Remote Sputum Collection in Cystic Fibrosis

Launched by UNIVERSITY OF PENNSYLVANIA · Apr 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well home-collected sputum samples can help diagnose lung infections in people with cystic fibrosis (CF). Normally, sputum is mucus that comes from the lungs, and it’s important for doctors to test this to check for infections. With new treatments like Trikafta improving lung health, collecting sputum has become more challenging since patients produce less. The trial will compare sputum samples collected at home to those collected in a clinic to see if the home samples are just as useful for identifying infections.

To participate, you need to be at least 18 years old and have a confirmed diagnosis of cystic fibrosis based on specific guidelines. You must also be able to follow the study's procedures and attend visits. However, if you have had a solid organ transplant or cannot provide sputum samples, you won't be eligible. If you join the study, you'll be asked to collect your sputum at home and send it in, helping researchers understand if this method can effectively detect infections as well as traditional clinic-based methods.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • People with a diagnosis of cystic fibrosis (CF) based on CF Foundation (CFF) guidelines. The CFF guidelines consider a diagnosis of CF based on: (1) two known disease-causing CFTR mutations (based on historical genetic testing in clinical documentation or PortCF, the CFF patient registry), OR (2) sweat chloride 60 mmol/L (based on historical sweat chloride testing in clinical documentation or PortCF) and phenotypic findings consistent with cystic fibrosis in more than one organ system, OR (3) CFF accredited center physician diagnosis, based on clinical manifestations in the absence of two CFTR mutations with full gene mapping (based on historical genetic testing in clinical documentation or PortCF).
• • Age 18 years old or greater
• • People with the ability to comply with study visits and study procedures as judged by the investigator.
• Exclusion Criteria:
• • Solid organ transplant recipients, given the presence of immunosuppression.
• • Those who are unable to tolerate sputum induction (hypertonic saline) or the inability to attempt sputum expectoration.
• • Subjects who do not have access to a FedEx location or pick-up services will be excluded.