Collecting sputum samples at home for cystic fibrosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of remote sputum collection in individuals with cystic fibrosis (CF) compared to traditional clinic-based methods. With the introduction of Elexacaftor/Tezacaftor/Ivacaftor, patients are producing less sputum, making it challenging to diagnose lung infections. The study will compare bacterial cultures from home-collected sputum samples to those obtained through saline-induced sputum and throat swabs during clinic visits. The goal is to determine the diagnostic performance of home-collected samples for detecting CF pathogens.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Jewish Health
  Denver, Colorado, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• Providence Medical Research Center
  Spokane, Washington, United States Recruiting

Study contacts

• Principal investigator: Gina Hong, MD — University of Pennsylvania
• Study coordinator: Krista Ludwig
• Email: Krista.ludwig@pennmedicine.upenn.edu
• Phone: 267-283-6223

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.