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

This study has been completed.
Information provided by (Responsible Party):
Polyphor Ltd. Identifier:
First received: March 18, 2014
Last updated: November 24, 2015
Last verified: November 2015
To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis bronchiectasis caused by Pseudomonas aeruginosa infection.

Condition Intervention Phase
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
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: POL7080
POL7080 administered daily
Drug: POL7080
Intravenous infusion

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.

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT02096315

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.
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. Identifier: NCT02096315     History of Changes
Other Study ID Numbers: POL7080-002
Study First Received: March 18, 2014
Last Updated: November 24, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Respiratory Tract Infections
Bronchial Diseases
Respiratory Tract Diseases processed this record on November 30, 2015