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 Information
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
Administrative Informations
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