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NCT04353752 · ClinicalTrials.gov registry record
Observational Trial of the Longitudinal Effects of CFTR Modulator Drugs
A clinical trial, sponsored by National Jewish Health.
- Completed
- Registry status
- 58
- Enrollment target
NCT04353752: Completed study, sponsored by National Jewish Health.
NCT04353752 is a clinical trial that has completed, run by National Jewish Health. The registered enrollment target is 58 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04353752 has completed, sponsored by National Jewish Health.
- COMPLETED
- Registry status
- 58 participants
- Enrollment target
Study Summary
CF patients enrolled in this protocol will be recruited from patients followed by the Adult CF Program at National Jewish Health. Patients will be selected based on planned use of a CFTR modulator by their primary physician. No patient will be started on (or will switch) CFTR modulator agents for the purpose of the study. After enrollment, biological samples may be collected at two different time points prior to treatment initiation. One set of samples will be collected at baseline health prior to CFTR modulator initiation or change. A second set of samples will be obtained in subjects at the time of acute pulmonary exacerbation, if one occurs prior to CFTR modulator initiation or change. Post CFTR modulator initiation study assessments will be obtained at least one month after starting treatment and continue up to 2 times a year (including during pulmonary exacerbations), in order to document longitudinal effects of therapies and changes in inflammatory biology over time. At the time of each biological sampling, blood, sputum sample, urine, and a quality of life assessment will be acquired in all enrolled subjects. In addition to demographic data, clinical data, such as quantitative microbiology and simple spirometry will be recorded at the time of sample collection.
Primary Outcome
Changes in host inflammation as measured in peripheral blood memory T cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2023-07-26 |
What the finished NCT04353752 record still lists
NCT04353752 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 58 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04353752 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04353752 about?
NCT04353752 is a clinical study titled "Observational Trial of the Longitudinal Effects of CFTR Modulator Drugs". CF patients enrolled in this protocol will be recruited from patients followed by the Adult CF Program at National Jewish Health. Patients will be selected based on planned use of a CFTR modulator by their primary physician. No patient will be started on (or will switch) CFTR modulator agents for th...
What is the current status of trial NCT04353752?
This trial is currently completed. The enrollment target is 58 participants. The study started on 2019-09-16. Estimated completion is 2023-07-26.
Who is sponsoring clinical trial NCT04353752?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
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