Cystic FibrosisMUCO-PNNNCT04970225
Cystic Fibrosis Blood Neutrophils
A study testing 1 blood sample and 2 blood samples in people with Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this prospective study is to analyze function and phenotype of blood neutrophils in cystic fibrosis patients and the impact of Pseudomonas aeruginosa chronic infection, treatment with CFTR modulators and acute exacerbation on blood neutrophils phenotype and function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- 1 blood sample and 2 blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2021to 8 Jan 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over the age of 18 who is not under legal protection
- Patients with CF according to the diagnostic criteria of the Cystic Fibrosis Foundation including:
- 15 patients with severe mutation but not chronically infected with PA and not treated with lumacaftor / ivacaftor
- 15 patients homozygous phe508del, chronically infected with PA and not treated with lumacaftor / ivacaftor
- 15 patients homozygous phe508del, chronically infected with PA and treated with lumacaftor / ivacaftor
- 15 hospitalized patients for respiratory exacerbation
Show all 10Show fewer
- 40 patients initiating Ivacaftor-Tezacaftor-Elexacaftor treatment.
- No change in baseline treatment for 15 days (including antibiotic treatment).
- Patient affiliated to a social security system
- Free, informed and written consent, dated and signed by the patient and the investigator, at the latest on the day of inclusion and before any action required by the study.
Who cannot join
- Informed consent impossible to obtain
- Involvement in an interventional research protocol in the previous 3 months if exclusion directive was given in this protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional and Phenotypic Characteristics of Blood Neutrophils in Cystic Fibrosis
The purpose of this prospective study is to analyze function and phenotype of blood neutrophils in cystic fibrosis patients and the impact of Pseudomonas aeruginosa chronic infection, treatment with CFTR modulators and acute exacerbation on blood neutrophils phenotype and function.
- Conditions
- Cystic Fibrosis
- Being tested
- 1 blood sample, 2 blood samples
- Keywords
- Blood neutrophils, Pseudomonas aeruginosa, Cystic fibrosis, CFTR modulators, respiratory exacerbation, airway chronic infection
- Medical subject headings
- Cystic Fibrosis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 blood sampleOther
4 tubes of 7 ml per sample (a single sample)
2 blood samplesOther
4 tubes of 7 ml per sample / 2 samples : before / after antibiotic treatment
| Study group | Role | What they receive |
|---|---|---|
| Stable state | Experimental | 45 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France:
* With severe cftr mutations
* With or without PA chronic infection
* Treated or not with Ivacaftor-Lumacaftor Receives: Other: 1 blood sample |
| Starting Ivacaftor-Tezacaftor-Elexacaftor | Experimental | 40 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France:
* With at least one severe cftr mutation
* With or without PA chronic infection
* Initiating Ivacaftor-Tezacaftor-Elexacaftor Receives: Other: 2 blood samples |
| Exacerbation | Experimental | 15 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France and hospitalized for respiratory exacerbation Receives: Other: 2 blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of blood low density neutrophils in cystic fibrosis (CF)
Quantitative flow cytometric evaluation of neutrophil membrane markers that differ according to whether they are :
- mature neutrophils : CD16high, CD15high, CD33high, CD10high
- or Low density neutrophils (LDG) : CD16low, CD15neg, CD33 neg, CD10 neg. Comparison of neutrophil membrane markers profile in CF patients versus control blood-donors.
Measured: Through study completion, an average of 1 year
Transcriptomic analysis of blood neutrophils in cystic fibrosis (CF)
Transcriptomic analysis of blood neutrophil proinflammatory or immunomodulatory potential.
Comparison of transcriptomic blood neutrophil profile in CF patients versus control blood-donors.
Measured: Through study completion, an average of 1 year
Effector function analysis of blood neutrophils in CF.
Comparison of effector function analysis of blood neutrophils of CF patients versus control blood-donors.
Measured: Through study completion, an average of 1 year
Phagocytosis potential of blood neutrophils in CF.
Comparison of phagocytosis potential of blood neutrophils of CF patients versus control blood-donors.
