Collecting sputum samples at home for cystic fibrosis patients
Remote Sputum Collection in Adults With Cystic Fibrosis
University of Pennsylvania · NCT06950892
This study is testing if collecting sputum samples at home can help people with cystic fibrosis better identify lung infections compared to traditional methods done at the clinic.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Locations | 3 sites (Denver, Colorado and 2 other locations) |
| Trial ID | NCT06950892 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of remote sputum collection in individuals with cystic fibrosis (CF) compared to traditional clinic-based methods. With the introduction of Elexacaftor/Tezacaftor/Ivacaftor, patients are producing less sputum, making it challenging to diagnose lung infections. The study will compare bacterial cultures from home-collected sputum samples to those obtained through saline-induced sputum and throat swabs during clinic visits. The goal is to determine the diagnostic performance of home-collected samples for detecting CF pathogens.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of cystic fibrosis.
Not a fit: Patients who have undergone solid organ transplants or are unable to tolerate study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance infection detection methods for cystic fibrosis patients, leading to better management of their condition.
How similar studies have performed: While the approach of remote sputum collection is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Denver, Colorado and 2 other locations
- National Jewish Health — Denver, Colorado, United States (RECRUITING)
- Johns Hopkins University — Baltimore, Maryland, United States (RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Gina Hong, MD — University of Pennsylvania
- Study coordinator: Krista Ludwig
- Email: Krista.ludwig@pennmedicine.upenn.edu
- Phone: 267-283-6223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cystic Fibrosis, Infections, Pseudomonas aeruginosa