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

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

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Sputum bacterial clearance

Secondary Outcome

 Adverse events

Condition

Bronchiectasis

Intervention

POL7080

Study Arms / Comparison Groups

 POL7080

Description:  POL7080 administered daily

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

20

Start Date

December 2013

Completion Date

November 2015

Primary Completion Date

November 2015

Eligibility 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
      

Gender

All

Ages

18 Years - 79 Years

Accepts Healthy Volunteers

No

Contacts

Eva Polverino, MD, , 

Location Countries

Spain

Location Countries

Spain

NCT ID

NCT02096315

Organization ID

POL7080-002

Responsible Party

Sponsor

Study Sponsor

Polyphor Ltd.

Study Sponsor

Eva Polverino, MD, Principal Investigator, Hospital Clinic, Barcelona, SPAIN

Verification Date

November 2015