A Phase 2 interventional study of POL7080 in Bronchiectasis and Lower Respiratory Infection, sponsored by Polyphor Ltd.. Terminated at 4 sites in 2 countries. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2017-02-01.
Sponsored by Polyphor Ltd. · Phase 2, Interventional, and Treatment
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Among 39 studies in Bronchiectasis with a site in Spain — 9 open to participants now, 11 under way, 3 of them phase 3. Bronchiectasis · Spain.
Among the 39 studies in Bronchiectasis with a site in Spain, this one is the 33rd largest by planned enrollment of the 33 interventional ones that give a count, is one of 4 that started in 2013, is one of 13 in phase 2, and was the 11th registered.
404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.
Browse Bronchiectasis studies →9 of the 39 studies in Bronchiectasis with a site in Spain are open now. Recruiting first, the newest first:
Corporacion Parc Tauli · Sites in Spain
Ages 5–18
AstraZeneca · Sites in Spain, United States, Argentina and 22 more countries
Ages 12+
GlaxoSmithKline · Sites in Spain, United States, Argentina and 9 more countries
Ages 18–85
Boehringer Ingelheim · Sites in Spain, United States, Argentina and 43 more countries
Ages 12+
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA · Sites in Spain, United States, Italy and 1 more country
Ages 18–80
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 93 Bronchiectasis studies recruiting now, 50 (54%) set no upper age limit and 13 (14%) stop at 75 or younger; 12 take children under 18; 26 take healthy volunteers.
This study: 18 Years to 79 Years · all sexes · no healthy volunteers.
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39 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 4 started in 2013.
This study's planned enrollment of 20 is below the median of 60 across 263 interventional studies indexed under Bronchiectasis.
Median enrollment 107 across the 33 interventional studies, 73 across the 6 observational. Of the 23 that completed or were terminated, 11 (48%) have results posted.
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21 of 39 have an industry lead sponsor. The 10 most frequent:
Polyphor Ltd. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Polyphor Ltd. has 1 study filed under Bronchiectasis — fewer than ten, so there is no comparison to draw.
5 of the studies in Bronchiectasis with a site in Spain that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06443658Phase 3Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaBenefits of Inhalation of Hypertonic Saline Solution Prior to Physiotherapy ELTGOL Technique in Bronchiectasis | 2027-02 |
| NCT06872892Phase 3Boehringer IngelheimThe AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis | 2027-06-15 |
| NCT05846230Boehringer IngelheimClairleafᵀᴹ: A Study to Test Long-term Treatment With BI 1291583 in People With Bronchiectasis Who Took Part in a Previous Study With This Medicine | 2027-03-31 |
| NCT07201051GlaxoSmithKlineA Study to Assess the Effectiveness and Safety of GSK3862995B in Adults With Bronchiectasis | 2027-05-04 |
| NCT06559150Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USAA Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis | 2027-09-24 |
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Among the 39 studies in Bronchiectasis with a site in Spain, from their registry updates:
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To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis bronchiectasis caused by Pseudomonas aeruginosa infection.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
POL7080 administered daily
Drug: POL7080
Intravenous infusion
Sputum bacterial clearance
Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa
Time frame: Day 4, Day 5, Day 10, Day 15 and Day 20
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.
Time frame: 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.
Time frame: 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
Time frame: Day 4, Day 10, Day 15 and Day 20
To measure the plasma concentrations of POL7080
Blood samples to measure POL7080 concentrations before, during and after administration of POL7080
Time frame: Day 3
The record gives a start of Dec 2013, a primary completion of Nov 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Murepavadin
Polyphor Ltd.