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Trial · Interventional

TerminatedPhase 2Registry data

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

NCTNCT02096315 (opens ClinicalTrials.gov in a new tab)Other idPOL7080-002
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Overview

Status
Terminated
Phase
Phase 2
Enrollment
20 participants (estimated)
Sponsor
Polyphor Ltd. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
2 countries

Spain, United Kingdom

Start
Dec 2013
Primary completion
Nov 2015
Completion
Nov 2015
First posted
26 Mar 2014 (estimated)
Last update posted
1 Feb 2017 (estimated)
Conditions
Bronchiectasis · Lower Respiratory Infection

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 2

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

    NCT02096315

    Dec 2013 to Nov 2015

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • POL7080Drug

Arms1

  • Experimental

    POL7080

    POL7080 administered daily

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Sputum bacterial clearance

    Time frame · Day 4, Day 5, Day 10, Day 15 and Day 20

    Registry description

    Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa

Secondary outcomes(3)

  1. Adverse events

    Time frame · Daily assessment up to 20 days from informed consent.

    Registry 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.

  2. Laboratory abnormalities.

    Time frame · Day 4, Day 10, Day 15 and Day 20

    Registry 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.

  3. Volume of sputum in 24 hours

    Time frame · Day 4, Day 10, Day 15 and Day 20

    Registry description

    Reduction in 24 hours sputum volume as compared to baseline will be computed

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 79 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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