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.
Key facts
- Who runs it
- University of Pennsylvania
- Where
- Baltimore, Denver, Philadelphia, and Spokane, United StatesSee the 4 sites
- Trial code
- Registry title
- Remote Sputum Collection in Cystic Fibrosis
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 15 Jan 2025
- Expected to end
- 30 Jun 2028
- Type of study
- Observational
- Record updated
- 19 August 2026
Who can take part
AI summary
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
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in United States
- Johns Hopkins UniversityBaltimore, United StatesContact: Noah Lechtzin, MDTaking people
- National Jewish HealthDenver, United StatesContact: Andrea McKenzieTaking people
- University of PennsylvaniaPhiladelphia, United StatesContact: Krista LudwigTaking people
- Providence Medical Research CenterSpokane, United StatesContact: Lauren WilcoxTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Adults with cystic fibrosis
People with cystic fibrosis age 18 years or older without a history of solid organ transplantation.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Remote Sputum Collection in Adults With Cystic Fibrosis
- Plain-language title
- Comparing Home and Clinic Sputum Samples for Lung Infections in Adults With Cystic FibrosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 19 August 2026