Biomarkers in Exhaled Breath From Asthmatic Patients

NCT ID: NCT00635271

Last Updated: 2019-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2012-11-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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.


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

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.



Reversible Airflow Obstruction (increase in FEV (1) by 12 percent and 200 cc after inhaled beta 2-agonist)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

Principal Investigators

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Stewart J Levine, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Heart, Lung, and Blood Institute (NHLBI)

Locations

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National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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Braman SS. The global burden of asthma. Chest. 2006 Jul;130(1 Suppl):4S-12S. doi: 10.1378/chest.130.1_suppl.4S.

Reference Type BACKGROUND
PMID: 16840363 (View on PubMed)

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. doi: 10.1164/rccm.200603-431OC. Epub 2006 Jun 8.

Reference Type BACKGROUND
PMID: 16763217 (View on PubMed)

Wenzel S. Severe asthma in adults. Am J Respir Crit Care Med. 2005 Jul 15;172(2):149-60. doi: 10.1164/rccm.200409-1181PP. Epub 2005 Apr 22.

Reference Type BACKGROUND
PMID: 15849323 (View on PubMed)

Other Identifiers

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08-H-0081

Identifier Type: -

Identifier Source: secondary_id

080081

Identifier Type: -

Identifier Source: org_study_id

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