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Biomarkers in Exhaled Breath From Asthmatic Patients

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ClinicalTrials.gov Identifier: NCT00635271
Recruitment Status : Terminated
First Posted : March 13, 2008
Last Update Posted : October 6, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:

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....


Condition or disease
Asthma

Detailed Description:
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.

Study Design

Study Type : Observational
Actual Enrollment : 19 participants
Time Perspective: Prospective
Official Title: Identification of Biomarkers in Exhaled Breath Condensates From Asthmatic Patients
Study Start Date : February 29, 2008
Estimated Study Completion Date : November 28, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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)

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00635271


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Stewart J Levine, M.D. National Heart, Lung, and Blood Institute (NHLBI)