What this study is
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.
Study details
- Official title
- Remote Sputum Collection in Adults With Cystic Fibrosis
- Sponsor
- University of Pennsylvania
- Conditions
- Cystic Fibrosis · Infections
- Enrolling
- 150 people
- Starts
- 2025-01-15
- Est. completion
- 2028-06-30
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openNational Jewish Health
Denver, Colorado, United States
- Andrea McKenzie · Contact303-398-1453mckenzieam@njhealth.org
- Milene Saveedra, MD · Principal investigator
RecruitingJohns Hopkins University
Baltimore, Maryland, United States
- Noah Lechtzin, MD · Contact443-287-7332nlechtz@jhmi.edu
- Noah Lechtzin, MD · Principal investigator
RecruitingUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
- Krista Ludwig · Contact267-283-6223
- Gina Hong, MD · Principal investigator
RecruitingProvidence Medical Research Center
Spokane, Washington, United States
- Lauren Wilcox · Contact509-474-3836Lauren.wilcox@providence.org
- Allison Lambert, MD, MHS · Principal investigator
Recruiting
Study team
Sponsor
University of Pennsylvania
Study ID 857045
Principal investigator
Gina Hong, MD
University of Pennsylvania
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.