The study is a breath biomarker validation study. It is anticipated that 300 patients with cystic fibrosis (CF) from 5 clinical sites in the USA will be enrolled. The study is funded by the US NIH and the US Cystic Fibrosis Foundation. Enrollment commenced in May 2019. Sputum, induced sputum, and oropharyngeal swabs will be collected and evaluated at each clinic as part of standard clinical practice. Excess sputum will be sent to Children's Colorado Hospital for molecular analysis. No swabs will be sent anywhere (other than the clinic from which they originate). Breath samples will be taken from all study participants.
AIM 1: Refine and validate volatile biomarkers in the breath of adult and pediatric CF patients for detecting established P. aeruginosa lung infections. For each expectorating subject (n ≥ 288; 5 centers), the diagnostic accuracy of the volatile biomarker panel will be tested, with sputum culture as the standard. AIM 2: Quantify intra-subject breath variability of the target pediatric population. We will collect longitudinal breath samples for two years from P. aeruginosa-negative subjects (n ≥ 58; \~60% non-expectorating) at 4 pediatric CF clinical centers. We will measure intra-subject variance in the breath signatures of expectorating and non-expectorating subjects, with the latter being the target population for the clinical trial. Two to 8 breath samples will be collected per patient.
Study Type
OBSERVATIONAL
Enrollment
300
Phoenix Children's Hospital
Phoenix, Arizona, United States
COMPLETEDChildren's Hospital Colorado
Aurora, Colorado, United States
COMPLETEDNational Jewish Health
Denver, Colorado, United States
COMPLETEDDartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
NOT_YET_RECRUITINGCincinnati Children's Hospital
Cincinnati, Ohio, United States
COMPLETEDBC Children's Hospital
Vancouver, British Columbia, Canada
RECRUITINGSt. Paul's Hospital
Vancouver, British Columbia, Canada
RECRUITINGDifferences in concentrations of individual volatile biomarkers and combinations of biomarkers in breath samples obtained from persons with and without P. aeruginosa lung infections
Measured using comprehensive two-dimensional gas chromatography of exhaled breath compared to sputum culture (gold standard)
Time frame: Enrollment thru 2023. Last Longitudinal Study Visit will be 24 months after last AIM 2 enrollment
Intra-subject changes in concentrations of individual volatile biomarkers and combinations of biomarkers in breath samples
Breath samples obtained over a duration of two years, measured using comprehensive two-dimensional gas chromatography of exhaled breath
Time frame: Thru end of 2025
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