Measured: Through study completion, an average of 1 year
Survival/apoptosis balance analysis in CF
Survival / apoptosis balance analysis : (PCNA localization) in CF patients blood neutrophils versus control blood-donors.
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Quantification of blood low density neutrophils in CF vs other chronic inflammatory disorders.
Quantitative flow cytometric evaluation of neutrophil membrane markers that differ according to whether they are:
- mature neutrophils : CD16high, CD15high, CD33high, CD10high
- Low density neutrophils (LDG) : CD16low, CD15neg, CD33 neg, CD10 neg. Comparison of neutrophil membrane markers profile in CF patients versus patients with other chronic inflammatory disease (eg. Rheumatoid arthritis, inflammatory bowel disease).
Measured: Through study completion, an average of 1 year
Quantification of blood low density neutrophils in CF according to different clinical situations.
Quantitative flow cytometric evaluation of neutrophil membrane markers.
- At stable state:
- presence or absence of airway chronic infection with PA
- whether or not patients are treated Ivacaftor-Lumacaftor
- At beginning of exacerbation or after antibiotic treatment.
- Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment
Measured: Through study completion, an average of 1 year
Transcriptomic analysis of blood neutrophils in CF according to different clinical situations.
Transcriptomic analysis of blood neutrophil proinflammatory or immunomodulatory potential.
- At stable state:
- presence or absence of airway chronic infection with PA
- whether or not patients are treated Ivacaftor-Lumacaftor
- At beginning of exacerbation or after antibiotic treatment.
- Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment
Measured: Through study completion, an average of 1 year
Effector function analysis of blood neutrophils in CF according to different clinical situations.
Effector function analysis of blood neutrophils:
- At stable state:
- presence or absence of airway chronic infection with PA
- whether or not patients are treated Ivacaftor-Lumacaftor
- At beginning of exacerbation or after antibiotic treatment.
- Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment
Measured: Through study completion, an average of 1 year
Phagocytosis potential of blood neutrophils in CF according to different clinical situations.
Phagocytosis potential analysis of blood neutrophils in CF:
- At stable state:
- presence or absence of airway chronic infection with PA
- whether or not patients are treated Ivacaftor-Lumacaftor
- At beginning of exacerbation or after antibiotic treatment.
- Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment
Measured: Through study completion, an average of 1 year
Survival/apoptosis balance analysis in CF according to different clinical situations.
Survival / apoptosis balance analysis (PCNA localization):
- At stable state:
- presence or absence of airway chronic infection with PA
- whether or not patients are treated Ivacaftor-Lumacaftor
- At beginning of exacerbation or after antibiotic treatment.
- Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start8 Jul 2021
- Primary completion6 Apr 2023
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Pierre-Régis BURGEL, MD PHD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970225
- Sponsor's protocol ID
- APHP180430
- Other IDs
- 2018-A03017-48
- Acronym
- MUCO-PNN
- Status last verified
- Sep 2025
- First submitted
- 17 Jan 2019
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adib-Conquy M, Pedron T, Petit-Bertron AF, Tabary O, Corvol H, Jacquot J, Clement A, Cavaillon JM. Neutrophils in cystic fibrosis display a distinct gene expression pattern. Mol Med. 2008 Jan-Feb;14(1-2):36-44. doi: 10.2119/2007-00081.Adib-Conquy.
PubMed 18026571Bonvillain RW, Painter RG, Adams DE, Viswanathan A, Lanson NA Jr, Wang G. RNA interference against CFTR affects HL60-derived neutrophil microbicidal function. Free Radic Biol Med. 2010 Dec 15;49(12):1872-80. doi: 10.1016/j.freeradbiomed.2010.09.012. Epub 2010 Sep 24.
PubMed 20870018Bouayad D, Pederzoli-Ribeil M, Mocek J, Candalh C, Arlet JB, Hermine O, Reuter N, Davezac N, Witko-Sarsat V. Nuclear-to-cytoplasmic relocalization of the proliferating cell nuclear antigen (PCNA) during differentiation involves a chromosome region maintenance 1 (CRM1)-dependent export and is a prerequisite for PCNA antiapoptotic activity in mature neutrophils. J Biol Chem. 2012 Sep 28;287(40):33812-25. doi: 10.1074/jbc.M112.367839. Epub 2012 Jul 30.
