Comparing Home and Clinic Sputum Samples for Lung Infections in Adults With Cystic Fibrosis
Compares sputum collected at home with clinic samples to find lung infections in adults.
Plain-language title generated from the registry record
Registry title: Remote Sputum Collection in Cystic Fibrosis
Key facts
- Where
- Baltimore, Denver, Philadelphia, and Spokane, United StatesSee the 4 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cystic fibrosis who can give sputum samples at home and in clinic. It compares the two kinds of samples for finding bacteria.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- A diagnosis of cystic fibrosis based on CF Foundation guidelines (two known disease-causing CFTR mutations, or sweat chloride 60 mmol/L with signs in more than one organ system, or a CF center physician's diagnosis)
Main reasons for not taking part
- Solid organ transplant recipients
- Cannot tolerate sputum induction with hypertonic saline, or cannot try to cough up sputum
- No access to a FedEx location or pick-up service
- Cannot keep up with study visits and procedures, as judged by the investigator
Read by machine on 9 November 2026.
Where in United States
- Johns Hopkins UniversityBaltimore, United StatesTaking people
- National Jewish HealthDenver, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- Providence Medical Research CenterSpokane, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Pennsylvania
- Trial code
- NCT06950892
- Record updated
- 19 August 2026
- Original description
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.Read full original descriptionShow less
Remote Sputum Collection in Adults With Cystic Fibrosis
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.
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.