080 administered daily
Drug: POL7080
Intravenous infusion



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Other Outcome Measures:
  1. To measure the plasma concentrations of POL7080 [ Time Frame: Day 3 ]
    Blood samples to measure POL7080 concentrations before, during and after administration of POL7080



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Spain
Hospital Bellvitge
Barcelona, Spain
Hospital Clinic
Barcelona, Spain
Hospital La Fe
Valencia, Spain
United Kingdom
Royal Infirmary
City of Edinburgh, United Kingdom
Sponsors and Collaborators
Polyphor Ltd.
Investigators
Principal Investigator: Eva Polverino, MD Hospital Clinic, Barcelona, SPAIN
Principal Investigator: Adam Hill, MD PhD Royal Infirmary, Edinburgh, U.K.

Responsible Party: Polyphor Ltd.
ClinicalTrials.gov Identifier: NCT02096315     History of Changes
Other Study ID Numbers: POL7080-002
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: November 2015

Keywords provided by Polyphor Ltd.:
POL7080
Pseudomonas aeruginosa
Non cystic fibrosis bronchiectasis
Exacerbation

Additional relevant MeSH terms:
Infection
Fibrosis
Bronchiectasis
Respiratory Tract Infections
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases