Breath Signature for Cystic Fibrosis Pulmonary Exacerbations
D
Don Sanders, MD
Primary Investigator
Enrolling By Invitation
8 years - 18 years
All
Phase
N/A
1 participants needed
1 Location
Brief description of study
What is this study about?
The purpose of this study is obtain and measure compounds found in exhaled breath. The study team believes that these compounds will be different when people are healthy compared to when they have an exacerbation. This information could help us develop a non-invasive way to monitor infections in people with Cystic Fibrosis (CF).
THIS STUDY IS ENROLLING BY INVITATION ONLY - Study staff will approach patients who have CF and have or had a pulmonary exacerbation and/or were hospitalized because of a pulmonary exacerbation at Riley Children's Hospital in Indianapolis, IN.
Detailed description of study
What is involved during study participation?
- One group of 10 children with CF will provide breath samples during a clinic visit for a pulmonary exacerbation and again at a subsequent CF clinic visit, with or without pulmonary exacerbation resolution. Participation for this group will end after the second clinic visit (approximately 3-4 months).
- One group of 10 children who are stable on ETI (Elexacaftor/Tezacaftor/Ivacaftor) will provide breath samples at each of 3 consecutive clinic visits. Participation for this group will end after the third clinic visit (approximately 9-10 months).
- One group of 10 children hospitalized for a pulmonary exacerbation will provide breath samples in conjunction with PFT tests every 3-4 days and again at a stable follow-up visit 4-6 weeks after release from the hospital. Participation for this group will end after the follow-up clinic visit (approximately 3-4 months).
- We will also obtain nasal swabs at least once during a pulmonary exacerbation at the same time that breath collection occurs.
Additional information
The study is being conducted by by Drs. D.B. Sanders and Michael Davis, Department of Pediatric Pulmonology, and Drs. Mangilal Agarwal and Mark Woollam, Department of Mechanical and Energy Engineering.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cystic Fibrosis, CF, Riley
-
Age: 8 years - 18 years
-
Gender: All
Inclusion Criteria
- Children with CF followed at Riley Hospital for Children
- Able to perform standard pulmonary function testing
- Aim 3: Hospitalized at Riley Hospital for Children for IV antibiotics to treat a PEx
Exclusion Criteria
- Respiratory culture positive for non-tuberculous mycobacteria in the prior 24 months
- History of solid organ transplantation
Updated on
08 Apr 2025.
Study ID: PPUL-IIR-CURE-CF, 18183
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