PubMed 22846997Bruijnzeel PL, Uddin M, Koenderman L. Targeting neutrophilic inflammation in severe neutrophilic asthma: can we target the disease-relevant neutrophil phenotype? J Leukoc Biol. 2015 Oct;98(4):549-56. doi: 10.1189/jlb.3VMR1214-600RR. Epub 2015 May 14.
PubMed 25977288Bulloch MN, Hanna C, Giovane R. Lumacaftor/ivacaftor, a novel agent for the treatment of cystic fibrosis patients who are homozygous for the F580del CFTR mutation. Expert Rev Clin Pharmacol. 2017 Oct;10(10):1055-1072. doi: 10.1080/17512433.2017.1378094. Epub 2017 Sep 22.
PubMed 28891346Chiara AD, Pederzoli-Ribeil M, Burgel PR, Danel C, Witko-Sarsat V. Targeting cytosolic proliferating cell nuclear antigen in neutrophil-dominated inflammation. Front Immunol. 2012 Oct 9;3:311. doi: 10.3389/fimmu.2012.00311. eCollection 2012.
PubMed 23181059Cantin A. Cystic fibrosis lung inflammation: early, sustained, and severe. Am J Respir Crit Care Med. 1995 Apr;151(4):939-41. doi: 10.1164/ajrccm.151.4.7697269. No abstract available.
PubMed 7697269Dibbert B, Weber M, Nikolaizik WH, Vogt P, Schoni MH, Blaser K, Simon HU. Cytokine-mediated Bax deficiency and consequent delayed neutrophil apoptosis: a general mechanism to accumulate effector cells in inflammation. Proc Natl Acad Sci U S A. 1999 Nov 9;96(23):13330-5. doi: 10.1073/pnas.96.23.13330.
PubMed 10557320Downey DG, Bell SC, Elborn JS. Neutrophils in cystic fibrosis. Thorax. 2009 Jan;64(1):81-8. doi: 10.1136/thx.2007.082388.
PubMed 19103874Fadok VA, Bratton DL, Henson PM. Phagocyte receptors for apoptotic cells: recognition, uptake, and consequences. J Clin Invest. 2001 Oct;108(7):957-62. doi: 10.1172/JCI14122. No abstract available.
PubMed 11581295Futosi K, Mocsai A. Tyrosine kinase signaling pathways in neutrophils. Immunol Rev. 2016 Sep;273(1):121-39. doi: 10.1111/imr.12455.
PubMed 27558332Gilroy DW, Lawrence T, Perretti M, Rossi AG. Inflammatory resolution: new opportunities for drug discovery. Nat Rev Drug Discov. 2004 May;3(5):401-16. doi: 10.1038/nrd1383. No abstract available.
PubMed 15136788Hayes E, Pohl K, McElvaney NG, Reeves EP. The cystic fibrosis neutrophil: a specialized yet potentially defective cell. Arch Immunol Ther Exp (Warsz). 2011 Apr;59(2):97-112. doi: 10.1007/s00005-011-0113-6. Epub 2011 Feb 11.
PubMed 21311988Khan TZ, Wagener JS, Bost T, Martinez J, Accurso FJ, Riches DW. Early pulmonary inflammation in infants with cystic fibrosis. Am J Respir Crit Care Med. 1995 Apr;151(4):1075-82. doi: 10.1164/ajrccm/151.4.1075.
PubMed 7697234Koenderman L, Chilvers ER. Future treatment in patients with chronic obstructive pulmonary disease: to reverse or not to reverse steroid resistance-that is the question. J Allergy Clin Immunol. 2014 Aug;134(2):323-4. doi: 10.1016/j.jaci.2014.04.030. Epub 2014 Jun 13. No abstract available.
PubMed 24934274
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Phenotypic Characteristics of Blood Neutrophils in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04970225
- Acronym / sponsor ID
- MUCO-PNN / APHP180430
- Conditions
- Cystic Fibrosis
- Keywords
- Blood neutrophils, Pseudomonas aeruginosa, Cystic fibrosis, CFTR modulators, respiratory exacerbation, airway chronic infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 21 Jul 2021 (actual)
- 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.
