Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04378153 · ClinicalTrials.gov registry record
Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy
A clinical trial, sponsored by Nicole Hamblett.
- Completed
- Registry status
- 987
- Enrollment target
NCT04378153: Completed study, sponsored by Nicole Hamblett.
NCT04378153 is a clinical trial that has completed, run by Nicole Hamblett. The registered enrollment target is 987 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04378153 has completed, sponsored by Nicole Hamblett.
- COMPLETED
- Registry status
- 987 participants
- Enrollment target
Study Summary
Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating CF, it is still largely unknown whether or not other chronic therapies can be safely stopped. The SIMPLIFY study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline or Pulmozyme® (dornase alfa) in those people that are also taking Trikafta™. Trikafta (elexacaftor/tezacaftor/ivacaftor) 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 Trikafta 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 and Pulmozyme (dornase alfa) also improve clearance of mucus from the lungs to support lung function and have been available to people with CF for many years. Both therapies are considered to be relatively burdensome and it is not known whether either therapy can improve or maintain lung function above what is already gained through Trikafta use. The goal of the SIMPLIFY study is to get information about whether or not it is safe to stop either inhaled hypertonic saline or Pulmozyme (dornase alfa) by testing if there is a change in lung function in subjects with cystic fibrosis (CF) who are assigned to stop their chronic medication (either hypertonic saline or Pulmozyme) as compared to those who are assigned to keep taking their medication while continuing to take Trikafta.
Primary Outcome
The number of participants completing the run-in period of the study and not meeting any of the exclusion criteria during the run-in period.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 987 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2022-07-11 |
What the finished NCT04378153 record still lists
NCT04378153 is an observational study that tracks outcomes without assigning an intervention. The registered 987 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04378153 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04378153 about?
NCT04378153 is a clinical study titled "Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy". Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating CF, it is still largely unknown whether or not other chronic therapies can be safely stopped. The SIMPLIFY study is being done to test whether or not it is safe to stop t...
What is the current status of trial NCT04378153?
This trial is currently completed. The enrollment target is 987 participants. The study started on 2020-08-25. Estimated completion is 2022-07-11.
Who is sponsoring clinical trial NCT04378153?
This trial is sponsored by Nicole Hamblett, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05079841 · 988 participants · Phase 4
The Stimulation To Induce Mothers Study
- NCT05441709 · 990 participants · NA
Furthering Equity Through Infant Feeding EDucation and Support
- NCT06340646 · 990 participants · NA
Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)
- NCT06878261 · 990 participants · Phase 3
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI