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NCT06350474 · ClinicalTrials.gov registry record · NA
Impact of Discontinuing Dornase Alfa in People With CF on Highly Effective CFTR Modulator Therapy-A SIMPLIFY Sub-Study
A NA study, sponsored by Nicole Hamblett.
- Completed
- Registry status
- NA
- Development phase
- 477
- Enrollment target
NCT06350474: Completed NA study, sponsored by Nicole Hamblett.
NCT06350474 is a NA study that has completed, run by Nicole Hamblett. The registered enrollment target is 477 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06350474, a NA study, has completed, sponsored by Nicole Hamblett.
- COMPLETED
- Registry status
- NA
- Development phase
- 477 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 dornase alfa (Dnase) 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. Dornase alfa (Dnase) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. Dnase is considered to be relatively burdensome and it is not known whether Dnase 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 Dnase by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking Dnase as compared to those who are assigned to keep taking Dnase 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 hypertonic saline is registered under NCT06350461.
Primary Outcome
Non-Inferiority statistical testing compared difference between study arms (discontinue - continue) in the absolute change in FEV1 % predicted from Week 0 to Week 6.
Interventions
- OTHER Discontinuation of dornase alfa (Dnase)
- OTHER Continuation of dornase alfa (Dnase)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 477 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2022-07-11 |
| Phase | NA |
What the finished NCT06350474 record still lists
NCT06350474 is an interventional study that assigns participants to a tested intervention. The registered 477 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 (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Discontinuation of dornase alfa (Dnase) is the first listed.
NCT06350474 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06350474 about?
NCT06350474 is a clinical study titled "Impact of Discontinuing Dornase Alfa in People With CF on Highly Effective CFTR Modulator Therapy-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 NCT06350474?
This trial is currently completed. It is a NA study. The enrollment target is 477 participants. The study started on 2020-08-25. Estimated completion is 2022-07-11.
What interventions are being tested in trial NCT06350474?
The interventions under investigation include: Discontinuation of dornase alfa (Dnase) (OTHER), Continuation of dornase alfa (Dnase) (OTHER).
Who is sponsoring clinical trial NCT06350474?
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 NCT06350474's enrollment target sits among peer trials
477 219th of 2000 higher than 1,781 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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