Status:
TERMINATED
Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Cystic Fibrosis
Mucociliary Clearance Defect
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cystic Fibrosis (CF) is an autosomal recessive disease cause by a mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) manifesting in multiple organs, the most common cause of mo...
Detailed Description
This will be a randomized controlled trial design with 2:1 randomization (2 to symptom driven to 1 in continuous) for this pilot study to determine if symptom-driven airway clearance after starting El...
Eligibility Criteria
Inclusion
- age \> 18 years at the time of recruitment
- treatment with Elexacaftor-Tezacaftor-Ivacaftor for \> 90 days prior to enrollment
- willing to continue twice daily airway clearance for a minimum of 90 days and up to180 days if enrolled in the continuing treatment arm
- no exacerbations in the last 28 days
Exclusion
- active smoking or vaping (tobacco, marijuana, recreational drugs)
- recent change in chronic airway clearance regimen with the last 28 days
- inability to tolerate airway clearance or intolerance to either/or hypertonic saline and Pulmozyme
- current treatment for an acute pulmonary exacerbation
- ongoing therapy for Nontuberculous Mycobacterium (NTM)
- investigational drug use
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05392855
Start Date
September 5 2023
End Date
September 18 2024
Last Update
September 20 2024
Active Locations (1)
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1
University of Missouri Hospital and Clinics
Columbia, Missouri, United States, 65212