Breath Condensate Study in Patients With Cystic Fibrosis.
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

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.
    

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.
    

Intervention name(s): Exhaled Breath Condensate
Intervention type(s): Other
Intervention description(s): Lab results of Exhaled Breath Condensate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with Cystic Fibrosis.
      
Biospecimen description: 
      Exhaled breath condensate.