Actively Recruiting

Age: 18Years +
All Genders
NCT06950892

Remote Sputum Collection in Cystic Fibrosis

Led by University of Pennsylvania · Updated on 2025-10-01

150

Participants Needed

3

Research Sites

180 weeks

Total Duration

On this page

Sponsors

U

University of Pennsylvania

Lead Sponsor

C

Cystic Fibrosis Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Remote Sputum Collection in Cystic Fibrosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with cystic fibrosis based on CF Foundation guidelines including genetic testing, sweat chloride levels, or physician diagnosis
  • Age 18 years or older
  • Ability to comply with study visits and procedures as judged by the investigator
Not Eligible

You will not qualify if you...

  • Solid organ transplant recipients due to immunosuppression
  • Unable to tolerate sputum induction with hypertonic saline or unable to attempt sputum expectoration
  • No access to FedEx location or pick-up services for sending samples

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

National Jewish Health

Denver, Colorado, United States, 80206

Actively Recruiting

2

Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

3

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

K

Krista Ludwig

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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