Breath Condensate Study in Patients With Cystic Fibrosis.
| Status: | Recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | February 2014 |
| End Date: | April 2019 |
| Contact: | Jorge Lascano, MD |
| Email: | jorge.lascano@medicine.ufl.edu |
| Phone: | 352-273-8740 |
Exhaled Breath Condensate for Evaluation of Lung Infections and Exacerbations in Patient With Cystic Fibrosis.
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.
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.
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.
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.
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.
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Jorge Lascano, MD
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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