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

NCT ID: NCT02096315

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-11-30

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.

Conditions

Bronchiectasis; Lower Respiratory Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

POL7080

POL7080 administered daily

Group Type: EXPERIMENTAL

POL7080

Intervention Type: DRUG

Intravenous infusion

Interventions

POL7080

Intravenous infusion

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polyphor Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Polverino, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic, Barcelona, SPAIN

Adam Hill, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Infirmary, Edinburgh, U.K.

Locations

Hospital Bellvitge

Barcelona, , Spain

Hospital Clinic

Barcelona, , Spain

Hospital La Fe

Valencia, , Spain

Royal Infirmary

City of Edinburgh, , United Kingdom

Countries

Spain; United Kingdom

Other Identifiers

POL7080-002

Identifier Type: -

Identifier Source: org_study_id