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Completed

NCT Number: NCT04970225

Cystic Fibrosis Blood Neutrophils

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.

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Key information

Conditions

Cystic Fibrosis Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Gram-Negative Bacterial Infections Infant, Newborn, Diseases Infections Lung Diseases Pancreatic Diseases Pseudomonas Infections Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochin hospital, AP-HP

Paris, 75014, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

  • Informed consent impossible to obtain
  • Involvement in an interventional research protocol in the previous 3 months if exclusion directive was given in this protocol.

Treatment and study plan

1 blood sample

Other

4 tubes of 7 ml per sample (a single sample)

2 blood samples

Other

4 tubes of 7 ml per sample / 2 samples : before / after antibiotic treatment

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Quantification of blood low density neutrophils in CF vs other chronic inflammatory disorders.

    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
    • 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).

  2. Quantification of blood low density neutrophils in CF according to different clinical situations.

    Time frame: Through study completion, an average of 1 year

    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

  3. Transcriptomic analysis of blood neutrophils in CF according to different clinical situations.

    Time frame: Through study completion, an average of 1 year

    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

  4. Effector function 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:

    • 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

  5. Phagocytosis potential of blood neutrophils in CF according to different clinical situations.

    Time frame: Through study completion, an average of 1 year

    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

  6. Survival/apoptosis balance analysis in CF according to different clinical situations.

    Time frame: Through study completion, an average of 1 year

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Functional and Phenotypic Characteristics of Blood Neutrophils in Cystic Fibrosis

Acronym: MUCO-PNN

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Jul 21, 2021
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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