Clinical trial NCT04354038: Host and Bacterial Mechanisms During Cystic Fibrosis Pulmonary Exacerbations
Official title: Host and Bacterial Mechanisms in Recovering FEV1 After Pulmonary Exacerbations in Patients With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cystic Fibrosis
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients followed by the Colorado Adult CF Center will be eligible. A subject will have a diagnosis of cystic fibrosis, be 18 years or older, and been diagnosed by clinical faculty with a pulmonary exacerbation (PEx) and need to be hospitalized to start on IV antibiotic treatment.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change between FEV1 and Th17/PD-1 expression during the course of treatment for pulmonary exacerbations using flow cytometry
timeFrame: Onset and end of CF pulmonary exacerbations, on average 10 days apart
measure: Change between FEV1 and Th17/PD-1 expression over time using flow cytometry
timeFrame: From initial CF pulmonary exacerbation to subsequent CF pulmonary exacerbation, assessed over a period of 60 months
measure: Change in FEV1 and Th1/Th2/Th17 gene expression during the course of treatment for pulmonary exacerbations using single cell sequencing
timeFrame: Onset and end of CF pulmonary exacerbations, on average 10 days apart
measure: Change in FEV1 and Th1/Th2/Th17 gene expression over time using single cell sequencing
timeFrame: From initial CF pulmonary exacerbation to subsequent CF pulmonary exacerbation, assessed over a period of 60 months
measure: Comparison of Th17 vs Th2 TCR repertoires during the course of treatment for pulmonary exacerbations through bulk TCR beta sequencing
timeFrame: Onset and end of CF pulmonary exacerbations, on average 10 days apart
measure: Comparison of Th17 vs Th2 TCR repertoires over time through bulk TCR beta sequencing
timeFrame: From initial CF pulmonary exacerbation to subsequent CF pulmonary exacerbation, assessed over a period of 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
References: