RecruitingNCT06950892

Remote Sputum Collection in Cystic Fibrosis

Remote Sputum Collection in Adults With Cystic Fibrosis

Sponsor

University of Pennsylvania

Enrollment

150 participants

Start Date

Jan 15, 2025

Study Type

OBSERVATIONAL

Conditions

Cystic Fibrosis Infections

Summary

Elexacaftor/Tezacaftor/Ivacaftor or Trikafta improves lung health in people with cystic fibrosis (CF), including decreased cough and mucous production. Diagnosing lung infections has become more challenging due to the decrease in sputum and rise of telehealth services. While the option of collecting sputum samples at home and sending them by mail may be feasible, uncertainty remains about how the collection of samples outside of clinic and delays in testing while in the mail impact infection detection. This study will compare bacterial cultures using sputum samples collected at home versus samples collected in clinic (saline-induced sputum and throat swab). This study seeks to shed light on how valuable home collected samples can be and help us better understand the usefulness of home-collected sputum samples for both clinical and research purposes.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria3

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.

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