BronchiectasisPhase 2NCT02096315
Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis.
A Phase 2 study testing POL7080 in people with Bronchiectasis and Lower Respiratory Infection, run by Polyphor Ltd. at 4 sites in 2 countries.
Trial summary
To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis bronchiectasis caused by Pseudomonas aeruginosa infection. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Bronchiectasis, Lower Respiratory Infection
- What is being tested?
- POL7080
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2013to Nov 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Spain3 sites
Hospital Bellvitge
Barcelona
Hospital Clinic
Barcelona
Hospital La Fe
Valencia
About this study
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
To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis bronchiectasis caused by Pseudomonas aeruginosa infection.
Read the 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.
- Conditions
- Bronchiectasis, Lower Respiratory Infection
- Being tested
- POL7080
- Keywords
- POL7080, Pseudomonas aeruginosa, Non cystic fibrosis bronchiectasis, Exacerbation
- Medical subject headings
- Bronchiectasis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POL7080Drug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| POL7080 | Experimental | POL7080 administered daily Receives: Drug: POL7080 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum bacterial clearance
Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa
Measured: Day 4, Day 5, Day 10, Day 15 and Day 20
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: Day 4, Day 10, Day 15 and Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polyphor Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eva Polverino, MD, Principal investigator, Hospital Clinic, Barcelona, SPAINAdam Hill, MD PhD, Principal investigator, Royal Infirmary, Edinburgh, U.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096315
- Sponsor's protocol ID
- POL7080-002
- Status last verified
- Nov 2015
- First submitted
- 18 Mar 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02096315
- Acronym / sponsor ID
- POL7080-002
- Conditions
- Bronchiectasis, Lower Respiratory Infection
- Keywords
- POL7080, Pseudomonas aeruginosa, Non cystic fibrosis bronchiectasis, Exacerbation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Polyphor Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POL7080 | Experimental | Drug: POL7080POL7080 administered daily |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POL7080Intravenous infusion | Drug | POL7080 |
Primary outcome
Sputum bacterial clearance
Time frame: Day 4, Day 5, Day 10, Day 15 and Day 20
Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa
3 secondary outcomes
Adverse events
Time frame: Daily assessment up to 20 days from informed consent.
Laboratory abnormalities.
Time frame: Day 4, Day 10, Day 15 and Day 20
Volume of sputum in 24 hours
Time frame: Day 4, Day 10, Day 15 and Day 20
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Polverino, MD principal investigator
Hospital Clinic, Barcelona, SPAIN
Adam Hill, MD PhD principal investigator
Royal Infirmary, Edinburgh, U.K.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing POL7080 in people with Bronchiectasis and Lower Respiratory Infection, run by Polyphor Ltd. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sputum bacterial clearance (time frame: Day 4, Day 5, Day 10, Day 15 and Day 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.