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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Polyphor Ltd.
Sponsor:
Information provided by (Responsible Party):
Polyphor Ltd.
ClinicalTrials.gov Identifier:
NCT02096315
First received: March 18, 2014
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Bronchiectasis
Lower Respiratory Infection
Drug: POL7080
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Polyphor Ltd.:

Primary Outcome Measures:
  • Sputum bacterial clearance [ Time Frame: Day 4, Day 5, Day 10, Day 15 and Day 20 ] [ Designated as safety issue: No ]
    Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa


Secondary Outcome Measures:
  • Adverse events [ Time Frame: Daily assessment up to 20 days from informed consent. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Reduction in 24 hours sputum volume as compared to baseline will be computed


Other Outcome Measures:
  • To measure the plasma concentrations of POL7080 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Blood samples to measure POL7080 concentrations before, during and after administration of POL7080


Estimated Enrollment: 20
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: POL7080
POL7080 administered daily
Drug: POL7080
Intravenous infusion
Other Name: 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.
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02096315

Contacts
Contact: Klaus Dembowsky, MD +41 61 567 16 00 Klaus.Dembowsky@polyphor.com
Contact: Manickam Rangaraju, MD +41 61 567 16 00 Manickam.Rangaraju@polyphor.com

Locations
Spain
Hospital Clinic Recruiting
Barcelona, Spain
Hospital Bellvitge Active, not recruiting
Barcelona, Spain
Hospital La Fe Recruiting
Valencia, Spain
United Kingdom
Royal Infirmary Recruiting
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.
  More Information

No publications provided

Responsible Party: Polyphor Ltd.
ClinicalTrials.gov Identifier: NCT02096315     History of Changes
Other Study ID Numbers: POL7080-002
Study First Received: March 18, 2014
Last Updated: March 21, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

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

ClinicalTrials.gov processed this record on July 31, 2014