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CFTR Modulator Therapy

Dnase-Discontinue (Study B) for Cystic Fibrosis (SIMPLIFY Trial)

N/A
Waitlist Available
Led By Nicole Mayer-Hamblett, PhD
Research Sponsored by David Nichols, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week -2 to week 0
Awards & highlights

SIMPLIFY Trial Summary

This trial is being done to see if it's safe to stop taking inhaled hypertonic saline or Pulmozyme when also taking Trikafta, a combination CFTR modulator therapy.

Eligible Conditions
  • Cystic Fibrosis

SIMPLIFY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week -2 to week 0
This trial's timeline: 3 weeks for screening, Varies for treatment, and week -2 to week 0 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute change in FEV1 % predicted from Week 0 to Week 6 in Dornase Alfa (Study B) Therapy Arms
Absolute change in FEV1 % predicted from Week 0 to Week 6 in Hypertonic Saline (Study A) Therapy Arms
Secondary outcome measures
Absolute Change in Respiratory Symptoms, as Measured by CFQ-R Respiratory Domain from Week 0 to Week 6 in Dornase Alfa (Study B) Therapy Arms
Absolute Change in Respiratory Symptoms, as Measured by CFQ-R Respiratory Domain from Week 0 to Week 6 in Hypertonic Saline (Study A) Therapy Arms
Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) from Week 0 to Week 6 in Dornase Alfa (Study B) Therapy Arms
+19 more

SIMPLIFY Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: HS-Discontinue (Study A)Experimental Treatment1 Intervention
Discontinuation of current hypertonic saline (HS) therapy in Study A
Group II: Dnase-Discontinue (Study B)Experimental Treatment1 Intervention
Discontinuation of current dornase alfa (dnase) therapy in Study B
Group III: Dnase-Continue (Study B)Active Control1 Intervention
Continuation of current dornase alfa (dnase) therapy in Study B
Group IV: HS-Continue (Study A)Active Control1 Intervention
Continuation of current hypertonic saline (HS) therapy in Study A

Find a Location

Who is running the clinical trial?

David Nichols, MDLead Sponsor
2 Previous Clinical Trials
670 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
670 Patients Enrolled for Cystic Fibrosis
Nicole HamblettLead Sponsor
5 Previous Clinical Trials
6,517 Total Patients Enrolled
5 Trials studying Cystic Fibrosis
6,517 Patients Enrolled for Cystic Fibrosis
University of WashingtonOTHER
1,740 Previous Clinical Trials
1,846,800 Total Patients Enrolled
24 Trials studying Cystic Fibrosis
44,997 Patients Enrolled for Cystic Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy
Nicole Hamblett 2020. "Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04378153.
~186 spots leftby Apr 2025
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