Protocol Number: 08-H-0081

Title:

Identification of Biomarkers in Exhaled Breath Condensates from Asthmatic Patients

Number:

08-H-0081

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.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility 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 5 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)

Special Instructions:

Currently Not Provided

Keywords:

Asthma

Biomarker

Exhaled Breath Condensate

Cytokine

Healthy Volunteer

Recruitment Keyword(s):

Asthma

Healthy Volunteer

HV

Condition(s):

Asthma

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Heart, Lung, and Blood Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Braman SS. The global burden of asthma. Chest. 2006 Jul;130(1 Suppl):4S-12S.

El-Ekiaby A, Brianas L, Skowronski ME, Coreno AJ, Galan G, Kaeberlein FJ, Seitz RE, Villaba KD, Dickey-White H, McFadden ER Jr. Impact of race on the severity of acute episodes of asthma and adrenergic responsiveness. Am J Respir Crit Care Med. 2006 Sep 1;174(5):508-13. Epub 2006 Jun 8.

Wenzel S. Severe asthma in adults. m J Respir Crit Care Med. 2005 Jul 15;172(2):149-60. Epub 2005 Apr 22.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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