Breath Condensate Study in Patients With Cystic Fibrosis.

• ClinicalTrials.gov Identifier: NCT02056132
• Recruitment Status: Recruiting
• First Posted: February 5, 2014
• Last Update Posted: August 6, 2020
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Study Description

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.

Condition or disease	Intervention/treatment
Cystic Fibrosis	Other: Exhaled Breath Condensate

Detailed Description:

We hypothesize that it is possible to recover microbial products causing infections in Exhaled Breath Condensate (EBC) samples as well as to measure markers of inflammation like Interleukin (IL)-8, Leukotriene B4 (LTB4), Interleukin IL-6, Interleukin IL-1B, Tumor Necrosis Factor alpha, as well as proteases like neutrophil elastase, matrix metalloproteinase 2 and 9 and antiproteases like secretory leukoprotease inhibitor (SLPI), alpha one antitrypsin and tissue inhibitor of metalloproteinase-1 (TIMP-1). As a way to compare our findings to systemic inflammation we will also measure C-reactive protein in serum.

20 patients with cystic fibrosis who have chronic bronchial infection and 20 controls will be recruited. Their exhaled breath condensate and sputum samples will be collected and analyzed for the presence of bacteria through traditional, molecular and nuclear acid amplification methods as well as Pyrosequencing analysis. We will also measure the above markers of inflammation and follow the CF patients for the following year so we can continue to collect exhaled breath condensate when they have an exacerbation and are admitted to the hospital as well as after treatment for the exacerbation. We will correlate these markers with patient's clinical features including pulmonary function test, Body max index, CF pathogens, and CF genotype. If our hypothesis turns out to be true it will open up a possibility for a new noninvasive diagnostic and follow up method that will benefit cystic fibrosis patients.

2. Hypothesis & Specific Aims:

A. Microbial products can be recovered from exhaled breath condensate. B. That these microbial products recovered from exhaled breath correlate with that recovered from sputum C. Markers of inflammation can be recovered from exhale breath condensate.

Study Design

• Study Type: Observational
• Estimated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Exhaled Breath Condensate for Evaluation of Lung Infections and Exacerbations in Patient With Cystic Fibrosis.
• Actual Study Start Date: February 2014
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: April 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Cystic Fibrosis patients.; Patients with Cystic Fibrosis. Results of Exhaled Breath Condensate lab.	Other: Exhaled Breath Condensate; Lab results of 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; Lab results of Exhaled Breath Condensate

Outcome Measures

Primary Outcome Measures :

1. correlation of EBC finding with exacerbations. [ Time Frame: 1 year ]

Secondary Outcome Measures :

1. ability to identify common airway pathogens on EBC. [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA

Exhaled breath condensate.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Patient with Cystic Fibrosis.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Jorge Lascano, MD; 352-273-8740; jorge.lascano@medicine.ufl.edu

Locations

United States, Florida

University of Florida; Recruiting

Gainesville, Florida, United States, 32610

Principal Investigator: Jorge Lascano, MD

Sponsors and Collaborators

University of Florida

Investigators

• Principal Investigator: Jorge Lascano, MD; University of Florida

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT02056132
• Other Study ID Numbers: IRB201200137
• First Posted: February 5, 2014
• Last Update Posted: August 6, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cystic Fibrosis; Fibrosis; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases