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Remote Sputum Collection in Cystic Fibrosis

This study is looking at how well at-home sputum (mucus from your lungs) collection works for people with cystic fibrosis (CF) who are taking Elexacaftor/Tezacaftor/Ivacaftor (Trikafta). Trikafta can make it harder to produce sputum, which makes it more challenging to check for lung infections. Researchers want to compare bacteria found in sputum samples collected at home and sent by mail to samples collected in a clinic. The main goal is to see if *Pseudomonas aeruginosa*, a common bacteria, can still be found in home-collected samples at the start of the study. You may be able to join if you are 18 or older and have a CF diagnosis based on specific guidelines, such as having two known CFTR gene mutations or a sweat chloride test of 60 mmol/L or higher. The study is currently unclear on its recruitment status and plans to enroll 150 participants.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any new treatments. It plans to include 150 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, checking for *Pseudomonas aeruginosa* positive culture, is measured at baseline (the start of the study).

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NCT06950892

Remote Sputum Collection in Cystic Fibrosis

Recruiting
Not specifiedAges 18+Observational
University of Pennsylvania
~150 participants
Updated 2026-08-19 on ClinicalTrials.gov

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pseudomonas aeruginosa positive culture
Measured over at baseline

Conditions

Cystic Fibrosis
Infections

Explore related trials

Cystic Fibrosis

Where it's being run

4 sites across 4 states
Colorado1
Maryland1
Pennsylvania1
Washington1

Study leadership

  • Gina Hong, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Krista Ludwig
[email protected]
267-283-6223
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Pseudomonas aeruginosa positive cultureat baseline