The purpose of this prospective study is to analyze function and phenotype of blood neutrophils in cystic fibrosis patients and the impact of Pseudomonas aeruginosa chronic infection, treatment with CFTR modulators and acute exacerbation on blood neutrophils phenotype and function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stable state | Experimental | Other: 1 blood sample45 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France: * With severe cftr mutations * With or without PA chronic infection * Treated or not with Ivacaftor-Lumacaftor |
| Starting Ivacaftor-Tezacaftor-Elexacaftor | Experimental | Other: 2 blood samples40 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France: * With at least one severe cftr mutation * With or without PA chronic infection * Initiating Ivacaftor-Tezacaftor-Elexacaftor |
| Exacerbation | Experimental | Other: 2 blood samples15 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France and hospitalized for respiratory exacerbation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient over the age of 18 who is not under legal protection
- Patients with CF according to the diagnostic criteria of the Cystic Fibrosis Foundation including:
- No change in baseline treatment for 15 days (including antibiotic treatment).
- Patient affiliated to a social security system
- Free, informed and written consent, dated and signed by the patient and the investigator, at the latest on the day of inclusion and before any action required by the study.
Key exclusion criteria (2 listed)
- Informed consent impossible to obtain
- Involvement in an interventional research protocol in the previous 3 months if exclusion directive was given in this protocol.
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 |
|---|---|---|
| 1 blood sample4 tubes of 7 ml per sample (a single sample) | Other | Stable state |
| 2 blood samples4 tubes of 7 ml per sample / 2 samples : before / after antibiotic treatment | Other | Exacerbation, Starting Ivacaftor-Tezacaftor-Elexacaftor |
Primary outcome
Quantification of blood low density neutrophils in cystic fibrosis (CF)
Time frame: Through study completion, an average of 1 year
Quantitative flow cytometric evaluation of neutrophil membrane markers that differ according to whether they are : * mature neutrophils : CD16high, CD15high, CD33high, CD10high * or Low density neutrophils (LDG) : CD16low, CD15neg, CD33 neg, CD10 neg. Comparison of neutrophil membrane markers profile in CF patients versus control blood-donors.
Transcriptomic analysis of blood neutrophils in cystic fibrosis (CF)
Time frame: Through study completion, an average of 1 year
Transcriptomic analysis of blood neutrophil proinflammatory or immunomodulatory potential. Comparison of transcriptomic blood neutrophil profile in CF patients versus control blood-donors.
Effector function analysis of blood neutrophils in CF.
Time frame: Through study completion, an average of 1 year
Comparison of effector function analysis of blood neutrophils of CF patients versus control blood-donors.
Phagocytosis potential of blood neutrophils in CF.
Time frame: Through study completion, an average of 1 year
Comparison of phagocytosis potential of blood neutrophils of CF patients versus control blood-donors.
Survival/apoptosis balance analysis in CF
Time frame: Through study completion, an average of 1 year
Survival / apoptosis balance analysis : (PCNA localization) in CF patients blood neutrophils versus control blood-donors.
6 secondary outcomes
Quantification of blood low density neutrophils in CF vs other chronic inflammatory disorders.
Time frame: Through study completion, an average of 1 year
Quantification of blood low density neutrophils in CF according to different clinical situations.
Time frame: Through study completion, an average of 1 year
Transcriptomic analysis of blood neutrophils in CF according to different clinical situations.
Time frame: Through study completion, an average of 1 year
Effector function analysis of blood neutrophils in CF according to different clinical situations.
Time frame: Through study completion, an average of 1 year
Phagocytosis potential of blood neutrophils in CF according to different clinical situations.
Time frame: Through study completion, an average of 1 year
Survival/apoptosis balance analysis in CF according to different clinical situations.
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: PubMed 18026571Adib-Conquy M, Pedron T, Petit-Bertron AF, Tabary O, Corvol H, Jacquot J, Clement A, Cavaillon JM. Neutrophils in cystic fibrosis display a distinct gene expression pattern. Mol Med. 2008 Jan-Feb;14(1-2):36-44. doi: 10.2119/2007-00081.Adib-Conquy.
