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Completed

NCT Number: NCT04354038

Host and Bacterial Mechanisms During Cystic Fibrosis Pulmonary Exacerbations

Cystic fibrosis pulmonary exacerbations (CF PEx) vary greatly in their severity, their pathogens, and their treatment responses. A failure to return to baseline lung function after treatment may be due to persistent infection or chronic inflammation or both. This constant infection and inflammation are believed to be tightly connected, making it difficult to know the exact reason why some patients fail to respond to treatment. The purpose of this study is to evaluate both infection and inflammation during CF PEx to allow for more personalized approaches to improve lung function responses and better CF PEx outcomes. Subjects will be asked to be in the study if they have CF, are 18 years of age or older, and are starting on IV antibiotics due to worsening lung infection. Subjects will stay in the study for up to 5 years, with visits occurring once a year if hospitalized for a CF PEx. Each visit will have blood, sputum, and urine collected and analyzed for changes in expression of certain genes and proteins. These changes may relate to improvements felt by people living with CF and determine what treatments are most helpful.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • CF patients 18 years or older
  • hospitalized for IV treatment of an acute pulmonary exacerbation
  • not on investigational drugs
  • who can provide written consent and are willing to comply with study procedure

Exclusion criteria

  • the presence of a condition or abnormality that, in the opinion of the Principal Investigator, would compromise the safety of the patient or the quality of the data.

Treatment and study plan

Primary outcomes

  1. Change between FEV1 and Th17/PD-1 expression during the course of treatment for pulmonary exacerbations using flow cytometry

    Time frame: Onset and end of CF pulmonary exacerbations, on average 10 days apart

    There is a Th17 skewing association with a failure to return to baseline FEV1 values post pulmonary exacerbation, as measured using conventional flow cytometry followed by linear mixed effects models.

  2. Change between FEV1 and Th17/PD-1 expression over time using flow cytometry

    Time frame: From initial CF pulmonary exacerbation to subsequent CF pulmonary exacerbation, assessed over a period of 60 months

    There is a Th17 skewing association with a failure to return to baseline FEV1 values post pulmonary exacerbation, as measured using conventional flow cytometry followed by linear mixed effects models.

  3. Change in FEV1 and Th1/Th2/Th17 gene expression during the course of treatment for pulmonary exacerbations using single cell sequencing

    Time frame: Onset and end of CF pulmonary exacerbations, on average 10 days apart

    Gene expression changes, with a particular emphasis on the relationship between changing cell composition (Th1, Th2, and Th17) single cell gene expression and FEV1 recovery, as measured by single cell sequencing of CD4+CD45RO+ memory cells, may be associated with a failure to return to baseline FEV1 during the course of treatment.

  4. Change in FEV1 and Th1/Th2/Th17 gene expression over time using single cell sequencing

    Time frame: From initial CF pulmonary exacerbation to subsequent CF pulmonary exacerbation, assessed over a period of 60 months

    Gene expression changes, with a particular emphasis on the relationship between changing cell composition (Th1, Th2, and Th17) single cell gene expression and FEV1 recovery, as measured by single cell sequencing of CD4+CD45RO+ memory cells, may be associated with a failure to return to baseline FEV1 over time.

  5. Comparison of Th17 vs Th2 TCR repertoires during the course of treatment for pulmonary exacerbations through bulk TCR beta sequencing

    Time frame: Onset and end of CF pulmonary exacerbations, on average 10 days apart

    Examining if an expanded clone within the Th17 lineage translates to greater inflammation and poorer FEV1 response during the course of treatment as measured by bulk TCR beta sequencing.

  6. Comparison of Th17 vs Th2 TCR repertoires over time through bulk TCR beta sequencing

    Time frame: From initial CF pulmonary exacerbation to subsequent CF pulmonary exacerbation, assessed over a period of 60 months

    Examining if an expanded clone within the Th17 lineage translates to greater inflammation and poorer FEV1 response over time as measured by bulk TCR beta sequencing.

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Registry information

Official study title

Host and Bacterial Mechanisms in Recovering FEV1 After Pulmonary Exacerbations in Patients With Cystic Fibrosis

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Apr 21, 2020
Registry last updated
Apr 13, 2026

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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