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 : September 20, 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 :	99999999 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

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, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Publications:

Azzawi M, Bradley B, Jeffery PK, Frew AJ, Wardlaw AJ, Knowles G, Assoufi B, Collins JV, Durham S, Kay AB. Identification of activated T lymphocytes and eosinophils in bronchial biopsies in stable atopic asthma. Am Rev Respir Dis. 1990 Dec;142(6 Pt 1):1407-13.

Poston RN, Chanez P, Lacoste JY, Litchfield T, Lee TH, Bousquet J. Immunohistochemical characterization of the cellular infiltration in asthmatic bronchi. Am Rev Respir Dis. 1992 Apr;145(4 Pt 1):918-21.

Laitinen LA, Laitinen A, Haahtela T. Airway mucosal inflammation even in patients with newly diagnosed asthma. Am Rev Respir Dis. 1993 Mar;147(3):697-704.


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:	September 20, 2018
Last Verified:	August 13, 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 Asthma Normal Volunteer

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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