- Background: PubMed 20870018Bonvillain RW, Painter RG, Adams DE, Viswanathan A, Lanson NA Jr, Wang G. RNA interference against CFTR affects HL60-derived neutrophil microbicidal function. Free Radic Biol Med. 2010 Dec 15;49(12):1872-80. doi: 10.1016/j.freeradbiomed.2010.09.012. Epub 2010 Sep 24.
- Background: PubMed 22846997Bouayad D, Pederzoli-Ribeil M, Mocek J, Candalh C, Arlet JB, Hermine O, Reuter N, Davezac N, Witko-Sarsat V. Nuclear-to-cytoplasmic relocalization of the proliferating cell nuclear antigen (PCNA) during differentiation involves a chromosome region maintenance 1 (CRM1)-dependent export and is a prerequisite for PCNA antiapoptotic activity in mature neutrophils. J Biol Chem. 2012 Sep 28;287(40):33812-25. doi: 10.1074/jbc.M112.367839. Epub 2012 Jul 30.
- Background: PubMed 25977288Bruijnzeel PL, Uddin M, Koenderman L. Targeting neutrophilic inflammation in severe neutrophilic asthma: can we target the disease-relevant neutrophil phenotype? J Leukoc Biol. 2015 Oct;98(4):549-56. doi: 10.1189/jlb.3VMR1214-600RR. Epub 2015 May 14.
- Background: PubMed 28891346Bulloch MN, Hanna C, Giovane R. Lumacaftor/ivacaftor, a novel agent for the treatment of cystic fibrosis patients who are homozygous for the F580del CFTR mutation. Expert Rev Clin Pharmacol. 2017 Oct;10(10):1055-1072. doi: 10.1080/17512433.2017.1378094. Epub 2017 Sep 22.
- Background: PubMed 23181059Chiara AD, Pederzoli-Ribeil M, Burgel PR, Danel C, Witko-Sarsat V. Targeting cytosolic proliferating cell nuclear antigen in neutrophil-dominated inflammation. Front Immunol. 2012 Oct 9;3:311. doi: 10.3389/fimmu.2012.00311. eCollection 2012.
- Background: PubMed 7697269Cantin A. Cystic fibrosis lung inflammation: early, sustained, and severe. Am J Respir Crit Care Med. 1995 Apr;151(4):939-41. doi: 10.1164/ajrccm.151.4.7697269. No abstract available.
- Background: PubMed 10557320Dibbert B, Weber M, Nikolaizik WH, Vogt P, Schoni MH, Blaser K, Simon HU. Cytokine-mediated Bax deficiency and consequent delayed neutrophil apoptosis: a general mechanism to accumulate effector cells in inflammation. Proc Natl Acad Sci U S A. 1999 Nov 9;96(23):13330-5. doi: 10.1073/pnas.96.23.13330.
- Background: PubMed 19103874Downey DG, Bell SC, Elborn JS. Neutrophils in cystic fibrosis. Thorax. 2009 Jan;64(1):81-8. doi: 10.1136/thx.2007.082388.
- Background: PubMed 11581295Fadok VA, Bratton DL, Henson PM. Phagocyte receptors for apoptotic cells: recognition, uptake, and consequences. J Clin Invest. 2001 Oct;108(7):957-62. doi: 10.1172/JCI14122. No abstract available.
- Background: PubMed 27558332Futosi K, Mocsai A. Tyrosine kinase signaling pathways in neutrophils. Immunol Rev. 2016 Sep;273(1):121-39. doi: 10.1111/imr.12455.
- Background: PubMed 15136788Gilroy DW, Lawrence T, Perretti M, Rossi AG. Inflammatory resolution: new opportunities for drug discovery. Nat Rev Drug Discov. 2004 May;3(5):401-16. doi: 10.1038/nrd1383. No abstract available.
- Individual participant dataSharing planned: No
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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.
Pierre-Régis BURGEL, MD PHD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 blood sample and 2 blood samples in people with Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 10 inclusion and 2 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: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantification of blood low density neutrophils in cystic fibrosis (CF) (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04970225, which also lists 44 linked publications.
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 12 Sep 2025.