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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: Completed NA study, sponsored by Nicole Hamblett.
NCT06350461 is a NA study that has completed, run by Nicole Hamblett. The registered enrollment target is 370 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Difference between study arms (discontinue - continue) in the absolute change in FEV1 % predicted from Week 0 to Week 6.
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 |
What the finished NCT06350461 record still lists
NCT06350461 is an interventional study that assigns participants to a tested intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Discontinuation of hypertonic saline (HS) is the first listed.
NCT06350461 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06350461's enrollment target sits among peer trials
370 281st of 2000 higher than 1,720 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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