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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Bronchiectasis, Lower Respiratory Infection

Intervention / Treatment
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* Drug: POL7080


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female aged ≥18 to <80 years and suffering from exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection Sputum sample collected for culture before starting treatment Exclusion Criteria: Female patients who are pregnant or breast feeding or unwilling to follow reliable method of contraception 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 Current exacerbation of bronchiectasis is associated with lung abscess or empyema Current exacerbation episode is suspected or documented to be due to pathogens other than Pseudomonas aeruginosa Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count < 200/mm3 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POL7080<br>POL7080 administered daily | Drug: POL7080<br>* Intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POL7080, Pseudomonas aeruginosa, Non cystic fibrosis bronchiectasis, Exacerbation