Remote Sputum Collection in Adults With Cystic Fibrosis

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
National Jewish Health
RECRUITING
Denver
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Krista Ludwig
Krista.ludwig@pennmedicine.upenn.edu
267-283-6223
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 150
Treatments
Adults with cystic fibrosis
People with cystic fibrosis age 18 years or older without a history of solid organ transplantation.
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania
Collaborators: Cystic Fibrosis Foundation

This content was sourced from clinicaltrials.gov