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NCT04354038 · ClinicalTrials.gov registry record

Host and Bacterial Mechanisms During Cystic Fibrosis Pulmonary Exacerbations

A clinical trial of Cystic Fibrosis, sponsored by National Jewish Health.

Active
Registry status
100
Enrollment target
1
Study location

NCT04354038: Active study of Cystic Fibrosis, sponsored by National Jewish Health.

NCT04354038 is a study of Cystic Fibrosis that is active but no longer recruiting, run by National Jewish Health. The registered enrollment target is 100 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04354038, a study of Cystic Fibrosis, is active but no longer recruiting, sponsored by National Jewish Health.

ACTIVE NOT RECRUITING
Registry status
100 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Conditions Studied

Study Locations (1)

Colorado

  • National Jewish Health - Denver

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2020-01-07
Est. Completion 2026-12
National Jewish Health

83 total trials

What the registry record for NCT04354038 still lists

NCT04354038 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (44% lower).

The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 0 interventions.

NCT04354038 reports a single indexed study location in Colorado.

Frequently Asked Questions

What is clinical trial NCT04354038 about?

NCT04354038 is a clinical study titled "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 ...

What is the current status of trial NCT04354038?

This trial is currently active not recruiting. The enrollment target is 100 participants. The study started on 2020-01-07. Estimated completion is 2026-12.

What conditions does trial NCT04354038 study?

This clinical trial studies the following conditions: Cystic Fibrosis.

Who is sponsoring clinical trial NCT04354038?

This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04354038 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cystic Fibrosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04354038's enrollment target sits among peer trials

100 60th of 169 higher than 107 of 169 other Cystic Fibrosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04354038, the US trial registry maintained by the National Library of Medicine. NCT04354038 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.