Clinical trial NCT02096315: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bronchiectasis
Lower Respiratory Infection
Keywords: POL7080
Pseudomonas aeruginosa
Non cystic fibrosis bronchiectasis
Exacerbation
Lead sponsor: Polyphor Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: 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.

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

Primary outcomes:
measure: Sputum bacterial clearance
timeFrame: Day 4, Day 5, Day 10, Day 15 and Day 20
Secondary outcomes:
measure: Adverse events
timeFrame: Daily assessment up to 20 days from informed consent.
measure: Laboratory abnormalities.
timeFrame: Day 4, Day 10, Day 15 and Day 20
measure: Volume of sputum in 24 hours
timeFrame: Day 4, Day 10, Day 15 and Day 20
Other outcomes:
measure: To measure the plasma concentrations of POL7080
timeFrame: Day 3
Locations:
city: Barcelona
country: Spain
facility: Hospital Bellvitge
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Valencia
country: Spain
facility: Hospital La Fe
city: City of Edinburgh
country: United Kingdom
facility: Royal Infirmary
Study officials:
affiliation: Hospital Clinic, Barcelona, SPAIN
name: Eva Polverino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Infirmary, Edinburgh, U.K.
name: Adam Hill, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: