Observational Study Comparing Home to Office Spirometry

Completed

Conditions studied: Cystic Fibrosis

In brief

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 accuracy and variability of home spirometric measurements over time, and to assess the feasibility and acceptability of home measurements.

Key facts

Study ID

NCT05285410

Run by

Chris Goss

People needed

116

Starts

2022-11-30

Expected to finish

2023-12-19

Last updated by the study team

2024-01-11

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• History of lung transplantation
• Initiation of a highly effective modulator therapy within 2 months before Screening Visit

Where it is running

• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Wayne State University Harper University Hospital — Detroit, Michigan, United States
• Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Lenox Hill Hospital Cystic Fibrosis Center — New York, New York, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Children's Hospital Medical Center of Akron — Akron, Ohio, United States
• Toledo Children's Hospital — Toledo, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• University of South Carolina School of Medicine — Columbia, South Carolina, United States
• Sanford USD Medical Center — Sioux Falls, South Dakota, United States
• The Adult Cystic Fibrosis Center of Central Texas — Austin, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics — Spokane, Washington, United States
• Froedtert & Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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