NCT06950892Recruiting
Remote Sputum Collection in Cystic Fibrosis
Remote Sputum Collection in Adults With Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 27 Mar 2025
- Start date
- 15 Jan 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- University of Pennsylvania
- Diseases
- Cystic fibrosis
- NCT number
- NCT06950892
What you commit to
- Study type: Observational
- Planned participants: 150
- From 15 Jan 2025 to the primary completion date, 30 Jun 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Solid organ transplant recipients, given the presence of immunosuppression.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| National Jewish Health Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Providence Medical Research Center Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.