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

Phase 2

Terminated

• Conditions: Bronchiectasis; Lower Respiratory Infection
• Interventions: Drug: POL7080

• Registration Number: NCT02096315
• Lead Sponsor: Polyphor Ltd.

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
POL7080	POL7080	POL7080 administered daily

Primary Outcome Measures

Name	Time	Method
Sputum bacterial clearance	Day 4, Day 5, Day 10, Day 15 and Day 20	Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa

Secondary Outcome Measures

Name	Time	Method
Adverse events	Daily assessment up to 20 days from informed consent.	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.	Day 4, Day 10, Day 15 and Day 20	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	Day 4, Day 10, Day 15 and Day 20	Reduction in 24 hours sputum volume as compared to baseline will be computed

Trial Locations

Locations (4)

Hospital Bellvitge; 🇪🇸 Barcelona, Spain

Royal Infirmary; 🇬🇧 City of Edinburgh, United Kingdom

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain