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NCT06350461 · ClinicalTrials.gov registry record · NA
Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-Study
A NA study, sponsored by Nicole Hamblett.
- Completed
- Registry status
- NA
- Development phase
- 370
- Enrollment target
NCT06350461 is a NA study that has completed, run by Nicole Hamblett. The registered enrollment target is 370 participants.
The verdict
NCT06350461, a NA study, has completed, sponsored by Nicole Hamblett.
- COMPLETED
- Registry status
- NA
- Development phase
- 370 participants
- Enrollment target
Study Summary
Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline in those people that are also taking elexacaftor/tezacaftor/ivacaftor (ETI). ETI is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up ETI work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function. Inhaled hypertonic saline (HS) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. HS is considered to be relatively burdensome and it is not known whether HS can improve or maintain lung function above what is already gained through ETI use. The goal of this SIMPLIFY sub-study is to get information about whether or not it is safe to stop hypertonic saline by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking HS as compared to those who are assigned to keep taking HS while continuing to take ETI. This is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153. The sub study investigating the impact of discontinuing and continuing dornase alfa is registered under NCTXXXXXXX (will add once available).
Interventions
- OTHER Discontinuation of hypertonic saline (HS)
- OTHER Continuation of hypertonic saline (HS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2022-07-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06350461
The ClinicalTrials.gov registry entry for NCT06350461 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nicole Hamblett, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Discontinuation of hypertonic saline (HS) is the first listed.
NCT06350461 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06350461 about?
NCT06350461 is a clinical study titled "Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-Study". Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or n...
What is the current status of trial NCT06350461?
This trial is currently completed. It is a NA study. The enrollment target is 370 participants. The study started on 2020-08-25. Estimated completion is 2022-07-11.
What interventions are being tested in trial NCT06350461?
The interventions under investigation include: Discontinuation of hypertonic saline (HS) (OTHER), Continuation of hypertonic saline (HS) (OTHER).
Who is sponsoring clinical trial NCT06350461?
This trial is sponsored by Nicole Hamblett, which has 8 total clinical trials registered on ClinicalTrials.gov.
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