Remote Sputum Collection in Cystic Fibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
150 Participants
are grouped into 1 trial groupSponsors and collaborators
University of Pennsylvania
Lead sponsor
Cystic Fibrosis Foundation
Collaborator
Source ClinicalTrials.gov