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Sample Collections From the Airways of Asthmatic Patients

This study is currently recruiting participants.
Verified October 30, 2017 by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001888
First Posted: November 4, 1999
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
  Purpose

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
Asthma

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Asthma Sample Collection Protocol

Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):

Estimated Enrollment: 99999999
Study Start Date: April 1, 1999
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.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:
Publications:
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 Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: November 2, 2017
Last Verified: October 30, 2017

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