NCT00635271

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 29, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2012

Completed
Last Updated

December 5, 2019

Status Verified

November 28, 2012

First QC Date

March 8, 2008

Last Update Submit

December 4, 2019

Conditions

Keywords

AsthmaBiomarkerExhaled Breath CondensateCytokineHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

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

    PMID: 16840363BACKGROUND
  • 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.

    PMID: 16763217BACKGROUND
  • 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.

    PMID: 15849323BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Stewart J Levine, M.D.

    National Heart, Lung, and Blood Institute (NHLBI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

March 8, 2008

First Posted

March 13, 2008

Study Start

February 29, 2008

Study Completion

November 28, 2012

Last Updated

December 5, 2019

Record last verified: 2012-11-28

Locations