Sample Collections From the Airways of Asthmatic Patients

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ClinicalTrials.gov Identifier: NCT00001888

Recruitment Status : Recruiting

First Posted : November 4, 1999

Last Update Posted : November 8, 2018

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Description

Brief Summary:

Fiberoptic bronchoscopy is a procedure which involves passing a pencil-thin tube into the lung in order to collect fluid and cells from the airways. Fiberoptic bronchoscopy can collect cells from the walls of airways by gently brushing them (bronchial brushing). In addition, squirting small amounts of sterile water in to the airway and gently suctioning it back into the bronchoscope (bronchoalveolar lavage) collects cells.

In this study, researchers plan to perform these tests on patients with asthma and normal volunteers. This research may help to improve the understanding of the processes involved in airway inflammation and asthma.

Condition or disease
Asthma

Detailed Description:

This tissue procurement protocol proposes to perform bronchoscopy with bronchoalveolar lavage, bronchial brushings, and bronchial wall biopsies as well as to collect samples of sputum, exhaled breath condensates and blood, in order to evaluate the molecular mechanisms underlying the pathogenesis of airway inflammation, airway hyperresponsiveness, and airway remodeling in asthmatic subjects.

Study Design


Study Type :	Observational
Estimated Enrollment :	9999 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	Asthma Sample Collection Protocol
Study Start Date :	April 1, 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Asthmatics Male and female adults between 18 and 75 years of age with a diagnosis of asthma.
Research Volunteers Male and female adults between 18 and 75 years of age that do not have asthma.

Outcome Measures

Primary Outcome Measures :

Assess the expression, regulation, and function of proteins regulating the release of soluble receptors and mediators from asthmatic inflammatory and structural cell populations [ Time Frame: Ongoing ]
These studies will increase understanding of the pathogenic mechanisms underlying asthmatic airway inflammation and may identify novel therapeutic targets.

Secondary Outcome Measures :

Assess the relative contribution of specific soluble pro-inflammatory cytokines and receptors in asthmatic bronchoalveolar lavage fluid (BALF) in mediating airway structural and inflammatory cell responses [ Time Frame: Ongoing ]
Assess the exressing, regulation, and function of differentially expressed proteins and genes in human airway structural and inflammatory cell populations in asthma [ Time Frame: Ongoing ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Any individual between the ages of 18 and 75 with asthma will be accepted into the study. Since asthma has a roughtly equivalent prevalence in groups differing in race and gender, recruitment of study participants will be aimed at selecting a study population which reflect this diversity. Asthmatic or research volunteers with HIV infection will be excluded from the study so as not to include patients with HIV-related lymphocytic airway inflammation. Volunteers will be obtained through the NIH Clinical Center Research Volunteer Program or other standard channels at NIH.

Criteria

INCLUSION CRITERIA:

ASTHMATICS:

Patients will be between 18 and 75 years of age, male or female.

The diagnosis of asthma requires a history of intermittent, reversible expiratory flow limitation.

In addition, patients will have demonstrated evidence of either an abnormal methacholine challenge or reversible airway obstruction. An abnormal methacholine challenge will be defined as a decrease in FEV(1) of at least 20% at a PD(20) dose less than 240 micrograms. Reversible airway obstruction will be defined as an improvement of at least 12% and 200 cc in either the FEV(1) or FVC folowing bronchodilator treatment. Methacholine challenge testing will not be performed if the subject has a history of allergy to methoacholine. Result of testing performed by the subject's primary care provider may be accepted as evidence of reversible airflow obstruction.

For women of childbearing potential, negative pregnancy test prior to study and willingness to adhere to reliable birth control methods during the study.

EXCLUSION CRITERIA:

ASTHMATICS:

Diagnosis of a pulmonary disorder other than asthma (e.g., chronic bronchitis, cystic fibrosis, HIV-related lymphocytic airway inflammation).

History of drug or alcohol abuse within the past year.

Positive test for human immunodeficiency virus (to exclude patients with HIV-related lymphocytic airway inflammation).

INCLUSION CRITERIA - RESEARCH VOLUNTEERS:

Research volunteers will be between 18 and 75 years of age, male or female.

A negative inhalational methacholine challenge as defined bv the absence of a 20% decrease in FEV(1), at a PD(20) dose of >960 micrograms (normal bronchial hyperresponsiveness). Methacholine challenge testing will not be performed if the subject has a history of allergy to methacholine. Results of testing performed by the subject's primary care provider may be accepted as evidence of a negative methacholine challenge.

For women of childbearing potential, negative pregnancy test within 2 weeks prior to study and willingness to adhere to reliable birth control methods during the study.

EXCLUSION CRITERIA - RESEARCH VOLUNTEERS:

Same as the asthmatic exclusion criteria plus a history of asthma.

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): NCT00001888

Contacts


Contact: Maryann M Kaler, C.R.N.P.	(301) 451-5916	mk371e@nih.gov
Contact: Stewart J Levine, M.D.	(301) 402-1553	levines@nhlbi.nih.gov

Locations


United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov

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)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site


Responsible Party:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00001888 History of Changes
Other Study ID Numbers:	990076 99-H-0076
First Posted:	November 4, 1999 Key Record Dates
Last Update Posted:	November 8, 2018
Last Verified:	November 2, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):


Induced Sputum Exhaled Breath Condensate Fiberoptic Bronchoscopy Bronchoscopy mRNA

Additional relevant MeSH terms:


Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases	Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases

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