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

Bronchiectasis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02096315
• Other study ID #: POL7080-002
• Status: Terminated
• Phase: Phase 2
• First received: March 18, 2014
• Last updated: January 31, 2017
• Start date: December 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Polyphor Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Fibrosis
• Infection
• Lower Respiratory Infection
• Respiratory Tract Infections

Intervention

Drug:
• POL7080
Intravenous infusion

Locations

Country	Name	City	State
Spain	Hospital Bellvitge	Barcelona
Spain	Hospital Clinic	Barcelona
Spain	Hospital La Fe	Valencia
United Kingdom	Royal Infirmary	City of Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Polyphor Ltd.

Countries where clinical trial is conducted

Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To measure the plasma concentrations of POL7080	Blood samples to measure POL7080 concentrations before, during and after administration of POL7080	Day 3
Primary	Sputum bacterial clearance	Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa	Day 4, Day 5, Day 10, Day 15 and Day 20
Secondary	Adverse events	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.	Daily assessment up to 20 days from informed consent.
Secondary	Laboratory abnormalities.	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.	Day 4, Day 10, Day 15 and Day 20
Secondary	Volume of sputum in 24 hours	Reduction in 24 hours sputum volume as compared to baseline will be computed	Day 4, Day 10, Day 15 and Day 20