Remote Sputum Collection in Cystic Fibrosis

NCT06950892 | Recruiting

• 1 other identifier: 857045
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cystic Fibrosis; Infections

Keywords

Cystic Fibrosis; Pseudomonas aeruginosa

Outcome Measures

Primary Outcomes (1)

• Pseudomonas aeruginosa positive culture

  at baseline

Secondary Outcomes (2)

• Culture-positive detection of Staphylococcus aureus, Burkholderia cepacia complex, Aspergillus fumigatus and other CF pathogens.

  at baseline

• Bacterial density in sputum measured by colony forming unit.

  at baseline

Study Arms (1)

Adults with cystic fibrosis

People with cystic fibrosis age 18 years or older without a history of solid organ transplantation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with cystic fibrosis from three cystic fibrosis centers

You 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 may not qualify 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (4)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Providence Medical Research Center

Spokane, Washington, 99204, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum

MeSH Terms

Conditions

Cystic Fibrosis; Infections; Pseudomonas Infections

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Gina Hong, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krista Ludwig

CONTACT

267-283-6223; Krista.ludwig@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 30, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)