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Breath Condensate Study in Patients With Cystic Fibrosis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02056132
Recruitment Status : Recruiting
First Posted : February 5, 2014
Last Update Posted : August 6, 2020
Information provided by (Responsible Party):
University of Florida

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02056132

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Contact: Jorge Lascano, MD 352-273-8740

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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Jorge Lascano, MD         
Sponsors and Collaborators
University of Florida
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Principal Investigator: Jorge Lascano, MD University of Florida
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Responsible Party: University of Florida Identifier: NCT02056132    
Other Study ID Numbers: IRB201200137
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases