Breath Condensate Study in Patients With Cystic Fibrosis.

NCT02056132 | Completed DMC

• 1 other identifier: IRB201200137
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

There is an urgent need for a noninvasive method to diagnose bronchial infections and exacerbations in patients with Cystic Fibrosis (CF). The current method to diagnosed infections involves either collecting a sputum sample or obtaining a bronchoalveolar lavage (BAL). However, some patients cannot produce sputum. At the same time the decision of when a patient has an exacerbation continues to be very subjective. In this exploratory study, we propose a new, noninvasive method to diagnose bronchial infections and to evaluate possible markers of inflammation that can assist in a noninvasive way in the determination of exacerbations.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• correlation of EBC finding with exacerbations.

  1 year

Secondary Outcomes (1)

• ability to identify common airway pathogens on EBC.

  1 year

Study Arms (2)

Cystic Fibrosis patients.

Patients with Cystic Fibrosis. Results of Exhaled Breath Condensate lab.

Other: Exhaled Breath Condensate

Control Subjects

Individuals without Cystic Fibrosis or signs of current respiratory infection. Results of Exhaled Breath Condensate lab.

Other: Exhaled Breath Condensate

Interventions

Exhaled Breath Condensate OTHER

Lab results of Exhaled Breath Condensate

Control Subjects; Cystic Fibrosis patients.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with Cystic Fibrosis.

You may qualify if:

• Any patient with Cystic Fibrosis (CF) in the age range 18-65 years who is known to be chronically infected in their respiratory tract will be eligible as cases. Any other patient or healthy subject in the age range 18-65 years who is not infected with Pseudomonas in their respiratory tract will be eligible as controls.

You may not qualify if:

• Any study subject, who cannot co-operate with the study, cannot co-ordinate breathing or cannot breathe through a mouthpiece.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Exhaled breath condensate.

MeSH Terms

Conditions

Cystic Fibrosis

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

Study Officials

• Jorge Lascano, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: February 1, 2014
• Primary Completion: August 22, 2023
• Study Completion: August 22, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

US (1)