Remote Sputum Collection in Cystic Fibrosis

Recruiting now

Conditions studied: Cystic Fibrosis, Infections

In brief

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.

Key facts

Study ID

NCT06950892

Run by

University of Pennsylvania

People needed

150

Starts

2025-01-15

Expected to finish

2028-06-30

Last updated by the study team

2025-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• National Jewish Health — Denver, Colorado, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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