Cystic FibrosisNCT04354038
Host and Bacterial Mechanisms During Cystic Fibrosis Pulmonary Exacerbations
An observational study of Cystic Fibrosis, run by National Jewish Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2020to 22 Sep 2023
- Phase
- Observational
- 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
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Host and Bacterial Mechanisms in Recovering FEV1 After Pulmonary Exacerbations in Patients With Cystic Fibrosis
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.
- Conditions
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between FEV1 and Th17/PD-1 expression during the course of treatment for pulmonary exacerbations using flow cytometry
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.
Measured: Onset and end of CF pulmonary exacerbations, on average 10 days apart
Change between FEV1 and Th17/PD-1 expression over time using flow cytometry
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.
Measured: From initial CF pulmonary exacerbation to subsequent CF pulmonary exacerbation, assessed over a period of 60 months
Change in FEV1 and Th1/Th2/Th17 gene expression during the course of treatment for pulmonary exacerbations using single cell sequencing
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.
Measured: Onset and end of CF pulmonary exacerbations, on average 10 days apart
Change in FEV1 and Th1/Th2/Th17 gene expression over time using single cell sequencing
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.
Measured: From initial CF pulmonary exacerbation to subsequent CF pulmonary exacerbation, assessed over a period of 60 months
Comparison of Th17 vs Th2 TCR repertoires during the course of treatment for pulmonary exacerbations through bulk TCR beta sequencing
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.
Measured: Onset and end of CF pulmonary exacerbations, on average 10 days apart
Comparison of Th17 vs Th2 TCR repertoires over time through bulk TCR beta sequencing
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.
Measured: From initial CF pulmonary exacerbation to subsequent CF pulmonary exacerbation, assessed over a period of 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start7 Jan 2020
- Primary completion21 Sep 2021
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354038
- Sponsor's protocol ID
- SAAVED19G0
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host and Bacterial Mechanisms in Recovering FEV1 After Pulmonary Exacerbations in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04354038
- Acronym / sponsor ID
- SAAVED19G0
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 21 Apr 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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 13 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by National Jewish Health at 1 site in United States.
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 4 inclusion and 1 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 13 Apr 2026. 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 United States. 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?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.