Status:
COMPLETED
Observational Study Comparing Home to Office Spirometry
Lead Sponsor:
Chris Goss
Collaborating Sponsors:
University of Washington
University of Arkansas
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Brief Summary
This is a prospective, longitudinal multicenter observational study comparing home to office spirometry and home to office weight and height measurements. The aim of the study is to estimate the accur...
Detailed Description
After successful completion of the run-in period, participants will have 3 in-person visits, at which office spirometry will be performed and weight and height measured. Participants will perform home...
Eligibility Criteria
Inclusion
- Documentation of a CF diagnosis
- Clinically stable
- ≥6 years of age at Screening Visit
- During the run-in period, performed acceptable home spirometry at least twice without virtually coaching and once with virtually coaching
Exclusion
- History of lung transplantation
- Initiation of a highly effective modulator therapy within 2 months before Screening Visit
Key Trial Info
Start Date :
November 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 19 2023
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT05285410
Start Date
November 30 2022
End Date
December 19 2023
Last Update
January 11 2024
Active Locations (19)
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1
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
4
Boston Children's Hospital
Boston, Massachusetts, United States, 02115