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Airway Clearance Techniques for Cystic Fibrosis (SPACE-CF Trial)

N/A
Waitlist Available
Led By Tahuanty Pena, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
treatment with Elexacaftor-Tezacaftor-Ivacaftor for > 90 days prior to enrollment
age > 18 years at the time of recruitment
Must not have
ongoing therapy for Nontuberculous Mycobacterium (NTM)
inability to tolerate airway clearance or intolerance to either/or hypertonic saline and Pulmozyme
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is investigating whether or not patients with CF will see additional benefits from continuous airway clearance regimens after starting Elexacaftor-Tezacaftor-Ivacaftor therapy.

Who is the study for?
Adults over 18 with Cystic Fibrosis who've been on Elexacaftor-Tezacaftor-Ivacaftor for at least 90 days can join. They must be willing to do airway clearance twice daily for up to 180 days and have had no lung flare-ups in the last month. Smokers, recent regimen changers, those intolerant to certain treatments, or on drugs for NTM or an acute lung issue can't participate.
What is being tested?
The trial is testing if doing airway clearance exercises every day adds any benefit after starting a CFTR modulator therapy called ETI. It looks at whether this extra effort improves lung function tests and imaging results compared to symptom-driven performance of these exercises.
What are the potential side effects?
While not explicitly stated, side effects may include discomfort from daily airway clearance techniques like coughing or fatigue and potential intolerance issues related to hypertonic saline and Pulmozyme used during the procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on Elexacaftor-Tezacaftor-Ivacaftor for over 90 days.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for a lung infection not caused by tuberculosis.
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I cannot tolerate treatments to clear my airways.
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I am currently being treated for a sudden worsening of lung symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absolute change in percent predicted FEV1 (ppFEV1) from week 0 to week 12 in symptom driven airway clearance arm
Absolute change in percent predicted FVC (ppFVC) from week 0 to week 12 in symptom driven airway clearance arm
Secondary study objectives
Absolute change in respiratory symptoms based upon Cystic Fibrosis Questionnaire Revise score
Change in airway colonization with S. aureus or P. aeruginosa
Frequency of performance of airway clearance in symptom driven airway clearance arm
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Symptom drivenExperimental Treatment1 Intervention
Symptom driven performance of airway clearance regimen
Group II: ContinuousActive Control1 Intervention
Continuous performance of baseline daily airway clearance regimen

Find a Location

Who is running the clinical trial?

University of IowaOTHER
471 Previous Clinical Trials
895,054 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
124 Patients Enrolled for Cystic Fibrosis
University of Missouri-ColumbiaLead Sponsor
379 Previous Clinical Trials
628,576 Total Patients Enrolled
Tahuanty Pena, MDPrincipal InvestigatorUniversity of Iowa

Media Library

Continuous daily performance of airway clearance Clinical Trial Eligibility Overview. Trial Name: NCT05392855 — N/A
Cystic Fibrosis Research Study Groups: Continuous, Symptom driven
Cystic Fibrosis Clinical Trial 2023: Continuous daily performance of airway clearance Highlights & Side Effects. Trial Name: NCT05392855 — N/A
Continuous daily performance of airway clearance 2023 Treatment Timeline for Medical Study. Trial Name: NCT05392855 — N/A
~3 spots leftby Dec 2025
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