Identification of Biomarkers in Exhaled Breath Condensates From Asthmatic Patients
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| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Asthma |
| Purpose: |
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This study will look for a relationship between asthma and factors released from the lungs
in exhaled breath. If a relationship can be established, the identified factors may be used
as biomarkers to predict episodes of increased asthma symptoms so that medications can be
given to prevent the onset of an asthma attack.
Healthy volunteers and people who have had asthma for at least 1 year may be eligible for
this study. Candidates must be between 18 and 75 years of age.
Participants undergo blood tests and breathing tests. For the latter, participants breathe
into a machine before and after inhaling an asthma medication called albuterol. The machine
measures the volume of air the subject can breathe out. Participants also provide a sample
of exhaled breath by breathing normally for up to 30 minutes while wearing a mask devised
for the procedure. Pulse rate, oxygen saturation and wheezing are monitored during the
breath collection....
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| Study Summary: |
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Asthma is a major public health problem that is associated with significant morbidity and
mortality. Patients at increased risk for asthma decompensations include those with severe
asthma that is refractory to therapy, as well as patients with poorly controlled disease due
to inadequate treatment. The aim of this exploratory specimen procurement protocol is to
develop a non-invasive method for the detection of asthma-specific biomarkers in exhaled
breath condensates (EBC) utilizing a novel collection device that was engineered at the
Johns Hopkins University Applied Physics Laboratory. Biomarkers in EBC will be identified by
mass spectroscopy. We propose that the identification of biomarkers in EBC that correlate
with airway inflammation and disease activity may be used to guide therapy and prevent
exacerbations in asthmatic patients.
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| Criteria: |
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- INCLUSION CRITERIA - ASTHMA:
Patients will be between 18 and 75 years of age, male or female, with a diagnosis of
asthma for at least one year.
Oxygen saturation on room air greater than or equal to 92 percent.
EXCLUSION CRITERIA - ASTHMA:
Diagnosis of a pulmonary disorder other than asthma (for example: chronic bronchitis,
emphysema, cystic fibrosis, bronchiectasis, sarcoidosis, HIV-related lymphocytic airway
inflammation).
Cigarette smoking within the past 3 months or a prior history of greater than 10
cumulative pack-years.
History of coronary artery disease.
INCLUSION CRITERIA - HEALTHY VOLUNTEERS:
Research volunteers will be between 18 and 75 years of age, male or female.
Oxygen saturation on room air greater than or equal to 92 percent.
EXCLUSION CRITERIA - HEALTHY VOLUNTEERS:
Same as the asthmatic exclusion criteria plus a history of asthma.
Reversible Airflow Obstruction (increase in FEV (1) by 12 percent and 200 cc after inhaled
beta 2-agonist)
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| NCT ID: |
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NCT00635271 |
| Primary Contact: |
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Principal Investigator
Richard W Childs, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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